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Sample records for double-blind non-inferiority rct

  1. Homeopathic Individualized Q-Potencies versus Fluoxetine for Moderate to Severe Depression: Double-Blind, Randomized Non-Inferiority Trial

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    U. C. Adler

    2011-01-01

    Full Text Available Homeopathy is a complementary and integrative medicine used in depression, The aim of this study is to investigate the non-inferiority and tolerability of individualized homeopathic medicines [Quinquagintamillesmial (Q-potencies] in acute depression, using fluoxetine as active control. Ninety-one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg day−1 (up to 40 mg day−1 in a prospective, randomized, double-blind double-dummy 8-week, single-center trial. Primary efficacy measure was the analysis of the mean change in the Montgomery & Åsberg Depression Rating Scale (MADRS depression scores, using a non-inferiority test with margin of 1.45. Secondary efficacy outcomes were response and remission rates. Tolerability was assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology. Mean MADRS scores differences were not significant at the 4th (P = .654 and 8th weeks (P = .965 of treatment. Non-inferiority of homeopathy was indicated because the upper limit of the confidence interval (CI for mean difference in MADRS change was less than the non-inferiority margin: mean differences (homeopathy-fluoxetine were −3.04 (95% CI −6.95, 0.86 and −2.4 (95% CI −6.05, 0.77 at 4th and 8th week, respectively. There were no significant differences between the percentages of response or remission rates in both groups. Tolerability: there were no significant differences between the side effects rates, although a higher percentage of patients treated with fluoxetine reported troublesome side effects and there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. This study illustrates the feasibility of randomized controlled double-blind trials of homeopathy in depression and indicates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetine in acute treatment of

  2. Homeopathic Individualized Q-Potencies versus Fluoxetine for Moderate to Severe Depression: Double-Blind, Randomized Non-Inferiority Trial

    Science.gov (United States)

    Adler, U. C.; Paiva, N. M. P.; Cesar, A. T.; Adler, M. S.; Molina, A.; Padula, A. E.; Calil, H. M.

    2011-01-01

    Homeopathy is a complementary and integrative medicine used in depression, The aim of this study is to investigate the non-inferiority and tolerability of individualized homeopathic medicines [Quinquagintamillesmial (Q-potencies)] in acute depression, using fluoxetine as active control. Ninety-one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg day−1 (up to 40 mg day−1) in a prospective, randomized, double-blind double-dummy 8-week, single-center trial. Primary efficacy measure was the analysis of the mean change in the Montgomery & Åsberg Depression Rating Scale (MADRS) depression scores, using a non-inferiority test with margin of 1.45. Secondary efficacy outcomes were response and remission rates. Tolerability was assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology. Mean MADRS scores differences were not significant at the 4th (P = .654) and 8th weeks (P = .965) of treatment. Non-inferiority of homeopathy was indicated because the upper limit of the confidence interval (CI) for mean difference in MADRS change was less than the non-inferiority margin: mean differences (homeopathy-fluoxetine) were −3.04 (95% CI −6.95, 0.86) and −2.4 (95% CI −6.05, 0.77) at 4th and 8th week, respectively. There were no significant differences between the percentages of response or remission rates in both groups. Tolerability: there were no significant differences between the side effects rates, although a higher percentage of patients treated with fluoxetine reported troublesome side effects and there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. This study illustrates the feasibility of randomized controlled double-blind trials of homeopathy in depression and indicates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetine in acute treatment of outpatients

  3. Radiation Protection, double-blind studies with radiopharmaceuticals

    International Nuclear Information System (INIS)

    Pujadas, M. C.; Camacho, C.; Guasp, M.; Villaescusa, J. I.

    2009-01-01

    In a double-blind randomized controlled clinical trial (RCT) subjects and researchers do not know the assignment to treatment groups to ovoid the appearance of subjective biases of information. The employment of radiopharmaceuticals in double-blind RCTs raises a dilemma from the point ov view of the radiological protection. On the one hand, the obligation to act in cases of contamination and/or risk of irradiation exists, but on the other hand the duty of keeping the blind study also exists. In this paper some of the possible problems that arise when conducting a double-blind RCT with radiopharmaceuticals from the point of view of the radiological protection are presented. We comment our experience with the radiopharmaceutical Alpharadin and, in addition, we propose useful recommendations based on the randomness of the decontamination process. (Author) 7 refs.

  4. Icotinib versus gefitinib in previously treated advanced non-small-cell lung cancer (ICOGEN): a randomised, double-blind phase 3 non-inferiority trial.

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    Shi, Yuankai; Zhang, Li; Liu, Xiaoqing; Zhou, Caicun; Zhang, Li; Zhang, Shucai; Wang, Dong; Li, Qiang; Qin, Shukui; Hu, Chunhong; Zhang, Yiping; Chen, Jianhua; Cheng, Ying; Feng, Jifeng; Zhang, Helong; Song, Yong; Wu, Yi-Long; Xu, Nong; Zhou, Jianying; Luo, Rongcheng; Bai, Chunxue; Jin, Yening; Liu, Wenchao; Wei, Zhaohui; Tan, Fenlai; Wang, Yinxiang; Ding, Lieming; Dai, Hong; Jiao, Shunchang; Wang, Jie; Liang, Li; Zhang, Weimin; Sun, Yan

    2013-09-01

    Icotinib, an oral EGFR tyrosine kinase inhibitor, had shown antitumour activity and favourable toxicity in early-phase clinical trials. We aimed to investigate whether icotinib is non-inferior to gefitinib in patients with non-small-cell lung cancer. In this randomised, double-blind, phase 3 non-inferiority trial we enrolled patients with advanced non-small-cell lung cancer from 27 sites in China. Eligible patients were those aged 18-75 years who had not responded to one or more platinum-based chemotherapy regimen. Patients were randomly assigned (1:1), using minimisation methods, to receive icotinib (125 mg, three times per day) or gefitinib (250 mg, once per day) until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival, analysed in the full analysis set. We analysed EGFR status if tissue samples were available. All investigators, clinicians, and participants were masked to patient distribution. The non-inferiority margin was 1·14; non-inferiority would be established if the upper limit of the 95% CI for the hazard ratio (HR) of gefitinib versus icotinib was less than this margin. This study is registered with ClinicalTrials.gov, number NCT01040780, and the Chinese Clinical Trial Registry, number ChiCTR-TRC-09000506. 400 eligible patients were enrolled between Feb 26, 2009, and Nov 13, 2009; one patient was enrolled by mistake and removed from the study, 200 were assigned to icotinib and 199 to gefitinib. 395 patients were included in the full analysis set (icotinib, n=199; gefitinib, n=196). Icotinib was non-inferior to gefitinib in terms of progression-free survival (HR 0·84, 95% CI 0·67-1·05; median progression-free survival 4·6 months [95% CI 3·5-6·3] vs 3·4 months [2·3-3·8]; p=0·13). The most common adverse events were rash (81 [41%] of 200 patients in the icotinib group vs 98 [49%] of 199 patients in the gefitinib group) and diarrhoea (43 [22%] vs 58 [29%]). Patients given icotinib had less drug

  5. Budesonide/formoterol as effective as prednisolone plus formoterol in acute exacerbations of COPD A double-blind, randomised, non-inferiority, parallel-group, multicentre study

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    Andersson Eva

    2009-02-01

    Full Text Available Abstract Background Oral corticosteroids and inhaled bronchodilators with or without antibiotics represent standard treatment of COPD exacerbations of moderate severity. Frequent courses of oral steroids may be a safety issue. We wanted to evaluate in an out-patient setting whether a 2-week course of inhaled budesonide/formoterol would be equally effective for treatment of acute COPD exacerbations as standard therapy in patients judged by the investigator not to require hospitalisation. Methods This was a double-blind, randomised, non-inferiority, parallel-group, multicentre study comparing two treatment strategies; two weeks' treatment with inhaled budesonide/formoterol (320/9 μg, qid was compared with prednisolone (30 mg once daily plus inhaled formoterol (9 μg bid in patients with acute exacerbations of COPD attending a primary health care centre. Inclusion criteria were progressive dyspnoea for less than one week, FEV1 30–60% of predicted normal after acute treatment with a single dose of oral corticosteroid plus nebulised salbutamol/ipratropium bromide and no requirement for subsequent immediate hospitalisation, i.e the clinical status after the acute treatment allowed for sending the patient home. A total of 109 patients (mean age 67 years, 33 pack-years, mean FEV1 45% of predicted were randomized to two weeks' double-blind treatment with budesonide/formoterol or prednisolone plus formoterol and subsequent open-label budesonide/formoterol (320/9 μg bid for another 12 weeks. Change in FEV1 was the primary efficacy variable. Non-inferiority was predefined. Results Non-inferiority of budesonide/formoterol was proven because the lower limit of FEV1-change (97.5% CI was above 90% of the efficacy of the alternative treatment. Symptoms, quality of life, treatment failures, need for reliever medication (and exacerbations during follow-up did not differ between the groups. No safety concerns were identified. Conclusion High dose budesonide

  6. Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study.

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    Ha, Chul-Won; Park, Yong-Beom; Choi, Chong-Hyuk; Kyung, Hee-Soo; Lee, Ju-Hong; Yoo, Jae Doo; Yoo, Ju-Hyung; Choi, Choong-Hyeok; Kim, Chang-Wan; Kim, Hee-Chun; Oh, Kwang-Jun; Bin, Seong-Il; Lee, Myung Chul

    2017-05-26

    This randomized, double-blind, multi-center, non-inferiority trial was conducted to assess the efficacy and safety of a cross-linked hyaluronate (XLHA, single injection form) compared with a linear high molecular hyaluronate (HMWHA, thrice injection form) in patients with symptomatic knee osteoarthritis. Two hundred eighty seven patients with osteoarthritis (Kellgren-Lawrence grade I to III) were randomized to each group. Three weekly injections were given in both groups but two times of saline injections preceded XLHA injection to maintain double-blindness. Primary endpoint was the change of weight-bearing pain (WBP) at 12 weeks after the last injection. Secondary endpoints included Western Ontario and McMaster Universities Osteoarthritis index; patient's and investigator's global assessment; pain at rest, at night, or in motion; OMERACT-OARSI responder rate; proportion of patients achieving at least 20 mm or 40% decrease in WBP; and rate of rescue medicine use and its total consumption. Mean changes of WBP at 12 weeks after the last injection were -33.3 mm with XLHA and -29.2 mm with HMWHA, proving non-inferiority of XLHA to HMWHA as the lower bound of 95% CI (-1.9 mm, 10.1 mm) was well above the predefined margin (-10 mm). There were no significant between-group differences in all secondary endpoints. Injection site pain was the most common adverse event and no remarkable safety issue was identified. This study demonstrated that a single injection of XLHA was non-inferior to three weekly injections of HMWHA in terms of WBP reduction, and supports XLHA as an effective and safe treatment for knee osteoarthritis. ClinicalTrials.gov ( NCT01510535 ). This trial was registered on January 6, 2012.

  7. Published and not fully published double-blind, randomised, controlled trials with oral naratriptan in the treatment of migraine

    DEFF Research Database (Denmark)

    Tfelt-Hansen, Peer Carsten

    2011-01-01

    Naratriptan 2.5 mg is now an over-the-counter drug in Germany. This should increase the interest in drug. The GSK Trial Register was searched for published and unpublished double-blind, randomised, controlled trials (RCTs) concerning the use of naratriptan in migraine. Only 7 of 17 RCTs are publi......Naratriptan 2.5 mg is now an over-the-counter drug in Germany. This should increase the interest in drug. The GSK Trial Register was searched for published and unpublished double-blind, randomised, controlled trials (RCTs) concerning the use of naratriptan in migraine. Only 7 of 17 RCTs...... are published in full. Naratriptan 2.5 mg is superior to placebo for acute migraine treatment in 6 RCTs, but inferior to sumatriptan 100 mg and rizatriptan 10 mg in one RCT each. This dose of naratriptan has no more adverse events than placebo. Naratriptan 1 mg b.i.d. has some effect in the short...

  8. Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study.

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    Choi, Yoon Jin; Lee, Dong Ho; Choi, Myung Gyu; Lee, Sung Joon; Kim, Sung Kook; Song, Geun Am; Rhee, Poong Lyul; Jung, Hwoon Yong; Kang, Dae Hwan; Lee, Yong Chan; Lee, Si Hyung; Choi, Suck Chei; Shim, Ki Nam; Seol, Sang Yong; Moon, Jeong Seop; Shin, Yong Woon; Kim, Hyun Soo; Lee, Soo Teik; Cho, Jin Woong; Choi, Eun Kwang; Lee, Oh Young; Jang, Jin Seok

    2017-11-01

    This study compared the efficacy of DA-9601 (Dong-A ST Co., Seoul, Korea) and its new formulation, DA-5204 (Dong-A ST Co.), for treating erosive gastritis. This phase III, randomized, multicenter, double-blind, non-inferiority trial randomly assigned 434 patients with endoscopically proven gastric mucosal erosions into two groups: DA-9601 3 times daily or DA-5,204 twice daily for 2 weeks. The final analysis included 421 patients (DA-5204, 209; DA-9601, 212). The primary endpoint (rate of effective gastric erosion healing) and secondary endpoints (cure rate of endoscopic erosion and gastrointestinal [GI] symptom relief) were assessed using endoscopy after the treatment. Drug-related adverse events (AEs), including GI symptoms, were also compared. At week 2, gastric healing rates with DA-5204 and DA-9601 were 42.1% (88/209) and 42.5% (90/212), respectively. The difference between the groups was -0.4% (95% confidence interval, -9.8% to 9.1%), which was above the non-inferiority margin of -14%. The cure rate of gastric erosion in both groups was 37.3%. The improvement rates of GI symptoms with DA-5204 and DA-9601 were 40.4% and 40.8%, respectively. There were no statistically significant differences between the two groups in both secondary endpoints. AEs were reported in 18 (8.4%) patients in the DA-5204 group and 19 (8.8%) in the DA-9601 group. Rates of AE were not different between the two groups. No serious AE or adverse drug reaction (ADR) occurred. These results demonstrate the non-inferiority of DA-5204 compared to DA-9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis. Registered randomized clinical trial at ClinicalTrials.gov (NCT02282670). © 2017 The Korean Academy of Medical Sciences.

  9. Efficacy of DA-9701 (Motilitone) in Functional Dyspepsia Compared to Pantoprazole: A Multicenter, Randomized, Double-blind, Non-inferiority Study.

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    Jung, Hye-Kyung; Lee, Kwang Jae; Choi, Myung-Gyu; Park, Hyojin; Lee, Joon Seong; Rhee, Poong-Lyul; Kim, Nayoung; Park, KyungSik; Choi, Suck Chei; Lee, Oh Young; Huh, Kyu Chan; Song, Geun Am; Hong, Su Jin; Sohn, Chong Il; Jung, Hwoon-Yong; Lee, Yong Chan; Rew, Jong Sun; Jee, Sam Ryong; Kwon, Joong Goo

    2016-04-30

    The effect of proton pump inhibitors (PPI) in Asian functional dyspepsia (FD) patients has not been well established as in Westerncountries. DA-9701, a novel prokinetic agent, stimulates gastric emptying and modulates visceral hypersensitivity in vivo and in human studies. This study was conducted to compare the efficacy of DA-9701 with a conventional PPI in mono or combination therapy in patients with FD. In this double-blind, randomized, non-inferiority trial, 389 patients diagnosed with FD using Rome III criteria were allocated among3 groups: 30-mg DA-9701 t.i.d (means 3 times a day), 40-mg pantoprazole, and 30-mg DA-9701 t.i.d + 40-mg pantoprazole. Theprimary efficacy end-point was a global assessment of the patient binary response or response on a 5-Likert scale after 4 weeks. The global symptomatic improvement was 60.5% in the DA-9701 group, 65.6% in the pantoprazole group, and 63.5% in the DA-9701 + pantoprazole group using a 5-Likert scale at week 4 with no significant difference among 3 groups (P = 0.685). Symptomimprovement measured by binary outcome was significantly achieved in each of the 3 groups, but not different among groups.Patients in all treatment groups reported significant improvement in the response rate and symptoms according to FD subtypes anddyspepsia-related quality of life (P DA-9701 improves global and individual symptoms and increases dyspepsia-specific quality of life in patients with FD. The efficacyof DA-9701 monotherapy is comparable with pantoprazole and there is no additive effect with combination of DA-9701 andpantoprazole in patients with FD.

  10. Enhanced efficacy of sequential administration of Albendazole for the clearance of Wuchereria bancrofti infection: Double blind RCT.

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    De Britto, R L; Vanamail, P; Sankari, T; Vijayalakshmi, G; Das, L K; Pani, S P

    2015-06-01

    Till today, there is no effective treatment protocol for the complete clearance of Wuchereria bancrofti (W.b) infection that causes secondary lymphoedema. In a double blind randomized control trial (RCT), 146 asymptomatic W. b infected individuals were randomly assigned to one of the four regimens for 12 days, DEC 300 mg + Doxycycline 100 mg coadministration or DEC 300 mg + Albendazole 400 mg co-administration or DEC 300 mg + Albendazole 400 mg sequential administration or control regimen DEC 300 mg and were followed up at 13, 26 and 52 weeks post-treatment for the clearance of infection. At intake, there was no significant variation in mf counts (F(3,137)=0.044; P=0.988) and antigen levels (F(3,137)=1.433; P=0.236) between the regimens. Primary outcome analysis showed that DEC + Albendazole sequential administration has an enhanced efficacy over DEC + Albendazole co-administration (80.6 Vs 64.7%), and this regimen is significantly different when compared to DEC + doxycycline co-administration and control (PAlbendazole sequential administration appears to be a better option for rapid clearance of W. b microfilariae in 13 weeks time. (Clinical trials.gov identifier - NCT02005653).

  11. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

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    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  12. Multicenter, double-blind, parallel group study investigating the non-inferiority of efficacy and safety of a 2% miconazole nitrate shampoo in comparison with a 2% ketoconazole shampoo in the treatment of seborrhoeic dermatitis of the scalp.

    Science.gov (United States)

    Buechner, Stanislaw A

    2014-06-01

    This study investigated the non-inferiority of efficacy and tolerance of 2% miconazole nitrate shampoo in comparison with 2% ketoconazole shampoo in the treatment of scalp seborrheic dermatitis. A randomized, double-blind, comparative, parallel group, multicenter study was done. A total of 274 patients (145 miconazole, 129 ketoconazole) were enrolled. Treatment was twice-weekly for 4 weeks. Safety and efficacy assessments were made at baseline and at weeks 2 and 4. Assessments included symptoms of erythema, itching, scaling ['Symptom Scale of Seborrhoeic Dermatitis' (SSSD)], disease severity and global change [Clinical Global Impressions (CGIs) and Patient Global Impressions (PGIs)]. Miconazole shampoo is at least as effective and safe as ketoconazole shampoo in treating scalp seborrheic dermatitis scalp.

  13. Electrical stimulation for chronic non-specific low back pain in a working-age population: a 12-week double blinded randomized controlled trial.

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    Thiese, Matthew S; Hughes, Matthew; Biggs, Jeremy

    2013-03-28

    Non-invasive electrotherapy is commonly used for treatment of chronic low back pain. Evidence for efficacy of most electrotherapy modalities is weak or lacking. This study aims to execute a high-quality, double-blinded randomized controlled clinical trial comparing 1) H-Wave(®) Device stimulation plus usual care with 2) transcutaneous electrical nerve stimulation (TENS) plus usual care, and 3) Sham electrotherapy plus usual care to determine comparative efficacy for treatment of chronic non-specific low back pain patients. Chronic non-specific low back pain patients between ages of 18-65 years, with pain of at least 3 months duration and minimal current 5/10 VAS pain. Patients will have no significant signs or symptoms of lumbosacral nerve impingement, malignancy, spinal stenosis, or mood disorders. Double blind RCT with 3 arms and 38 subjects per arm. Randomization by permuted blocks of random length, stratified by Workers Compensation claim (yes vs. no), and use of opioids. The null hypothesis of this study is that there are no statistically significant differences in functional improvement between treatment types during and at the end of a 12-week week treatment period. Subjective data will be collected using Filemaker Pro™ database management collection tools. Objective data will be obtained through functional assessments. Data will be collected at enrollment and at 1, 4, 8, and 12 weeks for each participant by a blinded assessor. H-Wave(®) device stimulation (Intervention A) plus usual care, transcutaneous electrical nerve stimulation (TENS) (Intervention B) plus usual care, and sham electrotherapy plus usual care (control). Each treatment arm will have identical numbers of visits (4) and researcher contact time (approximately 15 hours). Oswestry Disability Index. Secondary measures include: Rowland Morris Instrument, VAS pain score, functional evaluation including strength when pushing and pulling, pain free range of motion in flexion and extension

  14. Prevention of upper gastrointestinal bleeding in critically ill Chinese patients: a randomized, double-blind study evaluating esomeprazole and cimetidine.

    Science.gov (United States)

    Lou, Wenhui; Xia, Ying; Xiang, Peng; Zhang, Liangqing; Yu, Xiangyou; Lim, Sam; Xu, Mo; Zhao, Lina; Rydholm, Hans; Traxler, Barry; Qin, Xinyu

    2018-04-20

    To assess the efficacy and safety of esomeprazole in preventing upper gastrointestinal (GI) bleeding in critically ill Chinese patients, using cimetidine as an active comparator. A pre-specified non-inferiority limit (5%) was used to compare rates of significant upper GI bleeding in this randomized, double-blind, parallel-group, phase 3 study across 27 intensive care units in China. Secondary endpoints included safety and tolerability measures. Patients required mechanical ventilation and had at least one additional risk factor for stress ulcer bleeding. Patients were randomized to receive either active esomeprazole 40 mg, as a 30-min intravenous (IV) infusion twice daily, and an IV placebo cimetidine infusion or active cimetidine 50 mg/h, as a continuous infusion following an initial bolus of 300 mg, and placebo esomeprazole injections, given up to 14 days. Patients were blinded using this double-dummy technique. Of 274 patients, 2.7% with esomeprazole and 4.6% with cimetidine had significant upper GI bleeding (bright red blood in the gastric tube not clearing after lavage or persistent Gastroccult-positive "coffee grounds" material). Non-inferiority of esomeprazole to cimetidine was demonstrated. The safety profiles of both drugs were similar and as expected in critically ill patients. Esomeprazole is effective in preventing upper GI bleeding in critically ill Chinese patients, as demonstrated by the non-inferiority analysis using cimetidine as an active control. ClinicalTrials.gov identifier NCT02157376.

  15. Double-Blind Crossover Study to Compare Pain Experience During Inferior Alveolar Nerve Block Administration Using Buffered Two Percent Lidocaine in Children.

    Science.gov (United States)

    Chopra, Radhika; Jindal, Garima; Sachdev, Vinod; Sandhu, Meera

    2016-01-01

    Buffering of anesthetic solutions has been suggested to reduce pain on injection and onset of anesthesia. The purpose of this study was to assess the reduction in pain on injection during inferior alveolar nerve block administration in children. A double blind crossover study was designed where 30 six- to 12-year-old patients received two sessions of inferior alveolar nerve block scheduled one week apart. Two percent lidocaine with 1:200,000 epinephrine was given during one appointment, and a buffered solution was given during the other. Pain on injection was assessed using the sound, eye, and motor (SEM) scale, and the time to onset was assessed after gingival probing. The Heft-Parker visual analogue scale (HP-VAS) was self recorded by the patient after administration of local anesthesia. When tested using Mann-Whitney analysis, no significant differences were found between the SEM scores (P=0.71) and HP-VAS scores (P=0.93) for the two solutions used. Student's t test was used to assess the difference in the onset of anesthesia, which was also found to be statistically insignificant (P=0.824). Buffered lidocaine did not reduce the pain on injection or time to onset of anesthesia for inferior alveolar nerve block in children.

  16. Randomised controlled double-blind non-inferiority trial of two antivenoms for saw-scaled or carpet viper (Echis ocellatus envenoming in Nigeria.

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    Isa S Abubakar

    Full Text Available BACKGROUND: In West Africa, envenoming by saw-scaled or carpet vipers (Echis ocellatus causes great morbidity and mortality, but there is a crisis in supply of effective and affordable antivenom (ISRCTN01257358. METHODS: In a randomised, double-blind, controlled, non-inferiority trial, "EchiTAb Plus-ICP" (ET-Plus equine antivenom made by Instituto Clodomiro Picado was compared to "EchiTAb G" (ET-G ovine antivenom made by MicroPharm, which is the standard of care in Nigeria and was developed from the original EchiTAb-Fab introduced in 1998. Both are caprylic acid purified whole IgG antivenoms. ET-G is monospecific for Echis ocellatus antivenom (initial dose 1 vial and ET-Plus is polyspecific for E. ocellatus, Naja nigricollis and Bitis arietans (initial dose 3 vials. Both had been screened by pre-clinical and preliminary clinical dose-finding and safety studies. Patients who presented with incoagulable blood, indicative of systemic envenoming by E. ocellatus, were recruited in Kaltungo, north-eastern Nigeria. Those eligible and consenting were randomly allocated with equal probability to receive ET-Plus or ET-G. The primary outcome was permanent restoration of blood coagulability 6 hours after the start of treatment, assessed by a simple whole blood clotting test repeated 6, 12, 18, 24 and 48 hr after treatment. Secondary (safety outcomes were the incidences of anaphylactic, pyrogenic and late serum sickness-type antivenom reactions. FINDINGS: Initial doses permanently restored blood coagulability at 6 hours in 161/194 (83.0% of ET-Plus and 156/206 (75.7% of ET-G treated patients (Relative Risk [RR] 1.10 one-sided 95% CI lower limit 1.01; P = 0.05. ET-Plus caused early reactions on more occasions than did ET-G [50/194 (25.8% and 39/206 (18.9% respectively RR (1.36 one-sided 95% CI 1.86 upper limit; P = 0.06. These reactions were classified as severe in 21 (10.8% and 11 (5.3% of patients, respectively. CONCLUSION: At these doses, ET-Plus was

  17. Five-year results of vital pulp therapy in permanent molars with irreversible pulpitis: a non-inferiority multicenter randomized clinical trial.

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    Asgary, Saeed; Eghbal, Mohammad Jafar; Fazlyab, Mahta; Baghban, Alireza Akbarzadeh; Ghoddusi, Jamileh

    2015-03-01

    Previous reported results of up to 12 months as well as 24-month follow-ups revealed superior and equivalent treatment outcomes for vital pulp therapy (VPT) using calcium-enriched mixture cement (CEM) in comparison with root canal therapy (RCT) for mature molars with established irreversible pulpitis, respectively. Present non-inferiority multicenter randomized clinical trial assesses the final long-term (5-year) results as well as the effects of patients' age/gender and the presence of preoperative periapical lesion on the treatment outcomes. A total number of 407 patients were blindly allocated into two treatment groups [group 1 (VPT/CEM, n = 205) and group 2 (RCT, n = 202)] treated in 23 health-care centers by calibrated dentists. The treatment outcomes were assessed after 60 months. The 5-year results revealed no significant differences in the successes of both study arms (P = 0.29); a total number of 271 patients were available (~33 % were lost to follow-up). The patients' age/gender did not affect the outcomes; the presence of preoperative periapical lesion also did not implement a significant effect in both groups (P > 0.05). As an alternative for RCT, VPT/CEM can be considered as a valid treatment for vital mature permanent molars clinically diagnosed with irreversible pulpitis. Considering the favorable outcomes of 6- to 60-month follow-ups, as an evidence-based/simple/affordable/effective/biologic approach in cases of irreversible pulpitis, VPT/CEM is highly recommended for universal clinical practice.

  18. Temporary Blindness after Inferior Alveolar Nerve Block.

    Science.gov (United States)

    Barodiya, Animesh; Thukral, Rishi; Agrawal, Shaila Mahendra; Rai, Anshul; Singh, Siddharth

    2017-03-01

    Inferior Alveolar Nerve Block (IANB) anaesthesia is one of the common procedures in dental clinic. This procedure is safe, but complications may still occur. Ocular complications such as diplopia, loss of vision, or ophthalmoplegia are extremely rare. This case report explains an event where due to individual anatomic variation of the sympathetic vasoconstrictor nerve and maxillary and middle meningeal arteries, intravascular administration of anaesthetic agent caused unusual ocular signs and symptoms such as temporary blindness.

  19. Double-blind ureteral duplication: report of two cases

    International Nuclear Information System (INIS)

    Choi, Ja-Young; Kim, Seung Hyup; Kim, Sun Ho

    2002-01-01

    Blind ending of ureteral duplication is one of the most rare anomalies of the upper urinary tract. We report two cases of ureteral duplication with a blind ending both superiorly and inferiorly, and with no definite communication with the urinary tract. (orig.)

  20. Design of Phase II Non-inferiority Trials.

    Science.gov (United States)

    Jung, Sin-Ho

    2017-09-01

    With the development of inexpensive treatment regimens and less invasive surgical procedures, we are confronted with non-inferiority study objectives. A non-inferiority phase III trial requires a roughly four times larger sample size than that of a similar standard superiority trial. Because of the large required sample size, we often face feasibility issues to open a non-inferiority trial. Furthermore, due to lack of phase II non-inferiority trial design methods, we do not have an opportunity to investigate the efficacy of the experimental therapy through a phase II trial. As a result, we often fail to open a non-inferiority phase III trial and a large number of non-inferiority clinical questions still remain unanswered. In this paper, we want to develop some designs for non-inferiority randomized phase II trials with feasible sample sizes. At first, we review a design method for non-inferiority phase III trials. Subsequently, we propose three different designs for non-inferiority phase II trials that can be used under different settings. Each method is demonstrated with examples. Each of the proposed design methods is shown to require a reasonable sample size for non-inferiority phase II trials. The three different non-inferiority phase II trial designs are used under different settings, but require similar sample sizes that are typical for phase II trials.

  1. Effect of preoperative acetaminophen/hydrocodone on the efficacy of the inferior alveolar nerve block in patients with symptomatic irreversible pulpitis: a prospective, randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Fullmer, Spencer; Drum, Melissa; Reader, Al; Nusstein, John; Beck, Mike

    2014-01-01

    The purpose of this prospective, randomized, double-blind, placebo-controlled study was to determine the effect of the administration of the combination acetaminophen/hydrocodone on the anesthetic success of mandibular posterior teeth in patients experiencing symptomatic irreversible pulpitis. One hundred emergency patients in moderate to severe pain diagnosed with symptomatic irreversible pulpitis of a mandibular posterior tooth randomly received, in a double-blind manner, identical capsules of either a combination dose of 1000 mg acetaminophen/10 mg hydrocodone or placebo 60 minutes before the administration of a conventional inferior alveolar nerve (IAN) block. Endodontic access was begun 15 minutes after completion of the block, and all patients used for data analysis had profound lip numbness. Success was defined as no or mild pain (visual analog scale recordings) on pulpal access or instrumentation. The success rate for the IAN block was 32% for the combination dose of 1000 mg acetaminophen/10 hydrocodone and 28% for the placebo dose, with no statistically significant difference between the 2 groups (P = .662). A combination dose of 1000 mg acetaminophen/10 mg hydrocodone given 60 minutes before the administration of the IAN block did not result in a statistically significant increase in anesthetic success for mandibular posterior teeth in patients experiencing symptomatic irreversible pulpitis. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  2. Comparative evaluation of effect of preoperative oral medication of ibuprofen and ketorolac on anesthetic efficacy of inferior alveolar nerve block with lidocaine in patients with irreversible pulpitis: a prospective, double-blind, randomized clinical trial.

    Science.gov (United States)

    Aggarwal, Vivek; Singla, Mamta; Kabi, Debipada

    2010-03-01

    Anesthetic efficacy of inferior alveolar nerve block decreases in patients with irreversible pulpitis. It was hypothesized that premedication with nonsteroidal anti-inflammatory drugs might improve the success rates in patients with inflamed pulps. Sixty-nine adult volunteers who were actively experiencing pain participated in this prospective, randomized, double-blind study. The patients were divided into 3 groups on a random basis and were randomly given 1 of the 3 drugs including ibuprofen, ketorolac, and placebo 1 hour before anesthesia. All patients received standard inferior alveolar nerve block of 2% lidocaine with 1:200,000 epinephrine. Endodontic access preparation was initiated after 15 minutes of initial inferior alveolar nerve block. Pain during treatment was recorded by using a Heft Parker visual analog scale. Success was recorded as none or mild pain. Statistical analysis with nonparametric chi2 tests showed that placebo gave 29% success rate. Premedication with ibuprofen gave 27%, and premedication with ketorolac gave 39% success rate. There was no significant difference between the 3 groups. Preoperative administration of ibuprofen or ketorolac has no significant effect on success rate of inferior alveolar nerve block in patients with irreversible pulpitis. Copyright (c) 2010 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  3. Anesthetic Efficacy of Articaine and Ketamine for Inferior Alveolar Nerve Block in Symptomatic Irreversible Pulpitis: A Prospective Randomized Double-Blind Study.

    Science.gov (United States)

    Sakhaeimanesh, Vahid; Khazaei, Saber; Kaviani, Naser; Saatchi, Masoud; Shafiei, Maryam; Khademi, Abbasali

    2017-01-01

    The aim of this prospective, randomized, double-blind study was to investigate the effect of articaine combined with ketamine on the success rate of inferior alveolar nerve block (IANB) in posterior mandible teeth with symptomatic irreversible pulpitis. Forty two adult patients with diagnosis of symptomatic irreversible pulpitis of a mandibular posterior tooth were selected. The patients received two cartridges of either containing 3.2 mL 4% articaine with epinephrine 1:200000 and 0.4 mL 50 mg/mL ketamine hydrochloride (A-ketamine group) or 3.2 mL 4% articaine with epinephrine 1:200000 and 0.4 mL normal saline (A-saline group) using conventional IANB injections. Access cavity preparation started 15 min after injection. Lip numbness was required for all the patients. Success was considered as no or mild pain on the basis of Heft-Parker visual analog scale recordings upon access cavity preparation or initial instrumentation. Data were analyzed by independent student t , Mann-Whitney and Chi -square tests. The success rates were 55% and 42.9% for A-ketamine and A-saline group, respectively, with no significant differences between the two groups ( P =0.437) . Adding 0.4 mL 50 mg/mL ketamine hydrochloride to the articaine local anesthetic did not increase the efficacy of IANB for posterior mandibular teeth with symptomatic irreversible pulpitis.

  4. Anesthetic Efficacy of Articaine and Ketamine for Inferior Alveolar Nerve Block in Symptomatic Irreversible Pulpitis: A Prospective Randomized Double-Blind Study

    Science.gov (United States)

    Sakhaeimanesh, Vahid; Khazaei, Saber; Kaviani, Naser; Saatchi, Masoud; Shafiei, Maryam; Khademi, Abbasali

    2017-01-01

    Introduction: The aim of this prospective, randomized, double-blind study was to investigate the effect of articaine combined with ketamine on the success rate of inferior alveolar nerve block (IANB) in posterior mandible teeth with symptomatic irreversible pulpitis. Methods and Materials: Forty two adult patients with diagnosis of symptomatic irreversible pulpitis of a mandibular posterior tooth were selected. The patients received two cartridges of either containing 3.2 mL 4% articaine with epinephrine 1:200000 and 0.4 mL 50 mg/mL ketamine hydrochloride (A-ketamine group) or 3.2 mL 4% articaine with epinephrine 1:200000 and 0.4 mL normal saline (A-saline group) using conventional IANB injections. Access cavity preparation started 15 min after injection. Lip numbness was required for all the patients. Success was considered as no or mild pain on the basis of Heft-Parker visual analog scale recordings upon access cavity preparation or initial instrumentation. Data were analyzed by independent student t, Mann-Whitney and Chi-square tests. Results: The success rates were 55% and 42.9% for A-ketamine and A-saline group, respectively, with no significant differences between the two groups (P=0.437). Conclusion: Adding 0.4 mL 50 mg/mL ketamine hydrochloride to the articaine local anesthetic did not increase the efficacy of IANB for posterior mandibular teeth with symptomatic irreversible pulpitis. PMID:29225640

  5. 3g mesalazine granules are superior to 9mg budesonide for achieving remission in active ulcerative colitis: a double-blind, double-dummy, randomised trial.

    Science.gov (United States)

    Gross, Volker; Bunganic, Ivan; Belousova, Elena A; Mikhailova, Tatyana L; Kupcinskas, Limas; Kiudelis, Gediminas; Tulassay, Zsolt; Gabalec, Libor; Dorofeyev, Andrey E; Derova, Jelena; Dilger, Karin; Greinwald, Roland; Mueller, Ralph

    2011-04-01

    Budesonide may be an effective therapy for mild-to-moderately active ulcerative colitis (UC). This study aimed to demonstrate non-inferiority for oral 9mg budesonide once daily (OD) versus 3g mesalazine granules OD. This was an eight-week randomised, double-blind, double-dummy, multicentre study in which patients with mild-to-moderately active UC, defined as Clinical Activity Index (CAI) ≥6 and Endoscopic Index (EI) ≥4, received budesonide (Budenofalk® 3mg capsules×3) or mesalazine (Salofalk® 1000mg granules×3). The primary endpoint was clinical remission at week 8 (CAI ≤4 with stool frequency and rectal bleeding subscores of "0"). 343 patients were randomised (177 budesonide, 166 mesalazine). Fewer patients achieved the primary endpoint with budesonide versus mesalazine (70/177 [39.5%] versus 91/166 [54.8%]) with a difference in proportions of -15.3% (95% CI [-25.7%, -4.8%]; p=0.520 for non-inferiority). The median time to first resolution of symptoms was 14.0 days (budesonide) and 11.0 days (mesalazine) (hazard ratio 1.19; 95% CI [0.94, 1.51]). Mucosal healing was observed in 54/177 (30.5%) budesonide patients versus 65/166 (39.2%) mesalazine patients, a difference of -8.6% (95% CI [-18.7%, 1.4%]; p=0.093). The incidences of adverse events (budesonide 26.6%, mesalazine 25.3%) and serious adverse events (budesonide 1.7%, mesalazine 1.2%) were similar. Once-daily 3g mesalazine administered as granules is superior to 9mg budesonide OD administered as capsules for achieving remission in mild-to-moderately active UC. However, it is noteworthy that remission of UC was attained in about 40% of budesonide-treated patients with a rapid onset of resolution. Copyright © 2010. Published by Elsevier B.V.

  6. Relapsed or Refractory Double-Expressor and Double-Hit Lymphomas Have Inferior Progression-Free Survival After Autologous Stem-Cell Transplantation.

    Science.gov (United States)

    Herrera, Alex F; Mei, Matthew; Low, Lawrence; Kim, Haesook T; Griffin, Gabriel K; Song, Joo Y; Merryman, Reid W; Bedell, Victoria; Pak, Christine; Sun, Heather; Paris, Tanya; Stiller, Tracey; Brown, Jennifer R; Budde, Lihua E; Chan, Wing C; Chen, Robert; Davids, Matthew S; Freedman, Arnold S; Fisher, David C; Jacobsen, Eric D; Jacobson, Caron A; LaCasce, Ann S; Murata-Collins, Joyce; Nademanee, Auayporn P; Palmer, Joycelynne M; Pihan, German A; Pillai, Raju; Popplewell, Leslie; Siddiqi, Tanya; Sohani, Aliyah R; Zain, Jasmine; Rosen, Steven T; Kwak, Larry W; Weinstock, David M; Forman, Stephen J; Weisenburger, Dennis D; Kim, Young; Rodig, Scott J; Krishnan, Amrita; Armand, Philippe

    2017-01-01

    Purpose Double-hit lymphomas (DHLs) and double-expressor lymphomas (DELs) are subtypes of diffuse large B-cell lymphoma (DLBCL) associated with poor outcomes after standard chemoimmunotherapy. Data are limited regarding outcomes of patients with relapsed or refractory (rel/ref) DEL or DHL who undergo autologous stem-cell transplantation (ASCT). We retrospectively studied the prognostic impact of DEL and DHL status on ASCT outcomes in patients with rel/ref DLBCL. Methods Patients with chemotherapy-sensitive rel/ref DLBCL who underwent ASCT at two institutions and in whom archival tumor material was available were enrolled. Immunohistochemistry for MYC, BCL2, and BCL6 and fluorescence in situ hybridization (FISH) for MYC were performed. In cases with MYC rearrangement or copy gain, FISH for BCL2 and BCL6 was also performed. Results A total of 117 patients were included; 44% had DEL and 10% had DHL. DEL and DHL were associated with inferior progression-free survival (PFS), and DHL was associated with poorer overall survival (OS). The 4-year PFS in patients with DEL compared with those with non-DEL was 48% versus 59% ( P = .049), and the 4-year OS was 56% versus 67% ( P = .10); 4-year PFS in patients with DHL compared with those with non-DHL was 28% versus 57% ( P = .013), and 4-year OS was 25% versus 61% ( P = .002). The few patients with concurrent DEL and DHL had a poor outcome (4-year PFS, 0%). In multivariable models, DEL and DHL were independently associated with inferior PFS, whereas DHL and partial response ( v complete response) at transplant were associated with inferior OS. Conclusion DEL and DHL are both associated with inferior outcomes after ASCT in patients with rel/ref DLBCL. Although ASCT remains a potentially curative approach, these patients, particularly those with DHL, are a high-risk subset who should be targeted for investigational strategies other than standard ASCT.

  7. Effect of Sodium Bicarbonate Buccal Infiltration on the Success of Inferior Alveolar Nerve Block in Mandibular First Molars with Symptomatic Irreversible Pulpitis: A Prospective, Randomized Double-blind Study.

    Science.gov (United States)

    Saatchi, Masoud; Farhad, Ali Reza; Shenasa, Naghmeh; Haghighi, Saeideh Karimi

    2016-10-01

    The purpose of this prospective, randomized, double-blind study was to evaluate the effect of a buccal infiltration of sodium bicarbonate on the anesthetic success of the inferior alveolar nerve block (IANB) for mandibular first molars in patients with symptomatic irreversible pulpitis. One hundred patients diagnosed with symptomatic irreversible pulpitis of a mandibular first molar were selected. The patients randomly received a buccal infiltration injection of either 0.7 mL 8.4% sodium bicarbonate with 0.3 mL 2% lidocaine containing 1:80,000 epinephrine or 0.7 mL sterile distilled water with 0.3 mL 2% lidocaine containing 1:80,000 epinephrine in a double-blind manner. After 15 minutes, all the patients received conventional IANB injection using 3.6 mL 2% lidocaine with 1:80,000 epinephrine. Access cavity preparation was initiated 15 minutes after the IANB injection. Lip numbness was a requisite for all the patients. Success was determined as no or mild pain on the basis of Heft-Parker visual analog scale recordings upon access cavity preparation or initial instrumentation. Data were analyzed using the t, chi-square and Mann-Whitney U tests. The success rate after the buccal infiltration of sodium bicarbonate was 78%, whereas without the buccal infiltration of sodium bicarbonate it was 44% (P < .001). A buccal infiltration of 0.7 mL 8.4% sodium bicarbonate increased the success rate of IANBs in mandibular first molars with symptomatic irreversible pulpitis. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  8. E-learning in pediatric basic life support: a randomized controlled non-inferiority study.

    Science.gov (United States)

    Krogh, Lise Qvirin; Bjørnshave, Katrine; Vestergaard, Lone Due; Sharma, Maja Bendtsen; Rasmussen, Stinne Eika; Nielsen, Henrik Vendelbo; Thim, Troels; Løfgren, Bo

    2015-05-01

    Dissemination of pediatric basic life support (PBLS) skills is recommended. E-learning is accessible and cost-effective, but it is currently unknown whether laypersons can learn PBLS through e-learning. The hypothesis of this study was to investigate whether e-learning PBLS is non-inferior to instructor-led training. Participants were recruited among child-minders and parents of children aged 0-6 years. Participants were randomized to either 2-h instructor-led training or e-learning using an e-learning program (duration 17 min) including an inflatable manikin. After training, participants were assessed in a simulated pediatric cardiac arrest scenario. Tests were video recorded and PBLS skills were assessed independently by two assessors blinded to training method. Primary outcome was the pass rate of the PBLS test (≥8 of 15 skills adequately performed) with a pre-specified non-inferiority margin of 20%. In total 160 participants were randomized 1:1. E-learning was non-inferior to instructor-led training (difference in pass rate -4%; 95% CI -9:0.5). Pass rates were 100% among instructor-led trained (n=67) and 96% among e-learned (n=71). E-learners median time spent on the e-learning program was 30 min (range: 15-120 min) and the median number of log-ons was 2 (range: 1-5). After the study, all participants felt that their skills had improved. E-learning PBLS is non-inferior to instructor-led training among child-minders and parents with children aged 0-6 years, although the pass rate was 4% (95% CI -9:0.5) lower with e-learning. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  9. Comparison of anesthetic efficacy of 2 and 4 % articaine in inferior alveolar nerve block for tooth extraction-a double-blinded randomized clinical trial.

    Science.gov (United States)

    Kämmerer, P W; Schneider, D; Palarie, V; Schiegnitz, E; Daubländer, M

    2017-01-01

    The purpose of this clinical prospective, randomized, double-blind trial was to compare the anesthetic efficacy of 2 % articaine and 4 % articaine in inferior alveolar nerve block anesthesia for extraction of mandibular teeth. In 95 patients, 105 lower molar and premolar teeth were extracted after intraoral inferior alveolar nerve block. In 53 cases, 2 % articaine (group I) and, in 52 cases, 4 % articaine (group II) was administered. The primary objective was to analyze the differences of anesthetic effects between the two groups (complete/sufficient vs. insufficient/none). Furthermore, differences in pulpal anesthesia (onset and depth, examined with pulp vitality tester (min)), as well as in length of soft tissue anesthesia (min), were evaluated. Additionally, the need of a second injection, pain while injecting (numeric rating scale (NRS)), pain during treatment (NRS), pain after treatment (NRS), and other possible complications (excessive pain, bleeding events, prolonged deafness) were analyzed. Anesthesia was sufficient for dental extractions in both groups without significant differences (p = 0.201). The onset of anesthesia did not differ significantly (p = 0.297). A significantly shorter duration of soft tissue anesthesia was seen in group I (2.9 vs. 4 h; p < 0.001). There was no significant difference in the need for a second injection (p = 0.359), in injection pain (p = 0.386), as well as in pain during (p = 0.287) or after treatment (p = 0.121). In both groups, no complications were seen. The local anesthetic effect of the 4 % articaine solution is not significantly better when compared to 2 % articaine. For mandibular tooth extraction, articaine 2 % may be used as alternative as well.

  10. Buffered Lidocaine With Sodium Bicarbonate did not Increase Inferior Alveolar Nerve Block Success Rate in Patients Having Symptomatic Irreversible Pulpitis.

    Science.gov (United States)

    Parirokh, Masoud

    2016-03-01

    Effect of buffered 4% lidocaine on the success of the inferior alveolar nerve block in patients with symptomatic irreversible pulpitis: a prospective, randomized, double-blind study. Schellenberg J, Drum M, Reader A, Nusstein J, Fowler S, Beck M. J Endod 2015;41(6):791-6. The study was supported by Meyers/Reader Graduate Endodontic Support Fund Double blinded randomized controlled trial. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. Radiological evidence of double inferior vena cava in a young adult male

    International Nuclear Information System (INIS)

    Nevruz, O.; Ural, U.; Kirici, Y.; Kilic, C.; Bozlar, U.

    2007-01-01

    The development of the inferior vena cava IVC is a complex process comprising the formation and regression of some anastomoses, so various anomalies may occur during embryogenesis. These variations can increase the difficulty of aneurysm resection as well as the risk of venous injury and subsequent excessive bleeding during retroperitoneal and thoracic surgical interventions. Here, we report a patient with double inferior vena cava by radiographically during his investigation for the etiology of pancytopenia. (author)

  12. Efficacy and tolerability of transdermal granisetron for the control of chemotherapy-induced nausea and vomiting associated with moderately and highly emetogenic multi-day chemotherapy: a randomized, double-blind, phase III study.

    Science.gov (United States)

    Boccia, Ralph V; Gordan, Lucio N; Clark, Gemma; Howell, Julian D; Grunberg, Steven M

    2011-10-01

    A novel transdermal formulation of granisetron (the granisetron transdermal delivery system (GTDS)) has been developed to deliver granisetron continuously over 7 days. This double-blind, phase III, non-inferiority study compared the efficacy and tolerability of the GTDS to daily oral granisetron for the control of chemotherapy-induced nausea and vomiting (CINV). Six hundred forty-one patients were randomized to oral (2 mg/day, 3-5 days) or transdermal granisetron (one GTDS patch, 7 days), before receiving multi-day chemotherapy. The primary endpoint was complete control of CINV (no vomiting/retching, no more than mild nausea, no rescue medication) from chemotherapy initiation until 24 h after final administration. The prespecified non-inferiority margin was 15%. Five hundred eighty-two patients were included in the per protocol analysis. The GTDS displayed non-inferiority to oral granisetron: complete control was achieved by 60% of patients in the GTDS group, and 65% in the oral granisetron group (treatment difference, -5%; 95% confidence interval, -13-3). Both treatments were well tolerated, the most common adverse event being constipation. The GTDS provides effective, well-tolerated control of CINV associated with moderately or highly emetogenic multi-day chemotherapy. It offers a convenient alternative route for delivering granisetron for up to 7 days that is as effective as oral granisetron.

  13. Results of a randomized, prospective, double-dummy, double-blind trial to compare efficacy and safety of a herbal combination containing Tropaeoli majoris herba and Armoraciae rusticanae radix with co-trimoxazole in patients with acute and uncomplicated cystitis

    Directory of Open Access Journals (Sweden)

    Stange R

    2017-03-01

    Full Text Available Rainer Stange,1 Berthold Schneider,2 Uwe Albrecht,3 Valentina Mueller,3 Joerg Schnitker,4 Andreas Michalsen1 1Internal and Complementary Medicine, Immanuel Krankenhaus Berlin-Wannsee, Berlin, 2Institute for Biostatistics, Medical University, 3Mediconomics GmbH, Hannover, 4Institute for Applied Statistics, Bielefeld, Germany Objectives: To demonstrate non-inferiority of an herbal combination (horseradish root and nasturtium herb to an antibiotic (co-trimoxazole in acute uncomplicated cystitis. Design: Randomized, prospective, double-blind, double-dummy, multicenter, phase III clinical study, using block randomization of 4 blocks (size 2. Setting: Twenty-six centers in Germany, from May 2011 to June 2013. Participants: Adult patients (median age, 38.5 years; 90% female with acute uncomplicated cystitis confirmed via urinalysis and bacterial counts. Interventions: Patients received the herbal combination (five tablets, four times per day or the antibiotic (two tablets daily for a period of 7 or 3 days, respectively, followed by a 21-days without drug treatment. Placebos ensured blinding. Primary and secondary outcome measures: The primary endpoint was the percentage of responders, expressed as reduction of germ count from >105 to <103 CFU/mL of pathogens between visit 1 (day 0 and 3 (day 15. Secondary endpoints included change of symptom scores, duration of symptoms, efficacy assessments, relapse frequency, and safety. A sample size of 178 patients per group was estimated. Results: Of the 96 randomized patients (intent-to-treat; 45 in the phytotherapy group, 51 in the antibiotic group, 51 were considered per-protocol patients (22 in the phytotherapy group, 29 in the antibiotic group. Responder rates were 10/22 (45.5% for the phytotherapy group and 15/29 (51.1% for the antibiotic group (group difference: –6.27% [95% CI: –33.90%–21.3%]. The study was terminated prematurely due to slow recruitment rates. Non-inferiority could not be assumed by

  14. Randomised, double-blind trial of intravenous diltiazem versus glyceryl trinitrate for unstable angina pectoris

    NARCIS (Netherlands)

    Gobel, EJAM; Hautvast, RWM; vanGilst, WH; Spanjaard, JN; Hillege, HL; DeJongste, MJL; Molhoek, GP; Lie, KI

    1995-01-01

    The effect of dihydropyridines in patients with unstable angina is discouraging. To find out the effect of the non- dihydropyridine-like calcium-channel blocker diltiazem, a randomised, double-blind trial was conducted comparing diltiazem with glyceryl trinitrate. both given intravenously, in 129

  15. One-year results of vital pulp therapy in permanent molars with irreversible pulpitis: an ongoing multicenter, randomized, non-inferiority clinical trial.

    Science.gov (United States)

    Asgary, Saeed; Eghbal, Mohammad Jafar; Ghoddusi, Jamileh; Yazdani, Shahram

    2013-03-01

    Root canal therapy (RCT) and tooth extraction have been conventional treatment options for management of human mature teeth with irreversible pulpitis. Excellent short-term treatment outcomes of vital pulp therapy with calcium-enriched mixture cement (VPT/CEM), as a new treatment option, on postoperative pain relief was demonstrated; if intermediate- and long-term treatment outcomes of the new treatment are also non-inferior compared to RCT, then VPT/CEM may become a viable treatment option for management of mature teeth with irreversible pulpitis. In 23 healthcare centers, 407 9- to 65-year-old patients were randomly allocated into two study arms including one-visit RCT (reference treatment; n = 202) and VPT/CEM (alternative treatment; n = 205). Six- and twelve-month clinical and radiographic successes were assessed. Mean follow-up times at 6- and 12-month follow-ups were "6.70 ± 0.68 and 6.72 ± 0.71 months" and "12.96 ± 0.67 and 12.90 ± 0.66 months" in the available cases of RCT and VPT/CEM arms, respectively. Favorable clinical success rates in the two study arms did not show statistical difference; however, the radiographic success rate in the VPT/CEM was significantly greater than RCT arm at the two follow-ups (P pulpitis. The performance of biomaterials such CEM cement may assist in the shift towards more biologic treatments. VPT/CEM may be a realistic alternative treatment for human mature molar teeth with symptoms of irreversible pulpitis; the use of VPT/CEM is highly beneficial for patients as well as general dentists.

  16. Randomised clinical trial: efficacy and safety of vonoprazan vs. lansoprazole in patients with gastric or duodenal ulcers - results from two phase 3, non-inferiority randomised controlled trials.

    Science.gov (United States)

    Miwa, H; Uedo, N; Watari, J; Mori, Y; Sakurai, Y; Takanami, Y; Nishimura, A; Tatsumi, T; Sakaki, N

    2017-01-01

    Vonoprazan is a new potassium-competitive acid blocker for treatment of acid-related diseases. To conduct two randomised-controlled trials, to evaluate the non-inferiority of vonoprazan vs. lansoprazole, a proton pump inhibitor, for treatment of gastric ulcer (GU) or duodenal ulcer (DU). Patients aged ≥20 years with ≥1 endoscopically-confirmed GU or DU (≥5 mm white coating) were randomised 1:1 using double-dummy blinding to receive lansoprazole (30 mg) or vonoprazan (20 mg) for 8 (GU study) or 6 (DU study) weeks. The primary endpoint was the proportion of patients with endoscopically confirmed healed GU or DU. For GU, 93.5% (216/231) of vonoprazan-treated patients and 93.8% (211/225) of lansoprazole-treated patients achieved healed GU; non-inferiority of vonoprazan to lansoprazole was confirmed [difference = -0.3% (95% CI -4.750, 4.208); P = 0.0011]. For DU, 95.5% (170/178) of vonoprazan-treated patients and 98.3% (177/180) of lansoprazole-treated patients achieved healed DU; non-inferiority to lansoprazole was not confirmed [difference = -2.8% (95% CI -6.400, 0.745); P = 0.0654]. The incidences of treatment-emergent adverse events were slightly lower for GU and slightly higher for DU with vonoprazan than with lansoprazole. There was one death (subarachnoid haemorrhage) in the vonoprazan group (DU). The possibility of a relationship between this unexpected patient death and the study drug could not be ruled out. In both studies, increases in serum gastrin levels were greater in vonoprazan-treated vs. lansoprazole-treated patients; levels returned to baseline after treatment in both groups. Vonoprazan 20 mg has a similar tolerability profile to lansoprazole 30 mg and is non-inferior with respect to GU healing and has similar efficacy for DU healing. © 2016 Takeda Pharmaceutical Company, Ltd. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

  17. Transdiagnostic group CBT vs. standard group CBT for depression, social anxiety disorder and agoraphobia/panic disorder: Study protocol for a pragmatic, multicenter non-inferiority randomized controlled trial.

    Science.gov (United States)

    Arnfred, Sidse M; Aharoni, Ruth; Hvenegaard, Morten; Poulsen, Stig; Bach, Bo; Arendt, Mikkel; Rosenberg, Nicole K; Reinholt, Nina

    2017-01-23

    Transdiagnostic Cognitive Behavior Therapy (TCBT) manuals delivered in individual format have been reported to be just as effective as traditional diagnosis specific CBT manuals. We have translated and modified the "The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP-CBT) for group delivery in Mental Health Service (MHS), and shown effects comparable to traditional CBT in a naturalistic study. As the use of one manual instead of several diagnosis-specific manuals could simplify logistics, reduce waiting time, and increase therapist expertise compared to diagnosis specific CBT, we aim to test the relative efficacy of group UP-CBT and diagnosis specific group CBT. The study is a partially blinded, pragmatic, non-inferiority, parallel, multi-center randomized controlled trial (RCT) of UP-CBT vs diagnosis specific CBT for Unipolar Depression, Social Anxiety Disorder and Agoraphobia/Panic Disorder. In total, 248 patients are recruited from three regional MHS centers across Denmark and included in two intervention arms. The primary outcome is patient-ratings of well-being (WHO Well-being Index, WHO-5), secondary outcomes include level of depressive and anxious symptoms, personality variables, emotion regulation, reflective functioning, and social adjustment. Assessments are conducted before and after therapy and at 6 months follow-up. Weekly patient-rated outcomes and group evaluations are collected for every session. Outcome assessors, blind to treatment allocation, will perform the observer-based symptom ratings, and fidelity assessors will monitor manual adherence. The current study will be the first RCT investigating the dissemination of the UP in a MHS setting, the UP delivered in groups, and with depressive patients included. Hence the results are expected to add substantially to the evidence base for rational group psychotherapy in MHS. The planned moderator and mediator analyses could spur new hypotheses about mechanisms of change in

  18. Reflexology has an acute (immediate) haemodynamic effect in healthy volunteers: a double-blind randomised controlled trial.

    Science.gov (United States)

    Jones, Jenny; Thomson, Patricia; Lauder, William; Howie, Kate; Leslie, Stephen J

    2012-11-01

    Reflexologists claim that massage to specific points of the feet increases blood supply to internal organs. This study measured changes in cardiovascular parameters in subjects receiving reflexology to areas of their feet thought to correspond to the heart (intervention) compared with other areas which are not (control). 16 reflexology-naive healthy volunteers received an active and control reflexology treatment in an RCT, double-blind repeated measures study. 'Beat-to-beat' continuous measurement of selected cardiovascular parameters, State Anxiety Inventory. Cardiac index decreased significantly in the intervention group during left foot treatment (LFT) (baseline mean 2.6; standard deviation (SD) 0.75; 95% CI ± 0.38 vs. LFT mean 2.45; SD 0.68; CI 0.35), effect size (p = 0.035, omega squared effect (w2) = 0.002; w = 0.045). Reflexology massage applied to the upper part of the left foot may have a modest specific effect on the cardiac index of healthy volunteers. Copyright © 2012 Elsevier Ltd. All rights reserved.

  19. Control of Lower Extremity Edema in Patients with Diabetes: Double Blind Randomized Controlled Trial Assessing the Efficacy of Mild Compression Diabetic Socks

    Science.gov (United States)

    Wu, Stephanie C.; Crews, Ryan T.; Skratsky, Melissa; Overstreet, Julia; Yalla, Sai V.; Winder, Michelle; Ortiz, Jacquelyn; Andersen, Charles A.

    2017-01-01

    Aims Persons with diabetes frequently present with lower extremity (LE) edema; however, compression therapy is generally avoided for fear of compromising arterial circulation in a population with a high prevalence of peripheral arterial disease. This double blind randomized controlled trial (RCT) assessed whether diabetic socks with mild compression could reduce LE edema in patients with diabetes without negatively impacting vascularity. Methods Eighty subjects with LE edema and diabetes were randomized to receive either mild-compression knee high diabetic socks (18–25mmHg) or non-compression knee high diabetic socks. Subjects were instructed to wear the socks during all waking hours. Follow-up visits occurred weekly for four consecutive weeks. Edema was quantified through midfoot, ankle, and calf circumferences and cutaneous fluid measurements. Vascular status was tracked via ankle brachial index (ABI), toe brachial index (TBI), and skin perfusion pressure (SPP). Results Seventy-seven subjects (39 controls and 38 mild-compression subjects) successfully completed the study. No statistical differences between the two groups in terms of age, body mass index, gender, and ethnicity. Repeated measures analysis of variance and Sidak corrections for multiple comparisons were used for data analyses. Subjects randomized to mild-compression diabetic socks demonstrated significant decreases in calf and ankle circumferences at the end of treatment as compared to baseline. LE circulation did not diminish throughout the study with no significant decreases in ABI, TBI or SPP for either group. Conclusions Results of this RCT suggest that mild compression diabetic sock may be effectively and safely used in patients with diabetes and LE edema. PMID:28315576

  20. Some problems with non-inferiority tests in psychotherapy research: psychodynamic therapies as an example.

    Science.gov (United States)

    Rief, Winfried; Hofmann, Stefan G

    2018-02-14

    In virtually every field of medicine, non-inferiority trials and meta-analyses with non-inferiority conclusions are increasingly common. This non-inferiority approach has been frequently used by a group of authors favoring psychodynamic therapies (PDTs), concluding that PDTs are just as effective as cognitive-behavioral therapies (CBT). We focus on these examples to exemplify some problems associated with non-inferiority tests of psychological treatments, although the problems also apply to psychopharmacotherapy research, CBT research, and others. We conclude that non-inferiority trials have specific risks of different types of validity problems, usually favoring an (erroneous) non-inferiority conclusion. Non-inferiority trials require the definition of non-inferiority margins, and currently used thresholds have a tendency to be inflationary, not protecting sufficiently against degradation. The use of non-inferiority approaches can lead to the astonishing result that one single analysis can suggest both, superiority of the comparator (here: CBT) and non-inferiority of the other treatment (here PDT) at the same time. We provide recommendations how to improve the quality of non-inferiority trials, and we recommend to consider them among other criteria when evaluating manuscripts examining non-inferiority trials. If psychotherapeutic families (such as PDT and CBT) differ on the number of investigating trials, and in the fields of clinical applications, and in other validity aspects mentioned above, conclusions about their general non-inferiority are no more than a best guess, typically expressing the favored approach of the lead author.

  1. Telephone cognitive-behavioral therapy for adolescents with obsessive-compulsive disorder: a randomized controlled non-inferiority trial.

    Science.gov (United States)

    Turner, Cynthia M; Mataix-Cols, David; Lovell, Karina; Krebs, Georgina; Lang, Katie; Byford, Sarah; Heyman, Isobel

    2014-12-01

    Many adolescents with obsessive-compulsive disorder (OCD) do not have access to evidence-based treatment. A randomized controlled non-inferiority trial was conducted in a specialist OCD clinic to evaluate the effectiveness of telephone cognitive-behavioral therapy (TCBT) for adolescents with OCD compared to standard clinic-based, face-to-face CBT. Seventy-two adolescents, aged 11 through 18 years with primary OCD, and their parents were randomized to receive specialist TCBT or CBT. The intervention provided differed only in the method of treatment delivery. All participants received up to 14 sessions of CBT, incorporating exposure with response prevention (E/RP), provided by experienced therapists. The primary outcome measure was the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS). Blind assessor ratings were obtained at midtreatment, posttreatment, 3-month, 6-month, and 12-month follow-up. Intent-to-treat analyses indicated that TCBT was not inferior to face-to-face CBT at posttreatment, 3-month, and 6-month follow-up. At 12-month follow-up, there were no significant between-group differences on the CY-BOCS, but the confidence intervals exceeded the non-inferiority threshold. All secondary measures confirmed non-inferiority at all assessment points. Improvements made during treatment were maintained through to 12-month follow-up. Participants in each condition reported high levels of satisfaction with the intervention received. TCBT is an effective treatment and is not inferior to standard clinic-based CBT, at least in the midterm. This approach provides a means of making a specialized treatment more accessible to many adolescents with OCD. Clinical trial registration information-Evaluation of telephone-administered cognitive-behaviour therapy (CBT) for young people with obsessive-compulsive disorder (OCD); http://www.controlled-trials.com; ISRCTN27070832. Crown Copyright © 2014. Published by Elsevier Inc. All rights reserved.

  2. Telephone Cognitive-Behavioral Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Non-inferiority Trial

    Science.gov (United States)

    Turner, Cynthia M.; Mataix-Cols, David; Lovell, Karina; Krebs, Georgina; Lang, Katie; Byford, Sarah; Heyman, Isobel

    2014-01-01

    Objective Many adolescents with obsessive-compulsive disorder (OCD) do not have access to evidence-based treatment. A randomized controlled non-inferiority trial was conducted in a specialist OCD clinic to evaluate the effectiveness of telephone cognitive-behavioral therapy (TCBT) for adolescents with OCD compared to standard clinic-based, face-to-face CBT. Method Seventy-two adolescents, aged 11 through 18 years with primary OCD, and their parents were randomized to receive specialist TCBT or CBT. The intervention provided differed only in the method of treatment delivery. All participants received up to 14 sessions of CBT, incorporating exposure with response prevention (E/RP), provided by experienced therapists. The primary outcome measure was the Children’s Yale–Brown Obsessive-Compulsive Scale (CY-BOCS). Blind assessor ratings were obtained at midtreatment, posttreatment, 3-month, 6-month, and 12-month follow-up. Results Intent-to-treat analyses indicated that TCBT was not inferior to face-to-face CBT at posttreatment, 3-month, and 6-month follow-up. At 12-month follow-up, there were no significant between-group differences on the CY-BOCS, but the confidence intervals exceeded the non-inferiority threshold. All secondary measures confirmed non-inferiority at all assessment points. Improvements made during treatment were maintained through to 12-month follow-up. Participants in each condition reported high levels of satisfaction with the intervention received. Conclusion TCBT is an effective treatment and is not inferior to standard clinic-based CBT, at least in the midterm. This approach provides a means of making a specialized treatment more accessible to many adolescents with OCD. Clinical trial registration information–Evaluation of telephone-administered cognitive-behaviour therapy (CBT) for young people with obsessive-compulsive disorder (OCD); http://www.controlled-trials.com; ISRCTN27070832. PMID:25457928

  3. Effect of sodium bicarbonate-buffered lidocaine on the success of inferior alveolar nerve block for teeth with symptomatic irreversible pulpitis: a prospective, randomized double-blind study.

    Science.gov (United States)

    Saatchi, Masoud; Khademi, Abbasali; Baghaei, Badri; Noormohammadi, Hamid

    2015-01-01

    The purpose of this prospective, randomized, double-blind study was to compare the anesthetic efficacy of buffered with nonbuffered 2% lidocaine with 1:80,000 epinephrine solution for inferior alveolar nerve (IAN) block in patients with mandibular posterior teeth experiencing symptomatic irreversible pulpitis. Eighty adult patients diagnosed with symptomatic irreversible pulpitis of a mandibular posterior tooth were selected. The patients received 2 cartridges of either 2% lidocaine with 1:80,000 epinephrine buffered with 0.18 mL 8.4% sodium bicarbonate or 2% lidocaine with 1:80,000 epinephrine with 0.18 mL sterile distilled water using conventional IAN block injections. Endodontic access preparation was initiated 15 minutes after injection. Lip numbness was required for all the patients. Success was determined as no or mild pain on the basis of Heft-Parker visual analog scale recordings upon access cavity preparation or initial instrumentation. Data were analyzed by the t, Mann-Whitney, and chi-square tests. The success rates were 62.5% and 47.5% for buffered and nonbuffered groups, respectively, with no significant differences between the two groups (P = .381). Buffering the 2% lidocaine with 1:80,000 epinephrine with 8.4% sodium bicarbonate did not improve the success of the IAN block in mandibular molars in patients with symptomatic irreversible pulpitis. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  4. Clevidipine compared with nitroglycerin for blood pressure control in coronary artery bypass grafting: a randomized double-blind study.

    Science.gov (United States)

    Merry, Alan F; Avery, Edwin G; Nussmeier, Nancy A; Playford, Hugh R; Warman, Guy R; Wang, Yamei; Sladen, Robert N

    2014-05-01

    We tested the hypothesis that clevidipine, a rapidly acting dihydropyridine calcium channel blocker, is not inferior to nitroglycerin (NTG) in controlling blood pressure before cardiopulmonary bypass (CPB) during coronary artery bypass grafting (CABG). In this double-blind study from October 4, 2003 to April 26, 2004, 100 patients undergoing CABG with CPB were randomized at four centres to receive intravenous infusions of clevidipine (0.2-8 μg·kg(-1)·min(-1)) or NTG (0.4 μg·kg(-1)·min(-1) to a clinician-determined maximum dose rate) from induction of anesthesia through 12 hr postoperatively. The study drug was titrated in the pre-CPB period with the aim of maintaining mean arterial pressure (MAP) within ± 5 mmHg of a clinician-predetermined target. The primary endpoint was the area under the curve (AUC) for the total time each patient's MAP was outside the target range from drug initiation to the start of CPB, normalized per hour (AUCMAP-D). The predefined non-inferiority criterion for the primary endpoint was a 95% confidence interval (CI) upper limit no greater than 1.50 for the geometric means ratio between clevidipine and NTG. Total mean [standard deviation (SD)] dose pre-bypass was 4.5 (4.7) mg for clevidipine and 6.9 (5.4) mg for NTG (P blood pressure control pre-bypass.

  5. A Bayesian non-inferiority test for two independent binomial proportions.

    Science.gov (United States)

    Kawasaki, Yohei; Miyaoka, Etsuo

    2013-01-01

    In drug development, non-inferiority tests are often employed to determine the difference between two independent binomial proportions. Many test statistics for non-inferiority are based on the frequentist framework. However, research on non-inferiority in the Bayesian framework is limited. In this paper, we suggest a new Bayesian index τ = P(π₁  > π₂-Δ₀|X₁, X₂), where X₁ and X₂ denote binomial random variables for trials n1 and n₂, and parameters π₁ and π₂ , respectively, and the non-inferiority margin is Δ₀> 0. We show two calculation methods for τ, an approximate method that uses normal approximation and an exact method that uses an exact posterior PDF. We compare the approximate probability with the exact probability for τ. Finally, we present the results of actual clinical trials to show the utility of index τ. Copyright © 2013 John Wiley & Sons, Ltd.

  6. Efficacy of Ketorolac Buccal Infiltrations and Inferior Alveolar Nerve Blocks in Patients with Irreversible Pulpitis: A Prospective, Double-blind, Randomized Clinical Trial.

    Science.gov (United States)

    Akhlaghi, Nahid Mohammadzadeh; Hormozi, Behnoush; Abbott, Paul V; Khalilak, Zohreh

    2016-05-01

    The purpose of this prospective, randomized, double-blind, placebo-controlled study was to determine whether ketorolac buccal infiltrations (BIs) helped to improve the success of inferior alveolar nerve blocks (IANBs) in patients with acute irreversible pulpitis (AIP). Forty adult volunteers with AIP in a mandibular molar were included in this study. Patients were instructed to evaluate their pain by using a Heft-Parker visual analog scale. They were randomly divided into 2 groups (n = 20). All patients received standard IANB injection and after that a BI of 4% articaine with 1:100,000 epinephrine. After 5 minutes, 20 patients received a BI of 30 mg/mL ketorolac, and the other received a BI of normal saline (control group). Endodontic access cavity preparation (ACP) was initiated 15 minutes after the IANB when the patient reported lip numbness and had 2 electric pulp tests with no responses. The patient's pain during caries and dentin removal, ACP, and canal length measurements (CLM) was recorded by using Heft-Parker visual analog scale. Successful anesthesia was defined as no or mild pain during any of these steps, without the need for additional injection. Data were statistically analyzed by using Mann-Whitney U and χ(2) tests. Successful anesthesia after an IANB plus BI of articaine was obtained in 15% of patients in the control group at the end of CLM. Adding BI of ketorolac significantly increased the success rate to 40% (P < .05). Patient's pain during ACP and CLM was significantly lower in the ketorolac group (P < .05). Ketorolac BI can increase the success rate of anesthesia after IANB and BI with articaine in patients with AIP. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  7. Cerebellar projections to the red nucleus and inferior olive originate from separate populations of neurons in the rat: A non-fluorescent double labeling study

    NARCIS (Netherlands)

    T.M. Teune (Thea); J. van der Burg (Johannes); T.J.H. Ruigrok (Tom)

    1995-01-01

    textabstractIn the rat, the extent of collateralization of projections from the cerebellar nuclei to the red nucleus and inferior olive was investigated using a retrograde double labeling technique. The combination of tracers selected, cholera toxin-β-subunit and WGA-BSA-gold, not only enabled the

  8. 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.

    Science.gov (United States)

    Saha, Suparna Ganguly; Jain, Sohini; Dubey, Sandeep; Kala, Shubham; Misuriya, Abhinav; Kataria, Devendra

    2016-02-01

    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. 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. 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. 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 (pinferior alveolar block in patients with irreversible pulpitis than pre-medication with 50 mg DP & PLAC.

  9. Effect of Oral Premedication on the Efficacy of Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

    Science.gov (United States)

    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 (ppulpitis than pre-medication with 50 mg DP & PLAC. PMID

  10. Primary research on direct multi-slice spiral CT venography in inferior vena cava

    International Nuclear Information System (INIS)

    Gong Peiyou; Liu Fengli; Ma Xianying; Zhao Li; Wang Liping; Li Xuehua; Li Jian

    2010-01-01

    Objective: To investigate the superiority of direct multi-slice spiral CT venography in inferior vena cava. Methods: Twenty-eight patients performed MSCT venography in inferior vena cava, including 2 cases with both indirect and direct venography, 10 cases with indirect venography, 20 cases with direct venography through unilateral or bilateral lower extremity venous injection. The image quality and enhancement degree of the inferior vena cava were compared in double-blind method. Results: Of 10 cases with indirect venography of inferior vena cava, 1 case was failed due to mild enhancement in inferior vena cava. Image quality was good in 2 cases, poor in 7 cases, no excellent case. Of 20 cases with direct venography of inferior vena cava, the enhancement degree was scored 1, 2 degree in 16, 4 cases respectively and no case was scored 3 degree, the image quality was excellent, good in 16, 4 cases and no case was bad. The success rate was 100%. Conclusion: The image quality of direct MSCT venography in inferior vena cava is better than that of indirect method. (authors)

  11. A randomized, double-blind, multicentre study comparing daily 2 and 5 mg of tropisetron for the control of nausea and vomiting induced by low-dose cisplatin- or non-cisplatin-containing chemotherapy

    NARCIS (Netherlands)

    Wymenga, ANM; vanderGraaf, WTA; Wils, JA; vanHeukelom, LS; vanderLinden, GHM; DullemondWestland, AC; Nooy, M; vanderHeul, C; deBruijn, KM; deVries, EGE

    Background: This study compares efficacy safety and tolerability of 2 and 5 mg tropisetron in prevention of nausea and vomiting induced by low-dose cisplatin- or non-cisplatin-containing chemotherapy. Patients and methods: 152 chemotherapy-naive cancer patients were randomized in a double-blind

  12. Articaine and mepivacaine buccal infiltration in securing mandibular first molar pulp anesthesia following mepivacaine inferior alveolar nerve block: A randomized, double-blind crossover study

    Directory of Open Access Journals (Sweden)

    Giath Gazal

    2015-01-01

    Full Text Available Aims: A crossover double-blind, randomized study was designed to explore the efficacy of 2% mepivacaine with 1:100,000 adrenaline buccal infiltration and 4% articaine with 1:100,000 adrenaline buccal infiltration following 2% mepivacaine with 1:100,000 adrenaline inferior alveolar nerve block (IANB for testing pulp anesthesia of mandibular first molar teeth in adult volunteers. Materials and Methods: A total of 23 healthy adult volunteers received two regimens with at least 1-week apart; one with 4% articaine buccal infiltration and 2% mepivacaine IANB (articaine regimen and another with 2% mepivacaine buccal infiltration supplemented to 2% mepivacaine IANB (mepivacaine regimen. Pulp testing of first molar tooth was electronically measured twice at baseline, then at intervals of 2 min for the first 10 min, then every 5 min until 45 min postinjection. Anesthetic success was considered when two consecutive maximal stimulation on pulp testing readings without sensation were obtained within 10 min and continuously sustained for 45 min postinjection. Results: In total, the number of no sensations to maximum pulp testing for first molar teeth were significantly higher after articaine regimen than mepivacaine during 45 min postinjection (267 vs. 250 episodes, respectively, P 0.05. Interestingly, volunteers in the articaine regimen provided faster onset and longer duration (means 2.78 min, 42.22 min, respectively than mepivacaine regimen (means 4.26 min, 40.74 min, respectively for first molar pulp anesthesia (P < 0.001. Conclusions: Supplementary mepivacaine and articaine buccal infiltrations produced similar successful first molar pulp anesthesia following mepivacaine IANB injections in volunteers. Articaine buccal infiltration produced faster onset and longer duration than mepivacaine buccal infiltration following mepivacaine IANB injections.

