A randomized phase II/III study of cabazitaxel versus vinflunine in metastatic or locally advanced transitional cell carcinoma of the urothelium (SECAVIN).

PubMed

Bellmunt, J; Kerst, J M; Vázquez, F; Morales-Barrera, R; Grande, E; Medina, A; González Graguera, M B; Rubio, G; Anido, U; Fernández Calvo, O; González-Billalabeitia, E; Van den Eertwegh, A J M; Pujol, E; Perez-Gracia, J L; González Larriba, J L; Collado, R; Los, M; Maciá, S; De Wit, R

2017-07-01

Despite the advent of immunotherapy in urothelial cancer, there is still a need to find effective cytotoxic agents beyond first and second lines. Vinflunine is the only treatment approved in this setting by the European Medicines Agency and taxanes are also widely used in second line. Cabazitaxel is a taxane with activity in docetaxel-refractory cancers. A randomized study was conducted to compare its efficacy versus vinflunine. This is a multicenter, randomized, open-label, phase II/III study, following a Simon's optimal method with stopping rules based on an interim futility analysis and a formal efficacy analysis at the end of the phase II. ECOG Performance Status, anaemia and liver metastases were stratification factors. Primary objectives were overall response rate for the phase II and overall survival for the phase III. Seventy patients were included in the phase II across 19 institutions in Europe. Baseline characteristics were well balanced between the two arms. Three patients (13%) obtained a partial response on cabazitaxel (95% CI 2.7-32.4) and six patients (30%) in the vinflunine arm (95% CI 11.9-54.3). Median progression-free survival for cabazitaxel was 1.9 versus 2.9 months for vinflunine (P = 0.039). The study did not proceed to phase III since the futility analysis showed a lack of efficacy of cabazitaxel. A trend for overall survival benefit was found favouring vinflunine (median 7.6 versus 5.5 months). Grade 3- to 4-related adverse events were seen in 41% patients with no difference between the two arms. This phase II/III second line bladder study comparing cabazitaxel with vinflunine was closed when the phase II showed a lack of efficacy of the cabazitaxel arm. Vinflunine results were consistent with those known previously. NCT01830231. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Undenatured type II collagen (UC-II®) for joint support: a randomized, double-blind, placebo-controlled study in healthy volunteers

PubMed Central

2013-01-01

Background UC-II contains a patented form of undenatured type II collagen derived from chicken sternum. Previous preclinical and clinical studies support the safety and efficacy of UC-II in modulating joint discomfort in osteoarthritis and rheumatoid arthritis. The purpose of this study was to assess the efficacy and tolerability of UC-II in moderating joint function and joint pain due to strenuous exercise in healthy subjects. Methods This randomized, double-blind, placebo-controlled study was conducted in healthy subjects who had no prior history of arthritic disease or joint pain at rest but experienced joint discomfort with physical activity. Fifty-five subjects who reported knee pain after participating in a standardized stepmill performance test were randomized to receive placebo (n = 28) or the UC-II (40 mg daily, n = 27) product for 120 days. Joint function was assessed by changes in degree of knee flexion and knee extension as well as measuring the time to experiencing and recovering from joint pain following strenuous stepmill exertion. Results After 120 days of supplementation, subjects in the UC-II group exhibited a statistically significant improvement in average knee extension compared to placebo (81.0 ± 1.3º vs 74.0 ± 2.2º; p = 0.011) and to baseline (81.0 ± 1.3º vs 73.2 ± 1.9º; p = 0.002). The UC-II cohort also demonstrated a statistically significant change in average knee extension at day 90 (78.8 ± 1.9º vs 73.2 ± 1.9º; p = 0.045) versus baseline. No significant change in knee extension was observed in the placebo group at any time. It was also noted that the UC-II group exercised longer before experiencing any initial joint discomfort at day 120 (2.8 ± 0.5 min, p = 0.019), compared to baseline (1.4 ± 0.2 min). By contrast, no significant changes were seen in the placebo group. No product related adverse events were observed during the study. At study conclusion, five individuals in the UC-II cohort reported no pain during or after the stepmill protocol (p = 0.031, within visit) as compared to one subject in the placebo group. Conclusions Daily supplementation with 40 mg of UC-II was well tolerated and led to improved knee joint extension in healthy subjects. UC-II also demonstrated the potential to lengthen the period of pain free strenuous exertion and alleviate the joint pain that occasionally arises from such activities. PMID:24153020

Undenatured type II collagen (UC-II®) for joint support: a randomized, double-blind, placebo-controlled study in healthy volunteers.

PubMed

Lugo, James P; Saiyed, Zainulabedin M; Lau, Francis C; Molina, Jhanna Pamela L; Pakdaman, Michael N; Shamie, Arya Nick; Udani, Jay K

2013-10-24

UC-II contains a patented form of undenatured type II collagen derived from chicken sternum. Previous preclinical and clinical studies support the safety and efficacy of UC-II in modulating joint discomfort in osteoarthritis and rheumatoid arthritis. The purpose of this study was to assess the efficacy and tolerability of UC-II in moderating joint function and joint pain due to strenuous exercise in healthy subjects. This randomized, double-blind, placebo-controlled study was conducted in healthy subjects who had no prior history of arthritic disease or joint pain at rest but experienced joint discomfort with physical activity. Fifty-five subjects who reported knee pain after participating in a standardized stepmill performance test were randomized to receive placebo (n = 28) or the UC-II (40 mg daily, n = 27) product for 120 days. Joint function was assessed by changes in degree of knee flexion and knee extension as well as measuring the time to experiencing and recovering from joint pain following strenuous stepmill exertion. After 120 days of supplementation, subjects in the UC-II group exhibited a statistically significant improvement in average knee extension compared to placebo (81.0 ± 1.3º vs 74.0 ± 2.2º; p = 0.011) and to baseline (81.0 ± 1.3º vs 73.2 ± 1.9º; p = 0.002). The UC-II cohort also demonstrated a statistically significant change in average knee extension at day 90 (78.8 ± 1.9º vs 73.2 ± 1.9º; p = 0.045) versus baseline. No significant change in knee extension was observed in the placebo group at any time. It was also noted that the UC-II group exercised longer before experiencing any initial joint discomfort at day 120 (2.8 ± 0.5 min, p = 0.019), compared to baseline (1.4 ± 0.2 min). By contrast, no significant changes were seen in the placebo group. No product related adverse events were observed during the study. At study conclusion, five individuals in the UC-II cohort reported no pain during or after the stepmill protocol (p = 0.031, within visit) as compared to one subject in the placebo group. Daily supplementation with 40 mg of UC-II was well tolerated and led to improved knee joint extension in healthy subjects. UC-II also demonstrated the potential to lengthen the period of pain free strenuous exertion and alleviate the joint pain that occasionally arises from such activities.

Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review

PubMed Central

Langrand-Escure, Julien; Rivoirard, Romain; Oriol, Mathieu; Tinquaut, Fabien; Rancoule, Chloé; Chauvin, Frank; Magné, Nicolas; Bourmaud, Aurélie

2017-01-01

Background Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials. Data sources A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010–2015). Study eligibility criteria All articles electronically published by three randomly-selected oncology journals with Impact-Factors>4 were included: Journal of Clinical Oncology, Annals of Oncology and British Journal of Cancer. Intervention Quality of reporting was assessed using the Key Methodological Score. Results 557 articles were included. 315 trials were single-arm studies (56.6%), 193 (34.6%) were randomized and 49 (8.8%) were non-randomized multiple-arm studies. The Methodological Score was equal to 0 (lowest level), 1, 2, 3 (highest level) respectively for 22 (3.9%), 119 (21.4%), 270 (48.5%) and 146 (26.2%) articles. The primary end point is almost systematically reported (90.5%), while sample size calculation is missing in 66% of the articles. 3 variables were independently associated with reporting of a high standard: presence of statistical design (p-value <0.001), multicenter trial (p-value = 0.012), per-protocol analysis (p-value <0.001). Limitations Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate. Conclusions & implications of key findings This literature review highlights the existence of gaps concerning the quality of reporting. It therefore raised the question of the suitability of the methodology as well as the quality of these trials, reporting being incomplete in the corresponding articles. PMID:29216190

Human interventions to characterize novel relationships between the renin-angiotensin-aldosterone system and parathyroid hormone.

PubMed

Brown, Jenifer M; Williams, Jonathan S; Luther, James M; Garg, Rajesh; Garza, Amanda E; Pojoga, Luminita H; Ruan, Daniel T; Williams, Gordon H; Adler, Gail K; Vaidya, Anand

2014-02-01

Observational studies in primary hyperaldosteronism suggest a positive relationship between aldosterone and parathyroid hormone (PTH); however, interventions to better characterize the physiological relationship between the renin-angiotensin-aldosterone system (RAAS) and PTH are needed. We evaluated the effect of individual RAAS components on PTH using 4 interventions in humans without primary hyperaldosteronism. PTH was measured before and after study (1) low-dose angiotensin II (Ang II) infusion (1 ng/kg per minute) and captopril administration (25 mg×1); study (2) high-dose Ang II infusion (3 ng/kg per minute); study (3) blinded crossover randomization to aldosterone infusion (0.7 µg/kg per hour) and vehicle; and study (4) blinded randomization to spironolactone (50 mg/daily) or placebo for 6 weeks. Infusion of Ang II at 1 ng/kg per minute acutely increased aldosterone (+148%) and PTH (+10.3%), whereas Ang II at 3 ng/kg per minute induced larger incremental changes in aldosterone (+241%) and PTH (+36%; P<0.01). Captopril acutely decreased aldosterone (-12%) and PTH (-9.7%; P<0.01). In contrast, aldosterone infusion robustly raised serum aldosterone (+892%) without modifying PTH. However, spironolactone therapy during 6 weeks modestly lowered PTH when compared with placebo (P<0.05). In vitro studies revealed the presence of Ang II type I and mineralocorticoid receptor mRNA and protein expression in normal and adenomatous human parathyroid tissues. We observed novel pleiotropic relationships between RAAS components and the regulation of PTH in individuals without primary hyperaldosteronism: the acute modulation of PTH by the RAAS seems to be mediated by Ang II, whereas the long-term influence of the RAAS on PTH may involve aldosterone. Future studies to evaluate the impact of RAAS inhibitors in treating PTH-mediated disorders are warranted.

Needful Implements in Improving the Study and Scholastic Skills of Nigerian Secondary School Students

ERIC Educational Resources Information Center

Adegoroye, Biodun-Smith; Ajagbe, Adesina Adunfe

2015-01-01

Showing concern about the consistent depreciation in expected study and scholastic behaviours among Secondary School students and the trailing failure in school test and exams and public exams, the authors gathered empirical report on the chosen variables among a randomly selected 1,200 secondary school students in JSS I, II, III, SSS I, II, III…

Maintenance of valvular integrity with Impella left heart support: Results from the multicenter PROTECT II randomized study.

PubMed

Goldstein, James A; Dixon, Simon R; Douglas, Pamela S; Ohman, E Magnus; Moses, Jeffrey; Popma, Jeffrey J; O'Neill, William W

2017-10-08

The Impella 2.5 axial flow pump, which is positioned across the aortic valve, is widely employed for hemodynamic support. The present study compared structural and functional integrity of the left heart valves in patients undergoing Impella vs intra-aortic balloon pump in the randomized PROTECT II trial. Transthoracic echocardiograms were performed at baseline, 1 and 3 months in 445 patients in the PROTECT II trial. Serial studies were analyzed by an independent echocardiography core laboratory for aortic and mitral valve structure and function, and left ventricular ejection fraction (LVEF). During Impella support there was no appreciable change in the degree of baseline valvular regurgitation. There were no cases of structural derangement of the mitral or aortic valve after use of the Impella device. At 90-day follow-up, there was an average 22% relative increase in LVEF from baseline (27% ± 9 vs. 33% ± 11, P < 0.001). The present echocardiographic analysis of the PROTECT II study confirms prior observations regarding the safety of the Impella 2.5 device with respect to mitral and aortic valve function. © 2017 Wiley Periodicals, Inc.

Efficacy of repetitive transcranial magnetic stimulation with quetiapine in treating bipolar II depression: a randomized, double-blinded, control study.

PubMed

Hu, Shao-Hua; Lai, Jian-Bo; Xu, Dong-Rong; Qi, Hong-Li; Peterson, Bradley S; Bao, Ai-Min; Hu, Chan-Chan; Huang, Man-Li; Chen, Jing-Kai; Wei, Ning; Hu, Jian-Bo; Li, Shu-Lan; Zhou, Wei-Hua; Xu, Wei-Juan; Xu, Yi

2016-07-27

The clinical and cognitive responses to repetitive transcranial magnetic stimulation (rTMS) in bipolar II depressed patients remain unclear. In this study, thirty-eight bipolar II depressed patients were randomly assigned into three groups: (i) left high-frequency (n = 12), (ii) right low-frequency (n = 13), (iii) sham stimulation (n = 13), and underwent four-week rTMS with quetiapine concomitantly. Clinical efficacy was evaluated at baseline and weekly intervals using the 17-item Hamilton Depression Rating Scale (HDRS-17) and Montgomery-Asberg Depression Rating Scale (MADRS). Cognitive functioning was assessed before and after the study with the Wisconsin Card Sorting Test (WCST), Stroop Word-Color Interference Test (Stroop), and Trail Making Test (TMT). Thirty-five patients were included in the final analysis. Overall, the mean scores of both the HDRS-17 and the MADRS significantly decreased over the 4-week trial, which did not differ among the three groups. Exploratory analyses revealed no differences in factor scores of HDRS-17s, or in response or remission rates. Scores of WCST, Stroop, or TMT did not differ across the three groups. These findings indicated active rTMS combined with quetiapine was not superior to quetiapine monotherapy in improving depressive symptoms or cognitive performance in patients with bipolar II depression.

No evidence for MHC class II-based non-random mating at the gametic haplotype in Atlantic salmon.

PubMed

Promerová, M; Alavioon, G; Tusso, S; Burri, R; Immler, S

2017-06-01

Genes of the major histocompatibility complex (MHC) are a likely target of mate choice because of their role in inbreeding avoidance and potential benefits for offspring immunocompetence. Evidence for female choice for complementary MHC alleles among competing males exists both for the pre- and the postmating stages. However, it remains unclear whether the latter may involve non-random fusion of gametes depending on gametic haplotypes resulting in transmission ratio distortion or non-random sequence divergence among fused gametes. We tested whether non-random gametic fusion of MHC-II haplotypes occurs in Atlantic salmon Salmo salar. We performed in vitro fertilizations that excluded interindividual sperm competition using a split family design with large clutch sample sizes to test for a possible role of the gametic haplotype in mate choice. We sequenced two MHC-II loci in 50 embryos per clutch to assess allelic frequencies and sequence divergence. We found no evidence for transmission ratio distortion at two linked MHC-II loci, nor for non-random gamete fusion with respect to MHC-II alleles. Our findings suggest that the gametic MHC-II haplotypes play no role in gamete association in Atlantic salmon and that earlier findings of MHC-based mate choice most likely reflect choice among diploid genotypes. We discuss possible explanations for these findings and how they differ from findings in mammals.

The Effect of Listening to Music During Percutaneous Nephrostomy Tube Placement on Pain, Anxiety, and Success Rate of Procedure: A Randomized Prospective Study.

PubMed

Hamidi, Nurullah; Ozturk, Erdem

2017-05-01

To evaluate the effect of listening to music on pain, anxiety, and success of procedure during office-based percutaneous nephrostomy tube placement (PNTP). One hundred consecutive patients (age >18 years) with hydronephrosis were prospectively enrolled in this study. All patients were prospectively randomized to undergo office-based PNTP with (Group I, n = 50) or without music (Group II, n = 50). Anxiety levels were evaluated with State Trait Anxiety Inventory. A visual analog scale was used to evaluate pain levels, patient's satisfaction, and willingness to undergo the procedure. We also compared success rates of procedures. The mean age, duration of procedure, and gender distribution were statistically similar between the two groups. The mean postprocedural heart rates and systolic blood pressures in Group I patients were significantly lower than Group II patients (p = 0.01 and p = 0.028, respectively), whereas preprocedural pulse rate and systolic blood pressure were similar. The mean anxiety level and mean pain score of Group I were significantly lower than those of Group II (p = 0.008 and p < 0.001, respectively). Group I also carried a significant greater mean satisfaction score and willingness to undergo repeat procedure compared with Group II (p < 0.001 for both). Success rate of nephrostomy tube placement in Group I was significantly higher compared with Group II (92% vs 66%, p = 0.04). The present randomized prospective study demonstrates that listening to music during office-based PNTP decreases anxiety or pain and increases success rate of procedure. As an alternative to sedation or general anesthesia, music is easily accessible without side effect and cost.

Arthroscopic versus mini-open rotator cuff repair: a prospective, randomized study with 24-month follow-up.

PubMed

Zhang, Zhenxiang; Gu, Beibei; Zhu, Wei; Zhu, Lixian; Li, Qingsong

2014-08-01

This prospective, randomized study was performed to evaluate the results of mini-open and arthroscopic rotator cuff repair in a comparative case series of patients followed for 24 months. A total of 125 patients were randomized to mini-open (Group I) or arthroscopic (Group II) rotator cuff repair at the time of surgical intervention. The University of California Los Angeles (UCLA) score, the American Shoulder and Elbow Surgeons (ASES) index, and muscle strength were measured to evaluate the clinical results, while magnetic resonance arthrography was used at 24-month follow-up to investigate the postoperative rotator cuff integrity. Fifty-three patients in Group I and 55 patients in Group II were available for evaluation at 24-month follow-up. At 24-month follow-up, the UCLA score, the ASES index, and muscle strength were statistically significantly increased in both groups postoperatively, while no significant difference was detected between the 2 groups. Intact rotator cuffs were investigated in 42 patients in Group I and 35 in Group II, and there was a significant difference in postoperative structural integrity between the two groups (P < 0.05). When analysis was limited to the patients with full-thickness tear, the muscle strength of the shoulder was significantly better in Group II, and the retearing rate was significantly higher in Group II. Based on the results obtained from this study, it can be indicated that arthroscopic and mini-open rotator cuff repair displayed substantially equal outcomes, except for higher retearing rate in the arthroscopic repair group. While for patients with full-thickness tear, arthroscopic rotator cuff repair displayed better shoulder strength and significantly higher retearing rate as compared to mini-open rotator cuff repair at 24-month follow-up.

Horse-Related Injuries among Agricultural Household Members: Regional Rural Injury Study II (RRIS-II)

ERIC Educational Resources Information Center

Erkal, Sibel; Gerberich, Susan G.; Ryan, Andrew D.; Alexander, Bruce H.; Renier, Colleen M.

2009-01-01

Purpose: To determine the incidence, associated consequences, and potential risk factors for horse-related injuries among youth and adults residing in Midwestern agricultural households. Methods: Demographic, injury, and exposure data were collected for 1999 and 2001 among randomly selected agricultural households within a 5-state region. A causal…

Alternative Dosing of Exemestane Before Surgery in Treating Postmenopausal Patients With Stage 0-II Estrogen Positive Breast Cancer | Division of Cancer Prevention

Cancer.gov

This randomized phase IIb trial studies how well alternative dosing of exemestane before surgery works in treating in postmenopausal patients with stage 0-II estrogen positive breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of exemestane may treat early stage (stage 0-II) breast cancer. Comparing the exemestane

Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review.

PubMed

Langrand-Escure, Julien; Rivoirard, Romain; Oriol, Mathieu; Tinquaut, Fabien; Rancoule, Chloé; Chauvin, Frank; Magné, Nicolas; Bourmaud, Aurélie

2017-01-01

Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials. A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010-2015). All articles electronically published by three randomly-selected oncology journals with Impact-Factors>4 were included: Journal of Clinical Oncology, Annals of Oncology and British Journal of Cancer. Quality of reporting was assessed using the Key Methodological Score. 557 articles were included. 315 trials were single-arm studies (56.6%), 193 (34.6%) were randomized and 49 (8.8%) were non-randomized multiple-arm studies. The Methodological Score was equal to 0 (lowest level), 1, 2, 3 (highest level) respectively for 22 (3.9%), 119 (21.4%), 270 (48.5%) and 146 (26.2%) articles. The primary end point is almost systematically reported (90.5%), while sample size calculation is missing in 66% of the articles. 3 variables were independently associated with reporting of a high standard: presence of statistical design (p-value <0.001), multicenter trial (p-value = 0.012), per-protocol analysis (p-value <0.001). Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate. This literature review highlights the existence of gaps concerning the quality of reporting. It therefore raised the question of the suitability of the methodology as well as the quality of these trials, reporting being incomplete in the corresponding articles.

A double-blind randomized discontinuation phase II study of sorafenib (BAY 43-9006) in previously treated non-small cell lung cancer patients: Eastern Cooperative Oncology Group study E2501

PubMed Central

Wakelee, Heather A.; Lee, Ju-Whei; Hanna, Nasser H.; Traynor, Anne M.; Carbone, David P.; Schiller, Joan H.

2012-01-01

Introduction Sorafenib is a raf kinase and angiogenesis inhibitor with activity in multiple cancers. This phase II study in heavily pretreated non-small cell lung cancer (NSCLC) patients (≥ two prior therapies) utilized a randomized discontinuation design. Methods Patients received 400 mg of sorafenib orally twice daily for two cycles (two months) (Step 1). Responding patients on Step 1 continued on sorafenib; progressing patients went off study, and patients with stable disease were randomized to placebo or sorafenib (Step 2), with crossover from placebo allowed upon progression. The primary endpoint of this study was the proportion of patients having stable or responding disease two months after randomization. Results : There were 299 patients evaluated for Step 1 with 81 eligible patients randomized on Step 2 who received sorafenib (n=50) or placebo (n=31). The two-month disease control rates following randomization were 54% and 23% for patients initially receiving sorafenib and placebo respectively, p=0.005. The hazard ratio for progression on Step 2 was 0.51 (95% CI 0.30, 0.87, p=0.014) favoring sorafenib. A trend in favor of overall survival with sorafenib was also observed (13.7 versus 9.0 months from time of randomization), HR 0.67 (95% CI 0.40-1.11), p=0.117. A dispensing error occurred which resulted in unblinding of some patients, but not before completion of the 8 week initial step 2 therapy. Toxicities were manageable and as expected. Conclusions : The results of this randomized discontinuation trial suggest that sorafenib has single agent activity in a heavily pretreated, enriched patient population with advanced NSCLC. These results support further investigation with sorafenib as a single agent in larger, randomized studies in NSCLC. PMID:22982658

Risperidone Added to Psychostimulant in Children with Severe Aggression and Attention-Deficit/Hyperactivity Disorder: Lack of Effect on Attention and Short-Term Memory

PubMed Central

Epstein, Jeffery N.; Findling, Robert L.; Gadow, Kenneth D.; Arnold, L. Eugene; Kipp, Heidi; Kolko, David J.; Butter, Eric; Schneider, Jayne; Bukstein, Oscar G.; McNamara, Nora K.; Molina, Brooke S.G.; Aman, Michael G.

2017-01-01

Abstract Objective: Professionals have periodically expressed concern that atypical antipsychotics may cause cognitive blunting in treated patients. In this study, we report data from a double-blind, randomized, controlled study of stimulant plus placebo versus combined stimulant and risperidone to evaluate the effects of the atypical antipsychotic on attention and short-term memory. Methods: A total of 165 (n = 83 combined treatment; n = 82 stimulant plus placebo) children with attention-deficit/hyperactivity disorder and severe physical aggression, aged 6–12 years, were evaluated with Conners' Continuous Performance Test (CPT-II) and the Wechsler Intelligence Scale for Children-III (WISC) Digit Span subscale at baseline, after 3 weeks of stimulant-only treatment, and after six additional weeks of randomized treatment (stimulant+placebo vs. stimulant+risperidone). Results: At 3 weeks, improvement on CPT-II performance (Commissions and Reaction Time Standard Error; p < 0.001) and on Digit Span memory performance (p < 0.006) was noted for the full sample. At study week 9, no difference in CPT-II or Digit Span performance was observed between the randomized groups (ps = 0.41 to 0.83). Conclusions: Similar to other studies, we found no deleterious effects on attention and short-term memory associated with short-term use of risperidone. NCT00796302. PMID:27348211

Mature Results of a Prospective Randomized Trial Comparing 5-Flourouracil with Leucovorin to 5-Flourouracil with Levamisole as Adjuvant Therapy of Stage II and III Colorectal Cancer- The Israel Cooperative Oncology Group (ICOG) Study

PubMed Central

Figer, Arie; Nissan, Aviram; Shani, Adi; Borovick, Riva; Stiener, Mariana; Baras, Mario; Freund, Herbert R.; Sulkes, Aaron; Stojadinovic, Alexander; Peretz, Tamar

2011-01-01

Objective: Survival benefit with adjuvant therapy was shown in patients with Stage III colorectal cancer (CRC). This study evaluates long-term (10-year) outcome in patients with CRC randomly assigned to adjuvant 5-Fluorouracil/Leucovorin (5FU+LV) or 5-FU/Levamisole (5FU+LEV). Methods: Between 1990 and 1995, 398 patients with curatively resected Stage II-III CRC were randomly assigned to adjuvant 5FU+LV or 5FU+LEV for 12 months. Results: No difference was evident in 10-year relapse-free or overall survival between study groups. Grade III toxicity was similar between groups; however, neurotoxicity was significantly greater with 5FU+LEV (p=0.02) and gastrointestinal toxicity with 5FU+LV (p=0.03). Female patients treated with 5FU+LEV had improved overall survival. Conclusions: Adjuvant treatment of CRC is still based on leucovorin modulated fluorouracil. The long-term follow-up results of this trial indicate that the adjuvant treatment of Stage II-III CRC with 5FU+LV or 5FU+LEV is equally effective. The finding of improved survival in female subjects treated with 5FU+LEV warrants further study to determine if Levamisole is a better modulator of 5-FU than Leucovorin in this patient subset. PMID:21475636

Effect of oral cranberry extract (standardized proanthocyanidin-A) in patients with recurrent UTI by pathogenic E. coli: a randomized placebo-controlled clinical research study.