  13. Articaine and mepivacaine buccal infiltration in securing mandibular first molar pulp anesthesia following mepivacaine inferior alveolar nerve block: A randomized, double-blind crossover study.

    Science.gov (United States)

    Gazal, Giath; Alharbi, Abdullah Muteb; Al-Samadani, Khalid HidayatAllah; Kanaa, Mohammad Dib

    2015-01-01

    A crossover double-blind, randomized study was designed to explore the efficacy of 2% mepivacaine with 1:100,000 adrenaline buccal infiltration and 4% articaine with 1:100,000 adrenaline buccal infiltration following 2% mepivacaine with 1:100,000 adrenaline inferior alveolar nerve block (IANB) for testing pulp anesthesia of mandibular first molar teeth in adult volunteers. A total of 23 healthy adult volunteers received two regimens with at least 1-week apart; one with 4% articaine buccal infiltration and 2% mepivacaine IANB (articaine regimen) and another with 2% mepivacaine buccal infiltration supplemented to 2% mepivacaine IANB (mepivacaine regimen). Pulp testing of first molar tooth was electronically measured twice at baseline, then at intervals of 2 min for the first 10 min, then every 5 min until 45 min postinjection. Anesthetic success was considered when two consecutive maximal stimulation on pulp testing readings without sensation were obtained within 10 min and continuously sustained for 45 min postinjection. In total, the number of no sensations to maximum pulp testing for first molar teeth were significantly higher after articaine regimen than mepivacaine during 45 min postinjection (267 vs. 250 episodes, respectively, P 0.05). Interestingly, volunteers in the articaine regimen provided faster onset and longer duration (means 2.78 min, 42.22 min, respectively) than mepivacaine regimen (means 4.26 min, 40.74 min, respectively) for first molar pulp anesthesia (P < 0.001). Supplementary mepivacaine and articaine buccal infiltrations produced similar successful first molar pulp anesthesia following mepivacaine IANB injections in volunteers. Articaine buccal infiltration produced faster onset and longer duration than mepivacaine buccal infiltration following mepivacaine IANB injections.

  14. Comparison of Effect of Oral Premedication with Ibuprofen or Dexamethasone on Anesthetic Efficacy of Inferior Alveolar Nerve Block in Patients with Irreversible Pulpitis: A Prospective, Randomized, Controlled, Double-blind Study.

    Science.gov (United States)

    Bidar, Maryam; Mortazavi, Soheil; Forghani, Maryam; Akhlaghi, Saeed

    2017-01-01

    The purpose of this prospective, randomized, double-blind, placebo-controlled study was to determine the effect of preoperative oral administration of ibuprofen or dexamethasone on the success rate of inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis. Seventy-eight patients with irreversible pulpitis were randomly divided into 3 groups (26 per group) and given one of the following at 1 hr prior to performing local anesthesia: a placebo; 400 mg ibuprofen; or 4 mg dexamethasone. Each patient recorded their pain level on a visual analog scale before taking the medication or placebo, at 15 min after completion of IANB, and during treatment if pain occurred. The success of the anesthesia was defined as no or mild pain at any stage during the endodontic procedure. The success rate of the IANB was 38.5, 73.1, and 80.8% with the placebo, ibuprofen, and dexamethasone, respectively. Both ibuprofen and dexamethasone were significantly more effective than the placebo. No significant difference was observed, however, between the two experimental medications in terms of effectiveness. The results of the present study suggest that premedication with ibuprofen or dexamethasone increases the success rate of an IANB in patients with symptomatic irreversible pulpitis in the mandibular molars.

  15. Randomized, double-blind, placebo-controlled study of Malarone for malaria prophylaxis in non-immune Colombian soldiers.

    Science.gov (United States)

    Soto, Jaime; Toledo, Julia; Luzz, Magda; Gutierrez, Patricia; Berman, Jonathan; Duparc, Stephane

    2006-09-01

    Malarone was compared with placebo in a double-blind, randomized, placebo-controlled trial of prophylaxis of malaria in predominately Plasmodium vivax areas of Colombia. The study population consisted of 180 completely non-immune Colombian soldiers, male, average age 19 years, and average weight 63 kg. Twenty-four subjects were considered unevaluable because of compliance issues, including one Malarone subject (with no detectable drug levels) who became infected with P. vivax. Of the 97 evaluable subjects who received Malarone (250 mg atovaquone plus 100 mg proguanil hydrochloride) daily from 1 day before entering the endemic area to 7 days after leaving the endemic area, none became parasitemic. Of the 46 evaluable placebo subjects, 11 became infected with P. vivax and 2 became infected with Plasmodium falciparum. The protective efficacy of Malarone for all malaria and for P. vivax malaria was 100% (LL 95% CI = 63%) and 100% (LL 95% CI = 58%), respectively, and was 96% if the one case with undetectable blood levels was included. Malarone has high protective efficacy for P. vivax in Colombia.

  16. Double-blind, placebo-controlled food challenge with apple

    DEFF Research Database (Denmark)

    Skamstrup Hansen, K; Vestergaard, H; Stahl Skov, P

    2001-01-01

    The aim of the study was to develop and evaluate different methods of double-blind, placebo-controlled food challenge (DBPCFC) with apple. Three different DBPCFC models were evaluated: fresh apple juice, freshly grated apple, and freeze-dried apple powder. All challenges were performed outside...... frequency of reactions to placebo, probably due to the ingredients used for blinding. The sensitivity of the models with freshly grated apple and freeze-dried apple powder was 0.74/0.60. An increase in sensitivity is desirable. The freeze-dried apple powder proved to be useful for SPT, HR, and oral...

  17. Detecting and accounting for violations of the constancy assumption in non-inferiority clinical trials.

    Science.gov (United States)

    Koopmeiners, Joseph S; Hobbs, Brian P

    2018-05-01

    Randomized, placebo-controlled clinical trials are the gold standard for evaluating a novel therapeutic agent. In some instances, it may not be considered ethical or desirable to complete a placebo-controlled clinical trial and, instead, the placebo is replaced by an active comparator with the objective of showing either superiority or non-inferiority to the active comparator. In a non-inferiority trial, the experimental treatment is considered non-inferior if it retains a pre-specified proportion of the effect of the active comparator as represented by the non-inferiority margin. A key assumption required for valid inference in the non-inferiority setting is the constancy assumption, which requires that the effect of the active comparator in the non-inferiority trial is consistent with the effect that was observed in previous trials. It has been shown that violations of the constancy assumption can result in a dramatic increase in the rate of incorrectly concluding non-inferiority in the presence of ineffective or even harmful treatment. In this paper, we illustrate how Bayesian hierarchical modeling can be used to facilitate multi-source smoothing of the data from the current trial with the data from historical studies, enabling direct probabilistic evaluation of the constancy assumption. We then show how this result can be used to adapt the non-inferiority margin when the constancy assumption is violated and present simulation results illustrating that our method controls the type-I error rate when the constancy assumption is violated, while retaining the power of the standard approach when the constancy assumption holds. We illustrate our adaptive procedure using a non-inferiority trial of raltegravir, an antiretroviral drug for the treatment of HIV.

  18. Efficacy of high doses of penicillin versus amoxicillin in the treatment of uncomplicated community acquired pneumonia in adults. A non-inferiority controlled clinical trial.

    Science.gov (United States)

    Llor, Carl; Pérez, Almudena; Carandell, Eugenia; García-Sangenís, Anna; Rezola, Javier; Llorente, Marian; Gestoso, Salvador; Bobé, Francesc; Román-Rodríguez, Miguel; Cots, Josep M; Hernández, Silvia; Cortés, Jordi; Miravitlles, Marc; Morros, Rosa

    2017-10-20

    Community-acquired pneumonia (CAP) is treated with penicillin in some northern European countries. To evaluate whether high-dose penicillin V is as effective as high-dose amoxicillin for the treatment of non-severe CAP. Multicentre, parallel, double-blind, controlled, randomized clinical trial. 31 primary care centers in Spain. Patients from 18 to 75 years of age with no significant associated comorbidity and with symptoms of lower respiratory tract infection and radiological confirmation of CAP were randomized to receive either penicillin V 1.6 million units, or amoxicillin 1000mg three times per day for 10 days. The main outcome was clinical cure at 14 days, and the primary hypothesis was that penicillin V would be non-inferior to amoxicillin with regard to this outcome, with a margin of 15% for the difference in proportions. EudraCT register 2012-003511-63. A total of 43 subjects (amoxicillin: 28; penicillin: 15) were randomized. Clinical cure was observed in 10 (90.9%) patients assigned to penicillin and in 25 (100%) patients assigned to amoxicillin with a difference of -9.1% (95% CI, -41.3% to 6.4%; p=.951) for non-inferiority. In the intention-to-treat analysis, amoxicillin was found to be 28.6% superior to penicillin (95% CI, 7.3-58.1%; p=.009 for superiority). The number of adverse events was similar in both groups. There was a trend favoring high-dose amoxicillin versus high-dose penicillin in adults with uncomplicated CAP. The main limitation of this trial was the low statistical power due to the low number of patients included. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  19. New validated recipes for double-blind placebo-controlled low-dose food challenges.

    Science.gov (United States)

    Winberg, Anna; Nordström, Lisbeth; Strinnholm, Åsa; Nylander, Annica; Jonsäll, Anette; Rönmark, Eva; West, Christina E

    2013-05-01

    Double-blind placebo-controlled food challenges are considered the most reliable method to diagnose or rule out food allergy. Despite this, there are few validated challenge recipes available. The present study aimed to validate new recipes for low-dose double-blind placebo-controlled food challenges in school children, by investigating whether there were any sensory differences between the active materials containing cow's milk, hen's egg, soy, wheat or cod, and the placebo materials. The challenge materials contained the same hypoallergenic amino acid-based product, with or without added food allergens. The test panels consisted of 275 school children, aged 8-10 and 14-15 yr, respectively, from five Swedish schools. Each participant tested at least one recipe. Standardized blinded triangle tests were performed to investigate whether any sensory differences could be detected between the active and placebo materials. In our final recipes, no significant differences could be detected between the active and placebo materials for any challenge food (p > 0.05). These results remained after stratification for age and gender. The taste of challenge materials was acceptable, and no unfavourable side effects related to test materials were observed. In summary, these new validated recipes for low-dose double-blinded food challenges contain common allergenic foods in childhood; cow's milk, hen's egg, soy, wheat and cod. All test materials contain the same liquid vehicle, which facilitates preparation and dosing. Our validated recipes increase the range of available recipes, and as they are easily prepared and dosed, they may facilitate the use of double-blind placebo-controlled food challenges in daily clinical practice. © 2013 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.

  20. Validation and acceptability of double-blind, placebo-controlled food challenges in children

    NARCIS (Netherlands)

    Venter, Carina; Maslin, Kate; Patil, Veeresh; Grundy, Jane; Glasbey, Gillian; Raza, Abid; Vlieg-Boerstra, Berber; Dean, Taraneh

    2016-01-01

    The Double Blind Placebo Controlled Food Challenge (DBPCFC) is considered the gold standard for food allergy diagnosis (1, 2). It is recommended that active and placebo challenge foods for DBPCFCs are sufficiently blinded in terms of smell, flavour and texture. Difficulties arise with children

  1. Efficacy and complications associated with a modified inferior alveolar nerve block technique. A randomized, triple-blind clinical trial.

    Science.gov (United States)

    Montserrat-Bosch, Marta; Figueiredo, Rui; Nogueira-Magalhães, Pedro; Arnabat-Dominguez, Josep; Valmaseda-Castellón, Eduard; Gay-Escoda, Cosme

    2014-07-01

    To compare the efficacy and complication rates of two different techniques for inferior alveolar nerve blocks (IANB). A randomized, triple-blind clinical trial comprising 109 patients who required lower third molar removal was performed. In the control group, all patients received an IANB using the conventional Halsted technique, whereas in the experimental group, a modified technique using a more inferior injection point was performed. A total of 100 patients were randomized. The modified technique group showed a significantly higher onset time in the lower lip and chin area, and was frequently associated to a lingual electric discharge sensation. Three failures were recorded, 2 of them in the experimental group. No relevant local or systemic complications were registered. Both IANB techniques used in this trial are suitable for lower third molar removal. However, performing an inferior alveolar nerve block in a more inferior position (modified technique) extends the onset time, does not seem to reduce the risk of intravascular injections and might increase the risk of lingual nerve injuries.

  2. randomised double blind study to compare effectiveness of honey

    African Journals Online (AJOL)

    2014-02-02

    Feb 2, 2014 ... EAsT AFRICAN MEDICAL JOURNAL. February 2014 .... based randomised double- blinded clinical trial evaluating effectiveness of ... study drugs was undertaken following a random ... included sodium citrate, citric acid monohydrate, ... post-hoc test to carry out pair-wise comparisons of .... self-care market.

  3. Double-Blinding and Bias in Medication and Cognitive-Behavioral Therapy Trials for Major Depressive Disorder [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Douglas Berger

    2015-08-01

    Full Text Available While double-blinding is a crucial aspect of study design in an interventional clinical trial of medication for a disorder with subjective endpoints such as major depressive disorder, psychotherapy clinical trials, particularly cognitive-behavioral therapy trials, cannot be double-blinded. This paper highlights the evidence-based medicine problem of double-blinding in the outcome research of a psychotherapy and opines that psychotherapy clinical trials should be called, “partially-controlled clinical data” because they are not double-blinded. The implications for practice are, 1. For practitioners to be clear with patients the level of rigor to which interventions have been studied, 2. For authors of psychotherapy outcome studies to be clear that the problem in the inability to blind a psychotherapy trial severely restricts the validity of any conclusions that can be drawn, and 3. To petition National Health Insurance plans to use caution in approving interventions studied without double-blinded confirmatory trials as they may lead patients to avoid other treatments shown to be effective in double-blinded trials.

  4. Comparative Evaluation of Mental Incisal Nerve Block, Inferior Alveolar Nerve Block, and Their Combination on the Anesthetic Success Rate in Symptomatic Mandibular Premolars: A Randomized Double-blind Clinical Trial.

    Science.gov (United States)

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

    2016-06-01

    The purpose of this study was to compare the effectiveness of mental incisive nerve block (MINB) and inferior alveolar nerve block (IANB) that were given alone or in combination to provide anesthesia to symptomatic mandibular premolars. One hundred fifty-three patients participated in this randomized, double-blind clinical trial. The patients were divided into 3 groups; first group received MINB with 2 mL 2% lidocaine with 1:200,000 epinephrine and a mock IANB with 2 mL sterile saline, patients in group 2 received mock MINB and an IANB with 2 mL 2% lidocaine, and patients in group 3 received both MINB and IANB with 2 mL each of 2% lidocaine. Access cavity preparation was initiated after 10 minutes. Success was defined as no pain or faint/weak/mild pain during endodontic access preparation and instrumentation. The anesthetic success rates were analyzed with Pearson χ(2) test at 5% significance levels. The MINB and IANB gave 53% and 47% anesthetic success rates, respectively, with no significant difference between them. Adding an IANB to MINB significantly improved the success rates to 82%. A combination of MINB and IANB can provide improved local anesthesia for symptomatic mandibular premolars. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  5. Effect of Buffered 4% Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Randomized, Double-blind Study.

    Science.gov (United States)

    Schellenberg, Jared; Drum, Melissa; Reader, Al; Nusstein, John; Fowler, Sara; Beck, Mike

    2015-06-01

    Medical studies have suggested that buffering local anesthetic may increase the ability to achieve anesthesia. The purpose of this study was to determine the effect of 4% buffered lidocaine on the anesthetic success of the inferior alveolar nerve (IAN) block in patients experiencing symptomatic irreversible pulpitis. One hundred emergency patients diagnosed with symptomatic irreversible pulpitis of a mandibular posterior tooth randomly received a conventional IAN block using either 2.8 mL 4% lidocaine with 1:100,000 epinephrine or 2.8 mL 4% lidocaine with 1:100,000 epinephrine buffered with sodium bicarbonate in a double-blind manner. For the buffered solution, each cartridge was buffered with 8.4% sodium bicarbonate using the OnPharma (Los Gatos, CA) system to produce a final concentration of 0.18 mEq/mL sodium bicarbonate. Fifteen minutes after administration of the IAN block, profound lip numbness was confirmed, and endodontic access was initiated. Success was defined as no or mild pain (≤54 mm on a 170-mm visual analog scale) on access or instrumentation of the root canal. The success rate for the IAN block was 32% for the buffered group and 40% for the nonbuffered group, with no significant difference (P = .4047) between the groups. Injection pain ratings for the IAN block were not significantly (P = .9080) different between the 2 formulations. For mandibular posterior teeth, a 4% buffered lidocaine formulation did not result in a statistically significant increase in the success rate or a decrease in injection pain of the IAN block in patients with symptomatic irreversible pulpitis. Copyright © 2015. Published by Elsevier Inc.

  6. A double-blind placebo controlled trial of paroxetine in the ...

    African Journals Online (AJOL)

    A double-blind placebo controlled trial of paroxetine in the management of social phobia (social anxiety disorder) in South Africa. Dan J. Stein, Michael Berk, Charl Els, Robin A. Emsley, Leon Gittelson, Don Wilson, Rosemary Oakes, Brian Hunter ...

  7. Validation of novel recipes for double-blind, placebo-controlled food challenges in children and adults

    NARCIS (Netherlands)

    Vlieg-Boerstra, B. J.; Herpertz, I.; Pasker, L.; van der Heide, S.; Kukler, J.; Jansink, C.; Vaessen, W.; Beusekamp, B. J.; Dubois, A. E. J.

    P>Background: In double-blind, placebo-controlled food challenges (DBPCFCs), the use of challenge materials in which blinding is validated is a prerequisite for obtaining true blinded conditions during the test procedure. Therefore, the aim of this study was to enlarge the available range of

  8. Cassava flour slurry as a low-cost alternative to commercially available gel for obstetrical ultrasound: a blinded non-inferiority trial comparison of image quality.

    Science.gov (United States)

    Aziz, A; Dar, P; Hughes, F; Solorzano, C; Muller, M M; Salmon, C; Salmon, M; Benfield, N

    2018-01-12

    To evaluate the quality of ultrasound images obtained with cassava flour slurry (CFS) compared with conventional gel in order to determine objectively whether CFS could be a true low-cost alternative. Blinded non-inferiority trial. Obstetrical ultrasound unit in an academic medical centre. Women with a singleton pregnancy, undergoing anatomy ultrasounds. Thirty pregnant women had standard biometry measures obtained with CFS and conventional gel. Images were compared side-by-side in random order by two blinded sonologists and rated for image resolution, detail and total image quality using a 10-cm visual analogue scale. Ratings were compared using paired t-tests. Participant and sonographer experience was measured using five-point Likert scales. Image resolution, detail, and total image quality. Participant experience of gel regarding irritation, messiness, and ease of removal. We found no significant difference between perceived image quality obtained with CFS (mean = 6.2, SD = 1.2) and commercial gel (mean = 6.4, SD = 1.2) [t (28) = -1.1; P = 0.3]. Images were not rated significantly differently for either reviewer in any measure, any standardized image or any view of a specific anatomic structure. All five sonographers rated CFS as easy to obtain clear images and easy for patient and machine cleanup. Only one participant reported itching with CFS. CFS produces comparable image quality to commercial ultrasound gel. The dissemination of these results and the simple CFS recipe could significantly increase access to ultrasound for screening, monitoring and diagnostic purposes in resource-limited settings. This study was internally funded by our department. Low-cost homemade cassava flour slurry creates images equal to commercial ultrasound gel, improving access. © 2018 Royal College of Obstetricians and Gynaecologists.

  9. Validation of novel recipes for double-blind, placebo-controlled food challenges in children and adults

    NARCIS (Netherlands)

    Vlieg-Boerstra, B. J.; Herpertz, I.; Pasker, L.; van der Heide, S.; Kukler, J.; Jansink, C.; Vaessen, W.; Beusekamp, B. J.; Dubois, A. E. J.

    2011-01-01

    In double-blind, placebo-controlled food challenges (DBPCFCs), the use of challenge materials in which blinding is validated is a prerequisite for obtaining true blinded conditions during the test procedure. Therefore, the aim of this study was to enlarge the available range of validated recipes for

  10. Oral S-adenosylmethionine in primary fibromyalgia. Double-blind clinical evaluation

    DEFF Research Database (Denmark)

    Jacobsen, Søren; Danneskiold-Samsøe, B; Andersen, R B

    1991-01-01

    S-adenosylmethionine is a relatively new anti-inflammatory drug with analgesic and anti-depressant effects. Efficacy of 800 mg orally administered s-adenosylmethionine daily versus placebo for six weeks was investigated in 44 patients with primary fibromyalgia in double-blind settings. Tender poi...... effects on primary fibromyalgia and could be an important option in the treatment hereof.......S-adenosylmethionine is a relatively new anti-inflammatory drug with analgesic and anti-depressant effects. Efficacy of 800 mg orally administered s-adenosylmethionine daily versus placebo for six weeks was investigated in 44 patients with primary fibromyalgia in double-blind settings. Tender point...... = 0.03) and mood evaluated by Face Scale (P = 0.006) in the actively treated group compared to placebo. The tender point score, isokinetic muscle strength, mood evaluated by Beck Depression Inventory and side effects did not differ in the two treatment groups. S-adenosylmethionine has some beneficial...

  11. Design challenges in a double-blinded RCT study of music therapy for people suffering from szhizophrenia with negative symptoms

    DEFF Research Database (Denmark)

    Pedersen, Inge Nygaard

    2016-01-01

    . The study includes 120 participants. Participants in the experimental group become 25 hours of individual music therapy by specific trained music therapists working from a manual, wheras the control Group become 25 hours of being together with a care persone (trained by a music therapist) for music...... listening from a selected playlist. Ethical refelctions around the design will be presented, and the possibilities of keeping the examination process blinded or not blinded to the participants with be shared. As this examination is currently running, the focus will be on the Development of abd application...

  12. A randomized, double-blind, placebo-controlled crossover study of ...

    African Journals Online (AJOL)

    Erectile dysfunction (ED) is one of the major health concerns affects the quality of life among Thai male. The treatment of ED by the first-line drugs is limited to a certain group of patients due to their side effects and costs. Alternative medicine can be beneficial for the treatment of ED. This is a randomized, double-blind, ...

  13. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia

    DEFF Research Database (Denmark)

    Branco, Jaime C; Zachrisson, Olof; Perrot, Serge

    2010-01-01

    This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population.......This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population....

  14. Efficacy of flurbiprofen 8.75 mg delivered as a spray or lozenge in patients with sore throat due to upper respiratory tract infection: a randomized, non-inferiority trial in the Russian Federation

    Directory of Open Access Journals (Sweden)

    Radkova E

    2017-07-01

    Full Text Available Eugenia Radkova,1 Natalia Burova,2 Valeria Bychkova,3 Robert DeVito4 1OCT Clinical Trials, Saint Petersburg, Russia; 2Federal State Establishment Clinical Diagnostic Medical Center, Saint Petersburg, Russia; 3Reckitt Benckiser (Russia, Moscow, Russia; 4Reckitt Benckiser, Parsippany, NJ, USA Objective: To assess the efficacy of flurbiprofen 8.75 mg delivered as a spray or lozenge in patients with sore throat due to upper respiratory tract infection (URTI.Materials and methods: This multicenter, double-blind, double-dummy, non-inferiority study randomized 440 adults with recent-onset, moderate-to-severe sore throat due to URTI to a single dose of either flurbiprofen 8.75 mg spray (n=218 or flurbiprofen 8.75 mg lozenge (n=222. The presence or absence of beta-hemolytic streptococci (A or C was confirmed by culture tests (throat swab. The primary efficacy end point was the difference from baseline to 2 hours post-dose in sore throat pain intensity scale (STPIS pain intensity difference [PID] 2h, a validated 100 mm visual analog scale (from 0=“no pain” to 100=“severe pain”, with a non-inferiority margin of −6 mm. Secondary end points included STPIS PID at 1 hour (STPIS PID 1h and over 2 hours (STPIS sum of sore throat pain intensity differences [SPID]0–2h and ratings of patient satisfaction and investigator assessment of drug efficacy at 2 hours. Safety (adverse events [AEs] was also assessed.Results: Reductions in sore throat pain intensity at 2 hours (STPIS PID 2h were similar for spray (least square mean −40.51 and lozenge (−40.10 (difference: 0.41, 95% confidence interval [95% CI] −3.20, 4.01, with non-inferiority demonstrated. Subgroup analyses showed similar efficacy (STPIS PID 2h for patients testing positive or negative for Strep A or C. There was no significant difference between spray and lozenge in STPIS PID 1h or STPIS SPID0–2h, and patient satisfaction and investigators’ assessment of efficacy at 2

  15. Pain physiology education improves health status and endogenous pain inhibition in fibromyalgia: a double-blind randomized controlled trial.

    Science.gov (United States)

    Van Oosterwijck, Jessica; Meeus, Mira; Paul, Lorna; De Schryver, Mieke; Pascal, Aurelie; Lambrecht, Luc; Nijs, Jo

    2013-10-01

    There is evidence that education on pain physiology can have positive effects on pain, disability, and catastrophization in patients with chronic musculoskeletal pain disorders. A double-blind randomized controlled trial (RCT) was performed to examine whether intensive pain physiology education is also effective in fibromyalgia (FM) patients, and whether it is able to influence the impaired endogenous pain inhibition of these patients. Thirty FM patients were randomly allocated to either the experimental (receiving pain physiology education) or the control group (receiving pacing self-management education). The primary outcome was the efficacy of the pain inhibitory mechanisms, which was evaluated by spatially accumulating thermal nociceptive stimuli. Secondary outcome measures included pressure pain threshold measurements and questionnaires assessing pain cognitions, behavior, and health status. Assessments were performed at baseline, 2 weeks, and 3 months follow-up. Repeated measures ANOVAS were used to reveal possible therapy effects and effect sizes were calculated. After the intervention the experimental group had improved knowledge of pain neurophysiology (Pphysiology. Pain physiology education seems to be a useful component in the treatment of FM patients as it improves health status and endogenous pain inhibition in the long term.

  16. Exposure of eyes to perfume: a double-blind, placebo-controlled experiment.

    Science.gov (United States)

    Elberling, J; Duus Johansen, J; Dirksen, A; Mosbech, H

    2006-08-01

    Environmental perfume exposure can elicit bothersome respiratory symptoms. Symptoms are induced at exposure levels which most people find tolerable, and the mechanisms are unclear. The aim of the study was to investigate patients with eye and respiratory symptoms related to environmental perfume, by exposing the eyes to perfume in a double-blind, placebo-controlled study.Twenty-one eczema patients with respiratory symptoms elicited by perfume were compared with 21 healthy volunteers in a sex- and age-matched case-control study. The participants completed a symptom questionnaire, and underwent a double-blind, placebo-controlled exposure to perfume. Of the 42 individuals tested, 10 had more eye symptoms (irritation, itching, and tears) during perfume exposure than during placebo exposures, and eight of these individuals (P = 0.07, Fisher's exact test) belonged to the patient group. A true positive eye reaction to perfume was significantly associated with identification of perfume as an active exposure (P perfume elicited irritation in the eyes independently of olfaction, but the relative importance of ocular chemoperception in relation to elicitation of respiratory symptoms from common environmental exposures to perfume remains unclear. We investigated the hypothesis of an association between respiratory symptoms related to perfume and ocular perfume sensitivity by exposing the eyes to perfume in a double blind, placebo-controlled experiment. Vapors of perfume provoked symptoms in the relevant eye in some patients and healthy control persons, but under our exposure conditions, ocular chemesthesis failed to elicit respiratory symptoms.

  17. Study protocol: Brief intervention for medication overuse headache - A double-blinded cluster randomised parallel controlled trial in primary care

    Directory of Open Access Journals (Sweden)

    Kristoffersen Espen

    2012-08-01

    Full Text Available Abstract Background Chronic headache (headache ≥ 15 days/month for at least 3 months affects 2–5% of the general population. Medication overuse contributes to the problem. Medication-overuse headache (MOH can be identified by using the Severity of Dependence Scale (SDS. A “brief intervention” scheme (BI has previously been used for detoxification from drug and alcohol overuse in other settings. Short, unstructured, individualised simple information may also be enough to detoxify a large portion of those with MOH. We have adapted the structured (BI scheme to be used for MOH in primary care. Methods/Design A double-blinded cluster randomised parallel controlled trial (RCT of BI vs. business as usual. Intervention will be performed in primary care by GPs trained in BI. Patients with MOH will be identified through a simple screening questionnaire sent to patients on the GPs lists. The BI method involves an approach for identifying patients with high likelihood of MOH using simple questions about headache frequency and the SDS score. Feedback is given to the individual patient on his/her score and consequences this might have regarding the individual risk of medication overuse contributing to their headache. Finally, advice is given regarding measures to be taken, how the patient should proceed and the possible gains for the patient. The participating patients complete a headache diary and receive a clinical interview and neurological examination by a GP experienced in headache diagnostics three months after the intervention. Primary outcomes are number of headache days and number of medication days per month at 3 months. Secondary outcomes include proportions with 25 and 50% improvement at 3 months and maintenance of improvement and quality of life after 12 months. Discussion There is a need for evidence-based and cost-effective strategies for treatment of MOH but so far no consensus has been reached regarding an optimal medication

  18. Safety and efficacy of intra-articular injections of a combination of hyaluronic acid and mannitol (HAnOX-M) in patients with symptomatic knee osteoarthritis: Results of a double-blind, controlled, multicenter, randomized trial.

    Science.gov (United States)

    Conrozier, Thierry; Eymard, Florent; Afif, Naji; Balblanc, Jean-Charles; Legré-Boyer, Virginie; Chevalier, Xavier

    2016-10-01

    To compare both safety and efficacy of a novel intra-articular viscosupplement made of intermediate molecular weight (MW) hyaluronic acid (HA) mixed with high concentration of mannitol with a marketed high MW HA, in patients with knee osteoarthritis (OA). Patients with symptomatic knee OA, with radiological OARSI grades 1 to 3, were enrolled in a controlled, double-blind, parallel-group, non-inferiority trial. They were randomized to receive three intra-articular injections, at weekly intervals, of either HAnOX-M made of a combination of HA (MW one to 1.5MDa, 31mg/2ml) and mannitol (70mg/2ml) or Bio-HA (MW 2.3 to 3.6MDa, 20mg/2ml). The primary outcome was six-month change in the WOMAC pain subscale (0 to 20). Sample size was calculated according to a non-inferiority margin of 1.35. Secondary endpoints included six-month change in function and walking pain, analgesic consumption and safety. The intention-to-treat (ITT) and per-protocol (PP) populations consisted of 205 and 171 patients. HAnOX-M and Bio-Ha groups did not differ statistically at baseline. The primary analysis was conducted in the PP population, then in the ITT population. The average WOMAC pain score at baseline was 9.5 in both groups. Mean (SD) variations in WOMAC pain score were -4.4 (3.8) and -4.5 (4.3) mm, for HAnOX and Bio-HA respectively, satisfying the claim for non-inferiority. Similar results were obtained for all other secondary endpoints. Treatment with of HAnOX-M is effective to alleviate knee OA symptoms and to improve joint function over six months, with similar safety than conventional HA viscosupplement. Copyright © 2016. Published by Elsevier B.V.

  19. Aspartame Sensitivity? A Double Blind Randomised Crossover Study

    OpenAIRE

    Sathyapalan, Thozhukat; Thatcher, Natalie J.; Hammersley, Richard; Rigby, Alan S.; Pechlivanis, Alexandros; Gooderham, Nigel J.; Holmes, Elaine; le Roux, Carel W.; Atkin, Stephen L.; Courts, Fraser

    2015-01-01

    Background Aspartame is a commonly used intense artificial sweetener, being approximately 200 times sweeter than sucrose. There have been concerns over aspartame since approval in the 1980s including a large anecdotal database reporting severe symptoms. The objective of this study was to compare the acute symptom effects of aspartame to a control preparation. Methods This was a double-blind randomized cross over study conducted in a clinical research unit in United Kingdom. Forty-eight indivi...

  20. A 6 week randomized double-blind placebo-controlled trial of ziprasidone for the acute depressive mixed state.

    Directory of Open Access Journals (Sweden)

    Ashwin Patkar

    Full Text Available OBJECTIVE: To examine the efficacy of ziprasidone vs. placebo for the depressive mixed state in patients with bipolar disorder type II or major depressive disorder (MDD. METHODS: 73 patients were randomized in a double-blinded, placebo-controlled study to ziprasidone (40-160 mg/d or placebo for 6 weeks. They met DSM-IV criteria for a major depressive episode (MDE, while also meeting 2 or 3 (but not more nor less DSM-IV manic criteria. They did not meet DSM-IV criteria for a mixed or manic episode. Baseline psychotropic drugs were continued unchanged. The primary endpoint measured was Montgomery-Åsberg Depression Rating Scale (MADRS scores over time. The mean dose of ziprasidone was 129.7±45.3 mg/day and 126.1±47.1 mg/day for placebo. RESULTS: The primary outcome analysis indicated efficacy of ziprasidone versus placebo (p = 0.0038. Efficacy was more pronounced in type II bipolar disorder than in MDD (p = 0.036. Overall ziprasidone was well tolerated, without notable worsening of weight or extrapyramidal symptoms. CONCLUSIONS: There was a statistically significant benefit with ziprasidone versus placebo in this first RCT of any medication for the provisional diagnostic concept of the depressive mixed state. TRIAL REGISTRATION: Clinicaltrials.gov NCT00490542.

  1. A Double-Blind Gastroscopic Study of a Bismuth-Peptide Complex ...

    African Journals Online (AJOL)

    Forty courses of treatment with bicitropeptide (BCP) were administered to 30 patients with gastric ulcers, in a double-blind crossover trial. Healing was judged gastro- scopically after 4 weeks, at which time 79% of ulcers had healed on BCP and 35% on placebo (P

  2. The Effect of 2 Injection Speeds on Local Anesthetic Discomfort During Inferior Alveolar Nerve Blocks.

    Science.gov (United States)

    de Souza Melo, Marcelo Rodrigo; Sabey, Mark Jon Santana; Lima, Carla Juliane; de Almeida Souza, Liane Maciel; Groppo, Francisco Carlos

    2015-01-01

    This randomized double-blind crossover trial investigated the discomfort associated with 2 injection speeds, low (60 seconds) and slow (100 seconds), during inferior alveolar nerve block by using 1.8 mL of 2% lidocaine with 1 : 100,000 epinephrine. Three phases were considered: (a) mucosa perforation, (b) needle insertion, and (c) solution injection. Thirty-two healthy adult volunteers needing bilateral inferior alveolar nerve blocks at least 1 week apart were enrolled in the present study. The anesthetic procedure discomfort was recorded by volunteers on a 10-cm visual analog scale in each phase for both injection speeds. Comparison between the 2 anesthesia speeds in each phase was performed by paired t test. Results showed no statistically significant difference between injection speeds regarding perforation (P = .1016), needle placement (P = .0584), or speed injection (P = .1806). The discomfort in all phases was considered low. We concluded that the 2 injection speeds tested did not affect the volunteers' pain perception during inferior alveolar nerve blocks.

  3. Double blind clinical trail comparing the safety and efficacy of ...

    African Journals Online (AJOL)

    Double blind clinical trail comparing the safety and efficacy of nimesulide (100g) and diclofenac in osteoarthrosis of the hip and knee joints. ... A significant proportion of the patients in the diclofenac group (50% vs 17.6%) had break through pain that warranted the use of at least two tablets of 500mg of paracetamol per week ...

  4. Rethinking non-inferiority: a practical trial design for optimising treatment duration.

    Science.gov (United States)

    Quartagno, Matteo; Walker, A Sarah; Carpenter, James R; Phillips, Patrick Pj; Parmar, Mahesh Kb

    2018-06-01

    Background Trials to identify the minimal effective treatment duration are needed in different therapeutic areas, including bacterial infections, tuberculosis and hepatitis C. However, standard non-inferiority designs have several limitations, including arbitrariness of non-inferiority margins, choice of research arms and very large sample sizes. Methods We recast the problem of finding an appropriate non-inferior treatment duration in terms of modelling the entire duration-response curve within a pre-specified range. We propose a multi-arm randomised trial design, allocating patients to different treatment durations. We use fractional polynomials and spline-based methods to flexibly model the duration-response curve. We call this a 'Durations design'. We compare different methods in terms of a scaled version of the area between true and estimated prediction curves. We evaluate sensitivity to key design parameters, including sample size, number and position of arms. Results A total sample size of ~ 500 patients divided into a moderate number of equidistant arms (5-7) is sufficient to estimate the duration-response curve within a 5% error margin in 95% of the simulations. Fractional polynomials provide similar or better results than spline-based methods in most scenarios. Conclusion Our proposed practical randomised trial 'Durations design' shows promising performance in the estimation of the duration-response curve; subject to a pending careful investigation of its inferential properties, it provides a potential alternative to standard non-inferiority designs, avoiding many of their limitations, and yet being fairly robust to different possible duration-response curves. The trial outcome is the whole duration-response curve, which may be used by clinicians and policymakers to make informed decisions, facilitating a move away from a forced binary hypothesis testing paradigm.

  5. A randomised clinical trial (RCT) of a symbiotic mixture in patients with irritable bowel syndrome (IBS): effects on symptoms, colonic transit and quality of life.

    Science.gov (United States)

    Cappello, Carmelina; Tremolaterra, Fabrizio; Pascariello, Annalisa; Ciacci, Carolina; Iovino, Paola

    2013-03-01

    The aim of this study is to test in a double-blinded, randomised placebo-controlled study the effects of a commercially available multi-strain symbiotic mixture on symptoms, colonic transit and quality of life in irritable bowel syndrome (IBS) patients who meet Rome III criteria. There is only one other double-blinded RCT on a single-strain symbiotic mixture in IBS. This is a double-blinded, randomised placebo-controlled study of a symbiotic mixture (Probinul, 5 g bid) over 4 weeks after 2 weeks of run-in. The primary endpoints were global satisfactory relief of abdominal flatulence and bloating. Responders were patients who reported at least 50 % of the weeks of treatment with global satisfactory relief. The secondary endpoints were change in abdominal bloating, flatulence, pain and urgency by a 100-mm visual analog scale, stool frequency and bowel functions on validated adjectival scales (Bristol Scale and sense of incomplete evacuation). Pre- and post-treatment colonic transit time (Metcalf) and quality of life (SF-36) were assessed. Sixty-four IBS patients (symbiotic n = 32, 64 % females, mean age 38.7 ± 12.6 years) were studied. This symbiotic mixture reduced flatulence over a 4-week period of treatment (repeated-measures analysis of covariance, p symbiotic group. This symbiotic mixture has shown a beneficial effect in decreasing the severity of flatulence in IBS patients, a lack of adverse events and a good side-effect profile; however, it failed to achieve an improvement in global satisfactory relief of abdominal flatulence and bloating. Further studies are warranted.

  6. The role of mineral elements and other chemical compounds used in balneology: data from double-blind randomized clinical trials

    Science.gov (United States)

    Morer, Carla; Roques, Christian-François; Françon, Alain; Forestier, Romain; Maraver, Francisco

    2017-12-01

    The aims of this study were to conduct a systematic literature review on balneotherapy about the specific therapeutic role of mineral elements and other chemical compounds of mineral waters and derivate peloids/muds and to discuss the study methods used to evaluate it (in musculoskeletal conditions). We searched Medline by PubMed using the following key words: "spa therapy" "balneotherapy" "mud" "peloid" "mud pack Therapy" in combination with "randomized controlled trial" "double blind trial." We also reviewed the reference list of articles retrieved by the Medline search. We selected the double-blind randomized clinical trials that assessed the effects of mineral water or mud treatments compared to tap water, attenuated peloid/mud therapy or similar treatments without the specific minerals or chemical compounds of the treatment group ("non-mineral"). We evaluated the internal validity and the quality of the statistical analysis of these trials. The final selection comprised 27 double-blind randomized clinical trials, 20 related to rheumatology. A total of 1118 patients with rheumatological and other musculoskeletal diseases were evaluated in these studies: 552 of knee osteoarthritis, 47 of hand osteoarthritis, 147 chronic low back pain, 308 of reumathoid arthritis, and 64 of osteoporosis; 293 of these participants were assigned to the experimental groups of knee osteoarthritis, 24 in hand osteoarthritis, 82 of low back pain, 152 with reumathoid arthritis, and 32 with osteoporosis. They were treated with mineral water baths and/or mud/peloid (with or without other forms of treatment, like physical therapy, exercise…). The rest were allocated to the control groups; they received mainly tap water and/or "non-mineral" mud/peloid treatments. Mineral water or mud treatments had better and longer improvements in pain, function, quality of life, clinical parameters, and others in some rheumatologic diseases (knee and hand osteoarthritis, chronic low back pain

  7. TVT-O vs. TVT for the treatment of SUI: a non-inferiority study.

    Science.gov (United States)

    Yang, Xiang; Jiang, Min; Chen, Xinliang; Tong, Xiaowen; Li, Huaifang; Qiu, Jin; Shao, Lingyun

    2012-01-01

    This study aimed to prospectively compare, in terms of efficacy and safety, the tension-free vaginal tape (TVT) and the transobturator vaginal tape inside-out (TVT-O) procedure for stress urinary incontinence. A cough stress test was applied to the objective outcomes, while urinary incontinence-specific quality of life questionnaire was applied to the subjective outcomes. A test for non-inferiority was carried out for detecting the success rate between the two groups. The objective success rates were found to be 95.4% (62/65) in the TVT group and 96.4% (108/112) in the TVT-O group. No significant difference was found between these two groups in the success rate by non-inferiority test (P 0.05). In the study, the TVT-O procedure could be defined to be identical to the TVT approach in success rate by non-inferiority test.

  8. Serum complement changes during double-blind food challenges in children with a history of food sensitivity.

    Science.gov (United States)

    Martin, M E; Guthrie, L A; Bock, S A

    1984-04-01

    Serum levels of C3, C4, factor B, properdin, total hemolytic complement and alternative-pathway hemolytic activity were measured before and after double-blind food challenge in 23 children with impressive histories of adverse reactions to foods. The 23 subjects had 11 positive food challenges and 12 negative food challenges. Nine patients with reagin-mediated positive food challenges showed increases in all six complement assays after double-blind food challenge, while the group with negative food challenges showed decreases in five of the six assays. The difference between the two groups for complement changes after double-blind food challenge was significant only for the alternative-pathway assay. Individual subject analysis revealed markedly heterogeneous changes in direction and magnitude within both groups for all complement assays. Therefore, it is concluded that measurement of serum complement levels is not a useful test for the clinical evaluation of a patient with suspected food sensitivity.

  9. Efficacy of Bee Venom Acupuncture for Chronic Low Back Pain: A Randomized, Double-Blinded, Sham-Controlled Trial

    OpenAIRE

    Seo, Byung-Kwan; Han, Kyungsun; Kwon, Ojin; Jo, Dae-Jean; Lee, Jun-Hwan

    2017-01-01

    Bee venom acupuncture (BVA) is an effective treatment for chronic low back pain (CLBP) through the pharmacological effects of bee venom and the simultaneous stimulation of acupoints. However, evidence of its efficacy and safety in humans remains unclear. Using a double-blind, randomized study, 54 patients with non-specific CLBP were assigned to the BVA and sham groups. All participants underwent six sessions of real or sham BVA for 3 weeks, in addition to administration of 180 mg of loxonin p...

  10. ADHD and EEG-neurofeedback: a double-blind randomized placebo-controlled feasibility study

    NARCIS (Netherlands)

    Lansbergen, M.M.; Dongen-Boomsma, M. van; Buitelaar, J.K.; Slaats-Willemse, D.I.E.

    2011-01-01

    Electroencephalography (EEG)-neurofeedback has been shown to offer therapeutic benefits to patients with attention-deficit/hyperactivity disorder (ADHD) in several, mostly uncontrolled studies. This pilot study is designed to test the feasibility and safety of using a double-blind placebo

  11. 75 FR 9228 - Draft Guidance for Industry on Non-Inferiority Clinical Trials; Availability

    Science.gov (United States)

    2010-03-01

    ... regulatory, study design, scientific, and statistical issues associated with the use of non-inferiority... as the advantages and disadvantages of available methods. The third part addresses commonly asked...- inferiority clinical trials. It does not create or confer any rights for or on any person and does not operate...

  12. A multiple-dose, double-blind comparison of intramuscularly and orally administered ketorolac tromethamine and Ketogan in patients with pain following orthopaedic surgery

    DEFF Research Database (Denmark)

    Gebuhr, Peter Henrik; Soelberg, M; Strauss, W

    1994-01-01

    In this multiple-dose, double-blind study 100 patients with moderate, severe or very severe pain following orthopaedic surgery were randomly assigned to receive ketorolac, a non-steroidal anti-inflammatory drug with potent analgesic properties (10 mg), or the standard regimen of Ketogan (a combin......-mg doses of oral ketorolac are as effective as Ketogan for the treatment of pain following orthopaedic surgery. Ketorolac appears to be better tolerated than Ketogan since significantly fewer patients reported adverse events (P = 0.004) when taking ketorolac.......In this multiple-dose, double-blind study 100 patients with moderate, severe or very severe pain following orthopaedic surgery were randomly assigned to receive ketorolac, a non-steroidal anti-inflammatory drug with potent analgesic properties (10 mg), or the standard regimen of Ketogan (a...... combination product containing the narcotic analgesic, ketobemidone, plus a spasmolytic agent) by intramuscular injection every 1-6 h as needed for pain. When patients were able to tolerate an oral diet and were expected to respond to oral analgesic medication, based on overall pain sensitivity, they were...

  13. Effect of a Combination of Intranasal Ketorolac and Nitrous Oxide on the Success of the Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Randomized, Double-blind Study.

    Science.gov (United States)

    Stentz, Daniel; Drum, Melissa; Reader, Al; Nusstein, John; Fowler, Sara; Beck, Mike

    2018-01-01

    Previous studies in patients with irreversible pulpitis have reported increased success of the inferior alveolar nerve block (IANB) using premedication with ketorolac. Preemptive nitrous oxide administration has also shown an increase in the success of the IANB. Recently, ketorolac has been made available for intranasal delivery. Perhaps combining ketorolac and nitrous oxide would increase success. Therefore, the purpose of this prospective, randomized, double-blind study was to determine the effect of a combination of intranasal ketorolac and nitrous oxide/oxygen on the anesthetic success of the IANB in patients presenting with symptomatic irreversible pulpitis. One hundred two patients experiencing spontaneous moderate to severe pain with symptomatic irreversible pulpitis in a mandibular posterior tooth participated. Patients were randomly divided into 2 groups and received either 31.5 mg intranasal ketorolac or intranasal saline placebo 20 minutes before the administration of nitrous oxide/oxygen. Ten minutes after the administration of nitrous oxide/oxygen, the IANB was given. After profound lip numbness, endodontic treatment was performed. Success was defined as the ability to perform endodontic access and instrumentation with no pain or mild pain. The odds of success for the IANB was 1.631 in the intranasal saline/nitrous oxide group versus the intranasal ketorolac/nitrous oxide group with no significant difference between the groups (P = .2523). Premedication with intranasal ketorolac did not significantly increase the odds of success for the IANB over the use of nitrous oxide/oxygen alone. Supplemental anesthesia will still be needed to achieve adequate anesthesia. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  14. Double-blind comparison of etodolac and diclofenac in patients with rheumatoid arthritis

    NARCIS (Netherlands)

    Lonauer, G.; Tisscher, J. R.; Lim, H. G.; Bijlsma, J. W.

    1993-01-01

    The efficacy and tolerability of etodolac was compared to diclofenac in a multi-centre, double-blind, randomized parallel group study. Fifty-three patients with rheumatoid arthritis received etodolac (400 mg/day) and 55 patients received diclofenac (150 mg/day) for 12 weeks. Thirty-nine

  15. Mefloquine prophylaxis prevents malaria during pregnancy: a double-blind, placebo-controlled study

    NARCIS (Netherlands)

    Nosten, F.; ter Kuile, F.; Maelankiri, L.; Chongsuphajaisiddhi, T.; Nopdonrattakoon, L.; Tangkitchot, S.; Boudreau, E.; Bunnag, D.; White, N. J.

    1994-01-01

    A double-blind, placebo-controlled study of mefloquine antimalarial prophylaxis in pregnancy (> 20 weeks of gestation) was conducted in 339 Karen women living in an area of multidrug-resistant malaria transmission on the Thai-Burmese border. Mefloquine gave > or = 86% (95% confidence interval [CI],

  16. A double-blind gastroscopic study of a Bismuth-peptide complex in ...

    African Journals Online (AJOL)

    Forty courses of treatment with bicitropeptide (BCP) were administered to 30 patients with gastric ulcers, in a double-blind crossover trial. Healing was judged gastroscopically after 4 weeks, at which time 79% of ulcers had healed on BCP and 35% on placebo (P

  17. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial.

    Science.gov (United States)

    Fleischmann, Roy; Mysler, Eduardo; Hall, Stephen; Kivitz, Alan J; Moots, Robert J; Luo, Zhen; DeMasi, Ryan; Soma, Koshika; Zhang, Richard; Takiya, Liza; Tatulych, Svitlana; Mojcik, Christopher; Krishnaswami, Sriram; Menon, Sujatha; Smolen, Josef S

    2017-07-29

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. The Oral Rheumatoid Arthritis triaL (ORAL) Strategy aimed to assess the comparative efficacy of tofacitinib monotherapy, tofacitinib plus methotrexate, and adalimumab plus methotrexate for the treatment of rheumatoid arthritis in patients with a previous inadequate response to methotrexate. ORAL Strategy was a 1 year, double-blind, phase 3b/4, head-to-head, non-inferiority, randomised controlled trial in patients aged 18 years or older with active rheumatoid arthritis despite methotrexate therapy. Patients were randomly assigned (1:1:1) to receive oral tofacitinib (5 mg twice daily) monotherapy, oral tofacitinib (5 mg twice daily) plus methotrexate, or subcutaneous adalimumab (40 mg every other week) plus methotrexate at 194 centres in 25 countries. Eligible patients received live zoster vaccine at investigators' discretion. The primary endpoint was the proportion of patients who attained an American College of Rheumatology response of at least 50% (ACR50) at month 6 in the full analysis set (patients who were randomly assigned to a group and received at least one dose of the study treatment). Non-inferiority between groups was shown if the lower bound of the 98·34% CI of the difference between comparators was larger than -13·0%. This trial is registered with ClinicalTrials.gov, number NCT02187055. 1146 patients received treatment (384 had tofacitinib monotherapy; 376 had tofacitinib and methotrexate; and 386 had adalimumab and methotrexate). At 6 months, ACR50 response was attained in 147 (38%) of 384 patients with tofacitinib monotherapy, 173 (46%) of 376 patients with tofacitinib and methotrexate, and 169 (44%) of 386 patients with adalimumab and methotrexate. Non-inferiority was declared for tofacitinib and methotrexate versus adalimumab and methotrexate (difference 2% [98·34% CI -6 to 11]) but not for tofacitinib monotherapy versus either adalimumab and methotrexate (-6

  18. Label-Free, Single Molecule Resonant Cavity Detection: A Double-Blind Experimental Study

    Directory of Open Access Journals (Sweden)

    Maria V. Chistiakova

    2015-03-01

    Full Text Available Optical resonant cavity sensors are gaining increasing interest as a potential diagnostic method for a range of applications, including medical prognostics and environmental monitoring. However, the majority of detection demonstrations to date have involved identifying a “known” analyte, and the more rigorous double-blind experiment, in which the experimenter must identify unknown solutions, has yet to be performed. This scenario is more representative of a real-world situation. Therefore, before these devices can truly transition, it is necessary to demonstrate this level of robustness. By combining a recently developed surface chemistry with integrated silica optical sensors, we have performed a double-blind experiment to identify four unknown solutions. The four unknown solutions represented a subset or complete set of four known solutions; as such, there were 256 possible combinations. Based on the single molecule detection signal, we correctly identified all solutions. In addition, as part of this work, we developed noise reduction algorithms.

  19. Double-Blind Comparison of Phlebitis Produced by Cefazolin Versus Cephalothin

    Science.gov (United States)

    Shemonsky, Natalie K.; Carrizosa, Jaime; Kaye, Donald; Levison, Matthew E.

    1975-01-01

    In a double-blind study with each patient as his own control, 1 g of cefazolin and 2 g of cephalothin were administered intravenously every 6 h to 20 patients in opposite arms for a period of 48 h each. The degree of phlebitis was significantly more severe with cephalothin than with cefazolin (P phlebitis nor the time of onset of phlebitis was significantly different between the two drugs. PMID:1147583

  20. Retroperitoneal arteriovenous malformation extending through the inferior vena cava into the heart and causing inferior vena cava dissection

    International Nuclear Information System (INIS)

    Sung, Yon Mi; Choe, Yeon Hyeon; Park, Seung Woo; Park, Pyo Won; Sung, Chang Ohk

    2005-01-01

    We present a case of retroperitoneal arteriovenous malformation extending through the inferior vena cava into the heart, which was associated with dissection of the inferior vena cava in a 32-year-old female. Computed tomography and magnetic resonance imaging showed a double-lumen inferior vena cava and a rod-like solid component attached to a sac-like lesion in the right heart chambers. Digital subtraction angiography showed an arteriovenous malformation draining to the inner lumen of the inferior vena cava. (orig.)

  1. Impact of probiotic Saccharomyces boulardii on the gut microbiome composition in HIV-treated patients: A double-blind, randomised, placebo-controlled trial

    OpenAIRE

    Villar-Garc?a, Judit; G?erri-Fern?ndez, Robert; Moya, Andr?s; Gonz?lez, Alicia; Hern?ndez, Juan J.; Lerma, Elisabet; Guelar, Ana; Sorli, Luisa; Horcajada, Juan P.; Artacho, Alejandro; D?Auria, Giuseppe; Knobel, Hernando

    2017-01-01

    Dysbalance in gut microbiota has been linked to increased microbial translocation, leading to chronic inflammation in HIV-patients, even under effective HAART. Moreover, microbial translocation is associated with insufficient reconstitution of CD4+T cells, and contributes to the pathogenesis of immunologic non-response. In a double-blind, randomised, placebo-controlled trial, we recently showed that, compared to placebo, 12 weeks treatment with probiotic Saccharomyces boulardii significantly ...

  2. A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial.

    Science.gov (United States)

    de Winter, Robbert J; Katagiri, Yuki; Asano, Taku; Milewski, Krzysztof P; Lurz, Philipp; Buszman, Pawel; Jessurun, Gillian A J; Koch, Karel T; Troquay, Roland P T; Hamer, Bas J B; Ophuis, Ton Oude; Wöhrle, Jochen; Wyderka, Rafał; Cayla, Guillaume; Hofma, Sjoerd H; Levesque, Sébastien; Żurakowski, Aleksander; Fischer, Dieter; Kośmider, Maciej; Goube, Pascal; Arkenbout, E Karin; Noutsias, Michel; Ferrari, Markus W; Onuma, Yoshinobu; Wijns, William; Serruys, Patrick W

    2018-02-03

    MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical effect of MiStent sirolimus-eluting stent compared with a durable polymer drug-eluting stents has not been investigated in a large randomised trial in an all-comer population. We did a randomised, single-blind, multicentre, phase 3 study (DESSOLVE III) at 20 hospitals in Germany, France, Netherlands, and Poland. Eligible participants were any patients aged at least 18 years who underwent percutaneous coronary intervention in a lesion and had a reference vessel diameter of 2·50-3·75 mm. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting bioresorbable polymer stent (MiStent) or an everolimus-eluting durable polymer stent (Xience). Randomisation was done by local investigators via web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint (DOCE)-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between the groups at 12 months after the procedure assessed by intention-to-treat. A margin of 4·0% was defined for non-inferiority of the MiStent group compared with the Xience group. All participants were included in the safety analyses. This trial is registered with ClinicalTrials.gov, number NCT02385279. Between March 20, and Dec 3, 2015, we randomly assigned 1398 patients with 2030 lesions; 703 patients with 1037 lesions were assigned to MiStent, of whom 697 received the index procedure, and 695 patients with 993 lesions were asssigned to Xience, of whom 690 received the index procedure. At 12 months, the primary endpoint had occurred in 40 patients (5·8%) in the sirolimus-eluting stent group and in 45

  3. Double-Blind Controlled Comparison of Phlebitis Produced by Cephapirin and Cephalothin

    Science.gov (United States)

    Carrizosa, Jaime; Levison, Matthew E.; Kaye, Donald

    1973-01-01

    In a double-blind study with each patient as his own control cephapirin and cephalothin were administered to 20 patients in opposite arms for a period of 48 hr each. Neither the incidence of phlebitis nor the degree of phlebitis was significantly different with the two drugs, and there was no difference in the time of onset of pain or phlebitis. PMID:4597719

  4. Benefits and Disadvantages of Neoadjuvant Radiochemotherapy (RCT) in the Multimodal Therapy of Squamous Esophageal Cancer (ESC).

    Science.gov (United States)

    Hanna, Adrian; Birla, Rodica; Iosif, Cristina; Boeriu, Marius; Constantinoiu, Silviu

    2016-01-01

    The purpose of this paper is to present the advantages and disadvantages of neoadjuvant RCT in multimodal therapyof ESC. Between 1998-2014 221 patients were treated with ESC, 85 of whom received neoadjuvant RCT. For these we have made imaging and pathologic assessment of response using RECIST and MANDARD criteria and statistical data were interpreted in terms of the factors that influence the response. Also, they were evaluated statistical correlations between RCT and resectability, postoperative morbidity, mortality and long-term survival. 45 patients were imagistic responders and 34 underwent surgery, 40 non-responders of which 14 underwent surgery. Of the 48 surgical patients with preoperative RCT, histopathological evaluation showed that 32 were pathological responders and 16 non responders. There were performed statistical analyzes of correlations between RCT and resectability, stage, location of ESC, morbidity, mortality and survival. RCT increase resectability, improves survival and maximum duration of survival, more in responders than in nonresponders and does not affect postoperative complications and postoperative mortality, nor among the responders or nonresponders. Imaging evaluation result of the response to RCT overestimate responders. Celsius.

  5. Management of oral lesions in HIV-positive patients.

    Science.gov (United States)

    Baccaglini, Lorena; Atkinson, Jane C; Patton, Lauren L; Glick, Michael; Ficarra, Giuseppe; Peterson, Douglas E

    2007-03-01

    HIV/AIDS is currently the leading cause of death in Africa and the fourth leading cause of death worldwide. This systematic review of the literature was conducted to evaluate the evidence for treatment of the most common oral lesions associated with HIV: oral candidiasis with or without oropharyngeal involvement (OPC), oral hairy leukoplakia (OHL), recurrent aphthous-like ulcerations (RAU), oral Kaposi's sarcoma (OKS), orolabial herpes simplex infection (HSV), oral herpes zoster infection (VZV), intraoral or perioral warts (HPV), and HIV-associated periodontal diseases. Treatment of HIV-associated salivary gland disease is addressed in a different section of this World Workshop. We found the largest body of evidence for treatment of OPC in HIV patients. Future trials will be needed to test drugs currently in development for treatment of Candida strains that are resistant to existing therapies. There were no double blind, placebo-controlled randomized clinical trials (RCT) for topical treatment of OHL, and only one RCT for systemic treatment of the lesion with desciclovir. Systemic thalidomide was the only drug tested in RCT for treatment or prevention of RAU. Only 1 double-blind RCT comparing vinblastine and sodium tetradecyl sulfate was identified for localized treatment of OKS. Three drugs (famciclovir, acyclovir, and valaciclovir) were shown to be effective in randomized, double-blind trials for treatment or suppression of mucocutaneous HSV lesions in HIV patients. In all 3 trials, the effects of these medications on orolabial HSV lesions were not reported separately. There were no double-blind, placebo-controlled RCT testing topical treatments for orolabial HSV lesions in HIV patients. No trials testing treatments of oral VZV were identified. There were no double-blind, placebo-controlled RCT for treatment of HIV-associated intraoral or perioral warts or periodontal diseases. In conclusion, there is a need for well-designed RCTs to assess the safety and

  6. Cilostazol induced migraine does not respond to sumatriptan in a double blind trial

    DEFF Research Database (Denmark)

    Falkenberg, Katrine; Dunga, Bára Óladóttir Á; Guo, Song

    2018-01-01

    participants were asked to subsequently treat their spontaneous attacks with sumatriptan (50 mg) or placebo in a double-blind cross-over design and 15 participants did so. RESULTS: Cilostazol induced headache with some migraine characteristics in all participants; 18 patients on the sumatriptan day and 19...

  7. A randomized controlled, non-inferiority trial of modified natural versus artificial cycle for cryo-thawed embryo transfer

    NARCIS (Netherlands)

    Groenewoud, E. R.; Cohlen, B. J.; Al-Oraiby, A.; Brinkhuis, E. A.; Broekmans, F. J M; De Bruin, J. P.; Van Den Dool, G.; Fleisher, K.; Friederich, J.; Goddijn, M.; Hoek, A.; Hoozemans, D. A.; Kaaijk, E. M.; Koks, C. A M; Laven, J. S E; Van Der Linden, P. J Q; Manger, A. P.; Slappendel, E.; Spinder, T.; Kollen, B. J.; Macklon, N. S.

    2016-01-01

    studyquestion: Are live birth rates (LBRs) after artificial cycle frozen-thawed embryo transfer (AC-FET) non-inferior to LBRs after modified natural cycle frozen-thawed embryo transfer (mNC-FET)? summaryanswer: AC-FET is non-inferior to mNC-FET with regard to LBRs, clinical and ongoing pregnancy

  8. An alternative approach to treating lateral epicondylitis. A randomized, placebo-controlled, double-blinded study

    NARCIS (Netherlands)

    Nourbakhsh, Mohammad Reza; Fearon, Frank J.

    Objective: To investigate the effect of noxious level electrical stimulation on pain, grip strength and functional abilities in subjects with chronic lateral epicondylitis. Design: Randomized, placebo-control, double-blinded study. Setting: Physical Therapy Department, North Georgia College and

  9. Implant decontamination during surgical peri-implantitis treatment : a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    de Waal, Yvonne C. M.; Raghoebar, Gerry M.; Huddleston Slater, James J. R.; Meijer, Henny J. A.; Winkel, Edwin G.; van Winkelhoff, Arie Jan

    Aim The objective of this randomized, double-blind, placebo-controlled trial was to study the effect of implant surface decontamination with chlorhexidine (CHX)/cetylpyridinium chloride (CPC) on microbiological and clinical parameters. Material & Methods Thirty patients (79 implants) with

  10. Implant decontamination during surgical peri-implantitis treatment : a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    de Waal, Yvonne C.M.; Raghoebar, Gerry M; Huddleston Slater, James J R; Meijer, Hendrikus; Winkel, Edwin G; van Winkelhoff, Arie Jan

    AIM: The objective of this randomized, double-blind, placebo-controlled trial was to study the effect of implant surface decontamination with chlorhexidine (CHX)/cetylpyridinium chloride (CPC) on microbiological and clinical parameters. MATERIAL & METHODS: Thirty patients (79 implants) with

  11. A randomized controlled, non-inferiority trial of modified natural versus artificial cycle for cryo-thawed embryo transfer

    NARCIS (Netherlands)

    Groenewoud, E. R.; Cohlen, B. J.; Al-Oraiby, A.; Brinkhuis, E. A.; Broekmans, F. J. M.; de Bruin, J. P.; van den Dool, G.; Fleisher, K.; Friederich, J.; Goddijn, M.; Hoek, A.; Hoozemans, D. A.; Kaaijk, E. M.; Koks, C. A. M.; Laven, J. S. E.; van der Linden, P. J. Q.; Manger, A. P.; Slappendel, E.; Spinder, T.; Kollen, B. J.; Macklon, N. S.

    STUDY QUESTION: Are live birth rates (LBRs) after artificial cycle frozen-thawed embryo transfer (AC-FET) non-inferior to LBRs after modified natural cycle frozen-thawed embryo transfer (mNC-FET)? SUMMARY ANSWER: AC-FET is non-inferior to mNC-FET with regard to LBRs, clinical and ongoing pregnancy

  12. Effectiveness evaluation of two volumizing hyaluronic acid dermal fillers in a controlled, randomized, double-blind, split-face clinical study

    Directory of Open Access Journals (Sweden)

    Kerscher M

    2017-06-01

    Full Text Available Martina Kerscher,1 Karla Agsten,2 Maria Kravtsov,3 Welf Prager4 1Department of Cosmetic Science, University of Hamburg, 2SCIderm GmbH, Hamburg, Germany; 3Anteis S.A., Geneva, Switzerland; 4Prager & Partner Dermatologische Praxis, Hamburg, Germany Background: Enhancement of the midface can be achieved with volumizing hyaluronic acid (HA fillers.Objective: The objective of this study was to compare the safety and effectiveness of Cohesive Polydensified Matrix® 26 mg/mL HA gel (CPM-26 and Vycross® 20 mg/ml HA gel (VYC-20 in a controlled, randomized, evaluator-blind, split-face clinical study.Patients and methods: Subjects with moderate-to-severe malar volume loss on the Merz Aesthetics Scale (MAS received CPM-26 on one side and VYC-20 on the contralateral side of the face. Effectiveness assessments were performed by blinded evaluators including photographic and live MAS ratings and live Global Aesthetic Improvement Scale (GAIS ratings. Calculations of anatomical volume variations at month 3 (M3, month 6 (M6, month 12 (M12 and month 18 (M18 were also performed.Results: Non-inferiority of CPM-26 versus VYC-20 was demonstrated at M3 (primary end point based on MAS. GAIS rating showed that significantly more subjects had better improvement with CPM-26 than with VYC-20 at month 1, M3, M12 and M18 (p=0.0032, p=0.0074, p=0.0384 and p=0.0110, respectively. Standardized evaluation of volume variations from baseline to M3, M12 and M18 showed that CPM-26 created more volume augmentation at all time points, and the difference was significant at M3.Conclusion: CPM-26 was non-inferior to VYC-20 based on MAS ratings at M3 and demonstrated a favorable safety and effectiveness profile for midfacial volume enhancement with results lasting up to M18. Keywords: cohesive polydensified matrix, hyaluronic acid fillers, Belotero® Volume, Modélis® SHAPE, Juvéderm® VOLUMA®, volumizing

  13. Tic Reduction with Risperidone Versus Pimozide in a Randomized, Double-Blind, Crossover Trial

    Science.gov (United States)

    Gilbert, Donald L.; Batterson, J. Robert; Sethuraman, Gopalan; Sallee, Floyd R.

    2004-01-01

    Objective: To compare the tic suppression, electrocardiogram (ECG) changes, weight gain, and side effect profiles of pimozide versus risperidone in children and adolescents with tic disorders. Method: This was a randomized, double-blind, crossover (evaluable patient analysis) study. Nineteen children aged 7 to 17 years with Tourette's or chronic…

  14. Direct phase retrieval in double blind Fourier holography.

    Science.gov (United States)

    Raz, Oren; Leshem, Ben; Miao, Jianwei; Nadler, Boaz; Oron, Dan; Dudovich, Nirit

    2014-10-20

    Phase measurement is a long-standing challenge in a wide range of applications, from X-ray imaging to astrophysics and spectroscopy. While in some scenarios the phase is resolved by an interferometric measurement, in others it is reconstructed via numerical optimization, based on some a-priori knowledge about the signal. The latter commonly use iterative algorithms, and thus have to deal with their convergence, stagnation, and robustness to noise. Here we combine these two approaches and present a new scheme, termed double blind Fourier holography, providing an efficient solution to the phase problem in two dimensions, by solving a system of linear equations. We present and experimentally demonstrate our approach for the case of lens-less imaging.

  15. A randomized controlled, non-inferiority trial of modified natural versus artificial cycle for cryo-thawed embryo transfer

    NARCIS (Netherlands)

    Groenewoud, E. R.; Cohlen, B. J.; Al-Oraiby, A.; Brinkhuis, E. A.; Broekmans, F. J. M.; de Bruin, J. P.; van den Dool, G.; Fleisher, K.; Friederich, J.; Goddijn, M.; Hoek, A.; Hoozemans, D. A.; Kaaijk, E. M.; Koks, C. A. M.; Laven, J. S. E.; van der Linden, P. J. Q.; Manger, A. P.; Slappendel, E.; Spinder, T.; Kollen, B. J.; Macklon, N. S.

    2016-01-01

    Are live birth rates (LBRs) after artificial cycle frozen-thawed embryo transfer (AC-FET) non-inferior to LBRs after modified natural cycle frozen-thawed embryo transfer (mNC-FET)? AC-FET is non-inferior to mNC-FET with regard to LBRs, clinical and ongoing pregnancy rates (OPRs) but AC-FET does

  16. Non-inferiority trials: methodological and regulatory challenges

    NARCIS (Netherlands)

    Wangge, G.

    2012-01-01

    A randomized clinical trial (RCT) is the gold standard to evaluate the intended effects of drugs. In such trials a drug can be compared with a placebo or with another active compound for the same indication. RCTs can be used to demonstrate that a drug is superior to placebo or an active comparator

  17. Digestive Enzyme Supplementation for Autism Spectrum Disorders: A Double-Blind Randomized Controlled Trial

    Science.gov (United States)

    Munasinghe, Sujeeva A.; Oliff, Carolyn; Finn, Judith; Wray, John A.

    2010-01-01

    To examine the effects of a digestive enzyme supplement in improving expressive language, behaviour and other symptoms in children with Autism Spectrum Disorder. Randomized, double-blind placebo-controlled trial using crossover design over 6 months for 43 children, aged 3-8 years. Outcome measurement tools included monthly Global Behaviour Rating…

  18. Clinical effects of buspirone in social phobia : A double-blind placebo-controlled study

    NARCIS (Netherlands)

    denBoer, JA; Westenberg, HGM; Pian, KLH

    Background: The results of open pilot studies suggest that the serotonin-1A (5-HT1A) receptor agonist buspirone might be effective in social phobia. Method: In the present study, the efficacy of buspirone was investigated in patients with social phobia using a 12-week double-blind placebo-controlled

  19. Anomalies of the vena cava inferior

    International Nuclear Information System (INIS)

    Koen, F.R.; Bouwer, A.J.; Bornman, M.S.; Du Plessis, D.J.

    1986-01-01

    Two cases of anomalous inferior vena cava are presented, with the emphasis on embryology. The firts patient was investigated by venography for a clinically proven varicocele as a probable cause of infertility. A double inferior vena cava was found during venography, and was confirmed by computed tomography (CT). In the second case a left-sided inferior vena cava was an incidental finding when a CT scan was done as a diagnostic procedure in a case of Hodgkin's disease. A short summary of the embryology and the significance of the variants is presented

  20. Vitamin D as supplementary treatment for tuberculosis: a double-blind, randomized, placebo-controlled trial

    DEFF Research Database (Denmark)

    Wejse, Christian; Gomes, Victor F; Rabna, Paulo

    2009-01-01

    RATIONALE: Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis. OBJECTIVES: To test whether vitamin D supplementation of patients with tuberculosis (TB) improved clinical outcome and reduced mortality. METHODS: We conducted a randomized, double-blind...

  1. Internet-based cognitive behavior therapy vs. cognitive behavioral group therapy for social anxiety disorder: a randomized controlled non-inferiority trial.

    Directory of Open Access Journals (Sweden)

    Erik Hedman

    2011-03-01

    Full Text Available Cognitive behavioral group therapy (CBGT is an effective, well-established, but not widely available treatment for social anxiety disorder (SAD. Internet-based cognitive behavior therapy (ICBT has the potential to increase availability and facilitate dissemination of therapeutic services for SAD. However, ICBT for SAD has not been directly compared with in-person treatments such as CBGT and few studies investigating ICBT have been conducted in clinical settings. Our aim was to investigate if ICBT is at least as effective as CBGT for SAD when treatments are delivered in a psychiatric setting.We conducted a randomized controlled non-inferiority trial with allocation to ICBT (n=64 or CBGT (n=62 with blinded assessment immediately following treatment and six months post-treatment. Participants were 126 individuals with SAD who received CBGT or ICBT for a duration of 15 weeks. The Liebowitz Social Anxiety Scale (LSAS was the main outcome measure. The following non-inferiority margin was set: following treatment, the lower bound of the 95 % confidence interval (CI of the mean difference between groups should be less than 10 LSAS-points.Both groups made large improvements. At follow-up, 41 (64% participants in the ICBT group were classified as responders (95% CI, 52%-76%. In the CBGT group, 28 participants (45% responded to the treatment (95% CI, 33%-58%. At post-treatment and follow-up respectively, the 95 % CI of the LSAS mean difference was 0.68-17.66 (Cohen's d between group=0.41 and -2.51-15.69 (Cohen's d between group=0.36 favoring ICBT, which was well within the non-inferiority margin. Mixed effects models analyses showed no significant interaction effect for LSAS, indicating similar improvement across treatments (F=1.58; df=2, 219; p=.21.ICBT delivered in a psychiatric setting can be as effective as CBGT in the treatment of SAD and could be used to increase availability to CBT.ClinicalTrials.gov NCT00564967.

  2. Comparative trial of two intravenous doses of granisetron (1 versus 3 mg) in the prevention of chemotherapy-induced acute emesis: a double-blind, randomized, non-inferiority trial.

    Science.gov (United States)

    Tsuji, Daiki; Kim, Yong-Il; Taku, Keisei; Nakagaki, Shigeru; Ikematsu, Yoshito; Tsubota, Hiromi; Maeda, Masato; Hashimoto, Naoya; Kimura, Masayuki; Daimon, Takashi

    2012-05-01

    A single 3 mg or 40 μg/kg intravenous dose of granisetron combined with dexamethasone is routinely used in several countries, although the antiemetic guidelines have recommended granisetron at the dose of 1 mg or 10 μg/kg. A randomized, multicenter trial was conducted to determine the optimal intravenous granisetron dose, 1 or 3 mg, in cancer patients receiving emetogenic chemotherapy. We enrolled 365 patients and randomly assigned them to receive intravenous granisetron 3 mg (3-mg group) or 1 mg (1-mg group), combined with dexamethasone at an adequate dose fixed as per the emetic risk category. The primary end point was the proportion of patients with a complete response during the first 24 h after chemotherapy. The study demonstrated that 1 mg of granisetron was not inferior in effect to 3 mg. For the primary end point, 359 patients were evaluable according to the modified intention-to-treat (ITT) analysis. Complete protection was achieved in the modified ITT population, 90.6% and 88.8% for the 3- and 1-mg groups, respectively (p granisetron is not inferior to 3 mg when both doses are combined with dexamethasone. Therefore, 1-mg dose of intravenous granisetron should be the recommended prophylactic regimen for the prevention of acute emesis.

  3. Repeated tender point injections of granisetron alleviate chronic myofascial pain--a randomized, controlled, double-blinded trial.

    Science.gov (United States)

    Christidis, Nikolaos; Omrani, Shahin; Fredriksson, Lars; Gjelset, Mattias; Louca, Sofia; Hedenberg-Magnusson, Britt; Ernberg, Malin

    2015-01-01

    Serotonin (5-HT) mediates pain by peripheral 5-HT3-receptors. Results from a few studies indicate that intramuscular injections of 5-HT3-antagonists may reduce musculoskeletal pain. The aim of this study was to investigate if repeated intramuscular tender-point injections of the 5-HT3-antagonist granisetron alleviate pain in patients with myofascial temporomandibular disorders (M-TMD). This prospective, randomized, controlled, double blind, parallel-arm trial (RCT) was carried out during at two centers in Stockholm, Sweden. The randomization was performed by a researcher who did not participate in data collection with an internet-based application ( www.randomization.com ). 40 patients with a diagnose of M-TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) were randomized to receive repeated injections, one week apart, with either granisetron (GRA; 3 mg) or isotonic saline as control (CTR). The median weekly pain intensities decreased significantly at all follow-ups (1-, 2-, 6-months) in the GRA-group (Friedman test; P  0.075). The numbers needed to treat (NNT) were 4 at the 1- and 6-month follow-ups, and 3.3 at the 2-month follow-up in favor of granisetron. Repeated intramuscular tender-point injections with granisetron provide a new pharmacological treatment possibility for myofascial pain patients with repeated intramuscular tender-point injections with the serotonin type 3 antagonist granisetron. It showed a clinically relevant pain reducing effect in the temporomandibular region, both in a short- and long-term aspect. European Clinical Trials Database 2005-006042-41 as well as at Clinical Trials NCT02230371 .