PubMed

Singh, Iqbal; Gautam, Lokesh Kumar; Kaur, Iqbal R

2016-09-01

To evaluate the effect of cranberry extract (PAC-A ~ proanthocyanidin-A) on the in vitro bacterial properties of uropathogenic (E. coli) and its efficacy/tolerability in patients with subclinical or uncomplicated recurrent UTI (r-UTI). After obtaining clearance from the ethics committee and administering a written informed consent, 72 patients with r-UTI were enrolled as per protocol (November 2011 to March 2013) in this prospective study, to randomly receive (PAC-A: group I, 36) or (placebo: group II, 36), for 12 weeks. Any change/reduction in the incidence of r-UTI at 12 weeks was construed to be the primary endpoint of this study. After 12 weeks, bacterial adhesion scoring decreased (0.28)/(2.14) in group I/II (p < 0.001); 32/36 (88.8 %) and 2/36 (5.5 %) in groups I and II, respectively, turned MRHA negative (p < 0.001); biofilm (p < 0.01) and bacterial growth (p < 0.001) decreased in group I; microscopic pyuria score was 0.36/2.0 in group I/II (p < 0.001); r-UTI decreased to 33.33 versus 88.89 % in group I/II (p < 0.001); mean subjective dysuria score was 0.19 versus 1.47 in group I/II (p < 0.001), while mean urine pH was 5.88 versus 6.30 in group I/II (p < 0.001). No in vitro antibacterial activity of cranberry could be demonstrated, and no adverse events were noted. The overall efficacy and tolerability of standardized cranberry extract containing (PAC-A) as a food supplement were superior to placebo in terms of reduced bacterial adhesion; bacterial MRHA negativity; urine pH reduction; and in preventing r-UTI (dysuria, bacteriuria and pyuria). Larger randomized controlled trials are needed to elucidate the precise role, exact dose and optimal duration of PAC-A therapy in patients at risk of r-UTI.

Varying levels of difficulty index of skills-test items randomly selected by examinees on the Korean emergency medical technician licensing examination.

PubMed

Koh, Bongyeun; Hong, Sunggi; Kim, Soon-Sim; Hyun, Jin-Sook; Baek, Milye; Moon, Jundong; Kwon, Hayran; Kim, Gyoungyong; Min, Seonggi; Kang, Gu-Hyun

2016-01-01

The goal of this study was to characterize the difficulty index of the items in the skills test components of the class I and II Korean emergency medical technician licensing examination (KEMTLE), which requires examinees to select items randomly. The results of 1,309 class I KEMTLE examinations and 1,801 class II KEMTLE examinations in 2013 were subjected to analysis. Items from the basic and advanced skills test sections of the KEMTLE were compared to determine whether some were significantly more difficult than others. In the class I KEMTLE, all 4 of the items on the basic skills test showed significant variation in difficulty index (P<0.01), as well as 4 of the 5 items on the advanced skills test (P<0.05). In the class II KEMTLE, 4 of the 5 items on the basic skills test showed significantly different difficulty index (P<0.01), as well as all 3 of the advanced skills test items (P<0.01). In the skills test components of the class I and II KEMTLE, the procedure in which examinees randomly select questions should be revised to require examinees to respond to a set of fixed items in order to improve the reliability of the national licensing examination.

Evaluation of the effectiveness of low-dose aspirin and omega 3 in treatment of asymmetrically intrauterine growth restriction: A randomized clinical trial.

PubMed

Ali, Mohammed K; Amin, Maggy E; Amin, Ahmed F; Abd El Aal, Diaa Eldeen M

2017-03-01

To test the effect of aspirin and omega 3 on fetal weight as well as feto-maternal blood flow in asymmetrical intrauterine growth restriction (IUGR). This study is a clinically registered (NCT02696577), open, parallel, randomized controlled trial, conducted at Assiut Woman's Health Hospital, Egypt including 80 pregnant women (28-30 weeks) with IUGR. They were randomized either to group I: aspirin or group II: aspirin plus omega 3. The primary outcome was the fetal weight after 6 weeks of treatment. Secondary outcomes included Doppler blood flow changes in both uterine and umbilical arteries, birth weight, time and method of delivery and admission to NICU. The outcome variables were analyzed using paired and unpaired t-test. The estimated fetal weight increased significant in group II more than group I (p=0.00). The uterine and umbilical arteries blood flow increased significantly in group II (p<0.05). The birth weight in group II was higher than that observed in group I (p<0.05). The using of aspirin with omega 3 is more effective than using aspirin only in increasing fetal weight and improving utero-placental blood flow in IUGR. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Recruitment strategies in two Reproductive Medicine Network infertility trials

PubMed Central

Usadi, Rebecca S.; Diamond, Michael P.; Legro, Richard S.; Schlaff, William D.; Hansen, Karl R.; Casson, Peter; Christman, Gregory; Bates, G. Wright; Baker, Valerie; Seungdamrong, Aimee; Rosen, Mitchell P.; Lucidi, Scott; Thomas, Tracey; Huang, Hao; Santoro, Nanette; Eisenberg, Esther; Zhang, Heping; Alvero, Ruben

2016-01-01

Background Recruitment of individuals into clinical trials is a critical step in completing studies. Reports examining the effectiveness of different recruitment strategies, and specifically in infertile couples, are limited. Methods We investigated recruitment methods used in two NIH sponsored trials, Pregnancy in Polycystic Ovary Syndrome (PPCOS II) and Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS), and examined which strategies yielded the greatest number of participants completing the trials. Results 3683 couples were eligible for screening. 1650 participants were randomized and 1339 completed the trials. 750 women were randomized in PPCOS II; 212 of the participants who completed the trial were referred by physicians. Participants recruited from radio ads (84/750) and the internet (81/750) resulted in similar rates of trial completion in PPCOS II. 900 participants were randomized in AMIGOS. 440 participants who completed the trial were referred to the study by physicians. The next most successful method in AMIGOS was use of the internet, achieving 78 completed participants. Radio ads proved the most successful strategy in both trials for participants who earned <$50,000 annually. Radio ads were most successful in enrolling white patients in PPCOS II and black patients in AMIGOS. Seven ancillary Clinical Research Scientist Training (CREST) sites enrolled 324 of the participants who completed the trials. Conclusions Physician referral was the most successful recruitment strategy. Radio ads and the internet were the next most successful strategies, particularly for women of limited income. Ancillary clinical sites were important for overall recruitment. PMID:26386293

Randomized Controlled Trial Comparing Orthosis Augmented by Either Stretching or Stretching and Strengthening for Stage II Tibialis Posterior Tendon Dysfunction.

PubMed

Houck, Jeff; Neville, Christopher; Tome, Josh; Flemister, Adolph

2015-09-01

The value of strengthening and stretching exercises combined with orthosis treatment in a home-based program has not been evaluated. The purpose of this study was to compare the effects of augmenting orthosis treatment with either stretching or a combination of stretching and strengthening in participants with stage II tibialis posterior tendon dysfunction (TPTD). Participants included 39 patients with stage II TPTD who were recruited from a medical center and then randomly assigned to a strengthening or stretching treatment group. Excluding 3 dropouts, there were 19 participants in the strengthening group and 17 in the stretching group. The stretching treatment consisted of a prefabricated orthosis used in conjunction with stretching exercises. The strengthening treatment consisted of a prefabricated orthosis used in conjunction with the stretching and strengthening exercises. The main outcome measures were self-report (ie, Foot Function Index and Short Musculoskeletal Function Assessment) and isometric deep posterior compartment strength. Two-way analysis of variance was used to test for differences between groups at 6 and 12 weeks after starting the exercise programs. Both groups significantly improved in pain and function over the 12-week trial period. The self-report measures showed minimal differences between the treatment groups. There were no differences in isometric deep posterior compartment strength. A moderate-intensity, home-based exercise program was minimally effective in augmenting orthosis wear alone in participants with stage II TPTD. Level I, prospective randomized study. © The Author(s) 2015.

Recruitment strategies in two reproductive medicine network infertility trials.

PubMed

Usadi, Rebecca S; Diamond, Michael P; Legro, Richard S; Schlaff, William D; Hansen, Karl R; Casson, Peter; Christman, Gregory; Wright Bates, G; Baker, Valerie; Seungdamrong, Aimee; Rosen, Mitchell P; Lucidi, Scott; Thomas, Tracey; Huang, Hao; Santoro, Nanette; Eisenberg, Esther; Zhang, Heping; Alvero, Ruben

2015-11-01

Recruitment of individuals into clinical trials is a critical step in completing studies. Reports examining the effectiveness of different recruitment strategies, and specifically in infertile couples, are limited. We investigated recruitment methods used in two NIH sponsored trials, Pregnancy in Polycystic Ovary Syndrome (PPCOS II) and Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS), and examined which strategies yielded the greatest number of participants completing the trials. 3683 couples were eligible for screening. 1650 participants were randomized and 1339 completed the trials. 750 women were randomized in PPCOS II; 212 of the participants who completed the trial were referred by physicians. Participants recruited from radio ads (84/750) and the internet (81/750) resulted in similar rates of trial completion in PPCOS II. 900 participants were randomized in AMIGOS. 440 participants who completed the trial were referred to the study by physicians. The next most successful method in AMIGOS was the use of the internet, achieving 78 completed participants. Radio ads proved the most successful strategy in both trials for participants who earned <$50,000 annually. Radio ads were most successful in enrolling white patients in PPCOS II and black patients in AMIGOS. Seven ancillary Clinical Research Scientist Training (CREST) sites enrolled 324 of the participants who completed the trials. Physician referral was the most successful recruitment strategy. Radio ads and the internet were the next most successful strategies, particularly for women of limited income. Ancillary clinical sites were important for overall recruitment. Copyright © 2015 Elsevier Inc. All rights reserved.

A comparative analysis of the results from 4 trials of beta-blocker therapy for heart failure: BEST, CIBIS-II, MERIT-HF, and COPERNICUS.

PubMed

Domanski, Michael J; Krause-Steinrauf, Heidi; Massie, Barry M; Deedwania, Prakash; Follmann, Dean; Kovar, David; Murray, David; Oren, Ron; Rosenberg, Yves; Young, James; Zile, Michael; Eichhorn, Eric

2003-10-01

Recent large randomized, controlled trials (BEST [Beta-blocker Evaluation of Survival Trial], CIBIS-II [Cardiac Insufficiency Bisoprolol Trial II], COPERNICUS [Carvedilol Prospective Randomized Cumulative Survival Study], and MERIT-HF [Metoprolol Randomized Intervention Trial in Congestive Heart Failure]) have addressed the usefulness of beta-blockade in the treatment of advanced heart failure. CIBIS-II, COPERNICUS, and MERIT-HF have shown that beta-blocker treatment with bisoprolol, carvedilol, and metoprolol XL, respectively, reduce mortality in advanced heart failure patients, whereas BEST found a statistically nonsignificant trend toward reduced mortality with bucindolol. We conducted a post hoc analysis to determine whether the response to beta-blockade in BEST could be related to differences in the clinical and demographic characteristics of the study populations. We generated a sample from BEST to resemble the patient cohorts studied in CIBIS-II and MERIT-HF to find out whether the response to beta-blocker therapy was similar to that reported in the other trials. These findings are further compared with COPERNICUS, which entered patients with more severe heart failure. To achieve conformity with the entry criteria for CIBIS-II and MERIT-HF, the BEST study population was adjusted to exclude patients with systolic blood pressure <100 mm Hg, heart rate <60 bpm, and age >80 years (exclusion criteria employed in those trials). The BEST comparison subgroup (BCG) was further modified to more closely reflect the racial demographics reported for patients enrolled in CIBIS-II and MERIT-HF. The association of beta-blocker therapy with overall survival and survival free of cardiac death, sudden cardiac death, and progressive pump failure in the BCG was assessed. In the BCG subgroup, bucindolol treatment was associated with significantly lower risk of death from all causes (hazard ratio (HR)=0.77 [95% CI=0.65, 0.92]), cardiovascular death (HR=0.71 [0.58, 0.86]), sudden death (HR=0.77 [0.59, 0.999]), and pump failure death (HR=0.64 [0.45, 0.91]). Although not excluding the possibility of differences resulting from chance alone or to different properties among beta-blockers, this study suggests the possibility that different heart failure population subgroups may have different responses to beta-blocker therapy.

Process Evaluation of a Multi-Component Intervention to Reduce Infectious Diseases and Improve Hygiene and Well-Being among School Children: The Hi Five Study

ERIC Educational Resources Information Center

Bonnesen, C. T.; Plauborg, R.; Denbaek, A. M.; Due, P.; Johansen, A.

2015-01-01

The Hi Five study was a three-armed cluster randomized controlled trial designed to reduce infections and improve hygiene and well-being among pupils. Participating schools (n = 43) were randomized into either control (n = 15) or one of two intervention groups (n = 28). The intervention consisted of three components: (i) a curriculum (ii)…

Randomized prospective study comparing tri-cortical iliac crest autograft to allograft in the lateral column lengthening component for operative correction of adult acquired flatfoot deformity.

PubMed

Dolan, Christopher M; Henning, Jeffrey A; Anderson, John G; Bohay, Donald R; Kornmesser, Marc J; Endres, Terrence J

2007-01-01

Operative treatment of stage II posterior tibial tendon insufficiency (PTTI) is controversial. Many soft-tissue and bony procedures and various combinations of the two have been reported for treatment of stage II PTTI. Orthopaedists recognize the lateral column lengthening component of the procedure as a successful reconstructive technique. The use of cortical allograft for lateral column lengthening in the correction of pes planus in the pediatric patient population has been routine. In the adult population, however, tricortical iliac crest autograft has been the bone graft of choice. Harvest of this autograft can precipitate significant morbidity and cost. Therefore, we undertook this randomized controlled trial to compare graft incorporation and healing of allograft and autograft in the lateral column lengthening component of adult flatfoot reconstruction. Lateral column lengthening was done as a component of operative correction for stage II PTTI in adult patients (older than 18 years) by two surgeons using similar procedures. The patients were randomized to either the allograft or autograft procedures. The primary endpoint was graft incorporation and healing as assessed by radiographs. The study included 33 randomized feet in 31 patients. We followed 18 feet in the allograft group and 15 in the autograft group to the point of union. There were 21 women and 10 men. There were no delayed unions, nonunions, or hardware failures. All patients in both groups achieved bony union by the 12-week followup evaluation. Two superficial foot infections were successfully treated with oral antibiotics. Two patients in the autograft group continued to have hip donor site pain at 3 months. This study suggests that union rates of allograft and autograft (iliac crest bone graft) are equal. The use of allograft in the lateral column lengthening component of operative correction of adult stage II PTTI appears to be a viable alternative to the use of iliac crest autograft and eliminates the morbidity and increased cost associated with autograft harvest.

The Youth-Nominated Support Team for Suicidal Adolescents – Version II: A Randomized Controlled Intervention Trial

PubMed Central

King, Cheryl A.; Klaus, Nicole; Kramer, Anne; Venkataraman, Sanjeev; Quinlan, Paul; Gillespie, Brenda

2010-01-01

The purpose of this study was to examine the efficacy of the Youth-Nominated Support Team – Version II (YST-II) for suicidal adolescents, an intervention based on social support and health behavior models, which was designed to supplement standard treatments. Psychiatrically hospitalized and suicidal adolescents, ages 13 to 17 years, were randomly assigned to treatment-as-usual (TAU) plus YST-II (n = 223) or TAU only (n = 225). YST-II provided tailored psychoeducation to youth-nominated adults in addition to weekly check-ins for three months following hospitalization. In turn, these adults had regular supportive contact with adolescents. Adolescents assigned to TAU+YST-II had an average of 3.43 (SD = .83) nominated adults. Measures included the Suicidal Ideation Questionnaire-JR (SIQ-JR), Children's Depression Rating Scale-Revised (CDRS-R), Beck Hopelessness Scale (BHS), and Child and Adolescent Functional Assessment Scale (CAFAS). YST-II had very limited positive effects, which were moderated by history of multiple suicide attempts, and no negative effects. It resulted in more rapid decreases in suicidal ideation (SIQ-JR) for multiple suicide attempters during the initial 6 weeks after hospitalization (small – moderate effect size). For non-multiple attempters, it was associated with greater declines in functional impairment (CAFAS) at 3- and 12-months (small effect sizes). YST-II had no effects on suicide attempts, and no enduring effects on SIQ-JR scores. PMID:19803568

Safety, tolerability, and immunogenicity of the novel antituberculous vaccine RUTI: randomized, placebo-controlled phase II clinical trial in patients with latent tuberculosis infection.

PubMed

Nell, Andre S; D'lom, Eva; Bouic, Patrick; Sabaté, Montserrat; Bosser, Ramon; Picas, Jordi; Amat, Mercè; Churchyard, Gavin; Cardona, Pere-Joan

2014-01-01

To evaluate the safety, tolerability and immunogenicity of three different doses (5, 25 and 50 µg) of the novel antituberculous vaccine RUTI compared to placebo in subjects with latent tuberculosis infection. Double-blind, randomized, placebo-controlled Phase II Clinical Trial (95 patients randomized). Three different RUTI doses and placebo were tested, randomized both in HIV-positive (n = 47) and HIV-negative subjects (n = 48), after completion of one month isoniazid (INH) pre-vaccination. Each subject received two vaccine administrations, 28 Days apart. Five patients withdrew and 90 patients completed the study. Assessment of safety showed no deaths during study. Two subjects had serious adverse events one had a retinal detachment while taking INH and was not randomized and the other had a severe local injection site abscess on each arm and was hospitalized; causality was assessed as very likely and by the end of the study the outcome had resolved. All the patients except 5 (21%) patients of the placebo group (3 HIV+ and 2 HIV-) reported at least one adverse event (AE) during the study. The most frequently occurring AEs among RUTI recipients were (% in HIV+/-): injection site reactions [erythema (91/92), induration (94/92), local nodules (46/25), local pain (66/75), sterile abscess (6/6), swelling (74/83), ulcer (20/11), headache (17/22) and nasopharyngitis (20/5)]. These events were mostly mild and well tolerated. Overall, a polyantigenic response was observed, which differed by HIV- status. The best polyantigenic response was obtained when administrating 25 µg RUTI, especially in HIV-positive subjects which was not increased after the second inoculation. This Phase II clinical trial demonstrates reasonable tolerability of RUTI. The immunogenicity profile of RUTI vaccine in LTBI subjects, even being variable among groups, allows us considering one single injection of one of the highest doses in future trials, preceded by an extended safety clinical phase. ClinicalTrials.gov NCT01136161.

Randomized phase II study comparing gemcitabine plus dacarbazine versus dacarbazine alone in patients with previously treated soft tissue sarcoma: a Spanish Group for Research on Sarcomas study.

PubMed

García-Del-Muro, Xavier; López-Pousa, Antonio; Maurel, Joan; Martín, Javier; Martínez-Trufero, Javier; Casado, Antonio; Gómez-España, Auxiliadora; Fra, Joaquín; Cruz, Josefina; Poveda, Andrés; Meana, Andrés; Pericay, Carlos; Cubedo, Ricardo; Rubió, Jordi; De Juan, Ana; Laínez, Nuria; Carrasco, Juan Antonio; de Andrés, Raquel; Buesa, José M

2011-06-20

To assess the activity and toxicity of the combination of gemcitabine plus dacarbazine (DTIC) in patients with advanced soft tissue sarcoma (STS) in a randomized, multicenter, phase II study using DTIC alone as a control arm. Patients with previously treated advanced STS were randomly assigned to receive either fixed-dose rate gemcitabine (10 mg/m2/min) at 1800 mg/m2 followed by DTIC at 500 mg/m2 every 2 weeks, or DTIC alone at 1200 mg/m2 every 3 weeks. The primary end point of the study was progression-free rate (PFR) at 3 months. From November 2005 to September 2008, 113 patients were included. PFR at 3 months was 56% for gemcitabine plus DTIC versus 37% for DTIC alone (P = .001). Median progression-free survival was 4.2 months versus 2 months (hazard ratio [HR], 0.58; 95% CI, 0.39 to 0.86; P = .005), and median overall survival was 16.8 months versus 8.2 months (HR, 0.56; 95% CI, 0.36 to 0.90; P = .014); both favored the arm of gemcitabine plus DTIC. Gemcitabine plus DTIC was also associated with a higher objective response or higher stable disease rate than was DTIC alone (49% v 25%; P = .009). Severe toxicities were uncommon, and treatment discontinuation for toxicity was rare. Granulocytopenia was the more common serious adverse event, but febrile neutropenia was uncommon. Asthenia, emesis, and stomatitis were the most frequent nonhematologic effects. The combination of gemcitabine and DTIC is active and well tolerated in patients with STS, providing in this phase II randomized trial superior progression-free survival and overall survival than DTIC alone. This regimen constitutes a valuable therapeutic alternative for these patients.

Randomized phase II study of a bendamustine monotherapy schedule for relapsed or refractory low-grade B-cell non-Hodgkin lymphoma or mantle cell lymphoma (RABBIT-14).

PubMed

Itoh, Kuniaki; Igarashi, Tadahiko; Irisawa, Hiroyuki; Aotsuka, Nobuyuki; Masuda, Shinichi; Utsu, Yoshikazu; Tsujimura, Hideki; Tsukasaki, Kunihiro; Wakita, Hisashi

2017-10-30

The aim of this randomized phase II study was to improve the treatment delays and discontinuations associated with bendamustine use by comparing the effect of Benda-14 (intravenous bendamustine, 120 mg/m 2 on days 1 and 15, repeated every 4 weeks for a total of 6 cycles) with those of the standard treatment in relapsed indolent lymphoma and/or mantle cell lymphoma. Forty-six patients were randomly assigned to the treatments from September 2012 to February 2016. Treatment accomplishment rate and median relative dose intensity were similar in both arms: 38 and 63.4% in the Benda-14 arm and 41 and 66.3% in the standard treatment arm, respectively. The overall response rate and median progression-free survival, respectively, were 83% and 21.0 months for Benda-14, and 77% and 15.5 months for the standard treatment. Benda-14 induced favorable responses with less frequent hematological toxicities.

Reliability and Validity of Self-Concept Scores in Secondary School Students in Trinidad and Tobago

ERIC Educational Resources Information Center

Worrell, Frank C.; Watkins, Marley W.; Hall, Tracey E.

2008-01-01

In this study we examined the reliability and validity of global, mathematics and English self-concept scores from the Self-Description Questionnaire II (SDQ-II, Marsh, 1990b) in a random sample of 870 secondary school students in Trinidad and Tobago. The results provided strong evidence for the structural validity of the scores and yielded…

Instructional Climates in Preschool Children Who Are At-Risk. Part II: Perceived Physical Competence

ERIC Educational Resources Information Center

Robinson, Leah E.; Rudisill, Mary E.; Goodway, Jacqueline D.

2009-01-01

In Part II of this study, we examined the effect of two 9-week instructional climates (low-autonomy [LA] and mastery motivational climate [MMC]) on perceived physical competence (PPC) in preschoolers (N = 117). Participants were randomly assigned to an LA, MMC, or comparison group. PPC was assessed by a pretest, posttest, and retention test with…

A Two-Year Randomized Trial of Interventions to Decrease Stress Hormone Vasopressin Production in Patients with Meniere's Disease-A Pilot Study.

PubMed

Kitahara, Tadashi; Okamoto, Hidehiko; Fukushima, Munehisa; Sakagami, Masaharu; Ito, Taeko; Yamashita, Akinori; Ota, Ichiro; Yamanaka, Toshiaki

2016-01-01

Meniere's disease, a common inner ear condition, has an incidence of 15-50 per 100,000. Because mental/physical stress and subsequent increase in the stress hormone vasopressin supposedly trigger Meniere's disease, we set a pilot study to seek new therapeutic interventions, namely management of vasopressin secretion, to treat this disease. We enrolled 297 definite Meniere's patients from 2010 to 2012 in a randomized-controlled and open-label trial, assigning Group-I (control) traditional oral medication, Group-II abundant water intake, Group-III tympanic ventilation tubes and Group-IV sleeping in darkness. Two hundred sixty-three patients completed the planned 2-year-follow-up, which included assessment of vertigo, hearing, plasma vasopressin concentrations and changes in stress/psychological factors. At 2 years, vertigo was completely controlled in 54.3% of patients in Group-I, 81.4% in Group-II, 84.1% in Group-III, and 80.0% in Group-IV (statistically I < II = III = IV). Hearing was improved in 7.1% of patients in Group-I, 35.7% in Group-II, 34.9% in Group-III, and 31.7% in Group-IV (statistically I < II = III = IV). Plasma vasopressin concentrations decreased more in Groups-II, -III, and -IV than in Groups-I (statistically I < II = III = IV), although patients' stress/psychological factors had not changed. Physicians have focused on stress management for Meniere's disease. However, avoidance of stress is unrealistic for patients who live in demanding social environments. Our findings in this pilot study suggest that interventions to decrease vasopressin secretion by abundant water intake, tympanic ventilation tubes and sleeping in darkness is feasible in treating Meniere's disease, even though these therapies did not alter reported mental/physical stress levels. ClinicalTrials.gov NCT01099046.

Roux-en-Y or Billroth II Reconstruction After Radical Distal Gastrectomy for Gastric Cancer: A Multicenter Randomized Controlled Trial.

PubMed

So, Jimmy Bok-Yan; Rao, Jaideepraj; Wong, Andrew Siang-Yih; Chan, Yiong-Huak; Pang, Ning Qi; Tay, Amy Yuh Ling; Yung, Man Yee; Su, Zheng; Phua, Janelle Niam Sin; Shabbir, Asim; Ng, Enders Kwok Wai

2018-02-01

The aim of the study was to compare the clinical symptoms between Billroth II (B-II) and Roux-en-Y (R-Y) reconstruction after distal subtotal gastrectomy (DG) for gastric cancer. Surgery is the mainstay of curative treatment for gastric cancer. The technique for reconstruction after DG remains controversial. Both B-II and R-Y are popular methods. This is a prospective multicenter randomized controlled trial. From October 2008 to October 2014, 162 patients who underwent DG were randomly allocated to B-II (n = 81) and R-Y (n = 81) groups. The primary endpoint is Gastrointestinal (GI) Symptoms Score 1 year after surgery. We also compared the nutritional status, extent of gastritis on endoscopy, and quality of life after surgery between the 2 procedures at 1 year. Operative time was significantly shorter for B-II than for R-Y [mean difference 21.5 minutes, 95% confidence interval (95% CI) 3.8-39.3, P = 0.019]. The B-II and R-Y groups had a peri-operative morbidity of 28.4% and 33.8%, respectively (P = 0.500) and a 30-day mortality of 2.5% and 1.2%, respectively (P = 0.500). GI symptoms score did not differ between R-Y versus B-II reconstruction (mean difference -0.45, 95% CI -1.21 to 0.31, P = 0.232). R-Y resulted in a lower median endoscopic grade for gastritis versus B-II (mean difference -1.32, 95% CI -1.67 to -0.98, P < 0.001). We noted no difference in nutritional status (R-Y versus B-II mean difference -0.31, 95% CI -3.27 to 2.65, P = 0.837) and quality of life at 1 year between the 2 groups too. Although BII is associated with a higher incidence of heartburn symptom and higher median endoscopic grade for gastritis, BII and RY are similar in terms of overall GI symptom score and nutritional status at 1 year after distal gastrectomy.

The Effect of Holly Quran Voice With and Without Translation on Stress, Anxiety and Depression During Pregnancy: A Randomized Controlled Trial.

PubMed

Jabbari, Batoul; Mirghafourvand, Mojgan; Sehhatie, Fahimeh; Mohammad-Alizadeh-Charandabi, Sakineh

2017-05-30

This study aimed to investigate the effect of Holy Quran on stress, anxiety and depression in Iranian pregnant women. A total of 168 participants were allocated randomly into three groups. Group I received broadcast of the Holy Quran with translation, group II received broadcast of the Holy Quran without translation, and group III was the control group. After intervention, scores of perceived stress, state anxiety, trait anxiety and depression in group I and group II were significantly lower compared with the control group. The Holly Quran with translation and without it, both are the effective for reducing stress, anxiety and depression during pregnancy.

Systematic Review of Integrative Health Care Research: Randomized Control Trials, Clinical Controlled Trials, and Meta-Analysis

DTIC Science & Technology

2010-01-01

to usual care (control). Also, in the pilot study of the 4 individual Noetic therapies, off-site prayer was associated with the lowest absolute...mortality in-hospital and at 6 months [16]. The parallel randomization to 4 different Noetic therapies across 5 study arms limited the assessment of...interventional cardiac care: the Monitoring and Actualisation of Noetic Trainings (MANTRA) II randomised study ,” Lancet, vol. 366, no. 9481, pp. 211–217, 2005. [18

Unblinded randomized control trial on prophylactic antibiotic use in gustilo II open tibia fractures at Kenyatta National Hospital, Kenya.

PubMed

Ondari, Joshua Nyaribari; Masika, Moses Muia; Ombachi, Richard Bwana; Ating'a, John Ernest

2016-10-01

To determine the difference in infection rate between 24h versus five days of prophylactic antibiotic use in management of Gustilo II open tibia fractures. Unblinded randomized control trial. Accident and Emergency, orthopedic wards and outpatient clinics at Kenyatta National Hospital (KNH). The study involved patients aged 18-80 years admitted through accident and emergency department with Gustilo II traumatic open tibia fractures. Patients were randomized into either 24hour or five day group and antibiotics started for 24hours or five days after surgical debridement. The wounds were exposed and scored using ASEPSIS wound scoring system for infection after 48h, 5days and at 14days. The main outcomes of interest were presence of infection at days 2, 5 and 14 and effect of duration to antibiotic administration on infection rate. There was no significant difference in infection rates between 24-hour and 5-day groups with infection rates of 23% (9/40) vs. 19% (7/37) respectively (p=0.699). The infection rate was significantly associated with time lapsed before administration of antibiotics (p=0.004). In the use of prophylactic antibiotics for the management of Gustilo II traumatic open tibia fractures, there is no difference in infection rate between 24hours and five days regimen but time to antibiotic administration correlates with infection rate. Antibiotic use for 24hours only has proven adequate prophylaxis against infection. This is underlined in our study which we hope shall inform practice in our setting. A larger, more appropriately controlled study would be useful. Copyright © 2016 Elsevier Ltd. All rights reserved.

Varying levels of difficulty index of skills-test items randomly selected by examinees on the Korean emergency medical technician licensing examination

PubMed Central

2016-01-01

Purpose: The goal of this study was to characterize the difficulty index of the items in the skills test components of the class I and II Korean emergency medical technician licensing examination (KEMTLE), which requires examinees to select items randomly. Methods: The results of 1,309 class I KEMTLE examinations and 1,801 class II KEMTLE examinations in 2013 were subjected to analysis. Items from the basic and advanced skills test sections of the KEMTLE were compared to determine whether some were significantly more difficult than others. Results: In the class I KEMTLE, all 4 of the items on the basic skills test showed significant variation in difficulty index (P<0.01), as well as 4 of the 5 items on the advanced skills test (P<0.05). In the class II KEMTLE, 4 of the 5 items on the basic skills test showed significantly different difficulty index (P<0.01), as well as all 3 of the advanced skills test items (P<0.01). Conclusion: In the skills test components of the class I and II KEMTLE, the procedure in which examinees randomly select questions should be revised to require examinees to respond to a set of fixed items in order to improve the reliability of the national licensing examination. PMID:26883810

Homeopathy for Depression: A Randomized, Partially Double-Blind, Placebo-Controlled, Four-Armed Study (DEP-HOM)

PubMed Central

Adler, Ubiratan C.; Krüger, Stephanie; Teut, Michael; Lüdtke, Rainer; Schützler, Lena; Martins, Friederike; Willich, Stefan N.; Linde, Klaus; Witt, Claudia M.

2013-01-01

Background The specific clinical benefit of the homeopathic consultation and of homeopathic remedies in patients with depression has not yet been investigated. Aims To investigate the 1) specific effect of individualized homeopathic Q-potencies compared to placebo and 2) the effect of an extensive homeopathic case taking (case history I) compared to a shorter, rather conventional one (case history II) in the treatment of acute major depression (moderate episode) after six weeks. Methods A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2×2 factorial design with a six-week study duration per patient was performed. Results A total of 44 from 228 planned patients were randomized (2∶1∶2∶1 randomization: 16 homeopathic Q-potencies/case history I, 7 placebo/case history I, 14 homeopathic Q-potencies/case history II, 7 placebo/case history II). Because of recruitment problems, the study was terminated prior to full recruitment, and was underpowered for the preplanned confirmatory hypothesis testing. Exploratory data analyses showed heterogeneous and inconclusive results with large variance in the sample. The mean difference for the Hamilton-D after 6 weeks was 2.0 (95%CI −1.2;5.2) for Q-potencies vs. placebo and −3.1 (−5.9;−0.2) for case history I vs. case history II. Overall, no consistent or clinically relevant results across all outcomes between homeopathic Q-potencies versus placebo and homeopathic versus conventional case taking were observed. The frequency of adverse events was comparable for all groups. Conclusions Although our results are inconclusive, given that recruitment into this trial was very difficult and we had to terminate early, we cannot recommend undertaking a further trial addressing this question in a similar setting. Prof. Dr. Claudia Witt had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Trial registration clinicaltrials.gov identifier NCT01178255. Protocol publication: http://www.trialsjournal.com/content/12/1/43 PMID:24086352

Effectiveness of Mutual Learning Approach in the Academic Achievement of B.Ed Students in Learning Optional II English

ERIC Educational Resources Information Center

Arulselvi, Evangelin

2013-01-01

The present study aims at finding out the effectiveness of Mutual learning approach over the conventional method in learning English optional II among B.Ed students. The randomized pre-test, post test, control group and experimental group design was employed. The B.Ed students of the same college formed the control and experimental groups. Each…

Evaluation of the effectiveness of lumbar interlaminar epidural injections in managing chronic pain of lumbar disc herniation or radiculitis: a randomized, double-blind, controlled trial.

PubMed

Manchikanti, Laxmaiah; Singh, Vijay; Falco, Frank J E; Cash, Kimberly A; Pampati, Vidyasagar

2010-01-01

The pathophysiology of lumbar radicular pain is the subject of ongoing research, with a reported prevalence of sciatica or radiculitis ranging from 1.2% to 43%. Among the numerous non-surgical interventions available, epidural injections are the most commonly performed interventions in the United States in managing chronic low back and lower extremity pain. A randomized, double-blind, controlled trial. An interventional pain management practice, a specialty referral center, a private practice setting in the United States. To evaluate the effectiveness of lumbar interlaminar epidural injections with local anesthetic, with or without steroids, in managing chronic low back and lower extremity pain secondary to disc herniation or radiculitis in providing effective and long-lasting pain relief. Patients were assigned to one of 2 groups with local anesthetic only or with local anesthetic mixed with non-particulate betamethasone. Randomization was performed by computer-generated random allocations sequence by simple randomization. Seventy patients were included in this analysis. Patient outcomes were measured at baseline, 3, 6, and 12 months post-treatment with the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake. Decrease of > or = 50% of NRS scores and Oswestry scores were considered significant. Significant pain relief (> or = 50%) was seen at 12 months in 74% of patients in Group I and 86% in Group II, and 69% and 83% in ODI scores respectively. Significant differences were noted in pain relief characteristics at 6 months between Group I and Group II (p = 0.001) and functional status improvement was significantly better in Group II at 6 months and 12 months (p = 0.019 and 0.045). The overall average procedures per year were 4.3 in Group I and 4.2 in Group II with an average total relief per year of 42.2 +/- 10.5 weeks in Group I and 41.4 +/- 11.0 weeks in Group II over a period of 52 weeks in the successful group. The study limitations include the lack of a placebo group and the fact that this is a preliminary report of 35 patients in each group. Overall, 74% of patients in Group I without steroids and 86% in Group II with steroids with lumbar disc herniation or radiculitis might benefit from lumbar interlaminar epidural injections.

The impact of written information and counseling (WOMAN-PRO II Program) on symptom outcomes in women with vulvar neoplasia: A multicenter randomized controlled phase II study.

PubMed

Raphaelis, Silvia; Mayer, Hanna; Ott, Stefan; Mueller, Michael D; Steiner, Enikö; Joura, Elmar; Senn, Beate

2017-07-01

To determine whether written information and/or counseling based on the WOMAN-PRO II Program decreases symptom prevalence in women with vulvar neoplasia by a clinically relevant degree, and to explore the differences between the 2 interventions in symptom prevalence, symptom distress prevalence, and symptom experience. A multicenter randomized controlled parallel-group phase II trial with 2 interventions provided to patients after the initial diagnosis was performed in Austria and Switzerland. Women randomized to written information received a predefined set of leaflets concerning wound care and available healthcare services. Women allocated to counseling were additionally provided with 5 consultations by an Advanced Practice Nurse (APN) between the initial diagnosis and 6months post-surgery that focused on symptom management, utilization of healthcare services, and health-related decision-making. Symptom outcomes were simultaneously measured 5 times to the counseling time points. A total of 49 women with vulvar neoplasia participated in the study. Symptom prevalence decreased in women with counseling by a clinically relevant degree, but not in women with written information. Sporadically, significant differences between the 2 interventions could be observed in individual items, but not in the total scales or subscales of the symptom outcomes. The results indicate that counseling may reduce symptom prevalence in women with vulvar neoplasia by a clinically relevant extent. The observed group differences between the 2 interventions slightly favor counseling over written information. The results justify testing the benefit of counseling thoroughly in a comparative phase III trial. Copyright © 2017 Elsevier Inc. All rights reserved.

Stem Cell Therapy Using Bone Marrow-Derived Mononuclear Cells in Treatment of Lower Limb Lymphedema: A Randomized Controlled Clinical Trial.

PubMed

Ismail, Ahmed Mohammed; Abdou, Said M; Abdelnaby, Amira Y; Hamdy, Mennat Allah; El Saka, Ayman A; Gawaly, Amr

2018-06-01

Up till now, there is no satisfactory treatment for lymphedema. The aim of this study is to evaluate stem cell therapy in lymphedema. This prospective randomized study includes 40 patients with chronic lymphedema divided randomly into two groups: group I (stem cell therapy group) and group II (control group). In group I, bone marrow was aspirated and mononuclear cells were separated and then transplanted into the patients. In group II, patients compression therapy alone was applied. Group I included 20 patients (12 males and 8 females), their age ranged from 18 to 38 years with a mean age of 24.8 ± 6.39 years, whereas group II included 20 patients (10 males and 10 females), their age ranged from 18 to 36 years with a mean value of 25.6 ± 8.18 years. In group I, there was a decrease in the mean circumference at ankle after 6 months, which was statistically significant (t = 3.250, p = 0.014). This was associated with marked improvement of pain and walking ability. Whereas in group II, the change in the circumference was statistically insignificant (t = 1256, p = 0.349) with no satisfactory pain relief and improvement in walking ability. Biopsies examined by immunohistochemistry showed marked increase in the number of lymphatic capillaries in group I. Stem cell therapy can achieve improvement in limb circumference as well as pain relief and improvement in walking ability in patients with chronic lymphedema compared with those in control group.

Evaluation of the efficacy of Ajuga decumbens extract supplement in individuals with knee discomfort associated with physical activity: A randomized, double-blind, placebo-controlled study

PubMed Central

Sawada, Yoko; Sugimoto, Atsushi; Hananouchi, Takehito; Sato, Norimasa; Nagaoka, Isao

2017-01-01

The aim of the present study was to assess the efficacy and safety of the oral administration of Ajuga decumbens extract (ADE) supplement to individuals with knee discomfort associated with physical activity. A randomized, double-blind, placebo-controlled study was conducted using 48 subjects. The subjects were randomly allocated to an ADE diet group (oral administration of ADE-containing diet, n=24) or a placebo group (n=24), and the intervention was conducted for 12 weeks. A total of 22 subjects in the placebo group and 22 subjects in the ADE diet group were assessed to be eligible for assessment of the efficacy of supplement. Knee function was assessed by changes in the scores of the Japanese Knee Osteoarthritis Measure (JKOM) questionnaire and the scores of the Japan Orthopedic Association (JOA) criteria, as well as by analyzing the levels of type II collagen synthesis and degradation biomarkers (procollagen II C-terminal propeptide, cross-linked C-telopeptide of type II collagen, collagen type II cleavage and matrix metalloproteinase-13). Outcomes were measured at the baseline and at 4, 8 and 12 weeks from the start of administration. Subscale II (joint flexion/stiffness) of the JOA criteria was markedly improved in the ADE diet group compared with the placebo group at 8 and 12 weeks during the intervention. Furthermore, in the subgroup analyses using subjects with mild knee discomfort, subscale II (pain/stiffness) and IV (general activities) scores of JKOM were significantly improved (P<0.05) and total JKOM score was markedly improved in the ADE diet group compared with the placebo group at week 8 of the intervention. No adverse effects were identified for the administration of ADE. In conclusion, these observations suggest that the administration of an ADE-containing diet is safe and improves joint function (flexion and stiffness) and general activity in subjects with mild knee discomfort. Therefore, ADE could be a promising candidate as a functional food that is beneficial to joint health. PMID:29109757

Sertraline Versus Placebo in Patients with Major Depressive Disorder Undergoing Hemodialysis: A Randomized, Controlled Feasibility Trial.

PubMed

Friedli, Karin; Guirguis, Ayman; Almond, Michael; Day, Clara; Chilcot, Joseph; Da Silva-Gane, Maria; Davenport, Andrew; Fineberg, Naomi A; Spencer, Benjamin; Wellsted, David; Farrington, Ken

2017-02-07

Depression is common in patients on hemodialysis, but data on the benefits and risks of antidepressants in this setting are limited. We conducted a multicenter, randomized, double-blind, placebo-controlled trial of sertraline over 6 months in patients on hemodialysis with depression to determine study feasibility, safety, and effectiveness. Patients on hemodialysis at five United Kingdom renal centers completed the Beck Depression Inventory II. Those scoring ≥16 and not already on treatment for depression were invited to undergo diagnostic interview to confirm major depressive disorder. Eligible patients with major depressive disorder were randomized to receive the study medication-either sertraline or placebo. Outcomes included recruitment and dropout rates, change in the Montgomery-Asberg Depression Rating Scale and Beck Depression Inventory II, and qualitative information to guide design of a large-scale trial. In total, 709 patients were screened and enrolled between April of 2013 and October of 2014; 231 (32.6%) had Beck Depression Inventory II scores ≥16, and 68 (29%) of these were already receiving treatment for depression. Sixty-three underwent diagnostic interview, 37 were diagnosed with major depressive disorder, and 30 were randomized; 21 completed the trial: eight of 15 on sertraline and 13 of 15 on placebo (P=0.05). Dropouts due to adverse and serious adverse events were greater in the sertraline group. All occurred in the first 3 months. Over 6 months, depression scores improved in both groups. Beck Depression Inventory II score fell from 29.1±8.4 to 17.3±12.4 (P<0.001), and Montgomery-Asberg Depression Rating Scale score fell from 24.5±4.1 to 10.3±5.8 (P<0.001). There were no differences between sertraline and placebo groups. Although small, this is the largest randomized trial to date of antidepressant medication in patients on hemodialysis. Our results highlight recruitment issues. No benefit was observed, but trial size and the substantial dropout render consideration of benefit inconclusive. A definitive trial could use shorter follow-up and include depressed patients already taking antidepressants. Copyright © 2017 by the American Society of Nephrology.

Influence of work clothing on physiological responses and performance during treadmill exercise and the Wildland Firefighter Pack Test.

PubMed

Phillips, Devin B; Ehnes, Cameron M; Welch, Bradley G; Lee, Lauren N; Simin, Irina; Petersen, Stewart R

2018-04-01

This study investigated physiological responses and performance during three separate exercise challenges (Parts I, II, and III) with wildland firefighting work clothing ensemble (boots and coveralls) and a 20.4 kg backpack in four conditions: U-EX (no pack, exercise clothing); L-EX (pack, exercise clothing); U-W (no pack, work clothing); and, L-W (pack and work clothing). Part I consisted of randomly-ordered graded exercise tests, on separate days, in U-EX, L-EX and L-W conditions. Part II consisted of randomly-ordered bouts of sub-maximal treadmill exercise in the four conditions. In Part III, subjects completed, in random-order on separate days, 4.83 km Pack Tests in L-EX or L-W conditions. In Part I, peak oxygen uptake was reduced (p < .05) in L-W. In Part II, mass-specific oxygen uptake was significantly higher in both work clothing conditions. In Part III, Pack Test time was slower (p < .05) in L-W. These results demonstrate the negative impact of work clothing and load carriage on physiological responses to exercise and performance. Copyright © 2017 Elsevier Ltd. All rights reserved.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bradonjic, Milan; Elsasser, Robert; Friedrich, Tobias

In this work, we consider the random broadcast time on random geometric graphs (RGGs). The classic random broadcast model, also known as push algorithm, is defined as: starting with one informed node, in each succeeding round every informed node chooses one of its neighbors uniformly at random and informs it. We consider the random broadcast time on RGGs, when with high probability: (i) RGG is connected, (ii) when there exists the giant component in RGG. We show that the random broadcast time is bounded by {Omicron}({radical} n + diam(component)), where diam(component) is a diameter of the entire graph, or themore » giant component, for the regimes (i), or (ii), respectively. In other words, for both regimes, we derive the broadcast time to be {Theta}(diam(G)), which is asymptotically optimal.« less

Administration of steroids after 34 weeks gestation enhances fetal lung maturity profiles

PubMed Central

Shanks, Anthony; Gross, Gilad; Shim, Tammy; Allsworth, Jenifer; Bildirici, Ibrahim; Sadovsky, Yoel

2013-01-01

Objective To estimate the effect of antenatal glucocorticoid administration on fetal lung maturity in pregnancies with known fetal lung immaturity between the 34th and 37th weeks of gestation. Study Design Pregnancies between 340/7-366/7 weeks undergoing amniocentesis to determine fetal lung maturity were targeted. Women with negative results (TDx-FLM-II < 45 mg/g) were randomized to intramuscular (IM) glucocorticoid injection or no treatment. A repeat TDx-FLM-II test was obtained one week after enrollment. Results 32 women who met inclusion criteria were randomized. Seven women delivered within a week of testing for fetal lung maturity, and were excluded from the analysis. Ten received glucocorticoid and 15 did not. Women assigned to glucocorticoids had a mean increase TDx-FLM-II in one week of 28.37 mg/g. Women assigned to no-treatment had an increase of 9.76 mg/g (p <0.002). Conclusion A single course of IM glucocorticoids after 34 weeks in pregnancies with documented fetal lung immaturity significantly increases TDx- FLM-II. PMID:20478551

Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: Results of an open-label Phase I and a randomized, standard-of-care-controlled Phase I/II study

PubMed Central

2012-01-01

Background Bleeding severity, anatomic location, tissue characteristics, and visibility are common challenges encountered while managing intraoperative bleeding, and conventional hemostatic measures (suture, ligature, and cautery) may sometimes be ineffective or impractical. While topical absorbable hemostats (TAH) are useful hemostatic adjuvants, each TAH has associated disadvantages. Methods We evaluated the safety and hemostatic efficacy of a new advanced biologic combination product―fibrin pad―to potentially address some gaps associated with TAHs. Fibrin pad was assessed as adjunctive hemostat in open partial nephrectomy in single-center, open-label, Phase I study (N = 10), and as primary hemostat in multicenter, single-blind, randomized, standard-of-care (SOC)-controlled Phase I/II study (N = 7) in Israel. It was used to control mild-to-moderate bleeding in Phase I and also spurting arterial bleeding in Phase I/II study. Phase I study assessed safety and Phase I/II study, proportion of successes at 10 min following randomization, analyzed by Fisher exact tests at 5% significance level. Results Phase I (N = 10): All patients completed the study. Hemostasis was achieved within 3–4 min (average = 3.1 min) of a single application in all patients. Fibrin pad was found to be safe for human use, with no product-related adverse events reported. Phase I/II (N = 7): Hemostatic success at 10 min (primary endpoint) was achieved in 3/4 patients treated with fibrin pad versus 0/3 patients treated with SOC. No clinically significant change in laboratory or coagulation parameters was recorded, except a case of post-procedural hemorrhage with fibrin pad, which was considered serious and related to the fibrin pad treatment, and required re-operation. Although Data Safety Monitoring Board authorized trial continuation, the sponsor decided against proceeding toward an indication for primary treatment of severe arterial hemorrhage as a replacement for sutures. The study was suspended after 7/30 planned subjects were enrolled. Conclusions The first-in-man trial of fibrin pad demonstrated its safety and efficacy as an adjunctive hemostatic technique for mild-to-moderate bleeding in partial nephrectomy. The study also suggested that the product should not replace sutures or meticulous surgical techniques for the treatment of severe arterial hemorrhage. Trial registration Phase I/II trial, NCT00598130 PMID:23137020

A comparison of numerical solutions of partial differential equations with probabilistic and possibilistic parameters for the quantification of uncertainty in subsurface solute transport.

PubMed

Zhang, Kejiang; Achari, Gopal; Li, Hua

2009-11-03

Traditionally, uncertainty in parameters are represented as probabilistic distributions and incorporated into groundwater flow and contaminant transport models. With the advent of newer uncertainty theories, it is now understood that stochastic methods cannot properly represent non random uncertainties. In the groundwater flow and contaminant transport equations, uncertainty in some parameters may be random, whereas those of others may be non random. The objective of this paper is to develop a fuzzy-stochastic partial differential equation (FSPDE) model to simulate conditions where both random and non random uncertainties are involved in groundwater flow and solute transport. Three potential solution techniques namely, (a) transforming a probability distribution to a possibility distribution (Method I) then a FSPDE becomes a fuzzy partial differential equation (FPDE), (b) transforming a possibility distribution to a probability distribution (Method II) and then a FSPDE becomes a stochastic partial differential equation (SPDE), and (c) the combination of Monte Carlo methods and FPDE solution techniques (Method III) are proposed and compared. The effects of these three methods on the predictive results are investigated by using two case studies. The results show that the predictions obtained from Method II is a specific case of that got from Method I. When an exact probabilistic result is needed, Method II is suggested. As the loss or gain of information during a probability-possibility (or vice versa) transformation cannot be quantified, their influences on the predictive results is not known. Thus, Method III should probably be preferred for risk assessments.

Physical Therapy Versus a General Exercise Programme in Patients with Hoehn Yahr Stage II Parkinson's Disease: A Randomized Controlled Trial.

PubMed

Dipasquale, Savina; Meroni, Roberto; Sasanelli, Francesco; Messineo, Ivan; Piscitelli, Daniele; Perin, Cecilia; Cornaggia, Cesare Maria; Cerri, Cesare G

2017-01-01

Several studies suggest that general exercise (GE) and physical therapy programmes (PT) improve the outcomes of Parkinson's disease (PD) patients; however, the available data do not allow a determination of which treatment is more effective. Our study aims to compare the effects of physiotherapy and general exercise in Parkinson's disease. Design and setting: Randomized controlled trial -general hospital outpatient clinic. The participants were patients with Hoehn Yahr stage II PD. Two randomized groups: one receiving PT and one receiving GE. The outcome measures were the FIM, Hamilton Rating Scale, TUG test, and UPDRS. FIM median scores improved by 3 points in the PT group after treatment, and the improvements were maintained at follow-up. The GE FIM median scores were unchanged after treatment and were reduced by 1 point at follow-up (p < 0.05). The TUG test time was reduced in the PT group but increased in the GE group with a 3-second difference between groups at follow-up, suggesting improved functional mobility after specific physiotherapy (p < 0.05). The UPDRS median score change from baseline was significantly different between the two groups at the end of treatment (6.5 points) and at follow-up (11 points), with a benefit for the physiotherapy group. Physiotherapy seems to be more effective than a generic exercise programme in patients with Hoehn Yahr stage II PD.

Adaptation and Latent Structure of the Swahili Version of Beck Depression Inventory-II in a Low Literacy Population in the Context of HIV.