  4. Double-blind trial of flurbiprofen and phenylbutazone in acute gouty arthritis.

    OpenAIRE

    Butler, R C; Goddard, D H; Higgens, C S; Hollingworth, P; Pease, C T; Stodell, M A; Scott, J T

    1985-01-01

    Flurbiprofen has been compared with phenylbutazone in a double-blind study involving 33 patients with acute gout. Patients received either flurbiprofen 400 mg daily for 48 h followed by 200 mg daily, or phenylbutazone 800 mg daily for 48 h followed by 400 mg daily. The drugs were of comparable efficacy, while side-effects were uncommon and relatively mild. Flurbiprofen appears to be a satisfactory alternative to phenylbutazone in the management of acute gouty arthritis.

  5. Determining the sample size required to establish whether a medical device is non-inferior to an external benchmark.

    Science.gov (United States)

    Sayers, Adrian; Crowther, Michael J; Judge, Andrew; Whitehouse, Michael R; Blom, Ashley W

    2017-08-28

    The use of benchmarks to assess the performance of implants such as those used in arthroplasty surgery is a widespread practice. It provides surgeons, patients and regulatory authorities with the reassurance that implants used are safe and effective. However, it is not currently clear how or how many implants should be statistically compared with a benchmark to assess whether or not that implant is superior, equivalent, non-inferior or inferior to the performance benchmark of interest.We aim to describe the methods and sample size required to conduct a one-sample non-inferiority study of a medical device for the purposes of benchmarking. Simulation study. Simulation study of a national register of medical devices. We simulated data, with and without a non-informative competing risk, to represent an arthroplasty population and describe three methods of analysis (z-test, 1-Kaplan-Meier and competing risks) commonly used in surgical research. We evaluate the performance of each method using power, bias, root-mean-square error, coverage and CI width. 1-Kaplan-Meier provides an unbiased estimate of implant net failure, which can be used to assess if a surgical device is non-inferior to an external benchmark. Small non-inferiority margins require significantly more individuals to be at risk compared with current benchmarking standards. A non-inferiority testing paradigm provides a useful framework for determining if an implant meets the required performance defined by an external benchmark. Current contemporary benchmarking standards have limited power to detect non-inferiority, and substantially larger samples sizes, in excess of 3200 procedures, are required to achieve a power greater than 60%. It is clear when benchmarking implant performance, net failure estimated using 1-KM is preferential to crude failure estimated by competing risk models. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No

  6. No matrix effect in double-blind, placebo-controlled egg challenges in egg allergic children

    NARCIS (Netherlands)

    Libbers, L.; Flokstra-de Blok, B. M. J.; Vlieg-Boerstra, B. J.; van der Heide, S.; van der Meulen, G. N.; Kukler, J.; Kerkhof, M.; Dubois, A. E. J.

    Background Diagnostic and accidental food allergic reactions may be modified by the matrix containing the allergenic food. Previous studies of double-blind, placebo-controlled food challenges (DBPCFCs) with peanut found an effect of the fat content of the challenge matrix on the severity of the

  7. Exclusively breastfed infants at risk for false negative double blind placebo controlled milk challenge

    NARCIS (Netherlands)

    Petrus, N. C. M.; Kole, E. A.; Schoemaker, A. A.; van Aalderen, W. M. C.; Sprikkelman, A. B.

    2014-01-01

    The double blind placebo controlled food challenge (DBPCFC) is the gold standard for diagnosing cow's milk allergy (CMA). However, false-negative DBPCFC have been reported. We present 2 cases with a false negative DBPCFC in exclusively breastfed infants suspected of CMA. These cases highlight the

  8. Early visual experience and the recognition of basic facial expressions: involvement of the middle temporal and inferior frontal gyri during haptic identification by the early blind.

    Science.gov (United States)

    Kitada, Ryo; Okamoto, Yuko; Sasaki, Akihiro T; Kochiyama, Takanori; Miyahara, Motohide; Lederman, Susan J; Sadato, Norihiro

    2013-01-01

    Face perception is critical for social communication. Given its fundamental importance in the course of evolution, the innate neural mechanisms can anticipate the computations necessary for representing faces. However, the effect of visual deprivation on the formation of neural mechanisms that underlie face perception is largely unknown. We previously showed that sighted individuals can recognize basic facial expressions by haptics surprisingly well. Moreover, the inferior frontal gyrus (IFG) and posterior superior temporal sulcus (pSTS) in the sighted subjects are involved in haptic and visual recognition of facial expressions. Here, we conducted both psychophysical and functional magnetic-resonance imaging (fMRI) experiments to determine the nature of the neural representation that subserves the recognition of basic facial expressions in early blind individuals. In a psychophysical experiment, both early blind and sighted subjects haptically identified basic facial expressions at levels well above chance. In the subsequent fMRI experiment, both groups haptically identified facial expressions and shoe types (control). The sighted subjects then completed the same task visually. Within brain regions activated by the visual and haptic identification of facial expressions (relative to that of shoes) in the sighted group, corresponding haptic identification in the early blind activated regions in the inferior frontal and middle temporal gyri. These results suggest that the neural system that underlies the recognition of basic facial expressions develops supramodally even in the absence of early visual experience.

  9. Prevalence of lactose intolerance in Chile: a double-blind placebo study.

    Science.gov (United States)

    Latorre, Gonzalo; Besa, Pablo; Parodi, Carmen G; Ferrer, Verónica; Azocar, Lorena; Quirola, Marife; Villarroel, Luis; Miquel, Juan F; Agosin, Eduardo; Chianale, José

    2014-01-01

    Lactase non-persistence (LNP), or primary hypolactasia, is a genetic condition that mediates lactose malabsorption and can cause lactose intolerance. Here we report the prevalence of lactose intolerance in a double-blind placebo study. The LCT C>T-13910 variant was genotyped by RT-PCR in 121 volunteers and lactose malabsorption was assessed using the hydrogen breath test (HBT) after consuming 25 g of lactose. Lactose intolerance was assessed by scoring symptoms (SS) using a standardized questionnaire following challenge with a lactose solution or saccharose placebo. The LNP genotype was observed in 57% of the volunteers, among whom 87% were HBT⁺. In the HBT⁺ group the median SS was 9 and in the HBT⁻ group the median SS was 3 (p lactose intolerance was defined as the presence of an SS ≥ 6 points after subtracting the placebo effect and 34% of the study population met this definition. The LNP genotype was present in more than half of subjects evaluated and the observed prevalence of lactose intolerance was 34%. © 2014 S. Karger AG, Basel.

  10. Azathioprine versus Beta Interferons for Relapsing-Remitting Multiple Sclerosis: A Multicentre Randomized Non-Inferiority Trial

    Science.gov (United States)

    Massacesi, Luca; Tramacere, Irene; Amoroso, Salvatore; Battaglia, Mario A.; Benedetti, Maria Donata; Filippini, Graziella; La Mantia, Loredana; Repice, Anna; Solari, Alessandra; Tedeschi, Gioacchino; Milanese, Clara

    2014-01-01

    For almost three decades in many countries azathioprine has been used to treat relapsing-remitting multiple sclerosis. However its efficacy was usually considered marginal and following approval of β interferons for this indication it was no longer recommended as first line treatment, even if presently no conclusive direct β interferon-azathioprine comparison exists. To compare azathioprine efficacy versus the currently available β interferons in relapsing-remitting multiple sclerosis, a multicenter, randomized, controlled, single-blinded, non-inferiority trial was conducted in 30 Italian multiple sclerosis centers. Eligible patients (relapsing-remitting course; ≥2 relapses in the last 2 years) were randomly assigned to azathioprine or β interferons. The primary outcome was annualized relapse rate ratio (RR) over 2 years. Key secondary outcome was number of new brain MRI lesions. Patients (n = 150) were randomized in 2 groups (77 azathioprine, 73 β interferons). At 2 years, clinical evaluation was completed in 127 patients (62 azathioprine, 65 β interferons). Annualized relapse rate was 0.26 (95% Confidence Interval, CI, 0.19–0.37) in the azathioprine and 0.39 (95% CI 0.30–0.51) in the interferon group. Non-inferiority analysis showed that azathioprine was at least as effective as β interferons (relapse RRAZA/IFN 0.67, one-sided 95% CI 0.96; p<0.01). MRI outcomes were analyzed in 97 patients (50 azathioprine and 47 β interferons). Annualized new T2 lesion rate was 0.76 (95% CI 0.61–0.95) in the azathioprine and 0.69 (95% CI 0.54–0.88) in the interferon group. Treatment discontinuations due to adverse events were higher (20.3% vs. 7.8%, p = 0.03) in the azathioprine than in the interferon group, and concentrated within the first months of treatment, whereas in the interferon group discontinuations occurred mainly during the second year. The results of this study indicate that efficacy of azathioprine is not inferior to that of

  11. Centbutindole vs trifluoperazine : a double-blind controlled clinical study in acute schizophrenia.

    Directory of Open Access Journals (Sweden)

    Doongaji D

    1989-01-01

    Full Text Available Twenty-nine acute schizophrenic patients were treated under double-blind conditions for six weeks with either centbutindole in a dose range of 3 mg/day to 4.5 mg/day or trifluoperazine in the dose range of 15 mg/day to 22.5 mg/day. Both drugs produced a significant improvement in initial psychopathology. No significant differences were demonstrated between the two treatment conditions.

  12. Study protocol for a non-inferiority trial of a blended smoking cessation treatment versus face-to-face treatment (LiveSmokefree-Study

    Directory of Open Access Journals (Sweden)

    Lutz Siemer

    2016-11-01

    Full Text Available Abstract Background Smoking cessation can significantly reduce the risk of developing smoking-related diseases. Several face-to-face and web-based treatments have shown to be effective. Blending of web-based and face-to-face treatment is expected to improve smoking cessation treatment. The primary objective of this study is to compare the prolonged abstinence rate of the blended smoking cessation treatment with the face-to-face treatment. Secondary objectives are to assess the benefits of blended treatment in terms of cost effectiveness and patient satisfaction, and to identify mechanisms underlying successful smoking cessation. Methods/Design This study will be a single-center randomized controlled non-inferiority-trial with parallel group design. Patients (n = 344 will be randomly assigned to either the blended or the face-to-face group. Both treatments will consist of ten sessions with equal content held within 6 months. In the blended treatment five out of ten sessions will be delivered online. The treatments will cover the majority of behavior change techniques that are evidence-based within smoking cessation counseling. All face-to-face sessions in both treatments will take place at the outpatient smoking cessation clinic of a hospital. The primary outcome parameter will be biochemically validated prolonged abstinence at 15 months from the start of the smoking cessation treatment. Discussion This RCT will be the first study to examine the effectiveness of a blended smoking cessation treatment. It will also be the first study to explore patient satisfaction, adherence, cost-effectiveness, and the clinically relevant influencing factors of a blended smoking cessation treatment. The findings of this RCT are expected to substantially strengthen the base of evidence available to inform the development and delivery of smoking cessation treatment. Trial registration Nederlands Trialregister NTR5113 . Registered 24 March 2015.

  13. Comparative Analysis Between Computed and Conventional Inferior Alveolar Nerve Block Techniques.

    Science.gov (United States)

    Araújo, Gabriela Madeira; Barbalho, Jimmy Charles Melo; Dias, Tasiana Guedes de Souza; Santos, Thiago de Santana; Vasconcellos, Ricardo José de Holanda; de Morais, Hécio Henrique Araújo

    2015-11-01

    The aim of this randomized, double-blind, controlled trial was to compare the computed and conventional inferior alveolar nerve block techniques in symmetrically positioned inferior third molars. Both computed and conventional anesthetic techniques were performed in 29 healthy patients (58 surgeries) aged between 18 and 40 years. The anesthetic of choice was 2% lidocaine with 1: 200,000 epinephrine. The Visual Analogue Scale assessed the pain variable after anesthetic infiltration. Patient satisfaction was evaluated using the Likert Scale. Heart and respiratory rates, mean time to perform technique, and the need for additional anesthesia were also evaluated. Pain variable means were higher for the conventional technique as compared with computed, 3.45 ± 2.73 and 2.86 ± 1.96, respectively, but no statistically significant differences were found (P > 0.05). Patient satisfaction showed no statistically significant differences. The average computed technique runtime and the conventional were 3.85 and 1.61 minutes, respectively, showing statistically significant differences (P <0.001). The computed anesthetic technique showed lower mean pain perception, but did not show statistically significant differences when contrasted to the conventional technique.

  14. Slow-release L-Cysteine (Acetium®) Lozenge Is an Effective New Method in Smoking Cessation. A Randomized, Double-blind, Placebo-controlled Intervention.

    Science.gov (United States)

    Syrjänen, Kari; Eronen, Katja; Hendolin, Panu; Paloheimo, Lea; Eklund, Carita; Bäckström, Anna; Suovaniemi, Osmo

    2017-07-01

    Because of the major health problems and annual economic burden caused by cigarette smoking, effective new tools for smoking intervention are urgently needed. Our previous randomized controlled trial (RCT) provided promising results on the efficacy of slow-release L-cysteine lozenge in smoking intervention, but the study was not adequately powered. To confirm in an adequately-powered study the results of the previous RCT implicating that effective elimination of acetaldehyde in saliva by slow-release L-cysteine (Acetium® lozenge, Biohit Oyj, Helsinki), would assist in smoking cessation by reducing acetaldehyde-enhanced nicotine addiction. On this matter, we undertook a double-blind, randomized, placebo-controlled trial comparing Acetium® lozenge and placebo in smoking intervention. A cohort of 1,998 cigarette smokers were randomly allocated to intervention (n=996) and placebo arms (n=1,002). At baseline, smoking history was recorded by a questionnaire, with nicotine dependence testing according to the Fagerström scale (FTND). The subjects used smoking diary recording the daily numbers of cigarettes, lozenges and subjective sensations of smoking. The data were analysed separately for point prevalence of abstinence (PPA) and prolonged abstinence (PA) endpoints. Altogether, 753 study subjects completed the trial per protocol (PP), 944 with violations (mITT), and the rest (n=301) were lost to follow-up (LTF). During the 6-month intervention, 331 subjects stopped smoking; 181 (18.2%) in the intervention arm and 150 (15.0%) in the placebo arm (OR=1.43; 95%CI=1.09-1.88); p=0.010). In the PP group, 170 (45.3%) quitted smoking in the intervention arm compared to 134 (35.4%) in the placebo arm (OR=1.51, 95%CI=1.12-2.02; p=0.006). In multivariate (Poisson regression) model, decreased level of smoking pleasure (p=0.010) and "smoking sensations changed" were powerful independent predictors of quit events (IRR=12.01; 95%CI=1.5-95.6). Acetium® lozenge, herein confirmed in an

  15. Cophenylcaine spray vs. placebo in flexible nasendoscopy: a prospective double-blind randomised controlled trial

    NARCIS (Netherlands)

    Georgalas, C.; Sandhu, G.; Frosh, A.; Xenellis, J.

    2005-01-01

    Practices vary across the UK on the use of topical preparation prior to flexible fibreoptic nasendoscopy. In this double-blind study, we randomised 98 patients to receive cophenylcaine or placebo nasal spray before flexible nasendoscopy. A visual analogue scale (1-100) was used to record pain,

  16. A non-recurrent inferior laryngeal nerve in a man undergoing thyroidectomy: a case report

    Directory of Open Access Journals (Sweden)

    Sousa Daniel

    2010-11-01

    Full Text Available Abstract Introduction A non-recurrent variant of the inferior laryngeal nerve has been seldom reported. These reports are mostly based on cadaveric dissection studies or large chart review studies in which the emphasis is placed on the determination of the frequency of the variation, and not on the clinical appearance of this variant. We graphically describe the intraoperative identification of a non-recurrent inferior laryngeal nerve. Case Presentation A 44-year old Caucasian man was referred to the Head and Neck Surgery Outpatient Clinic with the diagnosis of a nodular mass in his left thyroid lobe that had been growing for one year. A fine needle aspiration puncture was compatible with thyroid papillary cancer. It was decided that the patient should undergo total thyroidectomy. During surgery, a non-recurrent right inferior laryngeal nerve was noted. This nerve emanated from the right vagus nerve, entering the larynx 3 cm after its origin. The nerve did not show a recurrent course. The nerve on the left side had a normal configuration. The surgery and post-operative period were uneventful, and the patient had no change in his voice. Conclusion This paper allows those interested to become acquainted with the normal intraoperative appearance of a non-recurrent inferior laryngeal nerve. This will undoubtedly be of significance for all of those performing invasive diagnostic and surgical procedures in the neck and upper thoracic regions, in order to minimize the risk of iatrogenic injury to this nerve. This is of extreme importance, since a unilateral lesion of this nerve may result in permanent hoarseness, and a bilateral lesion may lead to aphonia and life-threatening dyspnea.

  17. Aspartame sensitivity? A double blind randomised crossover study.

    Directory of Open Access Journals (Sweden)

    Thozhukat Sathyapalan

    Full Text Available Aspartame is a commonly used intense artificial sweetener, being approximately 200 times sweeter than sucrose. There have been concerns over aspartame since approval in the 1980s including a large anecdotal database reporting severe symptoms. The objective of this study was to compare the acute symptom effects of aspartame to a control preparation.This was a double-blind randomized cross over study conducted in a clinical research unit in United Kingdom. Forty-eight individual who has self reported sensitivity to aspartame were compared to 48 age and gender matched aspartame non-sensitive individuals. They were given aspartame (100mg-containing or control snack bars randomly at least 7 days apart. The main outcome measures were acute effects of aspartame measured using repeated ratings of 14 symptoms, biochemistry and metabonomics.Aspartame sensitive and non-sensitive participants differed psychologically at baseline in handling feelings and perceived stress. Sensitive participants had higher triglycerides (2.05 ± 1.44 vs. 1.26 ± 0.84mmol/L; p value 0.008 and lower HDL-C (1.16 ± 0.34 vs. 1.35 ± 0.54 mmol/L; p value 0.04, reflected in 1H NMR serum analysis that showed differences in the baseline lipid content between the two groups. Urine metabonomic studies showed no significant differences. None of the rated symptoms differed between aspartame and control bars, or between sensitive and control participants. However, aspartame sensitive participants rated more symptoms particularly in the first test session, whether this was placebo or control. Aspartame and control bars affected GLP-1, GIP, tyrosine and phenylalanine levels equally in both aspartame sensitive and non-sensitive subjects.Using a comprehensive battery of psychological tests, biochemistry and state of the art metabonomics there was no evidence of any acute adverse responses to aspartame. This independent study gives reassurance to both regulatory bodies and the public that

  18. Aspartame sensitivity? A double blind randomised crossover study.

    Science.gov (United States)

    Sathyapalan, Thozhukat; Thatcher, Natalie J; Hammersley, Richard; Rigby, Alan S; Courts, Fraser L; Pechlivanis, Alexandros; Gooderham, Nigel J; Holmes, Elaine; le Roux, Carel W; Atkin, Stephen L

    2015-01-01

    Aspartame is a commonly used intense artificial sweetener, being approximately 200 times sweeter than sucrose. There have been concerns over aspartame since approval in the 1980s including a large anecdotal database reporting severe symptoms. The objective of this study was to compare the acute symptom effects of aspartame to a control preparation. This was a double-blind randomized cross over study conducted in a clinical research unit in United Kingdom. Forty-eight individual who has self reported sensitivity to aspartame were compared to 48 age and gender matched aspartame non-sensitive individuals. They were given aspartame (100mg)-containing or control snack bars randomly at least 7 days apart. The main outcome measures were acute effects of aspartame measured using repeated ratings of 14 symptoms, biochemistry and metabonomics. Aspartame sensitive and non-sensitive participants differed psychologically at baseline in handling feelings and perceived stress. Sensitive participants had higher triglycerides (2.05 ± 1.44 vs. 1.26 ± 0.84mmol/L; p value 0.008) and lower HDL-C (1.16 ± 0.34 vs. 1.35 ± 0.54 mmol/L; p value 0.04), reflected in 1H NMR serum analysis that showed differences in the baseline lipid content between the two groups. Urine metabonomic studies showed no significant differences. None of the rated symptoms differed between aspartame and control bars, or between sensitive and control participants. However, aspartame sensitive participants rated more symptoms particularly in the first test session, whether this was placebo or control. Aspartame and control bars affected GLP-1, GIP, tyrosine and phenylalanine levels equally in both aspartame sensitive and non-sensitive subjects. Using a comprehensive battery of psychological tests, biochemistry and state of the art metabonomics there was no evidence of any acute adverse responses to aspartame. This independent study gives reassurance to both regulatory bodies and the public that acute ingestion of

  19. Anesthetic Efficacy of Bupivacaine Solutions in Inferior Alveolar Nerve Block

    Science.gov (United States)

    Volpato, Maria Cristina; Ranali, José; Ramacciato, Juliana Cama; de Oliveira, Patrícia Cristine; Ambrosano, Glaúcia Maria Bovi; Groppo, Francisco Carlos

    2005-01-01

    The purpose of this study was to compare the anesthetic efficacy of 2 bupivacaine solutions. Twenty-two volunteers randomly received in a crossover, double-blinded manner 2 inferior alveolar nerve blocks with 1.8 mL of racemic bupivacaine and a mixture of 75% levobupivacaine and 25% dextrobupivacaine, both 0.5% and with 1 : 200,000 epinephrine. Before and after the injection, the first mandibular pre-molar was evaluated every 2 minutes until no response to the maximal output (80 reading) of the pulp tester and then again every 20 minutes. Data were analyzed using the Wilcoxon paired test and the paired t test. No differences were found between the solutions for onset and duration of pulpal anesthesia and duration of soft tissue anesthesia (P > .05). It was concluded that the solutions have similar anesthetic efficacy. PMID:16596912

  20. Inferior alveolar nerve function after sagittal split osteotomy by reciprocating saw or piezosurgery instrument: prospective double-blinded study.

    Science.gov (United States)

    Monnazzi, Marcelo Silva; Real Gabrielli, Mario Francisco; Passeri, Luis Augusto; Cabrini Gabrielli, Marisa Aparecida; Spin-Neto, Rubens; Pereira-Filho, Valfrido Antonio

    2014-06-01

    The aim of this prospective study was to objectively evaluate inferior alveolar nerve (IAN) sensory disturbances in patients who underwent sagittal split ramus osteotomy (SSRO) by comparing 1 side treated with a reciprocating saw with the other side treated with a piezosurgery device. Clinical evaluation of IAN sensory disturbance was undertaken preoperatively and at 1 week, 4 weeks, 2 months, and 6 months postoperatively in 20 patients who underwent SSRO at the Division of Oral and Maxillofacial Surgery, Araraquara Dental School, São Paulo State University. The 20 patients were examined at all periods for IAN functionality by Semmes-Weinstein testing; neither the patients nor the examiner knew which side was treated using piezosurgery or a reciprocating saw. The mean age of the patients was 28.4 years (range, 20 to 48 yr). Before surgery, no patient had impaired function of the IAN in any of the 8 zones in the mental and inferior lip areas. All patients reported feeling the first monofilament at the time of the preoperative test. Seven days postoperatively, all patients reported some kind of altered sensitivity in at least 1 zone evaluated. The results of this study suggest there was no statistically significant difference in the sensitivity of the labiomental area regarding the instrument used to perform the osteotomy. Future studies will focus on enlarging the sample and evaluating the results. Copyright © 2014 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  1. A double-blind, placebo-controlled study of sertraline with naltrexone for alcohol dependence.

    LENUS (Irish Health Repository)

    Farren, Conor K

    2009-01-01

    Significant preclinical evidence exists for a synergistic interaction between the opioid and the serotonin systems in determining alcohol consumption. Naltrexone, an opiate receptor antagonist, is approved for the treatment of alcohol dependence. This double-blind placebo-controlled study examined whether the efficacy of naltrexone would be augmented by concurrent treatment with sertraline, a selective serotonin receptor uptake inhibitor (SSRI).

  2. Controlling pain during orthodontic fixed appliance therapy with non-steroidal anti-inflammatory drugs (NSAID): a randomized, double-blinded, placebo-controlled study.

    Science.gov (United States)

    Gupta, Mudit; Kandula, Srinivas; Laxmikanth, Sarala M; Vyavahare, Shreyas S; Reddy, Satheesha B H; Ramachandra, Chanila S

    2014-11-01

    Despite all the technological advances in orthodontics, orthodontic treatment still seems to involve some degree of discomfort and/or pain. Pain control during orthodontic therapy is of great concern to both orthodontists and patients. However, there has been limited research into controlling such pain. The purpose of this work was to assess patient-perceived pain following fixed orthodontic treatment and to evaluate the comparative analgesic efficacy of non-steroidal anti-inflammatory drugs for controlling pain. A total of 45 patients about to undergo fixed appliance orthodontic treatment were enrolled in this double-blind prospective study. Patients were evenly and randomly distributed in a blinded manner to one of three groups as follows: paracetamol/acetaminophen 500 mg thrice daily; placebo in the form of empty capsules; and etoricoxib 60 mg once daily. Drug administration began 1 h before initiating the bonding procedure and archwire placement, and given until the day 3. The pain perceived was recorded by the patients on a linear and graded Visual Analogue Scale at time intervals of 2 h after insertion of the appliance; 6 h thereafter and again at nighttime of the same day of the appointment; 24 h later and on the 2nd day at nighttime; 48 h after the appointment and on day 3 at nighttime. Our results revealed that moderately intense pain is associated with routine orthodontic treatment, and that the amount of pain individuals perceive varies widely. We observed statistically significant differences in the pain control among the three groups, and that etoricoxib 60 mg proved most efficient. Etoricoxib 60 mg is highly efficacious for controlling pain during fixed orthodontic appliance therapy.

  3. Inferior hilar window on lateral chest radiographs

    International Nuclear Information System (INIS)

    Park, C.K.; Webb, W.R.; Klein, J.S.

    1990-01-01

    This paper determines the accuracy of lateral chest radiography in the detection of masses in the inferior hilar window, a normally avascular hilar region anterior to the lower lobe bronchi. Fifty patients with normal thoracic CT scans and 25 with hilar masses/adenopathy were selected retrospectively. The 75 corresponding lateral chest radiographs were blindly evaluated for visibility of the anterior walls of the lower lobe bronchi and the presence and laterality of abnormal soft tissue (>1 cm) in the inferior hilar window. Only a 7 x 7-cm square of the lateral radiograph was viewed

  4. Antidepressants for bipolar disorder A meta-analysis of randomized, double-blind, controlled trials

    Institute of Scientific and Technical Information of China (English)

    Yingli Zhang; Huan Yang; Shichang Yang; Wei Liang; Ping Dai; Changhong Wang; Yalin Zhang

    2013-01-01

    OBJECTIVE: To examine the efficacy and safety of short-term and long-term use of antidepres-sants in the treatment of bipolar disorder. DATA SOURCES:A literature search of randomized, double-blind, control ed trials published until December 2012 was performed using the PubMed, ISI Web of Science, Medline and Cochrane Central Register of Control ed Trials databases. The keywords“bipolar disorder, bipolar I disorder, bipolar II disorder, bipolar mania, bipolar depression, cyclothymia, mixed mania and depression, rapid cycling and bipolar disorder”, AND “antidepressant agent, antidepressive agents second-generation, antidepressive agents tricyclic, monoamine oxidase inhibitor, noradrenaline uptake in-hibitor, serotonin uptake inhibitor, and tricyclic antidepressant agent” were used. The studies that were listed in the reference list of the published papers but were not retrieved in the above-mentioned databases were supplemented. STUDY SELECTION: Studies selected were double-blind randomized control ed trials assessing the efficacy and safety of antidepressants in patients with bipolar disorder. Al participants were aged 18 years or older, and were diagnosed as having primary bipolar disorder. Antidepressants or antidepressants combined with mood stabilizers were used in experimental interventions. Placebos, mood stabilizers, antipsychotics and other antide pressants were used in the control interventions. Studies that were quasi-randomized studies, or used antidepressants in combination with antipsy-chotics in the experimental group were excluded. Al analyses were conducted using Review Man-ager 5.1 provided by the Cochrane Col aboration. MAIN OUTCOME MEASURES:The primary outcome was the response and switching to mania. The secondary outcomes included remission, discontinuation rate, and suicidality. RESULTS: Among 5 001 treatment studies published, 14 double-blind randomized control ed trials involving 1 244 patients were included in the meta

  5. Nests of red wood ants (Formica rufa-group) are positively associated with tectonic faults: a double-blind test.

    Science.gov (United States)

    Del Toro, Israel; Berberich, Gabriele M; Ribbons, Relena R; Berberich, Martin B; Sanders, Nathan J; Ellison, Aaron M

    2017-01-01

    Ecological studies often are subjected to unintentional biases, suggesting that improved research designs for hypothesis testing should be used. Double-blind ecological studies are rare but necessary to minimize sampling biases and omission errors, and improve the reliability of research. We used a double-blind design to evaluate associations between nests of red wood ants ( Formica rufa , RWA) and the distribution of tectonic faults. We randomly sampled two regions in western Denmark to map the spatial distribution of RWA nests. We then calculated nest proximity to the nearest active tectonic faults. Red wood ant nests were eight times more likely to be found within 60 m of known tectonic faults than were random points in the same region but without nests. This pattern paralleled the directionality of the fault system, with NNE-SSW faults having the strongest associations with RWA nests. The nest locations were collected without knowledge of the spatial distribution of active faults thus we are confident that the results are neither biased nor artefactual. This example highlights the benefits of double-blind designs in reducing sampling biases, testing controversial hypotheses, and increasing the reliability of the conclusions of research.

  6. Treatment Assignment Guesses by Study Participants in a Double-Blind Dose Escalation Clinical Trial of Saw Palmetto

    OpenAIRE

    Lee, Jeannette Y.; Moore, Page; Kusek, John; Barry, Michael

    2014-01-01

    Objectives: This report assesses participant perception of treatment assignment in a randomized, double-blind, placebo-controlled trial of saw palmetto for the treatment of benign prostatic hyperplasia (BCM).

  7. The effect of neuromuscular blockade on canine laparoscopic ovariectomy: A double-blinded, prospective clinical trial

    NARCIS (Netherlands)

    van Goethem, B.; van Nimwegen, S.A.; Akkerdaas, L.C.; Murrell, J.C.; Kirpensteijn, J.

    2012-01-01

    The Effect of Neuromuscular Blockade on Canine Laparoscopic Ovariectomy: A Double-Blinded, Prospective Clinical Trial Bart Van Goethem, Diplomate ECVS, Sebastiaan Alexander van Nimwegen, PhD, Ies Akkerdaas, DVM, Joanna Claire Murrell, BVSc., PhD, Diplomate ECVAA, and Jolle Kirpensteijn, PhD,

  8. A single dose desensitization for summer hay fever. Results of a double blind study-1988.

    Science.gov (United States)

    Fell, P; Brostoff, J

    1990-01-01

    A new type of desensitising vaccine, enzyme potentiated was subjected to a double-blind randomised study during the hay fever season. The vaccine is a convenient single injection given in March and the results show good protection throughout the grass pollen season.

  9. A randomized double-blind crossover trial comparing subthalamic and pallidal deep brain stimulation for dystonia

    DEFF Research Database (Denmark)

    Schjerling, Lisbeth; Hjermind, Lena E; Jespersen, Bo

    2013-01-01

    Object The authors' aim was to compare the subthalamic nucleus (STN) with the globus pallidus internus (GPi) as a stimulation target for deep brain stimulation (DBS) for medically refractory dystonia. Methods In a prospective double-blind crossover study, electrodes were bilaterally implanted in ...

  10. Early visual experience and the recognition of basic facial expressions: involvement of the middle temporal and inferior frontal gyri during haptic identification by the early blind

    Science.gov (United States)

    Kitada, Ryo; Okamoto, Yuko; Sasaki, Akihiro T.; Kochiyama, Takanori; Miyahara, Motohide; Lederman, Susan J.; Sadato, Norihiro

    2012-01-01

    Face perception is critical for social communication. Given its fundamental importance in the course of evolution, the innate neural mechanisms can anticipate the computations necessary for representing faces. However, the effect of visual deprivation on the formation of neural mechanisms that underlie face perception is largely unknown. We previously showed that sighted individuals can recognize basic facial expressions by haptics surprisingly well. Moreover, the inferior frontal gyrus (IFG) and posterior superior temporal sulcus (pSTS) in the sighted subjects are involved in haptic and visual recognition of facial expressions. Here, we conducted both psychophysical and functional magnetic-resonance imaging (fMRI) experiments to determine the nature of the neural representation that subserves the recognition of basic facial expressions in early blind individuals. In a psychophysical experiment, both early blind and sighted subjects haptically identified basic facial expressions at levels well above chance. In the subsequent fMRI experiment, both groups haptically identified facial expressions and shoe types (control). The sighted subjects then completed the same task visually. Within brain regions activated by the visual and haptic identification of facial expressions (relative to that of shoes) in the sighted group, corresponding haptic identification in the early blind activated regions in the inferior frontal and middle temporal gyri. These results suggest that the neural system that underlies the recognition of basic facial expressions develops supramodally even in the absence of early visual experience. PMID:23372547

  11. Femicomfort in the Treatment of Premenstrual Syndromes: A Double-Blind, Randomized and Placebo Controlled Trial

    Directory of Open Access Journals (Sweden)

    Shahin Akhondzadeh

    2010-06-01

    Full Text Available "nObjective:Premenstrual syndromes (PMS affecting 20-40% of women of reproductive age. The aim of this double blind and placebo controlled trial was to investigate whether femicofort a supplement contains Vitamin B6, Vitamin E and evening primrose oil could relieve symptoms of PMS. "nMethod: This was a randomized and double blind clinical trial. The trial was conducted between November 2009 and April March 2010. Women aged 20 to 45 years with regular menstrual cycles and experience of PMS symptoms (According to the current diagnostic criteria proposed by the American College of Obstetrics and Gynecology for at least 6 months were eligible for the study. Patients were randomized to receive femicomfort or placebo in a 1: ratio using a computer-generated code. The assignments were kept in sealed, opaque envelopes until the point of analysis of data. In this double-blind, patients were randomly assigned to receive capsule of femicomfort (Group A or capsule placebo for two menstrual cycles (cycles 3 and 4. The primary outcome measure was the Daily Symptom Report, a checklist of 17 premenstrual symptoms rated from 0 to 4 according to their severity throughout the menstrual cycle. Secondary outcome measure was Hamilton Depression Rating Scale (17-item. "nResults:Femicomfort at this dose was found to be effective in relieving symptoms of PMS. The difference between the femicomfort and placebo in the frequency of side effects was not significant. Conclusion: The results of this study indicate the efficacy of femicomfort in the treatment of PMS.

  12. Double-blind evaluation of the DKL LifeGuard Model 2

    International Nuclear Information System (INIS)

    Murray, D.W.; Spencer, F.W.; Spencer, D.D.

    1998-05-01

    On March 20, 1998, Sandia National Laboratories performed a double-blind test of the DKL LifeGuard human presence detector and tracker. The test was designed to allow the device to search for individuals well within the product's published operational parameters. The Test Operator of the DKL LifeGuard was provided by the manufacturer and was a high-ranking member of DKL management. The test was developed and implemented to verify the performance of the device as specified by the manufacturer. The device failed to meet its published specifications and it performed no better than random chance

  13. High-volume infiltration analgesia in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial

    DEFF Research Database (Denmark)

    Andersen, L.O.; Husted, H.; Otte, K.S.

    2008-01-01

    with a detailed description of the infiltration technique. METHODS: In a randomized, double-blind, placebo-controlled trial in 12 patients undergoing bilateral knee arthroplasty, saline or high-volume (170 ml) ropivacaine (0.2%) with epinephrine was infiltrated around each knee, with repeated doses administered...

  14. Development and validation of challenge materials for double-blind, placebo-controlled food challenges in children

    NARCIS (Netherlands)

    Vlieg-Boerstra, BJ; Bijleveld, CMA; van der Heide, S; Beusekamp, BJ; Wolt-Plompen, SAA; Kukler, J; Brinkman, J; Duiverman, EJ; Dubois, AEJ

    Background: The use of double-blind, placebo-controlled food challenges (DBPCFCs) is considered the gold standard for the diagnosis of food allergy. Despite this, materials and methods used in DBPCFCs have not been standardized. Objective: The purpose of this study was to develop and validate

  15. Treatment of knee osteoarthritis with pulsed electromagnetic fields: a randomized, double-blind, placebo-controlled study

    DEFF Research Database (Denmark)

    Thamsborg, G; Florescu, A; Oturai, P

    2005-01-01

    OBJECTIVE: The investigation aimed at determining the effectiveness of pulsed electromagnetic fields (PEMF) in the treatment of osteoarthritis (OA) of the knee by conducting a randomized, double-blind, placebo-controlled clinical trial. DESIGN: The trial consisted of 2h daily treatment 5 days per...

  16. Iron supplementation in HIV-infected Malawian children with anemia: a double-blind, randomized, controlled trial

    NARCIS (Netherlands)

    Esan, Michael O.; van Hensbroek, Michael Boele; Nkhoma, Ernest; Musicha, Crispin; White, Sarah A.; ter Kuile, Feiko O.; Phiri, Kamija S.

    2013-01-01

    It is unknown whether iron supplementation in human immunodeficiency virus (HIV)-infected children living in regions with high infection pressure is safe or beneficial. A 2-arm, double-blind, randomized, controlled trial was conducted to examine the effects of iron supplementation on hemoglobin, HIV

  17. A soft double regularization approach to parametric blind image deconvolution.

    Science.gov (United States)

    Chen, Li; Yap, Kim-Hui

    2005-05-01

    This paper proposes a blind image deconvolution scheme based on soft integration of parametric blur structures. Conventional blind image deconvolution methods encounter a difficult dilemma of either imposing stringent and inflexible preconditions on the problem formulation or experiencing poor restoration results due to lack of information. This paper attempts to address this issue by assessing the relevance of parametric blur information, and incorporating the knowledge into the parametric double regularization (PDR) scheme. The PDR method assumes that the actual blur satisfies up to a certain degree of parametric structure, as there are many well-known parametric blurs in practical applications. Further, it can be tailored flexibly to include other blur types if some prior parametric knowledge of the blur is available. A manifold soft parametric modeling technique is proposed to generate the blur manifolds, and estimate the fuzzy blur structure. The PDR scheme involves the development of the meaningful cost function, the estimation of blur support and structure, and the optimization of the cost function. Experimental results show that it is effective in restoring degraded images under different environments.

  18. Efficacy and safety of tribendimidine, tribendimidine plus ivermectin, tribendimidine plus oxantel pamoate, and albendazole plus oxantel pamoate against hookworm and concomitant soil-transmitted helminth infections in Tanzania and Côte d'Ivoire: a randomised, controlled, single-blinded, non-inferiority trial.

    Science.gov (United States)

    Moser, Wendelin; Coulibaly, Jean T; Ali, Said M; Ame, Shaali M; Amour, Amour K; Yapi, Richard B; Albonico, Marco; Puchkov, Maxim; Huwyler, Jörg; Hattendorf, Jan; Keiser, Jennifer

    2017-11-01

    Preventive chemotherapy is the current strategy to control soil-transmitted helminth infections (caused by Ascaris lumbricoides, hookworm, and Trichuris trichiura). But, to improve efficacy and avoid emerging resistance, new drugs are warranted. Tribendimidine has shown good anthelmintic efficacy and is therefore a frontrunner for monotherapy and combination chemotherapy. We did a randomised, controlled, single-blinded, non-inferiority trial on Pemba Island, Tanzania, and in Côte d'Ivoire. We recruited adolescents aged 15-18 years from four primary schools on Pemba, and school attendees and non-schoolers from two districts in Côte d'Ivoire. Only hookworm-positive participants were randomly assigned (1:1:1:1) to single, oral doses of tribendimidine 400 mg plus placebo (tribendimidine monotherapy), tribendimidine 400 mg plus ivermectin 200 μg/kg, tribendimidine 400 mg plus oxantel pamoate 25 mg/kg, or albendazole 400 mg plus oxantel pamoate 25 mg/kg. Randomisation was done via a computer-generated list in block sizes of four or eight. Participants were asked to provide two stool samples on 2 consecutive days at baseline and again 14-21 days at follow-up. The primary outcome was the difference in egg-reduction rates (ERRs; ie, the geometric mean reduction) in hookworm egg counts between treatment groups, measured by the Kato-Katz technique. Differences in coadministrated treatment groups were assessed for non-inferiority with a margin of -3% to albendazole plus oxantel pamoate based on the available-case population, analysed by intention to treat. Safety was assessed 3 h and 24 h after treatment. This study is registered with ISRCTN (number 14373201). Between July 26, and Dec 23, 2016, we treated 636 hookworm-positive participants, and outcome data were available for 601 participants (151 assigned to tribendimidine monotherapy, 154 to tribendimidine plus ivermectin, 148 to tribendimidine plus oxantel pamoate, and 148 to albendazole plus oxantel pamoate

  19. Safety of ingestion of yellow tartrazine by double-blind placebo controlled challenge in 26 atopic adults.

    Science.gov (United States)

    Pestana, S; Moreira, M; Olej, B

    2010-01-01

    Yellow dye tartrazine is a potential cause of exacerbations of asthma, allergic rhinitis and urticaria in atopic patients. The Brazilian Sanitary Surveillance Agency (ANVISA) published a consultation about the possibility of issuing a label warning addressing these potential effects of food and drugs containing tartrazine. The present study aims to evaluate tartrazine dye safety in atopic subjects suffering from allergic rhinitis, asthma, urticaria or sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs). Atopic patients with allergic rhinitis, asthma, urticaria or pseudo-allergic reactions to non-steroidal anti-inflammatory drugs were studied (n=26). The gold standard, double-blind placebo controlled, crossed-over challenge was used There were no statistical differences between placebo and drug in cutaneous, respiratory or cardiovascular aspects. In a group of atopic subjects with allergic rhinitis, asthma, urticaria or pseudo-allergic reactions to non-steroidal anti-inflammatory drugs, the administration of 35 mg of the tartrazine dye did not precipitate any kind of significant cutaneous, respiratory or cardiovascular reactions when compared to placebo. 2009 SEICAP. Published by Elsevier Espana. All rights reserved.

  20. Comparative efficacy of low-dose versus standard-dose azithromycin for patients with yaws: a randomised non-inferiority trial in Ghana and Papua New Guinea

    Directory of Open Access Journals (Sweden)

    Michael Marks, PhD

    2018-04-01

    Full Text Available Summary: Background: A dose of 30 mg/kg of azithromycin is recommended for treatment of yaws, a disease targeted for global eradication. Treatment with 20 mg/kg of azithromycin is recommended for the elimination of trachoma as a public health problem. In some settings, these diseases are co-endemic. We aimed to determine the efficacy of 20 mg/kg of azithromycin compared with 30 mg/kg azithromycin for the treatment of active and latent yaws. Methods: We did a non-inferiority, open-label, randomised controlled trial in children aged 6–15 years who were recruited from schools in Ghana and schools and the community in Papua New Guinea. Participants were enrolled based on the presence of a clinical lesion that was consistent with infectious primary or secondary yaws and a positive rapid diagnostic test for treponemal and non-treponemal antibodies. Participants were randomly assigned (1:1 to receive either standard-dose (30 mg/kg or low-dose (20 mg/kg azithromycin by a computer-generated random number sequence. Health-care workers assessing clinical outcomes in the field were not blinded to the patient's treatment, but investigators involved in statistical or laboratory analyses and the participants were blinded to treatment group. We followed up participants at 4 weeks and 6 months. The primary outcome was cure at 6 months, defined as lesion healing at 4 weeks in patients with active yaws and at least a four-fold decrease in rapid plasma reagin titre from baseline to 6 months in patients with active and latent yaws. Active yaws was defined as a skin lesion that was positive for Treponema pallidum ssp pertenue in PCR testing. We used a non-inferiority margin of 10%. This trial was registered with ClinicalTrials.gov, number NCT02344628. Findings: Between June 12, 2015, and July 2, 2016, 583 (65·1% of 895 children screened were enrolled; 292 patients were assigned a low dose of azithromycin and 291 patients were assigned a standard dose of

  1. Human norovirus inactivation in oysters by high hydrostatic pressure processing: A randomized double-blinded study

    Science.gov (United States)

    This randomized, double-blinded, clinical trial assessed the effect of high hydrostatic pressure processing (HPP) on genogroup I.1 human norovirus (HuNoV) inactivation in virus-seeded oysters when ingested by subjects. The safety and efficacy of HPP treatments were assessed in three study phases wi...

  2. Does the combination of 3% mepivacaine plain plus 2% lidocaine with epinephrine improve anesthesia and reduce the pain of anesthetic injection for the inferior alveolar nerve block? A prospective, randomized, double-blind study.

    Science.gov (United States)

    Lammers, Emily; Nusstein, John; Reader, Al; Drum, Melissa; Beck, Mike; Fowler, Sara

    2014-09-01

    In theory, using 3% mepivacaine initially for an inferior alveolar nerve (IAN) block would decrease the pain of injection, provide faster onset, and increase anesthetic success. The purpose of this prospective, randomized, double-blind study was to compare the degree of pulpal anesthesia obtained with a combination of 3% mepivacaine/2% lidocaine (1:100,000 epinephrine) versus a combination of 2% lidocaine (1:100,000 epinephrine)/2% lidocaine (1:100,000 epinephrine) in IAN blocks. Injection pain was also studied. One hundred asymptomatic subjects were randomly given a combination of a 1-cartridge volume of 3% mepivacaine plus a 1-cartridge volume of 2% lidocaine with 1:100,000 epinephrine and a combination of a 1-cartridge volume of 2% lidocaine with 1:100,000 epinephrine plus a 1-cartridge volume of 2% lidocaine with 1:100,000 epinephrine for the IAN block at 2 separate appointments. Subjects rated the pain of injection. The molars, premolars, and incisors were tested with an electric pulp tester in 4-minute cycles for 60 minutes. Anesthetic success was defined as the subject achieving 2 consecutive 80 readings within 15 minutes after completion of the IAN blocks and sustaining the 80 reading for 60 minutes. Success was not significantly different (P > .05) between the 2 combinations. No statistical differences in injection pain or onset times were found. The combination of 3% mepivacaine plus 2% lidocaine with 1:100,000 epinephrine was equivalent to the combination of 2 cartridges of 2% lidocaine with 1:100,000 epinephrine in terms of injection pain, onset time, and pulpal anesthetic success for the IAN block. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  3. The effects of resveratrol supplementation on cardiovascular risk factors in patients with non-alcoholic fatty liver disease: a randomised, double-blind, placebo-controlled study.

    Science.gov (United States)

    Faghihzadeh, Forouzan; Adibi, Payman; Hekmatdoost, Azita

    2015-09-14

    Non-alcoholic fatty liver disease (NAFLD) is usually associated with insulin resistance, central obesity, reduced glucose tolerance, type 2 diabetes mellitus and hypertriacylglycerolaemia. The beneficial effects of resveratrol on metabolic disorders have been shown previously. The aim of this study was to evaluate the effects of resveratrol supplementation on cardiovascular risk factors in patients with NAFLD. In this randomised double-blinded placebo-controlled clinical trial, fifty NAFLD patients were supplemented with either a 500-mg resveratrol capsule or a placebo capsule for 12 weeks. Both groups were advised to follow an energy-balanced diet and physical activity recommendations. resveratrol supplementation reduced alanine aminotransferase (ALT) and hepatic steatosis significantly more than placebo (P0·05). There were no significant changes in blood pressure, insulin resistance markers and TAG in either group (P>0·05). Our data have shown that 12-week supplementation of 500 mg resveratrol does not have any beneficial effect on anthropometric measurements, insulin resistance markers, lipid profile and blood pressure; however, it reduced ALT and hepatic steatosis in patients with NAFLD.

  4. Lactotripeptides Show No Effect on Human Blood Pressure: Results from a double-blind randomized controlled trial

    NARCIS (Netherlands)

    Engberink, M.F.; Schouten, E.G.; Kok, F.J.; Mierlo, van L.A.J.; Brouwer, I.A.; Geleijnse, J.M.

    2008-01-01

    Milk-derived peptides with ACE-inhibiting properties may have antihypertensive effects in humans. We conducted a randomized double-blind placebo-controlled trial to examine the blood pressure lowering potential of 2 ACE-inhibiting lactotripeptides, ie, Isoleucine-Proline-Proline and

  5. Effect of Miradol (Sulpiride) on radiation sickness studied by a double-blind test

    International Nuclear Information System (INIS)

    Murakami, Yuko; Morita, Shinroku

    1981-01-01

    Effect of Miradol on radiation sickness was investigated by a double-blind test. The rate of ''effective'' was 66.7% of the patients given Miradol and 20.1% of those given placebo (p < 0.01). The drug was especially effective on the patients chiefly complaining of nausea and vomiting. Placebo was also effective in some of the cases with appetite loss etc. (Ueda, J.)

  6. Voriconazole versus a regimen of amphotericin B followed by fluconazole for candidaemia in non-neutropenic patients: a randomised non-inferiority trial.

    NARCIS (Netherlands)

    Kullberg, B.J.; Sobel, J.D.; Ruhnke, M.; Pappas, P.G.; Viscoli, C.; Rex, J.H.; Cleary, J.D.; Rubinstein, E.; Church, L.W.; Brown, J.M.; Schlamm, H.T.; Oborska, I.T.; Hilton, F.; Hodges, M.R.

    2005-01-01

    BACKGROUND: Voriconazole has proven efficacy against invasive aspergillosis and oesophageal candidiasis. This multicentre, randomised, non-inferiority study compared voriconazole with a regimen of amphotericin B followed by fluconazole for the treatment of candidaemia in non-neutropenic patients.

  7. Treatment with silver nitrate versus topical steroid treatment for umbilical granuloma: A non-inferiority randomized control trial.

    Directory of Open Access Journals (Sweden)

    Chikako Ogawa

    Full Text Available The aim of this prospective multicenter randomized controlled trial was to compare the efficacy of silver nitrate cauterization against that of topical steroid ointment in the treatment of neonatal umbilical granuloma.An open-label, non-inferiority randomized controlled trial was conducted from January 2013 to January 2016. The primary endpoint for the silver nitrate cauterization and topical steroid ointment groups was the healing rate after 2 weeks of treatment, applying a non-inferiority margin of 10%. The healing rate was evaluated until completion of 3 weeks of treatment.Participants comprised 207 neonates with newly diagnosed umbilical granuloma, randomized to receive silver nitrate cauterization (n = 104 or topical steroid ointment (n = 103. Healing rates after 2 weeks of treatment were 87.5% (91/104 in the silver nitrate cauterization and 82% (82/100 in the topical steroid ointment group group. The difference between groups was -5.5% (95% confidence interval, -19.1%, 8.4%, indicating that the non-inferiority criterion was not met. After 3 weeks of treatment, the healing rate with topical steroid ointment treatment was almost identical to that of silver nitrate cauterization (94/104 [90.4%] vs. 91/100 [91.0%]; 0.6% [-13.2 to 14.3]. No major complications occurred in either group.This study did not establish non-inferiority of topical steroid ointment treatment relative to silver nitrate cauterization, presumably due to lower healing rates than expected leading to an underpowered trial. However, considering that silver nitrate cauterization carries a distinct risk of chemical burns and that the overall efficacy of topical steroid ointment treatment is similar to that of silver nitrate cauterization, topical steroid ointment might be considered as a good alternative in the treatment of neonatal umbilical granuloma due to its safety and simplicity. To clarify non-inferiority, a larger study is needed.

  8. Double-blind, placebo controlled food challenge with apple

    DEFF Research Database (Denmark)

    Hansen, K.S.; Vestergaard, H.S.; Skov, P.S.

    2001-01-01

    The aim of the study was to develop and evaluate different methods of double-blind, placebo-controlled food challenge (DBPCFC) with apple. Three different DBPCFC models were evaluated: fresh apple juice, freshly grated apple, and freeze-dried apple powder. All challenges were performed outside...... the pollen season and took place from 1997 to 1999. The freeze-dried apple material was characterized by means of leukocyte histamine release (HR), skin prick test (SPT), and immunoblotting experiments. The study population consisted of birch pollen-allergic patients with a history of rhinitis in the birch......-pollen season and positive specific IgE to birch. For comparison of the DBPCFC models, 65 patients with a positive open oral challenge with apple were selected. In the characterization of the freeze-dried apple material, 46 birch pollen-allergic patients were included. The IgE reactivity to apple was evaluated...

  9. Topical glyceryl trinitrate treatment of chronic patellar tendinopathy : a randomised, double-blind, placebo-controlled clinical trial

    NARCIS (Netherlands)

    Steunebrink, Mirjam; Zwerver, Johannes; Brandsema, Ruben; Groenenboom, Petra; van den Akker-Scheek, Inge; Weir, Adam

    Objectives To assess if continuous topical glyceryl trinitrate (GTN) treatment improves outcome in patients with chronic patellar tendinopathy when compared with eccentric training alone. Methods Randomised double-blind, placebo-controlled clinical trial comparing a 12-week programme of using a GTN

  10. Implant decontamination with 2% chlorhexidine during surgical peri-implantitis treatment : a randomized, double-blind, controlled trial

    NARCIS (Netherlands)

    de Waal, Y. C. M.; Raghoebar, G. M.; Meijer, H. J. A.; Winkel, E. G.; van Winkelhoff, A. J.

    ObjectiveThe objective of this randomized, double-blind, controlled trial was to evaluate the clinical, radiographic, and microbiological effects of implant surface decontamination with a 2% chlorhexidine (CHX) solution in comparison with a 0.12% chlorhexidine+0.05% cetylpyridinium chloride (CPC)

  11. Adverse reactions to simultaneous influenza and pneumococcal conjugate vaccinations in children : randomized double-blind controlled trial

    NARCIS (Netherlands)

    Jansen, Angelique G S C; Sanders, Elisabeth A M; Smulders, Sara; Hoes, Arno W; Hak, Eelko

    In a randomized double-blind controlled trial, the safety was assessed of simultaneous administration of influenza and pneumococcal conjugate vaccines in children with previous physician-diagnosed respiratory tract infections. In total, 579 children aged 18-72 months were assigned to receive

  12. Does Prolonged Enteral Feeding With Supplemental Omega-3 Fatty Acids Impact on Recovery Post-esophagectomy: Results of a Randomized Double-Blind Trial.

    Science.gov (United States)

    Healy, Laura A; Ryan, Aoife; Doyle, Suzanne L; Ní Bhuachalla, Éadaoin Bríd; Cushen, Samantha; Segurado, Ricardo; Murphy, Thomas; Ravi, Narayanasamy; Donohoe, Claire L; Reynolds, John V

    2017-11-01

    This randomized controlled trial (RCT) hypothesized that prolonged enteral nutrition (EN) with supplemental eicosapentanoic acid (EPA), an omega-3 fatty acid with immune and anabolic properties, may impact on clinical and nutritional outcomes. Esophagectomy is associated with significant weight loss and catabolism, and negatively impacts quality of life (QL). Strategies to counter sustained catabolism have therapeutic rationale. This multicenter, double-blind, placebo-controlled RCT was powered on a 5% difference in lean body mass (LBM) at 1 month. Patients were randomly assigned to receive either EN-EPA (2.2 g EPA/day) (n = 97) or isocaloric isonitrogenous standard EN (EN-S) (n = 94), preoperatively (5 days orally), and postoperatively via a jejunostomy until 1 month postdischarge. Assessments perioperatively, and at 1, 3, and 6 months included weight, body mass index (BMI), body composition, muscle strength, cytokines, complications, and QL. The median (range) nutrition support was for 51 (36 to 78) days, and overall compliance was 96%. For the entire cohort, a significant (P < 0.005) decrease in weight (-7.4 ± 6.6 kg), BMI (-2.6 ± 2.2 kg/m), LBM (-2.5 ± 8.7 kg), and fat mass (-3.4 ± 5.8 kg) was evident from preoperatively to 6 months. The mean (±SD) loss of LBM (kg) at 1 month was -3.7 ± 8.7 in the EN-S group, compared with -5.6 ± 12.1 in the EN-EPA group (P = 0.355). Per-protocol analysis revealed no difference between the EN-EPA and EN-S in any clinical, nutritional, functional, QL or immune parameter at any time point. The thesis that EPA impacts on anabolism, immune function, and clinical outcomes post-esophagectomy was not supported. Compliance with home EN was excellent, but weight, muscle, and fat loss was significant in 30% of patients, highlighting the complexity of postoperative weight loss.

  13. Prospective, double-blind comparison of shoulder MR imaging, US, arthrography, and arthroscopy

    International Nuclear Information System (INIS)

    Resendes, M.; Drace, J.E.; Pyka, W.

    1988-01-01

    To determine the efficacy of diagnostic imaging modalities in the evaluation of shoulder pain, magnetic resonance (MR) imaging, ultrasonography (US) and arthrography were prospectively compared in a double-blind experimental protocol. Thirty consecutive patients were studied by these modalities, which received separate, blinded interpretations. The images and interpretations were sealed in an envelope and blinded from the arthroscopist for initial arthroscopy, but second-look arthroscopy, and in some cases open surgery, was performed after the envelopes were unsealed. To avoid selection bias, negative MR and/or US examinations never affected confirmation by arthrography and/or arthroscopy, so negatives and positives were equivalently tested. To date, MR imaging and US are equally sensitive in the detection of rotator cuff tears, but the combination is more sensitive. Both MR imaging and US demonstrated tears not diagnosed by means of arthrography, and MR imaging distinguished hemorrhagic muscle tears from rotator cuff tears, which arthrography and arthroscopy did not. Both MR imaging and US showed characteristic appearances of biceps tendonitis, but neither demonstrated adhesive capsulitis. The authors conclude that all three imaging modalities have a role in shoulder diagnosis

  14. Effect of valsartan on systemic right ventricular function: a double-blind, randomized, placebo-controlled pilot trial

    NARCIS (Netherlands)

    Bom, T. van der; Winter, M.M.; Bouma, B.J.; Groenink, M.; Vliegen, H.W.; Pieper, P.G.; Dijk, A.P.J. van; Sieswerda, G.T.; Roos-Hesselink, J.W.; Zwinderman, A.H.; Mulder, B.J.

    2013-01-01

    BACKGROUND: The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated. METHODS AND RESULTS: We conducted a multicenter, double-blind, parallel, randomized controlled trial of angiotensin II receptor blocker valsartan 160 mg twice daily compared

  15. Effect of Valsartan on Systemic Right Ventricular Function A Double-Blind, Randomized, Placebo-Controlled Pilot Trial

    NARCIS (Netherlands)

    van der Bom, Teun; Winter, Michiel M.; Bouma, Berto J.; Groenink, Maarten; Vliegen, Hubert W.; Pieper, Petronella G.; van Dijk, Arie P. J.; Sieswerda, Gertjan T.; Roos-Hesselink, Jolien W.; Zwinderman, Aeilko H.; Mulder, Barbara J. M.

    2013-01-01

    Background-The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated. Methods and Results-We conducted a multicenter, double-blind, parallel, randomized controlled trial of angiotensin II receptor blocker valsartan 160 mg twice daily compared

  16. Effect of valsartan on systemic right ventricular function: a double-blind, randomized, placebo-controlled pilot trial

    NARCIS (Netherlands)

    van der Bom, Teun; Winter, Michiel M.; Bouma, Berto J.; Groenink, Maarten; Vliegen, Hubert W.; Pieper, Petronella G.; van Dijk, Arie P. J.; Sieswerda, Gertjan T.; Roos-Hesselink, Jolien W.; Zwinderman, Aeilko H.; Mulder, Barbara J. M.

    2013-01-01

    The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated. We conducted a multicenter, double-blind, parallel, randomized controlled trial of angiotensin II receptor blocker valsartan 160 mg twice daily compared with placebo in patients with a

  17. Prospective double blind randomized placebo-controlled clinical trial of the pectoral nerves (Pecs) block type II

    NARCIS (Netherlands)

    Versyck, B.; Geffen, G.J. van; Houwe, P. Van

    2017-01-01

    STUDY OBJECTIVE: The aim of this clinical trial was to test the hypothesis whether adding the pectoral nerves (Pecs) block type II to the anesthetic procedure reduces opioid consumption during and after breast surgery. DESIGN: A prospective randomized double blind placebo-controlled study. SETTING:

  18. Comparing Formation or Non-Formation of Bladder Flap at Cesarean Section on Perioperative and Postoperative Complications: Double-Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Farideh Akhlaghi

    2018-03-01

    Full Text Available Objective: To investigating formation or non-formation of bladder flap at Cesarean section on the complications during and after surgery.Materials and methods: This is a double-blind clinical trial study conducted during February 2014 to May 2015 on 64 pregnant women with gestational age of 36 weeks or more who were delivered by Cesarean section for the first time. They were randomly divided into two groups (intervention group: non-formation of bladder flap; control group: formation of bladder flap. The time to cut out the baby by Cesarean section, total duration of operation, bladder injury, intraoperative bleeding, hematocrit changes expected prior to during and following operation, postoperative pain, macroscopic and microscopic hematuria, postoperative complications and duration of  hospitalization were compared between two groups. The data were analyzed with SPSS version 16 using and statistics tests. p < 0.05 was considered significant.Results: Time to cut out the baby for the intervention group (124.9 ± 40.5 seconds and for control group 155.1 ± 42.9 seconds and total duration of the operation (intervention group: 27.7 ± 5.2 min and control group: 34 ± 4.73 min were significantly different (p = 0.000. Number of gauze consumption during operation and postoperative hematocrit drop in the intervention group was significantly lower in the intervention group compared the control group (p = 0.000. The postoperative pain score in the intervention group (4.8 ± 1.1 and in control group (6.3 ± 0.9 were significantly different (p = 0.000.Conclusion: Omission of the bladder flap at Cesarean section leads to short-term benefits such as reducing the time to cut out the fetus, duration of surgery, decreasing postoperative bleeding and lowering pain.

  19. Oral paracetamol versus oral ibuprofen for closure of haemodynamically significant patent ductus arteriosus in preterm neonates (<32 weeks): a blinded, randomised, active-controlled, non-inferiority trial

    Science.gov (United States)

    Kumar, Ashutosh; Sundaram, Venkataseshan; Yadav, Rahul; Oleti, Tejo Pratap; Murki, Srinivas; Krishna, Arun; Sundaram, Mangalabharathi; Saini, Shiv Sajan; Dutta, Sourabh

    2017-01-01

    Introduction Haemodynamically significant patent ductus arteriosus (hsPDA) is a common cause of mortality and morbidity in preterm infants. Existing medical therapies with ibuprofen or indomethacin have multiple adverse effects. Hence, an alternative drug like paracetamol given through oral route with less side effects need to be tested in an appropriate study design with least risk of bias to arrive at a conclusion. Methods and analysis Multisite, randomised, active-controlled, non-inferiority design. The primary objective is to study the efficacy of oral paracetamol for closure of hsPDA in comparison to oral ibuprofen in preterm neonates of Closure of PDA by the end of last dose of study drug or earlier would be the study endpoint. A sample size of 196 neonates would be enrolled with a non-inferiority margin of 15%. Both intention-to-treat and per-protocol analysis will be done to assess the effect of contamination and protocol violations in the primary outcome. Ethics and dissemination The trial would follow international code of ethics for clinical trial. The trial protocol was approved by the Institute Ethics Committee of all three centres. All serious adverse events would be reported in detail to the Institute Ethics Committee. A written informed consent would be obtained from one of the parents. No plan has been made for dissemination. Trial registration number CTRI/2014/08/004805. PMID:29637155

  20. Rationale, design, and baseline characteristics of the CArdiovascular safety and Renal Microvascular outcomE study with LINAgliptin (CARMELINA®): a randomized, double-blind, placebo-controlled clinical trial in patients with type 2 diabetes and high cardio-renal risk.

    Science.gov (United States)

    Rosenstock, Julio; Perkovic, Vlado; Alexander, John H; Cooper, Mark E; Marx, Nikolaus; Pencina, Michael J; Toto, Robert D; Wanner, Christoph; Zinman, Bernard; Baanstra, David; Pfarr, Egon; Mattheus, Michaela; Broedl, Uli C; Woerle, Hans-Juergen; George, Jyothis T; von Eynatten, Maximilian; McGuire, Darren K

    2018-03-14

    Cardiovascular (CV) outcome trials in type 2 diabetes (T2D) have underrepresented patients with chronic kidney disease (CKD), leading to uncertainty regarding their kidney efficacy and safety. The CARMELINA ® trial aims to evaluate the effects of linagliptin, a DPP-4 inhibitor, on both CV and kidney outcomes in a study population enriched for cardio-renal risk. CARMELINA ® is a randomized, double-blind, placebo-controlled clinical trial conducted in 27 countries in T2D patients at high risk of CV and/or kidney events. Participants with evidence of CKD with or without CV disease and HbA1c 6.5-10.0% (48-86 mmol/mol) were randomized 1:1 to receive linagliptin once daily or matching placebo, added to standard of care adjusted according to local guidelines. The primary outcome is time to first occurrence of CV death, non-fatal myocardial infarction, or non-fatal stroke. The key secondary outcome is a composite of time to first sustained occurrence of end-stage kidney disease, ≥ 40% decrease in estimated glomerular filtration rate (eGFR) from baseline, or renal death. CV and kidney events are prospectively adjudicated by independent, blinded clinical event committees. CARMELINA ® was designed to continue until at least 611 participants had confirmed primary outcome events. Assuming a hazard ratio of 1.0, this provides 90% power to demonstrate non-inferiority of linagliptin versus placebo within the pre-specified non-inferiority margin of 1.3 at a one-sided α-level of 2.5%. If non-inferiority of linagliptin for the primary outcome is demonstrated, then its superiority for both the primary outcome and the key secondary outcome will be investigated with a sequentially rejective multiple test procedure. Between July 2013 and August 2016, 6980 patients were randomized and took ≥ 1 dose of study drug (40.6, 33.1, 16.9, and 9.4% from Europe, South America, North America, and Asia, respectively). At baseline, mean ± SD age was 65.8 ± 9.1 years, HbA1c

  1. The blind leading the blind: use and misuse of blinding in randomized controlled trials.

    Science.gov (United States)

    Miller, Larry E; Stewart, Morgan E

    2011-03-01

    The use of blinding strengthens the credibility of randomized controlled trials (RCTs) by minimizing bias. However, there is confusion surrounding the definition of blinding as well as the terms single, double, and triple blind. It has been suggested that these terms should be discontinued due to their broad misinterpretation. We recommend that, instead of abandoning the use of these terms, explicit definitions of blinding should be adopted. We address herein the concept of blinding, propose standard definitions for the consistent use of these terms, and detail when different types of blinding should be utilized. Standardizing the definition of blinding and utilizing proper blinding methods will improve the quality and clarity of reporting in RCTs. Copyright © 2010 Elsevier Inc. All rights reserved.

  2. A double blind controlled trial of prednisolone-21-phosphate suppositories in the treatment of idiopathic proctitis

    Science.gov (United States)

    Lennard-Jones, J. E.; Baron, J. H.; Connell, A. M.; Jones, F. Avery

    1962-01-01

    A double blind trial of prednisolone suppositories in out-patients with idiopathic proctitis is reported. Significant improvement was noted. When prednisolone suppositories were given after the patient had already used suppositories of base alone for three weeks the active treatment was no longer so effective. PMID:13929632

  3. A cluster randomized non-inferiority field trial on the immunogenicity and safety of tetanus toxoid vaccine kept in controlled temperature chain compared to cold chain.

    Science.gov (United States)

    Juan-Giner, Aitana; Domicent, Camille; Langendorf, Céline; Roper, Martha H; Baoundoh, Paul; Fermon, Florence; Gakima, Primitive; Zipursky, Simona; Tamadji, Mbaihol; Grais, Rebecca F

    2014-10-29

    In resource-poor settings, cold chain requirements present barriers for vaccine delivery. We evaluated the immunogenicity and safety of tetanus toxoid (TT) vaccine in "Controlled Temperature Chain" (CTC; up to 40 °C for cold chain (SCC; 2-8 °C). Prior to the study, stability parameters of TT-CTC were shown to meet international requirements. A cluster randomized, non-inferiority trial was conducted in Moïssala district, Chad, December 2012-March 2013. Thirty-four included clusters were randomized to CTC or SCC. Women aged 14-49 years, eligible for TT vaccination and with a history of ≤1 TT dose, received two TT doses 4 weeks apart. Participants were blinded to allocation strategy. Tetanus antibody titers were measured using standard ELISA at inclusion and 4 weeks post-TT2. Primary outcome measures were post-vaccination seroconversion and fold-increase in geometric mean concentrations (GMC). Non-inferiority was by seroconversion difference (TTSCC-TTCTC) 95% of participants; upper 95%CI of the difference was 5.6%. Increases in GMC were over 4-fold; upper 95%CI of GMC ratio was 1.36 in the adjusted analysis. Few adverse events were recorded. This study demonstrates the immunogenicity and safety of TT in CTC at cold chain cannot be maintained. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  4. A double-blind placebo-controlled randomized trial of adalimumab in the treatment of hidradenitis suppurativa

    DEFF Research Database (Denmark)

    Miller, I; Lynggaard, C D; Lophaven, S

    2011-01-01

    BACKGROUND: Hidradenitis suppurativa (HS) has an impact on patients' quality of life. Treatment of HS is generally unsatisfactory, thus new treatments are needed. OBJECTIVES: To test the efficacy of adalimumab in HS. METHODS: This was a prospective, randomized, double-blinded, placebo-controlled,......BACKGROUND: Hidradenitis suppurativa (HS) has an impact on patients' quality of life. Treatment of HS is generally unsatisfactory, thus new treatments are needed. OBJECTIVES: To test the efficacy of adalimumab in HS. METHODS: This was a prospective, randomized, double-blinded, placebo......-controlled, two-centre clinical trial conducted in Denmark. Inclusion criteria were age above 18 years and a clinical diagnosis of moderate to severe HS defined as Hurley stage II or III for at least 6 months. The patients were randomized 1:2 (placebo/active). Actively treated patients received adalimumab 80 mg...... subcutaneously (s.c.) at baseline followed by 40 mg s.c. every other week for 12 weeks. Placebo-treated patients received identical-looking injections with no active ingredient. The medicine was dispensed in sequentially numbered computer-randomized containers. Participants, care givers and those assessing...

  5. A double blind, randomised, parallel group study on the efficacy and safety of treating acute lateral ankle sprain with oral hydrolytic enzymes

    NARCIS (Netherlands)

    Kerkhoffs, G. M. M. J.; Struijs, P. A. A.; de Wit, C.; Rahlfs, V. W.; Zwipp, H.; van Dijk, C. N.

    2004-01-01

    Objective: To compare the effectiveness and safety of the triple combination Phlogenzym ( rutoside, bromelain, and trypsin) with double combinations, the single substances, and placebo. Design: Multinational, multicentre, double blind, randomised, parallel group design with eight groups structured

  6. Double-blind, randomized, controlled, pilot study comparing classic ayurvedic medicine, methotrexate, and their combination in rheumatoid arthritis.

    Science.gov (United States)

    Furst, Daniel E; Venkatraman, Manorama M; McGann, Mary; Manohar, P Ram; Booth-LaForce, Cathryn; Sarin, Reshmi; Sekar, P G; Raveendran, K G; Mahapatra, Anita; Gopinath, Jidesh; Kumar, P R Krishna

    2011-06-01

    To compare classic Ayurveda, methotrexate (MTX), and their combination in a double-blind, randomized, double-dummy, pilot trial in rheumatoid arthritis (RA) for 36 weeks. Forty-three seropositive RA patients by American College of Rheumatology (ACR) criteria with disease duration of less than 7 years were assigned to the following treatment groups: MTX plus Ayurvedic placebo (n = 14), Ayurveda plus MTX placebo (n = 12), or Ayurveda plus MTX (n = 17). Outcomes included the Disease Activity Score (DAS28-CRP), ACR20/50/70, and Health Assessment Questionnaire--Disability Index. All measures were obtained every 12 weeks for 36 weeks. Analyses included descriptive statistics, analysis of variance, χ², or Student t test. The unique features of this study included the development of placebos for each Ayurvedic pharmacological dosage form and individualization of Ayurvedic therapy. All groups were comparable at baseline in demographics and disease characteristics. There were no statistically significant differences among the 3 groups on the efficacy measures. ACR20 results were MTX 86%, Ayurveda 100%, and combination 82%, and DAS28-CRP response were MTX -2.4, Ayurveda -1.7, and combination -2.4. Differences in adverse events among groups were also not statistically significant, although the MTX groups experienced more adverse event (MTX 174, Ayurveda 112, combination 176). No deaths occurred. In this first-ever, double-blind, randomized, placebo-controlled pilot study comparing Ayurveda, MTX, and their combination, all 3 treatments were approximately equivalent in efficacy, within the limits of a pilot study. Adverse events were numerically fewer in the Ayurveda-only group. This study demonstrates that double-blind, placebo-controlled, randomized studies are possible when testing individualized classic Ayurvedic versus allopathic treatment in ways acceptable to western standards and to Ayurvedic physicians. It also justifies the need for larger studies.

  7. Double-Blind Comparison of Phlebitis Produced by Cephalothin Infusions with Buffered and Unbuffered Diluents

    Science.gov (United States)

    Carrizosa, Jaime; Levison, Matthew E.; Kaye, Donald

    1974-01-01

    In a double-blind study with each patient as his own control, a buffered and an unbuffered cephalothin solution was administered to 13 patients in opposite arms for a period of 48 h each. Neither the incidence of phlebitis nor the degree of phlebitis was different with the two diluents, and there was no difference in the time of onset of phlebitis. PMID:4840431

  8. The effect of preoperative submucosal administration of tramadol on the success rate of inferior alveolar nerve block on mandibular molars with symptomatic irreversible pulpitis: a randomized, double-blind placebo-controlled clinical trial.

    Science.gov (United States)

    De Pedro-Muñoz, A; Mena-Álvarez, J

    2017-12-01

    This randomized, double-blind, placebo-controlled, clinical trial was designed to improve the success of inferior alveolar nerve blocks (IANB) in mandibular molars with symptomatic irreversible pulpitis (SIP) by means of preoperative submucosal administration of 50 mg tramadol. Forty-two patients with a mandibular molar diagnosed with SIP took part in the trial. Patients were assigned randomly to one of two groups: tramadol group (n = 21), who received 50 mg tramadol in 1 mL by mandibular infiltration, and a placebo group (n = 21), who received 1 mL of normal saline administered to the affected tooth by the same means. Ten minutes later, all patients received an IANB with 4% articaine with epinephrine 1 : 100 000. A 10-min waiting time was established after local anaesthetic (LA) administration before carrying out three consecutive tests to assess anaesthesia of the pulp, that is two consecutive negative responses to an electric pulp test, positive or negative response to a cold test and no pain during access cavity preparation. IANB was considered successful only if the patient did not experience pain arising from these tests. Data were analysed by the Chi-squared frequency test and the Fisher's exact test, for qualitative variables, Mann-Whitney U-test for independent samples and two-way anova for more than two independent samples. In the tramadol group IANB was achieved successfully in 57% of the sample, whilst the placebo group obtained 29%. The difference between groups was not significant (P = 0.06). When performing endodontic access, the anaesthetic success rate was significantly in favour of tramadol (P = 0.03). Preoperative submucosal administration of 50 mg tramadol in mandibular molars with SIP significantly improved the success of IANB using 4% articaine with 1 : 100 000 epinephrine during access cavity preparation in comparison with a placebo. © 2017 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  9. Gentamicin-collagen sponge reduces sternal wound complications after heart surgery : A controlled, prospectively randomized, double-blind study

    NARCIS (Netherlands)

    Schimmer, Christoph; Oezkur, Mehmet; Sinha, Bhanu; Hain, Johannes; Gorski, Armin; Hager, Benjamin; Leyh, Rainer

    Objective: Prophylactic retrosternal placement of a gentamicin-collagen sponge has been the subject of several recent clinical studies and is a matter of controversy. The present study is the first controlled, prospective, randomized, double-blind, single-center study to investigate the efficacy of

  10. The effectiveness of Lee Silverman Voice Treatment therapy issued interactively through an iPad device: A non-inferiority study.

    Science.gov (United States)

    Griffin, Murray; Bentley, John; Shanks, Joseph; Wood, Carly

    2018-04-01

    Introduction This study compared the differences in recorded speech variables between people treated with conventional 'in person' Lee Silverman Voice Treatment (LSVT) and those treated remotely via iPad-based 'Facetime'. Method Eight participants were selected for the iPad LSVT, and 21 similarly matched subjects were selected from existing data to form the 'in person' group. Participants in both groups had diagnosed idiopathic Parkinson's disease and moderate hypokinetic dysarthria. Eighteen sessions of prescribed LSVT comprising a pre-treatment assessment, 16 treatment sessions, and a six months' post-treatment assessment were administered for each person. In both groups, pre- and post-treatment assessments were conducted face-to-face. Performance measures were recorded during assessment and treatment. Average measures were determined for all tasks at all time points and a summary outcome variable was composed from across-task performance. Results Non-inferiority testing confirmed that iPad LSVT was non-inferior in treating all LSVT task 3 variables except generating words, with the 90% upper confidence intervals (CI) lying between the non-inferiority margin of ± 2.25 and zero. The iPad was superior in treating the task 3 rainbow reading passage and describing motor task variables with upper and lower 90% CI values being negative. The improvement in the summary outcome variable score was also superior in the iPad group. Discussion Non-inferiority testing implies that the iPad LSVT is non-inferior in treating task three variables when compared to traditional LSVT. The study supports further development of remote delivery solutions involving the Apple iPad and 'Facetime' system as a means of improving access to services and the participant's experience.

  11. Comparison of periodontal ligament injection and inferior alveolar nerve block in mandibular primary molars pulpotomy: a randomized control trial.

    Science.gov (United States)

    Haghgoo, Roza; Taleghani, Ferial

    2015-05-01

    Inferior alveolar nerve block is a common technique for anesthesia of the primary mandibular molars. A number of disadvantages have been shown to be associated with this technique. Periodontal ligament (PDL) injection could be considered as an alternative to inferior alveolar nerve block. The aim of this study was to evaluate the effectiveness of PDL injection in the anesthesia of primary molar pulpotomy with mandibular block. This study was performed using a sequential double-blind randomized trial design. 80 children aged 3-7 years old who required pulpotomy in symmetrical mandibular primary molars were selected. The teeth of these children were anesthetized with periodontal injection on one side of the mandible and block on the other. Pulpotomy was performed on each patient during the same appointment. Signs of discomfort, including hand and body tension and eye movement, the verbal complaint and crying (SEM scale), were evaluated by a dental assistant who was blinded to the treatment allocation of the patients. Finally, the data were analyzed using the exact Fisher test and Pearson Chi-squared exact test. Success rate was 88/75 and 91/25 in the PDL injection and nerve block groups, respectively. There was no statistically significant difference between the two techniques (P = 0.250). Results showed that PDL injection can be used as an alternative to nerve block in pulpotomy of the mandibular primary molars.

  12. Threshold electrical stimulation (TES) in ambulant children with CP: a randomized double-blind placebo-controlled clinical trial

    DEFF Research Database (Denmark)

    Dali, Christine í; Hansen, Flemming Juul; Pedersen, Søren Anker

    2002-01-01

    A randomized double-blind placebo-controlled clinical trial was carried out to determine whether a group of stable children with cerebral palsy (36 males, 21 females; mean age 10 years 11 months, range 5 to 18 years) would improve their motor skills after 12 months of threshold electrical...... stimulation (TES). Two thirds received active and one third received inactive stimulators. For the primary outcome we constructed a set of plausible motor function tests and studied the change in summary indices of the performance measurements. Tests were videotaped and assessed blindly to record qualitative...

  13. Randomized, Double-Blind, Placebo-Controlled Trial of Asenapine Maintenance Therapy in Adults With an Acute Manic or Mixed Episode Associated With Bipolar I Disorder.

    Science.gov (United States)

    Szegedi, Armin; Durgam, Suresh; Mackle, Mary; Yu, Sung Yun; Wu, Xiao; Mathews, Maju; Landbloom, Ronald P

    2018-01-01

    The authors determined the efficacy and safety of asenapine in preventing recurrence of any mood episode in adults with bipolar I disorder. Adults with an acute manic or mixed episode per DSM-IV-TR criteria were enrolled in this randomized, placebo-controlled trial consisting of an initial 12- to 16-week open-label period and a 26-week double-blind randomized withdrawal period. The target asenapine dosage was 10 mg b.i.d. in the open-label period but could be titrated down to 5 mg b.i.d. After completing the open-label period, subjects meeting stabilization/stable-responder criteria were randomized to asenapine or placebo treatment in the double-blind period. The primary efficacy endpoint was time to recurrence of any mood event during the double-blind period. Kaplan-Meier estimation was performed, and 95% confidence intervals were determined. Safety was assessed throughout. A total of 549 subjects entered the open-label period, of whom 253 enrolled in the double-blind randomized withdrawal period (127 in the placebo group; 126 in the asenapine group). Time to recurrence of any mood episode was statistically significantly longer for asenapine- than placebo-treated subjects. In post hoc analyses, significant differences in favor of asenapine over placebo were seen in time to recurrence of manic and depressive episodes. The most common treatment-emergent adverse events were somnolence (10.0%), akathisia (7.7%), and sedation (7.7%) in the open-label period and mania (11.9% of the placebo group compared with 4.0% of the asenapine group) and bipolar I disorder (6.3% compared with 1.6%) in the double-blind period. Long-term treatment with asenapine was more effective than placebo in preventing recurrence of mood events in adults with bipolar I disorder and was generally well-tolerated.

  14. Effects of long-term weekly iron and folic acid supplementation on lower genital tract infection - a double blind, randomised controlled trial in Burkina Faso.

    Science.gov (United States)

    Brabin, Loretta; Roberts, Stephen A; Gies, Sabine; Nelson, Andrew; Diallo, Salou; Stewart, Christopher J; Kazienga, Adama; Birtles, Julia; Ouedraogo, Sayouba; Claeys, Yves; Tinto, Halidou; d'Alessandro, Umberto; Faragher, E Brian; Brabin, Bernard

    2017-11-23

    Provision of routine iron supplements to prevent anaemia could increase the risk for lower genital tract infections as virulence of some pathogens depends on iron availability. This trial in Burkina Faso assessed whether weekly periconceptional iron supplementation increased the risk of lower genital tract infection in young non-pregnant and pregnant women. Genital tract infections were assessed within a double blind, controlled, non-inferiority trial of malaria risk among nulliparous women, randomised to receive either iron and folic acid or folic acid alone, weekly, under direct observation for 18 months. Women conceiving during this period entered the pregnancy cohort. End assessment (FIN) for women remaining non-pregnant was at 18 months. For the pregnancy cohort, end assessment was at the first scheduled antenatal visit (ANC1). Infection markers included Nugent scores for abnormal flora and bacterial vaginosis (BV), T. vaginalis PCR, vaginal microbiota, reported signs and symptoms, and antibiotic and anti-fungal prescriptions. Iron biomarkers were assessed at baseline, FIN and ANC1. Analysis compared outcomes by intention to treat and in iron replete/deficient categories. A total of 1954 women (mean 16.8 years) were followed and 478 (24.5%) became pregnant. Median supplement adherence was 79% (IQR 59-90%). Baseline BV prevalence was 12.3%. At FIN and ANC1 prevalence was 12.8% and 7.0%, respectively (P Iron-supplemented non-pregnant women received more antibiotic treatments for non-genital infections (P = 0.014; mainly gastrointestinal infections (P = 0.005), anti-fungal treatments for genital infections (P = 0.014) and analgesics (P = 0.008). Weekly iron did not significantly reduce iron deficiency prevalence. At baseline, iron-deficient women were more likely to have normal vaginal flora (P = 0.016). Periconceptional weekly iron supplementation of young women did not increase the risk of lower genital tract infections but did increase

  15. Effect of preoperative medications on the efficacy of inferior alveolar nerve block in patients with irreversible pulpitis: A placebo-controlled clinical study.

    Science.gov (United States)

    Jena, Amit; Shashirekha, Govind

    2013-03-01

    The purpose of this prospective, randomized, double-blind, placebo-controlled study was to compare the effect of the administration of preoperative ibuprofen, ketorolac, combination of etodolac with paracetamol and combination of aceclofenac with paracetamol versus placebo for the potential increased effectiveness of the inferior alveolar nerve block [IANB] anesthesia. A total of 100 endodontic emergency patients in moderate to severe pain diagnosed with irreversible pulpitis of a mandibular posterior tooth randomly received, in a double-blind manner, either a drug or placebo 30 minutes before the administration of a conventional IANB. Cold testing was done before administration of anesthesia to determine level of pain using Heft-Parker Visual Analogue Scale (VAS) score. Success was defined as no pain or pain (VAS) on access or initial instrumentation. Overall success was 54% for all the groups. Success was highest (70%) for the ketorolac group, 55% for both ibuprofen group and combination of aceclofenac with paracetamol group, 50% for combination of etodolac with paracetamol group, and 40% for the placebo group. Under the conditions of this study, the use of preoperative medication did improve the anesthetic efficacy of IANB for the treatment of teeth diagnosed with irreversible pulpitis but not significantly.

  16. A double-blind, placebo controlled trial of high-dose lecithin in Alzheimer's disease.

    OpenAIRE

    Little, A; Levy, R; Chuaqui-Kidd, P; Hand, D

    1985-01-01

    The first long-term double-blind placebo controlled trial of high dose lecithin in senile dementia of the Alzheimer type is reported. Fifty one subjects were given 20-25 g/day of purified soya lecithin (containing 90% phosphatidyl plus lysophosphatidyl choline) for six months and followed up for at least a further six months. Plasma choline levels were monitored throughout the treatment period. There were no differences between the placebo group and the lecithin group but there was an improve...

  17. Gabapentin in traumatic nerve injury pain: A randomized, double-blind, placebo-controlled, cross-over, multi-center study

    DEFF Research Database (Denmark)

    Gordh, Torsten E; Stubhaug, Audun; Jensen, Troels S

    2008-01-01

    A double-blind, randomized, placebo-controlled cross-over multi-center study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain caused by traumatic or postsurgical peripheral nerve injury, using doses up to 2400mg/day. The study comprised a run...

  18. Cognitive, health and psychosocial effects of melatonin and light therapy in childhood insomnia. Double-blind placebo-controlled study

    NARCIS (Netherlands)

    Smits, M.; van Maanen, A.; Meijer, A.M.; van der Heijden, K.; Oort, F.

    2017-01-01

    Introduction: To examine effects of melatonin and light therapy on cognitive, health and psychosocial outcomes in children with chronic sleep onset insomnia; and to disentangle direct effects from indirect effects through sleep improvement. Methods: A randomized, double-blind placebo-controlled

  19. Double-blinded, placebo-controlled study to evaluate an antipruritic shampoo for dogs with allergic pruritus.

    Science.gov (United States)

    Schilling, J; Mueller, R S

    2012-07-28

    Shampoo therapy is frequently used on pruritic dogs. However, there are few double-blinded, placebo-controlled studies of this form of therapy. This randomised, double-blinded, placebo-controlled study evaluated the efficacy of a commercial medicated shampoo (DermaTopic; Almapharm) containing chlorhexidine, lactoferrin, piroctone olamine, chitosan and essential fatty acids in 27 dogs with mild to moderate allergic pruritus without secondary skin infections. All dogs received shampoo therapy with either DermaTopic or a shampoo vehicle as placebo twice weekly for four weeks. The extent of pruritus was evaluated before the study and then on a daily basis by the owners using a visual analogue scale. Before beginning the treatment and after four weeks, the skin lesions were evaluated by an experienced clinician with a validated lesion score (Canine Atopic Dermatitis Extent and Severity Index - CADESI). The pruritus was reduced significantly by both DermaTopic and placebo. However, there was no significant difference between both groups. There was no statistically significant difference in the CADESI scores pre- and post-treatment in either group or between the two types of treatment. This study provides further evidence of the benefit of shampoo therapy for pruritic dogs.

  20. Efficacy and Safety of a Fixed-Dose Combination Therapy of Tamsulosin and Tadalafil for Patients With Lower Urinary Tract Symptoms and Erectile Dysfunction: Results of a Randomized, Double-Blinded, Active-Controlled Trial.

    Science.gov (United States)

    Kim, Sae Woong; Park, Nam Cheol; Lee, Seung Wook; Yang, Dae Yul; Park, Jong Kwan; Moon, Du Geon; Yang, Sang-Kuk; Lee, Sung Won; Moon, Ki Hak; Ahn, Tai Young; Kim, Soo Woong; Park, Kwangsung; Min, Kweon Sik; Ryu, Ji-Kan; Son, Hankil; Jung, Jina; Hyun, Jae Seog

    2017-08-01

    Phosphodiesterase type 5 inhibitors and α-adrenergic blocking agents (α-blockers) are widely used for the treatment of erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). To assess the efficacy and safety of fixed-dose combinations (FDCs) of tamsulosin and tadalafil compared with tadalafil monotherapy in patients with comorbid BPH-associated LUTS and ED. A randomized, double-blinded, active-controlled trial was conducted of 510 men with BPH-associated LUTS and ED. Patients were treated with FDCs of tamsulosin 0.4 mg plus tadalafil 5 mg (FDC 0.4/5 mg), tamsulosin 0.2 mg plus tadalafil 5 mg (FDC 0.2/5 mg), or tadalafil 5 mg for a 12-week treatment period. For a subsequent 12-week extension period, the patients were administered FDC 0.4/5 mg. The primary outcomes were changes from baseline in total International Prostate Symptom Score (IPSS) and International Index of Erectile Function erectile function domain (IIEF-EF) score at week 12 to prove superiority and non-inferiority of FDCs compared with tadalafil 5 mg. The safety assessments were adverse reactions, laboratory test results, and vital signs at week 24. The mean changes in total IPSS and IIEF-EF scores were -9.46 and 9.17 for FDC 0.4/5 mg and -8.14 and 9.49 for tadalafil 5 mg, respectively, which indicated superiority in LUTS improvement (P = .0320) and non-inferiority in ED treatment with FDC 0.4/5 mg compared with tadalafil 5 mg. However, the results from FDC 0.2/5 mg failed to demonstrate superiority in LUTS improvement. No clinically significant adverse events regarding the investigational products were observed during the 24-week period. The FDC 0.4/5 mg is the first combined formulation of an α-blocker and a phosphodiesterase type 5 inhibitor that offers benefits in patient compliance and as add-on therapy in patients with comorbid BPH-associated LUTS and ED. The study clearly demonstrated the advantage of FDC 0.4/5 mg. The main

  1. Identification of hazelnut major allergens in sensitive patients with positive double-blind, placebo-controlled food challenge results

    DEFF Research Database (Denmark)

    Pastorello, Elide A; Vieths, Stefan; Pravettoni, Valerio

    2002-01-01

    The hazelnut major allergens identified to date are an 18-kd protein homologous to Bet v 1 and a 14-kd allergen homologous to Bet v 2. No studies have reported hazelnut allergens recognized in patients with positive double-blind, placebo-controlled food challenge (DBPCFC) results or in patients...

  2. Double blind evaluation of the effects of various contrast media on extremity veins in the dog

    International Nuclear Information System (INIS)

    Laerum, F.; Dehner, L.P.; Rysavy, J.; Amplatz, K.; Minnesota Univ., Minneapolis

    1987-01-01

    Canine superficial extremity veins were examined grossly and microscopically in a double blind fashion for endothelial damage and phlebitis one hour and four days after the injection of ionic monomeric or dimeric, and non-ionic monomeric, 300 mg I/ml, contrast media. Superficial veins of all four extremities and the tail vein were injected with the same amounts of contrast medium after application of tourniquets for 20 minutes following the injections. Silver staining and prefixation of the veins were done in situ. The specimens were evaluated together with cross-sectioned, hematoxylin-eosin stained biopsies. On the basis of a randomized study of 77 dogs, endothelial damage or thrombosis caused by various contrast media as seen in man was not demonstrated. This may be due to species differences. It is postulated that canine endothelium may have a higher resistance to contrast medium injury than human endothelium. (orig.)

  3. Changes in endothelial function, arterial stiffness and blood pressure in pregnant women after consumption of high-flavanol and high-theobromine chocolate: a double blind randomized clinical trial.

    Science.gov (United States)

    Babar, Asma; Bujold, Emmanuel; Leblanc, Vicky; Lavoie-Lebel, Élise; Paquette, Joalee; Bazinet, Laurent; Lemieux, Simone; Marc, Isabelle; Abdous, Belkacem; Dodin, Sylvie

    2018-04-16

    The aim of this 2-group, parallel, double blind single-centre RCT was to evaluate the acute and chronic impacts of high flavanol high theobromine (HFHT) chocolate consumption on endothelial function, arterial stiffness and blood pressure (BP) in women at risk of preeclampsia. 131 pregnant women considered at risk of preeclampsia based on uterine artery Doppler ultrasound were divided into two groups (HFHT or low flavanol and theobromine chocolate (LFLT). Acute changes in plasma flavanol and theobromine, peripheral arterial tonometry and BP were evaluated at randomization (0, 60 and 120 min after a single 40-g dose of chocolate) and again 6 and 12 weeks after daily 30-g chocolate intake. The EndoPAT 2000 provided reactive hyperemia index (RHI) and adjusted augmentation index (AIx) as markers for endothelial function and arterial stiffness, respectively. Compared with LFLT, acute HFHT intake significantly increased plasma epicatechin and theobromine (p theobromine (p theobromine concentrations and decreased arterial stiffness, with no effect on endothelial function and a marginal increase in diastolic BP. Chronic HFHT intake increased plasma theobromine, though it did not have positive impacts on endothelial function, arterial stiffness or BP when compared to LFLT in pregnant women at risk of PE.

  4. The Gluten-Free/Casein-Free Diet: A Double-Blind Challenge Trial in Children with Autism

    Science.gov (United States)

    Hyman, Susan L.; Stewart, Patricia A.; Foley, Jennifer; Cain, Usa; Peck, Robin; Morris, Danielle D.; Wang, Hongyue; Smith, Tristram

    2016-01-01

    To obtain information on the safety and efficacy of the gluten-free/casein-free (GFCF) diet, we placed 14 children with autism, age 3-5 years, on the diet for 4-6 weeks and then conducted a double-blind, placebo-controlled challenge study for 12 weeks while continuing the diet, with a 12-week follow-up. Dietary challenges were delivered via weekly…

  5. Prevention of bone loss by vitamin D supplementation in elderly women : A randomized double-blind trial

    NARCIS (Netherlands)

    Ooms, Marcel E.; Roos, Jan C.; Bezemer, P. Dick; van der Vijgh, Wim J F; Bouter, Lex M.; Lips, Paul

    1995-01-01

    The purpose of the study was to determine the effect of vitamin D supplementation on bone turnover and bone loss in elderly women. Three hundred forty-eight women, ages 70 yr and older, were randomized to receive 400 IU vitamin D3 per day (n = 177) or placebo (n = 171), double-blind, for a period of

  6. The Gluten-Free, Casein-Free Diet in Autism: Results of a Preliminary Double Blind Clinical Trial

    Science.gov (United States)

    Elder, Jennifer Harrison; Shankar, Meena; Shuster, Jonathan; Theriaque, Douglas; Burns, Sylvia; Sherrill, Lindsay

    2006-01-01

    This study tested the efficacy of a gluten-free and casein-free (GFCF) diet in treating autism using a randomized, double blind repeated measures crossover design. The sample included 15 children aged 2-16 years with autism spectrum disorder. Data on autistic symptoms and urinary peptide levels were collected in the subjects' homes over the 12…

  7. Dolutegravir as maintenance monotherapy for HIV (DOMONO): a phase 2, randomised non-inferiority trial.

    Science.gov (United States)

    Wijting, Ingeborg; Rokx, Casper; Boucher, Charles; van Kampen, Jeroen; Pas, Suzan; de Vries-Sluijs, Theodora; Schurink, Carolina; Bax, Hannelore; Derksen, Maarten; Andrinopoulou, Eleni-Rosalina; van der Ende, Marchina; van Gorp, Eric; Nouwen, Jan; Verbon, Annelies; Bierman, Wouter; Rijnders, Bart

    2017-12-01

    The high genetic barrier to resistance of dolutegravir might allow for its use as maintenance monotherapy in patients with HIV. We investigated whether dolutegravir monotherapy was non-inferior to combination antiretroviral therapy (ART) for maintaining virological suppression in patients with HIV-1 infection successfully treated with combination ART. We did this open-label, phase 2, randomised non-inferiority trial at two medical centres in the Netherlands. Eligible patients (aged ≥18 years) were on combination ART, had been virologically suppressed (HIV RNA <50 copies per mL) for at least 6 months, and had CD4 nadirs of 200 cells per μL or higher, HIV RNA zeniths of 100 000 copies per mL or less, and no history of virological failure. Patients were randomly assigned (1:1), via a web-based block randomisation method (variable block sizes of 4 and 6), to switch to dolutegravir monotherapy (50 mg once a day) either immediately or after a delay of 24 weeks of continued combination ART. Randomisation was stratified by HIV RNA zenith (<50 000 copies per mL vs 50 000-99 999 copies per mL). Investigators and patients were not masked to group allocation. The primary endpoint was the proportion of patients with plasma HIV RNA viral loads of less than 200 copies per mL at week 24, with a non-inferiority margin of 12%. We did analyses in the on-treatment and intention-to-treat populations. This trial is registered with ClinicalTrials.gov, NCT02401828. Between March 10, 2015, and Feb 4, 2016, we randomly assigned 51 patients to the immediate switch group and 53 patients to the delayed switch group. One patient who received immediate monotherapy discontinued treatment at week 12 because of disturbed sleep. At week 24, dolutegravir monotherapy was non-inferior to combination ART, with plasma HIV RNA loads of 200 copies per mL or higher observed in 2% (1/50) of patients in the immediate switch group and in no patients in the delayed switch group (difference 2%, 95% CI

  8. Constraint-Induced Aphasia Therapy for Treatment of Chronic Post-Stroke Aphasia: A Randomized, Blinded, Controlled Pilot Trial.

    Science.gov (United States)

    Szaflarski, Jerzy P; Ball, Angel L; Vannest, Jennifer; Dietz, Aimee R; Allendorfer, Jane B; Martin, Amber N; Hart, Kimberly; Lindsell, Christopher J

    2015-09-24

    To provide a preliminary estimate of efficacy of constraint-induced aphasia therapy (CIAT) when compared to no-intervention in patients with chronic (>1 year) post-stroke aphasia in order to plan an appropriately powered randomized controlled trial (RCT). We conducted a pilot single-blinded RCT. 24 patients were randomized: 14 to CIAT and 10 to no-intervention. CIAT groups received up to 4 hours/day of intervention for 10 consecutive business days (40 hours or therapy). Outcomes were assessed within 1 week of intervention and at 1 and 12 weeks after intervention and included several linguistic measures and a measure of overall subjective communication abilities (mini-Communicative Abilities Log (mini-CAL)). Clinicians treating patients (CIAT group) did not communicate with other team members to maintain blinding and the testing team members were blinded to treatment group assignment. Overall, the results of this pilot RCT support the results of previous observational studies that CIAT may lead to improvements in linguistic abilities. At 12 weeks, the treatment group reported better subjective communication abilities (mini-CAL) than the no-intervention group (p=0.019). Other measures trended towards better performance in the CIAT group. In this pilot RCT intensive language therapy led to an improvement in subjective language abilities. The effects demonstrated allow the design of a definitive trial of CIAT in patients with a variety of post-stroke aphasia types. In addition, our experiences have identified important considerations for designing subsequent trial(s) of CIAT or other interventions for post-stroke aphasia.

  9. Effects on muscle performance of NSAID treatment with piroxicam versus placebo in geriatric patients with acute infection-induced inflammation. A double blind randomized controlled trial.

    Science.gov (United States)

    Beyer, Ingo; Bautmans, Ivan; Njemini, Rose; Demanet, Christian; Bergmann, Pierre; Mets, Tony

    2011-12-30

    Inflammation is the main cause of disease-associated muscle wasting. In a previous single blind study we have demonstrated improved recovery of muscle endurance following celecoxib treatment in hospitalized geriatric patients with acute infection. Here we further evaluate NSAID treatment with piroxicam in a double blind RCT and investigate the role of cytokines and heat shock proteins (Hsp) with respect to muscle performance. We hypothesized that NSAID treatment would preserve muscle performance better than antibiotic treatment alone, by reducing infection-associated inflammation and by increasing expression of cytoprotective Hsp. Consecutive admissions to the geriatric ward were screened. 30 Caucasian patients, median age 84.5 years, with acute infection-induced inflammation and serum levels of CRP > 10 mg/L were included and randomized to active treatment with 10 mg piroxicam daily or placebo. Assessment comprised general clinical and biochemical parameters, 25 cytokines in serum, intra-and extracellular Hsp27 and Hsp70, Elderly Mobility Scale (EMS) scores, grip strength (GS), fatigue resistance (FR) and lean body mass (LBM). Patients were evaluated until discharge with a maximum of 3 weeks after treatment allocation. EMS scores, FR and grip work (GW), a measure taking into account GS and FR, significantly improved with piroxicam, but not with placebo. Early decreases in IL-6 serum levels with piroxicam correlated with better muscle performance at week 2. Basal expression of Hsp27 in monocytes without heat challenge (WHC) was positively correlated with FR at baseline and significantly increased by treatment with piroxicam compared to placebo. Profound modifications in the relationships between cytokines or Hsp and changes in muscle parameters were observed in the piroxicam group. Piroxicam improves clinically relevant measures of muscle performance and mobility in geriatric patients hospitalized with acute infection-induced inflammation. Underlying mechanisms may

  10. Analysis of opioid-mediated analgesia in Phase III studies of methylnaltrexone for opioid-induced constipation in patients with chronic noncancer pain

    Directory of Open Access Journals (Sweden)

    Webster LR

    2015-10-01

    Full Text Available Lynn R Webster,1 Darren M Brenner,2 Andrew C Barrett,3 Craig Paterson,3 Enoch Bortey,3 William P Forbes3 1PRA Health Sciences, Salt Lake City, UT, 2Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, 3Salix, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, USA Background: Subcutaneous methylnaltrexone is efficacious and well tolerated for opioid-induced constipation (OIC but may theoretically disrupt opioid-mediated analgesia. Methods: Opioid use, pain intensity, and opioid withdrawal (Objective Opioid Withdrawal Scale [OOWS] and Subjective Opiate Withdrawal Scale [SOWS] scores were reported in a randomized, double-blind trial with an open-label extension (RCT and an open-label trial (OLT evaluating safety in adults with chronic noncancer pain. In the RCT, patients taking ≥50 mg of oral morphine equivalents daily with <3 rescue-free bowel movements weekly received methylnaltrexone 12 mg once daily (n=150, every other day (n=148, or placebo (n=162 for 4 weeks, followed by open-label methylnaltrexone 12 mg (as needed [prn]; n=364 for 8 weeks. In the OLT, patients (n=1,034 on stable opioid doses with OIC received methylnaltrexone 12 mg prn for up to 48 weeks. Results: Minimal fluctuations of median morphine equivalent dose from baseline (BL were observed in the RCT double-blind period (BL, 154.8–161.0 mg/d; range, 137.1–168.0 mg/d, RCT open-label period (BL, 156.3–174.6; range, 144.0–180.0 and OLT (BL, 120 mg/d; range, 117.3–121.1 mg/d. No significant change from BL in pain intensity score occurred in any group at weeks 2 or 4 (both P≥0.1 of the RCT double-blind period, and scores remained stable during the open-label period and in the OLT (mean change, —0.2 to 0.1. Changes from BL in OOWS and SOWS scores during the double-blind period were not significantly impacted by methylnaltrexone exposure at weeks 2 or 4 (P>0.05 for all. Conclusion: Methylnaltrexone did not affect

  11. The Effect of Adjuvant Zinc Therapy on Recovery from Pneumonia in Hospitalized Children: A Double-Blind Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Mohammad Javad Qasemzadeh

    2014-01-01

    Full Text Available Objectives. Pneumonia is one of the common mortality causes in young children. Some studies have shown beneficial effect of zinc supplements on treatment of pneumonia. The present study aimed to investigate the effects of short courses of zinc administration on recovery from this disease in hospitalized children. Methods. In a parallel Double-Blind Randomized Controlled Trial at Ayatollah Golpaygani Hospital in Qom, 120 children aged 3–60 months with pneumonia were randomly assigned 1 : 1 to receive zinc or placebo (5 mL every 12 hours along with the common antibiotic treatments until discharge. Primary outcome was recovery from pneumonia which included the incidence and resolving clinical symptoms and duration of hospitalization. Results. The difference between two groups in all clinical symptoms at admittance and the variables affecting the disease such as age and sex were not statistically significant (P<0.05 at baseline. Compared to the placebo group, the treatment group showed a statistically significant decrease in duration of clinical symptoms (P=0.044 and hospitalization (P=0.004. Conclusions. Supplemental administration of zinc can expedite the healing process and results in faster resolution of clinical symptoms in children with pneumonia. In general, zinc administration, along with common antibiotic treatments, is recommended in this group of children. It can also reduce the drug resistance caused by multiple antibiotic therapies. This trial is approved by Medical Ethic Committee of Islamic Azad University in Iran (ID Number: 8579622-Q. This study is also registered in AEARCTR (The American Economic Association's Registry for Randomized Controlled Trials. This trial is registered with RCT ID: AEARCTR-0000187.

  12. Microlaparoscopic vs conventional laparoscopic cholecystectomy: a prospective randomized double-blind trial

    DEFF Research Database (Denmark)

    Bisgaard, T; Klarskov, B; Trap, R

    2002-01-01

    cholecystectomy using two 10-mm and two 5-mm trocars (LC). Incisional pain at each port incision and overall pain were recorded for 1 week after the operation. Fatigue, nausea and vomiting, pulmonary function, and cosmetic results were also measured. RESULTS: Data from 52 patients were analyzed; eight patients......BACKGROUND: Downsizing the port incisions may reduce pain after laparoscopic cholecystectomy. METHODS: In a double-blind controlled study, 60 patients were randomized to undergo either microlaparoscopic cholecystectomy using one 10-mm and three 3.5-mm trocars (3.5-mm LC) or traditional laparoscopic.......01). In both groups, pain scores at the supraumbilical 10-mm port were significantly higher compared with other port sites (p

  13. Minocycline versus co-trimoxazole in chancroid : A double-blind randomised study

    Directory of Open Access Journals (Sweden)

    Oberoi C

    1994-01-01

    Full Text Available This double-blind randomised parallel-group study comparing the efficacy and side effects of minocycline with that of cotrimoxazole in chancroid, had 56 analysable cases, 28 in each group. All admissible cases were assessed clinically on a scale of 0 to 3 for number and size of ulcers, pain, discharge, surrounding erythema and bubo. Each drug individually showed significant improvement in all clinical parameters. Minocycline showed significantly better improvement than cotrimoxazole in all parameters. Minocycline had 43% cure rate, and no failures, against 36% cure and 25% failure for cotrimoxazole. Both the drug were well tolerated. We conclude that minocycline is a superior alternative to cotrimoxazole in the therapy of chancroid.

  14. Do TETRA (Airwave) base station signals have a short-term impact on health and well-being? A randomized double-blind provocation study.

    Science.gov (United States)

    Wallace, Denise; Eltiti, Stacy; Ridgewell, Anna; Garner, Kelly; Russo, Riccardo; Sepulveda, Francisco; Walker, Stuart; Quinlan, Terence; Dudley, Sandra; Maung, Sithu; Deeble, Roger; Fox, Elaine

    2010-06-01

    "Airwave" is the new communication system currently being rolled out across the United Kingdom for the police and emergency services, based on the Terrestrial Trunked Radio Telecommunications System (TETRA). Some police officers have complained about skin rashes, nausea, headaches, and depression as a consequence of using their Airwave handsets. In addition, a small subgroup in the population self-report being sensitive to electromagnetic fields (EMFs) in general. We conducted a randomized double-blind provocation study to establish whether short-term exposure to a TETRA base station signal has an impact on the health and well-being of individuals with self-reported "electrosensitivity" and of participants who served as controls. Fifty-one individuals with self-reported electrosensitivity and 132 age- and sex-matched controls participated in an open provocation test; 48 sensitive and 132 control participants went on to complete double-blind tests in a fully screened semianechoic chamber. Heart rate, skin conductance, and blood pressure readings provided objective indices of short-term physiological response. Visual analog scales and symptom scales provided subjective indices of well-being. We found no differences on any measure between TETRA and sham (no signal) under double-blind conditions for either controls or electrosensitive participants, and neither group could detect the presence of a TETRA signal at rates greater than chance (50%). When conditions were not double blind, however, the self-reported electrosensitive individuals did report feeling worse and experienced more severe symptoms during TETRA compared with sham. Our findings suggest that the adverse symptoms experienced by electrosensitive individuals are due to the belief of harm from TETRA base stations rather than to the low-level EMF exposure itself.

  15. A double-blind study of the efficacy of apomorphine and its assessment in "off-periods in Parkinson's disease

    NARCIS (Netherlands)

    van Laar, T.; Jansen, E.N.H.; Essink, A.W.G.; Neef, C.; Oosterloo, Sebe J.

    1993-01-01

    Five patients with idiopathic Parkinson's disease with severe response fluctuations were selected for a randomized double-blind placebo-controlled study, concerning the clinical effects of subcutaneous apomorphine and its assessment in `off¿-periods. The study was designed as five n = 1 studies, in

  16. A double-blind placebo-controlled study of controlled release fluvoxamine for the treatment of generalized social anxiety disorder

    NARCIS (Netherlands)

    Westenberg, HGM; Stein, DJ; Yang, HC; Li, D; Barbato, LM

    This was a randomized double-blind placebo-controlled multicenter study to assess the efficacy, safety, and tolerability of fluvoxamine in a controlled release (CR) formulation for treatment of generalized social anxiety disorder (GSAD). A total of 300 subjects with GSAD were randomly assigned to

  17. Pregabalin in patients with central neuropathic pain: a randomized, double-blind, placebo-controlled trial of a flexible-dose regimen

    NARCIS (Netherlands)

    Vranken, J. H.; Dijkgraaf, M. G. W.; Kruis, M. R.; van der Vegt, M. H.; Hollmann, M. W.; Heesen, M.

    2008-01-01

    The effective treatment of patients suffering from central neuropathic pain remains a clinical challenge, despite a standard pharmacological approach in combination with anticonvulsants and antidepressants. A randomized, double-blinded, placebo-controlled trial evaluated the effects of pregabalin on

  18. Efficacy and safety of teneligliptin add-on to insulin monotherapy in Japanese patients with type 2 diabetes mellitus: a 16-week, randomized, double-blind, placebo-controlled trial with an open-label period.

    Science.gov (United States)

    Kadowaki, Takashi; Kondo, Kazuoki; Sasaki, Noriyuki; Miyayama, Kyoko; Yokota, Shoko; Terata, Ryuji; Gouda, Maki

    2017-09-01

    To assess the efficacy and safety of teneligliptin as add-on to insulin monotherapy in patients with type 2 diabetes mellitus (T2DM). In a 16-week, double-blind period, 148 Japanese T2DM patients with inadequate glycemic control with insulin and diet/exercise therapies were randomized to placebo or teneligliptin 20 mg. In a subsequent 36-week, open-label period, all patients received teneligliptin once daily. The primary outcome measure was change in HbA1c at the end of the double-blind period. The difference between placebo and teneligliptin in change in HbA1c in the double-blind period (least squares mean ± SE) was -0.80% ± 0.11%; teneligliptin was superior (ANCOVA, P 1). The HbA1c-lowering effect of teneligliptin was maintained throughout the open-label period. The incidence of adverse events was 53.5% with placebo and 44.2% with teneligliptin in the double-blind period, 66.7% in the placebo/teneligliptin group in the open-label period, and 77.9% in the teneligliptin/teneligliptin group over both double-blind/open-label periods. The incidence of hypoglycemic symptoms was 11.1% in the placebo/teneligliptin group in the open-label period and 27.3% in the teneligliptin/teneligliptin group over both double-blind/open-label periods. Teneligliptin was effective and well tolerated in Japanese T2DM patients with inadequate glycemic control. NCT02081599.

  19. "Live high-train low" using normobaric hypoxia: a double-blinded, placebo-controlled study

    DEFF Research Database (Denmark)

    Siebenmann, Christoph; Robach, Paul; Jacobs, Robert A

    2012-01-01

    The combination of living at altitude and training near sea level [live high-train low (LHTL)] may improve performance of endurance athletes. However, to date, no study can rule out a potential placebo effect as at least part of the explanation, especially for performance measures. With the use o...... of a placebo-controlled, double-blinded design, we tested the hypothesis that LHTL-related improvements in endurance performance are mediated through physiological mechanisms and not through a placebo effect. Sixteen endurance cyclists trained for 8 wk at low altitude (...

  20. Double-Blind Maintenance Safety and Effectiveness Findings from the Treatment of Early-Onset Schizophrenia Spectrum (TEOSS) Study

    Science.gov (United States)

    Findling, Robert L.; Johnson, Jacqueline L.; McClellan, Jon; Frazier, Jean A.; Vitiello, Benedetto; Hamer, Robert M.; Lieberman, Jeffrey A.; Ritz, Louise; McNamara, Nora K.; Lingler, Jacqui; Hlastala, Stefanie; Pierson, Leslie; Puglia, Madeline; Maloney, Ann E.; Kaufman, Emily Michael; Noyes, Nancy; Sikich, Linmarie

    2010-01-01

    Objective: To examine the long-term safety and efficacy of three antipsychotics in early-onset schizophrenia spectrum disorders. Method: Patients (8 to 19 years old) who had improved during an 8-week, randomized, double-blind acute trial of olanzapine, risperidone, or molindone (plus benztropine) were eligible to continue on the same medication…

  1. Role of dominant versus non-dominant hand position during uninterrupted chest compression CPR by novice rescuers: a randomized double-blind crossover study.

    Science.gov (United States)

    Nikandish, Reza; Shahbazi, Sharbanoo; Golabi, Sedigheh; Beygi, Najimeh

    2008-02-01

    Previous research has suggested improved quality of chest compressions when the dominant hand was in contact with the sternum. However, the study was in health care professionals and during conventional chest compression-ventilation CPR. The aim of this study was to test the hypothesis, in null form, that the quality of external chest compressions (ECC) in novice rescuers during 5min of uninterrupted chest compression CPR (UCC-CPR) is independent of the hand in contact with the sternum. Confirmation of the hypothesis would allow the use of either hand by the novice rescuers during UCC-CPR. Fifty-nine first year public heath students participated in this randomised double-blind crossover study. After completion of a standard adult BLS course, they performed single rescuer adult UCC-CPR for 5 min on a recording Resusci Anne. One week later they changed the hand of contact with the sternum while performing ECC. The quality of ECC was recorded by the skill meter for the dominant and non-dominant hand during 5 min ECC. The total number of correct chest compressions in the dominant hand group (DH), mean 183+/-152, was not statistically different from the non-dominant hand group (NH), mean 152+/-135 (P=0.09). The number of ECC with inadequate depth in the DH group, mean 197+/-174 and NH group, mean 196+/-173 were comparable (P=0.1). The incidence of ECC exceeding the recommended depth in the DH group, mean 51+/-110 and NH group, mean 32+/-75 were comparable (P=0.1). Although there is a trend to increased incidence of correct chest compressions with positioning the dominant hand in contact with the sternum, it does not reach statistical significance during UCC-CPR by the novice rescuers for 5 min.

  2. NILVAD protocol: a European multicentre double-blind placebo-controlled trial of nilvadipine in mild-to-moderate Alzheimer's disease

    NARCIS (Netherlands)

    Lawlor, B.; Kennelly, S.; O'Dwyer, S.; Cregg, F.; Walsh, C.; Coen, R.; Kenny, R.A.; Howard, R.; Murphy, C.; Adams, J.; Daly, L.; Segurado, R.; Gaynor, S.; Crawford, F.; Mullan, M.; Lucca, U.; Banzi, R.; Pasquier, F.; Breuilh, L.; Riepe, M.; Kalman, J.; Wallin, A.; Borjesson, A.; Molloy, W.; Tsolaki, M.; Olde Rikkert, M.G.M.

    2014-01-01

    INTRODUCTION: This study is a European multicentre, randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of nilvadipine as a disease course modifying treatment for mild-to-moderate Alzheimer's disease (AD) in a phase III study that will run for a period of 82

  3. Masking foods for food challenge: practical aspects of masking foods for a double-blind, placebo-controlled food challenge

    NARCIS (Netherlands)

    Huijbers, G. B.; Colen, A. A.; Jansen, J. J.; Kardinaal, A. F.; Vlieg-Boerstra, B. J.; Martens, B. P.

    1994-01-01

    In diagnosing a food allergy or food intolerance, a double-blind, placebo-controlled food challenge (DBPCFC) with the suspected food or food substance is the only method available for objective confirmation of an assumed relationship between a suspected agent and a complaint. When the use of

  4. The safety and efficacy of subcutaneous birch pollen immunotherapy - a one-year, randomised, double-blind, placebo-controlled study

    DEFF Research Database (Denmark)

    Bødtger, Uffe; Poulsen, L K; Jacobi, H H

    2002-01-01

    BACKGROUND: There is only very limited documentation of the efficacy and safety of high-dose subcutaneous birch pollen immunotherapy (IT) in double-blind, placebo-controlled (DBPC) studies. Birch pollen is a major cause of allergic morbidity in northern Europe and in eastern parts of North Americ...

  5. Telemedicine Provides Non-Inferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial

    Science.gov (United States)

    Bobb, Morgan R.; Van Heukelom, Paul G.; Faine, Brett A.; Ahmed, Azeemuddin; Messerly, Jeffrey T.; Bell, Gregory; Harland, Karisa K.; Simon, Christian; Mohr, Nicholas M.

    2016-01-01

    Objective Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study is to determine whether patient comprehension of telemedicine-enabled research informed consent is non-inferior to standard face-to-face research informed consent. Methods A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic Emergency Department (ED) to test whether telemedicine-enabled research informed consent provided non-inferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of oral chlorhexidine gluconate 0.12% in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard face-to-face consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc., Hackensack, NJ) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified Quality of Informed Consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. Results One-hundred thirty-one patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to face-to-face consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p=0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Conclusion Telemedicine is non-inferior to face

  6. Hyperkinesis and diet: a double-blind crossover trial with a tartrazine challenge.

    Science.gov (United States)

    Levy, F; Dumbrell, S; Hobbes, G; Ryan, M; Wilton, N; Woodhill, J M

    1978-01-28

    A pilot study was conducted on 22 children (19 boys and three girls) aged between four and eight years, who were selected as hyperactive on the basis of developmental history and clinical judgement. Conners' parent-teacher ratings, objective tests of attention, standard perceptualmotor tests and subtests from the Wechsler Intelligence Scale for Children (WISC), were used as response variables. The children were tested before and after four weeks on the elimination diet, after a tartrazine and placebo challenge, and, finally, after a four-week washout period on the diet. Results showed a statistically significant improvement in the mothers' ratings of the children's behaviour after the first four weeks of the diet. The improvement was maintained in a combined analysis of the initial four-week diet period and four-week washout period. This result was not substantiated by the statistical analysis of the results from objective tests. The rating scales and objective tests for the full sample did not show a statistically significant deterioration in the children's behaviour when they were challenged under double-blind test conditions with the Yellow Dye No. 5, tartrazine, and the tests were conducted the day after a two-week challenge period. A comparison of mother ratings of behaviour during challenge and placebo double-blind trial and in the 24 hours preceding tests, in a subgroup of the children who, while on the diet, showed a 25% reduction of symptoms on the Conner's rating scale, indicated a significant challenge effect (P less than 0.025), with mothers reporting more symptoms during the challenge period. Dietary infringements with suspected trigger substances occurred throughout the trial.

  7. Randomized double-blind comparison of metoprolol, nifedipine, and their combination in chronic stable angina

    DEFF Research Database (Denmark)

    Egstrup, K

    1988-01-01

    In a randomized double-blind study, treatment with either metoprolol, nifedipine, or their combination was compared for effects on ischemic variables and heart rate obtained during ambulatory monitoring in 42 patients with chronic stable angina. All patients had severe chronic stable angina...... could be detected during nifedipine monotherapy. It is concluded that metoprolol monotherapy, as well as its combination with nifedipine, effectively reduces total ischemic activity compared with placebo and nifedipine monotherapy. Control of ischemic activity in chronic stable angina may have...

  8. N-Acetylcysteine in the Treatment of Pediatric Trichotillomania: A Randomized, Double-Blind, Placebo-Controlled Add-On Trial

    Science.gov (United States)

    Bloch, Michael H.; Panza, Kaitlyn E.; Grant, Jon E.; Pittenger, Christopher; Leckman, James F.

    2013-01-01

    Objective: To examine the efficacy of N-acetylcysteine (NAC) for the treatment of pediatric trichotillomania (TTM) in a double-blind, placebo-controlled, add-on study. Method: A total of 39 children and adolescents aged 8 to 17 years with pediatric trichotillomania were randomly assigned to receive NAC or matching placebo for 12 weeks. Our primary…

  9. A double-blind assessment of additive intolerance in children using a 12 day challenge period at home.

    Science.gov (United States)

    Wilson, N; Scott, A

    1989-05-01

    Alleged food-additive intolerance (respiratory, dermatological, behavioural or abdominal) was assessed in 19 children using daily challenge drinks of either, base product alone, base product plus sunset yellow/tartrazine, or base product plus sodium metabisulphite/sodium benzoate. The same type of drink was given for 12 days, double-blind and in random order. During the trial the children were maintained on an additive-free diet under supervision. Diary cards were used to record symptoms and medication usage. If there was an apparent association between symptoms and drink ingredient the trial was repeated, again double-blind. Additive intolerance was confirmed by a consistent deterioration of symptoms in only three children. In one, urticaria was induced by the colourings, in another extremely abnormal behaviour was induced by the preservatives and a third child was only free of asthma and abdominal pain on placebo. This form of individual trial, using 12 daily drinks, overcomes some of the objections to a single challenge study. Despite this, intolerance to the additives was only confirmed in 3/19 children in whom it had been believed to occur.

  10. History of early abuse as a predictor of treatment response in patients with fibromyalgia : A post-hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release

    NARCIS (Netherlands)

    Pae, Chi-Un; Masand, Prakash S.; Marks, David M.; Krulewicz, Stan; Han, Changsu; Peindl, Kathleen; Mannelli, Paolo; Patkar, Ashwin A.

    2009-01-01

    Objectives. We conducted a post-hoc analysis to determine whether a history of physical or sexual abuse was associated with response to treatment in a double-blind, randomized, placebo-controlled trial of paroxetine controlled release (CR) in fibromyalgia. Methods. A randomized, double-blind,

  11. Visible-blind ultraviolet photodetector based on double heterojunction of n-ZnO/insulator-MgO/p-Si

    International Nuclear Information System (INIS)

    Zhang, T. C.; Guo, Y.; Mei, Z. X.; Gu, C. Z.; Du, X. L.

    2009-01-01

    Exploiting a double heterojunction of n-ZnO/insulator-MgO/p-Si grown by molecular beam epitaxy, a visible-blind ultraviolet (UV) photodetector has been fabricated. The photodetector shows a rectification ratio of ∼10 4 at ±2 V and a dark current of 0.5 nA at a reverse bias of -2 V.The photoresponse spectrum indicates a visible-blind UV detectivity of our devices with a sharp cut off at the wavelength of 378 nm and a high UV/visible rejection ratio. The key role of the middle insulating MgO layer, as a barrier layer for minority carrier transport, has been demonstrated

  12. Efficacy of articaine versus lidocaine in block and infiltration anesthesia administered in teeth with irreversible pulpitis: a prospective, randomized, double-blind study.

    Science.gov (United States)

    Ashraf, Hengameh; Kazem, Majeed; Dianat, Omid; Noghrehkar, Fatemeh

    2013-01-01

    Profound pulpal anesthesia in posterior mandibular teeth with irreversible pulpitis usually requires administering an inferior alveolar nerve block (IANB) plus other supplemental injections. The purpose of this prospective, randomized, double-blind study was to compare the anesthetic success rate of buccal infiltration injections of articaine and lidocaine when supplemented with an IANB. One hundred twenty-five emergency patients who had their first or second mandibular molar diagnosed with irreversible pulpitis participated in the study and received the IANB by using either 2% lidocaine with 1:100,000 epinephrine or 4% articaine with 1:100,000 epinephrine. One hundred two of the patients reported moderate-to-severe pain upon initiation of their endodontic treatment or through filing of their tooth canals and received supplemental buccal infiltration injections by using the same anesthetic that the IANB had been performed. After the block or the supplemental buccal infiltration injections, success was achieved with no or mild pain during instrumentation of the tooth canals. The success rate after the administration of the infiltration injections after an incomplete IANB by using lidocaine was 29%, whereas by using articaine it was 71% (P pulpitis. Copyright © 2013 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  13. Laxation of critically ill patients with lactulose or polyethylene glycol : a two-center randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    van der Spoel, Johan I; Oudemans-van Straaten, Heleen M; Kuiper, Michael A; van Roon, Eric N; Zandstra, Durk F; van der Voort, Peter H J

    2007-01-01

    OBJECTIVE: To study whether lactulose or polyethylene glycol is effective to promote defecation in critically ill patients, whether either of the two is superior, and whether the use of enteral laxatives is related to clinical outcome. DESIGN: Double-blind, placebo-controlled, randomized study.

  14. A Randomized Double-Blind Placebo-Controlled Trial of Lactobacillus reuteri for Chronic Functional Abdominal Pain in Children

    OpenAIRE

    Kambiz Eftekhari; Zahra Vahedi; Mojtaba Kamali Aghdam; Diana Noemi Diaz

    2015-01-01

    Background: Functional abdominal pain (FAP) is one of the most common diseases, and large percentages of children suffer from it. Objectives: The purpose of the study was to evaluate the effect of Lactobacillus reuteri in treatment of children with functional abdominal pain. Patients and Methods: This study was a randomized double-blind placebo-controlled trial. Children aged 4 to ...

  15. Effects of Tamsulosin and Tolterodine on double J stent–related symptoms: A double-blind, randomized, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Mahmoudreza Moradi

    2017-02-01

    Full Text Available Background: Ureteral double J stent are routinely applied for urologic patients although stent-related symptoms are common. Several attempts have been reported to minimize these symptoms. Objective: To compare Tolterodine, Tamsulosin, and placebo effects on double J stent–related symptoms. Material and method: In all, 125 patients (82 males and 43 females with double J stent were randomly divided into three groups (group 1, n: 42, group2, n: 40 and group 3, n: 43. Each patient randomly received one pack of drug in different colors by a nurse unaware of the content to take Tamsulosin 0.4 mg before sleep (MODALUSINE, Tolterodine 2 mg twice a day or placebo once daily (capsules filled with starch: group 1 received placebo, group 2 Tamsulosin and group 3 Tolterodine for 1 month in a double-blind manner. Ureteral stent-related morbidity indices which analyzed include urinary symptom, pain, general health, quality of work and sex scores. All of indices measured by Ureteral Symptom Score Questionnaire for first and fourth weeks after drug consumption and the first week after double J stent removal (labeled as w1, w4, and w5, respectively. Result: The mean age was 44.8 years (range: 15–83 years. There was no statistically significant difference in background characteristics between groups (p value > 0.05. The most important and statistically significant results were Tolterodine-reduced urinary symptom score (p value = 0.001 and improved general health score (p value = 0.007 of the fourth week. The pain score in groups of Tamsulosin and Tolterodine significantly reduced between weeks 4 and 1 and 5 and 1 (both with the p value < 0.05, but in other indices, there was no significant difference between them. Conclusion: According to our results, we suggest Tolterodine to minimize stent-related urinary symptom and improve general health in patients with double J stent.

  16. Efficacy and safety of extended- versus immediate-release pramipexole in Japanese patients with advanced and L-dopa-undertreated Parkinson disease: a double-blind, randomized trial.

    Science.gov (United States)

    Mizuno, Yoshikuni; Yamamoto, Mitsutoshi; Kuno, Sadako; Hasegawa, Kazuko; Hattori, Nobutaka; Kagimura, Tatsuro; Sarashina, Akiko; Rascol, Olivier; Schapira, Anthony H V; Barone, Paolo; Hauser, Robert A; Poewe, Werner

    2012-01-01

    To compare the efficacy, safety, tolerability, and trough plasma levels of pramipexole extended-release (ER) and pramipexole immediate-release (IR), and to assess the effects of overnight switching from an IR to an ER formulation, in L-dopa-treated patients with Parkinson disease (PD). After a 1- to 4-week screening/enrollment, 112 patients who had exhibited L-dopa-related problems or were receiving suboptimal L-dopa dosage were randomized in double-blind, double-dummy, 1:1 fashion to pramipexole ER once daily or pramipexole IR 2 to 3 times daily for 12 weeks, both titrated to a maximum daily dose of 4.5 mg. Successful completers of double-blind treatment were switched to open-label pramipexole ER, beginning with a 4-week dose-adjustment phase. Among the double-blind treatment patients (n = 56 in each group), Unified Parkinson's Disease Rating Scale Parts II+III total scores decreased significantly from baseline and to a similar degree with pramipexole ER and IR formulations. In each group, 47 double-blind patients (83.9%) reported adverse events (AEs), requiring withdrawal of 3 ER patients (5.4%) and 2 IR patients (3.6%). Trough plasma levels at steady state (at the same doses and dose-normalized concentrations) were also similar with both formulations. Among open-label treatment patients (n = 53 from IR to ER), 83% were successfully switched (no worsening of PD symptoms) to pramipexole ER. In L-dopa-treated patients, pramipexole ER and pramipexole IR demonstrated similar efficacy, safety, tolerability, and trough plasma levels. Patients can be safely switched overnight from pramipexole IR to pramipexole ER with no impact on efficacy.

  17. Study Protocol- Lumbar Epidural Steroid Injections for Spinal Stenosis (LESS: a double-blind randomized controlled trial of epidural steroid injections for lumbar spinal stenosis among older adults

    Directory of Open Access Journals (Sweden)

    Friedly Janna L

    2012-03-01

    and costs to assess cost-effectiveness of epidural steroid injection. Discussion This study is the first multi-center, double-blind RCT to evaluate the effectiveness of epidural steroid injections in improving pain and function among older adults with lumbar spinal stenosis. The study will also yield data on the safety and cost-effectiveness of this procedure for older adults. Trial Registration Clinicaltrials.gov NCT01238536

  18. Tasimelteon for non-24-hour sleep-wake disorder in totally blind people (SET and RESET): two multicentre, randomised, double-masked, placebo-controlled phase 3 trials.

    Science.gov (United States)

    Lockley, Steven W; Dressman, Marlene A; Licamele, Louis; Xiao, Changfu; Fisher, Dennis M; Flynn-Evans, Erin E; Hull, Joseph T; Torres, Rosarelis; Lavedan, Christian; Polymeropoulos, Mihael H

    2015-10-31

    Most totally blind people have non-24-hour sleep-wake disorder (non-24), a rare circadian rhythm disorder caused by an inability of light to reset their circadian pacemaker. In two consecutive placebo-controlled trials (SET and RESET), we assessed safety and efficacy (in terms of circadian entrainment and maintenance) of once-daily tasimelteon, a novel dual-melatonin receptor agonist. We undertook the placebo-controlled, randomised, double-masked trials in 27 US and six German clinical research centres and sleep centres. We screened totally blind adults (18-75 years of age), who were eligible for the randomisation phase of SET if they had a non-24-hour circadian period (τ) of 24·25 h or longer (95% CI greater than 24·0 and up to 24·9 h), as calculated from measurements of urinary 6-sulphatoxymelatonin rhythms. For SET, we used block randomisation to assign patients (1:1) to receive tasimelteon (20 mg) or placebo every 24 h at a fixed clock time 1 h before target bedtime for 26 weeks. Patients who entered the open-label group receiving tasimelteon in SET or who did not meet the SET inclusion criteria but did meet the RESET inclusion criteria were screened for RESET. A subset of the patients who entered the open-label group before the RESET study and who had eligible τ values were screened for RESET after completing the open-label treatment. In RESET, we withdrew tasimelteon in a randomised manner (1:1) in patients who responded (ie, entrained) after a tasimelteon run-in period. Entrainment was defined as having τ of 24·1 h or less and a 95% CI that included 24·0 h. In SET, the primary endpoint was the proportion of entrained patients, assessed in the intention-to-treat population. The planned step-down primary endpoint assessed the proportion of patients who had a clinical response (entrainment at month 1 or month 7 plus clinical improvement, measured by the Non-24 Clinical Response Scale). In RESET, the primary endpoint was the proportion of non

  19. Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial.

    Science.gov (United States)

    Hannemann, Pascal; Göttgens, Kevin W A; van Wely, Bob J; Kolkman, Karel A; Werre, Andries J; Poeze, Martijn; Brink, Peter R G

    2011-05-06

    The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences.Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning).Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory.Study parameters are clinical consolidation, radiological consolidation evaluated by CT-scanning, functional

  20. Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial

    Directory of Open Access Journals (Sweden)

    Poeze Martijn

    2011-05-01

    Full Text Available Abstract Background The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%, non-union (5-21% and early osteo-arthritis (up to 32% which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences. Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. Methods/Design This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning. Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory. Study parameters are clinical consolidation

  1. Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study.

    Science.gov (United States)

    Arnold, Lesley M; Arsenault, Pierre; Huffman, Cynthia; Patrick, Jeffrey L; Messig, Michael; Chew, Marci L; Sanin, Luis; Scavone, Joseph M; Pauer, Lynne; Clair, Andrew G

    2014-10-01

    Safety and efficacy of a once daily controlled-released (CR) formulation of pregabalin was evaluated in patients with fibromyalgia using a placebo-controlled, randomized withdrawal design. This multicenter study included 6 week single-blind pregabalin CR treatment followed by 13 week double-blind treatment with placebo or pregabalin CR. The starting dose of 165 mg/day was escalated during the first 3 weeks, up to 495 mg/day based on efficacy and tolerability. Patients with ≥50% reduction in average daily pain score at the end of the single-blind phase were randomized to continue pregabalin CR at the optimized dose (330-495 mg/day) or to placebo. The primary endpoint was time to loss of therapeutic response (LTR), defined as treatment' (Benefit, Satisfaction, and Willingness to Continue Scale) in the pregabalin CR group; no other secondary endpoints were statistically significant. Most AEs were mild to moderate in severity (most frequent: dizziness, somnolence). The percentage of pregabalin CR patients discontinuing because of AEs was 12.2% and 4.8% in the single-blind and double-blind phases, respectively (placebo, 0%). Time to LTR was significantly longer with pregabalin CR versus placebo in fibromyalgia patients who initially showed improvement with pregabalin CR, indicating maintenance of response. Pregabalin CR was well tolerated in most patients. Generalizability may be limited by study duration and selective population.

  2. Blindness alters the microstructure of the ventral but not the dorsal visual stream

    DEFF Research Database (Denmark)

    Reislev, Nina L; Kupers, Ron; Siebner, Hartwig R

    2016-01-01

    Visual deprivation from birth leads to reorganisation of the brain through cross-modal plasticity. Although there is a general agreement that the primary afferent visual pathways are altered in congenitally blind individuals, our knowledge about microstructural changes within the higher...... pathways in 12 congenitally blind, 15 late blind and 15 normal sighted controls. We also studied six prematurely born individuals with normal vision to control for the effects of prematurity on brain connectivity. Our data revealed a reduction in fractional anisotropy in the ventral but not the dorsal......-order visual streams, and how this is affected by onset of blindness, remains scant. We used diffusion tensor imaging and tractography to investigate microstructural features in the dorsal (superior longitudinal fasciculus) and ventral (inferior longitudinal and inferior fronto-occipital fasciculi) visual...

  3. Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis : results of a multicentre, double-blind, randomised-withdrawal trial

    NARCIS (Netherlands)

    Brunner, Hermine I; Ruperto, Nicolino; Tzaribachev, Nikolay; Horneff, Gerd; Chasnyk, Vyacheslav G.; Panaviene, Violeta Vladislava; Abud-Mendoza, Carlos; Reiff, Andreas; Alexeeva, Ekaterina; Rubio-Pérez, Nadina; Keltsev, Vladimir; Kingsbury, Daniel J.; Del Rocio Maldonado Velázquez, Maria; Nikishina, Irina; Silverman, Earl D.; Joos, Rik; Smolewska, Elzbieta; Bandeira, Márcia; Minden, Kirsten; van Royen-Kerkhof, Annet; Emminger, Wolfgang; Foeldvari, Ivan; Lauwerys, Bernard R.; Sztajnbok, Flavio; Gilmer, Keith E.; Xu, Zhenhua; Leu, Jocelyn H.; Kim, Lilianne; Lamberth, Sarah L.; Loza, Matthew J.; Lovell, Daniel J.; Martini, Alberto

    2018-01-01

    OBJECTIVE: This report aims to determine the safety, pharmacokinetics (PK) and efficacy of subcutaneous golimumab in active polyarticular-course juvenile idiopathic arthritis (polyJIA). METHODS: In this three-part randomised double-blinded placebo-controlled withdrawal trial, all patients received

  4. The effect of magnesium on maternal blood pressure in pregnancy-induced hypertension. A randomized double-blind placebo-controlled trial

    DEFF Research Database (Denmark)

    Rudnicki, M; Frölich, A; Rasmussen, W F

    1991-01-01

    The effects of magnesium were compared with those of placebo in a randomized double-blind controlled study of 58 patients with pregnancy-induced hypertension, of whom 27 received magnesium and 31 placebo. Twenty patients in each group were nulliparas. The treatment comprised 48 h of either intrav...

  5. Efficacy and safety of statin therapy in children with familial hypercholesterolemia - A randomized, double-blind, placebo-controlled trial with simvastatin

    NARCIS (Netherlands)

    de Jongh, Saskia; Ose, Leiv; Szamosi, Tamás; Gagné, Claude; Lambert, M.; Scott, Russell; Perron, P.; Dobbelaere, Dries; Saborio, M.; Tuohy, Mary B.; Stepanavage, Michael; Sapre, Aditi; Gumbiner, Barry; Mercuri, Michele; van Trotsenburg, A. S. Paul; Bakker, Henk D.; Kastelein, John J. P.

    2002-01-01

    Background-A multicenter, randomized, double-blind, placebo-controlled study was conducted to evaluate LDL cholesterol-lowering efficacy, overall safety, and tolerability and the influence on growth and pubertal development of simvastatin in a large cohort of boys and girls with heterozygous

  6. Does sucralfate reduce early side effects of pelvic radiation? A double-blind randomized trial.

    Science.gov (United States)

    Stellamans, Karin; Lievens, Yolande; Lambin, Philippe; Van den Weyngaert, Danielle; Van den Bogaert, Walter; Scalliet, Pierre; Hutsebaut, Liesbeth; Haustermans, Karin

    2002-11-01

    STUDY AND METHODS: A double-blind placebo-controlled study randomized 108 patients to investigate the effect of sucralfate on gastrointestinal side effects of pelvic radiation. Overall, pelvic radiation with the administered doses and fields and performed according to nowadays technical standards, was well tolerated. Comparison of the mean scores and the peak reactions for radiotherapy discomfort, diarrhoea and number of stools per day in the 80 evaluable patients showed no statistically significant difference between sucralfate and placebo. Based on these results, the use of sucralfate can not be recommended as standard practice.

  7. Does sucralfate reduce early side effects of pelvic radiation? A double-blind randomized trial

    International Nuclear Information System (INIS)

    Stellamans, Karin; Lievens, Yolande; Lambin, Philippe; Van den Weyngaert, Danielle; Van den Bogaert, Walter; Scalliet, Pierre; Hutsebaut, Liesbeth; Haustermans, Karin

    2002-01-01

    Study and methods: A double-blind placebo-controlled study randomized 108 patients to investigate the effect of sucralfate on gastrointestinal side effects of pelvic radiation. Results: Overall, pelvic radiation with the administered doses and fields and performed according to nowadays technical standards, was well tolerated. Comparison of the mean scores and the peak reactions for radiotherapy discomfort, diarrhoea and number of stools per day in the 80 evaluable patients showed no statistically significant difference between sucralfate and placebo. Conclusion: Based on these results, the use of sucralfate can not be recommended as standard practice

  8. Validation of novel recipes for double-blind, placebo-controlled food challenges in children and adults.

    Science.gov (United States)

    Vlieg-Boerstra, B J; Herpertz, I; Pasker, L; van der Heide, S; Kukler, J; Jansink, C; Vaessen, W; Beusekamp, B J; Dubois, A E J

    2011-07-01

    In double-blind, placebo-controlled food challenges (DBPCFCs), the use of challenge materials in which blinding is validated is a prerequisite for obtaining true blinded conditions during the test procedure. Therefore, the aim of this study was to enlarge the available range of validated recipes for DBPCFCs to facilitate oral challenge tests in all age groups, including young children, while maximizing the top dose in an acceptable volume. Recipes were developed and subsequently validated by a panel recruited by a matching sensory test. The best 30% of candidates were selected to participate in sensory testing using the paired comparison test. For young children, three recipes with cow's milk and one recipe with peanut could be validated which may be utilized in DBPCFCs. For children older than 4 years and adults, one recipe with egg, two with peanut, one with hazelnut, and one with cashew nut were validated for use in DBPCFCs. All recipes contained larger amounts of allergenic foods than previously validated. These recipes increase the range of validated recipes for use in DBPCFCs in adults and children. © 2011 John Wiley & Sons A/S.

  9. A Randomized, Double-Blind, Crossover Comparison of MK-0929 and Placebo in the Treatment of Adults with ADHD

    Science.gov (United States)

    Rivkin, Anna; Alexander, Robert C.; Knighton, Jennifer; Hutson, Pete H.; Wang, Xiaojing J.; Snavely, Duane B.; Rosah, Thomas; Watt, Alan P.; Reimherr, Fred W.; Adler, Lenard A.

    2012-01-01

    Objective: Preclinical models, receptor localization, and genetic linkage data support the role of D4 receptors in the etiology of ADHD. This proof-of-concept study was designed to evaluate MK-0929, a selective D4 receptor antagonist as treatment for adult ADHD. Method: A randomized, double-blind, placebo-controlled, crossover study was conducted…

  10. Atovaquone-proguanil versus chloroquine-proguanil for malaria prophylaxis in non-immune travellers: a randomised, double-blind study. Malarone International Study Team.

    Science.gov (United States)

    Høgh, B; Clarke, P D; Camus, D; Nothdurft, H D; Overbosch, D; Günther, M; Joubert, I; Kain, K C; Shaw, D; Roskell, N S; Chulay, J D

    2000-12-02

    Chloroquine plus proguanil is widely used for malaria chemoprophylaxis despite low effectiveness in areas where multidrug-resistant malaria occurs. Studies have shown that atovaquone and proguanil hydrochloride is safe and effective for prevention of falciparum malaria in lifelong residents of malaria-endemic countries, but little is known about non-immune travellers. In a double-blind equivalence trial, 1083 participants travelling to a malaria-endemic area were randomly assigned to two treatment groups: atovaquone-proguanil plus placebos for chloroquine and proguanil, or chloroquine, proguanil, and placebo for atovaquone-proguanil. Follow-up was by telephone 7 and 60 days after travel and at a clinic at 28 days. Serum samples were tested for antibodies to a malaria circumsporozoite protein. Blood and serum samples of participants with a potential malaria diagnosis were tested in a reference laboratory. 7 days after travel, at least one adverse event was reported by 311 (61%) of 511 participants who received atovaquone-proguanil and 329 (64%) of 511 who received chloroquine-proguanil. People receiving atovaquone-proguanil had a lower frequency of treatment-related gastrointestinal adverse events (59 [12%] vs 100 [20%], p=0.001), and of treatment-related adverse events of moderate or severe intensity (37 [7%] vs 56 [11%], p=0.05). There were fewer treatment-related adverse events that caused prophylaxis to be discontinued in the atovaquone-proguanil group than in the chloroquine-proguanil group (one [0.2%] vs ten [2%], p=0.015). Overall the two preparations were similarly tolerated. However, significantly fewer adverse gastrointestinal events were observed in the atovaquone-proguanil group in than in the chloroquine-proguanil group.

  11. A randomized controlled non-inferiority study comparing the antiemetic effect between intravenous granisetron and oral azasetron based on estimated 5-HT3 receptor occupancy.

    Science.gov (United States)

    Endo, Junki; Iihara, Hirotoshi; Yamada, Maya; Yanase, Koumei; Kamiya, Fumihiko; Ito, Fumitaka; Funaguchi, Norihiko; Ohno, Yasushi; Minatoguchi, Shinya; Itoh, Yoshinori

    2012-09-01

    The acute antiemetic effect was compared between oral azasetron and intravenous granisetron based on the 5-hydroxytryptamine(3) (5-HT(3)) receptor occupancy theory. Receptor occupancy was estimated from reported data on plasma concentrations and affinity constants to 5-HT(3) receptor. A randomized non-inferiority study comparing acute antiemetic effects between oral azasetron and intravenous granisetron was performed in 105 patients receiving the first course of carboplatin-based chemotherapy for lung cancer. Azasetron exhibited the highest 5-HT(3) receptor occupancy among various first-generation 5-HT(3) antagonists. The complete response to oral azasetron was shown to be non-inferior to that of intravenous granisetron, in which the risk difference was 0.0004 (95% confidence interval: -0.0519-0.0527). The lower limit of the confidence intervals did not exceed the negative non-inferiority margin (-0.1). The complete response during the overall period was not different (68% versus 67%). Oral azasetron was found to be non-inferior to intravenous granisetron in the acute antiemetic effect against moderately emetogenic chemotherapy.

  12. Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid)--a double-blind, randomised, multicentre study in adults

    DEFF Research Database (Denmark)

    Klek, Stanislaw; Chambrier, Cecile; Singer, Pierre

    2013-01-01

    The aim of this study was to evaluate the safety and tolerance of a soybean/MCT/olive/fish oil emulsion in intestinal failure patients on long-term parenteral nutrition. 73 patients took part in a randomized, double-blind, multi-centre study. The study demonstrates that the lipid emulsion...

  13. A prospective, randomized, double-blinded, placebo-controlled trial of empirical teicoplanin in febrile neutropenia with persistent fever after imipenem monotherapy

    NARCIS (Netherlands)

    Erjavec, Z; de Vries-Hospers, HG; Halie, RM; Daenen, S

    Glycopeptide antibiotics are used extensively in the empirical treatment of febrile patients with neutropenia. To come to a more rational and restricted application of these expensive drugs and to reduce the risk of emergence of resistance, we carried out a prospective, double-blinded,

  14. Insight into the prebiotic concept: lessons from an exploratory, double blind intervention study with inulin-type fructans in obese women

    NARCIS (Netherlands)

    Dewulf, E.M.; Cani, P.D.; Claus, S.P.; Fuentes, S.; Puylaert, P.G.B.; Neyrinck, A.M.; Bindels, L.B.; Vos, de W.M.; Gibson, G.R.; Thissen, J.P.; Delzenne, N.M.

    2013-01-01

    OBJECTIVE: To highlight the contribution of the gut microbiota to the modulation of host metabolism by dietary inulin-type fructans (ITF prebiotics) in obese women. METHODS: A double blind, placebo controlled, intervention study was performed with 30 obese women treated with ITF prebiotics

  15. Penicillin for acute sore throat : randomised double blind trial of seven days versus three days treatment or placebo in adults

    NARCIS (Netherlands)

    Zwart, S; Sachs, APE; Ruijs, GJHM; Gubbels, JW; Hoes, AW; de Melker, RA

    2000-01-01

    Objective To assess whether treatment with penicillin for three days and the traditional treatment for seven days were equally as effective at accelerating resolution of symptoms in patients with sore throat compared with placebo. Design Randomised double blind placebo controlled trial. Setting 43

  16. Is ginger effective for the treatment of irritable bowel syndrome? A double blind randomized controlled pilot trial.

    Science.gov (United States)

    van Tilburg, Miranda A L; Palsson, Olafur S; Ringel, Yehuda; Whitehead, William E

    2014-02-01

    Ginger is one of the most commonly used herbal medicines for irritable bowel syndrome (IBS) but no data exists about its effectiveness. Double blind randomized controlled trial. University of North Carolina, Chapel Hill, North Carolina, USA. Forty-five IBS patients were randomly assigned to three groups: placebo, 1g of ginger, and 2g of ginger daily for 28 days. The IBS severity scale (IBS-SS) was administered, as well as adequate relief of symptoms scale. A responder was defined as having at least 25% reduction in IBS-SS post-treatment. There were 57.1% responders to placebo, 46.7% to 1g and 33.3% to 2g of ginger. Adequate relief was reported by 53.3% on placebo and 53.3% in both ginger groups combined. Side effects were mild and reported by 35.7% in the placebo and 16.7% in the ginger groups. This double blind randomized controlled pilot study suggests ginger is well tolerated but did not perform better than placebo. Larger trials are needed before any definitive conclusions can be drawn. Copyright © 2014 Elsevier Ltd. All rights reserved.

  17. Oral lysine clonixinate in the acute treatment of migraine: a double-blind placebo-controlled study

    OpenAIRE

    Krymchantowski,Abouch V.; Barbosa,Jackeline S.; Cheim,Celia; Alves,Luiz A.

    2001-01-01

    Several oral nonsteroidal anti-inflammatory drugs (NSAIDs) are effective to treat migraine attacks. Lysine clonixinate (LC) is a NSAID derived from nicotinic acid that has proven to be effective in various pain syndromes such as renal colic and muscular pain. The aim of this double-blind, placebo-controlled study was to evaluate the efficacy of oral LC compared to placebo in the acute treatment of migraine. Sixty four patients with the diagnosis of migraine, according to the IHS criteria, wer...

  18. Duloxetine in patients with central neuropathic pain caused by spinal cord injury or stroke: a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Vranken, J. H.; Hollmann, M. W.; van der Vegt, M. H.; Kruis, M. R.; Heesen, M.; Vos, K.; Pijl, A. J.; Dijkgraaf, M. G. W.

    2011-01-01

    The mechanisms underlying central neuropathic pain are poorly understood. Pain inhibitory mechanisms including sertononergic and norepinephrine systems may be dysfunctional. In this randomized, double-blinded, placebo-controlled trial we evaluated the effects of duloxetine on pain relief

  19. Non-Celiac Gluten Sensitivity Has Narrowed the Spectrum of Irritable Bowel Syndrome: A Double-Blind Randomized Placebo-Controlled Trial.

    Science.gov (United States)

    Shahbazkhani, Bijan; Sadeghi, Amirsaeid; Malekzadeh, Reza; Khatavi, Fatima; Etemadi, Mehrnoosh; Kalantri, Ebrahim; Rostami-Nejad, Mohammad; Rostami, Kamran

    2015-06-05

    Several studies have shown that a large number of patients who are fulfilling the criteria for irritable bowel syndrome (IBS) are sensitive to gluten. The aim of this study was to evaluate the effect of a gluten-free diet on gastrointestinal symptoms in patients with IBS. In this double-blind randomized, placebo-controlled trial, 148 IBS patients fulfilling the Rome III criteria were enrolled between 2011 and 2013. However, only 72 out of the 148 commenced on a gluten-free diet for up to six weeks and completed the study; clinical symptoms were recorded biweekly using a standard visual analogue scale (VAS). In the second stage after six weeks, patients whose symptoms improved to an acceptable level were randomly divided into two groups; patients either received packages containing powdered gluten (35 cases) or patients received placebo (gluten free powder) (37 cases). Overall, the symptomatic improvement was statistically different in the gluten-containing group compared with placebo group in 9 (25.7%), and 31 (83.8%) patients respectively (p gluten. Using the term of IBS can therefore be misleading and may deviate and postpone the application of an effective and well-targeted treatment strategy in gluten sensitive patients.

  20. Efficacy of polyglucosamine for weight loss?confirmed in a randomized double-blind, placebo-controlled clinical investigation

    OpenAIRE

    Pokhis, Karina; Bitterlich, Norman; Cornelli, Umberto; Cassano, Giuseppina

    2015-01-01

    Background The purpose of this clinical study was to ascertain whether low molecular weight chitosan polyglucosamine is able to produce significantly better weight loss than placebo. Method 115 participants were included in the study. We used a two-center randomized, double blind, placebo-controlled design. The participants followed a standard treatment (ST), which included the combination of a low-calorie diet achieved through creating a daily calorie deficit (500 cal) and an increased daily...

  1. A Randomised Non-inferiority Trial on the Effect of an Antibiotic or Non-antibiotic Topical Treatment Protocol for Digital Dermatitis in Dairy Cattle : a knowledge summary

    NARCIS (Netherlands)

    Jorritsma, R.; Nielen, M.; Dotinga, Amarins

    2017-01-01

    Objective: Investigation of the therapeutic effect of a protocol using non-antibiotic Intra Epidine (IE) spray containing copper and zinc chelate on M2 digital dermatitis (DD) lesions compared to a treatment protocol using antibiotic chlortetracycline (CTC) spray for non-inferiority testing.