PubMed

Abubakar, Amina; Kalu, Raphael Birya; Katana, Khamis; Kabunda, Beatrice; Hassan, Amin S; Newton, Charles R; Van de Vijver, Fons

2016-01-01

We set out to adapt the Beck Depression Inventory (BDI)-II in Kenya and examine its factorial structure. In the first phase we carried out in-depth interviews involving 29 adult members of the community to elicit their understanding of depression and identify aspects of the BDI-II that required adaptation. In the second phase, a modified version of BDI-II was administered to 221 adults randomly selected from the community to allow for the evaluation of its psychometric properties. In the third phase of the study we evaluated the discriminative validity of BDI-11 by comparing a randomly chosen community sample (n = 29) with caregivers of adolescents affected by HIV (n = 77). A considerable overlap between the BDI symptoms and those generated in the interviews was observed. Relevant idioms and symptoms such as 'thinking too much' and 'Kuchoka moyo (having a tired heart)' were identified. The administration of the BDI had to be modified to make it suitable for the low literacy levels of our participants. Fit indices for several models (one factorial, two-factor model and a three factor model) were all within acceptable range. Evidence indicated that while multidimensional models could be fitted, the strong correlations between the factors implied that a single factor model may be the best suited solution (alpha [0.89], and a significant correlation with locally identified items [r = 0.51]) confirmed the good psychometric properties of the adapted BDI-II. No evidence was found to support the hypothesis that somatization was more prevalent. Lastly, caregivers of HIV affected adolescents had significantly higher scores compared to adults randomly selected from the community F(1, 121) = 23.31, p < .001 indicating the discriminative validity of the adapted BDI = II. With an adapted administration procedure, the BDI-II provides an adequate measure of depressive symptoms which can be used alongside other measures for proper diagnosis in a low literacy population.

Randomized controlled dissemination study of community-to-clinic navigation to promote CRC screening: Study design and implications.

PubMed

Larkey, Linda; Szalacha, Laura; Herman, Patricia; Gonzalez, Julie; Menon, Usha

2017-02-01

Regular screening facilitates early diagnosis of colorectal cancer (CRC) and reduction of CRC morbidity and mortality. Screening rates for minorities and low-income populations remain suboptimal. Provider referral for CRC screening is one of the strongest predictors of adherence, but referrals are unlikely among those who have no clinic home (common among poor and minority populations). This group randomized controlled study will test the effectiveness of an evidence based tailored messaging intervention in a community-to-clinic navigation context compared to no navigation. Multicultural, underinsured individuals from community sites will be randomized (by site) to receive CRC screening education only, or education plus navigation. In Phase I, those randomized to education plus navigation will be guided to make a clinic appointment to receive a provider referral for CRC screening. Patients attending clinic appointments will continue to receive navigation until screened (Phase II) regardless of initial arm assignment. We hypothesize that those receiving education plus navigation will be more likely to attend clinic appointments (H1) and show higher rates of screening (H2) compared to those receiving education only. Phase I group assignment will be used as a control variable in analysis of screening follow-through in Phase II. Costs per screening achieved will be evaluated for each condition and the RE-AIM framework will be used to examine dissemination results. The novelty of our study design is the translational dissemination model that will allow us to assess the real-world application of an efficacious intervention previously tested in a randomized controlled trial. Copyright © 2016. Published by Elsevier Inc.

A randomized, phase II study of pazopanib in castrate-sensitive prostate cancer: a University of Chicago Phase II Consortium/Department of Defense Prostate Cancer Clinical Trials Consortium study.

PubMed

Ward, J E; Karrison, T; Chatta, G; Hussain, M; Shevrin, D; Szmulewitz, R Z; O'Donnell, P H; Stadler, W M; Posadas, E M

2012-03-01

Intermittent androgen suppression (IAS) is an increasingly popular treatment option for castrate-sensitive prostate cancer. On the basis of previous data with anti-angiogenic strategies, we hypothesized that pan-inhibition of the vascular endothelial growth factor receptor using pazopanib during the IAS off period would result in prolonged time to PSA failure. Men with biochemically recurrent prostate cancer, whose PSA was <0.5 ng ml(-1) after 6 months of androgen deprivation therapy were randomized to pazopanib 800 mg daily or observation. The planned primary outcome was time to PSA progression >4.0 ng ml(-1). Thirty-seven patients were randomized. Of 18 patients randomized to pazopanib, at the time of study closure, 4 had progressive disease, 1 remained on treatment and 13 (72%) electively disenrolled, the most common reason being patient request due to grade 1/2 toxicity (8 patients). Two additional patients were removed from treatment due to adverse events. Of 19 patients randomized to observation, at the time of study closure, 4 had progressive disease, 7 remained under protocol-defined observation and 8 (42%) had disenrolled, most commonly due to non-compliance with protocol visits (3 patients). Because of high dropout rates in both arms, the study was halted. IAS is a treatment approach that may facilitate investigation of novel agents in the hormone-sensitive state. This trial attempted to investigate the role of antiangiogenic therapy in this setting, but encountered several barriers, including toxicities and patient non-compliance, which can make implementation of such a study difficult. Future investigative efforts in this arena should carefully consider drug toxicity and employ a design that maximizes patient convenience to reduce the dropout rate.

Effects of a low-fat versus a low-carbohydrate diet on adipocytokines in obese adults.

PubMed

de Luis, D A; Aller, R; Izaola, O; Gonzalez Sagrado, M; Bellioo, D; Conde, R

2007-01-01

There are few studies addressing the effect of weight loss on circulating levels of adipocytokines. The aim of our study was to determine whether different diets would have different weight loss effects and to examine the changes in adipocytokine levels. A population of 90 obesity non-diabetic outpatients was analyzed in a prospective way. The patients were randomly allocated to two groups: (a) diet I (low-fat diet), and (b) diet II (low-carbohydrate diet). At baseline and after 3 months on the diet, adipocytokines were evaluated. 43 patients were randomized to group I and 47 patients to diet group II. No differences were detected between weight loss in either group (3.3 +/- 0.51 vs. 4.4 +/- 0.6 kg; n.s.). In group I, a significant decrease in leptin levels was found. In group II, leptin and C-reactive protein (CRP) levels also decreased. The decrease in leptin levels was lower with diet I than II (16.4 vs. 22.8%; p < 0.05). The serum leptin concentration decreased due to the 3-month intervention with low-fat and low-carbohydrate diets, without changes in other adipocytokines. The decrease in leptin and CRP levels were higher with a low-carbohydrate diet than a low-fat diet. Copyright 2007 S. Karger AG, Basel.

No evidence of benefit from class-II compression stockings in the prevention of lower-limb lymphedema after inguinal lymph node dissection: results of a randomized controlled trial.

PubMed

Stuiver, M M; de Rooij, J D; Lucas, C; Nieweg, O E; Horenblas, S; van Geel, A N; van Beurden, M; Aaronson, N K

2013-09-01

Graduated compression stockings have been advocated for prevention of lymphedema after inguinal lymph node dissection (ILND) although scientific evidence of their efficacy in preventing lymphedema is lacking. The primary objective of this study was to assess the efficacy of class II compression stockings for the prevention of lymphedema in cancer patients following ILND. Secondary objectives were to investigate the influence of stockings on the occurrence of wound complications and genital edema, health-related quality of life (HRQoL) and body image. Eighty patients (45 with melanoma, 35 with urogenital tumors) who underwent ILND at two specialized cancer centers were randomly allocated to class II compression stocking use for six months or to a usual care control group. Lymphedema of the leg and genital area, wound complications, HRQoL, and body image were assessed at regular intervals prior to and up to 12 months after ILND. No significant differences were observed between groups in the incidence of edema, median time to the occurrence of edema, incidence of genital edema, frequency of complications, HRQoL, or body image. Based on the results of the current study, routine prescription of class II graduated compression stockings after ILND should be questioned and alternative prevention strategies should be considered.

Validation of the phase II feasibility study in a palliative care setting: gastrografin in malignant bowel obstruction.

PubMed

Lee, Cindy; Vather, Ryash; O'Callaghan, Anne; Robinson, Jackie; McLeod, Briar; Findlay, Michael; Bissett, Ian

2013-12-01

Malignant bowel obstruction (MBO) is common in patients with advanced cancer. To perform a phase II study to assess the feasibility of conducting a phase III trial investigating the therapeutic value of gastrografin in MBO. Randomized double-blinded placebo-controlled feasibility study. Participants received 100 mL of either gastrografin or placebo. Over 8 months, 57 patients were screened and 9 enrolled (15.8% recruitment rate). Of the 9 enrolled, 4 received gastrografin (with 2 completing assessment) and 5 received placebo (with 4 completing assessment). It is not feasible to conduct a phase III trial using the same study protocol. This study validates the use of the phase II feasibility study to assess protocol viability in a palliative population prior to embarking on a larger trial.

Low power and type II errors in recent ophthalmology research.

PubMed

Khan, Zainab; Milko, Jordan; Iqbal, Munir; Masri, Moness; Almeida, David R P

2016-10-01

To investigate the power of unpaired t tests in prospective, randomized controlled trials when these tests failed to detect a statistically significant difference and to determine the frequency of type II errors. Systematic review and meta-analysis. We examined all prospective, randomized controlled trials published between 2010 and 2012 in 4 major ophthalmology journals (Archives of Ophthalmology, British Journal of Ophthalmology, Ophthalmology, and American Journal of Ophthalmology). Studies that used unpaired t tests were included. Power was calculated using the number of subjects in each group, standard deviations, and α = 0.05. The difference between control and experimental means was set to be (1) 20% and (2) 50% of the absolute value of the control's initial conditions. Power and Precision version 4.0 software was used to carry out calculations. Finally, the proportion of articles with type II errors was calculated. β = 0.3 was set as the largest acceptable value for the probability of type II errors. In total, 280 articles were screened. Final analysis included 50 prospective, randomized controlled trials using unpaired t tests. The median power of tests to detect a 50% difference between means was 0.9 and was the same for all 4 journals regardless of the statistical significance of the test. The median power of tests to detect a 20% difference between means ranged from 0.26 to 0.9 for the 4 journals. The median power of these tests to detect a 50% and 20% difference between means was 0.9 and 0.5 for tests that did not achieve statistical significance. A total of 14% and 57% of articles with negative unpaired t tests contained results with β > 0.3 when power was calculated for differences between means of 50% and 20%, respectively. A large portion of studies demonstrate high probabilities of type II errors when detecting small differences between means. The power to detect small difference between means varies across journals. It is, therefore, worthwhile for authors to mention the minimum clinically important difference for individual studies. Journals can consider publishing statistical guidelines for authors to use. Day-to-day clinical decisions rely heavily on the evidence base formed by the plethora of studies available to clinicians. Prospective, randomized controlled clinical trials are highly regarded as a robust study and are used to make important clinical decisions that directly affect patient care. The quality of study designs and statistical methods in major clinical journals is improving overtime, 1 and researchers and journals are being more attentive to statistical methodologies incorporated by studies. The results of well-designed ophthalmic studies with robust methodologies, therefore, have the ability to modify the ways in which diseases are managed. Copyright © 2016 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

The Role of Critical Self-Reflection of Assumptions in an Online HIV Intervention for Men Who Have Sex with Men

ERIC Educational Resources Information Center

Wilkerson, J. Michael; Danilenko, Gene P.; Smolenski, Derek J.; Myer, Bryn B.; Rosser, B. R. Simon

2011-01-01

The Men's INTernet Study II included a randomized controlled trial to develop and test an Internet-based HIV prevention intervention for U.S men who use the Internet to seek sex with men. In 2008, participants (n = 560) were randomized to an online, interactive, sexual risk-reduction intervention or to a wait list null control. After 3 months,…

Safety, Tolerability, and Immunogenicity of the Novel Antituberculous Vaccine RUTI: Randomized, Placebo-Controlled Phase II Clinical Trial in Patients with Latent Tuberculosis Infection

PubMed Central

Nell, Andre S.; D’lom, Eva; Bouic, Patrick; Sabaté, Montserrat; Bosser, Ramon; Picas, Jordi; Amat, Mercè; Churchyard, Gavin; Cardona, Pere-Joan

2014-01-01

Objectives To evaluate the safety, tolerability and immunogenicity of three different doses (5, 25 and 50 µg) of the novel antituberculous vaccine RUTI compared to placebo in subjects with latent tuberculosis infection. Methods and Findings Double-blind, randomized, placebo-controlled Phase II Clinical Trial (95 patients randomized). Three different RUTI doses and placebo were tested, randomized both in HIV-positive (n = 47) and HIV-negative subjects (n = 48), after completion of one month isoniazid (INH) pre-vaccination. Each subject received two vaccine administrations, 28 Days apart. Five patients withdrew and 90 patients completed the study. Assessment of safety showed no deaths during study. Two subjects had serious adverse events one had a retinal detachment while taking INH and was not randomized and the other had a severe local injection site abscess on each arm and was hospitalized; causality was assessed as very likely and by the end of the study the outcome had resolved. All the patients except 5 (21%) patients of the placebo group (3 HIV+ and 2 HIV−) reported at least one adverse event (AE) during the study. The most frequently occurring AEs among RUTI recipients were (% in HIV+/−): injection site reactions [erythema (91/92), induration (94/92), local nodules (46/25), local pain (66/75), sterile abscess (6/6), swelling (74/83), ulcer (20/11), headache (17/22) and nasopharyngitis (20/5)]. These events were mostly mild and well tolerated. Overall, a polyantigenic response was observed, which differed by HIV− status. The best polyantigenic response was obtained when administrating 25 µg RUTI, especially in HIV-positive subjects which was not increased after the second inoculation. Conclusion This Phase II clinical trial demonstrates reasonable tolerability of RUTI. The immunogenicity profile of RUTI vaccine in LTBI subjects, even being variable among groups, allows us considering one single injection of one of the highest doses in future trials, preceded by an extended safety clinical phase. Trial Registration ClinicalTrials.gov NCT01136161 PMID:24586912

Efficacy of tramadol and butorphanol pretreatment in reducing pain on propofol injection: A placebo-controlled randomized study.

PubMed

Singh, Arvinderpal; Sharma, Geeta; Gupta, Ruchi; Kumari, Anita; Tikko, Deepika

2016-01-01

Pain of propofol injection has been recalled by many patients as the most painful part of the induction of anesthesia. Tramadol and butorphanol are commonly used analgesics for perioperative analgesia in anesthesia practice. However, their potential to relieve propofol injection pain still needs to be explored. A randomized, double-blind, placebo-controlled study was conducted on 90 American Society of Anesthesiologists I and II adult patients undergoing elective surgery under general anesthesia with propofol as an induction agent. Consecutive sampling technique with random assignment was used to allocate three groups of 30 patients each. Group I patients received an injection of normal saline 3 ml intravenously (placebo) while Group II and Group III patients received injection of tramadol 50 mg and butorphanol 1 mg intravenously, respectively. Before induction of anesthesia patients were asked about the intensity of pain on propofol injection by using visual analog scale (VAS) before the loss of consciousness. Descriptive statistics and analysis of variance with Chi-square test were used to analyze the data. The value of P < 0.05 was considered as a significant and P < 0.0001 as highly significant. The incidence of pain in Group I was observed in 80% of the patients, while it was observed in 23.33% and 20% of patients in Group II and III, respectively. Mean VAS scores were 2.27 ± 1.51, 1.14 ± 1.74, and 1.03 ± 1.72 in Group I, II, and Group III patients, respectively. The incidence of pruritus was 10% and 6.7% and erythema in 13.2% and 6.7% in Group II and III, respectively. Pretreatment with both butorphanol and tramadol significantly reduced pain on propofol injection; however, they exhibited comparable efficacy among each other. Thus, either of these two drugs can be considered for pretreatment to reduce propofol injection pain.

A Double-Blind Randomized Controlled Trial Comparing Epidural Clonidine vs Bupivacaine for Pain Control During and After Lower Abdominal Surgery

PubMed Central

Abd-Elsayed, Alaa A.; Guirguis, Maged; DeWood, Mark S.; Zaky, Sherif S.

2015-01-01

Background Alpha-2 adrenergic agonists produce safe and effective analgesia, but most investigations studying the analgesic effect of alpha-2 adrenoceptor agonists postoperatively included previous or concomitant administration of other analgesics. Because clonidine potentiates the effect of these drugs, its own intrinsic analgesic effect has been difficult to establish. This study was designed to compare the intraoperative and postoperative effects of epidural clonidine vs bupivacaine for patients undergoing lower abdominal surgery. Methods This randomized controlled trial included 40 patients aged 18-50 who were scheduled for elective lower abdominal surgery. Patients were randomly divided into 2 groups. Group I (n=20) received epidural clonidine; Group II (n=20) received epidural bupivacaine. Intraoperative and postoperative hemodynamics, pain scores, and complications were monitored. Results Mean pain scores were significantly lower in Group I compared to Group II (1.5 ± 0.5 compared to 3.4 ± 1.0, respectively) in the first 12 hours after surgery. Sedation was more prominent in Group I until 9 hours after surgery. Opioid requirements were significantly lower in Group I. Respiratory rate was similar in the 2 groups. Group I had larger decreases from baseline in systolic blood pressure and diastolic blood pressure than Group II. Heart rate in Group I was reduced from baseline, while it was increased in Group II. Less postoperative nausea and vomiting, urinary retention, pruritus, and shivering were observed in Group I. Conclusion Compared to bupivacaine, epidural clonidine provided effective intraoperative and postoperative analgesia in selected patients, resulting in a decreased intravenous pain medication requirement and prolonged duration of analgesia after epidural infusion was discontinued. PMID:26130975

Randomized Phase II, Double-Blind, Placebo-Controlled Study of Exemestane With or Without Entinostat in Postmenopausal Women With Locally Recurrent or Metastatic Estrogen Receptor-Positive Breast Cancer Progressing on Treatment With a Nonsteroidal Aromatase Inhibitor

PubMed Central

Yardley, Denise A.; Ismail-Khan, Roohi R.; Melichar, Bohuslav; Lichinitser, Mikhail; Munster, Pamela N.; Klein, Pamela M.; Cruickshank, Scott; Miller, Kathy D.; Lee, Min J.; Trepel, Jane B

2013-01-01

Purpose Entinostat is an oral isoform selective histone deacetylase inhibitor that targets resistance to hormonal therapies in estrogen receptor–positive (ER+) breast cancer. This randomized, placebo-controlled, phase II study evaluated entinostat combined with the aromatase inhibitor exemestane versus exemestane alone. Patients and Methods Postmenopausal women with ER+ advanced breast cancer progressing on a nonsteroidal aromatase inhibitor were randomly assigned to exemestane 25 mg daily plus entinostat 5 mg once per week (EE) or exemestane plus placebo (EP). The primary end point was progression-free survival (PFS). Blood was collected in a subset of patients for evaluation of protein lysine acetylation as a biomarker of entinostat activity. Results One hundred thirty patients were randomly assigned (EE group, n = 64; EP group, n = 66). Based on intent-to-treat analysis, treatment with EE improved median PFS to 4.3 months versus 2.3 months with EP (hazard ratio [HR], 0.73; 95% CI, 0.50 to 1.07; one-sided P = .055; two-sided P = .11 [predefined significance level of .10, one-sided]). Median overall survival was an exploratory end point and improved to 28.1 months with EE versus 19.8 months with EP (HR, 0.59; 95% CI, 0.36 to 0.97; P = .036). Fatigue and neutropenia were the most frequent grade 3/4 toxicities. Treatment discontinuation because of adverse events was higher in the EE group versus the EP group (11% v 2%). Protein lysine hyperacetylation in the EE biomarker subset was associated with prolonged PFS. Conclusion Entinostat added to exemestane is generally well tolerated and demonstrated activity in patients with ER+ advanced breast cancer in this signal-finding phase II study. Acetylation changes may provide an opportunity to maximize clinical benefit with entinostat. Plans for a confirmatory study are underway. PMID:23650416

Multicenter prospective randomized phase II study of antimicrobial prophylaxis in low-risk patients undergoing colon surgery.

PubMed

Shimizu, Junzo; Ikeda, Kimimasa; Fukunaga, Mutsumi; Murata, Kohei; Miyamoto, Atsushi; Umeshita, Koji; Kobayashi, Tetsuro; Monden, Morito

2010-10-01

Postoperative antimicrobial therapy is generally administered as standard prophylaxis against postoperative infection, despite a lack of sufficient evidence for its usefulness. This study was a phase II study to evaluate the necessity of postoperative antibiotic prophylaxis in patients undergoing a colectomy. Patients received 1 g cefmetazole or flomoxef immediately after anesthetic induction, every 3 h during surgery, and then later once again on the next day. They were randomly assigned to receive either cefmetazole or flomoxef. Ninety-one patients were enrolled in the study. A surgical site infection (SSI) occurred in 7.7% (7/91) of patients. All cases were superficial incisional infections. When comparing the two drugs, SSI occurred in 8.3% (4/48) of patients treated with cefmetazole and in 7.0% (3/43) treated with flomoxef, showing no significant difference (P > 0.99). Antimicrobial prophylaxis was well tolerated when used on the day of a colectomy and once again on the next day.

Efficacy and safety of tofacitinib for active rheumatoid arthritis with an inadequate response to methotrexate or disease-modifying antirheumatic drugs: a meta-analysis of randomized controlled trials

PubMed Central

Song, Gwan Gyu; Bae, Sang-Cheol

2014-01-01

Background/Aims The aim of this study was to assess the efficacy and safety of tofacitinib (5 and 10 mg twice daily) in patients with active rheumatoid arthritis (RA). Methods A systematic review of randomized controlled trials (RCTs) that examined the efficacy and safety of tofacitinib in patients with active RA was performed using the Medline, Embase, and Cochrane Controlled Trials Register databases as well as manual searches. Results Five RCTs, including three phase-II and two phase-III trials involving 1,590 patients, met the inclusion criteria. The three phase-II RCTs included 452 patients with RA (144 patients randomized to 5 mg of tofacitinib twice daily, 156 patients randomized to 10 mg of tofacitinib twice daily, and 152 patients randomized to placebo) who were included in this meta-analysis. The American College of Rheumatology 20% response rate was significantly higher in the tofacitinib 5- and 10-mg groups than in the control group (relative risk [RR], 2.445; 95% confidence interval [CI], 1.229 to 4.861; p = 0.011; and RR, 2.597; 95% CI, 1.514 to 4.455; p = 0.001, respectively). The safety outcomes did not differ between the tofacitinib 5- and 10-mg groups and placebo groups with the exception of infection in the tofacitinib 10-mg group (RR, 2.133; 95% CI, 1.268 to 3.590; p = 0.004). The results of two phase-III trials (1,123 patients) confirmed the findings in the phase-II studies. Conclusions Tofacitinib at dosages of 5 and 10 mg twice daily was found to be effective in patients with active RA that inadequately responded to methotrexate or disease-modifying antirheumatic drugs, and showed a manageable safety profile. PMID:25228842

Prosthetic aspects and patient satisfaction with resilient liner and clip attachments for bar- and implant-retained mandibular overdentures: a 3-year randomized clinical study.

PubMed

ELsyad, Moustafa Abdou

2012-01-01

This report aimed to compare prosthetic aspects and patient satisfaction during a 3-year randomized clinical trial of bar- and implant-retained mandibular overdentures attached with either resilient liners or clips. Thirty edentulous male patients (mean age: 62.5 years) received two implants in the anterior mandible after being allocated into two equal groups (according to attachment type received) using balanced randomization. After 3 months, implants were connected with resilient bars. New maxillary complete dentures were then constructed, and mandibular overdentures were retained to the bars with either clips (group I) or silicone resilient liners (group II). Subjects indicated satisfaction with their prostheses using a questionnaire and visual analog scale. Patient satisfaction and prosthetic complications were recorded for both attachments at 6 months and 1 and 3 years after overdenture insertion. Comfort and stability with the maxillary denture and ease of hygiene procedures were rated higher in group II, while ease of handling the dentures was rated higher in group I. No significant differences in other parameters of patient satisfaction between groups were noted after 3 years. The mean number of prosthetic adjustments and repairs in group I (11.9) was significantly higher (P = .00) compared to that in group II (4.8). The most common complication in group I was clip wear, while separation of the resilient liner from the denture base was the most common problem in group II. Hyperplasia under the bar and flabby ridge in the maxilla occurred significantly more often in group I compared to group II. Resilient liner-retained mandibular overdentures had comparable patient satisfaction, less prosthetic maintenance and costs, and less soft tissue complications when compared to clip-retained ones after 3 years.

Exploring the statistical and clinical impact of two interim analyses on the Phase II design with option for direct assignment.

PubMed

An, Ming-Wen; Mandrekar, Sumithra J; Edelman, Martin J; Sargent, Daniel J

2014-07-01

The primary goal of Phase II clinical trials is to understand better a treatment's safety and efficacy to inform a Phase III go/no-go decision. Many Phase II designs have been proposed, incorporating randomization, interim analyses, adaptation, and patient selection. The Phase II design with an option for direct assignment (i.e. stop randomization and assign all patients to the experimental arm based on a single interim analysis (IA) at 50% accrual) was recently proposed [An et al., 2012]. We discuss this design in the context of existing designs, and extend it from a single-IA to a two-IA design. We compared the statistical properties and clinical relevance of the direct assignment design with two IA (DAD-2) versus a balanced randomized design with two IA (BRD-2) and a direct assignment design with one IA (DAD-1), over a range of response rate ratios (2.0-3.0). The DAD-2 has minimal loss in power (<2.2%) and minimal increase in T1ER (<1.6%) compared to a BRD-2. As many as 80% more patients were treated with experimental vs. control in the DAD-2 than with the BRD-2 (experimental vs. control ratio: 1.8 vs. 1.0), and as many as 64% more in the DAD-2 than with the DAD-1 (1.8 vs. 1.1). We illustrate the DAD-2 using a case study in lung cancer. In the spectrum of Phase II designs, the direct assignment design, especially with two IA, provides a middle ground with desirable statistical properties and likely appeal to both clinicians and patients. Copyright © 2014 Elsevier Inc. All rights reserved.

[Crataegus Special Extract WS 1442 in NYHA II heart failure. A placebo controlled randomized double-blind study].

PubMed

Leuchtgens, H

1993-07-20

In 30 patients with stage NYHA II cardiac insufficiency, a placebo-controlled randomized double-blind study was carried out to determine the efficacy of the Crataegus special extract WS 1442. Treatment duration was 8 weeks, and the substance was administered at a dose of 1 capsule taken twice a day. The main target parameters were alteration in the pressure-x-rate product (PRP) under standardised loading on a bicycle ergometer, and a score of subjective improvement of complaints elicited by a questionnaire. Secondary parameters were exercise tolerance and the change in heart rate and arterial blood pressure. The active substance group showed a statistically significant advantage over placebo in terms of changes in PRP (at a load of 50 W) and the score, but also in the secondary parameter heart rate. In both groups, systolic and diastolic blood pressure was mildly reduced. No adverse reactions occurred.