  2. Implications of Clinical Trial Design on Sample Size Requirements

    OpenAIRE

    Leon, Andrew C.

    2008-01-01

    The primary goal in designing a randomized controlled clinical trial (RCT) is to minimize bias in the estimate of treatment effect. Randomized group assignment, double-blinded assessments, and control or comparison groups reduce the risk of bias. The design must also provide sufficient statistical power to detect a clinically meaningful treatment effect and maintain a nominal level of type I error. An attempt to integrate neurocognitive science into an RCT poses additional challenges. Two par...

  3. Venlafaxine versus clonidine for the treatment of hot flashes in breast cancer patients : a double-blind, randomized cross-over study

    NARCIS (Netherlands)

    Buijs, Ciska; Mom, Constantijne H.; Willemse, Pax H. B.; Boezen, H. Marike; Maurer, J. Marina; Wymenga, A. N. Machteld; de Jong, Robert S.; Nieboer, Peter; de Vries, Elisabeth G. E.; Mourits, Marian J. E.

    Purpose Breast cancer patients with treatment-induced menopause experience frequent and severe hot flashes (HF). We compared venlafaxine and clonidine for the treatment of HF with regard to side effects, efficacy, quality of life and sexual functioning. Methods In a double-blind, cross-over study,

  4. Analgesic effects of preinjection low-level laser/light therapy (LLLT) before third molar surgery: a double-blind randomized controlled trial

    NARCIS (Netherlands)

    Tuk, Jacco G. C.; van Wijk, Arjen J.; Mertens, Ine C.; Keleş, Zühal; Lindeboom, Jérôme A. H.; Milstein, Dan M. J.

    2017-01-01

    The aim of this study was to evaluate the analgesic effects of low-level laser therapy (LLLT) on preinjection sites in patients scheduled for third molar removal. This double-blind randomized controlled trial included 163 healthy patients undergoing third molar extractions. The study participants

  5. Reiki therapy for postoperative oral pain in pediatric patients: pilot data from a double-blind, randomized clinical trial.

    Science.gov (United States)

    Kundu, Anjana; Lin, Yuting; Oron, Assaf P; Doorenbos, Ardith Z

    2014-02-01

    To examine the effects of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. This was a double-blind, randomized controlled study of children undergoing dental procedures. Participants were randomly assigned to receive either Reiki therapy or the control therapy (sham Reiki) preoperatively. Postoperative pain scores, opioid requirements, and side effects were assessed. Family members were also asked about perioperative care satisfaction. Multiple linear regressions were used for analysis. Thirty-eight children participated. The blinding procedure was successful. No statistically significant difference was observed between groups on all outcome measures. Our study provides a successful example of a blinding procedure for Reiki therapy among children in the perioperative period. This study does not support the effectiveness of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. Copyright © 2013 Elsevier Ltd. All rights reserved.

  6. Exploring the Effect of Lactium™ and Zizyphus Complex on Sleep Quality: A Double-Blind, Randomized Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Andrew Scholey

    2017-02-01

    Full Text Available Acute, non-clinical insomnia is not uncommon. Sufferers commonly turn to short-term use of herbal supplements to alleviate the symptoms. This placebo-controlled, double-blind study investigated the efficacy of LZComplex3 (lactium™, Zizyphus, Humulus lupulus, magnesium and vitamin B6, in otherwise healthy adults with mild insomnia. After a 7-day single-blind placebo run-in, eligible volunteers (n = 171 were randomized (1:1 to receive daily treatment for 2 weeks with LZComplex3 or placebo. Results revealed that sleep quality measured by change in Pittsburgh Sleep Quality Index (PSQI score improved in both the LZComplex3 and placebo groups. There were no significant between group differences between baseline and endpoint on the primary outcome. The majority of secondary outcomes, which included daytime functioning and physical fatigue, mood and anxiety, cognitive performance, and stress reactivity, showed similar improvements in the LZComplex3 and placebo groups. A similar proportion of participants reported adverse events (AEs in both groups, with two of four treatment-related AEs in the LZComplex3 group resulting in permanent discontinuation. It currently cannot be concluded that administration of LZComplex3 for 2 weeks improves sleep quality, however, a marked placebo response (despite placebo run-in and/or short duration of treatment may have masked a potential beneficial effect on sleep quality.

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

    NARCIS (Netherlands)

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

    2015-01-01

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

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

    NARCIS (Netherlands)

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

    2015-01-01

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

  9. RCT: Module 2.07, Respiratory Protection, Course 8773

    Energy Technology Data Exchange (ETDEWEB)

    Hillmer, Kurt T. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-08-10

    Internal dosimetry controls require the use of engineering controls to prevent the internal deposition of radioactive and nonradiological contaminants. However, when engineering and administrative controls are not available or feasible, respiratory protection may be necessary. The radiation control technician (RCT) should know and apply the considerations used in determining the respiratory protection equipment that is most appropriate for the job. The inappropriate use of or the use of the wrong respiratory protection equipment may result in undesirable health effects. This course will prepare the student with the skills necessary for RCT qualification by passing quizzes, tests, and the RCT Comprehensive Phase 1, Unit 2 Examination (TEST 27566) and will provide in-the-field skills.

  10. Efficacy of Probiotic Escherichia coli Nissle 1917 in Patients with Irritable Bowel Syndrome: a Double Blind Placebocontrolled Randomized Trial

    Directory of Open Access Journals (Sweden)

    Amir H Faghihi

    2015-07-01

    Full Text Available Aim: to evaluate potential improvement effect for probiotic E. coliNissle 1917 in the management of refractory IBS in an Iranian population. Methods: a double blind placebo controlled approach as been used in the current clinical trial. 139 confirmed IBS patients were included into the study, and were given probiotic E.coli Nissle 1917 for 6 weeks. 11 items Birmingham IBS Symptom Questionnairehas been used for evaluation of changes in the symptoms every 2 weeks. Results: sixty eight subjects (49% were males. Mean±SD age of the participants was 38±13.3 years. 49(35.3% of the patients were diarrhea-predominant. The total scores showed no significant difference between the intervention vs. control group(-6.7±6.8 vs. -6.7±6.5, respectively; p=0.95; neither did any of the questionnaire items any significant alterations in the two groups. After stratification of patients based on their IBS type, diarrhea-predominant patients showed a positive response to the probiotic improving their sleep (p=0.05&0.03 at weeks 2&6, respectively. Patients with constipation-predominant IBS showed no response to the probiotic; while patients with diarrhea-constipation mixed IBS showed unfavorable response to the probiotic in the need for strain to pass a motion compared to the placebo (p=0.03&0.02 at weeks 4&6, respectively. Conclusion: probiotic therapy with E.coliNissle 1917 was not able to induce significant improvement in the symptoms of patients with non-categorized IBS. Nevertheless, when IBS patients were recategorized to subgroups according to their main symptoms, evaluation of the efficacy of the probiotic on some individual items in the symptom list reached the significance level. Prospective clinical trials are recommended to confirm our findings. Key words: probiotic Escherichia Coli Nissle 1917, irritable bowel syndrome, double blind randomized controlled trial.

  11. A double-blind comparison of terazosin and tamsulosin on their differential effects on ambulatory blood pressure and nocturnal orthostatic stress testing

    NARCIS (Netherlands)

    de Mey, C.; Michel, M. C.; McEwen, J.; Moreland, T.

    1998-01-01

    OBJECTIVES: This single-centre, double-blind, randomized parallel-group study compared ambulatory blood pressure (AMBP) and heart rate (HR) profiles and responses to orthostatic testing (OT) for recommended regimens of tamsulosin (TAM, modified release formulation) and terazosin (TER), two

  12. Potent corticosteroid cream (mometasone furoate) significantly reduces acute radiation dermatitis: results from a double-blind, randomized study

    International Nuclear Information System (INIS)

    Bostroem, Aasa; Lindman, Henrik; Swartling, Carl; Berne, Berit; Bergh, Jonas

    2001-01-01

    Purpose: Radiation-induced dermatitis is a very common side effect of radiation therapy, and may necessitate interruption of the therapy. There is a substantial lack of evidence-based treatments for this condition. The aim of this study was to investigate the effect of mometasone furoate cream (MMF) on radiation dermatitis in a prospective, double-blind, randomized study. Material and methods: The study comprised 49 patients with node-negative breast cancer. They were operated on with sector resection and scheduled for postoperative radiotherapy using photons with identical radiation qualities and dosage to the breast parenchyma. The patients were randomized to receive either MMF or emollient cream. The cream was applied on the irradiated skin twice a week from the start of radiotherapy until the 12th fraction (24 Gy) and thereafter once daily until 3 weeks after completion of radiation. Both groups additionally received non-blinded emollient cream daily. The intensity of the acute radiation dermatitis was evaluated on a weekly basis regarding erythema and pigmentation, using a reflectance spectrophotometer together with visual scoring of the skin reactions. Results: MMF in combination with emollient cream treatment significantly decreased acute radiation dermatitis (P=0.0033) compared with emollient cream alone. There was no significant difference in pigmentation between the two groups. Conclusions: Adding MMF, a potent topical corticosteroid, to an emollient cream is statistically significantly more effective than emollient cream alone in reducing acute radiation dermatitis

  13. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial

    DEFF Research Database (Denmark)

    Lassen, Michael Rud; Raskob, Gary E; Gallus, Alexander

    2010-01-01

    efficacy and safety of these drugs after elective total knee replacement. METHODS: In ADVANCE-2, a multicentre, randomised, double-blind phase 3 study, patients undergoing elective unilateral or bilateral total knee replacement were randomly allocated through an interactive central telephone system......BACKGROUND: Low-molecular-weight heparins such as enoxaparin are preferred for prevention of venous thromboembolism after major joint replacement. Apixaban, an orally active factor Xa inhibitor, might be as effective, have lower bleeding risk, and be easier to use than is enoxaparin. We assessed...

  14. Prevention of preterm delivery with vaginal progesterone in women with preterm labour (4P): randomised double-blind placebo-controlled trial

    NARCIS (Netherlands)

    Martinez de Tejada, B.; Karolinski, A.; Ocampo, M. C.; Laterra, C.; Hösli, I.; Fernández, D.; Surbek, D.; Huespe, M.; Drack, G.; Bunader, A.; Rouillier, S.; López de Degani, G.; Seidenstein, E.; Prentl, E.; Antón, J.; Krähenmann, F.; Nowacki, D.; Poncelas, M.; Nassif, J. C.; Papera, R.; Tuma, C.; Espoile, R.; Tiberio, O.; Breccia, G.; Messina, A.; Peker, B.; Schinner, E.; Mol, B. W.; Kanterewicz, L.; Wainer, V.; Boulvain, M.; Othenin-Girard, V.; Bertolino, M. V.; Irion, O.; Tellenbach, M.; Vögele, E.; Azbar, R.; Raggi, A.; Birkenmaier, A.; Kann, S.; Scheibner, K.; Huguelet, M.; Amann, E.; Baumann, M.; Jakob, E.; Biedermann, K.; Hodel, M.; Fischer, T.; Pfau, K.; Estermann, K.

    2015-01-01

    To evaluate the effectiveness of 200 mg of daily vaginal natural progesterone to prevent preterm birth in women with preterm labour. Multicentre, randomised, double-blind, placebo-controlled trial. Twenty-nine centres in Switzerland and Argentina. A total of 385 women with preterm labour (24(0/7) to

  15. Treatment of Patients With Complex Regional Pain Syndrome Type I With Mannitol: A Prospective, Randomized, Placebo-Controlled, Double-Blinded Study

    NARCIS (Netherlands)

    Perez, R.S.G.M.; Pragt, E.; Geurts, J.J.G.; Zuurmond, W.W.A.; Patijn, J.; van Kleef, M.

    2008-01-01

    To assess the effects of intravenous administration of the free radical scavenger mannitol 10% on complaints associated with complex regional pain syndrome Type I (CRPS I), a randomized, placebo-controlled, double-blinded trial was performed. Forty-one CRPS I patients according to the Bruehl et al

  16. Double-blind placebo-controlled pilot study of paroxetine for specific phobia.

    Science.gov (United States)

    Benjamin, J; Ben-Zion, I Z; Karbofsky, E; Dannon, P

    2000-04-01

    Drugs are not recognized as a standard treatment for specific phobia, despite its apparent similarities to other kinds of phobia. Reluctance on the part of patients and clinicians to see the disorder as more than normal anxiety may explain the apparent resistance to pharmacotherapy. Eleven patients fulfilling DSM-IV criteria for specific phobia were randomized to 4 weeks of double-blind treatment with placebo or paroxetine up to 20 mg/day. They were assessed weekly with the Fear Questionnaire and the Hamilton Rating Scale for Anxiety. Paroxetine showed significant superiority in reducing all measures (ANCOVA for reductions in phobia scores F=7.9, P=0.02). One out of six patients responded to placebo, compared to three out of five patients on paroxetine. This new therapeutic option (i.e. drug treatment) for specific phobia deserves further examination in a larger trial.

  17. Online versus Live Delivery of Education to Pharmacists in a Large Multicentre Health Region: A Non-inferiority Assessment of Learning Outcomes.

    Science.gov (United States)

    Taylor, Robert; Jung, Joanne; Loewen, Peter; Spencer, Carrie; Dossa, Anar; de Lemos, Jane

    2013-07-01

    The prevalence of online modules for continuing education in the health professions has been increasing in recent years. However, the effectiveness of online modules for pharmacist learning has not been thoroughly studied. The primary aim of this study was to determine if providing education to pharmacists through a self-paced enhanced online module was non-inferior to a face-to-face learning module with respect to knowledge application on the topic of postoperative insulin dosing. Secondary aims were to determine pharmacists' knowledge gain and retention, as well as their satisfaction with the modules. The participants in this prospective, randomized, parallel-group non-inferiority trial were pharmacists in a large multicentre health region. Outcomes were measured by comparing scores obtained on pre- and post-module knowledge-assessment questionnaires. A between-group difference in change on knowledge application scores of less than 25 percentage points was the predetermined non-inferiority margin. A total of 74 pharmacists consented to participate, 38 randomly assigned to use the enhanced online module and 36 to attend the face-to-face learning session. For questions examining knowledge application, the mean improvement achieved by the online learning group was 26 percentage points greater than that achieved by the face-to-face learning group (95% confidence interval [CI] 25 to 27; p online learning group was 7 percentage points less than that achieved by the face-to-face learning group (95% CI 2 to 12; p = 0.008). Therefore, the enhanced online module was deemed to be non-inferior to the face-to-face learning session in terms of knowledge application and knowledge gain. Insufficient data were available to analyze the secondary outcome of knowledge retention over time. Participant satisfaction was similar for the 2 groups (p = 0.62). The self-paced enhanced online module was non-inferior to facilitated face-to-face learning in terms of improving application and

  18. Better than sham? A double-blind placebo-controlled neurofeedback study in primary insomnia.

    Science.gov (United States)

    Schabus, Manuel; Griessenberger, Hermann; Gnjezda, Maria-Teresa; Heib, Dominik P J; Wislowska, Malgorzata; Hoedlmoser, Kerstin

    2017-04-01

    measures and sleep spindle parameters remained unchanged following 12 training sessions. A stratification into 'true' insomnia patients and 'insomnia misperceivers' (subjective, but no objective sleep problems) did not alter the results. Based on this comprehensive and well-controlled study, we conclude that for the treatment of primary insomnia, neurofeedback does not have a specific efficacy beyond unspecific placebo effects. Importantly, we do not find an advantage of neurofeedback over placebo feedback, therefore it cannot be recommended as an alternative to cognitive behavioural therapy for insomnia, the current (non-pharmacological) standard-of-care treatment. In addition, our study may foster a critical discussion that generally questions the effectiveness of neurofeedback, and emphasizes the importance of demonstrating neurofeedback efficacy in other study samples and disorders using truly placebo and double-blind controlled trials. © The Author (2017). Published by Oxford University Press on behalf of the Guarantors of Brain.

  19. Hydroxyurea: a radiation potentiator in carcinoma of the uterine cervix. A randomized double-blind study

    International Nuclear Information System (INIS)

    Piver, M.S.; Barlow, J.J.; Vongtama, V.; Blumenson, L.

    1983-01-01

    From June, 1972, to December, 1976, 40 patients with FIGO (International Federation of Gynaecology and Obstetrics) Stage IIB carcinoma of the uterine cervix were entered into a prospective, double-blind, randomized study to evaluate the possible radiation-potentiating properties (i.e., improved survival) of the S-phase cell cycle-specific inhibitor of DNA synthesis, hydroxyurea. All patients were documented to be without aortic lymph node metastasis by pretherapy staging para-aortic lymphadenectomy. All 40 patients were followed up for longer than 5 years (5.2 to 9.2 years) or until death. The double-blind code was not broken until all patients had been followed up for a minimum of 2 to 5 years. Leukopenia (white blood cell count less than 2,500 mm3) was significantly increased in the patients given hydroxyurea as compared to those given placebo (P less than 0.0001). There was no statistically significant difference relative to anemia, thrombocytopenia, radiation-induced skin reaction, and radiation-induced intestinal reaction between the patients given placebo or those given hydroxyurea. Life-table survival for the patients given hydroxyurea was 94% as compared to 53% for the patients given placebo (P . 0.006). Only one (5%) patient given hydroxyurea died of cervical cancer. Of the other patients who died in the group given hydroxyurea, all were confirmed by postmortem examination to have been without recurrent cervical cancer. In contrast, 45% (nine) of the patients given placebo died of cervical cancer

  20. International double (non-)taxation : comparative guidelines from European legal principles

    OpenAIRE

    Vijver, Van de, Anne

    2015-01-01

    Abstract: The principle of fairness advocates against international double taxation and international double non-taxation. Countries and international organizations (OECD, G20 and EU) have taken several initiatives against such taxation. However, these initiatives are not always effective. Also, certain legal authors question the legitimacy of the OECD and its action plan on BEPS. The essential goal of this research is to find guidelines to address international double (non-) taxation. We fir...

  1. Tolerability and safety of souvenaid in patients with mild Alzheimer's disease

    NARCIS (Netherlands)

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

    2015-01-01

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

  2. Double scaling limits and twisted non-critical superstrings

    International Nuclear Information System (INIS)

    Bertoldi, Gaetano

    2006-01-01

    We consider double-scaling limits of multicut solutions of certain one matrix models that are related to Calabi-Yau singularities of type A and the respective topological B model via the Dijkgraaf-Vafa correspondence. These double-scaling limits naturally lead to a bosonic string with c ≤ 1. We argue that this non-critical string is given by the topologically twisted non-critical superstring background which provides the dual description of the double-scaled little string theory at the Calabi-Yau singularity. The algorithms developed recently to solve a generic multicut matrix model by means of the loop equations allow to show that the scaling of the higher genus terms in the matrix model free energy matches the expected behaviour in the topological B-model. This result applies to a generic matrix model singularity and the relative double-scaling limit. We use these techniques to explicitly evaluate the free energy at genus one and genus two

  3. Efficacy and safety of pimecrolimus cream 1% in mild-to-moderate chronic hand dermatitis: a randomized, double-blind trial.

    Science.gov (United States)

    Hordinsky, Maria; Fleischer, Alan; Rivers, Jason K; Poulin, Yves; Belsito, Donald; Hultsch, Thomas

    2010-08-01

    Chronic hand dermatitis is common and difficult to treat. Our aim was to assess the efficacy of pimecrolimus cream 1% in mild-to-moderate chronic hand dermatitis. Adult patients (n = 652) were randomized to pimecrolimus 1% or vehicle cream twice daily with overnight occlusion for 6 weeks, followed by a 6-week open-label pimecrolimus treatment. Primary efficacy was 5-point Investigators' Global Assessment of prospectively selected 'target hand' as treatment success (Investigators' Global Assessment 0 or 1) and treatment failure. Pruritus relief was also assessed. Following double-blind phase treatment, target hand treatment success was achieved in 29.8 and 23.2% of the patients in the pimecrolimus and vehicle groups, respectively (p = 0.057). The proportion of patients experiencing pruritus relief was significantly higher in the pimecrolimus group compared to the vehicle group at all time points throughout the double-blind phase. The groups were comparable with respect to treating disease signs. Pruritus relief, however, was significantly greater in the pimecrolimus group. Copyright 2010 S. Karger AG, Basel.

  4. Double-blind, placebo-controlled pilot study of adjunctive quetiapine SR in the treatment of PMS/PMDD.

    Science.gov (United States)

    Jackson, Christine; Pearson, Brenda; Girdler, Susan; Johnson, Jacqueline; Hamer, Robert M; Killenberg, Susan; Meltzer-Brody, Samantha

    2015-11-01

    Premenstrual dysphoric disorder (PMDD), a more severe form of premenstrual syndrome (PMS), afflicts 5-8% of reproductive age women and results in significant functional impairment. We conducted a double-blind, placebo-controlled trial of adjunctive quetiapine in patients with PMS/PMDD who had inadequate response to selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor therapy for their symptoms. A PMS/PMDD diagnosis was confirmed by 2-month prospective diagnostic assessment of PMS/PMDD using the Prospective Record of the Impact and Severity of Premenstrual Symptoms (PRISM) calendar. Women were randomized equally to receive quetiapine sustained-release (SR) or placebo (25-mg starting dose) during the luteal phase for 3 months. Outcome variables included the Hamilton Depression and Anxiety Scales, Clinical Global Impression Scale, and PRISM. Twenty women were enrolled in the treatment phase. Although the study was underpowered, greater reductions in luteal phase mood ratings were observed in the quetiapine group on the 17-item Hamilton Depression Rating Scale, Clinical Global Impression improvement rating, and PRISM daily score. The quetiapine group showed most improvement in symptoms of mood lability, anxiety, and irritability. This small double-blind study suggests that adjunctive treatment with quetiapine SR may be a useful addition to selective serotonin reuptake inhibitor therapy in women with PMS/PMDD by reducing symptoms and improving quality of life. Copyright © 2015 John Wiley & Sons, Ltd.

  5. A double-blind comparison of clebopride and placebo in dyspepsia secondary to delayed gastric emptying.

    Science.gov (United States)

    Bavestrello, L; Caimi, L; Barbera, A

    1985-01-01

    Seventy-six patients suffering from dyspeptic symptoms secondary to roentgenologically demonstrated delayed gastric emptying were treated with clebopride (0.5 mg TID) or with placebo during a three-month double-blind trial. Clebopride was more effective (P less than or equal to 0.001) than placebo in reducing or relieving symptoms and roentgenological findings associated with delayed gastric emptying. No interactions of clebopride with concomitant drugs or coexisting disorders were observed, and the incidence of side effects was low. We conclude that clebopride will be beneficial in the management of patients with delayed gastric emptying.

  6. Ease of intubation: A randomized, double-blind study to compare two doses of rocuronium bromide for endotracheal intubation.

    Science.gov (United States)

    Shukla, Aparna; Misra, Shilpi

    2016-01-01

    Clinical need for a nondepolarizing agent with a rapid onset time and a brief duration of action has led to the development of rocuronium bromide. The aim of this study was to evaluate optimal dose of rocuronium bromide for intubation and to compare the onset time, duration of action, intubating conditions, and hemodynamic effects of two doses of rocuronium bromide. A prospective, randomized, double-blind study. All the patients were divided in a randomized, double-blind fashion into two groups of twenty patients each. Group I patients received rocuronium bromide 0.6 mg/kg intravenously and intubated at 60 s, Group II patients received rocuronium bromide 0.9 mg/kg and intubated at 60 s. The neuromuscular block was assessed using single twitch stimulation of 0.1 Hz at adductor pollicis muscle of hand at every 10 s. The results were compiled and analyzed statistically using Chi-square test for qualitative data and Student's t -test for quantitative data. Time of onset was significantly shorter ( P Rocuronium bromide 0.9 mg/kg is a safer alternative to rocuronium bromide 0.6 mg/kg for endotracheal intubation with shorter time of onset and better intubating conditions.

  7. Tolerability and safety of souvenaid in patients with mild Alzheimer's disease

    OpenAIRE

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

    2015-01-01

    Background: The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to improve synapse formation and function in patients with Alzheimer's disease (AD). Two double-blind randomized controlled trials (RCT) with Souvenaid of 12 and 24 week duration (Souvenir I and Souvenir II) showed that memory performance was improved in drug-naïve mild AD patients, whereas no effects on cognition were observed in a 24-week RCT (S-Connect) in mild to moderate AD ...

  8. Polyethylene glycol 3350 plus electrolytes for chronic constipation in children: a double blind, placebo controlled, crossover study.

    Science.gov (United States)

    Thomson, M A; Jenkins, H R; Bisset, W M; Heuschkel, R; Kalra, D S; Green, M R; Wilson, D C; Geraint, M

    2007-11-01

    To assess the efficacy and safety of polyethylene glycol 3350 plus electrolytes (PEG+E) for the treatment of chronic constipation in children. Randomised, double blind, placebo controlled crossover trial, with two 2-week treatment periods separated by a 2-week placebo washout. Six UK paediatric departments. 51 children (29 girls, 22 boys) aged 24 months to 11 years with chronic constipation (lasting > or =3 months), defined as or =25% of bowel movements with straining; > or =25% of bowel movements with hard/lumpy stools. 47 children completed the double blind treatment. Number of complete defaecations per week (primary efficacy variable), total number of complete and incomplete defaecations per week, pain on defaecation, straining on defaecation, faecal incontinence, stool consistency, global assessment of treatment, adverse events and physical examination. The mean number of complete defaecations per week was significantly higher for children on PEG+E than on placebo (3.12 (SD 2.05) v 1.45 (SD 1.20), respectively; pPEG+E were observed for total number of defaecations per week (p = 0.003), pain on defaecation (p = 0.041), straining on defaecation (pPEG+E (41%) and placebo during treatment (45%). PEG+E is significantly more effective than placebo, and appears to be safe and well tolerated in the treatment of chronic constipation in children.

  9. The role of Octenidol(®), Glandomed(®) and chlorhexidine mouthwash in the prevention of mucositis and in the reduction of the oropharyngeal flora: a double-blind randomized controlled trial.

    Science.gov (United States)

    Mutters, Nico T; Neubert, Thomas R; Nieth, Rudolf; Mutters, Reinier

    2015-01-01

    The oropharyngeal flora is of importance for the development of oral mucositis, which is a frequent complication in oncologic practice. It also plays a role in the pathogenesis of ventilator-associated pneumonia. Mucositis is associated with significantly worse clinical and economic outcomes. The aim of our study was to assess the efficacy of Octenidol(®), Glandomed(®) and chlorhexidine mouthwash in the prevention of mucositis and reduction of the oropharyngeal flora. A prospective, double-blinded RCT including two strata was conducted between October 2008 and November 2010. Stratum i consisted of ventilated cardiothoracic surgical patients. Stratum ii consisted of medical patients with haemato-oncological malignancies requiring stem cell transplantation. The primary outcome measures were development of mucositis regarding to OMAS/WHO score and reduction of the oropharyngeal flora. Both strata showed low OMAS/WHO scores which did not differ significantly between the groups. The overall mean reduction of colony forming units was significantly higher in the Octenidol(®) group compared to the chlorhexidine and the Glandomed(®) groups. No significant differences in the development of mucositis were found, thus all solutions proved successful in the prevention of mucositis. However, Octenidol(®) was superior in the reduction of the oropharyngeal flora. Hence, the preventive effect on nosocomial infections might be higher in patients using Octenidol(®) rather than chlorhexidine or Glandomed(®).

  10. Liberal Versus Restrictive Fluid Management in Knee Arthroplasty: A Randomized, Double-Blind Study

    DEFF Research Database (Denmark)

    Holte, Kathrine; Kristensen, Billy Bjarne; Valentiner, Lotte

    2007-01-01

    BACKGROUND: There are few data describing the relationship between amount of perioperative fluid and organ function. In this study we investigated the effects of two levels of intravascular fluid administration ("liberal" versus "restrictive") in knee arthroplasty on physiological recovery...... with a standardized volume of colloid. All other aspects of perioperative management (including anesthesia, preoperative fluid status, and postoperative management) were standardized. Primary outcome variables included pulmonary function (spirometry), exercise capacity ("timed up and go" test), coagulation...... as the primary outcome variable. METHODS: In a double-blind study, 48 ASA I-III patients undergoing fast-track elective knee arthroplasty were randomized to restrictive or liberal perioperative intravascular fluid administration. Patients received a fixed rate infusion of Ringer's lactate solution...

  11. Adult height after long-term, continuous growth hormone (GH) treatment in short children born small for gestational age: results of a randomized, double-blind, dose-response GH trial

    NARCIS (Netherlands)

    Y. van Pareren; M. Houdijk; M. Jansen (Maarten); M. Reeser; P.G.H. Mulder (Paul); A.C.S. Hokken-Koelega (Anita)

    2003-01-01

    textabstractThe GH dose-response effect of long-term continuous GH treatment on adult height (AH) was evaluated in 54 short children born small for gestational age (SGA) who were participating in a randomized, double-blind, dose-response trial. Patients were randomly and blindly

  12. Obliquely Propagating Non-Monotonic Double Layer in a Hot Magnetized Plasma

    International Nuclear Information System (INIS)

    Kim, T.H.; Kim, S.S.; Hwang, J.H.; Kim, H.Y.

    2005-01-01

    Obliquely propagating non-monotonic double layer is investigated in a hot magnetized plasma, which consists of a positively charged hot ion fluid and trapped, as well as free electrons. A model equation (modified Korteweg-de Vries equation) is derived by the usual reductive perturbation method from a set of basic hydrodynamic equations. A time stationary obliquely propagating non-monotonic double layer solution is obtained in a hot magnetized-plasma. This solution is an analytic extension of the monotonic double layer and the solitary hole. The effects of obliqueness, external magnetic field and ion temperature on the properties of the non-monotonic double layer are discussed

  13. Brief Report: Oxytocin Enhances Paternal Sensitivity to a Child with Autism--A Double-Blind Within-Subject Experiment with Intranasally Administered Oxytocin

    Science.gov (United States)

    Naber, Fabienne B. A.; Poslawsky, Irina E.; van Ijzendoorn, Marinus H.; van Engeland, Herman; Bakermans-Kranenburg, Marian J.

    2013-01-01

    Oxytocin seems associated with parenting style, and experimental work showed positive effects of intranasally administered oxytocin on parenting style of fathers. Here, the first double-blind, placebo-controlled, within-subject experiment with intranasal oxytocin administration to fathers of children with autism spectrum disorder (ASD) is…

  14. Non-Celiac Gluten Sensitivity Has Narrowed the Spectrum of Irritable Bowel Syndrome: A Double-Blind Randomized Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Bijan Shahbazkhani

    2015-06-01

    Full Text Available Several studies have shown that a large number of patients who are fulfilling the criteria for irritable bowel syndrome (IBS are sensitive to gluten. The aim of this study was to evaluate the effect of a gluten-free diet on gastrointestinal symptoms in patients with IBS. In this double-blind randomized, placebo-controlled trial, 148 IBS patients fulfilling the Rome III criteria were enrolled between 2011 and 2013. However, only 72 out of the 148 commenced on a gluten-free diet for up to six weeks and completed the study; clinical symptoms were recorded biweekly using a standard visual analogue scale (VAS. In the second stage after six weeks, patients whose symptoms improved to an acceptable level were randomly divided into two groups; patients either received packages containing powdered gluten (35 cases or patients received placebo (gluten free powder (37 cases. Overall, the symptomatic improvement was statistically different in the gluten-containing group compared with placebo group in 9 (25.7%, and 31 (83.8% patients respectively (p < 0.001. A large number of patients labelled as irritable bowel syndrome are sensitive to gluten. Using the term of IBS can therefore be misleading and may deviate and postpone the application of an effective and well-targeted treatment strategy in gluten sensitive patients.

  15. Effect of Preoperative Pain on Inferior Alveolar Nerve Block.

    Science.gov (United States)

    Aggarwal, Vivek; Singla, Mamta; Subbiya, Arunajatesan; Vivekanandhan, Paramasivam; Sharma, Vikram; Sharma, Ritu; Prakash, Venkatachalam; Geethapriya, Nagarajan

    2015-01-01

    The present study tested the hypothesis that the amount and severity of preoperative pain will affect the anesthetic efficacy of inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis. One-hundred seventy-seven adult volunteer subjects, actively experiencing pain in a mandibular molar, participated in this prospective double-blind study carried out at 2 different centers. The patients were classified into 3 groups on the basis of severity of preoperative pain: mild, 1-54 mm on the Heft-Parker visual analog scale (HP VAS); moderate, 55-114 mm; and severe, greater than 114 mm. After IANB with 1.8 mL of 2% lidocaine, endodontic access preparation was initiated. Pain during treatment was recorded using the HP VAS. The primary outcome measure was the ability to undertake pulp access and canal instrumentation with no or mild pain. The success rates were statistically analyzed by multiple logistic regression test. There was a significant difference between the mild and severe preoperative pain group (P = .03). There was a positive correlation between the values of preoperative and intraoperative pain (r = .2 and .4 at 2 centers). The amount of preoperative pain can affect the anesthetic success rates of IANB in patients with symptomatic irreversible pulpitis.

  16. Effect of Preoperative Pain on Inferior Alveolar Nerve Block

    Science.gov (United States)

    Aggarwal, Vivek; Singla, Mamta; Subbiya, Arunajatesan; Vivekanandhan, Paramasivam; Sharma, Vikram; Sharma, Ritu; Prakash, Venkatachalam; Geethapriya, Nagarajan

    2015-01-01

    The present study tested the hypothesis that the amount and severity of preoperative pain will affect the anesthetic efficacy of inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis. One-hundred seventy-seven adult volunteer subjects, actively experiencing pain in a mandibular molar, participated in this prospective double-blind study carried out at 2 different centers. The patients were classified into 3 groups on the basis of severity of preoperative pain: mild, 1–54 mm on the Heft-Parker visual analog scale (HP VAS); moderate, 55–114 mm; and severe, greater than 114 mm. After IANB with 1.8 mL of 2% lidocaine, endodontic access preparation was initiated. Pain during treatment was recorded using the HP VAS. The primary outcome measure was the ability to undertake pulp access and canal instrumentation with no or mild pain. The success rates were statistically analyzed by multiple logistic regression test. There was a significant difference between the mild and severe preoperative pain group (P = .03). There was a positive correlation between the values of preoperative and intraoperative pain (r = .2 and .4 at 2 centers). The amount of preoperative pain can affect the anesthetic success rates of IANB in patients with symptomatic irreversible pulpitis. PMID:26650491

  17. Pterygium excision with or without postoperative irradiation, a double-blind study

    Energy Technology Data Exchange (ETDEWEB)

    de Keizer, R.J.W. (Amsterdam Univ. (Netherlands). Academisch Ziekenhuis)

    1982-01-29

    A double-blind study (covering 40 months) of 40 eyes with a pterygium which had not previously been operated on, was carried out to study the effect of post-operative irradiation. Nineteen eyes were treated by the 'bare sclera' operation technique only and in 13 cases (68%) a recurrence occurred within 4 months. In 18 eyes from the group of patients treated with Sr 90 irradiation on the 1st, 7th and 14th postoperative day (maximum 3 x 1000 rad) no recurrences were seen. Patients with a recurrent pterygium and diplopia, symblepharon, visual disturbances (growth over the pupil or severe astigmatism) or many previous operations, were treated by lamellar keratoplasty (Dake, 1980). The recurrences without these complications were treated with success by the 'bare sclera' technique and postoperative irradiation. Complications did not occur in any of the series.

  18. Comparison of Murraya koenigii- and Tribulus terrestris-based oral formulation versus tamsulosin in the treatment of benign prostatic hyperplasia in men aged >50 years: a double-blind, double-dummy, randomized controlled trial.

    Science.gov (United States)

    Sengupta, Gairik; Hazra, Avijit; Kundu, Anup; Ghosh, Anirban

    2011-12-01

    Drug treatment can defer surgical intervention in benign prostatic hyperplasia (BPH), a common disorder in elderly men, and is widely practiced. Various herbal formulations have been used for the treatment of BPH, but few have been compared with established modern medicines in head-to-head clinical trials. We compared the effectiveness and tolerability of an oral formulation, comprising standardized extracts of Murraya koenigii and Tribulus terrestris leaves being marketed in India under Ayurvedic license, versus tamsulosin in the treatment of symptomatic BPH. A double-blind, double-dummy, parallel-group, randomized controlled trial was conducted with treatment-naive ambulatory patients with BPH aged >50 years. Patients received either the plant drug in a dose of 2 capsules BID or tamsulosin 400 μg once daily for 12 weeks with 2 interim follow-up visits at the end of 4 and 8 weeks. The double-dummy technique was used to ensure double-blinding. The primary effectiveness measure was reduction in the International Prostate Symptom Score (IPSS). Proportion of patients becoming completely or relatively symptom free (IPSS terrestris-based formulation significantly lowered IPSS scores in the initial treatment of symptomatic BPH. Further trials are needed to determine if the beneficial effect is sustained beyond the 12-week observation period of this trial. Copyright © 2011 Elsevier HS Journals, Inc. All rights reserved.

  19. Metoclopramide improves the quality of tramadol PCA indistinguishable to morphine PCA: a prospective, randomized, double blind clinical comparison.

    Science.gov (United States)

    Pang, Weiwu; Liu, Yu-Cheng; Maboudou, Edgard; Chen, Tom Xianxiu; Chois, John M; Liao, Cheng-Chun; Wu, Rick Sai-Chuen

    2013-09-01

    Multimodal analgesia has been effectively used in postoperative pain control. Tramadol can be considered "multimodal" because it has two main mechanisms of action, an opioid agonist and a reuptake inhibitor of norepinephrine and serotonin. Tramadol is not as commonly used as morphine due to the increased incidence of postoperative nausea and vomiting (PONV). As metoclopramide is an antiemetic and an analgesic, it was hypothesized that when added to reduce PONV, metoclopromide may enhance the multimodal feature of tramadol by the analgesic property of metoclopramide. Therefore, the effectiveness of postoperative patient-controlled analgesia (PCA) with morphine was compared against PCA with combination of tramadol and metoclopramide. A prospective, randomized, double blind clinical trial. Academic pain service of a university hospital. Sixty patients undergoing elective total knee arthroplasty with general anesthesia. Sixty patients were randomly divided into Group M and Group T. In a double-blinded fashion, Group M received intraoperative 0.2 mg/kg morphine and postoperative PCA with 1 mg morphine per bolus, whereas Group T received intraoperative tramadol 2.5 mg/kg and postoperative PCA with 20 mg tramadol plus 1 mg metoclopramide per bolus. Lockout interval was 5 minutes in both groups. Pain scale, satisfaction rate, analgesic consumption, PCA demand, and side effects were recorded by a blind investigator. These two groups displayed no statistically significant difference between the items and variables evaluated. This combination provides analgesia equivalent to that of morphine and can be used as an alternative to morphine PCA. Wiley Periodicals, Inc.

  20. Anaesthetic efficacy of 4% articaine mandibular buccal infiltration compared to 2% lignocaine inferior alveolar nerve block in children with irreversible pulpitis.

    Science.gov (United States)

    Arali, Veena; P, Mytri

    2015-04-01

    Lidocaine is the gold standard anaesthetic solution that has been used since its inception into dentistry till date. Around 80% of failures have been reported when lignocaine has been used for inferior alveolar nerve block in children and adults with irreversible pulpitis. There is a need to use newer drugs which are available which have been reported to be effective like lignocaine, such as articaine. Although articaine has been used in adults, literature supporting its use in children is sparse. The purpose of this study is to compare the anaesthetic efficacy of 4% articaine buccal infiltration and 2% lignocaine inferior alveolar nerve block in children with irreversible pulpitis. It also aims to assess the need for supplemental intrapulpal injections. This study was designed as a randomized double-blind cross over trial comparing the anaesthetic effectiveness of 4% articaine with 1:100,000 epinephrine in buccal infiltration and 2% lignocaine IAN block anaesthesia. The study subject and the pediatric dentist performing the pulpectomy procedures were blinded to the study. A sample size of 40 subjects in the age group of 5-8 y was included in the study. The onset of anaesthesia with 4% articaine was faster as compared to 2% lignocaine. The duration of anaesthesia with articaine infiltration was shorter. The need for supplemental injection in the articaine group was less. Four percent articaine infiltration can be used in children with irreversible pulpitis. It can be used to replace the IAN block in children thereby reducing the post anaesthetic complications like lip biting.

  1. Efficacy of a non-hormonal treatment, BRN-01, on menopausal hot flashes: a multicenter, randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Colau, Jean-Claude; Vincent, Stéphane; Marijnen, Philippe; Allaert, François-André

    2012-09-01

    Homeopathic medicines have a place among the non-hormonal therapies for the treatment of hot flashes during the menopause. The objective of this study was to evaluate the efficacy of the non-hormonal treatment BRN-01 in reducing hot flashes in menopausal women. This was a multicenter, randomized, double-blind, placebo-controlled study carried out between June 2010 and July 2011. The study was conducted in 35 active centers in France (gynecologists in private practice). One hundred and eight menopausal women, ≥ 50 years of age, were enrolled in the study. The eligibility criteria included menopause for professional and/or personal life. Treatment was either BRN-01 tablets, a registered homeopathic medicine containing Actaea racemosa (4 centesimal dilutions [4CH]), Arnica montana (4CH), Glonoinum (4CH), Lachesis mutus (5CH), and Sanguinaria canadensis (4CH), or identical placebo tablets, prepared by Laboratoires Boiron according to European Pharmacopoeia standards. Oral treatment (2 to 4 tablets per day) was started on day 3 after study enrollment and was continued for 12 weeks. The main outcome measure was the hot flash score (HFS) compared before, during, and after treatment. Secondary outcome criteria were the quality of life (QoL) [measured using the Hot Flash Related Daily Interference Scale (HFRDIS)], severity of symptoms (measured using the Menopause Rating Scale), evolution of the mean dosage, and compliance. All adverse events (AEs) were recorded. One hundred and one women were included in the final analysis (intent-to-treat population: BRN-01, n = 50; placebo, n = 51). The global HFS over the 12 weeks, assessed as the area under the curve (AUC) adjusted for baseline values, was significantly lower in the BRN-01 group than in the placebo group (mean ± SD 88.2 ± 6.5 versus 107.2 ± 6.4; p = 0.0411). BRN-01 was well tolerated; the frequency of AEs was similar in the two treatment groups, and no serious AEs were attributable to BRN

  2. Ubiquinol-10 supplementation improves autonomic nervous function and cognitive function in chronic fatigue syndrome.

    Science.gov (United States)

    Fukuda, Sanae; Nojima, Junzo; Kajimoto, Osami; Yamaguti, Kouzi; Nakatomi, Yasuhito; Kuratsune, Hirohiko; Watanabe, Yasuyoshi

    2016-07-08

    The aim of this study was to evaluate the benefit of oral ubiquinol-10 supplementation in CFS patients using an open-label study and a randomized, double-blinded, placebo-controlled (RCT) study. Twenty patients with CFS were randomly enrolled in an 8-week open-label oral ubiquinol-10 (150 mg ubiquinol-10/day) study. The patients and the attending physicians were not blinded to the supplementation. Forty-three patients with CFS were randomly assigned to receive either ubiquinol-10 (150 mg/day) or placebo every day for 12 weeks. The patients and the attending physicians were blinded to the supplementation, and a total of 31 patients (N = 17 in the ubiquinol group and 14 in the placebo group) completed the study. The beneficial effects of ubiquinol-10 were observed in the open-label study we conducted prior to the RCT. The RCT results suggest that supplementation with ubiquinol-10 for 12 weeks is effective for improving several CFS symptoms. © 2016 BioFactors, 42(4):431-440, 2016. © 2016 International Union of Biochemistry and Molecular Biology.

  3. A randomized double-blind study of atomoxetine versus placebo for attention-deficit/hyperactivity disorder symptoms in children with autism spectrum disorder.

    NARCIS (Netherlands)

    Harfterkamp, M.; Loo-Neus, G. van de; Minderaa, R.B.; Gaag, R.J. van der; Escobar, R.; Schacht, A.; Pamulapati, S.; Buitelaar, J.K.; Hoekstra, P.J.

    2012-01-01

    OBJECTIVE: The efficacy of atomoxetine as treatment of symptoms of attention-deficit/hyperactivity disorder (ADHD) in patients with autism spectrum disorder (ASD) has not been established. METHOD: In this study, 97 patients aged 6 to 17 years with ADHD and ASD were randomly assigned to double-blind

  4. A Randomized Double-Blind Study of Atomoxetine Versus Placebo for Attention-Deficit/Hyperactivity Disorder Symptoms in Children With Autism Spectrum Disorder

    NARCIS (Netherlands)

    Harfterkamp, Myriam; van de Loo-Neus, Gigi; Minderaa, Ruud B.; van der Gaag, Rutger-Jan; Escobar, Rodrigo; Schacht, Alexander; Pamulapati, Sireesha; Buitelaar, Jan K.; Hoekstra, Pieter J.

    Objective: The efficacy of atomoxetine as treatment of symptoms of attention-deficit/hyperactivity disorder (ADHD) in patients with autism spectrum disorder (ASD) has not been established. Method: In this study, 97 patients aged 6 to 17 years with ADHD and ASD were randomly assigned to double-blind

  5. Generalisability of an online randomised controlled trial: an empirical analysis.

    Science.gov (United States)

    Wang, Cheng; Mollan, Katie R; Hudgens, Michael G; Tucker, Joseph D; Zheng, Heping; Tang, Weiming; Ling, Li

    2018-02-01

    Investigators increasingly use online methods to recruit participants for randomised controlled trials (RCTs). However, the extent to which participants recruited online represent populations of interest is unknown. We evaluated how generalisable an online RCT sample is to men who have sex with men in China. Inverse probability of sampling weights (IPSW) and the G-formula were used to examine the generalisability of an online RCT using model-based approaches. Online RCT data and national cross-sectional study data from China were analysed to illustrate the process of quantitatively assessing generalisability. The RCT (identifier NCT02248558) randomly assigned participants to a crowdsourced or health marketing video for promotion of HIV testing. The primary outcome was self-reported HIV testing within 4 weeks, with a non-inferiority margin of -3%. In the original online RCT analysis, the estimated difference in proportions of HIV tested between the two arms (crowdsourcing and health marketing) was 2.1% (95% CI, -5.4% to 9.7%). The hypothesis that the crowdsourced video was not inferior to the health marketing video to promote HIV testing was not demonstrated. The IPSW and G-formula estimated differences were -2.6% (95% CI, -14.2 to 8.9) and 2.7% (95% CI, -10.7 to 16.2), with both approaches also not establishing non-inferiority. Conducting generalisability analysis of an online RCT is feasible. Examining the generalisability of online RCTs is an important step before an intervention is scaled up. NCT02248558. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  6. Single dose oral ranitidine improves MRCP image quality: a double-blind study

    International Nuclear Information System (INIS)

    Bowes, M.T.; Martin, D.F.; Melling, A.; Roberts, D.; Laasch, H.-U.; Sukumar, S.; Morris, J.

    2007-01-01

    Aim: To investigate the possibility of whether a single 300 mg dose of ranitidine given orally 2-3 h before magnetic resonance cholangiopancreatography (MRCP) could reduce the signal from the stomach and duodenum, and thus increase the conspicuousness of the biliary tree. Materials and methods: Thirty-five volunteers (22 female, 13 male), (age range 21-50) were underwent MRCP in a double-blind, placebo-controlled, randomized, crossover trial on a Philips Intera 1.5 T machine using a phased array surface coil. Imaging was carried out in the coronal oblique plane. Six 40 mm sections were acquired at varying angles to delineate the biliary tree and pancreatic duct. The 70 examinations were blindly scored by three consultants experienced in cholangiography. Results: After ranitidine administration there was a significant decrease in signal from the stomach (mean = 17.7, p = 0.0005, CI 10, 25.3) and duodenum (mean = 18.4, p = 0.0005, 95%CI 9.6, 27.1) with a significant increase in conspicuousness of the distal common duct (mean = 7.7, p = 0.033, 95%CI 0.7, 14.7) and proximal common duct (mean = 8.7, p = 0.010 CI 2.2, 15.2). There were no adverse effects. Conclusion: Oral ranitidine is a cheap and effective agent to decrease signal from the upper gastrointestinal tract and to improve visibility of the biliary tree

  7. Effect of Linear Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction—12-Month Follow-Up of a Randomized, Double-Blinded, Sham-Controlled Study

    Directory of Open Access Journals (Sweden)

    Grzegorz Lukasz Fojecki, MD

    2018-03-01

    Fojecki GL, Tiessen S, Osther PJS. Effect of Linear Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction—12-Month Follow-Up of a Randomized, Double-Blinded, Sham-Controlled Study. Sex Med 2018;6:1–7.

  8. Low-level laser therapy for pain relief after episiotomy: a double-blind randomised clinical trial.

    Science.gov (United States)

    Santos, Jaqueline de O; de Oliveira, Sonia M J V; da Silva, Flora M B; Nobre, Moacyr R C; Osava, Ruth H; Riesco, Maria L G

    2012-12-01

    To evaluate the effectiveness of a low-level laser therapy for pain relief in the perineum following episiotomy during childbirth. Laser irradiation is a painless and non-invasive therapy for perineal pain treatment and its effects have been investigated in several studies, with no clear conclusion on its effectiveness. A double-blind randomised controlled clinical trial. One hundred and fourteen women who underwent right mediolateral episiotomies during vaginal birth in an in-hospital birthing centre in São Paulo, Brazil and reported pain ≥ 3 on a numeric scale (0-10) were randomised into three groups of 38 women each: two experimental groups (treated with red and infrared laser) and a control group. The experimental groups were treated with laser applied at three points directly on the episiotomy after suturing in a single session between 6-56 hours postpartum. We used a diode laser with wavelengths of 660 nm (red laser) and 780 nm (infrared laser). The control group participants underwent all laser procedures, excluding the emission of irradiation. The participants and the pain scores evaluator were blinded to the type of intervention. The perineal pain scores were assessed at three time points: before, immediately after and 30 minutes after low-level laser therapy. The comparison of perineal pain between the three groups showed no significant differences in the three evaluations (p = 0.445), indicating that the results obtained in the groups treated with low-level laser therapy were equivalent to the control group. Low-level laser therapy did not decrease the intensity of perineal pain reported by women who underwent right mediolateral episiotomy. The effect of laser in perineal pain relief was not demonstrated in this study. The dosage may not have been sufficient to provide relief from perineal pain after episiotomy during a vaginal birth. © 2012 Blackwell Publishing Ltd.

  9. Buspirone Versus Methylphenidate in the Treatment of Children with Attention- Deficit/ Hyperactivity Disorder: Randomized Double-Blind Study

    Directory of Open Access Journals (Sweden)

    Shahin Akhondzadeh

    2012-11-01

    Full Text Available A recent randomized clinical trial showed buspirone efficacy in the treatment of attention-deficit/hyperactivity disorder (ADHD in children. However, results from a recent multi-site controlled clinical trial of transdermal buspirone failed to separate it from placebo in a large sample of children with ADHD. Therefore, due to these inconsistent findings, this study was designed to assess the efficacy of buspirone in the treatment of children with ADHD compared to methylphenidate in a double blind randomized clinical trial. Forty outpatients with a DSM-IV-TR diagnosis of ADHD were study population of this trial. Subjects were recruited from an outpatient child and adolescent clinic for a 6 week double blind, randomized clinical trial. All study subjects were randomly assigned to receive treatment using tablet of buspirone at a dose of 20-30 mg/day depending on weight (20 mg/day for 30kg (group 1 or methylphenidate at a dose of 20-30 mg/day depending on weight (20 mg/day for 30kg (group 2 for a 6 week double blind, randomized clinical trial. The principal measure of outcome was the Teacher and Parent ADHD Rating Scale IV. Patients were assessed at baseline and at 21 and 42 days after the medication started. Significant differences were observed between the two groups on the Parent and Teacher Rating Scale scores. The changes at the endpoint compared to baseline were: -8.95±8.73 (mean±SD and -15.60±7.81 (mean±SD for buspirone and methyphenidate, for Parent ADHD Rating Scale. The changes at the endpoint compared to baseline were: -9.80 ±7.06 (mean±SD and -22.40±9.90 (mean±SD for buspirone and methyphenidate, respectively for Teacher ADHD Rating Scale. The difference between the buspirone and methylphenidate groups in the frequency of side effects was not significant except for decreased appetite, headache and insomnia that were observed more frequently in the methylphenidate group. The results of this study suggest that administration of

  10. Effect of providing cancer patients with the audiotaped initial consultation on satisfaction, recall, and quality of life: a randomized, double-blind study

    NARCIS (Netherlands)

    Ong, L. M.; Visser, M. R.; Lammes, F. B.; van der Velden, J.; Kuenen, B. C.; de Haes, J. C.

    2000-01-01

    PURPOSE: By means of a randomized double-blind study, the effect of providing taped initial consultations on cancer patients' satisfaction, recall, and quality of life was investigated. PATIENTS AND METHODS: Consecutive cancer patients referred to either the gynecology or medical oncology outpatient

  11. ROPIVACAINE VERSUS LIDOCAINE FOR EPISIOTOMY-A RANDOMISED DOUBLE BLIND STUDY

    Directory of Open Access Journals (Sweden)

    Pushpalatha Nagaraj

    2017-04-01

    Full Text Available BACKGROUND Episiotomy is a most common surgical procedure for parturients during vaginal delivery. The problem encountered with episiotomy is pain, which is maximum during first 24 hours and may be severe enough to disturb the puerperium. This study aims to compare analgesic efficacy of analgesics, ropivacaine and lidocaine for perineal infiltration during episiotomy. MATERIALS AND METHODS We conducted a randomised double blind study for a period one year from August 2013 in a tertiary hospital. 100 parturients were included. RESULTS Ropivacaine 0.75% compared to lidocaine 2% did not show any statistical significant changes at suturing and after 4 hours; however, there were great statistically significant changes in VAS scores after 8 hours, 12 hours, 24 hours of episiotomy suturing. Ropivacaine group did not require systemic analgesics for 24 hours, but lidocaine group required systemic analgesics after 4 hours of suturing. Both groups (Ropivacaine and Lidocaine did not have any adverse effects. CONCLUSION Ropivacaine can be used safely for episiotomy wound infiltration thereby reducing the need for systemic analgesia.

  12. Maintenance N-acetyl cysteine treatment for bipolar disorder: A double-blind randomized placebo controlled trial

    Directory of Open Access Journals (Sweden)

    Berk Michael

    2012-08-01

    Full Text Available Abstract Background N-acetyl cysteine (NAC is a glutathione precursor that has been shown to have antidepressant efficacy in a placebo-controlled trial. The current study aimed to investigate the maintenance effects of NAC following eight weeks of open-label treatment for bipolar disorder. Method The efficacy of a double blind randomized placebo controlled trial of 2 g/day NAC as adjunct maintenance treatment for bipolar disorder was examined. Participants (n = 149 had a Montgomery Asberg Depression Rating Score of ≥12 at trial entry and, after eight weeks of open-label NAC treatment, were randomized to adjunctive NAC or placebo, in addition to treatment as usual. Participants (primarily outpatients were recruited through public and private services and through newspaper advertisements. Time to intervention for a mood episode was the primary endpoint of the study, and changes in mood symptoms, functionality and quality of life measures were secondary outcomes. Results There was a substantial decrease in symptoms during the eight-week open-label NAC treatment phase. During the subsequent double-blind phase, there was minimal further change in outcome measures with scores remaining low. Consequently, from this low plateau, between-group differences did not emerge on recurrence, clinical functioning or quality of life measures. Conclusions There were no significant between-group differences in recurrence or symptomatic outcomes during the maintenance phase of the trial; however, these findings may be confounded by limitations. Trial Registration The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12607000074493.

  13. A randomized, double-blind, placebo-controlled study of oral antioxidant supplement therapy in patients with dry eye syndrome

    OpenAIRE

    Huang, Jehn-Yu; Yeh, Po-Ting; Hou, Yu-Chih

    2016-01-01

    Jehn-Yu Huang, Po-Ting Yeh, Yu-Chih Hou Department of Ophthalmology, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan Purpose: To evaluate the efficacy of oral antioxidant supplementation in the treatment of patients with dry eye syndrome (DES). Methods: A prospective, randomized, double-blinded study compared the effects of an antioxidant supplement (containing anthocyanosides, astaxanthin, vitamins A, C, and E, and several herbal extract...

  14. Recombinant human thyrotropin prior to radioiodine therapy improves the size reduction of non-toxic nodular goiter: a prospective randomized double-blinded trial

    International Nuclear Information System (INIS)

    E Nielsen, Viveque; Bonnema, Steen; Hegedues, Laszlo; Grupe, Peter; Boel-Joergensen, Henrik

    2005-01-01

    Full text: Background: rh TSH increases the thyroid 131 I uptake (RAIU) and may have a role in the context of 131 I therapy of goiter. No placebo-controlled trial has yet been performed. Methods: In a double-blinded trial, 57 patients with nodular nontoxic goiter (51 F, 6 M) were randomized to receive either 0.3 mg rh TSH (n=28) or placebo (n=29) 24 h before 131 I. The thyroid dose was calculated based on thyroid size (measured by ultrasound) and RAUI at 24 h and 96 h. Thyroid size and function and patient satisfaction were monitored for 12 months. Results: At baseline the median goiter volume was 51 ml (range: 20-99 ml) in the placebo group and 59 ml (25-92 ml) in the rh TSH group (p=0.75). Three months after 131 I the goiter size was reduced to 38 ml (15-78 ml) and 43 ml (20-75 ml) in the two groups, respectively (p=0.001 within groups, p=0.96 between groups). At 12 months, the corresponding figures were 27 ml (15-82 ml) and 20 ml (6-59 ml); p=0.001 within groups compared with baseline, p=0.12 between groups. The relative goiter reduction at this time was 46 ± 22% in the placebo group, and 61 ± 15% in the rh TSH group (p=0.004). In addition to the influence of rh TSH, the magnitude of the goiter reduction correlated inversely with the initial goiter volume (p=0.019), whereas no significant correlation was found with the RAIU during therapy or with the absorbed thyroid dose. Discomfort during 131 I was reported by 10 patients in the placebo group and by 15 patients in the rh TSH group (p=0.12). Permanent hypothyroidism developed in 12% in the placebo group and in 52% in the rh TSH group (p=0.005). Patient satisfaction was generally very high without any major within group difference. Conclusion: In the first placebo-controlled double-blinded trial, we found that rh TSH prior to 131 I -therapy significantly improves thyroid size reduction by 33%, with a four-fold higher rate of hypothyroidism. These effects are, at least partially, mediated through other

  15. No Effects of D-Cycloserine Enhancement in Exposure With Response Prevention Therapy in Panic Disorder With Agoraphobia : A Double-Blind, Randomized Controlled Trial

    NARCIS (Netherlands)

    Hofmeijer-Sevink, Mieke Klein; Duits, Puck; Rijkeboer, Marleen M.; Hoogendoorn, Adriaan W.; van Megen, Harold J.; Vulink, Nienke C.; Denys, Damiaan A.; van den Hout, Marcel A.; van Balkom, Anton J.; Cath, Danielle C.

    2017-01-01

    Purpose/Background: D-cycloserine (DCS) is a partial N-methyl-Daspartate receptor agonist that potentially augments response to exposure therapy in anxiety disorders by enhancing extinction learning. This randomized, double-blinded, placebo-controlled augmentation trial examined (1) the

  16. No Effects of D-Cycloserine Enhancement in Exposure With Response Prevention Therapy in Panic Disorder With Agoraphobia A Double-Blind, Randomized Controlled Trial

    NARCIS (Netherlands)

    Hofmeijer-Sevink, Mieke Klein; Duits, Puck; Rijkeboer, Marleen M.; Hoogendoorn, Adriaan W.; van Megen, Harold J.; Vulink, Nienke C.; Denys, Damiaan A.; van den Hout, Marcel A.; van Balkom, Anton J.; Cath, Danielle C.

    2017-01-01

    Purpose/Background: D-cycloserine (DCS) is a partial N-methyl-Daspartate receptor agonist that potentially augments response to exposure therapy in anxiety disorders by enhancing extinction learning. This randomized, double-blinded, placebo-controlled augmentation trial examined (1) the

  17. Binomial confidence intervals for testing non-inferiority or superiority: a practitioner's dilemma.

    Science.gov (United States)

    Pradhan, Vivek; Evans, John C; Banerjee, Tathagata

    2016-08-01

    In testing for non-inferiority or superiority in a single arm study, the confidence interval of a single binomial proportion is frequently used. A number of such intervals are proposed in the literature and implemented in standard software packages. Unfortunately, use of different intervals leads to conflicting conclusions. Practitioners thus face a serious dilemma in deciding which one to depend on. Is there a way to resolve this dilemma? We address this question by investigating the performances of ten commonly used intervals of a single binomial proportion, in the light of two criteria, viz., coverage and expected length of the interval. © The Author(s) 2013.

  18. Reducing wound pain in venous leg ulcers with Biatain Ibu: A randomized, controlled double-blind clinical investigation on the performance and safety

    DEFF Research Database (Denmark)

    Gottrup, F.; Jorgensen, B.; Karlsmark, T.

    2008-01-01

    Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicenter randomized double-blind clinical investigation of 122 patients compared two moist wound healing dressings: a nonadhesive foam dressing with ibuprofen (62 patients randomized to Biatain Ibu...... Nonadhesive Coloplast A/S) and a nonadhesive foam without ibuprofen (60 patients to Biatain Non-Adhesive-comparator). Patients were recruited from September 2005 to April 2006. The ibuprofen foam was considered successful if the pain relief on a five-point Verbal Rating Scale was higher than the comparator...... higher in the ibuprofen-foam group, as compared with the comparator on day 1-5, with a quick onset of action (p ibuprofen foam during day 1-5 with 40% from baseline, compared with 30% with the comparator (p

  19. Effectiveness of telerehabilitation programme following surgery in shoulder impingement syndrome (SIS): study protocol for a randomized controlled non-inferiority trial.

    Science.gov (United States)

    Pastora-Bernal, Jose-Manuel; Martín-Valero, Rocío; Barón-López, Francisco Javier; García-Gómez, Oscar

    2017-02-23

    Shoulder pain is common in society, with high prevalence in the general population. Shoulder impingement syndrome (SIS) is the most frequent cause. Patients suffer pain, muscle weakness and loss of movement in the affected joint. Initial treatment is predominantly conservative. The surgical option has high success rates and is often used when conservative strategy fails. Traditional physiotherapy and post-operative exercises are needed for the recovery of joint range, muscle strength, stability and functionality. Telerehabilitation programmes have shown positive results in some orthopaedic conditions after surgery. Customized telerehabilitation intervention programmes should be developed to recover shoulder function after SIS surgery. The objective of this study is to evaluate the feasibility and effectiveness of a telerehabilitation intervention compared with usual care in patients after subacromial decompression surgery. We will compare an intervention group receiving videoconferences and a telerehabilitation programme to a control group receiving traditional physiotherapy intervention in a single-blind, randomized controlled non-inferiority trial study design. Through this study, we will further develop our preliminary data set and practical experience with the telerehabilitation programmes to evaluate their effectiveness and compare this with traditional intervention. We will also explore patient satisfaction and cost-effectiveness. Patient enrolment is ongoing. ClinicalTrials.gov, NCT02909920 . 14 September 2016.

  20. Effects of enzyme-potentiated desensitization in the treatment of pollinosis: a double-blind placebo-controlled trial.

    Science.gov (United States)

    Astarita, C; Scala, G; Sproviero, S; Franzese, A

    1996-01-01

    Several controlled clinical trials have shown that specific immunotherapy (SIT) using incremental injections of allergens can be effective in the treatment of allergic rhinitis and asthma. Nevertheless, the risk of side effects have led to some recommended limitations of SIT. Enzyme-potentiated desensitization (EPD) is a proposed method for immunotherapy with very low doses of mixed allergens plus beta-glucuronidase enzyme, for which irrelevant or no side effects have been claimed. The aim of this study was to determine the clinical efficacy of EPD in the treatment of pollinosis. A double-blind placebo-controlled trial of EPD among 20 patients sensitive to Parietaria and grass pollen was performed. All patients recorded daily symptom scores for nine months following a single intradermal injection of EPD or buffered saline received in February. Symptoms recorded were nasal itching and obstruction, sneezing, rhinorrhea, itchy eyes and excessive tear production. Moreover, total and specific lgE were measured and CD3+, CD4+ and CD8+ peripheral blood lymphocytes were counted at different times. In the same period, ten additional subjects, with an allergic clinical profile similar to the subjects admitted to the double-blind trial, were studied in an open clinical trial in order to evaluate the effects of EPD without enzyme using a mixture of allergens. Symptom scores were higher in the placebo group (p < 0.001), with a similar level of significance for both global symptom score and for each individual symptom. Active-treated patients had a significant post-treatment increase in the mean percentage of T-CD8+ peripheral blood cells and a significant post-seasonal decrease in the mean percentage of Parietaria specific lgE. On the contrary, placebo-treated patients had a borderline significant post-seasonal decrease in the mean percentage of CD8+ circulating cells and a significant seasonal increase in the mean percentage of Parietaria specific lgE with no significant post

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

    Science.gov (United States)

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

    2015-01-01

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

  2. The Addition of Platelet-Rich Plasma to Facial Lipofilling: A Double-Blind, Placebo-Controlled, Randomized Trial.

    Science.gov (United States)

    Willemsen, Joep C N; Van Dongen, Joris; Spiekman, Maroesjka; Vermeulen, Karin M; Harmsen, Martin C; van der Lei, Berend; Stevens, H P Jeroen

    2018-02-01

    Lipofilling is a treatment modality to restore tissue volume, but it may also rejuvenate the aging skin. Platelet-rich plasma has been reported to augment the efficacy of lipofilling, both on graft take and rejuvenation, by altering the adipose-derived stem cells. The authors hypothesized that addition of platelet-rich plasma would increase the rejuvenating effect and shorten recovery time. The study conducted was a single-center, double-blind, placebo-controlled, randomized trial (2012 to 2015). In total, a well-defined cohort of 32 healthy female patients enrolled in the study, with 25 completing the follow-up. All patients underwent aesthetic facial lipofilling with either saline or platelet-rich plasma added. Outcome was determined by changes in skin elasticity, volumetric changes of the nasolabial fold, recovery time, and patient satisfaction during follow-up (1 year). Platelet-rich plasma did not improve the outcome of facial lipofilling when looking at skin elasticity improvement, graft volume maintenance in the nasolabial fold. Reversal of the correlation between age and elasticity, however, might suggest a small effect size, and thus might not be significant with our small study population. This randomized, double-blind, placebo-controlled study clearly has shown that platelet-rich plasma significantly reduces postoperative recovery time but does not improve patient outcome when looking at skin elasticity, improvement of the nasolabial fold, or patient satisfaction. The reversal of the correlation between age and elasticity might indicate some effect on skin but requires more power in future studies. Therapeutic, II.

  3. Assessment of the Use of Venetian Blinds as Solar Thermal Collectors in Double Skin Facades in Mediterranean Climates

    Directory of Open Access Journals (Sweden)

    Abel Velasco

    2017-11-01

    Full Text Available The global trend on energy integration and building efficiency is making both researchers and building developers look for technical solutions to use facade surfaces for energy harvesting. In this work, the assessment of the thermal performance of a double-skin facade (DSF with a venetian blind-type of structure used as a solar thermal collector by means of computational fluid dynamics (CFD is presented. A Venetian blind collector would allow for heat rejection/energy harvesting and exterior views simultaneously and can be easily integrated into the DSF aesthetical design. For the purposes of this study, the modeled facades (south, west, and east-oriented were set to be located in Barcelona (Spain, where large solar gains are a constant condition throughout the year, and such large semi-transparent envelopes lead to interior over-heating in buildings, even during the winter. For the studied facades, both the reductions in radiative heat gains entering the building and the heat recovery in the Venetian blind collector were evaluated for a yearlong operation.

  4. No Effects of D-Cycloserine Enhancement in Exposure with Response Prevention Therapy in Panic Disorder with Agoraphobia : A Double-Blind, Randomized Controlled Trial

    NARCIS (Netherlands)

    Hofmeijer-Sevink, Mieke Klein; Duits, Puck; Rijkeboer, Marleen M.; Hoogendoorn, Adriaan W; Van Megen, Harold J.; Vulink, Nienke C.; Denys, Damiaan A.; Van Den Hout, Marcel A.; van Balkom, Anton J L M; Cath, Danielle C.

    2017-01-01

    Purpose/Background D-cycloserine (DCS) is a partial N-methyl-D-aspartate receptor agonist that potentially augments response to exposure therapy in anxiety disorders by enhancing extinction learning. This randomized, double-blinded, placebo-controlled augmentation trial examined (1) the

  5. No Effects of D-Cycloserine Enhancement in Exposure With Response Prevention Therapy in Panic Disorder With Agoraphobia : A Double-Blind, Randomized Controlled Trial

    NARCIS (Netherlands)

    Hofmeijer-Sevink, Mieke Klein; Duits, Puck; Rijkeboer, Marleen M; Hoogendoorn, Adriaan W; van Megen, Harold J; Vulink, Nienke C; Denys, D.; van den Hout, Marcel A; van Balkom, Anton J L M; Cath, Danielle C

    2017-01-01

    PURPOSE/BACKGROUND: D-cycloserine (DCS) is a partial N-methyl-D-aspartate receptor agonist that potentially augments response to exposure therapy in anxiety disorders by enhancing extinction learning. This randomized, double-blinded, placebo-controlled augmentation trial examined (1) the

  6. Bee venom acupuncture for the treatment of chronic low back pain: study protocol for a randomized, double-blinded, sham-controlled trial.

    Science.gov (United States)

    Seo, Byung-Kwan; Lee, Jun-Hwan; Sung, Won-Suk; Song, Eun-Mo; Jo, Dae-Jean

    2013-01-14

    Chronic non-specific low back pain is the most common medical problem for which patients seek complementary and alternative medical treatment, including bee venom acupuncture. However, the effectiveness and safety of such treatments have not been fully established by randomized clinical trials. The aim of this study is to determine whether bee venom acupuncture is effective for improving pain intensity, functional status and quality of life of patients with chronic non-specific low back pain. This study is a randomized, double-blinded, sham-controlled clinical trial with two parallel arms. Fifty-four patients between 18 and 65 years of age with non-radicular chronic low back pain experiencing low back pain lasting for at least the previous three months and ≥ 4 points on a 10-cm visual analog scale for bothersomeness at the time of screening will be included in the study. Participants will be randomly allocated into the real or sham bee venom acupuncture groups and treated by the same protocol to minimize non-specific and placebo effects. Patients, assessors, acupuncturists and researchers who prepare the real or sham bee venom acupuncture experiments will be blinded to group allocation. All procedures, including the bee venom acupuncture increment protocol administered into predefined acupoints, are designed by a process of consensus with experts and previous researchers according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture. Bothersomeness measured using a visual analogue scale will be the primary outcome. Back pain-related dysfunction, pain, quality of life, depressive symptoms and adverse experiences will be measured using the visual analogue scale for pain intensity, the Oswestry Disability Index, the EuroQol 5-Dimension, and the Beck's Depression Inventory. These measures will be recorded at baseline and 1, 2, 3, 4, 8 and 12 weeks. The results from this study will provide clinical evidence on the efficacy and safety of bee

  7. PONV in Ambulatory surgery: A comparison between Ramosetron and Ondansetron: a prospective, double-blinded, and randomized controlled study

    Directory of Open Access Journals (Sweden)

    Debasis Banerjee

    2014-01-01

    Full Text Available Background: postoperative nausea and vomiting (PONV frequently hampers implementation of ambulatory surgery in spite of so many antiemetic drugs and regimens. Aims: the study was carried out to compare the efficacy of Ramosetron and Ondansetron in preventing PONV after ambulatory surgery. Setting and Design: it was a prospective, double blinded, and randomized controlled study. Methods: 124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery, were randomly allocated into Group A [(n=62 receiving (IV Ondansetron (4 mg] and Group B [(n=62 receiving IV Ramosetron (0.3 mg] prior to the induction of general anesthesia in a double-blind manner. Episodes of PONV were noted at 0.5, 1, 2, 4 h, 6 , 12, and 18 h postoperatively. Statistical Analysis and Results: statistically significant difference between Groups A and B (P <0.05 was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity. Conclusion: it was evident that preoperative prophylactic administration of single dose IV Ramosetron (0.3 mg has better efficacy than single dose IV Ondansetron (4 mg in reducing the episodes of PONV over 18 h postoperatively in patients undergoing day-care surgery under general anesthesia.

  8. Flurbiprofen microgranules for relief of sore throat: a randomised, double-blind trial

    Science.gov (United States)

    Russo, Marc; Bloch, Mark; de Looze, Fred; Morris, Christopher; Shephard, Adrian

    2013-01-01

    Background Many people with sore throat seek, and are often inappropriately prescribed, antibiotics. Aim The objective of this study was to determine the analgesic efficacy of flurbiprofen 8.75 mg microgranules versus placebo. These microgranules are a possible alternative treatment for patients with sore throat due to upper respiratory tract infection (URTI). Design and setting Randomised, double-blind, placebo-controlled, multiple-dose study conducted at eight primary care sites in Australia. Method Participants with sore throat of onset within the past 4 days received either flurbiprofen 8.75 mg microgranules or non-medicated placebo microgranules. Throat soreness, difficulty in swallowing, sore throat pain intensity, sore throat relief, oral temperature, and treatment benefits were all assessed at regular intervals. Result Of 373 patients from eight centres, 186 received flurbiprofen 8.75 mg microgranules and 187 received placebo microgranules (intent-to-treat population). Throat soreness was significantly reduced over the first 2 hours after the first dose. Reductions in difficulty in swallowing were observed at all time points from 5 to 360 minutes after the first dose, after taking flurbiprofen microgranules versus placebo. Sore throat relief was also evident at 1 minute and lasted for at least 6 hours. The multiple-dose efficacy results showed reduction of difficulty in swallowing at the end of days 1–3 and sore throat relief at the end of day 1. Conclusion Microgranules containing flurbiprofen 8.75 mg provided fast and effective relief from sore throat due to URTI and represent an alternative treatment option to antibiotic therapy. PMID:23561694

  9. Double-blind test program for astrometric planet detection with Gaia

    Science.gov (United States)

    Casertano, S.; Lattanzi, M. G.; Sozzetti, A.; Spagna, A.; Jancart, S.; Morbidelli, R.; Pannunzio, R.; Pourbaix, D.; Queloz, D.

    2008-05-01

    Aims: The scope of this paper is twofold. First, it describes the simulation scenarios and the results of a large-scale, double-blind test campaign carried out to estimate the potential of Gaia for detecting and measuring planetary systems. The identified capabilities are then put in context by highlighting the unique contribution that the Gaia exoplanet discoveries will be able to bring to the science of extrasolar planets in the next decade. Methods: We use detailed simulations of the Gaia observations of synthetic planetary systems and develop and utilize independent software codes in double-blind mode to analyze the data, including statistical tools for planet detection and different algorithms for single and multiple Keplerian orbit fitting that use no a priori knowledge of the true orbital parameters of the systems. Results: 1) Planets with astrometric signatures α≃ 3 times the assumed single-measurement error σ_ψ and period P≤ 5 yr can be detected reliably and consistently, with a very small number of false positives. 2) At twice the detection limit, uncertainties in orbital parameters and masses are typically 15-20%. 3) Over 70% of two-planet systems with well-separated periods in the range 0.2≤ P≤ 9 yr, astrometric signal-to-noise ratio 2≤α/σ_ψ≤ 50, and eccentricity e≤ 0.6 are correctly identified. 4) Favorable orbital configurations (both planets with P≤ 4 yr and α/σ_ψ≥ 10, redundancy over a factor of 2 in the number of observations) have orbital elements measured to better than 10% accuracy > 90% of the time, and the value of the mutual inclination angle i_rel determined with uncertainties ≤ 10°. 5) Finally, nominal uncertainties obtained from the fitting procedures are a good estimate of the actual errors in the orbit reconstruction. Extrapolating from the present-day statistical properties of the exoplanet sample, the results imply that a Gaia with σ_ψ = 8 μas, in its unbiased and complete magnitude-limited census of

  10. The efficacy of Femal in women with premenstrual syndrome: a randomised, double-blind, parallel-group, placebo-controlled, multicentre study

    DEFF Research Database (Denmark)

    Gerhardsen, G.; Hansen, A.V.; Killi, M.

    2008-01-01

    Introduction: A double-blind, placebo-controlled, randomised, parallel-group, multicentre study was conducted to evaluate the effect of a pollen-based herbal medicinal product, Femal (R) (Sea-Band Ltd, Leicestershire, UK), on premenstrual sleep disturbances (PSD) in women with premenstrual syndrome...... as the main symptom cluster makes this herbal medicinal product a promising addition to the therapeutic arsenal for women with PMS Udgivelsesdato: 2008/6...

  11. Effects of oxcarbazepine versus carbamazepine on tinnitus: A randomized double-blind placebo-controlled clinical trial.

    Science.gov (United States)

    Gerami, Hooshang; Saberi, Alia; Nemati, Shadman; Kazemnejad, Ehsan; Aghajanpour, Mohammad

    2012-01-01

    It is still a challenge to find an effective treatment for tinnitus. The aim of this study was the evaluation of carbamazepine and oxcarbazepine effects on tinnitus. In a randomized double-blind clinical trial, 57 patients who were visited in a university hospital due to chronic non-pulsatile tinnitus, were randomized in three groups and treated with carbamazepine (300-600 mg/day), oxcarbazepine (450-900 mg/day) and placebo for 12 weeks. Visual analogue scale (VAS) and tinnitus severity index (TSI) were measured in all subjects in the beginning and at the end of the 8(th) and 12(th) weeks of the trial. Data was analyzed by repeated measure analysis, paired and independent t-test. Among 51 participants who completed the trial course (28 men, 23 women), carbamazepine, oxcarbazepine and placebo decreased tinnitus severity in 56.6%, 46.2% and 38.5% of patients according to VAS, and in 61.1%, 58.8% and 50% of patients according to TSI, respectively. The effects of carbamazepine and oxcarbazepine were better in the first 8 weeks of treatment. However, their effect on tinnitus did not show any statistical difference in comparison with placebo (P = 0.34, P = 0.28). Carbamazepine and oxcarbazepine are not more effective than placebo in decreasing tinnitus severity.

  12. Double-blind randomized controlled trial of rifaximin for persistent symptoms in patients with celiac disease.

    Science.gov (United States)

    Chang, Matthew S; Minaya, Maria T; Cheng, Jianfeng; Connor, Bradley A; Lewis, Suzanne K; Green, Peter H R

    2011-10-01

    Small intestinal bacterial overgrowth (SIBO) is one cause of a poor response to a gluten-free diet (GFD) and persistent symptoms in celiac disease. Rifaximin has been reported to improve symptoms in non-controlled trials. To determine the effect of rifaximin on gastrointestinal symptoms and lactulose-hydrogen breath tests in patients with poorly responsive celiac disease. A single-center, double-blind, randomized, controlled trial of patients with biopsy-proven celiac disease and persistent gastrointestinal symptoms despite a GFD was conducted. Patients were randomized to placebo (n = 25) or rifaximin (n = 25) 1,200 mg daily for 10 days. They completed the Gastrointestinal Symptom Rating Scale (GSRS) and underwent lactulose-hydrogen breath tests at weeks 0, 2, and 12. An abnormal breath test was defined as: (1) a rise in hydrogen of ≥20 parts per million (ppm) within 100 min, or (2) two peaks ≥20 ppm over baseline. GSRS scores were unaffected by treatment with rifaximin, regardless of baseline breath tests. In a multivariable regression model, the duration of patients' gastrointestinal symptoms significantly predicted their overall GSRS scores (estimate 0.029, p symptoms and hydrogen breath tests do not reliably identify who will respond to antibiotic therapy.

  13. An improved image non-blind image deblurring method based on FoEs

    Science.gov (United States)

    Zhu, Qidan; Sun, Lei

    2013-03-01

    Traditional non-blind image deblurring algorithms always use maximum a posterior(MAP). MAP estimates involving natural image priors can reduce the ripples effectively in contrast to maximum likelihood(ML). However, they have been found lacking in terms of restoration performance. Based on this issue, we utilize MAP with KL penalty to replace traditional MAP. We develop an image reconstruction algorithm that minimizes the KL divergence between the reference distribution and the prior distribution. The approximate KL penalty can restrain over-smooth caused by MAP. We use three groups of images and Harris corner detection to prove our method. The experimental results show that our algorithm of non-blind image restoration can effectively reduce the ringing effect and exhibit the state-of-the-art deblurring results.

  14. RETRACTED: Treatment of postoperative emetic symptoms with granisetron in women undergoing abdominal hysterectomy: a randomized, double-blind, placebo-controlled, dose-ranging study

    Directory of Open Access Journals (Sweden)

    MD Yoshitaka Fujii

    2004-07-01

    Fujii Y, Tanaka H, Somekawa Y. Treatment of postoperative emetic symptoms with granisetron in women undergoing abdominal hysterectomy: a randomised, double-blind, placebo-controlled, dose-ranging study. Current Therapeutic Research 2004;65:321–9. https://www.sciencedirect.com/science/article/pii/S0011393X04800018

  15. Dihydroartemisinin-piperaquine versus artesunate-amodiaquine for treatment of malaria infection in pregnancy in Ghana: an open-label, randomised, non-inferiority trial.

    Science.gov (United States)

    Osarfo, Joseph; Tagbor, Harry; Cairns, Matthew; Alifrangis, Michael; Magnussen, Pascal

    2017-08-01

    To determine whether dihydroartemisinin-piperaquine (DHA-PPQ) is non-inferior to artesunate-amodiaquine (ASAQ) for treating uncomplicated malaria infection in pregnancy. A total of 417 second/ third trimester pregnant women with confirmed asymptomatic Plasmodium falciparum parasitaemia were randomised to receive DHA-PPQ or ASAQ over 3 days. Women were followed up on days 1, 2, 3, 7, 14, 28 and 42 after treatment start and at delivery for parasitological, haematological, birth outcomes and at 6-week post-partum to ascertain the health status of the babies. Parasitological efficacy (PE) by days 28 and 42 were co-primary outcomes. Analysis was per-protocol (PP) and modified intention-to-treat (ITT). Non-inferiority was declared if the two-sided 95% confidence interval for PE at the endpoints excluded 5% lower efficacy for DHA-PPQ. Secondary outcomes were assessed for superiority. In PP analysis, PE was 91.6% for DHA-PPQ and 89.3% for ASAQ by day 28 and 89.0% and 86.5%, respectively, by day 42. DHA-PPQ was non-inferior to ASAQ with respect to uncorrected PE [adjusted difference by day 28 (DHA-PPQ-ASAQ); 3.5% (95%CI: -1.5, 8.5); and day 42: 3.9% (95%CI: -2.7, 10.4)]. ITT analysis gave similar results. PCR to distinguish recrudescence and reinfection was unsuccessful. DHA-PPQ recipients had fewer adverse events of vomiting, dizziness, and general weakness compared to ASAQ. Both drugs were well-tolerated, and there was no excess of adverse birth outcomes. DHA-PPQ was non-inferior to ASAQ for treatment of malaria infection during pregnancy. No safety concerns were identified. Our findings contribute to growing evidence that DHA-PPQ is useful for control of malaria in pregnancy. © 2017 John Wiley & Sons Ltd.

  16. Effect of Saccharomyces boulardii in dog with chronic enteropathies: double-blinded, placebo-controlled study.

    Science.gov (United States)

    D'Angelo, Simona; Fracassi, Federico; Bresciani, Francesca; Galuppi, Roberta; Diana, Alessia; Linta, Nikolina; Bettini, Giuliano; Morini, Maria; Pietra, Marco

    2018-03-03

    Saccharomyces boulardii is used to treat acute and chronic enteropathies in humans, but to date, no studies have evaluated the use of this yeast in dogs. The current study, a prospective non-randomised, double-blinded, placebo-controlled study, evaluated the effects of S boulardii in healthy dogs and dogs with chronic enteropathies (CE). Four healthy dogs and 20 dogs with CE were included. In healthy dogs, S boulardii was administered for 10 days. Possible short-term adverse effects were recorded, and quantitative stool cultures for yeasts were performed. In dogs with CE, S boulardii or a placebo was administered in addition to standard treatment protocols. Canine Chronic Enteropathy Clinical Activity Index, abdominal ultrasonography, gastroenteroscopy and histology were performed at the time of diagnosis and after 60 days of treatment. In healthy dogs, S boulardii reached a steady state in five days and was completely eliminated on day 4 after administration. No short-term side effects were seen. Clinical activity index, stool frequency, stool consistency and body condition score improved significantly in dogs with CE receiving S boulardii versus the placebo. In conclusion, S boulardii can be safely used in dogs with CE and seems to achieve better control of clinical signs than standard therapy alone. © British Veterinary Association (unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  17. Blindness alters the microstructure of the ventral but not the dorsal visual stream.

    Science.gov (United States)

    Reislev, Nina L; Kupers, Ron; Siebner, Hartwig R; Ptito, Maurice; Dyrby, Tim B

    2016-07-01

    Visual deprivation from birth leads to reorganisation of the brain through cross-modal plasticity. Although there is a general agreement that the primary afferent visual pathways are altered in congenitally blind individuals, our knowledge about microstructural changes within the higher-order visual streams, and how this is affected by onset of blindness, remains scant. We used diffusion tensor imaging and tractography to investigate microstructural features in the dorsal (superior longitudinal fasciculus) and ventral (inferior longitudinal and inferior fronto-occipital fasciculi) visual pathways in 12 congenitally blind, 15 late blind and 15 normal sighted controls. We also studied six prematurely born individuals with normal vision to control for the effects of prematurity on brain connectivity. Our data revealed a reduction in fractional anisotropy in the ventral but not the dorsal visual stream for both congenitally and late blind individuals. Prematurely born individuals, with normal vision, did not differ from normal sighted controls, born at term. Our data suggest that although the visual streams are structurally developing without normal visual input from the eyes, blindness selectively affects the microstructure of the ventral visual stream regardless of the time of onset. We suggest that the decreased fractional anisotropy of the ventral stream in the two groups of blind subjects is the combined result of both degenerative and cross-modal compensatory processes, affecting normal white matter development.

  18. The effects of alcohol mixed with energy drink (AMED) on subjective intoxication and alertness : results from a double-blind placebo-controlled clinical trial

    NARCIS (Netherlands)

    van de Loo, Aurora J A E; van Andel, Nienke; van Gelder, Charlotte A G H; Janssen, Boris S G; Titulaer, Joep; Jansen, Jimmy; Verster, Joris C

    2016-01-01

    OBJECTIVE: The purpose of this double blind placebo controlled study was to examine if specific effects on subjective intoxication and alertness-sleepiness ratings could be demonstrated after consuming alcohol mixed with energy drink (AMED) when compared to consuming alcohol only (AO). METHODS: 56

  19. Does interscalene catheter placement with stimulating catheters improve postoperative pain or functional outcome after shoulder surgery? A prospective, randomized and double-blinded trial

    NARCIS (Netherlands)

    Stevens, Markus F.; Werdehausen, Robert; Golla, Elisabeth; Braun, Sebastian; Hermanns, Henning; Ilg, Ansgar; Willers, Reinhardt; Lipfert, Peter

    2007-01-01

    BACKGROUND: In this prospective, randomized, double-blind trial we investigated the use of stimulating catheters in patients during and after shoulder surgery; functional improvement being the primary outcome measurement. METHODS: After eliciting an adequate muscular twitch at

  20. RECOMBINANT HUMAN INTERLEUKIN-1 RECEPTOR ANTAGONIST IN THE TREATMENT OF PATIENTS WITH SEPSIS SYNDROME - RESULTS FROM A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

    NARCIS (Netherlands)

    FISHER, C. J.; DHAINAUT, J. F. A.; Opal, S. M.; Pribble, J. P.; BALK, R. A.; SLOTMAN, G. J.; IBERTI, T. J.; RACKOW, E. C.; SHAPIRO, M. J.; GREENMAN, R. L.; REINES, H. D.; SHELLY, M. P.; THOMPSON, B. W.; LABRECQUE, J. F.; Catalano, M. A.; KNAUS, W. A.; Sadoff, J. C.; ASTIZ, M.; CARPATI, C.; BONE, R. C.; FREIDMAN, B.; MURE, A. J.; BRATHWAITE, C.; SHAPIRO, E.; MELHORN, L.; TAYLOR, R.; KEEGAN, M.; OBRIEN, J.; SCHEIN, R.; PENA, M.; WASSERLOUF, M.; OROPELLO, J.; BENJAMIN, E.; DELGUIDICE, R.; EMMANUEL, G.; LIE, T.; Anderson, L.; Marshall, J.; DEMAJO, W.; ROTSTEIN, O.; FOSTER, D.; Abraham, E.; MIDDLETON, H.; Perry, C.; LEVY, H.; FRY, D. E.; SIMPSON, S. Q.; CROWELL, R. E.; Neidhart, M.; Stevens, D.; COFFMAN, T.; NARASIMHAM, N.; MERRICK, D. K.; BERGQUIST, W.; MATZEL, K. E.; HUEBLER, M.; Foulke, G. E.; ALBERTSON, T. E.; WALBY, W. F.; ALLEN, R. P.; Baughman, R.; HASSELGREN, P. O.; Fink, M. P.; FAVORITO, F.; THOMPSON, B. T.; CORBIN, R.; SHELLHORSE, G. Y.; FRAZIER, A.; White, S.; GARRARD, C.; ACOURT, C.; STORER, S.; GERVICH, D. H.; FOSHE, D.; BRASE, R.; BAGDAHN, A.; COONEY, R.; Smith, J. S.; MARTIN, L. F.; Vincent, J. L.; Friedman, G.; Berlot, G.; FLETCHER, J. R.; WILLIAMS, M. D.; WRIGHT, T. F.; Johnson, S.; FEILD, C.; WOLF, K.; MACINTYRE, N.; DUBIN, H. G.; DURKIN, M. R.; DUBIN, P. K.; STAUBACH, K. H.; FEIN, A. M.; SCHULMAN, D. B.; NIEDERMAN, M. S.; CHALFIN, D. B.; van Leeuwen, P. A. M.; Boermeester, M. A.; Schneider, A. J.; BANDER, J.; IMM, A.; BERNARD, G.; Nelson, L.; Stroud, M.; SAFCSAK, K.; CERRA, F.; RINDAL, J.; Mann, H.; HALPERN, N.; SILVERSTEIN, J.; ALICEA, M.; Sibbald, W. J.; MARTIN, C. M.; RUTLEDGE, F. S.; PETTI, K.; RUSSELL, J. A.; KRUGER, R.; DRUMMOND, A.; LANGE, P.; SEIFERT, T.; DUROCHER, A.; TENAILLON, A.; BOITEAU, R.; LHERM, T.; Lowry, S. F.; Coyle, S. M.; Barie, P. S.; DEMARIA, E.; SNYDMAN, D. R.; SCHWAITZBERG, S. D.; NASRAWAY, S. A.; GRINDLINGER, J.; SUMMER, W.; DEBOISBLANC, B.; WAHL, M.; ALESTIG, K.; GROSSMAN, J.; MAKI, D.; PAZ, H. L.; Weiner, M.; BIHARI, D.; Campbell, D.; BLEICHNER, G.; DAHN, M. S.; LANGE, M. P. A.; Hall, J.; POHLMAN, A.; WENZEL, R. P.; GROSSERODE, M.; COSTIGAN, M.; MILESKI, W.; WEIGELT, J.; YESTON, N.; IRIZARRY, C.; Ross, J.; ROBBINS, J.; NIGHTINGALE, P.; OWEN, K.; SANDSTEDT, S.; Berg, S.; SIMON, G. L.; SENEFF, M. G.; CONRY, K. M.; ZIMMERMAN, J. L.; Dellinger, R. P.; Johnston, R.; ALLEE, P.; GRANDE, P. O.; MYHRE, E.; DHAINAUT, J. F.; HAMY, I.; Mira, J. P.; HARMON, J.; White, J.; MCKIE, L.; SILVERMAN, H.; TUMA, P.; Bennett, D.; PORTER, J. C.; LAURELL, M. H.; Jacobs, S.; ASH, S.; Stiles, D. M.; PRIOR, M. J.; KNATTERUD, G.; TERRIN, M.; KUFERA, J.; WILKENS, P.; RA, K.; MONROE, L.; SPRUNG, C.; HAMILTON, C. M.; MATTHAY, R.; MCCABE, W.; TONASCIA, J.; WIEDEMAN, H.; Wittes, J.; CAMPION, G. V.; CROFT, C. R.; LUSTICK, R.; LOOKABAUGH, J.; GORDON, G. S.; NOE, L.; BLOEDOW, D.; SMITH, C. G.; BRANNON, D.; KUSH, R.; NG, D.; MOORE, E.; BAZEMORE, K.; GALVAN, M.; Wagner, D.; HARRELL, F.; STABLEIN, D.

    1994-01-01

    Objective.-To further define the safety and efficacy of recombinant human interleukin 1 receptor antagonist (rhlL-1ra) in the treatment of sepsis syndrome. Study Design.-Randomized, double-blind, placebo-controlled, multicenter, multinational clinical trial. Population.-A total of 893 patients with

  1. Effects of Herbal vigRX on Premature Ejaculation: A randomized, double-blind study

    Directory of Open Access Journals (Sweden)

    Z Ghafuri

    2010-05-01

    Full Text Available Objective :   "nWe conducted a double-blind, placebo-controlled study todetermine the efficacy of an herbal sexual supplement (vigRX on premature ejaculation (PE. Method: "nA randomized double blind study was conducted on a fixed dose of herbal vigRX at Roozbeh Psychiatry Hospital, Tehran University of Medical Sciences. The sample consisted of 85 married patients diagnosed withprimary PE according to Diagnostic and Statistical Manual of Mental Disorders. Each patient underwent diagnostic evaluation by one trained psychiatrist, using Structured Clinical Interview for DSM-IV-TR. Each patient was evaluated by researchers to exclude the organic sexual dysfunctions. The patients were randomly assigned in to two groups: group 1 consisting of 42 patients receiving placebo, and group 2 consisting of 43 patients receiving 540 mg herbal vigRX for a 4-week treatment course. The effects of the drug on the ejaculatory function in each group were assessed by the intravaginal ejaculation latency time (IELT, and the Chinese Index of Premature Ejaculation (CIPE before and at the end of the treatment course. Statistical analysis was performed using SPSS software (15th version.      Results: "nThe mean IELT increased 22.4 and 32.0 seconds in the placebo and the vigRX group respectively after the treatment course. The mean IELT differences between the two groups was not significant. The mean CIPE score increased 2.40 and 4.37 in the placebo and the vigRX group respectively .The mean CIPE score differences between the two groups was not significant.No side effect was reported by the subjects in neither groups during the treatment course. "nConclusion: Although the improvement in IELT and CIPE scores in the herbal vigRX group was more than the placebo group, this difference was not statistically significant. The increasing of IELT and CIPE score in the placebo group may be due to the placebo effects. Further studies with higher vigRX doses, greater sample size

  2. Nurse-Moderated Internet-Based Support for New Mothers: Non-Inferiority, Randomized Controlled Trial.

    Science.gov (United States)

    Sawyer, Michael G; Reece, Christy E; Bowering, Kerrie; Jeffs, Debra; Sawyer, Alyssa C P; Mittinty, Murthy; Lynch, John W

    2017-07-24

    Internet-based interventions moderated by community nurses have the potential to improve support offered to new mothers, many of whom now make extensive use of the Internet to obtain information about infant care. However, evidence from population-based randomized controlled trials is lacking. The aim of this study was to test the non-inferiority of outcomes for mothers and infants who received a clinic-based postnatal health check plus nurse-moderated, Internet-based group support when infants were aged 1-7 months as compared with outcomes for those who received standard care consisting of postnatal home-based support provided by a community nurse. The design of the study was a pragmatic, preference, non-inferiority randomized control trial. Participants were recruited from mothers contacted for their postnatal health check, which is offered to all mothers in South Australia. Mothers were assigned either (1) on the basis of their preference to clinic+Internet or home-based support groups (n=328), or (2) randomly assigned to clinic+Internet or home-based groups if they declared no strong preference (n=491). The overall response rate was 44.8% (819/1827). The primary outcome was parenting self-competence, as measured by the Parenting Stress Index (PSI) Competence subscale, and the Karitane Parenting Confidence Scale scores. Secondary outcome measures included PSI Isolation, Interpersonal Support Evaluation List-Short Form, Maternal Support Scale, Ages and Stages Questionnaire-Social-Emotional and MacArthur Communicative Development Inventory (MCDI) scores. Assessments were completed offline via self-assessment questionnaires at enrolment (mean child age=4.1 weeks, SD 1.3) and again when infants were aged 9, 15, and 21 months. Generalized estimating equations adjusting for post-randomization baseline imbalances showed that differences in outcomes between mothers in the clinic+Internet and home-based support groups did not exceed the pre-specified margin of

  3. Double blind randomised controlled trial of two different breathing techniques in the management of asthma.

    Science.gov (United States)

    Slader, C A; Reddel, H K; Spencer, L M; Belousova, E G; Armour, C L; Bosnic-Anticevich, S Z; Thien, F C K; Jenkins, C R

    2006-08-01

    Previous studies have shown that breathing techniques reduce short acting beta(2) agonist use and improve quality of life (QoL) in asthma. The primary aim of this double blind study was to compare the effects of breathing exercises focusing on shallow nasal breathing with those of non-specific upper body exercises on asthma symptoms, QoL, other measures of disease control, and inhaled corticosteroid (ICS) dose. This study also assessed the effect of peak flow monitoring on outcomes in patients using breathing techniques. After a 2 week run in period, 57 subjects were randomised to one of two breathing techniques learned from instructional videos. During the following 30 weeks subjects practised their exercises twice daily and as needed for relief of symptoms. After week 16, two successive ICS downtitration steps were attempted. The primary outcome variables were QoL score and daily symptom score at week 12. Overall there were no clinically important differences between the groups in primary or secondary outcomes at weeks 12 or 28. The QoL score remained unchanged (0.7 at baseline v 0.5 at week 28, p = 0.11 both groups combined), as did lung function and airway responsiveness. However, across both groups, reliever use decreased by 86% (p0.10 between groups). Peak flow monitoring did not have a detrimental effect on asthma outcomes. Breathing techniques may be useful in the management of patients with mild asthma symptoms who use a reliever frequently, but there is no evidence to favour shallow nasal breathing over non-specific upper body exercises.

  4. Isolated inferior mesenteric portal hypertension with giant inferior mesenteric vein and anomalous inferior mesenteric vein insertion

    Directory of Open Access Journals (Sweden)

    G Raghavendra Prasad

    2013-01-01

    Full Text Available Extrahepatic portal hypertension is not an uncommon disease in childhood, but isolated inferior mesenteric portal varices and lower gastrointestinal (GI bleed have not been reported till date. A 4-year-old girl presented with lower GI bleed. Surgical exploration revealed extrahepatic portal vein obstruction with giant inferior mesenteric vein and colonic varices. Inferior mesenteric vein was joining the superior mesenteric vein. The child was treated successfully with inferior mesenteric - inferior vena caval anastomosis. The child was relieved of GI bleed during the follow-up.

  5. Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial.

    Science.gov (United States)

    Sugano, Kentaro; Kontani, Teiji; Katsuo, Shinichi; Takei, Yoshinori; Sakaki, Nobuhiro; Ashida, Kiyoshi; Mizokami, Yuji; Asaka, Masahiro; Matsui, Shigeyuki; Kanto, Tatsuya; Soen, Satoshi; Takeuchi, Tsutomu; Hiraishi, Hideyuki; Hiramatsu, Naoki

    2012-05-01

    Low-dose lansoprazole has not been intensively evaluated for its efficacy in the prevention of recurrent gastric or duodenal ulcers in patients receiving long-term non-steroidal anti-inflammatory drug (NSAID) therapy for pain relief in such diseases as rheumatoid arthritis, osteoarthritis, and low back pain. This multi-center, prospective, double-blind, randomized, active-controlled study involving 99 sites in Japan was designed to compare the efficacy of lansoprazole (15 mg daily) with gefarnate (50 mg twice daily). Patients with a history of gastric or duodenal ulcers who required long-term NSAID therapy were randomized to receive lansoprazole 15 mg daily (n = 185) or gefarnate 50 mg twice daily (n = 181) and followed up for 12 months or longer prospectively. The cumulative incidence of gastric or duodenal ulcer at days 91, 181, and 361 from the start of the study was calculated by the Kaplan-Meier method as 3.3, 5.9, and 12.7%, respectively, in the lansoprazole group versus 18.7, 28.5, and 36.9%, respectively, in the gefarnate group. The risk for ulcer development was significantly (log-rank test, P lansoprazole group than in the gefarnate group, with the hazard ratio being 0.2510 (95% CI 0.1400-0.4499). A long-term follow-up study showed an acceptable safety profile for low-dose lansoprazole therapy, with diarrhea as the most frequent adverse event. Lansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term NSAID therapy.

  6. Efficacy of different doses of cimetidine in the treatment of reflux esophagitis. A review of three large, double-blind, controlled trials

    NARCIS (Netherlands)

    Tytgat, G. N.; Nicolai, J. J.; Reman, F. C.

    1990-01-01

    Four different cimetidine dosage regimens--800 mg u.i.d. HS or nocte, 800 mg u.i.d. dinnertime, 400 mg q.i.d., and 800 mg b.i.d.--were investigated for the treatment of reflux esophagitis in three independent large-scale, double-blind, controlled multicenter trials in which more than 1100 patients

  7. Melatonin improves sleep in children with epilepsy: a randomized, double-blind, crossover study.

    Science.gov (United States)

    Jain, Sejal V; Horn, Paul S; Simakajornboon, Narong; Beebe, Dean W; Holland, Katherine; Byars, Anna W; Glauser, Tracy A

    2015-05-01

    Insomnia, especially maintenance insomnia, is widely prevalent in epilepsy. Although melatonin is commonly used, limited data address its efficacy. We performed a randomized, double-blind, placebo-controlled, crossover study to identify the effects of melatonin on sleep and seizure control in children with epilepsy. Eleven prepubertal, developmentally normal children aged 6-11 years with epilepsy were randomized by a software algorithm to receive placebo or a 9-mg sustained release (SR) melatonin formulation for four weeks, followed by a one-week washout and a four-week crossover condition. The pharmacy performed blinding; patients, parents, and study staff other than a statistician were blinded. The primary outcomes were sleep onset latency and wakefulness after sleep onset (WASO) measured on polysomnography. The secondary outcomes included seizure frequency, epileptiform spike density per hour of sleep on electroencephalogram (EEG), and reaction time (RT) measures on psychomotor vigilance task (PVT). Statistical tests appropriate for crossover designs were used for the analysis. Data were analyzed from 10 subjects who completed the study. Melatonin decreased sleep latency (mean difference, MD, of 11.4 min and p = 0.02) and WASO (MD of 22 min and p = 0.04) as compared to placebo. No worsening of spike density or seizure frequency was seen. Additionally, slow-wave sleep duration and rapid eye movement (REM) latency were increased with melatonin and REM sleep duration was decreased. These changes were statistically significant. Worsening of headache was noted in one subject with migraine on melatonin. SR melatonin resulted in statistically significant decreases in sleep latency and WASO. No clear effects on seizures were observed, but the study was too small to allow any conclusions to be drawn in this regard. Copyright © 2015 Elsevier B.V. All rights reserved.

  8. Phlebitis induced by parenteral treatment with flucloxacillin and cloxacillin: a double-blind study.

    Science.gov (United States)

    Svedhem, A; Alestig, K; Jertborn, M

    1980-01-01

    Two studies were performed on a total of 54 patients with staphylococcal infections. Study I compares with phlebitogenic properties of flucloxacillin after intravenous infusions when either saline or sterile water was used as a solvent. No difference was observed between the two solvents, and the frequency of phlebitis for the total material without respect to solvents was 5% after 1 day of treatment and 13% after 2 days. Study II was a double-blind comparison of phlebitis caused by intravenous infusions of either flucloxacillin or cloxacillin. The frequencies of phlebitis were found to be 18 and 13%, respectively. After 2 days of treatment the frequency of phlebitis increased dramatically for both drugs. All infusions were given through a plastic cannula of 5-cm length and 1.2-mm diameter. PMID:7447412

  9. Blind Compressed Sensing Parameter Estimation of Non-cooperative Frequency Hopping Signal

    Directory of Open Access Journals (Sweden)

    Chen Ying

    2016-10-01

    Full Text Available To overcome the disadvantages of a non-cooperative frequency hopping communication system, such as a high sampling rate and inadequate prior information, parameter estimation based on Blind Compressed Sensing (BCS is proposed. The signal is precisely reconstructed by the alternating iteration of sparse coding and basis updating, and the hopping frequencies are directly estimated based on the results. Compared with conventional compressive sensing, blind compressed sensing does not require prior information of the frequency hopping signals; hence, it offers an effective solution to the inadequate prior information problem. In the proposed method, the signal is first modeled and then reconstructed by Orthonormal Block Diagonal Blind Compressed Sensing (OBD-BCS, and the hopping frequencies and hop period are finally estimated. The simulation results suggest that the proposed method can reconstruct and estimate the parameters of noncooperative frequency hopping signals with a low signal-to-noise ratio.

  10. Effect of short-term estrogen therapy on endothelial function: a double-blinded, randomized, controlled trial.

    Science.gov (United States)

    Hurtado, R; Celani, M; Geber, S

    2016-10-01

    To evaluate the effect of short-term hormone replacement therapy with 0.625 mg conjugated estrogens daily on endothelial function of healthy postmenopausal women, using flow-mediated dilation (FMD) of the brachial artery. We performed a double-blinded, randomized, controlled trial over 3 years. Randomization was performed using computer-generated sorting. All participants were blinded to the use of conjugated equine estrogens (CEE) or placebo and FMD was assessed by a blinded examiner, before and after 28 days of medication. A total of 64 healthy postmenopausal women were selected and randomly assigned into two groups of treatment: 0.625 mg of CEE or placebo. FMD values were statistically different between the groups (p = 0.025): the group receiving CEE showed a FMD value of 0.011 compared to the placebo group (FMD = -0.082). The two groups were additionally evaluated for homogeneity through the Shapiro-Wilk test in respect to variables that could interfere with endothelial function such as age (p = 0.729), body mass index (p = 0.891), and time since menopause (p = 0.724). Other variables were excluded during selection of the participants such as chronic vascular conditions, smoking, and sedentary lifestyle. Our results demonstrate that the administration of 0.625 mg CEE for 28 days is effective in improving vascular nitric oxide-dependent dilation assessed by FMD of the brachial artery in postmenopausal women. NCT01482416.

  11. Blindness and Insight in King Lear

    Institute of Scientific and Technical Information of China (English)

    岳元玉

    2008-01-01

    This paper intends to explore how William Shakespeare illustrates the theme of blindness and insight in his great tragedy "King Lear".Four characters’ deeds and their fate are used as a case study to examine what blindness is,what insight is,and the relationship between the two.The writer finds that by depicting the characters’ deeds and their fate in a double plot,Shakespeare renders the folly of blindness,the transition from blindness to insight,and the use of reason and thought to understand the truth.

  12. [Comparative double-blind study of Bi-Profenid and oxyphenbutazone in sports pathology].

    Science.gov (United States)

    Commandré, F A; Fornaris, E; Fourré, J M; Raybaud, A; Colonna, P; Pirdas, C

    1983-12-12

    Effectiveness and tolerance of ketoprofen in sustained-release tablets (Bi-Profenid 150 mg) were investigated in a double blind trial in 44 athletes who had recently sprained an ankle. Patients were given either 300 mg Bi-Profenid or 400 mg oxyphenbutazone daily for seven days. Treatment regimens were assigned at random. Results were assessed as excellent or good in 85% of patients given Bi-Profenid and 50% of those given oxyphenbutazone. Spontaneous pain resolved in 19 patients receiving Bi-Profenid and in 6 under oxyphenbutazone. Decrease in pain upon physical examination and in articular circumference was significantly greater with Bi-Profenid as compared with oxyphenbutazone. The chance of rapidly resuming sport was better with Bi-Profenid. Tolerance was excellent in 68.2% of patients with Bi-Profenid and 59% of those with oxyphenbutazone. This investigation thus emphasizes the value of Bi-Profenid in sport pathology.

  13. A double-blind study comparing ibuprofen 1800 mg or 2400 mg daily and placebo in sports injuries.

    Science.gov (United States)

    Hutson, M A

    1986-01-01

    In a double-blind, placebo-controlled study of forty-six patients with acute ligamentous damage of the knee, ibuprofen in dosages 1800 mg and 2400 mg produced significant improvements in joint mobility, weight bearing ability and match fitness. Joint effusion, pain on stress and pain severity was significantly improved by all three treatments. Only two patients reported side-effects (one while taking placebo and one taking ibuprofen 2400 mg). The study confirmed the efficacy and excellent tolerance to ibuprofen in patients with sports injuries to the knee.

  14. A multiple-dose, double-blind comparison of intramuscularly and orally administered ketorolac tromethamine and Ketogan in patients with pain following orthopaedic surgery

    DEFF Research Database (Denmark)

    Gebuhr, Peter Henrik; Soelberg, M; Strauss, W

    1994-01-01

    combination product containing the narcotic analgesic, ketobemidone, plus a spasmolytic agent) by intramuscular injection every 1-6 h as needed for pain. When patients were able to tolerate an oral diet and were expected to respond to oral analgesic medication, based on overall pain sensitivity, they were...... and at the end of each day. Both treatments were effective immediately after the first dose and during the subsequent multiple-dose phase. There were no statistically significant differences between ketorolac and Ketogan. The results show that 10-mg doses of ketorolac in intramuscular injections followed by 10......In this multiple-dose, double-blind study 100 patients with moderate, severe or very severe pain following orthopaedic surgery were randomly assigned to receive ketorolac, a non-steroidal anti-inflammatory drug with potent analgesic properties (10 mg), or the standard regimen of Ketogan (a...

  15. Small incision lenticule extraction (SMILE) versus laser in-situ keratomileusis (LASIK): study protocol for a randomized, non-inferiority trial.

    Science.gov (United States)

    Ang, Marcus; Tan, Donald; Mehta, Jodhbir S

    2012-05-31

    Small incision lenticule extraction or SMILE is a novel form of 'flapless' corneal refractive surgery that was adapted from refractive lenticule extraction (ReLEx). SMILE uses only one femtosecond laser to complete the refractive surgery, potentially reducing surgical time, side effects, and cost. If successful, SMILE could potentially replace the current, widely practiced laser in-situ keratomileusis or LASIK. The aim of this study is to evaluate whether SMILE is non-inferior to LASIK in terms of refractive outcomes at 3 months post-operatively. Single tertiary center, parallel group, single-masked, paired-eye design, non-inferiority, randomized controlled trial. Participants who are eligible for LASIK will be enrolled for study after informed consent. Each participant will be randomized to receive SMILE and LASIK in each eye. Our primary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> -3.00 diopter (D)) at a tertiary eye center in terms of refractive predictability at 3 months post-operatively. Our secondary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> -3.00 D) at a tertiary eye center in terms of other refractive outcomes (efficacy, safety, higher-order aberrations) at 3 months post-operatively. Our primary outcome is refractive predictability, which is one of several standard refractive outcomes, defined as the proportion of eyes achieving a postoperative spherical equivalent (SE) within ±0.50 D of the intended target. Randomization will be performed using random allocation sequence generated by a computer with no blocks or restrictions, and implemented by concealing the number-coded surgery within sealed envelopes until just before the procedure. In this single-masked trial, subjects and their caregivers will be masked to the assigned treatment in each eye. This novel

  16. Efficacy of trans abdominis plane block for post cesarean delivery analgesia: A double-blind, randomized trial

    Directory of Open Access Journals (Sweden)

    Uma Srivastava

    2015-01-01

    Full Text Available Background: The transverse abdominis plane (TAP block, a regional block provides effective analgesia after lower abdominal surgeries if used as part of multimodal analgesia. In this prospective, randomized double-blind study, we determined the efficacy of TAP block in patients undergoing cesarean section. Materials and Methods: Totally, 62 parturients undergoing cesarean section were randomized in a double-blind manner to receive either bilateral TAP block at the end of surgery with 20 ml of 0.25% bupivacaine or no TAP block, in addition to standard analgesic comprising 75 mg diclofenac 8 hourly and intravenous patient-controlled analgesia (PCA tramadol. Each patient was assessed at 0, 4, 8, 12, 24, 36, and 48 h after surgery by an independent observer for pain at rest and on movement using numeric rating scale of 0-10, time of 1 st demand for tramadol, total consumption of PCA tramadol, satisfaction with pain management and side effects. Results: Use of tramadol was reduced in patients given TAP block by 50% compared to patients given no block during 48 h after surgery (P < 0.001. Pain scores were lower both on rest and activity at each time point for 24 h in study group (P < 0.001, time of first analgesia was significantly longer, satisfaction was higher, and side effects were less in study group compared to control group. Conclusion: Transverse abdominis plane block was effective in providing analgesia with a substantial reduction in tramadol use during 48 h after cesarean section when used as adjunctive to standard analgesia.

  17. EFEKTIVITAS TEKNIK MANAJEMEN DIRI UNTUK MENGATASI INFERIORITY FEELING

    Directory of Open Access Journals (Sweden)

    Kartika

    2016-04-01

    Full Text Available Siswa yang memiliki inferiority feeling selalu memandang rendah kemampuan yang dimiliki oleh dirinya. Untuk menutupi harga dirinya yang lemah, mereka akan melakukan kompensasi dengan cara menarik diri, bersikap agresif, ataupun membuat alasan. Sebagai upaya mengatasi inferiority feeling adalah dengan mengimplementasikan konseling kelompok dengan teknik manajemen diri. Teknik ini lebih menekankan pada pengelolaan diri yang timbul dari keinginan diri siswa. Penelitian ini bertujuan untuk menguji efektivitas konseling kelompok dengan menggunakan teknik manajemen diri untuk mengatasi inferiority feeling. Pengambilan subyek penelitian dilakukan secara non random menggunakan teknik purposive sampling. Metode penelitian yang digunakan adalah kuasi eksperimen dengan desain non equivalent pretest posttest design. Hasil penelitian menunjukkan bahwa intervensi menggunakan teknik manajemen diri efektif untuk menurunkan inferiority feeling pada subyek penelitian. Rekomendasi: (a Konselor sekolah, melakukan pemantauan secara berkala kepada siswa yang telah menjalani intervensi untuk melihat pengaruh jangka panjang dari intervensi yang telah diberikan; (b bagi peneliti selanjutnya dapat melakukan penelitian dengan keterlibatan pihak keluarga ataupun sahabat sebagai pendukung dalam memperoleh data mengenai keadaan sesungguhnya yang dialami oleh konsel

  18. A Randomized Double-Blind Study of Atomoxetine versus Placebo for Attention-Deficit/Hyperactivity Disorder Symptoms in Children with Autism Spectrum Disorder

    Science.gov (United States)

    Harfterkamp, Myriam; van de Loo-Neus, Gigi; Minderaa, Ruud B.; van der Gaag, Rutger-Jan; Escobar, Rodrigo; Schacht, Alexander; Pamulapati, Sireesha; Buitelaar, Jan K.; Hoekstra, Pieter J.

    2012-01-01

    Objective: The efficacy of atomoxetine as treatment of symptoms of attention-deficit/hyperactivity disorder (ADHD) in patients with autism spectrum disorder (ASD) has not been established. Method: In this study, 97 patients aged 6 to 17 years with ADHD and ASD were randomly assigned to double-blind treatment with 1.2 mg/kg/day atomoxetine or…

  19. Evaluation of a weight-adjusted single-bolus plasminogen activator in patients with myocardial infarction - A double-blind, randomized angiographic trial of lanoteplase versus alteplase

    NARCIS (Netherlands)

    den Heijer, P; Vermeer, F; Ambrosioni, E; Sadowski, Z; Lopez-Sendon, JL; von Essen, R; Beaufils, P; Thadani, U; Adgey, J; Pierard, L; Brinker, J; Davies, RF; Smalling, RW; Wallentin, L; Caspi, A; Pangerl, A; Trickett, L; Hauck, C; Henry, D; Chew, P

    1998-01-01

    Background-Lanoteplase (nPA) is a rationally designed variant of tissue plasminogen activator with greater fibrinolytic potency and slower plasma clearance than alteplase. Methods and Results-InTIME (Intravenous nPA for Treatment of Infarcting Myocardium Early), a multicenter, double-blind,

  20. The right inferior frontal gyrus processes nested non-local dependencies in music.

    Science.gov (United States)

    Cheung, Vincent K M; Meyer, Lars; Friederici, Angela D; Koelsch, Stefan

    2018-02-28

    Complex auditory sequences known as music have often been described as hierarchically structured. This permits the existence of non-local dependencies, which relate elements of a sequence beyond their temporal sequential order. Previous studies in music have reported differential activity in the inferior frontal gyrus (IFG) when comparing regular and irregular chord-transitions based on theories in Western tonal harmony. However, it is unclear if the observed activity reflects the interpretation of hierarchical structure as the effects are confounded by local irregularity. Using functional magnetic resonance imaging (fMRI), we found that violations to non-local dependencies in nested sequences of three-tone musical motifs in musicians elicited increased activity in the right IFG. This is in contrast to similar studies in language which typically report the left IFG in processing grammatical syntax. Effects of increasing auditory working demands are moreover reflected by distributed activity in frontal and parietal regions. Our study therefore demonstrates the role of the right IFG in processing non-local dependencies in music, and suggests that hierarchical processing in different cognitive domains relies on similar mechanisms that are subserved by domain-selective neuronal subpopulations.

  1. The SNAP trial: a double blind multi-center randomized controlled trial of a silicon nitride versus a PEEK cage in transforaminal lumbar interbody fusion in patients with symptomatic degenerative lumbar disc disorders: study protocol

    Science.gov (United States)

    2014-01-01

    Background Polyetheretherketone (PEEK) cages have been widely used in the treatment of lumbar degenerative disc disorders, and show good clinical results. Still, complications such as subsidence and migration of the cage are frequently seen. A lack of osteointegration and fibrous tissues surrounding PEEK cages are held responsible. Ceramic implants made of silicon nitride show better biocompatible and osteoconductive qualities, and therefore are expected to lower complication rates and allow for better fusion. Purpose of this study is to show that fusion with the silicon nitride cage produces non-inferior results in outcome of the Roland Morris Disability Questionnaire at all follow-up time points as compared to the same procedure with PEEK cages. Methods/Design This study is designed as a double blind multi-center randomized controlled trial with repeated measures analysis. 100 patients (18–75 years) presenting with symptomatic lumbar degenerative disorders unresponsive to at least 6 months of conservative treatment are included. Patients will be randomly assigned to a PEEK cage or a silicon nitride cage, and will undergo a transforaminal lumbar interbody fusion with pedicle screw fixation. Primary outcome measure is the functional improvement measured by the Roland Morris Disability Questionnaire. Secondary outcome parameters are the VAS leg, VAS back, SF-36, Likert scale, neurological outcome and radiographic assessment of fusion. After 1 year the fusion rate will be measured by radiograms and CT. Follow-up will be continued for 2 years. Patients and clinical observers who will perform the follow-up visits will be blinded for type of cage used during follow-up. Analyses of radiograms and CT will be performed independently by two experienced radiologists. Discussion In this study a PEEK cage will be compared with a silicon nitride cage in the treatment of symptomatic degenerative lumbar disc disorders. To our knowledge, this is the first randomized controlled

  2. Immunogenicity and safety of three aluminium hydroxide adjuvanted vaccines with reduced doses of inactivated polio vaccine (IPV-Al) compared with standard IPV in young infants in the Dominican Republic: a phase 2, non-inferiority, observer-blinded, randomised, and controlled dose investigation trial.

    Science.gov (United States)

    Rivera, Luis; Pedersen, Rasmus S; Peña, Lourdes; Olsen, Klaus J; Andreasen, Lars V; Kromann, Ingrid; Nielsen, Pernille I; Sørensen, Charlotte; Dietrich, Jes; Bandyopadhyay, Ananda S; Thierry-Carstensen, Birgit

    2017-07-01

    Cost and supply constraints are key challenges in the use of inactivated polio vaccine (IPV). Dose reduction through adsorption to aluminium hydroxide (Al) is a promising option, and establishing its effectiveness in the target population is a crucial milestone in developing IPV-Al. The aim of this clinical trial was to show the non-inferiority of three IPV-Al vaccines to standard IPV. In this phase 2, non-inferiority, observer-blinded, randomised, controlled, single-centre trial in the Dominican Republic, healthy infants aged 6 weeks, not previously polio vaccinated, were allocated after computer-generated randomisation by block-size of four, to receive one of four IPV formulations (three-times reduced dose [1/3 IPV-Al], five-times reduced dose [1/5 IPV-Al], ten-times reduced dose [1/10 IPV-Al], or IPV) intramuscularly in the thigh at 6, 10, and 14 weeks of age. The primary outcome was seroconversion for poliovirus types 1, 2, and 3 with titres more than or equal to four-fold higher than the estimated maternal antibody titre and more than or equal to 8 after three vaccinations. Non-inferiority was concluded if the lower two-sided 90% CI of the seroconversion rate difference between IPV-Al and IPV was greater than -10%. The safety analyses were based on the safety analysis set (randomly assigned participants who received at least one trial vaccination) and the immunogenicity analyses were based on the per-protocol population. This study is registered with ClinicalTrials.gov registration, number NCT02347423. Between Feb 2, 2015, and Sept 26, 2015, we recruited 824 infants. The per-protocol population included 820 infants; 205 were randomly assigned to receive 1/3 IPV-Al, 205 to receive 1/5 IPV-Al, 204 to receive 1/10 IPV-Al, and 206 to receive IPV. The proportion of individuals meeting the primary endpoint of seroconversion for poliovirus types 1, 2, and 3 was already high for the three IPV-Al vaccines after two vaccinations, but was higher after three vaccinations

  3. Oats in the Diet of Children with Celiac Disease: Preliminary Results of a Double-Blind, Randomized, Placebo-Controlled Multicenter Italian Study

    Directory of Open Access Journals (Sweden)

    Simona Gatti

    2013-11-01

    Full Text Available A gluten-free diet (GFD is currently the only available treatment for patients with celiac disease (CD. Several clinical trials have demonstrated that most celiac patients can tolerate a medium-high quantity of oats without any negative clinical effects; however, the inclusion of oats in GFD is still a matter of debate. In this study, Italian children with CD were enrolled in a 15-month, randomized, double-blind, placebo-controlled multicenter trial. Participants were randomized in two groups following either A-B treatment (6 months of diet “A”, 3 months of standard GFD, 6 months of diet “B”, or B-A treatment (6 months of diet “B”, 3 months of standard GFD, 6 months of diet “A”. A and B diets included gluten-free (GF products (flour, pasta, biscuits, cakes and crisp toasts with either purified oats or placebo. Clinical data (Gastrointestinal Symptoms Rate Scale [GSRS] score and intestinal permeability tests (IPT, were measured through the study period. Although the study is still blinded, no significant differences were found in GSRS score or the urinary lactulose/mannitol (L/M ratio between the two groups after 6 months of treatment. These preliminary results suggest that the addition of non-contaminated oats from selected varieties in the treatment of children with CD does not determine changes in intestinal permeability and gastrointestinal symptoms.

  4. Does EEG-Neurofeedback Improve Neurocognitive Functioning in Children with Attention-Deficit/Hyperactivity Disorder? A Systematic Review and a Double-Blind Placebo-Controlled Study

    Science.gov (United States)

    Vollebregt, Madelon A.; van Dongen-Boomsma, Martine; Buitelaar, Jan K.; Slaats-Willemse, Dorine

    2014-01-01

    Background: The number of placebo-controlled randomized studies relating to EEG-neurofeedback and its effect on neurocognition in attention-deficient/hyperactivity disorder (ADHD) is limited. For this reason, a double blind, randomized, placebo-controlled study was designed to assess the effects of EEG-neurofeedback on neurocognitive functioning…

  5. Effectiveness of transcranial direct current stimulation preceding cognitive behavioural management for chronic low back pain: sham controlled double blinded randomised controlled trial.

    Science.gov (United States)

    Luedtke, Kerstin; Rushton, Alison; Wright, Christine; Jürgens, Tim; Polzer, Astrid; Mueller, Gerd; May, Arne

    2015-04-16

    To evaluate the effectiveness of transcranial direct current stimulation alone and in combination with cognitive behavioural management in patients with non-specific chronic low back pain. Double blind parallel group randomised controlled trial with six months' follow-up conducted May 2011-March 2013. Participants, physiotherapists, assessors, and analyses were blinded to group allocation. Interdisciplinary chronic pain centre. 135 participants with non-specific chronic low back pain >12 weeks were recruited from 225 patients assessed for eligibility. Participants were randomised to receive anodal (20 minutes to motor cortex at 2 mA) or sham transcranial direct current stimulation (identical electrode position, stimulator switched off after 30 seconds) for five consecutive days immediately before cognitive behavioural management (four week multidisciplinary programme of 80 hours). Two primary outcome measures of pain intensity (0-100 visual analogue scale) and disability (Oswestry disability index) were evaluated at two primary endpoints after stimulation and after cognitive behavioural management. Analyses of covariance with baseline values (pain or disability) as covariates showed that transcranial direct current stimulation was ineffective for the reduction of pain (difference between groups on visual analogue scale 1 mm (99% confidence interval -8.69 mm to 6.3 mm; P=0.68)) and disability (difference between groups 1 point (-1.73 to 1.98; P=0.86)) and did not influence the outcome of cognitive behavioural management (difference between group 3 mm (-10.32 mm to 6.73 mm); P=0.58; difference between groups on Oswestry disability index 0 point (-2.45 to 2.62); P=0.92). The stimulation was well tolerated with minimal transitory side effects. This results of this trial on the effectiveness of transcranial direct current stimulation for the reduction of pain and disability do not support its clinical use for managing non-specific chronic low back pain

  6. A Double-Blind, Placebo-Controlled Study of Risperidone for the Treatment of Adolescents and Young Adults with Anorexia Nervosa: A Pilot Study

    Science.gov (United States)

    Hagman, Jennifer; Gralla, Jane; Sigel, Eric; Ellert, Swan; Dodge, Mindy; Gardner, Rick; O'Lonergan, Teri; Frank, Guido; Wamboldt, Marianne Z.

    2011-01-01

    Objective: The purpose of this double-blind, placebo-controlled exploratory pilot study was to evaluate the safety and efficacy of risperidone for the treatment of anorexia nervosa. Method: Forty female subjects 12 to 21 years of age (mean, 16 years) with primary anorexia nervosa in an eating disorders program were randomized to receive…

  7. Transdiagnostic group CBT vs. standard group CBT for depression, social anxiety disorder and agoraphobia/panic disorder

    DEFF Research Database (Denmark)

    Arnfred, Sidse Marie Hemmingsen; Aharoni, Ruth; Pedersen, Morten Hvenegaard

    2017-01-01

    Background: Transdiagnostic Cognitive Behavior Therapy (TCBT) manuals delivered in individual format have been reported to be just as effective as traditional diagnosis specific CBT manuals. We have translated and modified the “The Unified Protocol for Transdiagnostic Treatment of Emotional...... Disorders” (UP-CBT) for group delivery in Mental Health Service (MHS), and shown effects comparable to traditional CBT in a naturalistic study. As the use of one manual instead of several diagnosis-specific manuals could simplify logistics, reduce waiting time, and increase therapist expertise compared...... to diagnosis specific CBT, we aim to test the relative efficacy of group UP-CBT and diagnosis specific group CBT. Methods/design: The study is a partially blinded, pragmatic, non-inferiority, parallel, multi-center randomized controlled trial (RCT) of UP-CBT vs diagnosis specific CBT for Unipolar Depression...

  8. Metoprolol and propranolol in essential tremor: a double-blind, controlled study.

    Science.gov (United States)

    Calzetti, S; Findley, L J; Gresty, M A; Perucca, E; Richens, A

    1981-01-01

    Single oral doses of propranolol (120 mg), metoprolol (150 mg) and placebo were given in a randomised, double-blind fashion to 23 patients with essential tremor. Both beta blockers were significantly more effective than placebo in reducing the magnitude of tremor. The decrease in tremor produced by metoprolol (47, sem 9%, n = 23) was not significantly different from that observed propranolol (55, sem 5%, n = 23). Tachycardia on standing was antagonised by both drugs to a similar extent. These findings suggest that metoprolol may represent a valuable alternative to propranolol in the treatment of essential tremor. The data is consistent with the hypothesis that the tremorolytic effect of beta blockers in these patients may be unrelated to peripheral beta-2 adreno-receptor blockade, being possibly mediated by other central or peripheral modes of action of these drugs. However, it cannot be excluded that at the dose used, metoprolol had lost its relative cardio-selectivity and that the reduction in tremor was mediated by competitive antagonism at beta-2 receptor sites in skeletal muscle. PMID:7031187

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

    NARCIS (Netherlands)

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

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

  10. Treatment of pain associated to knee osteoarthritis in the elderly: a randomized double-blind clinical trial with lysine clonixinate

    OpenAIRE

    Santos,Fânia Cristina; Souza,Polianna Mara Rodrigues de; Toniolo Neto,João; Atallah,Álvaro Nagib

    2011-01-01

    BACKGROUND AND OBJECTIVES: Osteoarthritis (OA) is the most common arthropathy and one of the major causes of chronic pain in the elderly population, which may lead to major functional incapacity of these individuals. Aiming at treating pain of elderly patients with knee OA, we have used lysine clonixinate (LC) and have evaluated its effectiveness METHOD: Randomized, double-blind, placebo-controlled clinical trial with 109 elderly patients with knee OA-related pain. Participants were distribut...

  11. A randomized double-blind, placebo-controlled efficacy and safety study of ALO-02 (extended-release oxycodone surrounding sequestered naltrexone) for moderate-to-severe chronic low back pain treatment.

    Science.gov (United States)

    Rauck, Richard L; Hale, Martin E; Bass, Almasa; Bramson, Candace; Pixton, Glenn; Wilson, Jacquelyn G; Setnik, Beatrice; Meisner, Paul; Sommerville, Kenneth W; Malhotra, Bimal K; Wolfram, Gernot

    2015-09-01

    The objective of this multicenter, double-blind, placebo-controlled, randomized withdrawal study was to evaluate the efficacy and safety of ALO-02, an abuse-deterrent formulation containing pellets of extended-release oxycodone hydrochloride (HCl) surrounding sequestered naltrexone HCl, compared with placebo in the treatment of moderate-to-severe chronic low back pain. An open-label titration period in which all patients received ALO-02 was followed by a double-blind treatment period where patients meeting treatment response criteria were randomized to either a fixed dose of ALO-02 or placebo. Daily average low back pain was assessed using an 11-point numeric rating scale (NRS)-Pain. Of the 663 patients screened, 410 received ALO-02 during the open-label conversion and titration period and 281 patients were randomized to the double-blind treatment period (n = 134, placebo; n = 147, ALO-02). Change in the mean NRS-Pain score from randomization baseline to the final 2 weeks of the treatment period was significantly different favoring ALO-02 compared with placebo (P = 0.0114). Forty-four percent of patients treated with placebo and 57.5% of patients treated with ALO-02 reported ≥30% improvement in weekly average NRS-Pain scores from screening to the final 2 weeks of the treatment period (P = 0.0248). In the double-blind treatment period, 56.8% of patients in the ALO-02 group and 56.0% of patients in the placebo group experienced a treatment-emergent adverse event (TEAE). The most common treatment-related TEAEs for ALO-02 during the treatment period were nausea, vomiting, and constipation, consistent with opioid therapy. ALO-02 has been demonstrated to provide significant reduction of pain in patients with chronic low back pain and has a safety profile similar to other opioids.

  12. Olanzapine plus dialectical behavior therapy for women with high irritability who meet criteria for borderline personality disorder: a double-blind, placebo-controlled pilot study.

    Science.gov (United States)

    Linehan, Marsha M; McDavid, Joshua D; Brown, Milton Z; Sayrs, Jennifer H R; Gallop, Robert J

    2008-06-01

    This double-blind study examined whether olanzapine augments the efficacy of dialectical behavior therapy (DBT) in reducing anger and hostility in borderline personality disorder patients. Twenty-four women with borderline personality disorder (DSM-IV criteria) and high levels of irritability and anger received 6 months of DBT. Subjects were randomly assigned to receive either low-dose olanzapine or placebo and were assessed with standardized measures in a double-blind manner. The study was conducted from September 2000 to December 2002. Intent-to-treat analyses indicated that both treatment conditions resulted in significant improvement in irritability, aggression, depression, and self-inflicted injury (p borderline personality disorder. Effect sizes were moderate to large, with the small sample size likely limiting the ability to detect significant results. Overall, there were large and consistent reductions in irritability, aggression, depression, and self-injury for both groups of subjects receiving DBT.

  13. A double-blind, placebo-controlled trial of sibutramine for clozapine-associated weight gain.

    Science.gov (United States)

    Henderson, D C; Fan, X; Copeland, P M; Borba, C P; Daley, T B; Nguyen, D D; Zhang, H; Hayden, D; Freudenreich, O; Cather, C; Evins, A E; Goff, D C

    2007-02-01

    This study sought to examine the effectiveness of sibutramine, a weight loss agent, on clozapine-associated weight gain. This was a 12-week double-blind, placebo controlled, randomized trial of sibutramine for weight loss in obese clozapine-treated schizophrenia or schizoaffective disorder subjects. Ten patients were enrolled into the placebo group and 11 patients into the sibutramine group. There were no significant baseline differences between the two groups on age, gender, education, ethnicity, diagnosis, weight, body mass index (BMI), and blood pressure. At week 12, there were no significant differences in changes in weight, BMI, abdominal and waist circumferences, Hba1c, fasting glucose, or cholesterol levels. Sibutramine treatment did not show significant weight loss compared with placebo in clozapine-treated patients with schizophrenia or schizoaffective disorder. Further research with a larger sample size and longer follow-up duration is warranted.

  14. [Stimulation of wound healing by tetrachlordecaoxide. Results of a randomized double-blind study].

    Science.gov (United States)

    Hinz, J; Hautzinger, H; Helling, J; Schirren, G; Sell, G; Stahl, K W; Kühne, F W

    1984-05-10

    In 38 patients with chronic therapeutically resistant wounds, which, in 25 cases, had been existing for more than one year, Tetrachlorodecaoxide ( TCDO ) in a water solution containing glycerin was analyzed for its capacity to induce wound healing and compared in this respect to the standard in moist wound treatment, physiological sodium chloride. The results of the clinical trial demonstrate that the TCDO solution is significantly superior to physiological saline in local wound treatment regarding the degree of wound smear reduction, the formation of wound granulation tissue, the stimulation of epithelisation on the wound borders and the shrinking of the wound surface. The differences in therapeutic efficiency are so large that, in spite of the relatively small patient samples (21 + 17) it was possible to verify the superiority of a method for wound treatment in a randomized double blind clinical trial.

  15. The effect of barusiban, a selective oxytocin antagonist, in threatened preterm labor at late gestational age: a randomized, double-blind, placebo-controlled trial

    DEFF Research Database (Denmark)

    Thornton, Steven; Goodwin, Thomas M; Greisen, Gorm

    2009-01-01

    OBJECTIVE: The objective of the study was to compare barusiban with placebo in threatened preterm labor. STUDY DESIGN: This was a randomized, double-blind, placebo-controlled, multicenter study. One hundred sixty-three women at 34-35 weeks plus 6 days, and with 6 or more contractions of 30 seconds...

  16. Randomised, Double Blind, Placebo-Controlled Trial of Echinacea Supplementation in Air Travellers

    Directory of Open Access Journals (Sweden)

    E. Tiralongo

    2012-01-01

    Full Text Available Objective. To identify whether a standardised Echinacea formulation is effective in the prevention of respiratory and other symptoms associated with long-haul flights. Methods. 175 adults participated in a randomised, double-blind placebo-controlled trial travelling back from Australia to America, Europe, or Africa for a period of 1–5 weeks on commercial flights via economy class. Participants took Echinacea (root extract, standardised to 4.4 mg alkylamides or placebo tablets. Participants were surveyed before, immediately after travel, and at 4 weeks after travel regarding upper respiratory symptoms and travel-related quality of life. Results. Respiratory symptoms for both groups increased significantly during travel (P<0.0005. However, the Echinacea group had borderline significantly lower respiratory symptom scores compared to placebo (P=0.05 during travel. Conclusions. Supplementation with standardised Echinacea tablets, if taken before and during travel, may have preventive effects against the development of respiratory symptoms during travel involving long-haul flights.

  17. Double-Blind Randomized Clinical Trial: Gluten versus Placebo Rechallenge in Patients with Lymphocytic Enteritis and Suspected Celiac Disease.

    Directory of Open Access Journals (Sweden)

    Mercè Rosinach

    Full Text Available The role of gluten as a trigger of symptoms in non-coeliac gluten sensitivity has been questioned.To demonstrate that gluten is the trigger of symptoms in a subgroup of patients fulfilling the diagnostic criteria for non-coeliac gluten sensitivity (NCGS, which presented with lymphocytic enteritis, positive celiac genetics and negative celiac serology.Double-blind randomized clinical trial of gluten vs placebo rechallenge.>18 years of age, HLA-DQ2/8+, negative coeliac serology and gluten-dependent lymphocytic enteritis, and GI symptoms, with clinical and histological remission at inclusion. Eighteen patients were randomised: 11 gluten (20 g/day and 7 placebo. Clinical symptoms, quality of life (GIQLI, and presence of gamma/delta+ cells and transglutaminase deposits were evaluated.91% of patients had clinical relapse during gluten challenge versus 28.5% after placebo (p = 0.01. Clinical scores and GIQLI worsened after gluten but not after placebo (p<0.01. The presence of coeliac tissue markers at baseline biopsy on a gluten-free diet allowed classifying 9 out of the 18 (50% patients as having probable 'coeliac lite' disease.This proof-of-concept study indicates that gluten is the trigger of symptoms in a subgroup of patients fulfilling the diagnostic criteria for NCGS. They were characterized by positive celiac genetics, lymphocytic enteritis, and clinical and histological remission after a gluten-free diet.ClinicalTrials.gov NCT02472704.

  18. Evaluation of a fixed-dose combination of benazepril and pimobendan in dogs with congestive heart failure: a randomized non-inferiority clinical trial.

    Science.gov (United States)

    King, Jonathan N; Hirakawa, Atsushi; Sonobe, Junko; Otaki, Hiroshi; Sakakibara, Nobuhiro; Seewald, Wolfgang; Forster, Sophie

    2018-01-31

    A fixed-dose combination tablet of benazepril and pimobendan (Fortekor Plus; Elanco Animal Health) was tested in dogs with congestive heart failure (CHF) caused by myxomatous mitral valve disease (MMVD) in a three-arm, masked, randomized, non-inferiority clinical trial in Japan. The test group (n = 34) received Fortekor Plus twice daily. Two control groups received registered formulations of benazepril (Fortekor; Elanco Animal Health) and pimobendan (Vetmedin; Boehringer Ingelheim Vetmedica) with administration of Vetmedin twice daily and Fortekor twice (Control I, n = 14) or once (Control II, n = 19) daily. Diuretics were used in 22 dogs (32.8%). Global clinical scores decreased significantly from baseline in all groups; there were no significant differences between groups, and non-inferiority of Fortekor Plus compared to Control I, Control II, and combined Control I + II groups was demonstrated. There were no significant differences between groups for relevant clinical chemistry and hematology variables or frequency of all adverse events. Frequency of emesis was significantly ( p = 0.0042) lower in the Fortekor Plus (8.8%) group than in the Control I + II (39.4%) group. In conclusion, Fortekor Plus had non-inferior efficacy and was associated with significantly less emesis compared to Fortekor and Vetmedin in dogs with CHF caused by MMVD.

  19. Lysine clonixinate in minor dental surgery: double-blind randomized parallel study versus paracetamol.

    Science.gov (United States)

    Martí, M L; De los Santos, A R; Di Girolamo, G; Gil, M; Manero, E O; Fraga, C

    1993-01-01

    Lysine clonixinate (LC), an effective and well tolerated non-morphinic analgesic whose mechanism of action is basically due to the inhibition of cyclo-oxygenase, was assessed with a double-blind randomized dummy design versus paracetamol (P) on 200 patients suffering from pain after minor dental surgery. Patients received according to their needs 1 or 2 tablets of 125 mg lysine clonixinate or 500 mg paracetamol every 8 h during 48 h or until pain relief. Both groups, each composed of 100 patients, were comparable in terms of demographic conditions (t test), initial symptoms (chi-square test), characteristics of the extracted dental pieces, surgical complications and wound treatment (chi-square test). Pain intensity scores and daily average intake of tablets (3.4/day) documented in the patients' diary revealed no statistically significant differences between the two treatments (chi-square test). It was found that spontaneous pain measured using a visual analogue scale (VAS) decreased significantly in both treatment groups at the 24-h control examination. The following values were observed in the LC group: baseline 4.38 +/- 1.7; 24-h * 1.20 +/- 1.4; 48-h * 0.36 +/- 1.2. In the P group the values were: baseline 4.28 +/- 1.6; 24-h * 1.11 +/- 1.4; 48-h * 0.30 +/- 0.7 (*p < 0.05). Other variables like facial swelling and night pain, evaluated on a score from 0 to 4 and symptom presence or absence respectively, showed a similar response.(ABSTRACT TRUNCATED AT 250 WORDS)

  20. A Double-Blind, Randomized, Placebo-Controlled Trial of Divalproex Extended-Release in the Treatment of Bipolar Disorder in Children and Adolescents

    Science.gov (United States)

    Wagner, Karen Dineen; Redden, Laura; Kowatch, Robert A.; Wilens, Timothy E.; Segal, Scott; Chang, Kiki; Wozniak, Patricia; Vigna, Namita V.; Abi-Saab, Walid; Saltarelli, Mario

    2009-01-01

    A double-blind study that involves 150 patients aged 10-17 on the effect of divalproex extended-release in the treatment of bipolar disorder shows that the drug was similar to placebo based on adverse events and that no treatment effect was observed in the drug. The drug is not suitable for treatment of youths with bipolar I disorder, mixed or…

  1. Effect of levodopa in combination with physiotherapy on functional motor recovery after stroke: a prospective, randomised, double-blind study.

    Science.gov (United States)

    Scheidtmann, K; Fries, W; Müller, F; Koenig, E

    2001-09-08

    Functional disability is generally caused by hemiplegia after stroke. Physiotherapy used to be the only way of improving motor function in such patients. However, administration of amphetamines in addition to exercise improves motor recovery in animals, probably by increasing the concentration of norepinephrine in the central nervous system. Our aim was to ascertain whether levodopa could enhance the efficacy of physiotherapy after hemiplegia. We did a prospective, randomised, placebo-controlled, double-blind study in which we enrolled 53 primary stroke patients. For the first 3 weeks patients received single doses of levodopa 100 mg or placebo daily in combination with physiotherapy. For the second 3 weeks patients had only physiotherapy. We quantitatively assessed motor function every week with Rivermead motor assessment (RMA). Six patients were excluded from analyses because of non-neurological complications. Motor recovery was significantly improved after 3 weeks of drug intervention in those on levodopa (RMA improved by 6.4 points) compared with placebo (4.1), and the result was independent of initial degree of impairment (pstroke rehabilitation.

  2. Laser therapy for onychomycosis in patients with diabetes at risk for foot complications : study protocol for a randomized, double-blind, controlled trial (LASER-1)

    NARCIS (Netherlands)

    Nijenhuis-Rosien, Leonie; Kleefstra, Nanne; Wolfhagen, Maurice J.; Groenier, Klaas H.; Bilo, Henk J. G.; Landman, Gijs W. D.

    2015-01-01

    Background: In a sham-controlled double-blind trial, we aim to establish the efficacy and safety of the local application of laser therapy in patients with diabetes, onychomycosis and risk factors for diabetes-related foot complications. Onychomycosis leads to thickened and distorted nails, which in

  3. A multicenter, longitudinal, interventional, double blind randomized clinical trial in hematopoietic cell transplant recipients residing in remote areas: Lessons learned from the late cytomegalovirus prevention trial

    Directory of Open Access Journals (Sweden)

    Louise E. Kimball

    2016-12-01

    Conclusion: Complex randomized, double-blind, multicenter interventional trials with treatment decisions made at a central coordinating site can be conducted safely and effectively according to Good Clinical Practice (GCP guidelines over a large geographic area.

  4. Efficacy of articaine versus lidocaine as a supplemental buccal infiltration in mandibular molars with irreversible pulpitis: a prospective, randomized, double-blind study.

    Science.gov (United States)

    Rogers, Brandon S; Botero, Tatiana M; McDonald, Neville J; Gardner, Richard J; Peters, Mathilde C

    2014-06-01

    Profound pulpal anesthesia in mandibular molars with irreversible pulpitis (IP) is often difficult to obtain and often requires supplemental injections after an ineffective inferior alveolar nerve block (IANB). The purpose of this prospective, randomized, double-blind study was to compare the efficacy of 4% articaine with 2% lidocaine for supplemental buccal infiltrations (BIs) after an ineffective IANB in mandibular molars with IP. In addition, the use of articaine for IANB and intraosseous injections was investigated. One hundred emergency patients diagnosed with IP of a mandibular molar were selected and received an IANB with 4% articaine. All injections were 1.7 mL with 1:100,000 epinephrine. All patients reported profound lip numbness after IANB. Patients with ineffective IANB (positive pulpal response to cold or pain on access) randomly received 4% articaine or 2% lidocaine as a supplemental BI. Endodontic access was initiated 5 minutes after deposition of the infiltration solution. Success was defined as no pain or no more than mild pain during endodontic access and instrumentation as measured on a visual analogue scale. Seventy-four patients failed to achieve pulpal anesthesia after IANB with 4% articaine, resulting in IANB success rate of 26%. Success rates for supplemental BIs were 62% for articaine and 37% for lidocaine (P < .05). This effect was most pronounced in second molars (P < .05). Supplemental BI with articaine was significantly more effective than lidocaine. The IANB success rate of 4% articaine confirmed published data. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  5. A multicenter, randomized, double-blind, placebo-controlled, 6-month trial of bupropion hydrochloride sustained-release tablets as an aid to smoking cessation in hospital employees

    DEFF Research Database (Denmark)

    Dalsgareth, Oli Jacob; Hansen, Niels-Christian Gerner; Søes-Petersen, Ulrik

    2004-01-01

    Despite changes in smoking behavior, one-third of the Danish population continues to smoke. Many of these smokers are hospital employees. This 6-month, multicenter, parallel group, randomized, double-blind, placebo-controlled study evaluated treatment with bupropion hydrochloride sustained release...

  6. The angiotensin II receptor antagonist telmisartan reduces urinary albumin excretion in patients with isolated systolic hypertension: results of a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Vogt, Liffert; Navis, Gerjan; Koester, Juergen; Manolis, Athanasios J.; Reid, John L.; de Zeeuw, Dick

    2005-01-01

    Objective To examine the effect of telmisartan or hydrochlorothiazide on the control of urinary albumin excretion (UAE) in patients with isolated systolic hypertension (ISH) unselected for albuminuria in a pre-planned substudy of a large, multicentre, double-blind, placebo-controlled, randomized

  7. Successful Reach and Adoption of a workplace health promotion RCT targeting a group of high-risk workers

    Directory of Open Access Journals (Sweden)

    Ekner Dorte

    2010-06-01

    Full Text Available Abstract Background Cleaners are rarely introduced to workplace health promotion programs. The study's objective was to evaluate the reach and adoption of a workplace randomized controlled trial (RCT among cleaners in Denmark. Methods Cleaning businesses with at least 30 employees, that could offer a weekly 1-hour intervention during working hours, were invited to participate. Employees working at least 20 hours/week were invited to answer a screening questionnaire and consent to participate. Analyses determined the differences in health variables between responders and non-responders, consenters and non-consenters, participants and non-participants and between participants of the RCT's three groups: physical coordination training, cognitive-behavioural theory-based training and reference group. Results From 16 eligible workplaces, a representative sample of 50% adopted the trial. Of 758 eligible employees, 78% responded to the screening questionnaire and 49% consented to participate. Consenters and participants differed from non-consenters and non-participants by having higher BMI, more chronic diseases and poorer musculoskeletal health. Conclusions This study indicates that workplace health promotion programs directed at health risk factors among cleaners enable significant adoption and reach to a high-risk subgroup of the Danish workforce. Trial registration Trial registration ISRCTN96241850

  8. Adjuvant sunitinib or sorafenib for high-risk, non-metastatic renal-cell carcinoma (ECOG-ACRIN E2805): a double-blind, placebo-controlled, randomised, phase 3 trial

    Science.gov (United States)

    Haas, Naomi B; Manola, Judith; Uzzo, Robert G; Flaherty, Keith T; Wood, Christopher G; Kane, Christopher; Jewett, Michael; Dutcher, Janice P; Atkins, Michael B; Pins, Michael; Wilding, George; Cella, David; Wagner, Lynne; Matin, Surena; Kuzel, Timothy M; Sexton, Wade J; Wong, Yu-Ning; Choueiri, Toni K; Pili, Roberto; Puzanov, Igor; Kohli, Manish; Stadler, Walter; Carducci, Michael; Coomes, Robert; DiPaola, Robert S

    2016-01-01

    Summary Background Renal-cell carcinoma is highly vascular, and proliferates primarily through dysregulation of the vascular endothelial growth factor (VEGF) pathway. We tested sunitinib and sorafenib, two oral anti-angiogenic agents that are effective in advanced renal-cell carcinoma, in patients with resected local disease at high risk for recurrence. Methods In this double-blind, placebo-controlled, randomised, phase 3 trial, we enrolled patients at 226 study centres in the USA and Canada. Eligible patients had pathological stage high-grade T1b or greater with completely resected non-metastatic renal-cell carcinoma and adequate cardiac, renal, and hepatic function. Patients were stratified by recurrence risk, histology, Eastern Cooperative Oncology Group (ECOG) performance status, and surgical approach, and computerised double-blind randomisation was done centrally with permuted blocks. Patients were randomly assigned (1:1:1) to receive 54 weeks of sunitinib 50 mg per day orally throughout the first 4 weeks of each 6 week cycle, sorafenib 400 mg twice per day orally throughout each cycle, or placebo. Placebo could be sunitinib placebo given continuously for 4 weeks of every 6 week cycle or sorafenib placebo given twice per day throughout the study. The primary objective was to compare disease-free survival between each experimental group and placebo in the intention-to-treat population. All treated patients with at least one follow-up assessment were included in the safety analysis. This trial is registered with ClinicalTrials.gov, number NCT00326898. Findings Between April 24, 2006, and Sept 1, 2010, 1943 patients from the National Clinical Trials Network were randomly assigned to sunitinib (n=647), sorafenib (n=649), or placebo (n=647). Following high rates of toxicity-related discontinuation after 1323 patients had enrolled (treatment discontinued by 193 [44%] of 438 patients on sunitinib, 199 [45%] of 441 patients on sorafenib), the starting dose of each

  9. Reconstruction of Double-Exposed Terahertz Hologram of Non-isolated Object

    Science.gov (United States)

    Hu, Jiaqi; Li, Qi; Chen, Guanghao

    2016-04-01

    When the non-isolated imaging objects are complex or critical imaging precision is required, single-exposure digital hologram technique may be insufficient. So in this paper, double-exposure method is adopted in 2.52-THz inline digital holography simulations and experiments. Experimental results indicate that, compared with the results reconstructed by single-exposure amplitude-constrained phase retrieval algorithm (S-APRA), double-exposure phase-constrained phase retrieval algorithm (D-PPRA) increases the contrast of the reconstruction image by 0.146 and double-exposure amplitude-constrained phase retrieval algorithm (D-APRA) increases the contrast by 0.225. In addition, when applied to non-isolated object reconstruction, phase retrieval algorithms with only amplitude constraint on the object plane work better than those with both amplitude and phase constraints.