Rotigotine in Combination with the MAO-B Inhibitor Selegiline in Early Parkinson's Disease: A Post Hoc Analysis.

PubMed

Giladi, Nir; Asgharnejad, Mahnaz; Bauer, Lars; Grieger, Frank; Boroojerdi, Babak

2016-04-02

Monoamine oxidase B (MAO-B) inhibitors and dopamine receptor agonists are common first-line treatment options in early Parkinson's disease (PD). To evaluate the efficacy and safety of rotigotine transdermal patch as an add-on therapy to an MAO-B inhibitor in patients with early-PD. In two Phase III, randomized, double-blind, placebo-controlled studies in early-PD (SP512, SP513), patients were randomized to rotigotine (titrated to optimal dose ≤8 mg/24 h) or placebo, and maintained for 24 (SP512) or 33 (SP513) weeks. Post hoc analyses were performed on pooled data for patients receiving an MAO-B inhibitor (selegiline) at a stable dose at randomization and throughout the studies, with groups defined as "Selegiline+Rotigotine" and "Selegiline+Placebo". Outcome measures included change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS) II (activities of daily living), III (motor), UPDRS II+III and responders (patients achieving ≥20%, ≥25% or ≥30% decrease in UPDRS II+III). As post hoc analyses, p-values are exploratory. 130 patients were evaluable for efficacy analyses ("Selegiline+Rotigotine": 84, "Selegiline+Placebo": 46). Combined treatment with rotigotine and selegiline improved UPDRS III and UPDRS II+III scores versus selegiline alone (LS-mean [95% CI] treatment difference for UPDRS III: -4.89 [-7.87 to -1.91], p = 0.0015; for UPDRS II+III: -5.76 [-9.71 to -1.82], p = 0.0045). Higher proportion of patients in the "Selegiline+Rotigotine" group were classified as ≥20%, ≥25% or ≥30% responders (all p < 0.001). Combined treatment appeared more effective in patients aged ≤65 years versus > 65 years (although patient numbers in the subgroups were low). Adverse event profile was consistent with the known safety profile of rotigotine. In these post hoc analyses, adjunctive treatment with rotigotine in patients already receiving an MAO-B inhibitor improved UPDRS II+III score; this appeared to be largely driven by improvements in the motor aspects of PD.

Rotigotine in Combination with the MAO-B Inhibitor Selegiline in Early Parkinson’s Disease: A Post Hoc Analysis

PubMed Central

Giladi, Nir; Asgharnejad, Mahnaz; Bauer, Lars; Grieger, Frank; Boroojerdi, Babak

2016-01-01

Background: Monoamine oxidase B (MAO-B) inhibitors and dopamine receptor agonists are common first-line treatment options in early Parkinson’s disease (PD). Objective: To evaluate the efficacy and safety of rotigotine transdermal patch as an add-on therapy to an MAO-B inhibitor in patients with early-PD. Methods: In two Phase III, randomized, double-blind, placebo-controlled studies in early-PD (SP512, SP513), patients were randomized to rotigotine (titrated to optimal dose ≤8 mg/24 h) or placebo, and maintained for 24 (SP512) or 33 (SP513) weeks. Post hoc analyses were performed on pooled data for patients receiving an MAO-B inhibitor (selegiline) at a stable dose at randomization and throughout the studies, with groups defined as “Selegiline+Rotigotine” and “Selegiline+Placebo”. Outcome measures included change from baseline in Unified Parkinson’s Disease Rating Scale (UPDRS) II (activities of daily living), III (motor), UPDRS II+III and responders (patients achieving ≥20%, ≥25% or ≥30% decrease in UPDRS II+III). As post hoc analyses, p-values are exploratory. Results: 130 patients were evaluable for efficacy analyses (“Selegiline+Rotigotine”: 84, “Selegiline+Placebo”: 46). Combined treatment with rotigotine and selegiline improved UPDRS III and UPDRS II+III scores versus selegiline alone (LS-mean [95% CI] treatment difference for UPDRS III: –4.89 [–7.87 to –1.91], p = 0.0015; for UPDRS II+III: –5.76 [–9.71 to –1.82], p = 0.0045). Higher proportion of patients in the “Selegiline+Rotigotine” group were classified as ≥20%, ≥25% or ≥30% responders (all p < 0.001). Combined treatment appeared more effective in patients aged ≤65 years versus > 65 years (although patient numbers in the subgroups were low). Adverse event profile was consistent with the known safety profile of rotigotine. Conclusions: In these post hoc analyses, adjunctive treatment with rotigotine in patients already receiving an MAO-B inhibitor improved UPDRS II+III score; this appeared to be largely driven by improvements in the motor aspects of PD. PMID:27061066

SPIRIT: A seamless phase I/II randomized design for immunotherapy trials.

PubMed

Guo, Beibei; Li, Daniel; Yuan, Ying

2018-06-07

Immunotherapy-treatments that enlist the immune system to battle tumors-has received widespread attention in cancer research. Due to its unique features and mechanisms for treating cancer, immunotherapy requires novel clinical trial designs. We propose a Bayesian seamless phase I/II randomized design for immunotherapy trials (SPIRIT) to find the optimal biological dose (OBD) defined in terms of the restricted mean survival time. We jointly model progression-free survival and the immune response. Progression-free survival is used as the primary endpoint to determine the OBD, and the immune response is used as an ancillary endpoint to quickly screen out futile doses. Toxicity is monitored throughout the trial. The design consists of two seamlessly connected stages. The first stage identifies a set of safe doses. The second stage adaptively randomizes patients to the safe doses identified and uses their progression-free survival and immune response to find the OBD. The simulation study shows that the SPIRIT has desirable operating characteristics and outperforms the conventional design. Copyright © 2018 John Wiley & Sons, Ltd.

Effect Evaluation of a Randomized Trial to Reduce Infectious Illness and Illness-related Absenteeism Among Schoolchildren: The Hi Five Study.

PubMed

Denbæk, Anne Maj; Andersen, Anette; Bonnesen, Camilla Thørring; Laursen, Bjarne; Ersbøll, Annette Kjær; Due, Pernille; Johansen, Anette

2018-01-01

Previous school-based hand hygiene interventions have reported to successfully reduce infectious illness among schoolchildren. But few studies have tested the effect in large populations with adequate statistical power and analyses. The aim of this study was to evaluate whether a school-based multicomponent intervention to improve handwashing among schoolchildren, the Hi Five study, succeeded in reducing infectious illness and illness-related absenteeism in schools. The Hi Five study was a three-armed cluster-randomized controlled trial involving 43 randomly selected Danish schools; two intervention arms involving 14 schools each, and 15 control schools. Infectious illness days, infectious illness episodes and illness-related absenteeism were estimated in multilevel regressions, based on available cases of text messages answered by parents and based on questionnaire data reported by schoolchildren, respectively. At follow-up, children in the intervention schools did not differ from the control schools in number of illness days [odds ratio (OR)I-arm I: 0.91 (0.77-1.07) and ORI-arm II: 0.94 (0.79-1.12)] and illness episodes [ORI-arm I: 0.95 (0.81-1.11) and ORI-arm II: 0.98 (0.84-1.16)] or in reporting illness-related absenteeism [ORI-arm I: 1.09 (0.83-1.43) & ORI-arm II: 1.06 (0.81-1.40)]. The multicomponent Hi Five intervention achieved no difference in the number of illness days, illness episodes or illness-related absenteeism among children in intervention schools compared with control schools. It is noteworthy that one of the main components in the intervention, a mandatory daily handwashing before lunch, was only implemented by 1 of 3 of teachers in intervention schools.

Overall Survival Analysis From a Randomized Phase II Study of Axitinib With or Without Dose Titration in First-Line Metastatic Renal Cell Carcinoma.

PubMed

Rini, Brian I; Tomita, Yoshihiko; Melichar, Bohuslav; Ueda, Takeshi; Grünwald, Viktor; Fishman, Mayer N; Uemura, Hirotsugu; Oya, Mototsugu; Bair, Angel H; Andrews, Glen I; Rosbrook, Brad; Jonasch, Eric

2016-12-01

In a randomized phase II trial in metastatic renal cell carcinoma (mRCC), objective response rate was significantly higher with axitinib versus placebo titration (54% vs. 34%; 1-sided P = .019). Treatment-naive patients with mRCC (n = 213) received axitinib 5 mg twice per day (b.i.d.) for 4 weeks. Patients meeting dose titration criteria were randomized to receive axitinib 5 mg b.i.d. with axitinib or placebo titration (n = 56 each); 91 patients ineligible for randomization continued axitinib 5 mg b.i.d.; 10 discontinued before randomization. Median overall survival (95% confidence interval [CI]) was 42.7 months (24.7-not estimable) with axitinib titration versus 30.4 months (23.7-45.0) with placebo titration (stratified hazard ratio, 0.785; 95% CI, 0.485-1.272; 1-sided P = .162), and 41.6 months (95% CI, 33.0-not estimable) in nonrandomized patients. Safety data were consistent with previous reports. Median overall survival was numerically longer in patients with first-line mRCC who received axitinib versus placebo titration. No new safety signal was observed after long-term axitinib treatment in first-line mRCC. Copyright © 2016 Elsevier Inc. All rights reserved.

Systemic chemotherapy in patients with advanced transitional cell carcinoma of the urothelium and impaired renal function.

PubMed

Demery, Mounira El; Thézenas, Simon; Pouessel, Damien; Culine, Stéphane

2012-02-01

Cisplatin is the backbone of chemotherapeutic regimens used in the treatment of advanced transitional cell carcinoma of the urothelium. However, about 50% of patients cannot be administered cisplatin because of impaired renal functions. A review of the different approaches that have been developed in this patient population was performed through a Medline search from 1 January 1998 to 31 December 2010. Twenty-six studies including 25 phase II and one randomized phase II/III studies were analyzed. All regimens, except one, were based on gemcitabine and/or carboplatin and/or paclitaxel. Only five (20%) out of 25 phase II studies actually include homogeneous patients with an impaired renal function defined by a creatinine clearance below 60 ml/min. One hundred and eight patients with a median creatinine clearance ranging from 28 to 48 ml/min received four different chemotherapy regimens including one to four drugs. The results showed the response rates to vary from 24 to 56% and survival to range from 7 to 15 months. No standard chemotherapy can be recommended from literature data. Future randomized studies will have to solve the following questions: what is the optimal definition of cisplatin eligibility? Which platinum salt should be used? Is a platinum salt necessary? How many drugs should be delivered?

Optimal dose selection accounting for patient subpopulations in a randomized Phase II trial to maximize the success probability of a subsequent Phase III trial.

PubMed

Takahashi, Fumihiro; Morita, Satoshi

2018-02-08

Phase II clinical trials are conducted to determine the optimal dose of the study drug for use in Phase III clinical trials while also balancing efficacy and safety. In conducting these trials, it may be important to consider subpopulations of patients grouped by background factors such as drug metabolism and kidney and liver function. Determining the optimal dose, as well as maximizing the effectiveness of the study drug by analyzing patient subpopulations, requires a complex decision-making process. In extreme cases, drug development has to be terminated due to inadequate efficacy or severe toxicity. Such a decision may be based on a particular subpopulation. We propose a Bayesian utility approach (BUART) to randomized Phase II clinical trials which uses a first-order bivariate normal dynamic linear model for efficacy and safety in order to determine the optimal dose and study population in a subsequent Phase III clinical trial. We carried out a simulation study under a wide range of clinical scenarios to evaluate the performance of the proposed method in comparison with a conventional method separately analyzing efficacy and safety in each patient population. The proposed method showed more favorable operating characteristics in determining the optimal population and dose.

A randomized clinical trial of the efficacy of single versus double-daily dose of oral iron for prevention of iron deficiency anemia in women with twin gestations.

PubMed

Ali, Mohammed K; Abbas, Ahmed M; Abdelmagied, Ahmed M; Mohammed, Ghada E; Abdalmageed, Osama S

2017-12-01

The study aims to assess the efficacy of single versus double-daily oral iron dose on prevention of iron deficiency anemia in women with twin gestations. A randomized controlled trial (NCT02858505) conducted at Woman's Health Hospital, Assiut, Egypt, between August 2015 and June 2016 included 120 non-anemic pregnant women with twin gestations in the first trimester. Women were randomly assigned to either group I (27 mg elemental iron) or group II (54 mg elemental iron) daily starting from 12 weeks of pregnancy till 36 weeks. The primary outcomes included the mean level of hemoglobin, hematocrit and serum ferritin at 36 weeks' gestation. Both iron doses maintained the mean hemoglobin and hematocrit within the normal level from 12 weeks to 36 weeks (p = 0.378 and p = 0.244, respectively). However, the mean serum ferritin level was higher in group II than group I (p = 0.000) at 36 weeks' gestation. Moreover, women in group II reported more side effects than group I at 36 weeks' gestation. Doubling the prophylactic iron dose is comparable to single dose in the prevention of iron deficiency anemia among women with twin gestations with more side effects.

A comparative study of restricted randomization procedures for multiarm trials with equal or unequal treatment allocation ratios.

PubMed

Ryeznik, Yevgen; Sverdlov, Oleksandr

2018-06-04

Randomization designs for multiarm clinical trials are increasingly used in practice, especially in phase II dose-ranging studies. Many new methods have been proposed in the literature; however, there is lack of systematic, head-to-head comparison of the competing designs. In this paper, we systematically investigate statistical properties of various restricted randomization procedures for multiarm trials with fixed and possibly unequal allocation ratios. The design operating characteristics include measures of allocation balance, randomness of treatment assignments, variations in the allocation ratio, and statistical characteristics such as type I error rate and power. The results from the current paper should help clinical investigators select an appropriate randomization procedure for their clinical trial. We also provide a web-based R shiny application that can be used to reproduce all results in this paper and run simulations under additional user-defined experimental scenarios. Copyright © 2018 John Wiley & Sons, Ltd.

Interim analysis of postoperative chemoradiotherapy with capecitabine and oxaliplatin versus capecitabine alone for pathological stage II and III rectal cancer: a randomized multicenter phase III trial.

PubMed

Feng, Yan-Ru; Zhu, Yuan; Liu, Lu-Ying; Wang, Wei-Hu; Wang, Shu-Lian; Song, Yong-Wen; Wang, Xin; Tang, Yuan; Liu, Yue-Ping; Ren, Hua; Fang, Hui; Zhang, Shi-Ping; Liu, Xin-Fan; Yu, Zi-Hao; Li, Ye-Xiong; Jin, Jing

2016-05-03

The aim of this study is to present an interim analysis of a phase III trial (NCT00714077) of postoperative concurrent capecitabine and radiotherapy with or without oxaliplatin for pathological stage II and III rectal cancer. Patients with pathologically confirmed stage II and III rectal cancer were randomized to either radiotherapy with concurrent capecitabine (Cap-RT group) or with capecitabine and oxaliplatin (Capox-RT group). The primary endpoint was 3-year disease-free survival rate (DFS). The 3-year DFS rate was 73.9% in the Capox-RT group and 71.6% in the Cap-RT group (HR 0.92, p = 0.647), respectively. No significant difference was observed in overall survival, cumulative incidence of local recurrence and distant metastasis between the two groups (p > 0.05). More grade 3-4 acute toxicity was observed in the Capox-RT group than in the Cap-RT group (38.1% vs. 29.2%, p = 0.041). Inclusion of oxaliplatin in the capecitabine-based postoperative regimen did not improve DFS but increased toxicities for pathological stage II and III rectal cancer in this interim analysis.

Effectiveness of orthodontic treatment with functional appliances on maxillary growth in the short term: A systematic review and meta-analysis.

PubMed

Nucera, Riccardo; Lo Giudice, Antonino; Rustico, Lorenzo; Matarese, Giovanni; Papadopoulos, Moschos A; Cordasco, Giancarlo

2016-05-01

The aim of this systematic review was to evaluate the treatment effects on maxillary growth of removable functional appliances that advance the mandible to a more forward position in patients with Class II malocclusion. Sixteen electronic databases and reference lists of studies were searched up to April 2015. Only randomized clinical trials and prospective controlled clinical trials investigating Class II growing patients treated with removable functional appliances were included. Two authors independently accomplished study selection, data extraction, and risk of bias assessment. All pooled analyses of data were based on random-effects models. Statistical heterogeneity was evaluated. In total, 14 studies were included (5 randomized clinical trials, 9 prospective controlled clinical trials) that collected data from 765 patients (405 treated, 360 untreated controls). The mean differences in treatment effect of functional appliances, relative to the untreated controls, were -0.61° per year (95% CI, -0.69° to -0.25°) for SNA angle, -0.61 mm per year (95% CI, -0.90 to -0.32 mm) for anterior maxillary displacement, and +0.07° per year (95% CI, -0.17° to +0.32°) for maxillary plane rotation. Removable functional appliances in Class II growing patients have a slight inhibitory effect on the sagittal growth of the maxilla in the short term, but they do not seem to affect rotation of the maxillary plane. Copyright © 2016 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Hospital costs for treatment of acute heart failure: economic analysis of the REVIVE II study.

PubMed

de Lissovoy, Greg; Fraeman, Kathy; Teerlink, John R; Mullahy, John; Salon, Jeff; Sterz, Raimund; Durtschi, Amy; Padley, Robert J

2010-04-01

Acute heart failure (AHF) is the leading cause of hospital admission among older Americans. The Randomized EValuation of Intravenous Levosimendan Efficacy (REVIVE II) trial compared patients randomly assigned to a single infusion of levosimendan (levo) or placebo (SOC), each in addition to local standard treatments for AHF. We report an economic analysis of REVIVE II from the hospital perspective. REVIVE II enrolled patients (N = 600) hospitalized for treatment of acute decompensated heart failure (ADHF) who remained dyspneic at rest despite treatment with intravenous diuretics. Case report forms documented index hospital treatment (drug administration, procedures, days of treatment by care unit), as well as subsequent hospital and emergency department admissions during follow-up ending 90 days from date of randomization. These data were used to impute cost of admission based on an econometric cost function derived from >100,000 ADHF hospital billing records selected per REVIVE II inclusion criteria. Index admission mean length of stay (LOS) was shorter for the levo group compared with standard of care (SOC) (7.03 vs 8.96 days, P = 0.008) although intensive care unit (ICU)/cardiac care unit (CCU) days were similar (levo 2.88, SOC 3.22, P = 0.63). Excluding cost for levo, predicted mean (median) cost for the index admission was levo US $13,590 (9,458), SOC $19,021 (10,692) with a difference of $5,431 (1,234) favoring levo (P = 0.04). During follow-up through end of study day 90, no significant differences were observed in numbers of hospital admissions (P = 0.67), inpatient days (P = 0.81) or emergency department visits (P = 0.41). Cost-effectiveness was performed with a REVIVE-II sub-set conforming to current labeling, which excluded patients with low baseline blood pressure. Assuming an average price for levo in countries where currently approved, there was better than 50% likelihood that levo was both cost-saving and improved survival. Likelihood that levo would be cost-effective for willingness-to-pay below $50,000 per year of life gained was about 65%. In the REVIVE II trial, patients treated with levo had shorter LOS and lower cost for the initial hospital admission relative to patients treated with SOC. Based on sub-group analysis of patients administered per the current label, levo appears cost-effective relative to SOC.

RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia.

PubMed

Wolf, Sebastian; Balciuniene, Vilma Jurate; Laganovska, Guna; Menchini, Ugo; Ohno-Matsui, Kyoko; Sharma, Tarun; Wong, Tien Y; Silva, Rufino; Pilz, Stefan; Gekkieva, Margarita

2014-03-01

To compare the efficacy and safety of ranibizumab 0.5 mg, guided by visual acuity (VA) stabilization or disease activity criteria, versus verteporfin photodynamic therapy (vPDT) in patients with visual impairment due to myopic choroidal neovascularization (CNV). Phase III, 12-month, randomized, double-masked, multicenter, active-controlled study. Patients (N = 277) with visual impairment due to myopic CNV. Patients were randomized to receive ranibizumab on day 1, month 1, and thereafter as needed guided by VA stabilization criteria (group I, n = 106); ranibizumab on day 1 and thereafter as needed guided by disease activity criteria (group II, n=116); or vPDT on day 1 and disease activity treated with ranibizumab or vPDT at investigators' discretion from month 3 (group III, n = 55). Mean average best-corrected visual acuity (BCVA) change from baseline to month 1 through months 3 (primary) and 6, mean BCVA change and safety over 12 months. Ranibizumab treatment in groups I and II was superior to vPDT based on mean average BCVA change from baseline to month 1 through month 3 (group I: +10.5, group II: +10.6 vs. group III: +2.2 Early Treatment Diabetic Retinopathy Study [ETDRS] letters; both P<0.0001). Ranibizumab treatment guided by disease activity was noninferior to VA stabilization-guided retreatment based on mean average BCVA change from baseline to month 1 through month 6 (group II: +11.7 vs. group I: +11.9 ETDRS letters; P<0.00001). Mean BCVA change from baseline to month 12 was +13.8 (group I), +14.4 (group II), and +9.3 ETDRS letters (group III). At month 12, 63.8% to 65.7% of patients showed resolution of myopic CNV leakage. Patients received a median of 4.0 (group I) and 2.0 (groups II and III) ranibizumab injections over 12 months. No deaths or cases of endophthalmitis and myocardial infarction occurred. Ranibizumab treatment, irrespective of retreatment criteria, provided superior BCVA gains versus vPDT up to month 3. Ranibizumab treatment guided by disease activity criteria was noninferior to VA stabilization criteria up to month 6. Over 12 months, individualized ranibizumab treatment was effective in improving and sustaining BCVA and was generally well tolerated in patients with myopic CNV. Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

[Prospective randomized study regarding the effect of the preoperative antibiotic and chlorhexidine rinse on wound healing after mandibular third molar surgery].

PubMed

Kaposvári, István; Körmöczi, Kinga; László, Zsuzsa Beáta; Oberna, Ferenc; Horváth, Ferenc; Joób-Fancsaly, Árpád

2017-01-01

The study compares the antibiotic prophylaxis combined with postoperative antibiotic therapy to preoperative chlorhexidine rinse combined with postoperative antibiotic therapy in preventing complications after surgical removal of a mandibular third molar. 71 healthy patients in four groups were enrolled in the study: I. prophylactic dose of 2000 mg of amoxicillin clavulanate, continued with amoxicillin clavulanate postoperatively; II. prophylactic dose of 600 mg of clindamycin, continued with clindamycin postoperatively; III. prophylactic chlorhexidin rinsing, continued randomized amoxicillin clavulanate or clindamycin postoperatively; IV. control, with clindamycin postoperatively. The pain was smaller in the prophylaxis groups. Alveolitis occurred only in the control group: 2 patients. Wound opening occurred in 22,2 % in group IV., 14,2 % in group II, 10 % in group I., 5 % in group III. We consider completing the indicated postoperative antibiotic prescription with antibiotic or antiseptic prophylaxis. Chlorhexidin prophylaxis could have the same positive effect. Orv. Hetil., 2017, 158(1), 13-19.

Response to Instruction in Preschool: Results of Two Randomized Studies with Children at Significant Risk of Reading Difficulties

ERIC Educational Resources Information Center

Lonigan, Christopher J.; Phillips, Beth M.

2016-01-01

Although response-to-instruction (RTI) approaches have received increased attention, few studies have evaluated the potential impacts of RTI approaches with preschool populations. This article presents results of 2 studies examining impacts of Tier II instruction with preschool children. Participating children were identified as substantially…

Emergency department-initiated palliative care for advanced cancer patients: protocol for a pilot randomized controlled trial.

PubMed

Kandarian, Brandon; Morrison, R Sean; Richardson, Lynne D; Ortiz, Joanna; Grudzen, Corita R

2014-06-25

For patients with advanced cancer, visits to the emergency department (ED) are common. Such patients present to the ED with a specific profile of palliative care needs, including burdensome symptoms such as pain, dyspnea, or vomiting that cannot be controlled in other settings and a lack of well-defined goals of care. The goals of this study are: i) to test the feasibility of recruiting, enrolling, and randomizing patients with serious illness in the ED; and ii) to evaluate the impact of ED-initiated palliative care on health care utilization, quality of life, and survival. This is a protocol for a single center parallel, two-arm randomized controlled trial in ED patients with metastatic solid tumors comparing ED-initiated palliative care referral to a control group receiving usual care. We plan to enroll 125 to 150 ED-advanced cancer patients at Mount Sinai Hospital in New York, USA, who meet the following criteria: i) pass a brief cognitive screen; ii) speak fluent English or Spanish; and iii) have never been seen by palliative care. We will use balanced block randomization in groups of 50 to assign patients to the intervention or control group after completion of a baseline questionnaire. All research staff performing assessment or analysis will be blinded to patient assignment. We will measure the impact of the palliative care intervention on the following outcomes: i) timing and rate of palliative care consultation; ii) quality of life and depression at 12 weeks, measured using the FACT-G and PHQ-9; iii) health care utilization; and iv) length of survival. The primary analysis will be based on intention-to-treat. This pilot randomized controlled trial will test the feasibility of recruiting, enrolling, and randomizing patients with advanced cancer in the ED, and provide a preliminary estimate of the impact of palliative care referral on health care utilization, quality of life, and survival. Clinical Trials.gov identifier: NCT01358110 (Entered 5/19/2011).

Efficacy of a Multiplex Paclitaxel Emission Stent Using a Pluronic® Mixture Membrane versus a Covered Metal Stent in Malignant Biliary Obstruction: A Prospective Randomized Comparative Study.