  10. Bee venom acupuncture for the treatment of chronic low back pain: study protocol for a randomized, double-blinded, sham-controlled trial

    Directory of Open Access Journals (Sweden)

    Seo Byung-Kwan

    2013-01-01

    Full Text Available Abstract Background Chronic non-specific low back pain is the most common medical problem for which patients seek complementary and alternative medical treatment, including bee venom acupuncture. However, the effectiveness and safety of such treatments have not been fully established by randomized clinical trials. The aim of this study is to determine whether bee venom acupuncture is effective for improving pain intensity, functional status and quality of life of patients with chronic non-specific low back pain. Methods/design This study is a randomized, double-blinded, sham-controlled clinical trial with two parallel arms. Fifty-four patients between 18 and 65 years of age with non-radicular chronic low back pain experiencing low back pain lasting for at least the previous three months and ≥4 points on a 10-cm visual analog scale for bothersomeness at the time of screening will be included in the study. Participants will be randomly allocated into the real or sham bee venom acupuncture groups and treated by the same protocol to minimize non-specific and placebo effects. Patients, assessors, acupuncturists and researchers who prepare the real or sham bee venom acupuncture experiments will be blinded to group allocation. All procedures, including the bee venom acupuncture increment protocol administered into predefined acupoints, are designed by a process of consensus with experts and previous researchers according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture. Bothersomeness measured using a visual analogue scale will be the primary outcome. Back pain-related dysfunction, pain, quality of life, depressive symptoms and adverse experiences will be measured using the visual analogue scale for pain intensity, the Oswestry Disability Index, the EuroQol 5-Dimension, and the Beck’s Depression Inventory. These measures will be recorded at baseline and 1, 2, 3, 4, 8 and 12 weeks. Discussion The results from this study

  11. Photon induced non-linear quantized double layer charging in quaternary semiconducting quantum dots.

    Science.gov (United States)

    Nair, Vishnu; Ananthoju, Balakrishna; Mohapatra, Jeotikanta; Aslam, M

    2018-03-15

    Room temperature quantized double layer charging was observed in 2 nm Cu 2 ZnSnS 4 (CZTS) quantum dots. In addition to this we observed a distinct non-linearity in the quantized double layer charging arising from UV light modulation of double layer. UV light irradiation resulted in a 26% increase in the integral capacitance at the semiconductor-dielectric (CZTS-oleylamine) interface of the quantum dot without any change in its core size suggesting that the cause be photocapacitive. The increasing charge separation at the semiconductor-dielectric interface due to highly stable and mobile photogenerated carriers cause larger electrostatic forces between the quantum dot and electrolyte leading to an enhanced double layer. This idea was supported by a decrease in the differential capacitance possible due to an enhanced double layer. Furthermore the UV illumination enhanced double layer gives us an AC excitation dependent differential double layer capacitance which confirms that the charging process is non-linear. This ultimately illustrates the utility of a colloidal quantum dot-electrolyte interface as a non-linear photocapacitor. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. Effectiveness and Safety of Transdermal Buprenorphine Versus Sustained-release Tramadol in Patients With Moderate to Severe Musculoskeletal Pain: An 8-Week, Randomized, Double-Blind, Double-Dummy, Multicenter, Active-controlled, Noninferiority Study.

    Science.gov (United States)

    Leng, Xiaomei; Li, Zhanguo; Lv, Houshan; Zheng, Yi; Liu, Yi; Dai, Kerong; Yao, Chen; Yan, Xiaoyan; Zeng, Xiaofeng

    2015-07-01

    The aim of this noninferiority study was to investigate clinical effectiveness and safety of buprenorphine transdermal system (BTDS) in patients with moderate to severe musculoskeletal pain inadequately controlled with nonsteroidal anti-inflammatory drugs, compared with sustained-release tramadol tablets. Eligible patients were randomized (1:1) to receive low-dose 7-day BTDS (5, 10, and 20 μg/h, maximum dosage of 20 μg/h) or sustained-release tramadol tablets (100 mg, maximum dosage of 400 mg/d) over an 8-week double-blind treatment period (3-week titration, 5-week maintenance). The primary endpoint was the difference in the visual analogue scale (VAS) pain scores from baseline to treatment completion. Noninferiority was assumed if the treatment difference on the VAS scale was within ±1.5 cm, this threshold indicating a clinically meaningful result. ClinicalTrials.gov identifier: NCT01476774. Two hundred eighty patients were randomized to BTDS (n=141) or to tramadol (n=139). Both treatments were associated with a significant reduction in pain by the end of the treatment. The least squares mean difference of the change from baseline in VAS scores between the BTDS and tramadol groups were 0.45 (95% confidence interval, -0.02 to 0.91), which was within the ±1.5 cm predefined threshold, indicating that the effectiveness of BTDS was not inferior to the effectiveness of sustained-release tramadol tablets. The incidence of adverse events was comparable between the 2 treatment groups. Our results suggest that BTDS is a good therapeutic option for patients experiencing chronic musculoskeletal pain of moderate to severe intensity that is insufficiently controlled by nonsteroidal anti-inflammatory drugs.

  13. Evaluation of intralesional injection of hyaluronic acid compared with verapamil in Peyronie's disease: preliminary results from a prospective, double-blinded, randomized study.

    Science.gov (United States)

    Favilla, V; Russo, G I; Zucchi, A; Siracusa, G; Privitera, S; Cimino, S; Madonia, M; Cai, T; Cavallini, G; Liguori, G; D'Achille, G; Silvani, M; Franco, G; Verze, P; Palmieri, A; Torrisi, B; Mirone, V; Morgia, G

    2017-07-01

    Several intralesional therapeutic protocols have been proposed for the treatment of Peyronie's disease. Among all, hyaluronic acid (HA) and verapamil have been differently tested. We aimed to evaluate the efficacy of intralesional verapamil (ILVI) compared with intralesional HA in patients with early onset of Peyronie's disease (PD). This is a multi-centre prospective double-arm, randomized, double-blinded study comparing ILVI vs. intralesional HA after 12-weeks. Sexually active men, older than 18 years and affected by the acute phase of PD were eligible for this study. Patients have been double-blinded randomly divided into two groups (1 : 1 ratio): Group A received intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks, while group B received intralesional treatment with HA (0.8% highly purified sodium salt HA 16 mg/2 mL) weekly for 12 weeks. The primary efficacy outcome was the change from the baseline to the endpoint (12 weeks after therapy) for the penile curvature (degree). The secondary outcome was the change in the plaque size and in the International Index of erectile Function (IIEF-5) score. The difference between post- and pre-treatment plaque size was -1.36 mm (SD ± 1.27) for Group A and -1.80 mm (SD ± 2.47) for Group B (p-value = NS). IIEF-5 increased of 1.46 points (SD ± 2.18) in Group A and 1.78 (SD ± 2.48) in Group B (p-value ± NS). No difference in penile curvature was observed in Group A, while in Group B the penile curvature decreased of 4.60° (SD ± 5.63) from the baseline (p < 0.001) and vs. Group A. According to PGI-I results, we found significant difference as concerning patient global impression of improvement (PGI-I) (4.0 vs. 2.0; p < 0.05). This prospective, double-arm, randomized, double-blinded study comparing ILVI vs. HA as intralesional therapy showed greater efficacy of HA in terms of penile curvature and PGI-I. © 2017 American Society of Andrology and

  14. Memantine (a N-Methyl-D-aspartate receptor antagonist) in the treatment of neuropathic pain after amputation or surgery: A randomised, double-blinded, crossover study

    DEFF Research Database (Denmark)

    Nikolajsen, Lone; Gottrup, Hanne; Kristensen, Anders Due

    2000-01-01

    Evidence has accumulated that the N:-methyl-D-aspartate receptor system plays a role in continuous and particularly, in stimulus-evoked pain after nerve injury. We examined, in a randomized, double-blinded, cross-over fashion, the analgesic effect of memantine (a N:-methyl-D-aspartate receptor an...

  15. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study.

    Science.gov (United States)

    Ennis, William J; Foremann, Phil; Mozen, Neal; Massey, Joi; Conner-Kerr, Teresa; Meneses, Patricio

    2005-08-01

    An estimated 15% of patients with diabetes will develop a foot ulcer sometime in their life, making them 30 to 40 times more likely to undergo amputation due to a non-healing foot ulcer than the non-diabetic population. To determine the safety and efficacy of a new, non-contact, kilohertz ultrasound therapy for the healing of recalcitrant diabetic foot ulcers - as well as to evaluate the impact on total closure and quantitative bacterial cultures and the effect on healing of various levels of sharp/surgical debridement - a randomized, double-blinded, sham-controlled, multicenter study was conducted in hospital-based and private wound care clinics. Patients (55 met criteria for efficacy analysis) received standard of care, which included products that provide a moist environment, offloading diabetic shoes and socks, debridement, wound evaluation, and measurement. The "therapy" was either active 40 KHz ultrasound delivered by a saline mist or a "sham device" which delivered a saline mist without the use of ultrasound. After 12 weeks of care, the proportion of wounds healed (defined as complete epithelialization without drainage) in the active ultrasound therapy device group was significantly higher than that in the sham control group (40.7% versus 14.3%, P = 0.0366, Fisher's exact test). The ultrasound treatment was easy to use and no difference in the number and type of adverse events between the two treatment groups was noted. Of interest, wounds were debrided at baseline followed by a quantitative culture biopsy. The results of these cultures demonstrated a significant bioburden (greater than 10(5)) in the majority of cases, despite a lack of clinical signs of infection. Compared to control, this therapeutic modality was found to increase the healing rate of recalcitrant, diabetic foot ulcers.

  16. Side-effects in ascending cervical myelography using iopamidol and metrizamide - a double blind study

    International Nuclear Information System (INIS)

    Bockenheimer, S.; Eichenlaub, H.

    1986-01-01

    A double blind study was performed to examine the side-effects of Metrizamide (group 1) and of Jopamidol (group 2) in ascending cervical myelography. Both groups were compared to a control group (group 3) comprising patients who had undergone lumbar puncture only. EEG was taken of the patients in groups 1 and 2 before as well as 6 and 24 h after intervention. Side-effects were collected by means of a questionnaire. Response time, concentration, memory and mood were examined psychometrically. Training effects or defensive attitudes in the multiple test examinations were checked against another control group of patients (group 4) which had no myelographic nor lumbar-puncture-induced impairment. Statistical findings corroborated our clinical impression that side-effects occurred after Metrizamide administration at a more than simply random rate. (orig.) [de

  17. Synthetic food colourings and 'hyperactivity': a double-blind crossover study.

    Science.gov (United States)

    Rowe, K S

    1988-04-01

    Of 220 children referred for suspected 'hyperactivity', 55 were subjected to a 6 week trial of the Feingold diet. Forty (72.7%) demonstrated improved behaviour and 26 (47.3%) remained improved following liberalization of the diet over a period of 3-6 months. The parents of 14 children claimed that a particular cluster of behaviours was associated with the ingestion of foods containing synthetic colourings. A double-blind crossover study, employing a single-subject repeated measures design was conducted, using eight of these children. Subjects were maintained on a diet free from synthetic additives and were challenged daily for 18 weeks with either placebo (during lead-in and washout periods) or 50 mg of either tartrazine or carmoisine, each for 2 separate weeks. Two significant reactors were identified whose behavioural pattern featured extreme irritability, restlessness and sleep disturbance. One of the reactors did not have inattention as a feature. The findings raise the issue of whether the strict criteria for inclusion in studies concerned with 'hyperactivity' based on 'attention deficit disorder' may miss children who indicate behavioural changes associated with the ingestion of food colourings. Moreover, for further studies, the need to construct a behavioural rating instrument specifically validated for dye challenge is suggested.

  18. Non-visual Interfaces and Network Games for Blind Users

    OpenAIRE

    Ina, Satoshi

    2002-01-01

    Visually impaired people have difficulty with communication of graphical information. It is to be more difficult for them to work/play in cooperation with sighted people at a distance. We developed a non-visual access method to a graphical screen through tactile and auditory sense, and applied it into network board/card games as a joint workspace for blind and sighted users via communication of image, sound, and voice. We took an "IGO" type boardgame and a Card game "SEVENS" as sample subject...

  19. The angiotensin II receptor antagonist telmisartan reduces urinary albumin excretion in patients with isolated systolic hypertension: results of a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Vogt, Liffert; Navis, Gerjan; Köster, Jürgen; Manolis, Athanasios J.; Reid, John L.; de Zeeuw, Dick

    2005-01-01

    To examine the effect of telmisartan or hydrochlorothiazide on the control of urinary albumin excretion (UAE) in patients with isolated systolic hypertension (ISH) unselected for albuminuria in a pre-planned substudy of a large, multicentre, double-blind, placebo-controlled, randomized study. The

  20. Effects of influenza plus pneumococcal conjugate vaccination versus influenza vaccination alone in preventing respiratory tract infections in children : a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Jansen, Angelique G S C; Sanders, Elisabeth A M; Hoes, Arno W; van Loon, Anton M; Hak, Eelko

    2008-01-01

    OBJECTIVE: To evaluate the effects of influenza vaccination with or without heptavalent pneumococcal conjugate vaccination on respiratory tract infections (RTIs) in children. STUDY DESIGN: This was a randomized, double-blind, placebo-controlled trial comprising 579 children age 18 to 72 months with

  1. Combined therapy with levothyroxine and liothyronine in two ratios, compared with levothyroxine monotherapy in primary hypothyroidism: a double-blind, randomized, controlled clinical trial

    NARCIS (Netherlands)

    Appelhof, Bente C.; Fliers, Eric; Wekking, Ellie M.; Schene, Aart H.; Huyser, Jochanan; Tijssen, Jan G. P.; Endert, Erik; van Weert, Henk C. P. M.; Wiersinga, Wilmar M.

    2005-01-01

    Controversy remains about the value of combined treatment with levothyroxine (LT4) and liothyronine (LT3), compared with LT4 alone in primary hypothyroidism. We compared combined treatment with LT4 and LT3 in a ratio of 5: 1 or 10: 1 with LT4 monotherapy. We conducted a double-blind, randomized,

  2. Red Flags Are Missed in the Prevention of Hip Fractures: Baseline Results of the Zurich Hip Fracture Trial

    Science.gov (United States)

    From January 2005 to December 2007, we recruited 173 patients age 65 and older with acute hip fracture and a Folstein mini mental score of at least 15 into an ongoing double-blind RCT with vitamin D. 69% of hip fracture patients were admitted from home and 31% from institutions, 79% were women. Mean...

  3. Results of 2-year vitamin B treatment on cognitive performance Secondary data from an RCT

    NARCIS (Netherlands)

    van der Zwaluw, N.L.; Dhonukshe-Rutten, R.A.M.; van Wijngaarden, J.P.; Brouwer-Brolsma, E.M.; van de Rest, O.; 't Veld, P.H.I.; Enneman, A.W.; van Dijk, S.C.; van der Ham, A.C.; Swart, K.M.A.; van der Velde, N.; van Schoor, N.M.; van der Cammen, T.J.M.; Uitterlinden, A. G.; Lips, P.T.A.M.; Kessels, R.P.C.; de Groot, L.C.P.G.

    2014-01-01

    Objective: We investigated the effects of 2-year folic acid and vitamin B12 supplementation on cognitive performance in elderly people with elevated homocysteine (Hcy) levels. Methods: This multicenter, double-blind, randomized, placebo-controlled trial included 2,919 elderly participants (65 years

  4. Results of 2-year vitamin B treatment on cognitive performance Secondary data from an RCT

    NARCIS (Netherlands)

    Zwaluw, N.L. van der; Dhonukshe-Rutten, R.A.M.; Wijngaarden, J.P. van; Brouwer-Brolsma, E.M.; Rest, O. van de; Veld, P.H. in 't; Enneman, A.W.; Dijk, S.C. van; Ham, A.C.; Swart, K.M.A.; Velde, N. van der; Schoor, N.M. van; Cammen, T.J.M. van der; Uitterlinden, A.G.; Lips, P.J.; Kessels, R.P.C.; Groot, L.C.P.G.M. de

    2014-01-01

    Objective: We investigated the effects of 2-year folic acid and vitamin B-12 supplementation on cognitive performance in elderly people with elevated homocysteine (Hcy) levels. Methods: This multicenter, double-blind, randomized, placebo-controlled trial included 2,919 elderly participants (65 years

  5. Implante de filtro em veia cava inferior dupla: relato de caso e revisão da literatura Filter placement in duplicated inferior vena cava: case report and review of the literature

    Directory of Open Access Journals (Sweden)

    Rafael Demarchi Malgor

    2008-06-01

    Full Text Available Veia cava inferior dupla é uma variação anatômica rara cuja prevalência é de 0,2-3%. O implante de filtro de veia cava, quando indicado em casos com duplicidade da veia cava inferior, pode ser realizado de diferentes formas: em ambas as veias cavas; em uma delas, embolizando a anastomose entre ambas; em somente uma delas; ou por implante supra-renal. Relatamos um caso de trombose venosa profunda no pós-operatório de implante de prótese de quadril com contra-indicação para tratamento anticoagulante e cuja cavografia evidenciou duplicidade de veia cava inferior. O implante de filtro de veia cava inferior realizado em posição supra-renal mostrou-se opção adequada e segura.Double inferior vena cava is a rare anatomic variation with prevalence ranging between 0.2-3.0%. In cases of duplication, inferior vena cava filter placement options include placing it in both vena cava, coil-embolization of the intervenous segment plus placing a filter in the right inferior vena cava, or suprarenal filter placement. We report a case of deep venous thrombosis after unilateral primary total hip replacement, presenting with contraindications for anticoagulant therapy, in which cavography showed inferior vena cava duplication. Inferior vena cava filter placement was performed in the supra-renal portion and was proved to be an adequate and safe procedure.

  6. Effect of Metformin on Handgrip Strength, Gait Speed, Myostatin Serum Level, and Health-related Quality of Life: A Double Blind Randomized Controlled Trial among Non-diabetic Pre-frail Elderly Patients.

    Science.gov (United States)

    Laksmi, Purwita Wijaya; Setiati, Siti; Tamin, Tirza Z; Soewondo, Pradana; Rochmah, Wasilah; Nafrialdi, Nafrialdi; Prihartono, Joedo

    2017-04-01

    sarcopenia contributes to the development of frailty syndrome. Frailty syndrome is potentially improved by modifying insulin resistance, inflammation, and myostatin level. This study is aimed to investigate the effect of metformin on handgrip strength, gait speed, myostatin serum level, and health-related quality of life (HR-QoL) among non-diabetic pre-frail elderly patients. a double blind randomized controlled trial study was conducted on non-diabetic elderly outpatients aged ≥ 60 years with pre-frail status based on phenotype and/ or index criteria (Cardiovascular Health Study and/ or Frailty Index 40 items) consecutively recruited from March 2015 to June 2016 at Cipto Mangunkusumo Hospital. One-hundred-twenty subjects who met the research criteria were randomized and equally assigned into 3 x 500 mg metformin or placebo group. The study outcomes were measured at baseline and after 16 weeks of intervention. out of 120 subjects, 43 subjects in metformin group and 48 subjects in placebo group who completed the intervention. There was a significant improvement on the mean gait speed of metformin group by 0.39 (0.77) second or 0.13 (0.24) meter/second that remained significant after adjusting for important prognostic factors (p = 0.024). There was no significant difference on handgrip strength, myostatin serum level, and HR-QoL between both groups. 3 x 500 mg metformin for 16 weeks was statistically significant and clinically important in improving usual gait speed as one of the HR-QoL dimensions, but did not significantly improve the EQ-5D index score, handgrip strength, nor myostatin serum level.

  7. RCT: Module 2.04, Dosimetry, Course 8769

    Energy Technology Data Exchange (ETDEWEB)

    Hillmer, Kurt T. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-08-11

    This course will introduce the types of instruments used to measure external and internal radiation to people. Dosimetry is the quantitative assessment of radiation received by the human body. Several types of dosimeters are used worldwide. This information is valuable to all radiological control personnel because dosimeters are the only direct method to measure and document personnel radiation exposure and ensure regulatory compliance with applicable limits. This course will cover dosimetry terms, Department of Energy (DOE) limits, Los Alamos National Laboratory (LANL) administrative guidelines, thermoluminescent dosimeters (TLDs), LANL dosimetry, and bioassay assessment methods. This course will prepare the student with the skills necessary for radiological control technician (RCT) qualification by passing quizzes, tests, and the RCT Comprehensive Phase 1, Unit 2 Examination (TEST 27566) and providing in-thefield skills.

  8. Effect of soy lecithin on fatigue and menopausal symptoms in middle-aged women: a randomized, double-blind, placebo-controlled study

    OpenAIRE

    Hirose, Asuka; Terauchi, Masakazu; Osaka, Yurika; Akiyoshi, Mihoko; Kato, Kiyoko; Miyasaka, Naoyuki

    2018-01-01

    Background Lecithin is a complex mixture of phospholipids which compose lipid bilayer cell membranes. Lipid replacement therapy, or administration of phospholipids for the purpose of repairing the dmaged cell membranes, had been shown to alleviate fatigue. The present study aimed to investigate the effect of soy lecithin on fatigue in middle-aged women, as well as other menopausal symptoms and various health parameters. Methods This randomized, double-blind, placebo-controlled study included ...

  9. A novel submucosal injection solution for endoscopic resection of large colorectal lesions: a randomized, double-blind trial.

    Science.gov (United States)

    Repici, Alessandro; Wallace, Michael; Sharma, Prateek; Bhandari, Pradeep; Lollo, Gianluca; Maselli, Roberta; Hassan, Cesare; Rex, Douglas K

    2018-05-08

    SIC-8000 (Eleview) is a new FDA-approved solution for submucosal injection developed to provide long-lasting cushion to facilitate endoscopic resection maneuvers. Our aim was to compare the efficacy and safety of SIC-8000 with those of saline solution, when performing endoscopic mucosal resection (EMR) of large colorectal lesions. In a randomized double-blind trial, patients undergoing EMR for ≥20 mm colorectal non-pedunculated lesions were randomized in a 1:1 ratio between SIC-8000 and saline solution as control solution in 5 tertiary centers. Endoscopists and patients were blinded to the type of submucosal solution used. Total volume to complete EMR and per lesion size and time of resection were primary end-points, whereas the Sydney Resection Quotient (SRQ), as well as other EMR outcomes, and the rate of adverse events were secondary. A 30-day telephone follow up was performed. An alpha level <0.05 was considered as statistically significant (NCT 02654418). Of the 327 patients screened, 226 (mean age: 66±10; males: 56%) were enrolled in the study and randomized between the 2 submucosal agents. Of these, 211 patients (mean size of the lesions 33±13 mm; I-s: 36%; proximal colon: 74%) entered in the final analysis (SIC-8000: 102; saline solution: 109). EMR was complete in all cases. The total volume needed for EMR was significantly less in the SIC-8000 arm compared with saline solution (16.1±9.8 mL vs 31.6±32.0 mL; p<0.001). This corresponded to an average volume per lesion size of 0.5±0.3 mL/mm and 0.9±0.6 mL/mm with SIC-8000 and saline solution, respectively, (p<0.001). The mean time to completely resect the lesion tended to be lower with SIC-8000 as compared with saline solution (19.1±16.8 minutes vs 29.7±68.9 minutes; p=0.1). The SRQ was significantly higher with SIC-8000 as compared with saline solution (10.3±8.1 vs 8.0±5.7; p=0.04) with a trend for a lower number of resected pieces (5.7±6.0 vs 6.5±5.04; p=0.052) and a higher rate of en bloc

  10. A double-blind crossover comparison of clomipramine and desipramine in the treatment of panic disorder.

    Science.gov (United States)

    Sasson, Y; Iancu, I; Fux, M; Taub, M; Dannon, P N; Zohar, J

    1999-03-01

    To compare the efficacy of clomipramine hydrochloride (CMI), a serotonin reuptake inhibitor with the noradrenergic tricyclic antidepressant agent, and desipramine hydrochloride (DMI) for patients with panic disorder (PD). Following a 2-week, single-blind placebo washout phase, 17 PD outpatients completed a 16-week, double-blind, crossover comparison of CMI and DMI. Key outcome measures included panic attacks frequency, the NIMH Global Scales for Anxiety, Depression and Impairment, Hamilton Anxiety Scale (Psychic and Somatic Subscales), Zung Anxiety Inventory (Raw and Index Subscales) and the Spielberger State Anxiety Scale. Both CMI and DMI led to significant improvement from baseline placebo state in panic attacks frequency and behavioral ratings (p<0.001). CMI led to a greater reduction in the frequency of panic attacks (p=0.028) and was superior to DMI on ratings of anxiety: NIMH Global Anxiety, Zung Anxiety Scale (Raw and Index) and the Spielberger Anxiety Scale. No difference was found between the drugs on the NIMH Global Impairment Scale and the Hamilton Somatic and Psychic Scales. Both drugs appeared to have significant therapeutic effects in patients with PD, but CMI appeared to be more effective. The effectiveness of the serotonergic drug suggests that the role of the serotonergic system in the pathogenesis of PD should be further explored.

  11. Sucralfate for radiation mucositis: results of a double-blind randomized trial

    International Nuclear Information System (INIS)

    Meredith, R.; Salter, M.; Kim, R.; Spencer, S.; Weppelmann, B.; Rodu, B.; Smith, J.; Lee, J.

    1995-01-01

    Purpose: To determine if addition of the ulcer-coating polysaccharide sucralfate could improve symptomatic relief of radiation mucositis over a popular combination of Maalox, diphenhyrdramine and viscous lidocaine alone. Methods: A double-blind study was conducted in which nurses/pharmacists coded patient groups and distributed medication in a manner blinded to both the patients and physicians. Eligible patients receiving radiation to the head and neck and/or chest sites that included the esophagus were randomized to a standard combination of Maalox, diphenhydramime and viscous lidocaine verses the same solution plus sucralfate. Eligible patients were those receiving > 40 Gy at 1.8 Gy/fraction, 1 fraction/day, 5 fractions/week. Participating patients were stratified between chest, small field head and neck, and large field head and neck. Baseline information regarding use of tobacco, alcohol, and food intake was obtained prior to symptomatic mucositis. This was compared with similar information obtained weekly once symptoms occurred. The patients subjected evaluation of throat soreness and relief with medication was elicited as well as physician observations and smears for Candidiasis screening. Medication was prescribed when the patient became symptomatic and concomitant use of other locally effective non-study agents was not allowed. Subjective soreness was graded on a scale of 0-20 with 0 indicating no soreness and 20 designating severe soreness that compromised ability to swallow secretions. The ability to eat various consistency of foods was graded 0-5 with 5 indicating no compromise of ability to ingest a food compared to baseline. Statistical analysis included mean + S.D. for food and soreness scores, paired t-test and two-way analyses of variance to evaluate effects of site and treatment group on the changes in scores. Results: Over 2 years, 110 patients were entered. Since some withdrew and others did not require medication, results are presented for

  12. Prospective, Double-Blind Evaluation of Umbilicoplasty Techniques Using Conventional and Crowdsourcing Methods.

    Science.gov (United States)

    van Veldhuisen, Charlotte L; Kamali, Parisa; Wu, Winona; Becherer, Babette E; Sinno, Hani H; Ashraf, Azra A; Ibrahim, Ahmed M S; Tobias, Adam; Lee, Bernard T; Lin, Samuel J

    2017-12-01

    Umbilical reconstruction is an important component of deep inferior epigastric perforator (DIEP) flap breast reconstruction. This study evaluated the aesthetics of three different umbilical reconstruction techniques during DIEP flap breast reconstruction. From January to April of 2013, a total of 29 consecutive patients undergoing DIEP flap breast reconstruction were randomized intraoperatively to receive one of three umbilicoplasty types: a diamond, an oval, or an inverted V incision. Independent plastic surgeons and members of the general public, identified using an online "crowdsourcing" platform, evaluated aesthetic outcomes in a blinded fashion. Reviewers were shown postoperative photographs of the umbilicus of all patients and a four-point Likert scale was used to rate the new umbilicus on the size, scar formation, shape, localization, and overall appearance. Results for the focus group of independent plastic surgeons and 377 members of the public were retrieved (n = 391). A total of 10 patients (34.5 percent) were randomized into having the diamond incision, 10 (34.5 percent) had the oval incision, and nine (31.0 percent) had the inverted V incision. Patients were well matched in terms of overall characteristics. The general public demonstrated a significant preference for the oval incision in all five parameters. There was no preference identified among surgeons. This study provides evidence that a sample of the U.S. general public prefers the aesthetics of the oval umbilicoplasty incision, which contrasted with the lack of preference identified within this focus group of plastic surgeons. Therapeutic, II.

  13. The effect of levetiracetam on focal nocturnal epileptiform activity during sleep--a placebo-controlled double-blind cross-over study.

    Science.gov (United States)

    Larsson, Pål Gunnar; Bakke, Kristin A; Bjørnæs, Helge; Heminghyt, Einar; Rytter, Elisif; Brager-Larsen, Line; Eriksson, Ann-Sofie

    2012-05-01

    Electric Status Epilepticus during Sleep (ESES) occurs in children with and without epilepsy. It may be related to disturbances as autism spectrum disorder, attention-deficit hyperactivity disorder and acquired aphasia (Landau-Kleffner syndrome). Antiepileptic drug (AED) treatment has been reported in small studies without placebo control. This study was designed to assess AED effect in a placebo-controlled double-blind cross-over study. Levetiracetam (LEV) was chosen based on clinical evidence. Eighteen patients fulfilled the inclusion criteria. The mean spike index at baseline was 56, falling to a mean of 37 at the end of the LEV treatment period. Assessed with a 2-way ANOVA, there is a significant treatment effect (pdouble-blind cross-over study for any AED in patients with ESES. The effect of LEV is comparable with its effect in treatment of epileptic seizures. Copyright © 2012 Elsevier Inc. All rights reserved.

  14. Efficacy of Bee Venom Acupuncture for Chronic Low Back Pain: A Randomized, Double-Blinded, Sham-Controlled Trial.

    Science.gov (United States)

    Seo, Byung-Kwan; Han, Kyungsun; Kwon, Ojin; Jo, Dae-Jean; Lee, Jun-Hwan

    2017-11-07

    Bee venom acupuncture (BVA) is an effective treatment for chronic low back pain (CLBP) through the pharmacological effects of bee venom and the simultaneous stimulation of acupoints. However, evidence of its efficacy and safety in humans remains unclear. Using a double-blind, randomized study, 54 patients with non-specific CLBP were assigned to the BVA and sham groups. All participants underwent six sessions of real or sham BVA for 3 weeks, in addition to administration of 180 mg of loxonin per day. The primary outcome, that is, "bothersomeness" derived from back pain, was assessed using the visual analog scale. Secondary outcomes included pain intensity, dysfunction related to back pain (Oswestry Disability Index), quality of life (EuroQol 5-Dimension), and depressive mood (Beck's depression inventory). Outcomes were evaluated every week during the treatment period and followed up at weeks 4, 8, and 12. After 3 weeks of the treatment, significant improvements were observed in the bothersomeness, pain intensity, and functional status in the BVA group compared with the sham group. Although minimal adverse events were observed in both groups, subsequent recovery was achieved without treatment. Consequently, our results suggest that it can be used along with conventional pharmacological therapies for the treatment of CLBP.

  15. Comparison of Two Forms of Loperamide-Simeticone and a Probiotic Yeast (Saccharomyces boulardii) in the Treatment of Acute Diarrhoea in Adults: A Randomised Non-Inferiority Clinical Trial.

    Science.gov (United States)

    Cottrell, Jeremy; Koenig, Kerstin; Perfekt, Roland; Hofmann, Robert

    2015-12-01

    Acute diarrhoea is a frequent health problem in both travellers and residents that has a social and economic impact. This study compared the efficacy and tolerability of two loperamide-simeticone formulations and a Saccharomyces boulardii capsule as symptomatic treatment. This was a prospective, randomised, single (investigator)-blind, three-arm, parallel group, non-inferiority clinical trial in adult subjects with acute diarrhoea at clinics in Mexico and India, with allocation to a loperamide-simeticone 2/125 mg caplet or chewable tablet (maximum eight in 48 h) or S. boulardii (250 mg twice daily for 5 days). The primary outcome measure was the number of unformed stools between 0 and 24 h following the initial dose of study medication (NUS 0-24). The secondary outcome measures were time to last unformed stool (TLUS), time to complete relief of diarrhoea (TCRD), time to complete relief of abdominal discomfort (TCRAD) and the subject's evaluation of treatment effectiveness. Follow-up endpoints at 7 days were feeling of complete wellness; stool passed since final study visit; and continued or recurrent diarrhoea. In this study, 415 subjects were randomised to either a loperamide-simeticone caplet (n = 139), loperamide-simeticone chewable tablet (n = 139) or S. boulardii capsule (n = 137) and were included in the intention-to-treat analysis. With regards to mean NUS 0-24, the loperamide-simeticone caplet was non-inferior to loperamide-simeticone tablets (3.4 vs. 3.3; one-sided 97.5 % confidence interval ≤0.5), with both significantly lower than S. boulardii (4.3; p boulardii); p boulardii. Treatment effectiveness for overall illness, diarrhoea and abdominal discomfort relief was greater (p boulardii. At 7-day follow-up most subjects reported passing stool at least once since the final study visit (loperamide-simeticone caplet 94.1 %, loperamide-simeticone chewable tablet 94.8 %, S. boulardii 97.0 %), did not experience continued or recurrent diarrhoea [loperamide

  16. A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Metformin Therapy in Overweight/Obese Youth with Type 1 Diabetes.

    Directory of Open Access Journals (Sweden)

    Benjamin Udoka Nwosu

    Full Text Available Insulin resistance has been proposed as one of the causes of poor glycemic control in overweight/obese youth with type 1 diabetes (T1D. However, the role of adjunctive metformin, an insulin sensitizer, on glycemic control in these patients is unclear.To compare the effect of metformin vs. placebo on hemoglobin A1c (HbA1c, total daily dose (TDD of insulin, and other parameters in overweight/obese youth with T1D.Adjunctive metformin therapy will improve glycemic control in overweight/obese youth with T1D.A 9-mo randomized, double-blind, placebo controlled trial of metformin and placebo in 28 subjects (13m/15f of ages 10-20years (y, with HbA1c >8% (64 mmol/mol, BMI >85%, and T1D > 12 months was conducted at a university outpatient facility. The metformin group consisted of 15 subjects (8 m/ 7f, of age 15.0 ± 2.5 y; while the control group was made up of 13 subjects (5m/ 8f, of age 14.5 ± 3.1y. All participants employed a self-directed treat-to-target insulin regimen based on a titration algorithm of (-2-0-(+2 units to adjust their long-acting insulin dose every 3rd day from -3 mo through +9 mo to maintain fasting plasma glucose (FPG between 90-120 mg/dL (5.0-6.7 mmol/L. Pubertal maturation was determined by Tanner stage.Over the course of the 9 months of observation, the between-treatment differences in HbA1c of 0.4% (9.85% [8.82 to 10.88] for placebo versus 9.46% [8.47 to 10.46] for metformin was not significant (p = 0.903. There were non-significant reduction in fasting plasma glucose (189.4 mg/dL [133.2 to 245.6] for placebo versus 170.5 mg/dL [114.3 to 226.7] for metformin, (p = 0.927; total daily dose (TDD of short-acting insulin per kg body weight/day(p = 0.936; and the TDD of long-acting insulin per kg body weight per day (1.15 units/kg/day [0.89 to 1.41] for placebo versus 0.90 units/kg/day [0.64 to 1.16] for metformin (p = 0.221. There was no difference in the occurrence of hypoglycemia between the groups.This 9-month RCT of adjunctive

  17. Double-blind, randomized placebo-controlled clinical trial of benfotiamine for severe alcohol dependence.

    Science.gov (United States)

    Manzardo, Ann M; He, Jianghua; Poje, Albert; Penick, Elizabeth C; Campbell, Jan; Butler, Merlin G

    2013-12-01

    Alcohol dependence is associated with severe nutritional and vitamin deficiency. Vitamin B1 (thiamine) deficiency erodes neurological pathways that may influence the ability to drink in moderation. The present study examines tolerability of supplementation using the high-potency thiamine analog, benfotiamine (BF), and BF's effects on alcohol consumption in severely affected, self-identified, alcohol dependent subjects. A randomized, double-blind, placebo-controlled trial was conducted on 120 non-treatment seeking, actively drinking, alcohol dependent men and women volunteers (mean age=47 years) from the Kansas City area who met DSM-IV-TR criteria for current alcohol dependence. Subjects were randomized to receive 600 mg benfotiamine or placebo (PL) once daily by mouth for 24 weeks with 6 follow-up assessments scheduled at 4 week intervals. Side effects and daily alcohol consumption were recorded. Seventy (58%) subjects completed 24 weeks of study (N=21 women; N=49 men) with overall completion rates of 55% (N=33) for PL and 63% (N=37) for BF groups. No significant adverse events were noted and alcohol consumption decreased significantly for both treatment groups. Alcohol consumption decreased from baseline levels for 9 of 10 BF treated women after 1 month of treatment compared with 2 of 11 on PL. Reductions in total alcohol consumption over 6 months were significantly greater for BF treated women (BF: N=10, -611 ± 380 standard drinks; PL: N=11, -159 ± 562 standard drinks, p-value=0.02). BF supplementation of actively drinking alcohol dependent men and women was well-tolerated and may discourage alcohol consumption among women. The results do support expanded studies of BF treatment in alcoholism. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  18. Prospective, Randomized, Double-Blind, Phase III Clinical Trial of Anti-T-Lymphocyte Globulin to Assess Impact on Chronic Graft-Versus-Host Disease-Free Survival in Patients Undergoing HLA-Matched Unrelated Myeloablative Hematopoietic Cell Transplantation.

    Science.gov (United States)

    Soiffer, Robert J; Kim, Haesook T; McGuirk, Joseph; Horwitz, Mitchell E; Johnston, Laura; Patnaik, Mrinal M; Rybka, Witold; Artz, Andrew; Porter, David L; Shea, Thomas C; Boyer, Michael W; Maziarz, Richard T; Shaughnessy, Paul J; Gergis, Usama; Safah, Hana; Reshef, Ran; DiPersio, John F; Stiff, Patrick J; Vusirikala, Madhuri; Szer, Jeff; Holter, Jennifer; Levine, James D; Martin, Paul J; Pidala, Joseph A; Lewis, Ian D; Ho, Vincent T; Alyea, Edwin P; Ritz, Jerome; Glavin, Frank; Westervelt, Peter; Jagasia, Madan H; Chen, Yi-Bin

    2017-12-20

    Purpose Several open-label randomized studies have suggested that in vivo T-cell depletion with anti-T-lymphocyte globulin (ATLG; formerly antithymocyte globulin-Fresenius) reduces chronic graft-versus-host disease (cGVHD) without compromising survival. We report a prospective, double-blind phase III trial to investigate the effect of ATLG (Neovii Biotech, Lexington, MA) on cGVHD-free survival. Patients and Methods Two hundred fifty-four patients 18 to 65 years of age with acute leukemia or myelodysplastic syndrome who underwent myeloablative HLA-matched unrelated hematopoietic cell transplantation (HCT) were randomly assigned one to one to placebo (n =128 placebo) or ATLG (n = 126) treatment at 27 sites. Patients received either ATLG or placebo 20 mg/kg per day on days -3, -2, -1 in addition to tacrolimus and methotrexate as GVHD prophylaxis. The primary study end point was moderate-severe cGVHD-free survival. Results Despite a reduction in grade 2 to 4 acute GVHD (23% v 40%; P = .004) and moderate-severe cGVHD (12% v 33%; P < .001) in ATLG recipients, no difference in moderate-severe cGVHD-free survival between ATLG and placebo was found (2-year estimate: 48% v 44%, respectively; P = .47). Both progression-free survival (PFS) and overall survival (OS) were lower with ATLG (2-year estimate: 47% v 65% [ P = .04] and 59% v 74% [ P = .034], respectively). Multivariable analysis confirmed that ATLG was associated with inferior PFS (hazard ratio, 1.55; 95% CI, 1.05 to 2.28; P = .026) and OS (hazard ratio, 1.74; 95% CI, 1.12 to 2.71; P = .01). Conclusion In this prospective, randomized, double-blind trial of ATLG in unrelated myeloablative HCT, the incorporation of ATLG did not improve moderate-severe cGVHD-free survival. Moderate-severe cGVHD was significantly lower with ATLG, but PFS and OS also were lower. Additional analyses are needed to understand the appropriate role for ATLG in HCT.

  19. Effect of Uric Acid-Lowering Agents on Endothelial Function: A Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Borgi, Lea; McMullan, Ciaran; Wohlhueter, Ann; Curhan, Gary C; Fisher, Naomi D; Forman, John P

    2017-02-01

    Higher levels of serum uric acid are independently associated with endothelial dysfunction, a mechanism for incident hypertension. Overweight/obese individuals are more prone to endothelial dysfunction than their lean counterparts. However, the effect of lowering serum uric acid on endothelial dysfunction in these individuals has not been examined thoroughly. In this randomized, double-blind, placebo-controlled trial of nonhypertensive, overweight, or obese individuals with higher serum uric acid (body mass index ≥25 kg/m 2 and serum uric acid ≥5.0 mg/dL), we assigned subjects to probenecid (500-1000 mg/d), allopurinol (300-600 mg/d), or matching placebo. The primary outcome was endothelium-dependent vasodilation measured by brachial artery ultrasound at baseline and 8 weeks. By the end of the trial, 47, 49, and 53 participants had been allocated to receive probenecid, allopurinol, and placebo, respectively. Mean serum uric acid levels significantly decreased in the probenecid (from 6.1 to 3.5 mg/dL) and allopurinol groups (from 6.1 to 2.9 mg/dL) but not in the placebo group (6.1 to 5.6 mg/dL). None of the interventions produced any significant change in endothelium-dependent vasodilation (probenecid, 7.4±5.1% at baseline and 8.3±5.1% at 8 weeks; allopurinol, 7.6±6.0% at baseline and 6.2±4.8% at 8 weeks; and placebo, 6.5±3.8% at baseline and 7.1±4.9% at 8 weeks). In this randomized, double-blind, placebo-controlled trial, uric acid lowering did not affect endothelial function in overweight or obese nonhypertensive individuals. These data do not support the hypothesis that uric acid is causally related to endothelial dysfunction, a potential mechanism for development of hypertension. © 2016 American Heart Association, Inc.

  20. Efficacy and safety of Citrus sudachi peel in obese adults: A randomized, double-blind, pilot study

    Directory of Open Access Journals (Sweden)

    Masashi Akaike

    2014-07-01

    Full Text Available Objective: This study was undertaken to explore the efficacy and safety of Citrus sudachi peel for metabolic risk factors in obese male and female adults. Background: Citrus sudachi Hort. ex Shirai (Rutaceae, called “sudachi”, is a small, round, green citrus fruit that is mainly cultivated in Tokushima Prefecture in Japan. Our group reported that Citrus sudachi peel powder improved glucose tolerance and dyslipidemia in Zucher-fatty rats and reduced hyperglycemia and hypertriglyceridemia in GK diabetic rats. Materials and Methods: We conducted a randomized, double-blind, placebo-controlled trial in 40 participants with abdominal obesity and metabolic risk factors including hypertension, impaired glucose tolerance and elevated triglyceride levels. Participants were randomized to receive either tablets that contained 1.3 g dried Citrus sudachi peel powder or placebo tablets for 12 weeks. The sudachi peel group included 14 males and 5 females with a mean age of 54.5 years, and the placebo group included 18 males and 2 females with a mean age of 51.9 years. Results: Physical status including body weight, waist circumference and blood pressure and laboratory markers including metabolic parameters were not different at any observation point between the two groups. However, among participants with serum triglyceride levels of more than 120 mg/dl, body weight, waist circumference and serum triglyceride levels were significantly decreased at several observation points after the start of treatment in the sudachi peel group but not in the placebo group. No serious adverse events were observed in the sudachi peel group. Conclusions: Citrus sudachi peel has the potential effect to safely improve abdominal obesity and lower serum levels of TG in obese individuals with hypertriglyceridemia. A large-scale randomized, double-blind clinical study targeting subjects with both abdominal obesity and high TG levels is needed to confirm the metabolic effects of

  1. Open-label trial and randomized, double-blind, placebo-controlled, crossover trial of hydrogen-enriched water for mitochondrial and inflammatory myopathies

    Directory of Open Access Journals (Sweden)

    Ito Mikako

    2011-10-01

    Full Text Available Abstract Background Molecular hydrogen has prominent effects on more than 30 animal models especially of oxidative stress-mediated diseases and inflammatory diseases. In addition, hydrogen effects on humans have been reported in diabetes mellitus type 2, hemodialysis, metabolic syndrome, radiotherapy for liver cancer, and brain stem infarction. Hydrogen effects are ascribed to specific radical-scavenging activities that eliminate hydroxyl radical and peroxynitrite, and also to signal-modulating activities, but the detailed molecular mechanisms still remain elusive. Hydrogen is a safe molecule that is largely produced by intestinal bacteria in rodents and humans, and no adverse effects have been documented. Methods We performed open-label trial of drinking 1.0 liter per day of hydrogen-enriched water for 12 weeks in five patients with progressive muscular dystrophy (PMD, four patients with polymyositis/dermatomyositis (PM/DM, and five patients with mitochondrial myopathies (MM, and measured 18 serum parameters as well as urinary 8-isoprostane every 4 weeks. We next conducted randomized, double-blind, placebo-controlled, crossover trial of 0.5 liter per day of hydrogen-enriched water or placebo water for 8 weeks in 10 patients with DM and 12 patients with MM, and measured 18 serum parameters every 4 weeks. Results In the open-label trial, no objective improvement or worsening of clinical symptoms was observed. We, however, observed significant effects in lactate-to-pyruvate ratios in PMD and MM, fasting blood glucose in PMD, serum matrix metalloproteinase-3 (MMP3 in PM/DM, and serum triglycerides in PM/DM. In the double-blind trial, no objective clinical effects were observed, but a significant improvement was detected in lactate in MM. Lactate-to-pyruvate ratios in MM and MMP3 in DM also exhibited favorable responses but without statistical significance. No adverse effect was observed in either trial except for hypoglycemic episodes in an insulin

  2. Topical corticosteroids in the treatment of acute sunburn - A randomized, double-blind clinical trial

    DEFF Research Database (Denmark)

    Faurschou, A.; Wulf, Hans Chr.

    2008-01-01

    Objective: To examine the effect of topical corticosteroid treatment on acute sunburn. Design: Randomized, double-blind clinical trial. Setting: University dermatology department. Patients: Twenty healthy volunteers with Fitzpatrick skin types I (highly sensitive, always burns easily, tans...... minimally) through III (sun-sensitive skin, sometimes burns, slowly tans to light brown). Intervention: Seven 34-cm(2) areas were marked on the upper aspect of the back of each participant. An untreated area was tested to determine UV sensitivity. Two areas were treated with excess amounts (2 mg/cm(2......) was determined by the following equation: SIF=MED(minimal erythema dose) on treated skin/MED on nontreated skin. An SIF greater than 1 indicated an effect of topical corticosteroids in sunburn relief. Results: The SIFs in the areas treated with either topical corticosteroid 30 minutes before UV-B exposure...

  3. Propranolol, clonidine, urapidil and trazodone infusion in essential tremor: a double-blind crossover trial.

    Science.gov (United States)

    Caccia, M R; Osio, M; Galimberti, V; Cataldi, G; Mangoni, A

    1989-05-01

    Accelerometric tremorgrams were recorded from 25 subjects affected by essential tremor and analysed by a Berg-Fourier frequency analyser before and during venous infusion of the following drugs: propranolol (beta-blocker), clonidine (alpha-presynaptic adrenergic agonist), urapidil (alpha-postsynaptic blocker), trazodone (adrenolytic agent) and placebo. The washout interval between infusions was 3 days. Recordings and data analyses were performed in a double-blind crossover trial. Tremor was classified as: at rest; postural (arms hyperextended); and intention (finger-nose test). Analysis of the results showed that propranolol and clonidine reduced significantly (P = 0.01 and P = 0.009, respectively) the power spectrum of postural tremor, but left at rest and intention tremors unchanged. No significant effects on the tremor power spectrum were observed after placebo, urapidil or trazodone administration. None of the drugs had any effect on tremor frequency.

  4. Pregabalin for anxiety in patients with schizophrenia - A randomized, double-blind placebo-controlled study

    DEFF Research Database (Denmark)

    Schjerning, Ole; Damkier, Per; Lykkegaard, Signe Engelhardt

    2017-01-01

    INTRODUCTION: Anxiety is frequent in patients with schizophrenia and poses a major impact on patients perceived quality of life, daily functioning and risk of suicide. Pregabalin has shown effective in the treatment of generalized anxiety disorder and has been suggested for the treatment of anxiety...... in patients with schizophrenia. As evidence is sparse regarding treatment of anxiety in this patient group, we aimed to investigate the use of pregabalin for anxiety in patients with schizophrenia. METHODS: A randomized, double-blind placebo controlled study was used. Patients were randomized to either...... placebo or pregabalin (≤600mg/d) as add-on treatment. Primary analyses were intention-to-treat based with change in Hamilton Anxiety Scale after 4 and 8weeks of treatment as primary outcome. Secondary outcomes were change in psychopathology, quality-of-life, cognitive functioning and sleep. The study used...

  5. Comparative assessment of image quality for coronary CT angiography with iobitridol and two contrast agents with higher iodine concentrations: iopromide and iomeprol. A multicentre randomized double-blind trial

    Energy Technology Data Exchange (ETDEWEB)

    Achenbach, Stephan [Friedrich-Alexander-Universitaet Erlangen-Nuernberg, Department of Cardiology, Erlangen (Germany); Paul, Jean-Francois [Centre Chirurgical Marie Lannelongue, Department of Radiology, Le Plessis Robinson (France); Laurent, Francois [University of Bordeaux, Centre de Recherche Cardio-Thoracique de Bordeaux, U1045, Bordeaux (France); CHU de Bordeaux, Service d' Imagerie Thoracique et Cardiovasculaire, Pessac (France); Becker, Hans-Christoph [University Hospital Grosshadern, Department of Clinical Radiology, Munich (Germany); Rengo, Marco [Sapienza - University of Rome, ICOT Hospital, Department of Radiological Sciences, Oncology and Pathology, Latina (Italy); Caudron, Jerome [University Hospital of Rouen, Department of Radiology, Rouen (France); Leschka, Sebastian [Saint Gallen Hospital, Department of Radiology, Saint Gallen (Switzerland); Vignaux, Olivier [Cochin Hospital, Department of Radiology, Paris (France); Knobloch, Gesine [La Charite, Department of Radiology, Berlin (Germany); Benea, Giorgio [Ospedale del Delta, Ferrara (Italy); Schlosser, Thomas [Elisabeth-Krankenhaus Hospital, Essen (Germany); Andreu, Jordi [Hospital Vall d' Hebron, Barcelona (Spain); Cabeza, Beatriz [Hospital Clinico San Carlos, Madrid (Spain); Jacquier, Alexis [La Timone Adult Hospital, Department of Radiology, Marseille (France); Souto, Miguel [Complejo Hospitalario Universitario, Santiago de Compostela (Spain); Revel, Didier [Louis Pradel Hospital, Department of Radiology, Lyon (France); Qanadli, Salah Dine [University of Lausanne, Department of Radiology, Lausanne (Switzerland); Cademartiri, Filippo [Giovanni XXIII Hospital, Department of Radiology, Monastier di Treviso (Italy); Collaboration: X-ACT Study Group

    2017-02-15

    To demonstrate non-inferiority of iobitridol 350 for coronary CT angiography (CTA) compared to higher iodine content contrast media regarding rate of patients evaluable for the presence of coronary artery stenoses. In this multicentre trial, 452 patients were randomized to receive iobitridol 350, iopromide 370 or iomeprol 400 and underwent coronary CTA using CT systems with 64-detector rows or more. Two core lab readers assessed 18 coronary segments per patient regarding image quality (score 0 = non diagnostic to 4 = excellent quality), vascular attenuation, signal and contrast to noise ratio (SNR, CNR). Patients were considered evaluable if no segment had a score of 0. Per-patient, the rate of fully evaluable CT scans was 92.1, 95.4 and 94.6 % for iobitridol, iopromide and iomeprol, respectively. Non-inferiority of iobitridol over the best comparator was demonstrated with a 95 % CI of the difference of [-8.8 to 2.1], with a pre-specified non-inferiority margin of -10 %. Although average attenuation increased with higher iodine concentrations, average SNR and CNR did not differ between groups. With current CT technology, iobitridol 350 mg iodine/ml is not inferior to contrast media with higher iodine concentrations in terms of image quality for coronary stenosis assessment. (orig.)

  6. A double-blind, randomized, comparative study to evaluate the efficacy and safety of zaleplon versus zolpidem in shortening sleep latency in primary insomnia.

    Science.gov (United States)

    Huang, Yu-Shu; Hsu, Shih-Chieh; Liu, Shen-Ing; Chen, Chih-Ken

    2011-01-01

    Benzodiazepines cause a high proportion of adverse effects while non-benzodiazepine compounds have demonstrated high efficacy and less adverse effects in patients with insomnia. The objective of this study was to compare the effectiveness and safety of non-BZ zaleplon and zolpidem in primary insomnia. This was a randomized, double-blind, active-controlled, double-dummy, comparative study. A total of 48 patients were enrolled, of which 45 patients completed the study. Patients who entered the study were required to take the study drug orally once daily at bedtime for two weeks. Each patient kept a sleep diary and answered a questionnaire. We used these documents to measure and evaluate changes from baseline to Week 2 in sleep latency, duration and quality of sleep, the number of awakenings and incidence of rebound insomnia. The data revealed a significant decrease in sleep latency from baseline to Week 2 for patients receiving zaleplon 10 mg and zolpidem 10 mg. Patients receiving zaleplon exhibited a marginally greater, but not statistically significant, reduction in sleep latency than those who received zolpidem. There was no significant difference in the frequency of adverse effects between the zaleplon and zolpidem groups; however, during this clinical trial there was one lethal event caused by a traffic accident in the zaleplon group. There was no significant difference between zaleplon and zolpidem in the efficacy of reducing sleep latency or adverse effects. A large pharmacovigilance study is needed before concluding that either zolpidem or zaleplon is free from next-day residual effects.

  7. RCT: Module 2.11, Radiological Work Coverage, Course 8777

    Energy Technology Data Exchange (ETDEWEB)

    Hillmer, Kurt T. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-07-20

    Radiological work is usually approved and controlled by radiation protection personnel by using administrative and procedural controls, such as radiological work permits (RWPs). In addition, some jobs will require working in, or will have the potential for creating, very high radiation, contamination, or airborne radioactivity areas. Radiological control technicians (RCTs) providing job coverage have an integral role in controlling radiological hazards. This course will prepare the student with the skills necessary for RCT qualification by passing quizzes, tests, and the RCT Comprehensive Phase 1, Unit 2 Examination (TEST 27566) and will provide in-the-field skills.

  8. Double-blind comparative study of droperidol, granisetron and granisetron plus dexamethasone as prophylactic anti-emetic therapy in patients undergoing abdominal, gynaecological, breast or otolaryngological surgery

    NARCIS (Netherlands)

    Janknegt, R; Pinckaers, JWM; Rohof, MHC; Ausems, MEM; Arbouw, MEL; van der Velden, RW; Brouwers, JRBJ

    In this double-blind study the clinical efficacy of a single pre-operative intravenous dose of droperidol 1.25 mg (137 patients), granisetron 1 mg (130 patients) and granisetron 1 mg plus dexamethasone 5 mg (130 patients) was investigated for the prevention of postoperative nausea and vomiting after

  9. Effect of symbiotic supplementation on glycemic control, lipid profiles and microalbuminuria in patients with non-obese type 2 diabetes: a randomized, double-blind, clinical trial.

    Science.gov (United States)

    Ebrahimi, Zarin Sadat; Nasli-Esfahani, Ensieh; Nadjarzade, Azadeh; Mozaffari-Khosravi, Hassan

    2017-01-01

    The prevalent raise of type 2 diabetes (T2D) around the globe, are creating higher risk for cardiovascular diseases (CVDs) and increasing strain on each country's health care budget in the world. Microalbuminuria has appeared as a key parameter in diabetic patients. Microalbuminuria is also related to increased cardiovascular morbidity in people who are non-obese diabetic. Some studies have suggested that consumption of symbiotic foods might help improve the metabolic profile, inflammatory factors and biomarkers of oxidative stress. The aim of trial was to determine the effect of symbiotic supplementation on glycemic control, lipid profiles and microalbuminuria in non-obese T2D. In this randomized, double-blind, clinically controlled trial, 70 patients with T2D (28 females, 42 males) were randomly divided into two groups ( n  = 35 for each group). The symbiotic group (SG) consumed 500 mg/d of symbiotic supplementations containing probiotics (Lactobacillus family, Bifidobacterium family, Streptococus thermophilus), Prebiotics (Fructo oligosaccharide) and B group vitamins (1 mg), lactose (0.5 mg), malt-dextrin, magnesium saturate and the placebo group (PG) consumed capsules filled with row starch and also B group vitamins (1 mg), lactose (0.5 mg), malt-dextrin, magnesium saturate for 9 weeks. Fasting blood glucose (FBG), hemoglobin A1c (HbA1c), blood lipid profiles, 24-h dietary recalls, and anthropometric measurements were measured at the baseline and at the end of trial. SPSS software, version 16 was used to test the data and the results were expressed as mean ± standard deviation. Paired samples T-Test were used to compare continuous variables within groups. Comparison between different groups was performed through two independent samples T-Test. In the absence of normal distribution, the comparison between the groups was made using non-parametric Wilcoxon on signed ranks and Mann-Whitney tests. P values Symbiotic supplementation decreased

  10. Homeopathy for Depression - DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study

    Science.gov (United States)

    2011-01-01

    Background Homeopathy is often sought by patients with depression. In classical homeopathy, the treatment consists of two main elements: the case history and the prescription of an individually selected homeopathic remedy. Previous data suggest that individualized homeopathic Q-potencies were not inferior to the antidepressant fluoxetine in a sample of patients with moderate to severe depression. However, the question remains whether individualized homeopathic Q-potencies and/or the type of the homeopathic case history have a specific therapeutical effect in acute depression as this has not yet been investigated. The study aims to assess the two components of individualized homeopathic treatment for acute depression, i.e., to investigate the specific effect of individualized Q-potencies versus placebo and to investigate the effect of different approaches to the homeopathic case history. Methods/Design A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2 × 2 factorial design with a six-week study duration per patient will be performed. 228 patients diagnosed with major depression (moderate episode) by a psychiatrist will be included. The primary endpoint is the total score on the 17-item Hamilton Depression Rating Scale after six weeks. Secondary end points are: Hamilton Depression Rating Scale total score after two and four weeks; response and remission rates, Beck Depression inventory total score, quality of life and safety at two, four and six weeks. Statistical analyses will be by intention-to-treat. The main endpoint will be analysed by a two-factorial analysis of covariance. Within this model generalized estimation equations will be used to estimate differences between verum and placebo, and between both types of case history. Discussion For the first time this study evaluates both the specific effect of homeopathic medicines and of a homeopathic case taking in patients with depression. It is an attempt to deal with the

  11. One year double blind study of high vs low frequency subcallosal cingulate stimulation for depression.

    Science.gov (United States)

    Eitan, Renana; Fontaine, Denys; Benoît, Michel; Giordana, Caroline; Darmon, Nelly; Israel, Zvi; Linesky, Eduard; Arkadir, David; Ben-Naim, Shiri; Iserlles, Moshe; Bergman, Hagai; Hulse, Natasha; Abdelghani, Mohamed; McGuffin, Peter; Farmer, Anne; DeLea, Peichel; Ashkan, Keyoumars; Lerer, Bernard

    2018-01-01

    Subcallosal Brodmann's Area 25 (Cg25) Deep Brain Stimulation (DBS) is a new promising therapy for treatment resistant major depressive disorder (TR-MDD). While different DBS stimulating parameters may have an impact on the efficacy and safety of the therapy, there is no data to support a protocol for optimal stimulation parameters for depression. Here we present a prospective multi-center double-blind randomized crossed-over 13-month study that evaluated the effects of High (130 Hz) vs Low (20 Hz) frequency Cg25 stimulation for nine patients with TR-MDD. Four out of nine patients achieved response criteria (≥40% reduction of symptom score) compared to mean baseline values at the end of the study. The mean percent change of MADRS score showed a similar improvement in the high and low frequency stimulation groups after 6 months of stimulation (-15.4 ± 21.1 and -14.7 ± 21.1 respectively). The mean effect at the end of the second period (6 months after cross-over) was higher than the first period (first 6 months of stimulation) in all patients (-23.4 ± 19.9 (n = 6 periods) and -13.0 ± 22 (n = 9 periods) respectively). At the end of the second period, the mean percent change of the MADRS scores improved more in the high than low frequency groups (-31.3 ± 19.3 (n = 4 patients) and -7.7 ± 10.9 (n = 2 patients) respectively). Given the small numbers, detailed statistical analysis is challenging. Nonetheless the results of this study suggest that long term high frequency stimulation might confer the best results. Larger scale, randomized double blind trials are needed in order to evaluate the most effective stimulation parameters. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. Evidence for a double dissociation of articulatory rehearsal and non-articulatory maintenance of phonological information in human verbal working memory.

    Science.gov (United States)

    Trost, Sarah; Gruber, Oliver

    2012-01-01

    Recent functional neuroimaging studies have provided evidence that human verbal working memory is represented by two complementary neural systems, a left lateralized premotor-parietal network implementing articulatory rehearsal and a presumably phylogenetically older bilateral anterior-prefrontal/inferior-parietal network subserving non-articulatory maintenance of phonological information. In order to corroborate these findings from functional neuroimaging, we performed a targeted behavioural study in patients with very selective and circumscribed brain lesions to key regions suggested to support these different subcomponents of human verbal working memory. Within a sample of over 500 neurological patients assessed with high-resolution structural magnetic resonance imaging, we identified 2 patients with corresponding brain lesions, one with an isolated lesion to Broca's area and the other with a selective lesion bilaterally to the anterior middle frontal gyrus. These 2 patients as well as groups of age-matched healthy controls performed two circuit-specific verbal working memory tasks. In this way, we systematically assessed the hypothesized selective behavioural effects of these brain lesions on the different subcomponents of verbal working memory in terms of a double dissociation. Confirming prior findings, the lesion to Broca's area led to reduced performance under articulatory rehearsal, whereas the non-articulatory maintenance of phonological information was unimpaired. Conversely, the bifrontopolar brain lesion was associated with impaired non-articulatory phonological working memory, whereas performance under articulatory rehearsal was unaffected. The present experimental neuropsychological study in patients with specific and circumscribed brain lesions confirms the hypothesized double dissociation of two complementary brain systems underlying verbal working memory in humans. In particular, the results demonstrate the functional relevance of the anterior

  13. Oral contraceptive use changes brain activity and mood in women with previous negative affect on the pill--a double-blinded, placebo-controlled randomized trial of a levonorgestrel-containing combined oral contraceptive.

    Science.gov (United States)

    Gingnell, Malin; Engman, Jonas; Frick, Andreas; Moby, Lena; Wikström, Johan; Fredrikson, Mats; Sundström-Poromaa, Inger

    2013-07-01

    Most women on combined oral contraceptives (COC) report high levels of satisfaction, but 4-10% complain of adverse mood effects. The aim of this randomized, double-blinded, placebo-controlled trial was to investigate if COC use would induce more pronounced mood symptoms than placebo in women with previous history of COC-induced adverse mood. A second aim was to determine if COC use is associated with changes in brain reactivity in regions previously associated with emotion processing. Thirty-four women with previous experience of mood deterioration during COC use were randomized to one treatment cycle with a levonorgestrel-containing COC or placebo. An emotional face matching task (vs. geometrical shapes) was administered during functional magnetic resonance imaging (fMRI) prior to and during the COC treatment cycle. Throughout the trial, women recorded daily symptom ratings on the Cyclicity Diagnoser (CD) scale. During the last week of the treatment cycle COC users had higher scores of depressed mood, mood swings, and fatigue than placebo users. COC users also had lower emotion-induced reactivity in the left insula, left middle frontal gyrus, and bilateral inferior frontal gyri as compared to placebo users. In comparison with their pretreatment cycle, the COC group had decreased emotion-induced reactivity in the bilateral inferior frontal gyri, whereas placebo users had decreased reactivity in the right amygdala. COC use in women who previously had experienced emotional side effects resulted in mood deterioration, and COC use was also accompanied by changes in emotional brain reactivity. These findings are of relevance for the understanding of how combined oral contraceptives may influence mood. Placebo-controlled fMRI studies in COC sensitive women could be of relevance for future testing of adverse mood effects in new oral contraceptives. Copyright © 2012 Elsevier Ltd. All rights reserved.

  14. RETRACTED: A randomized, double-blind comparison of granisetron alone and combined with dexamethasone for post—laparoscopic cholecystectomy emetic symptoms

    Directory of Open Access Journals (Sweden)

    Yoshitaka Fujii, MD

    2003-09-01

    Full Text Available This article has been retracted: please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/about/our-business/policies/article-withdrawal.This article has been retracted: please see Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy.The following articles are being retracted as a result of overwhelming evidence of fabrication, related to the fact that the distributions of many variables reported by Dr Fujii in these studies could not have occurred by chance, and the inability of Dr Fujii's institutions to attest to the integrity of the study and/or its data conducted under their auspices. Because both the Journal's independent and collaborative attempts have not yielded this required information, the Journal has decided to retract the remaining journal manuscripts authored by Dr. Yoshitaka Fujii. The Publisher apologises that the implementation of this retraction was delayed due to an administrative oversight.Fujii Y, Tanaka H, Kawasaki T. A randomised, double-blind comparison of granisetron alone and combined with dexamethasone for post-laparoscopic choleystectomy emetic symptoms. Current Therapeutic Research 2003;64:514–21. https://www.sciencedirect.com/science/article/pii/S0011393X03001590Fujii Y, Tanaka H, Somekawa Y. Treatment of postoperative emetic symptoms with granisetron in women undergoing abdominal hysterectomy: a randomised, double-blind, placebo-controlled, dose-ranging study. Current Therapeutic Research 2004;65:321–9. https://www.sciencedirect.com/science/article/pii/S0011393X04800018.

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

    Science.gov (United States)

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

    2017-12-01

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

  16. Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Barone Mark A

    2012-03-01

    Full Text Available Abstract Background A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. There are numerous challenges associated with providing fistula repair services in developing countries, including limited availability of operating rooms, equipment, surgeons with specialized skills, and funding from local or international donors to support surgeries and subsequent post-operative care. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity, lower costs of services, and potentially lower risk of healthcare-associated infections among fistula patients. There is a lack of empirical evidence supporting any particular length of time for urethral catheterization following fistula repair surgery. This study will examine whether short-term (7 day urethral catheterization is not worse by more than a minimal relevant difference to longer-term (14 day urethral catheterization in terms of incidence of fistula repair breakdown among women with simple fistula presenting at study sites for fistula repair service. Methods/Design This study is a facility-based, multicenter, non-inferiority randomized controlled trial (RCT comparing the new proposed short-term (7 day urethral catheterization to longer-term (14 day urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown up to three months following fistula repair surgery as assessed by a urinary dye test. Secondary outcomes will include repair breakdown one week following catheter removal, intermittent catheterization due to urinary retention and the occurrence of septic or febrile episodes, prolonged hospitalization for medical reasons, catheter blockage, and

  17. Effects of tonabersat on migraine with aura: a randomised, double-blind, placebo-controlled crossover study

    DEFF Research Database (Denmark)

    Hauge, Anne W; Asghar, Mohammed S; Schytz, Henrik W

    2009-01-01

    BACKGROUND: Migraine with aura is thought likely to be caused by cortical spreading depression (CSD). Tonabersat inhibits CSD, and we therefore investigated whether tonabersat has a preventive effect in migraine with aura. METHODS: In this randomised, double-blind, placebo-controlled crossover......, of whom 31 were included in the statistical analysis of efficacy. Median (IQR) attacks of aura were reduced from 3.2 (1.0-5.0) per 12 weeks on placebo to 1.0 (0-3.0) on tonabersat (p=0.01), whereas the other primary outcome measure, median migraine headache days with or without aura, was not significantly...... inhibitory effect on CSD. The results support the theory that auras are caused by CSD and that this phenomenon is not involved in attacks without aura. FUNDING: Minster Pharmaceuticals; Lundbeck Foundation....

  18. Stem cell mobilization induced by subcutaneous granulocyte-colony stimulating factor to improve cardiac regeneration after acute ST-elevation myocardial infarction: result of the double-blind, randomized, placebo-controlled stem cells in myocardial infarction (STEMMI) trial

    DEFF Research Database (Denmark)

    Ripa, Rasmus Sejersten; Jørgensen, Erik; Wang, Yongzhong

    2006-01-01

    BACKGROUND: Phase 1 clinical trials of granulocyte-colony stimulating factor (G-CSF) treatment after myocardial infarction have indicated that G-CSF treatment is safe and may improve left ventricular function. This randomized, double-blind, placebo-controlled trial aimed to assess the efficacy...... hours after symptom onset. Patients were randomized to double-blind treatment with G-CSF (10 microg/kg of body weight) or placebo for 6 days. The primary end point was change in systolic wall thickening from baseline to 6 months determined by cardiac magnetic resonance imaging (MRI). An independent core...

  19. Cryo-thawed embryo transfer: natural versus artificial cycle. A non-inferiority trial.(ANTARCTICA trial

    Directory of Open Access Journals (Sweden)

    Groenewoud Eva R

    2012-09-01

    Full Text Available Abstract Background Frozen thawed embryo transfer (FET is a cost- effective adjunct to IVF or IVF-ICSI treatment. In order to optimize treatment outcome, FET should be carried out during a period of optimal endometrial receptivity. To optimize implantation several methods for endometrium preparation have been proposed. In natural cycle FET (NC-FET, the endometrium develops under endogenous hormonal stimulation. The development of the dominant follicle and endometrium is monitored by ultrasound and FET is timed after triggering ovulation induction or determination of the spontaneous LH surge. In an artificial cycle FET (AC-FET estrogens and progesterone are administered to prepare the endometrium for implantation. While the currently available data show no significant difference in pregnancy rates between these methods, well designed randomized controlled trials are lacking. Moreover there is little literature on difference in cancellation rates, cost-efficiency and adverse events. Methods and design In this randomized, multi-centre, non-inferiority trial we aim to test the hypothesis that there is no significant difference in live birth rates between patients undergoing NC-FET versus AC-FET. The primary outcome will be live birth rate per embryo transfer procedure. Secondary outcomes will be ongoing and clinical pregnancy rate, cancellation rate, (serious adverse events and cost-efficiency. Based on a live birth rate of 20% and a minimal clinical important difference of 7,5% (one-sided alpha 2,5%, beta 20% a total of 1150 patients will be needed. Analyzes will be performed using both per protocol as well as intention to treat analyses. Discussion This prospective, randomized, noninferiority trial aims to address the hypothesis that there is no significant difference in live birth rates between patients undergoing NC-FET versus patients undergoing AC-FET. Moreover it addresses cost-efficiency as well as the perceived burden of both treatments

  20. Radiofrequency Coblation Versus Intramural Bipolar Cautery for the Treatment of Inferior Turbinate Hypertrophy.

    Science.gov (United States)

    Shah, Anil N; Brewster, Douglas; Mitzen, Kelly; Mullin, David

    2015-09-01

    Compare intramural bipolar electrocautery and radiofrequency coblation in the treatment of inferior turbinate hypertrophy with regards to objective and subjective improvement in nasal obstruction, rate and type of complications, experience during the procedure, and rate of recovery. Prospective, single-blinded study. Single tertiary medical center from 2008 to 2010. Forty-one adult patients with inferior turbinate hypertrophy refractory to medical management were treated with radiofrequency coblation in one nostril and intramural bipolar cautery in the other. Subjective and objective data, including use of a Visual Analog Scale (VAS) for subjective outcomes, acoustic rhinometry, and nasal endoscopy, were then obtained from each patient comparing the 2 techniques. Radiofrequency coblation was significantly less painful than intramural bipolar cautery during the procedure (P = .03) and during the early postoperative period (P measured by acoustic rhinometry and subjective VAS outcomes. Radiofrequency coblation seems to offer an equivalent alternative to bipolar electrocautery for the treatment of inferior turbinate hypertrophy with less discomfort during the procedure and early post-operative period. © The Author(s) 2015.

  1. Soy in hypercholesterolaemia: a double-blind, placebo-controlled trial.

    Science.gov (United States)

    Puska, P; Korpelainen, V; Høie, L H; Skovlund, E; Lahti, T; Smerud, K T

    2002-04-01

    To study whether Abacor, a product based on isolated soy protein with high and standardised levels of isoflavones and cotyledon soy fibres, was more effective in lowering total and LDL cholesterol than placebo. Randomised, placebo-controlled, double-blind, parallel group, single centre study. Primary care in Joensuu, North Karelia, Finland. Subjects were screened from the patient database of the health centre; 30 were randomised to the Abacor group and 30 subjects to placebo. Eight subjects were withdrawn, six from the active group, two from the placebo group. The preparations were given as two daily liquid supplements in addition to the subjects' regular diets for 6 weeks. Abacor showed a statistically significant lipid-lowering effect as compared to placebo, although an unexpected reduction was seen in the placebo group. The estimated difference between active treatment and placebo was 0.25 mmol/l (95% CI 0.01, 0.50; P=0.049) for total cholesterol, corresponding to reductions of 8.3 and 5.1%, respectively. The difference in reduction of LDL-cholesterol was 0.27 mmol/l (95% CI 0.06, 0.49; P=0.014) and corresponded to a reduction of 13.2% in the active treatment group, and 8.0% in the placebo group. Abacor showed a rapid onset of effect, as compared with placebo. During a wash-out period of 4 weeks after treatment, the subjects returned to pre-treatment cholesterol levels. Added to a regular diet, Abacor significantly reduced LDL-cholesterol and total cholesterol. These beneficial effects occurred within 6 weeks of treatment.

  2. Single-shot pectoral plane (PECs I and PECs II) blocks versus continuous local anaesthetic infusion analgesia or both after non-ambulatory breast-cancer surgery: a prospective, randomised, double-blind trial.

    Science.gov (United States)

    O'Scanaill, P; Keane, S; Wall, V; Flood, G; Buggy, D J

    2018-04-01

    Pectoral plane blocks (PECs) are increasingly used in analgesia for patients undergoing breast surgery, and were recently found to be at least equivalent to single-shot paravertebral anaesthesia. However, there are no data comparing PECs with the popular practice of continuous local anaesthetic wound infusion (LA infusion) analgesia for breast surgery. Therefore, we compared the efficacy and safety of PECs blocks with LA infusion, or a combination of both in patients undergoing non-ambulatory breast-cancer surgery. This single-centre, prospective, randomised, double-blind trial analysed 45 women to receive either PECs blocks [levobupivacaine 0.25%, 10 ml PECs I and levobupivacaine 0.25%, 20 ml PECs II (PECs group); LA infusion catheter (levobupivacaine 0.1% at 10 ml h -1 for 24 h (LA infusion group); or both (PECs and LA infusion)]. The primary outcome measure was area under the curve of the pain verbal rating score whilst moving vs time (AUC) over 24 h. Secondary outcomes included total opioid consumption at 24 h. AUC moving was mean (SD) 71 (34) mm h -1 vs 58 (41) vs 23 (20) in PECs, LA infusion, and both, respectively; P=0.002. AUC at rest was also significantly lower in patients receiving both. The total 24 h opioid consumption [median (25-75%)] was 14 mg (9-26) vs 11 (8-24) vs 9 (5-11); P=0.4. No adverse events were observed. The combination of both pre-incisional PECs blocks and postoperative LA infusion provides better analgesia over 24 h than either technique alone after non-ambulatory breast-cancer surgery. NCT 03024697. Copyright © 2018 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

  3. The effect of ranitidine on postoperative infectious complications following emergency colorectal surgery: a randomized, placebo-controlled, double-blind trial

    DEFF Research Database (Denmark)

    Moesgaard, F; Jensen, L S; Christiansen, P M

    1998-01-01

    AND TREATMENT: One hundred and ninety-four consecutive patients undergoing acute colorectal surgery for perforated and/or obstructed large bowel were randomized in a double-blind fashion to receive ranitidine 100 mg i.v. twice a day commencing at induction of anesthesia and continued for five days (group I...... patients were withdrawn from the study (for reasons such as other diagnosis, refused to continue, medication not given as prescribed). MAIN OUTCOME MEASURES: Patients were observed for signs of infectious complications; such as wound infection, intra-abdominal abscess, septicemia, and pneumonia. RESULTS...

  4. Prospective, randomized, open-label, blinded-endpoint (PROBE) designed trials yield the same results as double-blind, placebo-controlled trials with respect to ABPM measurements.

    Science.gov (United States)

    Smith, David H; Neutel, Joel M; Lacourcière, Yves; Kempthorne-Rawson, Joan

    2003-07-01

    This meta-analysis aimed to determine whether ambulatory blood pressure monitoring (ABPM) results from double-blind, placebo-controlled (DBPC) and prospective, randomized, open-label, blinded-endpoint (PROBE) hypertension trials are statistically comparable. Two DBPC and three PROBE parallel-group studies were selected from an angiotensin II receptor blocker clinical programme. These were fixed-dose studies involving similar mild to moderate hypertensive patient populations. All used SpaceLabs 90207 ABPM devices, and each comprised a 4-week placebo period and a 4-8-week treatment period. Data from patients receiving telmisartan 80 mg were used to compare the results of DBPC (126 patients) and PROBE (734 patients) trials. The analysis had approximately 87% power to show equivalence between the two design types in terms of ruling out differences of >or= 3 mmHg in SBP and >or= 2 mmHg in DBP. Office blood pressure was also compared. The change from baseline in mean 24-h ambulatory SBP was -12.2 mmHg in DBPC trials and -12.3 mmHg in PROBE trials, a rounded difference of 0.2 mmHg [95% confidence interval (CI): -1.8, 2.1]. The change from baseline in mean 24-h ambulatory DBP was -7.7 mmHg in DBPC trials versus -7.9 mmHg in PROBE trials, a difference of 0.2 mmHg (95% CI: -1.1, 1.5). Ambulatory pulse pressure results were identical. Thus, changes in mean 24-h ambulatory blood pressure from the DBPC and PROBE trials in this meta-analysis are statistically equivalent in terms of ruling out a difference of >or= 3 mmHg in SBP and >or= 2 mmHg in DBP. This supports the validity of the PROBE design in assessing antihypertensive efficacy based on blinded ABPM measurements.

  5. Effects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trial

    Directory of Open Access Journals (Sweden)

    Osborne Richard

    2007-09-01

    Full Text Available Abstract Background Whilst laterally wedged insoles, worn inside the shoes, are advocated as a simple, inexpensive, non-toxic self-administered intervention for knee osteoarthritis (OA, there is currently limited evidence to support their use. The aim of this randomised, double-blind controlled trial is to determine whether laterally wedges insoles lead to greater improvements in knee pain, physical function and health-related quality of life, and slower structural disease progression as well as being more cost-effective, than control flat insoles in people with medial knee OA. Methods/Design Two hundred participants with painful radiographic medial knee OA and varus malalignment will be recruited from the community and randomly allocated to lateral wedge or control insole groups using concealed allocation. Participants will be blinded as to which insole is considered therapeutic. Blinded follow up assessment will be conducted at 12 months after randomisation. The outcome measures are valid and reliable measures recommended for OA clinical trials. Questionnaires will assess changes in pain, physical function and health-related quality-of-life. Magnetic resonance imaging will measure changes in tibial cartilage volume. To evaluate cost-effectiveness, participants will record the use of all health-related treatments in a log-book returned to the assessor on a monthly basis. To test the effect of the intervention using an intention-to-treat analysis, linear regression modelling will be applied adjusting for baseline outcome values and other demographic characteristics. Discussion Results from this trial will contribute to the evidence regarding the effectiveness of laterally wedged insoles for the management of medial knee OA. Trial registration ACTR12605000503628; NCT00415259.

  6. Metformin efficacy and safety for colorectal polyps: a double-blind randomized controlled trial

    International Nuclear Information System (INIS)

    Higurashi, Takuma; Fujisawa, Nobutaka; Uchiyama, Shiori; Ezuka, Akiko; Nagase, Hajime; Kessoku, Takaomi; Matsuhashi, Nobuyuki; Yamanaka, Shoji; Inayama, Yoshiaki; Morita, Satoshi; Nakajima, Atsushi; Takahashi, Hirokazu; Endo, Hiroki; Hosono, Kunihiro; Yamada, Eiji; Ohkubo, Hidenori; Sakai, Eiji; Uchiyama, Takashi; Hata, Yasuo

    2012-01-01

    Colorectal cancer is one of the major neoplasms and a leading cause of cancer death worldwide, and new preventive strategies are needed to lower the burden of this disease. Metformin, a biguanide, which is widely used for treating diabetes mellitus, has recently been suggestive to have a suppressive effect on tumorigenesis and cancer cell growth. In a previous study conducted in non-diabetic subjects, we showed that oral short-term low-dose metformin suppressed the development of colorectal aberrant crypt foci (ACF). ACF have been considered as a useful surrogate biomarker of CRC, although the biological significance of these lesions remains controversial. We devised a prospective randomized controlled trial to evaluate the chemopreventive effect of metformin against metachronous colorectal polyps and the safety of this drug in non-diabetic post-polypectomy patients. This study is a multi-center, double-blind, placebo-controlled, randomized controlled trial to be conducted in non-diabetic patients with a recent history of undergoing colorectal polypectomy. All adult patients visiting the Yokohama City University hospital or affiliated hospitals for polypectomy shall be recruited for the study. Eligible patients will then be allocated randomly into either one of two groups: the metformin group and the placebo group. Patients in the metformin group shall receive oral metformin at 250 mg per day, and those in the placebo group shall receive an oral placebo tablet. At the end of 1 year of administration of metformin/placebo, colonoscopy will be performed to evaluate the polyp formation. This is the first study proposed to explore the effect of metformin against colorectal polyp formation. Metformin activates AMPK, which inhibits the mammalian target of rapamycin (mTOR) pathway. The mTOR pathway plays an important role in the cellular protein translational machinery and cell proliferation. Patients with type 2 diabetes taking under treatment with metformin have been

  7. Metformin efficacy and safety for colorectal polyps: a double-blind randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Higurashi Takuma

    2012-03-01

    Full Text Available Abstract Background Colorectal cancer is one of the major neoplasms and a leading cause of cancer death worldwide, and new preventive strategies are needed to lower the burden of this disease. Metformin, a biguanide, which is widely used for treating diabetes mellitus, has recently been suggestive to have a suppressive effect on tumorigenesis and cancer cell growth. In a previous study conducted in non-diabetic subjects, we showed that oral short-term low-dose metformin suppressed the development of colorectal aberrant crypt foci (ACF. ACF have been considered as a useful surrogate biomarker of CRC, although the biological significance of these lesions remains controversial. We devised a prospective randomized controlled trial to evaluate the chemopreventive effect of metformin against metachronous colorectal polyps and the safety of this drug in non-diabetic post-polypectomy patients. Methods/Design This study is a multi-center, double-blind, placebo-controlled, randomized controlled trial to be conducted in non-diabetic patients with a recent history of undergoing colorectal polypectomy. All adult patients visiting the Yokohama City University hospital or affiliated hospitals for polypectomy shall be recruited for the study. Eligible patients will then be allocated randomly into either one of two groups: the metformin group and the placebo group. Patients in the metformin group shall receive oral metformin at 250 mg per day, and those in the placebo group shall receive an oral placebo tablet. At the end of 1 year of administration of metformin/placebo, colonoscopy will be performed to evaluate the polyp formation. Discussion This is the first study proposed to explore the effect of metformin against colorectal polyp formation. Metformin activates AMPK, which inhibits the mammalian target of rapamycin (mTOR pathway. The mTOR pathway plays an important role in the cellular protein translational machinery and cell proliferation. Patients with

  8. The effects of an oral multivatimin combination with calcium, magnesium, and zinc on psychological well-being in healthy young male volunteers: A double-blind placebo-controlled trial.

    NARCIS (Netherlands)

    Carroll, D.; Ring, C.; Suter, M.; Willemsen, A.H.M.

    2000-01-01

    Rationale: Vitamin and mineral supplements may be associated with improved psychological status. Objective: The present study tested the effects of a multivitamin and mineral supplement (Berocca®) on psychological well-being. Methods: In a double-blind randomised-control trial, 80 healthy male

  9. Does granisetron eliminate the gag reflex? A crossover, double-blind, placebo-controlled pilot study.

    Science.gov (United States)

    Barenboim, Silvina Friedlander; Dvoyris, Vladislav; Kaufman, Eliezer

    2009-01-01

    Although gagging is a frequent problem that, when severe, can jeopardize the dental procedure, no single protocol is used to alleviate this phenomenon. Selective 5-HT3 antagonists, such as granisetron, may attenuate gagging. In this study, granisetron and placebo were administered intravenously, in a crossover, double-blind manner, to 25 healthy volunteers in 2 different sessions. Gagging levels were recorded before and after administration, as were BP, pulse, and O2 saturation. Recorded results were analyzed with the use of tests for nonparametric values (P = .05). A significant increase in the depth of swab insertion was noted after administration of both placebo and drug. The increase in drug effectiveness correlated with decreased body weight. The true efficacy of granisetron in gagger patients with this treatment protocol has yet to be fully established, although it has been theorized that an increased dosage of granisetron may have a better effect.

  10. Anxiety and methylphenidate in attention deficit hyperactivity disorder: a double-blind placebo-drug trial.

    Science.gov (United States)

    Moshe, Keren; Karni, Avi; Tirosh, Emanuel

    2012-09-01

    To examine the relationship between attention and anxiety and the response to methylphenidate in children with attention deficit hyperactivity disorder (ADHD), a total of 57 boys, between the ages of 7-12 years, were assessed for their attention and level of anxiety. Methylphenidate was administered for a week in a randomized double-blind drug/placebo-drug cross-over design. The levels of anxiety were evenly distributed between the inattentive and hyperactive/impulsive types. Anxiety was significantly correlated with the attention as reported by both teachers and parents. The response to methylphenidate was inversely correlated with the reported anxiety level only in boys with the hyperactive/impulsive and combined types. The higher the level of anxiety, the lower level of response to methylphenidate was observed. In the assessment and treatment of children with ADHD, the level of anxiety should be evaluated and taken into account while planning and monitoring treatment regiment.

  11. A Double-Blind, Randomised Study Comparing the Skin Hydration and Acceptability of Two Emollient Products in Atopic Eczema Patients with Dry Skin

    OpenAIRE

    Djokic-Gallagher, Jasmina; Rosher, Phil; Oliveira, Gabriela; Walker, Jennine

    2017-01-01

    Introduction Healthcare professionals tend to recommend emollients based primarily on patient/consumer preference and cost, with cheaper options assumed to be therapeutically equivalent. The aim of this study was therefore to compare the effects on skin hydration of two emollients prescribed in the UK, Doublebase Dayleve? gel (DELP) and a cheaper alternative, Zerobase Emollient? cream (ZBC). Methods This was a single-centre, randomised, double-blind, concurrent bi-lateral (within-patient) com...

  12. Efficacy and safety of the single-capsule combination of fluticasone/formoterol in patients with persistent asthma: a non-inferiority trial

    Directory of Open Access Journals (Sweden)

    Marti Antilla

    2014-12-01

    Full Text Available OBJECTIVE: Fluticasone and formoterol are effective in the treatment of asthma. When a corticosteroid alone fails to control asthma, combination therapy is the treatment of choice. The objective of this study was to compare the efficacy and safety of formulations containing budesonide/formoterol (BUD/FOR, fluticasone alone (FLU, and the single-capsule combination of fluticasone/formoterol (FLU/FOR on lung function in patients with mild-to-moderate persistent asthma. METHODS: This was a randomized, multicenter, open phase III trial conducted in Brazil. The primary efficacy analysis was the assessment of non-inferiority between FLU/FOR and BUD/FOR combinations regarding FEV1 (in L at the final visit. The secondary analyses were PEF, level of asthma control, serum cortisol levels, frequency of adverse events, adherence to treatment, and appropriate inhaler use. RESULTS: We randomized 243 patients to three groups: FLU/FOR (n = 79, BUD/FOR (n = 83, and FLU (n = 81. In terms of the mean FEV1 after 12 weeks of treatment, the difference between the FLU/FOR and BUD/FOR groups was 0.22 L (95% CI: −0.06 to 0.49, whereas the difference between the FLU/FOR and FLU groups was 0.26 L (95% CI: −0.002 to 0.52. Non-inferiority was demonstrated by the difference between the lower limits of the two 95% CIs (−0.06 vs. −0.002. The level of asthma control and PEF were significantly greater in the FLU/FOR and BUD/FOR groups than in the FLU group. There were no significant differences among the groups regarding patient adherence, patient inhaler use, or safety profile of the formulations. CONCLUSIONS: The single-capsule combination of FLU/FOR showed non-inferiority to the BUD/FOR and FLU formulations regarding efficacy and safety, making it a new treatment option for persistent asthma.

  13. High tie versus low tie of the inferior mesenteric artery in colorectal cancer: A meta-analysis.

    Science.gov (United States)

    Yang, Yafan; Wang, Guiying; He, Jingli; Zhang, Jianfeng; Xi, Jinchuan; Wang, Feifei

    2018-04-01

    Colorectal cancer surgery includes "high tie" and "low tie"of the inferior mesenteric artery(IMA). However, different ligation level is closely related to the blood supply of anastomosis, which may increase the leakage rate, and it is unclear which technique confers a lower anastomotic leakage rate(AL) and survival advantage. To compare the effectiveness and impact of inferior mesenteric artery (IMA) high ligation versus IMA low ligation on anastomotic leakage, lymph nodes yield rates and 5-year survival. A list of these studies, published in English from 1990 to 2017, was obtained independently by two reviewers from databases such as PubMed, Medline, ScienceDirect and Web of Science. Anastomotic leakage rate, the yield of lymph nodes and 5-year survival were compared using Review Manager 5.3. There was no significant difference in anastomotic leakage, number of lymph nodes retrieved and 5-year survival rate for both techniques. Neither the high tie nor the low tie strategy has an evidence in terms of anastomotic leakage rate, harvested lymph nodes, and the 5-year survival rate. Further RCT is needed. Copyright © 2018 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  14. Efficacy of kinesio taping on isokinetic quadriceps torque in knee osteoarthritis: a double blinded randomized controlled study.

    Science.gov (United States)

    Anandkumar, Sudarshan; Sudarshan, Shobhalakshmi; Nagpal, Pratima

    2014-08-01

    Double blind pre-test post-test control group design. To compare the isokinetic quadriceps torque, standardized stair-climbing task (SSCT) and pain during SSCT between subjects diagnosed with knee osteoarthritis pre and post kinesio tape (KT) application with and without tension. Strength of the quadriceps and torque producing capability is frequently found to be compromised in knee osteoarthritis. The efficacy of KT in improving isokinetic quadriceps torque in knee osteoarthritis is unknown, forming the basis for this study. Forty subjects were randomly allocated to either the experimental (therapeutic KT with tension) or control group (sham KT without tension) with the allocation being concealed. Pre and post test measurements of isokinetic quadriceps torque, SSCT and pain during SSCT were carried out by a blinded assessor. A large effect size with significant improvements in the peak quadriceps torque (concentric and eccentric at angular velocities of 90° per second and 120° per second), SSCT and pain were obtained in the experimental group when compared to the control group. Application of therapeutic KT is effective in improving isokinetic quadriceps torque, SSCT and reducing pain in knee osteoarthritis.

  15. Randomized, Double-Blind, and Placebo-Controlled Clinic Report of Intranasal Low-Intensity Laser Therapy on Vascular Diseases

    Directory of Open Access Journals (Sweden)

    Timon Cheng-Yi Liu

    2012-01-01

    Full Text Available The intranasal low intensity GaInP/AlGaInP diode 650 nm laser therapy (ILGLT might improve blood lipid and hemorheologic behavior of patients in view of its previous research, but it should be further supported by a randomized, double-blind, and placebo-controlled clinical study. In this paper, 90 patients with coronary heart disease or cerebral infarction were randomly divided into two groups, 60 in the treatment group and 30 in the control group, and were blindly treated with ILGLT at 8.38 and 0 mW/cm2 for 30 min each time once a day ten days each session for two sessions between which there were three days for rest, respectively. Fasting blood lipid such as total cholesterol and low/high-density lipoprotein cholesterol and hemorheologic behavior such as blood viscosity, plasma viscosity, redox viscosity and red blood cell aggregation were assessed before the first treatment and after the two sessions and were found to be significantly improved by ILGLT. It was concluded that ILGLT may improve blood lipid and hemorheologic behavior of patients with coronary heart disease or cerebral infarction.

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

    Science.gov (United States)

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

    2015-03-07

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

  17. Reducing sample size by combining superiority and non-inferiority for two primary endpoints in the Social Fitness study.

    Science.gov (United States)

    Donkers, Hanneke; Graff, Maud; Vernooij-Dassen, Myrra; Nijhuis-van der Sanden, Maria; Teerenstra, Steven

    2017-01-01

    In randomized controlled trials, two endpoints may be necessary to capture the multidimensional concept of the intervention and the objectives of the study adequately. We show how to calculate sample size when defining success of a trial by combinations of superiority and/or non-inferiority aims for the endpoints. The randomized controlled trial design of the Social Fitness study uses two primary endpoints, which can be combined into five different scenarios for defining success of the trial. We show how to calculate power and sample size for each scenario and compare these for different settings of power of each endpoint and correlation between them. Compared to a single primary endpoint, using two primary endpoints often gives more power when success is defined as: improvement in one of the two endpoints and no deterioration in the other. This also gives better power than when success is defined as: improvement in one prespecified endpoint and no deterioration in the remaining endpoint. When two primary endpoints are equally important, but a positive effect in both simultaneously is not per se required, the objective of having one superior and the other (at least) non-inferior could make sense and reduce sample size. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. The SPECT tracer [123I]ADAM binds selectively to serotonin transporters: a double-blind, placebo-controlled study in healthy young men

    International Nuclear Information System (INIS)

    Giessen, Elsmarieke van de; Booij, Jan

    2010-01-01

    The tracer 123 I-2-([2-({dimethylamino}methyl)phenyl]thio)-5-iodophenylamine ([ 123 I]ADAM) has been developed to image serotonin transporters (SERTs) with SPECT. Preclinical studies have shown that [ 123 I]ADAM binds selectively to SERTs. Moreover, initial human studies have shown that [ 123 I]ADAM binding could be blocked by selective serotonin reuptake inhibitors (SSRIs). However, in humans it has not been proven that [ 123 I]ADAM binds selectively to SERTs. We examined the in vivo availability of SERTs in 12 healthy young volunteers 5 h after bolus injection of [ 123 I]ADAM. To evaluate the selectivity of binding, four participants were pretreated (double-blinded design) with placebo, four with paroxetine (20 mg) and four with the dopamine/norepinephrine blocker methylphenidate (20 mg). SPECT studies were performed on a brain-dedicated system (Neurofocus), and the SPECT images were coregistered with individual MR scans of the brain. ADAM binding in SERT-rich brain areas and cerebellar cortex (representing non-specific binding) was assessed by drawing regions of interest (ROIs) on the individual MR images. Specific to non-specific ratios were used as the outcome measure. We found that specific to non-specific ratios were statistically significantly lower in paroxetine-pretreated participants than in placebo- or methylphenidate-pretreated participants. No such difference was found between groups pretreated with placebo or methylphenidate. Our preliminary findings suggest that [ 123 I]ADAM binds selectively to SERTs in human brain. (orig.)

  19. The Sokoto blind beggars: causes of blindness and barriers to rehabilitation services.

    Science.gov (United States)

    Balarabe, Aliyu Hamza; Mahmoud, Abdulraheem O; Ayanniyi, Abdulkabir Ayansiji

    2014-01-01

    To determine the causes of blindness and the barriers to accessing rehabilitation services (RS) among blind street beggars (bsb) in Sokoto, Nigeria. A cross-sectional survey of 202 bsb (VA blindness were diagnosed by clinical ophthalmic examination. There were 107 (53%) males and 95 (47%) females with a mean age of 49 years (SD 12.2). Most bsb 191 (94.6%) had non-formal education. Of 190 (94.1%) irreversibly bsb, 180/190 (94.7%) had no light perception (NPL) bilaterally. The major causes of blindness were non-trachomatous corneal opacity (60.8%) and trachoma corneal opacity (12.8%). There were 166 (82%) blind from avoidable causes and 190 (94.1%) were irreversibly blind with 76.1% due to avoidable causes. The available sub-standard RS were educational, vocational and financial support. The barriers to RS in the past included non-availability 151 (87.8%), inability to afford 2 (1.2%), unfelt need 4 (2.3%), family refusal 1 (0.6), ignorance 6 (3.5%) and being not linked 8 (4.7%). The barriers to RS during the study period included inability of 72 subjects (35.6%) to access RS and 59 (81.9%) were due to lack of linkage to the existing services. Corneal opacification was the major cause of blindness among bsb. The main challenges to RS include the inadequate services available, societal and users factors. Renewed efforts are warranted toward the prevention of avoidable causes of blindness especially corneal opacities. The quality of life of the blind street beggar should be improved through available, accessible and affordable well-maintained and sustained rehabilitation services.

  20. Double skin façade: Modelling technique and influence of venetian blinds on the airflow and heat transfer

    International Nuclear Information System (INIS)

    Iyi, Draco; Hasan, Reaz; Penlington, Roger; Underwood, Chris

    2014-01-01

    The demand to reduce building cooling load and annual energy consumption can be optimised with the use of Double Skin Facade (DSF). Computational Fluid Dynamics (CFD) methods are frequently used for the analysis of heat transfer through DSF. However, considerable uncertainty exists regarding few key parameters, such as modelling strategies and the solar heat transmitted to the indoor space as a function of the blind tilt angles and positioning within the façade channel. In this paper we have investigated four modelling strategies and the influence of blind tilt angle and their proximity to the façade walls. The DSF system used in this investigation is equipped with venetian blinds and facades that absorb and reflect the incident solar radiation and transfer the direct solar heat gain into the building. A finite volume discretization method with the SIMPLE solution algorithm of the velocity-pressure coupling involving the low-turbulence k–ε model is used. A ray-traced solar model is coupled with long wave radiation model to solve the complete solar and radiation fields along with convection and conduction fields. On the modelling strategies, three dimensional domains were cast over three computational zones; external zone with solar radiation entering the outer skin of glass; buoyancy-driven air cavity zone with convection and transmitted solar radiation; and an internal zone. Also investigated is the thermal behaviour of the DSF due to the blind tilt angles (30°, 45°, 60°, and 75°) and its position from the facade walls (104 mm, 195 mm, 287 mm and 379 mm). Validations of the results are based on experimental data from the literature and the predicted trends compared very well with the experimental measurements. The heat gain due to direct solar radiation and convection through the facades to the internal space are presented. Comparative analysis of the four modelling strategies shows little variation of the results. The implication is a reduction in

  1. A six-month double-blind, placebo-controlled, randomized clinical trial of duloxetine for the treatment of fibromyalgia

    Directory of Open Access Journals (Sweden)

    Amy S Chappell

    2008-12-01

    Full Text Available Amy S Chappell1, Laurence A Bradley2, Curtis Wiltse1, Michael J Detke1,3,4, Deborah N D’Souza1, Michael Spaeth51Lilly Research Laboratories, Indianapolis, IN, USA; 2University of Alabama at Birmingham, Birmingham, Alabama, USA; 3Indiana University School of Medicine, Indianapolis, IN, USA; 4Harvard Medical School, Boston, MA, USA; 5Practice for Internal Medicine/Rheumatology, Graefelfing, GermanyObjective: Assess the efficacy of duloxetine 60/120 mg (N = 162 once daily compared with placebo (N = 168 in the treatment of patients with fibromyalgia, during six months of treatment.Methods: This was a phase-III, randomized, double-blind, placebo-controlled, parallel-group study assessing the efficacy and safety of duloxetine.Results: There were no significant differences between treatment groups on the co-primary efficacy outcome measures, change in the Brief Pain Inventory (BPI average pain severity from baseline to endpoint (P = 0.053 and the Patient’s Global Impressions of Improvement (PGI-I at endpoint (P = 0.073. Duloxetine-treated patients improved significantly more than placebo-treated patients on the Fibromyalgia Impact Questionnaire pain score, BPI least pain score and average interference score, Clinical Global Impressions of Severity scale, area under the curve of pain relief, Multidimensional Fatigue Inventory mental fatigue dimension, Beck Depression Inventory-II total score, and 36-item Short Form Health Survey mental component summary and mental health score. Nausea was the most common treatment-emergent adverse event in the duloxetine group. Overall discontinuation rates were similar between groups.Conclusions: Although duloxetine 60/120 mg/day failed to demonstrate significant improvement over placebo on the co-primary outcome measures, in this supportive study, duloxetine demonstrated significant improvement compared with placebo on numerous secondary measures.Keywords: fibromyalgia, duloxetine, placebo, double-blind, trial

  2. Is magnetotherapy applied to bilateral hips effective in ankylosing spondylitis patients? A randomized, double-blind, controlled study.

    Science.gov (United States)

    Turan, Yasemin; Bayraktar, Kevser; Kahvecioglu, Fatih; Tastaban, Engin; Aydin, Elif; Kurt Omurlu, Imran; Berkit, Isil Karatas

    2014-03-01

    This double-blind, randomized controlled study was conducted with the aim to investigate the effect of magnetic field therapy applied to the hip region on clinical and functional status in ankylosing spondylitis (AS) patients. Patients with AS (n = 66) who were diagnosed according to modified New York criteria were enrolled in this study. Patients were randomly divided in two groups. Participants were randomly assigned to receive magnetic field therapy (2 Hz) (n = 35), or placebo magnetic field therapy (n = 31) each hip region for 20 min. Patients in each group were given heat pack and short-wave treatments applied to bilateral hip regions. Both groups had articular range of motion and stretching exercises and strengthening exercises for surrounding muscles for the hip region as well as breathing and postural exercises by the same physical therapist. These treatment protocols were continued for a total of 15 sessions (1 session per day), and patients were examined by the same physician at months 1, 3 and 6. Visual analogue scale (VAS) pain, VAS fatigue, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrologic Index (BASMI), DFI, Harris hip assessment index and Ankylosing Spondylitis Quality of Life scale (ASQOL) were obtained at the beginning of therapy and at month 1, month 3 and month 6 for each patient. There were no significant differences between groups in the VAS pain, VAS fatigue, morning stiffness, BASDAI, BASFI, BASMI, DFI, Harris hip assessment index and ASQoL at baseline, month 1, month 3 or month 6 (p > 0.05). Further randomized, double-blind controlled studies are needed in order to establish the evidence level for the efficacy of modalities with known analgesic and anti-inflammatory action such as magnetotherapy, particularly in rheumatic disorders associated with chronic pain.

  3. A randomized, non-inferiority study comparing efficacy and safety of a single dose of pegfilgrastim versus daily filgrastim in pediatric patients after autologous peripheral blood stem cell transplant.

    Directory of Open Access Journals (Sweden)

    Simone Cesaro

    Full Text Available PURPOSE: To assess the non-inferiority of pegfilgrastim versus filgrastim in speeding the recovery of polymorphonuclear cells (PMN in pediatric patients who underwent autologous peripheral blood stem cell transplant (PBSCT. METHODS: The sample size of this randomized, multicenter, phase III study, was calculated assuming that a single dose of pegfilgrastim of 100 ug/kg was not inferior to 9 doses of filgrastim of 5 ug/kg/day. Randomization was performed by a computer-generated list and stored by sequentially numbered sealed envelopes. RESULTS: Sixty-one patients, with a median age of 11.5 years, were recruited: 29 in the filgrastim arm and 32 in the pegfilgrastim arm. Twenty percent were affected by lymphoma/leukaemia and eighty percent by solid tumors. The mean time to PMN engraftment was 10.48 days (standard deviation [SD] 1.57 and 10.44 days (SD 2.44 in the filgrastim and pegfilgrastim arms, respectively. Having fixed a non-inferiority margin Delta of 3, the primary endpoint of non-inferiority was reached. No differences were observed for other secondary endpoints: platelet engraftment, mean time to platelet recovery (28 days vs. 33 days, fever of unknown origin (79% vs. 78%, proven infection (34% vs. 28%, mucositis (76% vs. 59%. After a median follow-up of 2.3 years (95% C.I.: 1.5, 3.3, 20 deaths were observed due to disease progression. CONCLUSIONS: We conclude that pegfilgrastim was not inferior to daily filgrastim in pediatric patients who underwent PBSCT. EU CLINICAL TRIAL REGISTER NUMBER: 2007-001430-14.

  4. The effects of additional care by a pulmonary nurse for asthma and COPD patients at a respiratory outpatient clinic: results from a double blind, randomized clinical trial

    NARCIS (Netherlands)

    Rootmensen, Geert N.; van Keimpema, Anton R. J.; Looysen, Elske E.; van der Schaaf, Letty; de Haan, Rob J.; Jansen, Henk M.

    2008-01-01

    OBJECTIVE: To assess the effects of additional information based nursing care program in the treatment of asthma and COPD patients at a pulmonary outpatient clinic. METHODS: In a double blind, randomized clinical trial, 191 patients were allocated to an additional care group or control group.

  5. Does short-term exposure to mobile phone base station signals increase symptoms in individuals who report sensitivity to electromagnetic fields? A double-blind randomized provocation study.

    Science.gov (United States)

    Eltiti, Stacy; Wallace, Denise; Ridgewell, Anna; Zougkou, Konstantina; Russo, Riccardo; Sepulveda, Francisco; Mirshekar-Syahkal, Dariush; Rasor, Paul; Deeble, Roger; Fox, Elaine

    2007-11-01

    Individuals with idiopathic environmental illness with attribution to electromagnetic fields (IEI-EMF) believe they suffer negative health effects when exposed to electromagnetic fields from everyday objects such as mobile phone base stations. This study used both open provocation and double-blind tests to determine if sensitive and control individuals experience more negative health effects when exposed to base station-like signals compared with sham. Fifty-six self-reported sensitive and 120 control participants were tested in an open provocation test. Of these, 12 sensitive and 6 controls withdrew after the first session. The remainder completed a series of double-blind tests. Subjective measures of well-being and symptoms as well as physiological measures of blood volume pulse, heart rate, and skin conductance were obtained. During the open provocation, sensitive individuals reported lower levels of well-being in both the global system for mobile communication (GSM) and universal mobile telecommunications system (UMTS) compared with sham exposure, whereas controls reported more symptoms during the UMTS exposure. During double-blind tests the GSM signal did not have any effect on either group. Sensitive participants did report elevated levels of arousal during the UMTS condition, whereas the number or severity of symptoms experienced did not increase. Physiological measures did not differ across the three exposure conditions for either group. Short-term exposure to a typical GSM base station-like signal did not affect well-being or physiological functions in sensitive or control individuals. Sensitive individuals reported elevated levels of arousal when exposed to a UMTS signal. Further analysis, however, indicated that this difference was likely to be due to the effect of order of exposure rather than the exposure itself.

  6. Identification of the rctA Gene, Which Is Required for Repression of Conjugative Transfer of Rhizobial Symbiotic Megaplasmids†

    Science.gov (United States)

    Pérez-Mendoza, Daniel; Sepúlveda, Edgardo; Pando, Victoria; Muñoz, Socorro; Nogales, Joaquina; Olivares, José; Soto, Maria J.; Herrera-Cervera, José A.; Romero, David; Brom, Susana; Sanjuán, Juan

    2005-01-01

    An analysis of the conjugative transfer of pRetCFN42d, the symbiotic plasmid (pSym) of Rhizobium etli, has revealed a novel gene, rctA, as an essential element of a regulatory system for silencing the conjugative transfer of R. etli pSym by repressing the transcription of conjugal transfer genes in standard laboratory media. The rctA gene product lacks sequence conservation with other proteins of known function but may belong to the winged-helix DNA-binding subfamily of transcriptional regulators. Similar to that of many transcriptional repressors, rctA transcription seems to be positively autoregulated. rctA expression is greatly reduced upon overexpression of another gene, rctB, previously identified as a putative activator of R. etli pSym conjugal transfer. Thus, rctB seems to counteract the repressive action of rctA. rctA homologs are present in at least three other bacterial genomes within the order Rhizobiales, where they are invariably located adjacent to and divergently transcribed from putative virB-like operons. We show that similar to that of R. etli pSym, conjugative transfer of the 1.35-Mb symbiotic megaplasmid A of Sinorhizobium meliloti is also subjected to the inhibitory action of rctA. Our data provide strong evidence that the R. etli and S. meliloti pSym plasmids are indeed self-conjugative plasmids and that this property would only be expressed under optimal, as yet unknown conditions that entail inactivation of the rctA function. The rctA gene seems to represent novel but probably widespread regulatory systems controlling the transfer of conjugative elements within the order Rhizobiales. PMID:16237017

  7. Baclofen for maintenance treatment of opioid dependence: A randomized double-blind placebo-controlled clinical trial [ISRCTN32121581

    Directory of Open Access Journals (Sweden)

    Ahmadi-Abhari Seyed Ali

    2003-11-01

    Full Text Available Abstract Background Results of preclinical studies suggest that the GABAB receptor agonist baclofen may be useful in treatment of opioid dependence. This study was aimed at assessing the possible efficacy of baclofen for maintenance treatment of opioid dependence. Methods A total of 40 opioid-dependent patients were detoxified and randomly assigned to receive baclofen (60 mg/day or placebo in a 12-week, double blind, parallel-group trial. Primary outcome measure was retention in treatment. Secondary outcome measures included opioids and alcohol use according to urinalysis and self-report ratings, intensity of opioid craving assessed with a visual analogue scale, opioid withdrawal symptoms as measured by the Short Opiate Withdrawal Scale and depression scores on the Hamilton inventory. Results Treatment retention was significantly higher in the baclofen group. Baclofen also showed a significant superiority over placebo in terms of opiate withdrawal syndrome and depressive symptoms. Non-significant, but generally favorable responses were seen in the baclofen group with other outcome measures including intensity of opioid craving and self-reported opioid and alcohol use. However, no significant difference was seen in the rates of opioid-positive urine tests. Additionally, the drug side effects of the two groups were not significantly different. Conclusion The results support further study of baclofen in the maintenance treatment of opioid dependence.

  8. Randomized, double-blind, placebo-controlled trial using lidocaine patch 5% in traumatic rib fractures.

    Science.gov (United States)

    Ingalls, Nichole K; Horton, Zachary A; Bettendorf, Matthew; Frye, Ira; Rodriguez, Carlos

    2010-02-01

    The lidocaine patch 5% was developed to treat postherpetic neuralgia. Anecdotal experience at our institution suggests the lidocaine patch 5% decreases narcotic usage in patients with traumatic rib fractures. This trial was developed to define the patch's efficacy. Patients with rib fractures admitted to the trauma service at our Level I trauma center were enrolled and randomized in a 1 to 1 double-blind manner to receive a lidocaine patch 5% or placebo patch. Fifty-eight patients who met the inclusion criteria were enrolled from January 2007 to August 2008. Demographic and clinical information were recorded. The primary outcomes variable was total narcotic use, analyzed using the 1-tailed Mann-Whitney test. The secondary outcomes variables included non-narcotic pain medication, average pain score, pulmonary complications, and length of stay. Significance was defined based on a 1-sided test for the primary outcome and 2-sided tests for other comparisons, at p rib fractures, gender, trauma mechanism, preinjury lung disease, smoking history, percent of current smokers, and need for placement of chest tube between the lidocaine patch 5% and placebo groups. There was no difference between the lidocaine patch 5% and placebo groups, respectively, with regard to total IV narcotic usage: median, 0.23 units versus 0.26 units; total oral narcotics: median, 4 units versus 7 units; pain score: 5.6 +/- 0.4 versus 6.0 +/- 0.3 (mean +/- SEM); length of stay: 7.8 +/- 1.1 versus 6.2 +/- 0.7; or percentage of patients with pulmonary complications: 72.7% versus 72.0%. The lidocaine patch 5% does not significantly improve pain control in polytrauma patients with traumatic rib fractures.

  9. Gluten causes gastrointestinal symptoms in subjects without celiac disease: a double-blind randomized placebo-controlled trial.

    Science.gov (United States)

    Biesiekierski, Jessica R; Newnham, Evan D; Irving, Peter M; Barrett, Jacqueline S; Haines, Melissa; Doecke, James D; Shepherd, Susan J; Muir, Jane G; Gibson, Peter R

    2011-03-01

    Despite increased prescription of a gluten-free diet for gastrointestinal symptoms in individuals who do not have celiac disease, there is minimal evidence that suggests that gluten is a trigger. The aims of this study were to determine whether gluten ingestion can induce symptoms in non-celiac individuals and to examine the mechanism. A double-blind, randomized, placebo-controlled rechallenge trial was undertaken in patients with irritable bowel syndrome in whom celiac disease was excluded and who were symptomatically controlled on a gluten-free diet. Participants received either gluten or placebo in the form of two bread slices plus one muffin per day with a gluten-free diet for up to 6 weeks. Symptoms were evaluated using a visual analog scale and markers of intestinal inflammation, injury, and immune activation were monitored. A total of 34 patients (aged 29-59 years, 4 men) completed the study as per protocol. Overall, 56% had human leukocyte antigen (HLA)-DQ2 and/or HLA-DQ8. Adherence to diet and supplements was very high. Of 19 patients (68%) in the gluten group, 13 reported that symptoms were not adequately controlled compared with 6 of 15 (40%) on placebo (P=0.0001; generalized estimating equation). On a visual analog scale, patients were significantly worse with gluten within 1 week for overall symptoms (P=0.047), pain (P=0.016), bloating (P=0.031), satisfaction with stool consistency (P=0.024), and tiredness (P=0.001). Anti-gliadin antibodies were not induced. There were no significant changes in fecal lactoferrin, levels of celiac antibodies, highly sensitive C-reactive protein, or intestinal permeability. There were no differences in any end point in individuals with or without DQ2/DQ8. "Non-celiac gluten intolerance" may exist, but no clues to the mechanism were elucidated.

  10. The efficacy of cetirizine hydrochloride on the pruritus of cats with atopic dermatitis: a randomized, double-blind, placebo-controlled, crossover study.

    Science.gov (United States)

    Wildermuth, Kerstin; Zabel, Sonja; Rosychuk, Rod A W

    2013-12-01

    Various antihistamines have been used in the management of feline atopic dermatitis, with variable reported benefit. To date, there have been no randomized, double-blind, placebo-controlled, crossover clinical trials on the use of this drug class in cats. To evaluate the clinical efficacy of cetirizine hydrochloride for the control of pruritus and dermatitis in cats diagnosed with atopic dermatitis. In this randomized, double-blind, placebo-controlled crossover clinical trial, 21 client-owned cats diagnosed with mild to moderate nonseasonal atopic dermatitis were randomly assigned to two groups. Cats in each group received either 1 mg/kg cetirizine hydrochloride or placebo once daily per os for 28 days followed by a 14 day wash-out period. Treatments were then crossed over, and cats received placebo or cetirizine hydrochloride for another 28 days. Owners marked a pruritus severity scale before inclusion in the study and weekly throughout the entire study period. Lesions were scored by the clinician using a Canine Atopic Dermatitis Extent and Severity Index (CADESI)-03 modified for the cat before enrolment and at day 28 of each treatment. Nineteen cats completed the study. There were no statistically significant differences between treatment with cetirizine hydrochloride and placebo for modified CADESI-03 or pruritus scores. This study suggests that cetirizine hydrochloride cannot be recommended for the management of feline atopic dermatitis. © 2013 ESVD and ACVD.

  11. Telemedicine in the management of non-acute headaches: A prospective, open-labelled non-inferiority, randomised clinical trial.

    Science.gov (United States)

    Müller, Kai I; Alstadhaug, Karl B; Bekkelund, Svein I

    2017-08-01

    Objectives We determined headache patients' satisfaction with telemedicine and assessed how telemedicine influenced headache burden, compliance with diagnosis and treatment, and need for follow-up consultations. Methods During 2.5 years, patients from Northern Norway referred with non-acute headaches for a specialist consultation at Tromsø University Hospital were consecutively randomised to either telemedicine or traditional visits. Baseline data were recorded and compared to data from a three-month follow-up questionnaire (see Supplementary material). The following were evaluated: (1) satisfaction with the consultation; (2) headache status; subjective improvement, average pain intensity, treatment, headache days per month, and Headache Impact Test (HIT-6); and (3) treatment compliance and follow-up visits. Results Out of 402 consultations, 348 (86.6%) answered the questionnaire. Satisfaction was similar in the telemedicine and the traditional group (88.8% vs. 92.3%; p = 0.35). Subgroup analyses were not prespecified, but there were no differences in satisfaction among females, migraineurs, rural patients and urban patients. Improvement from baseline after three months was reported equally in the telemedicine and the traditional groups. There were also no differences in treatment compliance, but rural telemedicine patients had less-frequent headache visits at three months' follow-up (28.9% vs. 48.7%, p = 0.002). Conclusion Telemedicine is non-inferior to traditional consultations in patient satisfaction, specialist evaluation, and treatment of non-acute headaches. ClinicalTrials.gov ID: NCT02270177.

  12. Double-blind, placebo-controlled study of dialectical behavior therapy plus olanzapine for borderline personality disorder.

    Science.gov (United States)

    Soler, Joaquim; Pascual, Juan Carlos; Campins, Josefa; Barrachina, Judith; Puigdemont, Dolors; Alvarez, Enrique; Pérez, Victor

    2005-06-01

    The aim of this study was to determine the efficacy and safety of dialectical behavior therapy plus olanzapine compared with dialectical behavior therapy plus placebo in patients with borderline personality disorder. Sixty patients with borderline personality disorder were included in a 12-week, double-blind, placebo-controlled study. All patients received dialectical behavior therapy and were randomly assigned to receive either olanzapine or placebo following a 1-month baseline period. Seventy percent of the patients completed the 4-month trial. Combined treatment showed an overall improvement in most symptoms studied in both groups. Olanzapine was associated with a statistically significant improvement over placebo in depression, anxiety, and impulsivity/aggressive behavior. The mean dose of olanzapine was 8.83 mg/day. A combined psychotherapeutic plus pharmacological approach appears to lower dropout rates and constitutes an effective treatment for borderline personality disorder.

  13. A double-blind placebo-controlled trial of omeprazole on urinary pH in healthy subjects

    DEFF Research Database (Denmark)

    Osther, P J; Rasmussen, L; Pedersen, S A

    1992-01-01

    Urinary pH is related to urinary calculus formation as well as urinary infection. Omeprazole is an effective inhibitor of gastric acid secretion through inhibition of the parietal cell H+K+ATPase. In this study we have evaluated a possible effect of omeprazole on urine acidification. Ten healthy...... male subjects took placebo and omeprazole, 40 mg o.m., for 10 days in a double-blind placebo-controlled trial. Morning fasting urinary pH was measured on day 10 of each treatment course using a pH meter. No effect of omeprazole on urinary pH could be demonstrated. It is thus unlikely...... that it is necessary to take omeprazole treatment into consideration in stone screening. As omeprazole did not affect urinary pH, no urological side effects related to changes in urinary pH can be expected....

  14. Double Regge model for non diffractive A1 production

    International Nuclear Information System (INIS)

    Anjos, J.C.; Endler, A.; Santoro, A.; Simao, F.R.A.

    1977-07-01

    A Reggeized double-nucleon-exchange model is shown to be able to to reproduce qualitatively the non-diffractive A 1 production recently observed in the reaction K - p → Σ - π + π - π + at 4.15 GeV/c

  15. Dual-layer spectral detector CT: non-inferiority assessment compared to dual-source dual-energy CT in discriminating uric acid from non-uric acid renal stones ex vivo.

    Science.gov (United States)

    Ananthakrishnan, Lakshmi; Duan, Xinhui; Xi, Yin; Lewis, Matthew A; Pearle, Margaret S; Antonelli, Jodi A; Goerne, Harold; Kolitz, Elysha M; Abbara, Suhny; Lenkinski, Robert E; Fielding, Julia R; Leyendecker, John R

    2018-04-07

    To assess the non-inferiority of dual-layer spectral detector CT (SDCT) compared to dual-source dual-energy CT (dsDECT) in discriminating uric acid (UA) from non-UA stones. Fifty-seven extracted urinary calculi were placed in a cylindrical phantom in a water bath and scanned on a SDCT scanner (IQon, Philips Healthcare) and second- and third-generation dsDECT scanners (Somatom Flash and Force, Siemens Healthcare) under matched scan parameters. For SDCT data, conventional images and virtual monoenergetic reconstructions were created. A customized 3D growing region segmentation tool was used to segment each stone on a pixel-by-pixel basis for statistical analysis. Median virtual monoenergetic ratios (VMRs) of 40/200, 62/92, and 62/100 for each stone were recorded. For dsDECT data, dual-energy ratio (DER) for each stone was recorded from vendor-specific postprocessing software (Syngo Via) using the Kidney Stones Application. The clinical reference standard of X-ray diffraction analysis was used to assess non-inferiority. Area under the receiver-operating characteristic curve (AUC) was used to assess diagnostic performance of detecting UA stones. Six pure UA, 47 pure calcium-based, 1 pure cystine, and 3 mixed struvite stones were scanned. All pure UA stones were correctly separated from non-UA stones using SDCT and dsDECT (AUC = 1). For UA stones, median VMR was 0.95-0.99 and DER 1.00-1.02. For non-UA stones, median VMR was 1.4-4.1 and DER 1.39-1.69. SDCT spectral reconstructions demonstrate similar performance to those of dsDECT in discriminating UA from non-UA stones in a phantom model.

  16. RCT: Module 2.08, Radiological Source Control, Course 8774

    Energy Technology Data Exchange (ETDEWEB)

    Hillmer, Kurt T. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-08-10

    radioactive source is material used for its emitted radiation. Sources are sealed or unsealed and are classified as accountable or exempt. Radioactive sources are used for response checks, functional checks, and the calibration of instruments and monitors to traceable standards. To ensure the safety and welfare of all personnel, it is important to maintain control of radioactive sources to minimize the potential for the spread of contamination, unnecessary exposure to personnel, loss or theft, and improper disposal. This course will prepare the student with the skills necessary for RCT qualification by passing quizzes, tests, and the RCT Comprehensive Phase 1, Unit 2 Examination (TEST 27566) and will provide in-the-field skills.

  17. Reduction of fatigue in Sjögren syndrome with rituximab: results of a randomised, double-blind, placebo-controlled pilot study.

    Science.gov (United States)

    Dass, S; Bowman, S J; Vital, E M; Ikeda, K; Pease, C T; Hamburger, J; Richards, A; Rauz, S; Emery, P

    2008-11-01

    Primary Sjögren syndrome (pSS) causes significant systemic symptoms including fatigue as well as glandular dysfunction. There are currently no effective systemic therapies; however, open label series have suggested that rituximab may be beneficial for systemic and glandular manifestations. Therefore, we performed a double blind, placebo-controlled, randomised pilot study of the efficacy of rituximab in reducing fatigue in pSS. A total of 17 patients with pSS and a score on fatigue visual analogue scale (VAS) >50 were randomised to receive either 2 infusions of rituximab 1 g or placebo; patients also received oral and intravenous steroids. Outcome measures included: the proportion of patients with >20% reduction in fatigue VAS, changes in pSS related symptoms, health related quality of life and immunological parameters of pSS. These were measured 6 months after therapy. There was significant improvement from baseline in fatigue VAS in the rituximab group (p<0.001) in contrast to the placebo group (p = 0.147). There was a significant difference between the groups at 6 months in the social functioning score of SF-36 (p = 0.01) and a trend to significant difference in the mental health domain score of SF-36 (p = 0.06). There was one episode of serum sickness in the rituximab treated group. This is the first double blind study of rituximab in pSS to show benefit; further studies are justified.

  18. Home-based, early intervention with mechatronic toys for preterm infants at risk of neurodevelopmental disorders (CARETOY): a RCT protocol.

    Science.gov (United States)

    Sgandurra, Giuseppina; Bartalena, Laura; Cioni, Giovanni; Greisen, Gorm; Herskind, Anna; Inguaggiato, Emanuela; Lorentzen, Jakob; Nielsen, Jens Bo; Sicola, Elisa

    2014-10-15

    Preterm infants are at risk for neurodevelopmental disorders, including motor, cognitive or behavioural problems, which may potentially be modified by early intervention. The EU CareToy Project Consortium (http://www.caretoy.eu) has developed a new modular system for intensive, individualized, home-based and family-centred early intervention, managed remotely by rehabilitation staff. A randomised controlled trial (RCT) has been designed to evaluate the efficacy of CareToy training in a first sample of low-risk preterm infants. The trial, randomised, multi-center, evaluator-blinded, parallel group controlled, is designed according to CONSORT Statement. Eligible subjects are infants born preterm without major complications, aged 3-9 months of corrected age with specific gross-motor abilities defined by Ages & Stages Questionnaire scores. Recruited infants, whose parents will sign a written informed consent for participation, will be randomized in CareToy training and control groups at baseline (T0). CareToy group will perform four weeks of personalized activities with the CareToy system, customized by the rehabilitation staff. The control group will continue standard care. Infant Motor Profile Scale is the primary outcome measure and a total sample size of 40 infants has been established. Bayley-Cognitive subscale, Alberta Infants Motor Scale and Teller Acuity Cards are secondary outcome measures. All measurements will be performed at T0 and at the end of training/control period (T1). For ethical reasons, after this first phase infants enrolled in the control group will perform the CareToy training, while the training group will continue standard care. At the end of open phase (T2) all infants will be assessed as at T1. Further assessment will be performed at 18 months corrected age (T3) to evaluate the long-term effects on neurodevelopmental outcome. Caregivers and rehabilitation staff will not be blinded whereas all the clinical assessments will be performed

  19. Duloxetine for the management of diabetic peripheral neuropathic pain: evidence-based findings from post hoc analysis of three multicenter, randomized, double-blind, placebo-controlled, parallel-group studies

    DEFF Research Database (Denmark)

    Kajdasz, Daniel K; Iyengar, Smriti; Desaiah, Durisala

    2007-01-01

    peripheral neuropathic pain (DPNP). METHODS: Data were pooled from three 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in which patients received 60 mg duloxetine either QD or BID or placebo. NNT was calculated based on rates of response (defined as >or=30...

  20. Seismic moment tensor for anisotropic media: implication for Non-double-couple earthquakes

    Science.gov (United States)

    Cai, X.; Chen, X.; Chen, Y.; Cai, M.

    2008-12-01

    It is often found that the inversion results of seismic moment tensor from real seismic recorded data show the trace of seismic moment tensor M is not zero, a phenomenon called non-double-couple earthquake sources mechanism. Recently we have derived the analytical expressions of M in transversely isotropic media with the titled axis of symmetry and the results shows even only pure shear-motion of fault can lead to the implosive components determined by several combined anisotropic elastic constants. Many non-double-couple earthquakes from observations often appear in volcanic and geothermal areas (Julian, 1998), where there exist a mount of stress-aligned fluid-saturated parallel vertical micro-cracks identical to transversely isotropic media (Crampin, 2008), this stress-aligned crack will modify the seismic moment tensor. In another word, non-double-couple earthquakes don't mean to have a seismic failure movement perpendicular to the fault plane, while traditional research of seismic moment tensor focus on the case of isotropy, which cannot provide correct interpretation of seismic source mechanism. Reference: Julian, B.R., Miller, A.D. and Foulger, G.R., 1998. Non-double-couple earthquakes,1. Theory, Rev. Geophys., 36, 525¨C549. Crampin,S., Peacock,S., 2008, A review of the current understanding of seismic shear-wave splitting in the Earth's crust and common fallacies in interpretation, wave motion, 45,675-722

  1. Comparison of Articaine and Lidocaine for Buccal Infiltration After Inferior Alveolar Nerve Block For Intraoperative Pain Control During Impacted Mandibular Third Molar Surgery.

    Science.gov (United States)

    da Silva-Junior, Geraldo Prisco; de Almeida Souza, Liane Maciel; Groppo, Francisco Carlos

    In order to compare the efficacy of lidocaine and articaine for pain control during third molar surgery, 160 patients presenting bilateral asymptomatic impacted mandibular third molars were selected. They received 1.8 mL of 2% lidocaine with epinephrine 1:100,000 during inferior alveolar nerve block. In group 1 (n = 80), an infiltrative injection of 0.9 mL of 2% lidocaine with epinephrine 1:100,000 was performed in buccal-distal mucosa of the third molar. Group 2 (n = 80) received 0.9 mL of 4% articaine with epinephrine 1:100,000 in the contralateral side. All procedures were performed at the same visit, by a single operator, in a double-blind and parallel design. The duration of each surgery and the moment when the patient expressed pain were noted. Data were analyzed by nonpaired t test and chi-square test (alpha = 5%). Duration of surgery did not differ (p = .83) between Groups 1 (19.8 ± 2.3 minutes) and 2 (19.7 ± 3.0 minutes). Pain was expressed more in group 1 (26.3%) than in group 2 (10%) (odds ratio = 3.2, p = .0138). In both groups, tooth sectioning was the most painful event (p inferior alveolar nerve block in controlling intraoperative pain related to impacted mandibular third molar surgery.

  2. RCT: 2.02 Communication Systems, Course #33339

    Energy Technology Data Exchange (ETDEWEB)

    Hillmer, Kurt T. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2016-05-01

    This unit will present an overview of communication systems at LANL. Good communication skills are essential to an RCT. RCTs should develop an ability to communicate, using both verbal and nonverbal media. These skills will ensure that important information is transmitted to the proper individuals in a clear and concise manner.

  3. In patients undergoing fast track total knee arthroplasty, addition of buprenorphine to a femoral nerve block has no clinical advantage A prospective, double-blinded, randomized, placebo controlled trial

    NARCIS (Netherlands)

    van Beek, Rienk; Zonneveldt, Harry J.; van der Ploeg, Tjeerd; Steens, Jeroen; Lirk, Phillip; Hollmann, Marcus W.

    2017-01-01

    Background: Several adjuvants have been proposed to prolong the effect of peripheral nerve blocks, one of which is buprenorphine. In this randomized double blinded placebo controlled trial we studied whether the addition of buprenorphine to a femoral nerve block prolongs analgesia in patients

  4. The effects of a new mouthrinse containing chlorhexidine, cetylpyridinium chloride and zinc lactate on the microflora of oral halitosis patients : a dual-centre, double-blind placebo-controlled study

    NARCIS (Netherlands)

    Roldan, S; Winkel, EG; Herrera, D; Sanz, M; Van Winkelhoff, AJ

    Aim: This study evaluated the microbial effects of a newly formulated mouthwash (Halita((R)) ) on oral halitosis patients. Methods: Forty subjects were included in this dual-centre, double-blind, placebo-controlled parallel study. Inclusion and exclusion criteria were used to select patients. At

  5. A double-blind randomised cross-over comparison of nabilone and metoclopramide in the control of radiation-induced nausea

    International Nuclear Information System (INIS)

    Priestman, S.G.; Priestman, T.J.; Canney, P.A.

    1987-01-01

    Forty patients who were suffering from radiation induced emesis were entered into a prospectively randomised double-blind cross-over study comparing nabilone with metoclopramide. Only patients who had at least five treatments remaining of their planned course of irradiation were randomised, in order to allow an adequate time to monitor the degree of symptom control and any adverse effects of the two drugs. Patient characteristics and the incidence and severity of nausea and vomiting were similar for the two groups. There was no difference in the efficacy of the two drugs but the incidence and severity of adverse reactions was significantly greater in those patients who received nabilone. (author)

  6. Spontaneous formation of non-uniform double helices for elastic rods under torsion

    International Nuclear Information System (INIS)

    Li, Hongyuan; Zhao, Shumin; Xia, Minggang; He, Siyu; Yang, Qifan; Yan, Yuming; Zhao, Hanqiao

    2017-01-01

    The spontaneous formation of double helices for filaments under torsion is common and significant. For example, the research on the supercoiling of DNA is helpful for understanding the replication and transcription of DNA. Similar double helices can appear in carbon nanotube yarns, cables, telephone wires and so forth. We noticed that non-uniform double helices can be produced due to the surface friction induced by the self-contact. Therefore an ideal model was presented to investigate the formation of double helices for elastic rods under torque. A general equilibrium condition which is valid for both the smooth surface and the rough surface situations is derived by using the variational method. By adding further constraints, the smooth and rough surface situations are investigated in detail respectively. Additionally, the model showed that the specific process of how to twist and slack the rod can determine the surface friction and hence influence the configuration of the double helix formed by rods with rough surfaces. Based on this principle, a method of manufacturing double helices with designed configurations was proposed and demonstrated. Finally, experiments were performed to verify the model and the results agreed well with the theory. - Highlights: • An ideal model is conceived to investigate the spontaneous formation of double helices for rods under torsion. • Variational method is used to obtain a universal result for the double helix formation process • Self-contact and surface friction is considered to analyze the non-uniform double helix. • A novel method of producing double helix with arbitrary configuration is proposed and demonstrated. • The experiment results agree well with the theory.

  7. Spontaneous formation of non-uniform double helices for elastic rods under torsion

    Energy Technology Data Exchange (ETDEWEB)

    Li, Hongyuan [Department of Applied Physics, School of Science, Xi' an Jiaotong University, Shaanxi 710049 (China); Zhao, Shumin, E-mail: zhaosm@mail.xjtu.edu.cn [Department of Applied Physics, School of Science, Xi' an Jiaotong University, Shaanxi 710049 (China); Xia, Minggang [Department of Optical Information Science and Technology, School of Science, Xi' an Jiaotong University, 710049 (China); Laboratory of Nanostructure and Physics Properties, School of Science, Xi' an Jiaotong University, 710049 (China); He, Siyu [Department of Applied Physics, School of Science, Xi' an Jiaotong University, Shaanxi 710049 (China); Yang, Qifan [Department of Biomedical Engineering, School of Life Science and Technology, Xi' an Jiaotong University, Shaanxi 710049 (China); Yan, Yuming [Department of Electrical Engineering and Automation, School of Electrical Engineering, Xi' an Jiaotong University, Shaanxi 710049 (China); Zhao, Hanqiao [Department of Biomedical Engineering, School of Life Science and Technology, Xi' an Jiaotong University, Shaanxi 710049 (China)

    2017-02-19

    The spontaneous formation of double helices for filaments under torsion is common and significant. For example, the research on the supercoiling of DNA is helpful for understanding the replication and transcription of DNA. Similar double helices can appear in carbon nanotube yarns, cables, telephone wires and so forth. We noticed that non-uniform double helices can be produced due to the surface friction induced by the self-contact. Therefore an ideal model was presented to investigate the formation of double helices for elastic rods under torque. A general equilibrium condition which is valid for both the smooth surface and the rough surface situations is derived by using the variational method. By adding further constraints, the smooth and rough surface situations are investigated in detail respectively. Additionally, the model showed that the specific process of how to twist and slack the rod can determine the surface friction and hence influence the configuration of the double helix formed by rods with rough surfaces. Based on this principle, a method of manufacturing double helices with designed configurations was proposed and demonstrated. Finally, experiments were performed to verify the model and the results agreed well with the theory. - Highlights: • An ideal model is conceived to investigate the spontaneous formation of double helices for rods under torsion. • Variational method is used to obtain a universal result for the double helix formation process • Self-contact and surface friction is considered to analyze the non-uniform double helix. • A novel method of producing double helix with arbitrary configuration is proposed and demonstrated. • The experiment results agree well with the theory.

  8. Auranofin in the treatment of steroid dependent asthma: a double blind study.

    Science.gov (United States)

    Nierop, G; Gijzel, W P; Bel, E H; Zwinderman, A H; Dijkman, J H

    1992-01-01

    BACKGROUND: Long term administration of oral corticosteroids in patients with asthma may be associated with serious side effects. Non-steroidal anti-inflammatory drugs, including gold salts, have been shown to reduce the need for systemic corticosteroid treatment in uncontrolled studies. The effect of oral gold (auranofin) on asthma symptoms, lung function, and the need for oral prednisone treatment was investigated. METHODS: A 26 week randomised, double blind, placebo controlled, parallel group trial of auranofin was performed in 32 patients with moderately severe chronic asthma who required an oral corticosteroid dose of at least 5 mg prednisone a day (or equivalent) or 2.5 mg/day prednisone plus more than 800 micrograms/day inhaled corticosteroids. Auranofin was given orally in a dose of 3 mg twice daily. Asthma symptoms, lung function, and adverse effects were assessed at regular intervals. After 12 weeks of treatment prednisone dosage was tapered down by 2.5 mg every two weeks if the patient was clinically stable. Asthma exacerbations were treated with short courses of high doses of oral steroids. RESULTS: Twenty eight of the 32 patients, 13 in the placebo group and 15 in the auranofin group, completed the study. The total corticosteroid reduction achieved after 26 weeks of treatment was significantly greater (4 mg) in the auranofin group than in the placebo group (0.3 mg). The number of exacerbations requiring an increase of steroids was greater in the placebo group (2.1) than in the active group (0.9). A significant increase in FEV1 of 6.4% predicted occurred in the auranofin group during the study and there was a reduction of asthma symptoms such as wheezing and cough. There was no difference between the groups in peak flow measurements or in the number of asthma attacks. The incidence of side effects of auranofin was low, but exacerbations of constitutional eczema were noticeable. CONCLUSION: Auranofin provides an effective adjunct to treatment for steroid

  9. Hormone therapy in menopausal women with cognitive complaints: a randomized, double-blind trial.

    Science.gov (United States)

    Maki, P M; Gast, M J; Vieweg, A J; Burriss, S W; Yaffe, K

    2007-09-25

    To evaluate the effects of hormone therapy (HT) on cognition and subjective quality of life (QoL) in recently postmenopausal women with cognitive complaints. Cognitive Complaints in Early Menopause Trial (COGENT) was a randomized, double-blind, placebo-controlled, multicenter, pilot study of 180 healthy postmenopausal women aged 45 to 55 years, randomly assigned to receive either placebo or conjugated equine estrogen 0.625 mg/medroxyprogesterone acetate 2.5 mg for 4 months. Outcome measures included memory, subjective cognition, QoL, sexuality, and sleep, which were assessed at baseline and month 4. The study was terminated before the expected final sample size of 275 due to a decrease in enrollment coinciding with the publication of findings from the Women's Health Initiative. There were no differences between groups on any cognitive or QoL measures, except for an increase in sexual interest and thoughts with HT. Modest negative effects on short- and long-term verbal memory approached significance (p or=0.45, this study suggests potential modest negative effects on verbal memory that are consistent with previous hormone therapy trials in older women.

  10. Enteral Antibiotics are Non-inferior to Intravenous Antibiotics After Complicated Appendicitis in Adults

    DEFF Research Database (Denmark)

    Kleif, Jakob; Rasmussen, Louise; Fonnes, Siv

    2017-01-01

    BACKGROUND: Prolonging post-operative antibiotic treatment beyond 3 days does not seem to reduce the incidence of post-operative abscess formation or wound infection after surgery for complicated appendicitis. The route of administration seems to be based on an empirical basis. Using enteral...... antibiotics could reduce length of stay and reduce overall costs. We aimed to examine whether treatment with enteral antibiotics during the first three post-operative days is non-inferior to intravenous antibiotics regarding intra-abdominal abscess formation or wound infection after surgery for complicated...... of surgery. Route of antibiotic administration for the first three post-operative days was registered for all patients. RESULTS: A total of 1141 patients were included in the study. The overall risk of developing an intra-abdominal abscess was 6.7% (95% CI 5.2%; 8.1%), and the risk of wound infection was 1...

  11. Effects on peripheral and central blood pressure of cocoa with natural or high-dose theobromine: A randomized, double-blind crossover trial

    OpenAIRE

    Bogaard, Bas; Draijer, Richard; Westerhof, Berend; Meiracker, Anton; Montfrans, Gert; Born, B.J.H.

    2010-01-01

    textabstractFlavanol-rich cocoa products have been reported to lower blood pressure. It has been suggested that theobromine is partially responsible for this effect. We tested whether consumption of flavanol-rich cocoa drinks with natural or added theobromine could lower peripheral and central blood pressure. In a double-blind, placebo-controlled 3-period crossover trial we assigned 42 healthy individuals (age 62±4.5 years; 32 men) with office blood pressure of 130 to 159 mm Hg/85 to 99 mm Hg...

  12. Application of three-dimensional CT reconstruction technology on inferior oblique muscle in congenital superior oblique palsy

    Directory of Open Access Journals (Sweden)

    Yang Zhang

    2014-05-01

    Full Text Available AIM: To investigate the viability of the morphology of inferior oblique muscle observed stereoscopically using 3-dimensional CT reconstruction technique. METHODS: This control study included of 29 cases which were clinically diagnosed with monocular congenital superior oblique palsy, examined by dimensional CT. The images of the inferior oblique muscle were reconstructed by Mimics software. 3D digital images on the basis of CT scanning data of the individuals were established. Observing the morphology of binocular inferior oblique muscle by self-controlled design, we compared the maximum transverse diameter of inferior oblique muscle of paralyzed eye with non-paralyzed one. We chose 5% as the significant level.RESULTS: The reconstructed results of 3-dimensional CT scan showed that not all of the inferior oblique abdominal muscle of paralyzed eyes were thinner than that of the non-paralyzed eye in maximum transverse diameter of cross-sectional area. The maximum transverse diameter of inferior oblique muscle was measured. The average maximum transverse diameter of the paralyzed eye was 6.797±1.083mm and the non-paralyzed eye was 6.507±0.848mm. The maximum transverse diameter of inferior oblique muscle of paralyzed eye did not, however, differ significantly from the normal(P>0.05. CONCLUSION: The three-dimensional CT reconstruction technology can be used for preoperative evaluation of the morphology of inferior oblique muscle.

  13. Iatrogenic injury to the inferior alveolar nerve

    DEFF Research Database (Denmark)

    Hillerup, Søren

    2008-01-01

    The purpose of this prospective, non-randomised, descriptive study is to characterise the neurosensory deficit and associated neurogenic discomfort in 52 patients with iatrogenic injury to the inferior alveolar nerve (IAN). All patients were examined and followed up according to a protocol...

  14. Immunogenicity of fractional doses of tetravalent a/c/y/w135 meningococcal polysaccharide vaccine: results from a randomized non-inferiority controlled trial in Uganda.

    Directory of Open Access Journals (Sweden)

    Philippe J Guerin

    Full Text Available Neisseria meningitidis serogroup A is the main causative pathogen of meningitis epidemics in sub-Saharan Africa. In recent years, serogroup W135 has also been the cause of epidemics. Mass vaccination campaigns with polysaccharide vaccines are key elements in controlling these epidemics. Facing global vaccine shortage, we explored the use of fractional doses of a licensed A/C/Y/W135 polysaccharide meningococcal vaccine.We conducted a randomized, non-inferiority trial in 750 healthy volunteers 2-19 years old in Mbarara, Uganda, to compare the immune response of the full dose of the vaccine versus fractional doses (1/5 or 1/10. Safety and tolerability data were collected for all subjects during the 4 weeks following the injection. Pre- and post-vaccination sera were analyzed by measuring serum bactericidal activity (SBA with baby rabbit complement. A responder was defined as a subject with a > or =4-fold increase in SBA against a target strain from each serogroup and SBA titer > or =128. For serogroup W135, 94% and 97% of the vaccinees in the 1/5- and 1/10-dose arms, respectively, were responders, versus 94% in the full-dose arm; for serogroup A, 92% and 88% were responders, respectively, versus 95%. Non-inferiority was demonstrated between the full dose and both fractional doses in SBA seroresponse against serogroups W135 and Y, in total population analysis. Non-inferiority was shown between the full and 1/5 doses for serogroup A in the population non-immune prior to vaccination. Non-inferiority was not shown for any of the fractionate doses for serogroup C. Safety and tolerability data were favourable, as observed in other studies.While the advent of conjugate A vaccine is anticipated to largely contribute to control serogroup A outbreaks in Africa, the scale-up of its production will not cover the entire "Meningitis Belt" target population for at least the next 3 to 5 years. In view of the current shortage of meningococcal vaccines for Africa

  15. Influence of inhomogeneous static magnetic field-exposure on patients with erosive gastritis: a randomized, self- and placebo-controlled, double-blind, single centre, pilot study.

    Science.gov (United States)

    Juhász, Márk; Nagy, Viktor L; Székely, Hajnal; Kocsis, Dorottya; Tulassay, Zsolt; László, János F

    2014-09-06

    This pilot study was devoted to the effect of static magnetic field (SMF)-exposure on erosive gastritis. The randomized, self- and placebo-controlled, double-blind, pilot study included 16 patients of the 2nd Department of Internal Medicine, Semmelweis University diagnosed with erosive gastritis. The instrumental analysis followed a qualitative (pre-intervention) assessment of the symptoms by the patient: lower heartburn (in the ventricle), upper heartburn (in the oesophagus), epigastric pain, regurgitation, bloating and dry cough. Medical diagnosis included a double-line upper panendoscopy followed by 30 min local inhomogeneous SMF-exposure intervention at the lower sternal region over the stomach with peak-to-peak magnetic induction of 3 mT and 30 mT m(-1) gradient at the target site. A qualitative (post-intervention) assessment of the same symptoms closed the examination. Sham- or SMF-exposure was used in a double-blind manner. The authors succeeded in justifying the clinically and statistically significant beneficial effect of the SMF- over sham-exposure on the symptoms of erosive gastritis, the average effect of inhibition was 56% by p = 0.001, n = 42 + 96. This pilot study was aimed to encourage gastroenterologists to test local, inhomogeneous SMF-exposure on erosive gastritis patients, so this intervention may become an evidence-based alternative or complementary method in the clinical use especially in cases when conventional therapy options are contraindicated. © 2014 The Author(s) Published by the Royal Society. All rights reserved.

  16. Cauchy problem for differential operators with double characteristics non-effectively hyperbolic characteristics

    CERN Document Server

    Nishitani, Tatsuo

    2017-01-01

    Combining geometrical and microlocal tools, this monograph gives detailed proofs of many well/ill-posed results related to the Cauchy problem for differential operators with non-effectively hyperbolic double characteristics. Previously scattered over numerous different publications, the results are presented from the viewpoint that the Hamilton map and the geometry of bicharacteristics completely characterizes the well/ill-posedness of the Cauchy problem. A doubly characteristic point of a differential operator P of order m (i.e. one where Pm = dPm = 0) is effectively hyperbolic if the Hamilton map FPm has real non-zero eigenvalues. When the characteristics are at most double and every double characteristic is effectively hyperbolic, the Cauchy problem for P can be solved for arbitrary lower order terms. If there is a non-effectively hyperbolic characteristic, solvability requires the subprincipal symbol of P to lie between − Pµj and P µj , where iµj are the positive imaginary eigenvalues of FPm ....

  17. Analysis of stroke in ATHENA: a placebo-controlled, double-blind, parallel-arm trial to assess the efficacy of dronedarone 400 mg BID for the prevention of cardiovascular hospitalization or death from any cause in patients with atrial fibrillation/atrial flutter

    DEFF Research Database (Denmark)

    Connolly, Stuart J; Crijns, Harry J G M; Torp-Pedersen, Christian

    2009-01-01

    , on stroke has been evaluated in a randomized, double-blind clinical trial, ATHENA (A placebo-controlled, double-blind, parallel-arm Trial to assess the efficacy of dronedarone 400 mg BID for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation....../atrial flutter). METHODS AND RESULTS: Patients with persistent or paroxysmal atrial fibrillation and at least 1 risk factor for cardiovascular hospitalization were randomized to receive dronedarone (400 mg BID) or double-blind matching placebo and followed up for a minimum of 1 year to a common termination at 30...... of either oral anticoagulant therapy or antiplatelet agent alone was 60%. Dronedarone reduced the risk of stroke from 1.8% per year to 1.2% per year (hazard ratio 0.66, 95% confidence interval 0.46 to 0.96, P=0.027). The effect of dronedarone was similar whether or not patients were receiving oral...

  18. Cerebellar transcranial direct current stimulation in patients with ataxia: A double-blind, randomized, sham-controlled study.

    Science.gov (United States)

    Benussi, Alberto; Koch, Giacomo; Cotelli, Maria; Padovani, Alessandro; Borroni, Barbara

    2015-10-01

    Numerous studies have highlighted the possibility of modulating the excitability of cerebellar circuits using transcranial direct current stimulation. The present study investigated whether a single session of cerebellar anodal transcranial direct current stimulation could improve symptoms in patients with ataxia. Nineteen patients with ataxia underwent a clinical and functional evaluation pre- and post-double-blind, randomized, sham, or anodal transcranial direct current stimulation. There was a significant interaction between treatment and time on the Scale for the Assessment and Rating of Ataxia, on the International Cooperative Ataxia Rating Scale, on the 9-Hole Peg Test, and on the 8-Meter Walking Time (P transcranial direct current stimulation can transiently improve symptoms in patients with ataxia and might represent a promising tool for future rehabilitative approaches. © 2015 International Parkinson and Movement Disorder Society.

  19. Biomechanical comparison of double-row locking plates versus single- and double-row non-locking plates in a comminuted metacarpal fracture model.

    Science.gov (United States)

    Gajendran, Varun K; Szabo, Robert M; Myo, George K; Curtiss, Shane B

    2009-12-01

    Open or unstable metacarpal fractures frequently require open reduction and internal fixation. Locking plate technology has improved fixation of unstable fractures in certain settings. In this study, we hypothesized that there would be a difference in strength of fixation using double-row locking plates compared with single- and double-row non-locking plates in comminuted metacarpal fractures. We tested our hypothesis in a gap metacarpal fracture model simulating comminution using fourth-generation, biomechanical testing-grade composite sawbones. The metacarpals were divided into 6 groups of 15 bones each. Groups 1 and 4 were plated with a standard 6-hole, 2.3-mm plate in AO fashion. Groups 2 and 5 were plated with a 6-hole double-row 3-dimensional non-locking plate with bicortical screws aimed for convergence. Groups 3 and 6 were plated with a 6-hole double-row 3-dimensional locking plate with unicortical screws. The plated metacarpals were then tested to failure against cantilever apex dorsal bending (groups 1-3) and torsion (groups 4-6). The loads to failure in groups 1 to 3 were 198 +/- 18, 223 +/- 29, and 203 +/- 19 N, respectively. The torques to failure in groups 4 to 6 were 2,033 +/- 155, 3,190 +/- 235, and 3,161 +/- 268 N mm, respectively. Group 2 had the highest load to failure, whereas groups 5 and 6 shared the highest torques to failure (p row plates had equivalent bending and torsional stiffness, significantly higher than observed for the single-row non-locking plate. No other statistical differences were noted between groups. When subjected to the physiologically relevant forces of apex dorsal bending and torsion in a comminuted metacarpal fracture model, double-row 3-dimensional non-locking plates provided superior stability in bending and equivalent stability in torsion compared with double-row 3-dimensional locking plates, whereas single-row non-locking plates provided the least stability.

  20. Double-read of skeletal surveys in suspected non-accidental trauma: what we learned

    Energy Technology Data Exchange (ETDEWEB)

    Karmazyn, Boaz; Wanner, Matthew R.; Marine, Megan B. [Indiana University School of Medicine, Department of Radiology and Imaging Sciences, Riley Hospital for Children, Indianapolis, IN (United States); Miller, Elise M.; Jennings, S.G. [Indiana University School of Medicine, Department of Radiology and Imaging Sciences, Indianapolis, IN (United States); Lay, Sara E. [Indiana University School of Medicine, Methodist Hospital, Department of Radiology and Imaging Sciences, Indianapolis, IN (United States); Massey, James M. [The Children' s Hospital at TriStar Centennial, Department of Imaging, Nashville, TN (United States); Ouyang, Fangqian [Indiana University School of Medicine, Department of Biostatistics, Indianapolis, IN (United States); Hibbard, Roberta A. [Indiana University School of Medicine, Department of Pediatrics, Section of Child Protection Programs, Riley Hospital for Children, Indianapolis, IN (United States)

    2017-05-15

    Missing a fracture in a child on skeletal surveys for suspected non-accidental trauma can have devastating results. Double-read has the potential to improve fracture detection. However the yield of double-read is unknown. To determine the advantage of double-read versus single-read of radiographic skeletal surveys for suspected non-accidental trauma. The study was performed in two phases. In the first phase (April 2013 to September 2013), double-read was performed for all skeletal surveys obtained during weekday working hours. Because we had no new double-read findings in studies initially read as negative, we conducted a second phase (January 2014 to March 2014). In the second phase we limited double-reads to skeletal surveys found positive on the first read. At the end of this period, we retrospectively performed double-read for all initially negative skeletal surveys. We excluded follow-up skeletal surveys. The difference in discrepancy (new fracture or false diagnosis of a fracture) ratio between negative and positive skeletal surveys was evaluated using the Fisher exact test, and change in discrepancy ratio between the first and second study phases was evaluated using the stratified Cochran-Mantel-Haenszel test. Overall in the two phases, 178 skeletal surveys were performed in 178 children (67 girls) with mean age of 9 months (range 3 days to 3.7 years). Double-read found 16 discrepancies in 8/178 (4.5%) skeletal surveys. Seven of these studies showed additional fractures (n=15). In one study, an initial read of a skull fracture was read as a variant on the second read. There was a significant (P=0.01) difference between rate of disagreement in negative skeletal surveys (1/104, 1.0%) and positive skeletal surveys (7/74, 9.5%). No significant change in disagreement rate was demonstrated between the two phases of the study (P=0.59). Double-read of skeletal survey for suspected non-accidental trauma found false-negative fractures in a few cases and rarely found