PubMed

Jang, Sung Ill; Lee, Se Joon; Jeong, Seok; Lee, Don Haeng; Kim, Myung-Hwan; Yoon, Hong Jin; Lee, Dong Ki

2017-07-15

A drug-eluting stent for unresectable malignant biliary obstruction was developed to increase stent patency by preventing tumor ingrowth. The safety and efficacy of a new generation of metallic stents covered with a paclitaxel-incorporated membrane using a Pluronic ® mixture (MSCPM-II) were compared prospectively with those of covered metal stents (CMSs) in patients with malignant biliary obstructions. This study was initially designed as a prospective randomized trial but was closed early because of a high incidence of early occlusion. Therefore, the data were analyzed using the intent-to-treat method. A total of 72 patients with unresectable distal malignant biliary obstructions were prospectively enrolled. The two groups did not differ significantly in basic characteristics and mean follow-up period (MSCPM-II 194 days vs CMS 277 days, p=0.063). Stent occlusion occurred in 14 patients (35%) who received MSCPM-II and in seven patients (21.9%) who received CMSs. Stent patency and survival time did not significantly differ between the two groups (p=0.355 and p=0.570). The complications were mild and resolved by conservative management in both groups. There were no significant differences in stent patency or patient survival in MSCPM-II and CMS patients with malignant biliary obstructions.

Effects of glargine insulin on glycemic control in patients with diabetes mellitus type II undergoing off-pump coronary artery bypass graft.

PubMed

Gandhi, Hemang; Sarvaia, Alpesh; Malhotra, Amber; Acharya, Himanshu; Shah, Komal; Rajavat, Jeevraj

2018-01-01

The prevalence of diabetes mellitus in patients requiring coronary artery bypass grafting (CABG) is noticeably high (20%-30%). These patients have inferior perioperative outcome, reduced long-term survival, and high risk of recurrent episodes of angina. To improve perioperative outcome surgical unit defined satisfactory glycemic control is desired during this period. Hence, the aim of our study is to compare the efficacy of glargine insulin combination with continuous human insulin infusion for perioperative glycemic control in patients with diabetes undergoing CABG. Fifty Patients, who were posted for off-pump CABG with diabetes mellitus type II, were randomized in two group, Group I normal saline + human insulin infusion during the perioperative period, Group II (glargine group): Glargine + human insulin infusion during perioperative period. During surgery and in the postoperative period, random blood sugar and human insulin requirement are significantly higher in control group than glargine group. Other infection, step-up antibiotics, intensive care unit (ICU) stay, and hospital stay were significantly higher in control groups in postoperative period. Our study results suggest that glargine effectively manages blood glucose level with significantly greater control over postoperative morbidity.

Improving practice in community-based settings: a randomized trial of supervision - study protocol.

PubMed

Dorsey, Shannon; Pullmann, Michael D; Deblinger, Esther; Berliner, Lucy; Kerns, Suzanne E; Thompson, Kelly; Unützer, Jürgen; Weisz, John R; Garland, Ann F

2013-08-10

Evidence-based treatments for child mental health problems are not consistently available in public mental health settings. Expanding availability requires workforce training. However, research has demonstrated that training alone is not sufficient for changing provider behavior, suggesting that ongoing intervention-specific supervision or consultation is required. Supervision is notably under-investigated, particularly as provided in public mental health. The degree to which supervision in this setting includes 'gold standard' supervision elements from efficacy trials (e.g., session review, model fidelity, outcome monitoring, skill-building) is unknown. The current federally-funded investigation leverages the Washington State Trauma-focused Cognitive Behavioral Therapy Initiative to describe usual supervision practices and test the impact of systematic implementation of gold standard supervision strategies on treatment fidelity and clinical outcomes. The study has two phases. We will conduct an initial descriptive study (Phase I) of supervision practices within public mental health in Washington State followed by a randomized controlled trial of gold standard supervision strategies (Phase II), with randomization at the clinician level (i.e., supervisors provide both conditions). Study participants will be 35 supervisors and 130 clinicians in community mental health centers. We will enroll one child per clinician in Phase I (N = 130) and three children per clinician in Phase II (N = 390). We use a multi-level mixed within- and between-subjects longitudinal design. Audio recordings of supervision and therapy sessions will be collected and coded throughout both phases. Child outcome data will be collected at the beginning of treatment and at three and six months into treatment. This study will provide insight into how supervisors can optimally support clinicians delivering evidence-based treatments. Phase I will provide descriptive information, currently unavailable in the literature, about commonly used supervision strategies in community mental health. The Phase II randomized controlled trial of gold standard supervision strategies is, to our knowledge, the first experimental study of gold standard supervision strategies in community mental health and will yield needed information about how to leverage supervision to improve clinician fidelity and client outcomes. ClinicalTrials.gov NCT01800266.

Improving practice in community-based settings: a randomized trial of supervision – study protocol

PubMed Central

2013-01-01

Background Evidence-based treatments for child mental health problems are not consistently available in public mental health settings. Expanding availability requires workforce training. However, research has demonstrated that training alone is not sufficient for changing provider behavior, suggesting that ongoing intervention-specific supervision or consultation is required. Supervision is notably under-investigated, particularly as provided in public mental health. The degree to which supervision in this setting includes ‘gold standard’ supervision elements from efficacy trials (e.g., session review, model fidelity, outcome monitoring, skill-building) is unknown. The current federally-funded investigation leverages the Washington State Trauma-focused Cognitive Behavioral Therapy Initiative to describe usual supervision practices and test the impact of systematic implementation of gold standard supervision strategies on treatment fidelity and clinical outcomes. Methods/Design The study has two phases. We will conduct an initial descriptive study (Phase I) of supervision practices within public mental health in Washington State followed by a randomized controlled trial of gold standard supervision strategies (Phase II), with randomization at the clinician level (i.e., supervisors provide both conditions). Study participants will be 35 supervisors and 130 clinicians in community mental health centers. We will enroll one child per clinician in Phase I (N = 130) and three children per clinician in Phase II (N = 390). We use a multi-level mixed within- and between-subjects longitudinal design. Audio recordings of supervision and therapy sessions will be collected and coded throughout both phases. Child outcome data will be collected at the beginning of treatment and at three and six months into treatment. Discussion This study will provide insight into how supervisors can optimally support clinicians delivering evidence-based treatments. Phase I will provide descriptive information, currently unavailable in the literature, about commonly used supervision strategies in community mental health. The Phase II randomized controlled trial of gold standard supervision strategies is, to our knowledge, the first experimental study of gold standard supervision strategies in community mental health and will yield needed information about how to leverage supervision to improve clinician fidelity and client outcomes. Trial registration ClinicalTrials.gov NCT01800266 PMID:23937766

Bilirubin and Stroke Risk Using a Mendelian Randomization Design.

PubMed

Lee, Sun Ju; Jee, Yon Ho; Jung, Keum Ji; Hong, Seri; Shin, Eun Soon; Jee, Sun Ha

2017-05-01

Circulating bilirubin, a natural antioxidant, is associated with decreased risk of stroke. However, the nature of the relationship between the two remains unknown. We used a Mendelian randomization analysis to assess the causal effect of serum bilirubin on stroke risk in Koreans. The 14 single-nucleotide polymorphisms (SNPs) (<10 -7 ) including rs6742078 of uridine diphosphoglucuronyl-transferase were selected from genome-wide association study of bilirubin level in the KCPS-II (Korean Cancer Prevention Study-II) Biobank subcohort consisting of 4793 healthy Korean and 806 stroke cases. Weighted genetic risk score was calculated using 14 SNPs selected from the top SNPs. Both rs6742078 (F statistics=138) and weighted genetic risk score with 14 SNPs (F statistics=187) were strongly associated with bilirubin levels. Simultaneously, serum bilirubin level was associated with decreased risk of stroke in an ordinary least-squares analysis. However, in 2-stage least-squares Mendelian randomization analysis, no causal relationship between serum bilirubin and stroke risk was found. There is no evidence that bilirubin level is causally associated with risk of stroke in Koreans. Therefore, bilirubin level is not a risk determinant of stroke. © 2017 American Heart Association, Inc.

Effect of supramolecular organization of a cartilaginous tissue on thermal stability of collagen II

NASA Astrophysics Data System (ADS)

Ignat'eva, N. Yu.; Averkiev, S. V.; Lunin, V. V.; Grokhovskaya, T. E.; Obrezkova, M. V.

2006-08-01

The thermal stability of collagen II in various cartilaginous tissues was studied. It was found that heating a tissue of nucleus pulposus results in collagen II melting within a temperature range of 60-70°C; an intact tissue of hyaline cartilage (of nasal septum and cartilage endplates) is a thermally stable system, where collagen II is not denatured completely up to 100°C. It was found that partial destruction of glycosaminoglycans in hyaline cartilage leads to an increase in the degree of denaturation of collagen II upon heating, although a significant fraction remains unchanged. It was shown that electrostatic interactions of proteoglycans and collagen only slightly affect the thermal stability of collagen II in the tissues. Evidently, proteoglycan aggregates play a key role: they create topological hindrances for moving polypeptide chains, thereby reducing the configurational entropy of collagen macromolecules in the state of a random coil.

Baseline characteristics and recruitment strategies in a randomized clinical trial of African-American light smokers.

PubMed

Okuyemi, Kolawole S; Cox, Lisa Sanderson; Nollen, Nicole L; Snow, Tricia M; Kaur, Harsohena; Choi, Won; Nazir, Niaman; Mayo, Matthew S; Ahluwalia, Jasjit S

2007-01-01

This study describes the design, recruitment, and baseline data of the first smoking-cessation clinical trial for African-American light smokers, Kick It at Swope II (KIS-II). KIS-II was a randomized trial testing the efficacy of nicotine gum (vs. placebo gum) in combination with counseling (motivational interviewing or health education). This study was conducted at an urban community-based clinic serving predominantly lower-income African-Americans. African-Americans who smoked 1 to 10 cigarettes per day were eligible. Of 1933 individuals screened, 1012 (52%) were eligible and 755 (75%) were enrolled in the study. Baseline assessment included smoking history and psychometric measures. The majority of participants were women (67%) with a mean age of 45.1 years (SD = 10.7). Participants smoked on average 7.6 cigarettes (SD = 3.21) per day, had a mean exhaled carbon monoxide level of 13.9 ppm (SD = 8.9) and a mean serum cotinine level of 244.2 ng/mL (SD = 154.4), and reported high levels of motivation and confidence to quit smoking. African-American light smokers were motivated to stop smoking and to enroll in a smoking-cessation program. Characteristics of our sample suggest African-American light smokers are an appropriate group for inclusion in smoking-cessation interventions.

Effect of spinal manipulative therapy with stretching compared with stretching alone on full-swing performance of golf players: a randomized pilot trial☆

PubMed Central

Costa, Soraya M.V.; Chibana, Yumi E.T.; Giavarotti, Leandro; Compagnoni, Débora S.; Shiono, Adriana H.; Satie, Janice; Bracher, Eduardo S.B.

2009-01-01

Abstract Objective There has been a steady growth of chiropractic treatment using spinal manipulative therapy (SMT) that aims to increase the performance of athletes in various sports. This study evaluates the effect of SMT by chiropractors on the performance of golf players. Methods Golfers of 2 golf clubs in São Paulo, Brazil, participated in this study. They were randomized to 1 of 2 groups: Group I received a stretch program, and group II received a stretch program in addition to SMT. Participants in both groups performed the same standardized stretching program. Spinal manipulative therapy to dysfunctional spinal segments was performed on group II only. All golfers performed 3 full-swing maneuvers. Ball range was considered as the average distance for the 3 shots. Treatment was performed after the initial measurement, and the same maneuvers were performed afterward. Each participant repeated these procedures for a 4-week period. Student t test, Mann-Whitney nonparametric test, and 1-way analysis of variance for repeated measures with significance level of 5% were used to analyze the study. Results Forty-three golfers completed the protocol. Twenty participants were allocated to group I and 23 to group II. Average age, handicap, and initial swing were comparable. No improvement of full-swing performance was observed during the 4 sessions on group I (stretch only). An improvement was observed at the fourth session of group II (P = .005); when comparing the posttreatment, group II had statistical significance at all phases (P = .003). Conclusions Chiropractic SMT in association with muscle stretching may be associated with an improvement of full-swing performance when compared with muscle stretching alone. PMID:19948307

Impact of Targeted Preoperative Optimization on Clinical Outcome in Emergency Abdominal Surgeries: A Prospective Randomized Trial.

PubMed

Sethi, Ashish; Debbarma, Miltan; Narang, Neeraj; Saxena, Anudeep; Mahobia, Mamta; Tomar, Gaurav Singh

2018-01-01

Perforation peritonitis continues to be one of the most common surgical emergencies that need a surgical intervention most of the times. Anesthesiologists are invariably involved in managing such cases efficiently in perioperative period. The assessment and evaluation of Acute Physiology and Chronic Health Evaluation II (APACHE II) score at presentation and 24 h after goal-directed optimization, administration of empirical broad-spectrum antibiotics, and definitive source control postoperatively. Outcome assessment in terms of duration of hospital stay and mortality in with or without optimization was also measured. It is a prospective, randomized, double-blind controlled study in hospital setting. One hundred and one patients aged ≥18 years, of the American Society of Anesthesiologists physical Status I and II (E) with clinical diagnosis of perforation peritonitis posted for surgery were enrolled. Enrolled patients were randomly divided into two groups. Group A is optimized by goal-directed optimization protocol in the preoperative holding room by anesthesiology residents whereas in Group S, managed by surgery residents in the surgical wards without any fixed algorithm. The assessment of APACHE II score was done as a first step on admission and 24 h postoperatively. Duration of hospital stay and mortality in both the groups were also measured and compared. Categorical data are presented as frequency counts (percent) and compared using the Chi-square or Fisher's exact test. The statistical significance for categorical variables was determined by Chi-square analysis. For continuous variables, a two-sample t -test was applied. The mean APACHE II score on admission in case and control groups was comparable. Significant lowering of serial scores in case group was observed as compared to control group ( P = 0.02). There was a significant lowering of mean duration of hospital stay seen in case group (9.8 ± 1.7 days) as compared to control group ( P = 0.007). Furthermore, a significant decline in death rate was noted in case group as compared to control group ( P = 0.03). Goal-directed optimized patients with perforation peritonitis were discharged early as compared to control group with significantly lesser mortality as compared with randomly optimized patients in the perioperative period.

Csk regulates angiotensin II-induced podocyte apoptosis.

PubMed

Zhang, Lu; Ren, Zhilong; Yang, Qian; Ding, Guohua

2016-07-01

Increasing data have shown that angiotensin II (Ang II) perpetuates podocyte injury and promotes progression to end-stage kidney disease. The mechanism underlying Ang II-induced podocyte apoptosis has not been established. C-terminal Src kinase (Csk) is a cytoplasmic kinase that interacts with scaffolding proteins involved in cell growth, adhesion, and polarization, and the role of Csk in regulating cellular apoptosis has gradually attracted attention. This study evaluates the role of Csk in Ang II-induced podocyte apoptosis. In vivo, Wistar rats were randomly subjected to a normal saline or Ang II infusion. In vitro, we exposed differentiated mouse podocytes to Ang II. Ang II increased Csk expression and induced podocyte apoptosis, stimulated Csk translocation and binding to Caveolin-1, and stimulated decreased Fyn pY416, increased Fyn pY529, and nephrin dephosphorylation. Csk knockdown prevented Ang II-induced podocyte apoptosis, reduced Fyn kinase inactivation, and increased the interaction between nephrin and the activated form of Fyn, accompanied by a reduced interaction between Csk and Caveolin-1. These findings indicate that Ang II induces podocyte injury via a Csk-dependent pathway.

Adaptation and Latent Structure of the Swahili Version of Beck Depression Inventory-II in a Low Literacy Population in the Context of HIV

PubMed Central

Abubakar, Amina; Kalu, Raphael Birya; Katana, Khamis; Kabunda, Beatrice; Hassan, Amin S.; Newton, Charles R.; Van de Vijver, Fons

2016-01-01

Objective We set out to adapt the Beck Depression Inventory (BDI)-II in Kenya and examine its factorial structure. Methods In the first phase we carried out in-depth interviews involving 29 adult members of the community to elicit their understanding of depression and identify aspects of the BDI-II that required adaptation. In the second phase, a modified version of BDI-II was administered to 221 adults randomly selected from the community to allow for the evaluation of its psychometric properties. In the third phase of the study we evaluated the discriminative validity of BDI-11 by comparing a randomly chosen community sample (n = 29) with caregivers of adolescents affected by HIV (n = 77). Results A considerable overlap between the BDI symptoms and those generated in the interviews was observed. Relevant idioms and symptoms such as ‘thinking too much’ and ‘Kuchoka moyo (having a tired heart)’ were identified. The administration of the BDI had to be modified to make it suitable for the low literacy levels of our participants. Fit indices for several models (one factorial, two-factor model and a three factor model) were all within acceptable range. Evidence indicated that while multidimensional models could be fitted, the strong correlations between the factors implied that a single factor model may be the best suited solution (alpha [0.89], and a significant correlation with locally identified items [r = 0.51]) confirmed the good psychometric properties of the adapted BDI-II. No evidence was found to support the hypothesis that somatization was more prevalent. Lastly, caregivers of HIV affected adolescents had significantly higher scores compared to adults randomly selected from the community F(1, 121) = 23.31, p < .001 indicating the discriminative validity of the adapted BDI = II. Conclusions With an adapted administration procedure, the BDI-II provides an adequate measure of depressive symptoms which can be used alongside other measures for proper diagnosis in a low literacy population. PMID:27258530

[How xenon works: neuro and cardioprotection mechanisms].

PubMed

Morais, Ricardo; Andrade, Luísa; Lourenço, André; Tavares, Jorge

2014-01-01

The Xenon, a noble gas, has anesthetics properties, associated with remarkable hemodynamic stability as well as cardioprotective, neuroprotective proprieties. Its physicochemical characteristics give him a quick induction and emergence of anesthesia, being free of deleterious effects in all organs and showing no teratogenicity. Such properties have led to a growing interest in improving the knowledge about this noble gas, in order to assess the mechanisms of neuro and cardioprotection induced and to assess the clinical indications for its use. Qualitative review of clinical trials on anesthesia with xenon. Studies were identified from MEDLINE and by hand-searching, using the following keywords: xenon, xenon anestesia, xenon neuroprotection, xenon cradioprotection. After several studies, including two randomized multicenter controlled trials, the use of xenon as an anesthetic in patients ASA I-II was approved in March 2007. However his use in clinical practice has been strongly limited by it's high price. It seems unlikely that the advantages it offers in relation to other anesthetics justify it's use in patients ASA I-II. Although, xenon may be a valuable asset in the reduction of co-morbilities and mortality in anesthesia of patients ASA III-IV, unfortunately, there are no large randomized control studies to prove it. Unfortunately, there are still no randomized or multicentric studies showing a favourable cost-benefit profile of xenon in ASA III-IV patients vs. other anaesthetics. The usefulness of xenon in Anesthesiology requires more studies to be defined.

Waveform Design for Multimedia Airborne Networks: Robust Multimedia Data Transmission in Cognitive Radio Networks

DTIC Science & Technology

2011-03-01

at the sensor. According to Candes, Tao and Romberg [1], a small number of random projections of a signal that is compressible is all the...Projection of Signal Transform i. DWT ii. FFT iii. DCT Solve the Minimization problem Reconstruct Signal Channel (AWGN ) De -noise Signal Original...Signal (Noisy) Random Projection of Signal Transform i. DWT ii. FFT iii. DCT Solve the Minimization problem Reconstruct Signal Channel (Noiseless) De

A Pilot Study of Safety and Efficacy of Cranial Electrotherapy Stimulation in Treatment of Bipolar II Depression

PubMed Central

McClure, Deimante; Greenman, Samantha C.; Koppolu, Siva Sundeep; Varvara, Maria; Yaseen, Zimri S.; Galynker, Igor I.

2015-01-01

Abstract This double-blind, sham-controlled study sought to investigate the effectiveness of cranial electrotherapy stimulation (CES) for the treatment of bipolar II depression (BD II). After randomization, the active group participants (n = 7) received 2 mA CES treatment for 20 minutes five days a week for 2 weeks, whereas the sham group (n = 9) had the CES device turned on and off. Symptom non-remitters from both groups received an additional 2 weeks of open-label active treatment. Active CES treatment but not sham treatment was associated with a significant decrease in the Beck Depression Inventory (BDI) scores from baseline to the second week (p = 0.003) maintaining significance until week 4 (p = 0.002). There was no difference between the groups in side effects frequency. The results of this small study indicate that CES may be a safe and effective treatment for BD II suggesting that further studies on safety and efficacy of CES may be warranted. PMID:26414234

A Pilot Study of Safety and Efficacy of Cranial Electrotherapy Stimulation in Treatment of Bipolar II Depression.

PubMed

McClure, Deimante; Greenman, Samantha C; Koppolu, Siva Sundeep; Varvara, Maria; Yaseen, Zimri S; Galynker, Igor I

2015-11-01

This double-blind, sham-controlled study sought to investigate the effectiveness of cranial electrotherapy stimulation (CES) for the treatment of bipolar II depression (BD II). After randomization, the active group participants (n = 7) received 2 mA CES treatment for 20 minutes five days a week for 2 weeks, whereas the sham group (n = 9) had the CES device turned on and off. Symptom non-remitters from both groups received an additional 2 weeks of open-label active treatment. Active CES treatment but not sham treatment was associated with a significant decrease in the Beck Depression Inventory (BDI) scores from baseline to the second week (p = 0.003) maintaining significance until week 4 (p = 0.002). There was no difference between the groups in side effects frequency. The results of this small study indicate that CES may be a safe and effective treatment for BD II suggesting that further studies on safety and efficacy of CES may be warranted.

Validity of Random Short Forms: II. The Marlowe-Crowne Social Desirability Scale.

ERIC Educational Resources Information Center

Silverstein, A. B.

1983-01-01

Appplied formulae for estimating the validity of random short forms to Reynolds' data on six short forms of the Marlowe-Crowne. Results showed some, but not all, of the short forms considered by Reynolds were appreciably better than random. (JAC)

The 12-month analysis from Basal Cell Carcinoma Outcomes with LDE225 Treatment (BOLT): A phase II, randomized, double-blind study of sonidegib in patients with advanced basal cell carcinoma.

PubMed

Dummer, Reinhard; Guminski, Alexander; Gutzmer, Ralf; Dirix, Luc; Lewis, Karl D; Combemale, Patrick; Herd, Robert M; Kaatz, Martin; Loquai, Carmen; Stratigos, Alexander J; Schulze, Hans-Joachim; Plummer, Ruth; Gogov, Sven; Pallaud, Celine; Yi, Tingting; Mone, Manisha; Chang, Anne Lynn S; Cornélis, Frank; Kudchadkar, Ragini; Trefzer, Uwe; Lear, John T; Sellami, Dalila; Migden, Michael R

2016-07-01

The hedgehog pathway inhibitor sonidegib demonstrated meaningful tumor shrinkage in more than 90% of patients with locally advanced basal cell carcinoma (BCC) or metastatic BCC in the BCC Outcomes with LDE225 Treatment study. This report provides long-term follow-up data collected up to 12 months after the last patient was randomized. In this multicenter, randomized, double-blind phase II study, patients were randomized 1:2 to sonidegib 200 or 800 mg. The primary end point was objective response rate assessed by central review. Objective response rates in the 200- and 800-mg arms were 57.6% and 43.8% in locally advanced BCC and 7.7% and 17.4% in metastatic BCC, respectively. Among the 94 patients with locally advanced BCC who responded, only 18 progressed or died and more than 50% had responses lasting longer than 6 months. In addition, 4 of 5 responders with metastatic BCC maintained an objective response. Grade 3/4 adverse events and those leading to discontinuation were less frequent with sonidegib 200 versus 800 mg (38.0% vs 59.3%; 27.8% vs 37.3%, respectively). No placebo or comparator arms were used because sonidegib demonstrated efficacy in advanced BCC in a phase I study, and the hedgehog pathway inhibitor vismodegib was not yet approved. With longer follow-up, sonidegib demonstrated sustained tumor responses in patients with advanced BCC. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial.

PubMed

Kulhari, S; Bharti, N; Bala, I; Arora, S; Singh, G

2016-09-01

Pectoral nerve (PecS) block is a recently introduced technique for providing surgical anaesthesia and postoperative analgesia during breast surgery. The present study was planned to compare the efficacy and safety of ultrasound-guided PecS II block with thoracic paravertebral block (TPVB) for postoperative analgesia after modified radical mastectomy. Forty adult female patients undergoing radical mastectomy were randomly allocated into two groups. Group 1 patients received a TPVB with ropivacaine 0.5%, 25 ml, whereas Group 2 patents received a PecS II block using same volume of ropivacaine 0.5% before induction of anaesthesia. Patient-controlled morphine analgesia was used for postoperative pain relief. The duration of analgesia was significantly prolonged in patients receiving the PecS II block compared with TPVB [mean (sd), 294.5 (52.76) vs 197.5 (31.35) min in the PecS II and TPVB group, respectively; P<0.0001]. The 24 h morphine consumption was also less in the PecS II block group [mean (sd), 3.90 (0.79) vs 5.30 (0.98) mg in PecS II and TPVB group, respectively; P<0.0001]. Postoperative pain scores were lower in the PecS II group compared with the TVPB group in the initial 2 h after surgery [median (IQR), 2 (2-2.5) vs 4 (3-4) in the Pecs II and TPVB group, respectively; P<0.0001]. Seventeen patients in the PecS II block group had T2 dermatomal spread compared with four patients in the TPVB group (P<0.001). No block-related complication was recorded. We found that the PecS II block provided superior postoperative analgesia than the TPVB in patients undergoing modified radical mastectomy without causing any adverse effect. CTRI/2014/06/004692. © The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Effects of Problem-Solving Method on Secondary School Students' Achievement and Retention in Social Studies, in Ekiti State, Nigeria

ERIC Educational Resources Information Center

Abdu-Raheem, B. O.

2012-01-01

This study investigated the effects of problem-solving method of teaching on secondary school students' achievement and retention in Social Studies. The study adopted the quasi-experimental, pre-test, post-test, control group design. The sample for the study consisted of 240 Junior Secondary School Class II students randomly selected from six…

A randomized, double-blind, dose-finding Phase II study to evaluate immunogenicity and safety of the third generation smallpox vaccine candidate IMVAMUNE®

PubMed Central

von Krempelhuber, Alfred; Vollmar, Jens; Pokorny, Rolf; Rapp, Petra; Wulff, Niels; Petzold, Barbara; Handley, Amanda; Mateo, Lyn; Siersbol, Henriette; Kollaritsch, Herwig; Chaplin, Paul

2009-01-01

IMVAMUNE® is a Modified Vaccinia Ankara-based virus that is being developed as a safer 3rd generation smallpox vaccine. In order to determine the optimal dose for further development, a double-blind, randomized Phase II trial was performed testing three different doses of IMVAMUNE® in 164 healthy volunteers. All three IMVAMUNE® doses displayed a favourable safety profile, with local reactions as the most frequent observation. The 1×108 TCID50 IMVAMUNE® dose induced a total antibody response in 94% of the subjects following the first vaccination and the highest peak seroconversion rates by ELISA (100%) and PRNT (71%). This IMVAMUNE® dose was considered to be optimal for the further clinical development of this highly attenuated poxvirus as a safer smallpox vaccine. PMID:19944151

Comparison of Enhancement of Analgesic Effect of Intrathecal Neostigmine by Intrathecal Clonidine and Transdermal Nitroglycerin Patch on Bupivacaine Spinal Anesthesia.

PubMed

Mammen, Mathew V; Tripathi, Manoj; Chandola, Harish C; Tyagi, Amit; Bais, Prateek Singh; Sanjeev, Om Prakash

2017-01-01

Relief of pain is very important goal intraoperatively and postoperatively. Neostigmine has been used successfully intrathecally with other agents such as clonidine and opioids for pain relief. This study aims to compare and evaluate the efficacy and safety of combining intrathecal (IT) neostigmine with IT clonidine and transdermal nitroglycerin (tNTG) patch for the relief of pain in patients after surgery. This was a randomized, prospective, and comparative study. In this study, recruited patients were randomly allocated into three groups. Groups I, II, and III received intrathecally 25 μg of neostigmine + 15 mg hyperbaric 0.5% bupivacaine, 25 μg of neostigmine + 25 μg clonidine + 15 mg hyperbaric 0.5% bupivacaine, and 25 μg of neostigmine + tNTG patch (3 cm × 5 cm, 5 mg/24 h) +15 mg hyperbaric 0.5% bupivacaine, respectively. Heart rate, mean arterial pressure, analgesic properties, and complications were assessed and compared among groups. Mean and standard deviation were calculated. Test of analysis between two groups was done by t -test and among three groups by ANOVA, then P value was calculated. Duration of analgesia was significantly longer in Group III in comparison to Group II (7.142 ± 1.81 vs. 4.408 ± 0.813 h) and was significantly longer in Group II in comparison to Group I (4.408 ± 0.813 vs. 2.583 ± 0.493 h). Analgesic requirement was significantly less in Group III in comparison to Group II (1.9 ± 0.76 vs. 2.5 ± 0.51) and was significantly less in Group II in comparison to Group I (2.5 ± 0.51 vs. 3.1 ± 0.48). Sedation score was found significantly high in Group II than other groups. Both IT clonidine and tNTG patch with bupivacaine + neostigmine spinal anesthesia were found effective in pain control. Results were found better with tNTG patch.

Hypoglycemic effects of Acacia nilotica in type II diabetes: a research proposal.

PubMed

Roozbeh, Nasibeh; Darvish, Leili; Abdi, Fatemeh

2017-07-26

Diabetes mellitus is a common metabolic disorder throughout the world which can negatively affect the function of various body organs. Due to their availability and few side effects, herbal medicines have been proposed as suitable alternatives in the management of diabetes. Previous studies have confirmed the anti diabetic properties of Acacia nilotica. The hypoglycemic effects of this plant have been attributed to its role in stimulating the islets of Langerhans to produce more insulin. The present paper describes a systematic review protocol for the assessment of the hypoglycemic effects of A. nilotica. Randomized and non-randomized placebo-controlled clinical trials, performed during 1999-2016 will be included. The outcomes will be measured through FBS, GCT, GTT, and OGTT in all of studies and in addition to these tests, will be measured 2HPP and HbA1c level in human study. Well-known databases will be searched for selected key terms A. nilotica, type II diabetes and hypoglycemia. The quality assessment of the selected papers will be evaluated based on SYRCLE and Cochrane Risk of Bias Tool. We believe that our findings will provide details about difficulties researchers face during the design of protocols or implementation of scientific studies. Ultimately, the publication of our findings will facilitate the development of effective treatment strategies to promote the health of people with type II DM. PROSPERO registration CRD42016053141.

Efficacy of Multivitamin/mineral Supplementation to Reduce Chronic Disease Risk: A Critical Review of the Evidence from Observational Studies and Randomized Controlled Trials.

PubMed

Angelo, Giana; Drake, Victoria J; Frei, Balz

2015-01-01

We reviewed recent scientific evidence regarding the effects of multivitamin/mineral (MVM) supplements on risk of chronic diseases, including cancer, cardiovascular disease, and age-related eye diseases. Data from randomized controlled trials (RCTs) and observational, prospective cohort studies were examined. The majority of scientific studies investigating the use of MVM supplements in chronic disease risk reduction reported no significant effect. However, the largest and longest RCT of MVM supplements conducted to date, the Physicians' Health Study II (PHS II), found a modest and significant reduction in total and epithelial cancer incidence in male physicians, consistent with the Supplémentation en Vitamines et Minéraux Antioxydants (SU.VI.MAX) trial. In addition, PHS II found a modest and significant reduction in the incidence of nuclear cataract, in agreement with several other RCTs and observational, prospective cohort studies. The effects of MVM use on other subtypes of cataract and age-related macular degeneration remain unclear. Neither RCTs nor prospective cohort studies are without their limitations. The placebo-controlled trial design of RCTs may be inadequate for nutrient interventions, and residual confounding, measurement error, and the possibility of reverse causality are inherent to any observational study. National surveys show that micronutrient inadequacies are widespread in the US and that dietary supplements, of which MVMs are the most common type, help fulfill micronutrient requirements in adults and children.

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

PubMed

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 < 0.01) and duration of action was prolonged ( P < 0.001) for Group II as compared to Group I. The intubating conditions were (excellent + good) in 100% patients of Group II and (excellent + good) in 80% of Group I. There was no significant change in pulse rate and mean arterial pressure from the baseline value after the administration of muscle relaxants in either of the two groups. 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.

Effects of an Internet-based cognitive behavioral therapy (iCBT) program in Manga format on improving subthreshold depressive symptoms among healthy workers: a randomized controlled trial.

PubMed

Imamura, Kotaro; Kawakami, Norito; Furukawa, Toshi A; Matsuyama, Yutaka; Shimazu, Akihito; Umanodan, Rino; Kawakami, Sonoko; Kasai, Kiyoto

2014-01-01

The purpose of this study was to develop a new Internet-based computerized cognitive behavior therapy (iCBT) program in Manga format, the Japanese cartoon, for workers and to examine the effects of the iCBT program on improving subthreshold depression using a randomized controlled trial (RCT) design among workers employed in private companies in Japan. All workers in a company (n = 290) and all workers in three departments (n = 1,500) at the headquarters of another large company were recruited by an invitation e-mail. Participants who fulfilled the inclusion criteria were randomly allocated to intervention or control groups (N = 381 for each group). A six-week, six-lesson iCBT program using Manga (Japanese comic) story was developed. The program included several CBT skills: self-monitoring, cognitive restructuring, assertiveness, problem solving, and relaxation. The intervention group studied the iCBT program at a frequency of one lesson per week. Depression (Beck Depression Inventory II; BDI-II) was assessed as a primary outcome at baseline, and three- and six-month follow-ups for both intervention and control groups were performed. The iCBT program showed a significant intervention effect on BDI-II (t = -1.99, p<0.05) with small effect sizes (Cohen's d: -0.16, 95% Confidence Interval: -0.32 to 0.00, at six-month follow-up). The present study first demonstrated that a computerized cognitive behavior therapy delivered via the Internet was effective in improving depression in the general working population. It seems critical to improve program involvement of participants in order to enhance the effect size of an iCBT program. UMIN Clinical Trials Registry UMIN000006210.

One-Year Follow-Up of the Effectiveness of Cognitive Behavioral Group Therapy for Patients' Depression: A Randomized, Single-Blinded, Controlled Study.

PubMed

Chiang, Kai-Jo; Chen, Tsai-Hui; Hsieh, Hsiu-Tsu; Tsai, Jui-Chen; Ou, Keng-Liang; Chou, Kuei-Ru

2015-01-01

The aim of the study was to investigate the long-term (one year) effectiveness of a 12-session weekly cognitive behavior group therapy (CBGT) on patients with depression. This was a single-blind randomized controlled study with a 2-arm parallel group design. Eighty-one subjects were randomly assigned to 12 sessions intervention group (CBGT) or control group (usual outpatient psychiatric care group) and 62 completed the study. The primary outcome was depression measured with Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD). The secondary outcomes were automatic thoughts measured by automatic thoughts questionnaire (ATQ). Both groups were evaluated at the pretest (before 2 weeks), posttest (after 12 therapy sessions), and short- (3 months), medium- (6 months), and long-term (12 months) follow-up. After receiving CBGT, the experimental group had a statistically significant reduction in the BDI-II from 40.30 at baseline to 17.82 points at session eight and to 10.17 points at postintervention (P < 0.001). Similar effects were seen on the HRSD. ATQ significantly decreased at the 12th session, 6 months after sessions, and 1 year after the sessions ended (P < 0.001). We concluded that CBGT is effective for reducing depression and continued to be effective at 1 year of follow-up.

A prospective, randomized clinical trial to assess the cost-effectiveness of a modern foam dressing versus a traditional saline gauze dressing in the treatment of stage II pressure ulcers.

PubMed

Payne, Wyatt G; Posnett, John; Alvarez, Oscar; Brown-Etris, Marie; Jameson, Gayle; Wolcott, Randall; Dharma, Hussein; Hartwell, Samantha; Ochs, Diane

2009-02-01

Modern dressings such as hydrocolloids, gels, and foams are typically more expensive than traditional dressings such as gauze. However, if modern dressings require fewer changes, the overall cost of treatment may be lower despite the higher initial purchase price. If healing rates are comparable or better, modern dressings also may be cost-effective. A 4-week, prospective, randomized clinical trial to assess differences in treatment costs and cost-effectiveness between a modern foam dressing and saline-soaked gauze was conducted among 36 patients (22 men, 14 women, mean age 72.8 years) with a Stage II pressure ulcer (mean duration 35 weeks) at five centers in the United States. Participants were randomized to treatment with a self-adhesive polyurethane foam (n = 20) or saline-soaked gauze dressing (n = 16). No difference in time to wound closure was observed (P = 0.817). Patients in the foam group had less frequent dressing changes (P <0.001). Total cost over the study period was lower by $466 per patient (P = 0.055) and spending on dressings was lower by $92 per patient in the foam group (P = 0.025). Cost per ulcer healed was lower by $1,517 and cost per ulcer-free day was lower by $80 for patients in the foam group. On the evidence of this study, the foam dressing is a more cost-effective treatment than saline-soaked gauze for the treatment of Stage II pressure ulcers.

Treatment of Major Depressive Disorder with Iyengar Yoga and Coherent Breathing: A Randomized Controlled Dosing Study

PubMed Central

Gerbarg, Patricia L.; Whitfield, Theodore H.; Owen, Liz; Johnston, Jennifer; Silveri, Marisa M.; Gensler, Marysia; Faulkner, Carol L.; Mann, Cathy; Wixted, Mary; Hernon, Anne Marie; Nyer, Maren B.; Brown, E. Richard P.; Jensen, John E.

2017-01-01

Abstract Objectives: The aims of this study were to assess the effects of an intervention of Iyengar yoga and coherent breathing at five breaths per minute on depressive symptoms and to determine optimal intervention yoga dosing for future studies in individuals with major depressive disorder (MDD). Methods: Subjects were randomized to the high-dose group (HDG) or low-dose group (LDG) for a 12-week intervention of three or two intervention classes per week, respectively. Eligible subjects were 18–64 years old with MDD, had baseline Beck Depression Inventory-II (BDI-II) scores ≥14, and were either on no antidepressant medications or on a stable dose of antidepressants for ≥3 months. The intervention included 90-min classes plus homework. Outcome measures were BDI-II scores and intervention compliance. Results: Fifteen HDG (Mage = 38.4 ± 15.1 years) and 15 LDG (Mage = 34.7 ± 10.4 years) subjects completed the intervention. BDI-II scores at screening and compliance did not differ between groups (p = 0.26). BDI-II scores declined significantly from screening (24.6 ± 1.7) to week 12 (6.0 ± 3.8) for the HDG (–18.6 ± 6.6; p < 0.001), and from screening (27.7 ± 2.1) to week 12 (10.1 ± 7.9) in the LDG (–17.7 ± 9.3; p < 0.001). There were no significant differences between groups, based on response (i.e., >50% decrease in BDI-II scores; p = 0.65) for the HDG (13/15 subjects) and LDG (11/15 subjects) or remission (i.e., number of subjects with BDI-II scores <14; p = 1.00) for the HDG (14/15 subjects) and LDG (13/15 subjects) after the 12-week intervention, although a greater number of subjects in the HDG had 12-week BDI-II scores ≤10 (p = 0.04). Conclusion: During this 12-week intervention of yoga plus coherent breathing, depressive symptoms declined significantly in patients with MDD in both the HDG and LDG. Both groups showed comparable compliance and clinical improvements, with more subjects in the HDG exhibiting BDI-II scores ≤10 at week 12. PMID:28296480

Bibliometric study of articles on skeletal Class II malocclusions published in four high impact factor journals.

PubMed

Ousehal, Lahcen; El Aouame, Amal; Fatene, Nassiba; Lazrak, Laila; Traiba, Loubna; N'Gom, Papa Ibrahima

2018-04-11

Perform a bibliometric analysis of the orthodontic literature on skeletal Class II malocclusions during the first decade of the 21st century. A retrospective, observational, and comprehensive study ranging from January the first 2001 to December 31 2010, based on the articles published in four high impact factor orthodontic journals: Angle Orthod, OCR, EJO, and AJODO (Quotation Report Newspaper of the Scientific Information Institute). In the 4565 reviewed articles, only 338 were published on Class II malocclusions. Brazil, the United States, Turkey, and Germany are the nationalities, which have published the most. The cross-sectional descriptive studies represent 33%, randomized clinical trials (RCTs) 10.5%, meta-analyses 0.3%. Kanavakis et al. (2006) reported 72.34% of original articles, 2.83% of synthetic reviews, 8.89% of case reports, and 15.75% of unclassifiable articles. In conclusion, searchers in Orthodontics are invited to publish more clinical trials on skeletal Class II malocclusions. Copyright © 2018. Published by Elsevier Masson SAS.

Uroplakin II Expression in Breast Carcinomas Showing Apocrine Differentiation: Putting Some Emphasis on Invasive Pleomorphic Lobular Carcinoma as a Potential Mimic of Urothelial Carcinoma at Metastatic Sites.

PubMed

Tajima, Shogo; Koda, Kenji

2016-01-01

Uroplakin II antibody is exclusively specific for urothelial carcinoma. Nonurothelial carcinoma has not been reported to be immunoreactive for uroplakin II. In the present study, we hypothesized that breast carcinoma showing apocrine differentiation, such as invasive pleomorphic lobular carcinoma (IPLC) and apocrine carcinoma (AC), stains positive for uroplakin II. We identified 6 cases of IPLC between 2000 and 2014 by searching a computerized pathological database. We randomly selected 10 cases of each classic invasive lobular carcinoma (cILC) and AC and five cases of apocrine metaplasia (AM) that coexisted in a surgically resected breast carcinoma specimen. Immunohistochemistry was performed for uroplakin II, GATA3, CK7, CK20, and other representative markers positive for urothelial carcinoma. All cases of IPLC, AC, and AM, except those of cILC, showed immunoreactivity for uroplakin II. Poorly differentiated urothelial carcinoma sometimes shows similar morphology to IPLC with the following immunophenotype: CK7+, CK20-, GATA3+, and uroplakin II+. In the present study, this immunophenotype was observed in all the cases of IPLC and AC. Therefore, when studying metastatic, poorly differentiated carcinoma showing the aforementioned immunophenotype, we should consider the possibility of it being IPLC in addition to metastatic urothelial carcinoma.

Questioning the rule of thumb: can verbal tasks be administered during the CVLT-II delay interval?

PubMed

Williams, Bethany R; Donovick, Peter J

2008-09-01

In the manual for the California Verbal Learning Test - II (CVLT-II), the authors suggest that nonverbal, rather than verbal, tasks be administered during the delay interval between administrations of the Short- and Long-Delay Recall trials of this test. They contend that this method minimizes the retroactive interference produced by intervening tasks. The purpose of the current study was to compare the extent to which verbal and nonverbal intervening tasks produce retroactive interference on CVLT-II List A recall following the long-delay. Participants in the present study were 120 undergraduate students. All participants completed the CVLT-II, and were randomly assigned to a group in which they were administered either a verbal (WAIS-III Vocabulary or Peabody Picture Vocabulary Test - IIIB) or nonverbal (Raven's Standard Progressive Matrices or WAIS-III Block Design) intervening task during the long-delay interval of the CVLT-II. Statistical analyses revealed that regardless of the type of intervening task given, participants in all groups recalled the same number of words and produced a similar number of intrusions during the CVLT-II recall trials. This indicates that not all verbal tasks produce retroactive effects beyond those produced by nonverbal tasks.

The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial.

PubMed

Eichhorn, Eric J; Bristow, Michael R

2001-01-01

Previous trials (Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS] II) have demonstrated a mortality benefit of beta-adrenergic blockade in patients with mild to moderate heart failure. The recent Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial has extended these results to a more advanced patient population. This trial did not, however, include patients who could not reach compensation, patients with far advanced heart failure symptoms, or a significant number of black patients. Future studies of beta-blockade may focus on these patients or patients with asymptomatic left ventricular dysfunction.

The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial

PubMed Central

Eichhorn, Eric J; Bristow, Michael R

2001-01-01

Previous trials (Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS] II) have demonstrated a mortality benefit of β-adrenergic blockade in patients with mild to moderate heart failure. The recent Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial has extended these results to a more advanced patient population. This trial did not, however, include patients who could not reach compensation, patients with far advanced heart failure symptoms, or a significant number of black patients. Future studies of β-blockade may focus on these patients or patients with asymptomatic left ventricular dysfunction. PMID:11806769

MHC class II-assortative mate choice in European badgers (Meles meles).

PubMed

Sin, Yung Wa; Annavi, Geetha; Newman, Chris; Buesching, Christina; Burke, Terry; Macdonald, David W; Dugdale, Hannah L

2015-06-01

The major histocompatibility complex (MHC) plays a crucial role in the immune system, and in some species, it is a target by which individuals choose mates to optimize the fitness of their offspring, potentially mediated by olfactory cues. Under the genetic compatibility hypothesis, individuals are predicted to choose mates with compatible MHC alleles, to increase the fitness of their offspring. Studies of MHC-based mate choice in wild mammals are under-represented currently, and few investigate more than one class of MHC genes. We investigated mate choice based on the compatibility of MHC class I and II genes in a wild population of European badgers (Meles meles). We also investigated mate choice based on microsatellite-derived pairwise relatedness, to attempt to distinguish MHC-specific effects from genomewide effects. We found MHC-assortative mating, based on MHC class II, but not class I genes. Parent pairs had smaller MHC class II DRB amino acid distances and smaller functional distances than expected from random pairings. When we separated the analyses into within-group and neighbouring-group parent pairs, only neighbouring-group pairs showed MHC-assortative mating, due to similarity at MHC class II loci. Our randomizations showed no evidence of genomewide-based inbreeding, based on 35 microsatellite loci; MHC class II similarity was therefore the apparent target of mate choice. We propose that MHC-assortative mate choice may be a local adaptation to endemic pathogens, and this assortative mate choice may have contributed to the low MHC genetic diversity in this population. © 2015 The Authors. Molecular Ecology published by John Wiley & Sons Ltd.

Switch Rates During Acute Treatment for Bipolar II Depression With Lithium, Sertraline, or the Two Combined: A Randomized Double-Blind Comparison.

PubMed

Altshuler, Lori L; Sugar, Catherine A; McElroy, Susan L; Calimlim, Brian; Gitlin, Michael; Keck, Paul E; Aquino-Elias, Ana; Martens, Brian E; Fischer, E Grace; English, Teri L; Roach, Janine; Suppes, Trisha

2017-03-01

The authors compared medication-induced mood switch risk (primary outcome), as well as treatment response and side effects (secondary outcomes) with three acute-phase treatments for bipolar II depression. In a 16-week, double-blind, multisite comparison study, 142 participants with bipolar II depression were randomly assigned to receive lithium monotherapy (N=49), sertraline monotherapy (N=45), or combination treatment with lithium and sertraline (N=48). At each visit, mood was assessed using standardized rating scales. Rates of switch were compared, as were rates of treatment response and the presence and severity of treatment-emergent side effects. Twenty participants (14%) experienced a switch during the study period (hypomania, N=17; severe hypomania, N=3). Switch rates did not differ among the three treatment groups, even after accounting for dropout. No patient had a manic switch or was hospitalized for a switch. Most switches occurred within the first 5 weeks of treatment. The treatment response rate for the overall sample was 62.7% (N=89), without significant differences between groups after accounting for dropout. The lithium/sertraline combination group had a significantly higher overall dropout rate than the monotherapy groups but did not have an accelerated time to response. Lithium monotherapy, sertraline monotherapy, and lithium/sertraline combination therapy were associated with similar switch and treatment response rates in participants with bipolar II depression. The dropout rate was higher in the lithium/sertraline combination treatment group, without any treatment acceleration advantage.

Randomness increases self-reported anxiety and neurophysiological correlates of performance monitoring

PubMed Central

Kay, Aaron C.; Inzlicht, Michael

2015-01-01

Several prominent theories spanning clinical, social and developmental psychology suggest that people are motivated to see the world as a sensible orderly place. These theories presuppose that randomness is aversive because it is associated with unpredictability. If this is the case, thinking that the world is random should lead to increased anxiety and heightened monitoring of one’s actions and their consequences. Here, we conduct experimental tests of both of these ideas. Participants read one of three passages: (i) comprehensible order, (ii) incomprehensible order and (iii) randomness. In Study 1, we examined the effects of these passages on self-reported anxiety. In Study 2, we examined the effects of the same manipulation on the error-related negativity (ERN), an event-related brain potential associated with performance monitoring. We found that messages about randomness increased self-reported anxiety and ERN amplitude relative to comprehensible order, whereas incomprehensible order had intermediate effects. These results lend support to the theoretically important idea that randomness is unsettling because it implies that the world is unpredictable. PMID:25062840

Treatment effects of fixed functional appliances in patients with Class II malocclusion: a systematic review and meta-analysis

PubMed Central

Zymperdikas, Vasileios F.; Koretsi, Vasiliki; Papageorgiou, Spyridon N.

2016-01-01

Summary Objective: To assess the treatment effects of fixed functional appliances (FFAs) in treated versus untreated Class II patients by means of lateral cephalometric radiographs. Search methods: Unrestricted electronic search of 18 databases and additional manual searches up to October 2014. Selection criteria: Prospective randomized and non-randomized controlled trials reporting on cephalometric angular measurements of Class II patients treated with FFAs and their matched untreated controls. Data collection and analysis: Skeletal, dental, and soft tissue cephalometric data were annualized and stratified according to the time of evaluation in effects. Following risk of bias evaluation, the mean differences (MDs) and 95 % confidence intervals (CIs) were calculated with random-effects models. Patient- and appliance-related subgroup analyses and sensitivity analyses were performed with mixed-effects models. Results: Nine studies were included (244 patients; mean age: 13.5 years and 174 untreated controls; mean age: 12.8 years) reporting on cephalometric effects directly after the removal of FFAs. FFAs were found to induce a small reduction of SNA angle (MD = −0.83 degree/year, 95 % CI: −1.17 to −0.48), a small increase of SNB angle (MD = 0.87 degree/year, 95 % CI: 0.30–1.43), and moderate decrease of ANB angle (MD = −1.74 degree/year, 95 % CI: −2.50 to −0.98) compared to untreated Class II patients. FFA treatment resulted in significant dentoalveolar and soft tissue changes. Several patient- or appliance-related factors seem to affect the treatment outcome. Long-term effectiveness of FFAs could not be assessed due to limited evidence. Conclusions: According to existing evidence, FFAs seem to be effective in improving Class II malocclusion in the short term, although their effects seem to be mainly dentoalveolar rather than skeletal. PMID:25995359

A randomized adaptive phase II/III study of buparlisib, a pan-class I PI3K inhibitor, combined with paclitaxel for the treatment of HER2- advanced breast cancer (BELLE-4).

PubMed

Martín, M; Chan, A; Dirix, L; O'Shaughnessy, J; Hegg, R; Manikhas, A; Shtivelband, M; Krivorotko, P; Batista López, N; Campone, M; Ruiz Borrego, M; Khan, Q J; Beck, J T; Ramos Vázquez, M; Urban, P; Goteti, S; Di Tomaso, E; Massacesi, C; Delaloge, S

2017-02-01

Phosphatidylinositol 3-kinase (PI3K) pathway activation in preclinical models of breast cancer is associated with tumor growth and resistance to anticancer therapies, including paclitaxel. Effects of the pan-Class I PI3K inhibitor buparlisib (BKM120) appear synergistic with paclitaxel in preclinical and clinical models. BELLE-4 was a 1:1 randomized, double-blind, placebo-controlled, adaptive phase II/III study investigating the combination of buparlisib or placebo with paclitaxel in women with human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer with no prior chemotherapy for advanced disease. Patients were stratified by PI3K pathway activation and hormone receptor status. The primary endpoint was progression-free survival (PFS) in the full and PI3K pathway-activated populations. An adaptive interim analysis was planned following the phase II part of the study, after ≥125 PFS events had occurred in the full population, to decide whether the study would enter phase III (in the full or PI3K pathway-activated population) or be stopped for futility. As of August 2014, 416 patients were randomized to receive buparlisib (207) or placebo (209) with paclitaxel. At adaptive interim analysis, there was no improvement in PFS with buparlisib versus placebo in the full (median PFS 8.0 versus 9.2 months, hazard ratio [HR] 1.18), or PI3K pathway-activated population (median PFS 9.1 versus 9.2 months, HR 1.17). The study met protocol-specified criteria for futility in both populations, and phase III was not initiated. Median duration of study treatment exposure was 3.5 months in the buparlisib arm versus 4.6 months in the placebo arm. The most frequent adverse events with buparlisib plus paclitaxel (≥40% of patients) were diarrhea, alopecia, rash, nausea, and hyperglycemia. Addition of buparlisib to paclitaxel did not improve PFS in the full or PI3K pathway-activated study population. Consequently, the trial was stopped for futility at the end of phase II. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Effect of Baseline Nutritional Status on Long-term Multivitamin Use and Cardiovascular Disease Risk

PubMed Central

Rautiainen, Susanne; Gaziano, J. Michael; Christen, William G.; Bubes, Vadim; Kotler, Gregory; Glynn, Robert J.; Manson, JoAnn E.; Buring, Julie E.

2017-01-01

Importance Long-term multivitamin use had no effect on risk of cardiovascular disease (CVD) in the Physicians’ Health Study II. Baseline nutritional status may have modified the lack of effect. Objective To investigate effect modification by various baseline dietary factors on CVD risk in the Physicians’ Health Study II. Design, Setting, and Participants The Physicians’ Health Study II was a randomized, double-blind, placebo-controlled trial testing multivitamin use (multivitamin [Centrum Silver] or placebo daily) among US male physicians. The Physicians’ Health Study II included 14 641 male physicians 50 years or older, 13 316 of whom (91.0%) completed a baseline 116-item semiquantitative food frequency questionnaire and were included in the analyses. This study examined effect modification by baseline intake of key foods, individual nutrients, dietary patterns (Alternate Healthy Eating Index and Alternate Mediterranean Diet Score), and dietary supplement use. The study began in 1997, with continued treatment and follow-up through June 1, 2011. Interventions Multivitamin or placebo daily. Main Outcomes and Measures Major cardiovascular events, including nonfatal myocardial infarction, nonfatal stroke, and CVD mortality. Secondary outcomes included myocardial infarction, total stroke, CVD mortality, and total mortality individually. Results In total, 13 316 male physicians (mean [SD] age at randomization, 64.0 [9.0] years in those receiving the active multivitamin and 64.0 [9.1] years in those receiving the placebo) were observed for a mean (SD) follow-up of 11.4 (2.3) years. There was no consistent evidence of effect modification by various foods, nutrients, dietary patterns, or baseline supplement use on the effect of multivitamin use on CVD end points. Statistically significant interaction effects were observed between multivitamin use and vitamin B6 intake on myocardial infarction, between multivitamin use and vitamin D intake on CVD mortality, and between multivitamin use and vitamin B12 intake on CVD mortality and total mortality. However, there were inconsistent patterns in hazard ratios across tertiles of each dietary factor that are likely explained by multiple testing. Conclusions and Relevance The results suggest that baseline nutritional status does not influence the effect of randomized long-term multivitamin use on major CVD events. Future studies are needed to investigate the role of baseline nutritional biomarkers on the effect of multivitamin use on CVD and other outcomes. Trial Registration clinicaltrials.gov Identifier: NCT00270647 PMID:28384735

A randomized 10-year prospective follow-up of Class II nanohybrid and conventional hybrid resin composite restorations.

PubMed

van Dijken, Jan W V; Pallesen, Ulla

2014-12-01

To evaluate the 10-year durability of a nanohybrid resin composite in Class II restorations in a randomized controlled intraindividual comparison with its conventional hybrid resin composite predecessor. Each of 52 participants received at least two Class II restorations that were as similar as possible. The cavities were chosen at random to be restored with a nanohybrid resin composite (Excite/Tetric EvoCeram (TEC); n=61) and a conventional hybrid (Excite/Tetric Ceram (TC); n=61). The restorations were evaluated with slightly modified USPHS criteria at baseline and then annually for 10 years. The overall performance of the experimental restorations was tested after intra-individual comparison and their ranking was tested using Friedman's two-way ANOVA. The level of significance was set at 5%. Four patient drop-outs with 8 restorations (4TEC, 4TC) were registered during the follow-up. A prediction of the caries risk showed that 16 of the evaluated 52 patients were considered as high risk patients. In total, 22 restorations, 11 TEC (3 premolars, 8 molars) and 11 TC (3 premolars, 8 molars) restorations failed during the 10 years. The main reason for failure was secondary caries (50%). 63% of the recurrent caries lesions were found in high caries risk participants. The overall success rate at 10 years was 80.7%, with an annual failure rate of 1.9%. No statistically significant difference was found in the overall survival rate between the two investigated resin composites. The nanohybrid and the conventional hybrid resin composite showed good clinical effectiveness in extensive Class II restorations during the 10-year study.

A Phase II/III randomized controlled trial comparing perioperative versus postoperative chemotherapy with mFOLFOX6 for lower rectal cancer with suspected lateral pelvic node metastasis: Japan Clinical Oncology Group Study JCOG1310 (PRECIOUS study).

PubMed

Ohue, Masayuki; Iwasa, Satoru; Kanemitsu, Yukihide; Hamaguchi, Tetsuya; Shiozawa, Manabu; Ito, Masaaki; Yasui, Masayoshi; Katayama, Hiroshi; Mizusawa, Junki; Shimada, Yasuhiro

2017-01-01

A randomized phase II/III trial was started in May 2015 comparing perioperative versus postoperative chemotherapy with modified infusional fluorouracil and folinic acid with oxaliplatin for lower rectal cancer patients with suspected lateral pelvic node metastasis. The standard arm is total mesorectal excision or tumor-specific mesorectal excision with lateral pelvic node dissection (LND) followed by postoperative chemotherapy (modified infusional fluorouracil and folinic acid with oxaliplatin; 12 cycles). The experimental (perioperative chemotherapy) arm is six courses of modified infusional fluorouracil and folinic acid with oxaliplatin before and six courses after total mesorectal excision with lateral pelvic node dissection. The aim of this trial is to confirm the superiority of perioperative chemotherapy. A total of 330 patients will be enrolled over 7 years. The primary endpoint in Phase II part is proportion of R0 resection and that in Phase III part is overall survival. Secondary endpoints are progression-free survival, local progression-free survival, etc. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000017603 [http://www.umin.ac.jp/ctr/index-j.htm]. © The Author 2016. Published by Oxford University Press.

Endoscopic ultrasound cytologic brushing vs endoscopic ultrasound: fine needle aspiration for cytological diagnosis of cystic pancreatic lesions. A multicenter, randomized open-label trial.

PubMed

Lariño-Noia, José; de la Iglesia, Daniel; Iglesias-García, Julio; Macías, Manuel; López Martín, Aurelio; Legaz, María Luisa; Vila, Juan; Reyes, Antonio; Abdulkader, Ihab; Domínguez-Muñoz, J Enrique

2018-04-24

the incidence of cystic pancreatic lesions (CPL) in the asymptomatic population is increasing. Achieving a preoperative diagnosis of CPL still remains a challenge. to evaluate the diagnostic accuracy of the cytological diagnosis of CPL from samples obtained by cytology brush versus standard endoscopic ultrasound fine needle aspiration (EUS-FNA). a multicenter, randomized, open-label trial was performed of EUS-cytology brush (EUS-EB) versus EUS-FNA for the cytological diagnosis of CPL. Patients that underwent EUS-FNA with a CPL > 15 mm were included and randomized into two groups: group I, EUS-EB; group II, EUS-FNA. The final diagnosis was based on the histological evaluation of surgical specimens and clinical parameters, imaging and a five year follow-up in non-operated patients. The main outcome was the diagnostic accuracy of both methods. Secondary outcomes were the diagnostic adequacy of specimens and the rate of adverse events. Data were compared using the Chi-squared test. An intention to treat (ITT) and per-protocol (PP) analysis were performed. sixty-five patients were included in the study, 31 in group I and 34 in group II. Three patients initially randomized to group I were changed to group II as it was impossible to obtain a sample using the brush. The mean size of the CPL was 28.2 mm (range 16-60 mm). The diagnostic accuracy of EUS-EB was not superior to EUS-FNA, neither in the ITT nor the PP analysis (44.8% vs 41.1%, p = 0.77 and 38.4% vs 45.9%, p = 0.55). EUS-EB does not improve the diagnostic accuracy of CPL in comparison with EUS-FNA.

Belatacept-based immunosuppression in de novo liver transplant recipients: 1-year experience from a phase II randomized study.

PubMed

Klintmalm, G B; Feng, S; Lake, J R; Vargas, H E; Wekerle, T; Agnes, S; Brown, K A; Nashan, B; Rostaing, L; Meadows-Shropshire, S; Agarwal, M; Harler, M B; Garcia-Valdecasas, J-C

2014-08-01

This exploratory phase II study evaluated the safety and efficacy of belatacept in de novo adult liver transplant recipients. Patients were randomized (N = 260) to one of the following immunosuppressive regimens: (i) basiliximab + belatacept high dose [HD] + mycophenolate mofetil (MMF), (ii) belatacept HD + MMF, (iii) belatacept low dose [LD] + MMF, (iv) tacrolimus + MMF, or (v) tacrolimus alone. All received corticosteroids. Demographic characteristics were similar among groups. The proportion of patients who met the primary end point (composite of acute rejection, graft loss, death by month 6) was higher in the belatacept groups (42–48%) versus tacrolimus groups (15–38%), with the highest number of deaths and grafts losses in the belatacept LD group. By month 12, the proportion surviving with a functioning graft was higher with tacrolimus + MMF (93%) and lower with belatacept LD (67%) versus other groups (90%: basiliximab + belatacept HD; 83%: belatacept HD; 88%: tacrolimus). Mean calculated GFR was 15–34 mL/min higher in belatacept-treated patients at 1 year. Two cases of posttransplant lymphoproliferative disease and one case of progressive multifocal leukoencephalopathy occurred in belatacept-treated patients. Follow-up beyond month 12 revealed an increase in death and graft loss in another belatacept group (belatacept HD), after which the study was terminated.

Surgical reconstruction of ruptured anterior cruciate ligament prolongs trauma-induced increase of inflammatory cytokines in synovial fluid: an exploratory analysis in the KANON trial.

PubMed

Larsson, S; Struglics, A; Lohmander, L S; Frobell, R

2017-09-01

Prospectively monitor how treatment of acutely ruptured anterior cruciate ligament (ACL) affects biomarkers of inflammation and proteolytic degradation over 5 years. We studied 119 subjects with acute ACL injury from the randomized controlled knee anterior cruciate ligament, non-surgical versus surgical treatment (KANON)-trial (Clinical trial ISRCTN 84752559) who had synovial fluid, serum and urine samples available from at least two out of six visits over 5 years after acute ACL rupture. All subjects followed a similar rehabilitation protocol where, according to randomization, 60 also had early ACL reconstruction and 59 had the option to undergo a delayed ACL reconstruction if needed. Interleukin (IL)-6, IL-8, IL-10, interferon-gamma (IFNγ), tumor necrosis factor (TNF), amino acids alanine, arginine, glycine, serine (ARGS)-aggrecan, C-terminal crosslinking telopeptide type II collagen (CTX-II) and N-terminal crosslinking telopeptide type I collagen (NTX-I) were quantified by enzyme-linked immunosorbent assays (ELISA). Subjects randomized to early ACL reconstruction had higher cytokine concentrations in index knee synovial fluid at 4 months (IL-6, IL-8, IL-10, TNF), 8 months (IL-6 and TNF) and at 5 years (IFNγ) compared to those randomized to optional delayed reconstruction. Those that underwent delayed ACL reconstruction within 5 years (30 subjects), had higher synovial fluid concentrations of IL-6 at 5 years compared to those treated with rehabilitation alone. No differences between groups were noted for ARGS-aggrecan in synovial fluid and serum or CTX-II and NTX-I in urine over 5 years, neither as randomized nor as treated. Surgical ACL reconstruction constitutes a second trauma to the acutely injured joint resulting in a prolonged elevation of already high synovial fluid levels of inflammatory cytokines. Copyright © 2017 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

An evaluation of efficacy of balloon inflation on venous cannulation pain in children: a prospective, randomized, controlled study.

PubMed

Gupta, Devendra; Agarwal, Anil; Dhiraaj, Sanjay; Tandon, Manish; Kumar, Mukesh; Singh, Ravi Shankar; Singh, Prabhat K; Singh, Uttam

2006-05-01

Venipuncture is the most common painful event for a hospitalized child. We evaluated the efficacy of balloon inflation for attenuating venipuncture pain in children. Seventy-five pediatric patients aged 6-12 yr, ASA physical status I-II, of either sex, undergoing elective surgery were included in this prospective and randomized study. Patients were randomly divided into 3 equal groups of 25 each; Group I (control), Group II (distraction) pressed a rubber ball, and Group III (balloon) inflated a balloon. A manual venous occlusion was applied on the forearm and venipuncture was performed with a 22-gauge venous cannula. Pain was self-reported by a pain face scale with a 10-cm visual analog scale (VAS) placed at its back, where 0 = "no pain" and 10 = "worst imaginable pain." VAS scores of 1-3 were rated as mild, 4-6 as moderate, and >6 as severe. Median (interquartile range) VAS score in the balloon group was 1 (3), which was reduced as compared with 2 (2) and 4 (2) observed in the distraction and control groups, respectively (P < 0.000). Significant reduction in the incidence and severity of venipuncture pain was also observed in the balloon group compared with the other 2 groups (P < 0.05).

Depressor and Anti-Inflammatory Effects of Angiotensin II Receptor Blockers in Metabolic and/or Hypertensive Patients With Coronary Artery Disease: A Randomized, Prospective Study (DIAMOND Study)

PubMed Central

Adachi, Sen; Miura, Shin-ichiro; Shiga, Yuhei; Arimura, Tadaaki; Kuwano, Takashi; Kitajima, Ken; Ike, Amane; Sugihara, Makoto; Iwata, Atsushi; Nishikawa, Hiroaki; Morito, Natsumi; Saku, Keijiro

2016-01-01

Background We compared the efficacy and safety of azilsartan to those of olmesartan in a prospective, randomized clinical trial. Methods Forty-four hypertensive patients who had coronary artery disease (CAD) were enrolled. We randomly assigned patients to changeover from their prior angiotensin II receptor blockers (ARBs) to either azilsartan or olmesartan, and followed the patients for 12 weeks. Results Office systolic blood pressure (SBP) in the azilsartan group was significantly decreased after 12 weeks. SBP and diastolic blood pressure (DBP) after 12 weeks in the azilsartan group were significantly lower than those in the olmesartan group. The percentage of patients who reached the target BP at 12 weeks (78%) in the azilsartan group was significantly higher than that at 12 weeks (45%) in the olmesartan group. There were no significant changes in pentraxin-3, high-sensitively C-reactive protein or adiponectin in blood after 12 weeks in either group. Although serum levels of creatinine (Cr) in the azilsartan group significantly increased, these changes were within the respective normal range. Conclusion In conclusion, the ability of azilsartan to reduce BP may be superior to that of prior ARBs with equivalent safety in hypertensive patients with CAD. PMID:27635180

Microdose GnRH Agonist Flare-Up versus Ultrashort GnRH Agonist Combined with Fixed GnRH Antagonist in Poor Responders of Assisted Reproductive Techniques Cycles.

PubMed

Eftekhar, Maryam; Mohammadian, Farnaz; Yousefnejad, Fariba; Khani, Parisa

2013-01-01

This study compares the microdose flare-up protocol to the ultrashort gonadotropinreleasing hormone (GnRH) agonist flare combined with the fixed multidose GnRH antagonist protocol in poor responders undergoing ovarian stimulation. In this randomized clinical trial, 120 women who were candidates for assisted reproductive techniques (ART) and had histories of one or more failed in vitro fertilization (IVF) cycles with three or fewer retrieved oocytes were prospectively randomized into two groups. Group I (60 patients) received the microdose flare-up regimen and group II (60 patients) received the ultrashort GnRH agonist combined with fixed GnRH antagonist. There were no significant differences between the groups in the number of used gonadotropin ampoules (p=0.591), duration of stimulation (p=0.610), number of retrieved oocytes (p=0.802), fertilization rate (p=0.456), and the number of transferred embryos (p=0.954). The clinical pregnancy rates were statistically similar in group I (10%) compared with group II (13.3%, p=0.389). According to our results, there is no significant difference between these protocols for improving the ART outcome in poor responders. Additional prospective, randomized studies with more patients is necessary to determine the best protocol (Registration Number: IRCT201105096420N1).

Evaluation of rotigotine transdermal patch for the treatment of depressive symptoms in patients with Parkinson's disease.

PubMed

Chung, Sun Ju; Asgharnejad, Mahnaz; Bauer, Lars; Ramirez, Francisco; Jeon, Beomseok

2016-08-01

To evaluate the dopamine receptor agonist, rotigotine, for improving depressive symptoms in patients with Parkinson's disease (PD). Patients were randomized 1:1 to rotigotine or placebo, titrated for ≤7 weeks, and maintained at optimal/maximum dose for 8-weeks. Primary efficacy variable: 17- item Hamilton Depression Rating Scale (HAM-D 17) total score change from baseline to end-of-maintenance. Secondary variables: changes in Beck Depression Inventory-II, Unified Parkinson's Disease Rating Scale (UPDRS) II (activities of daily living [ADL]) and III (motor) subscores, UPDRS II+III total, patient-rated Apathy Scale (AS), and Snaith-Hamilton Pleasure Scale. Of 380 patients randomized, 149/184 (81.0%) rotigotine-treated and 164/196 (83.7%) placebo-treated patients completed the study. mean (±SD) age 65.2 (±8.5) years; time since PD-diagnosis 2.74 (±3.08) years; 42.6% male. The treatment difference (LS mean [95% CI]) in change from baseline HAM-D 17 was -1.12 (-2.56, 0.33; p = 0.1286). UPDRS II, III, II+III and AS scores improved numerically with rotigotine versus placebo. Common adverse events with higher incidence with rotigotine: nausea, application/instillation site reactions, vomiting, and pruritus. Forty-one (10.8%) patients discontinued owing to adverse events (25 rotigotine/16 placebo). No statistically significant improvement in depressive symptoms were observed with rotigotine versus placebo. ADL, motor function, and patient-rated apathy improved numerically. ClinicalTrials.gov: NCT01523301.

Guided Imagery and Relaxation for Women with Early Stage Breast Cancer

ERIC Educational Resources Information Center

Goodwin, Linda K.; Lee, Sang Min; Puig, Ana I.; Sherrard, Peter A. D.

2005-01-01

Fifty-two women with Stage I and Stage II breast cancer agreed to participate in a study to determine the effectiveness of two interventions, guided imagery and relaxation, to enhance psychological well-being. Participants were randomly assigned to either a guided imagery or relaxation group. Forty women completed the study. A student's t-test was…

Unbiased quantitative testing of conventional orthodontic beliefs.

PubMed

Baumrind, S

1998-03-01

This study used a preexisting database to test in hypothesis from the appropriateness of some common orthodontic beliefs concerning upper first molar displacement and changes in facial morphology associated with conventional full bonded/banded treatment in growing subjects. In an initial pass, the author used data from a stratified random sample of 48 subjects drawn retrospectively from the practice of a single, experienced orthodontist. This sample consisted of 4 subgroups of 12 subjects each: Class I nonextraction, Class I extraction, Class II nonextraction, and Class II extraction. The findings indicate that, relative to the facial profile, chin point did not, on average, displace anteriorly during treatment, either overall or in any subgroup. Relative to the facial profile, Point A became significantly less prominent during treatment, both overall and in each subgroup. The best estimate of the mean displacement of the upper molar cusp relative to superimposition on Anterior Cranial Base was in the mesial direction in each of the four subgroups. In only one extraction subject out of 24 did the cusp appear to be displaced distally. Mesial molar cusp displacement was significantly greater in the Class II extraction subgroup than in the Class II nonextraction subgroup. Relative to superimposition on anatomical "best fit" of maxillary structures, the findings for molar cusp displacement were similar, but even more dramatic. Mean mesial migration was highly significant in both the Class II nonextraction and Class II extraction subgroups. In no subject in the entire sample was distal displacement noted relative to this superimposition. Mean increase in anterior Total Face Height was significantly greater in the Class II extraction subgroup than in the Class II nonextraction subgroup. (This finding was contrary to the author's original expectation.) The generalizability of the findings from the initial pass to other treated growing subjects was then assessed by retesting modified hypotheses against a second database stored sample that earlier had been drawn randomly from two other orthodontic practices. The implications of the author's study strategy to the design of future shared digital databases is discussed briefly.

Spatial versus sequential correlations for random access coding

NASA Astrophysics Data System (ADS)

Tavakoli, Armin; Marques, Breno; Pawłowski, Marcin; Bourennane, Mohamed

2016-03-01

Random access codes are important for a wide range of applications in quantum information. However, their implementation with quantum theory can be made in two very different ways: (i) by distributing data with strong spatial correlations violating a Bell inequality or (ii) using quantum communication channels to create stronger-than-classical sequential correlations between state preparation and measurement outcome. Here we study this duality of the quantum realization. We present a family of Bell inequalities tailored to the task at hand and study their quantum violations. Remarkably, we show that the use of spatial and sequential quantum correlations imposes different limitations on the performance of quantum random access codes: Sequential correlations can outperform spatial correlations. We discuss the physics behind the observed discrepancy between spatial and sequential quantum correlations.

A randomized phase II study comparing paclitaxel-carboplatin-bevacizumab with or without nitroglycerin patches in patients with stage IV nonsquamous nonsmall-cell lung cancer: NVALT12 (NCT01171170)†.

PubMed

Dingemans, A-M C; Groen, H J M; Herder, G J M; Stigt, J A; Smit, E F; Bahce, I; Burgers, J A; van den Borne, B E E M; Biesma, B; Vincent, A; van der Noort, V; Aerts, J G

2015-11-01

Nitroglycerin (NTG) increases tumor blood flow and oxygenation by inhibiting hypoxia-inducible-factor (HIF)-1. A randomized phase II study has shown improved outcome when NTG patches were added to vinorelbine/cisplatin in patients with advanced nonsmall-cell lung cancer (NSCLC). In addition, there is evidence that the combination of bevacizumab and HIF-1 inhibitors increases antitumor activity. In this randomized phase II trial, chemo-naive patients with stage IV nonsquamous NSCLC were randomized to four cycles of carboplatin (area under the curve 6)-paclitaxel (200 mg/m(2))-bevacizumab 15 mg/kg on day 1 every 3 weeks with or without NTG patches 15 mg (day -2 to +2) followed by bevacizumab with or without NTG until progression. Response was assessed every two cycles. Primary end point was progression-free survival (PFS). The study was powered (80%) to detect a decrease in the hazard of tumor progression of 33% at α = 0.05 with a two-sided log-rank test when 222 patients were enrolled and followed until 195 events were observed. Between 1 January 2011 and 1 January 2013, a total of 223 patients were randomized; 112 control arm and 111 experimental arm; response rate was 54% in control arm and 38% in experimental arm. Median [95% confidence interval (CI)] PFS in control arm was 6.8 months (5.6-7.3) and 5.1 months (4.2-5.8) in experimental arm, hazard ratio (HR) 1.27 (95% CI 0.96-1.67). Overall survival (OS) was 11.6 months (8.8-13.6) in control arm and 9.4 months (7.8-11.3) in experimental arm, HR 1.02 (95% CI 0.71-1.46). In the experimental arm, no additional toxicity was observed except headache (6% versus 52% in patients treated with NTG). Adding NTG to first-line carboplatin-paclitaxel-bevacizumab did not improve PFS and OS in patients with stage IV nonsquamous NSCLC. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

A phase II randomized trial of Observation versus stereotactic ablative RadiatIon for OLigometastatic prostate CancEr (ORIOLE).

PubMed

Radwan, Noura; Phillips, Ryan; Ross, Ashley; Rowe, Steven P; Gorin, Michael A; Antonarakis, Emmanuel S; Deville, Curtiland; Greco, Stephen; Denmeade, Samuel; Paller, Channing; Song, Daniel Y; Diehn, Maximilian; Wang, Hao; Carducci, Michael; Pienta, Kenneth J; Pomper, Martin G; DeWeese, Theodore L; Dicker, Adam; Eisenberger, Mario; Tran, Phuoc T

2017-06-29

We describe a randomized, non-blinded Phase II interventional study to assess the safety and efficacy of stereotactic ablative radiotherapy (SABR) for hormone-sensitive oligometastatic prostate adenocarcinoma, and to describe the biology of the oligometastatic state using immunologic, cellular, molecular, and functional imaging correlates. 54 men with oligometastatic prostate adenocarcinoma will be accrued. The primary clinical endpoint will be progression at 6 months from randomization with the hypothesis that SABR to all metastases will forestall progression by disrupting the metastatic process. Secondary clinical endpoints will include local control at 6 months post-SABR, toxicity and quality of life, and androgen deprivation therapy (ADT)-free survival (ADT-FS). Further fundamental analysis of the oligometastatic state with be achieved through correlation with investigational 18 F-DCFPyL PET/CT imaging and measurement of circulating tumor cells, circulating tumor DNA, and circulating T-cell receptor repertoires, facilitating an unprecedented opportunity to characterize, in isolation, the effects of SABR on the dynamics of and immunologic response to oligometastatic disease. Patients will be randomized 2:1 to SABR or observation with minimization to balance assignment by primary intervention, prior hormonal therapy, and PSA doubling time. Progression after 6 months will be compared using Fisher's exact test. Hazard ratios and Kaplan-Meier estimates of progression free survival (PFS), ADT free survival (ADT-FS), time to locoregional progression (TTLP) and time to distant progression (TTDP) will be calculated based on an intention-to-treat. Local control will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Withdrawal from the study prior to 6 months will be counted as progression. Adverse events will be summarized by type and grade. Quality of life pre- and post- SABR will be measured by Brief Pain Inventory. The ORIOLE trial is the first randomized, non-blinded Phase II interventional study in the North America evaluating the safety and efficacy of SABR in oligometastatic hormone-sensitive prostate cancer. Leading-edge laboratory and imaging correlates will provide unique insight into the effects of SABR on the oligometastatic state. ClinicalTrials.gov Identifier: NCT02680587. URL of Registry: https://clinicaltrials.gov/show/NCT02680587 Date of Registration: 02/08/2016. Date of First Participant Enrollment: 05/23/2016.

Community-based implementation and effectiveness in a randomized trial of a risk reduction intervention for HIV-serodiscordant couples: study protocol

PubMed Central

2014-01-01

Background The HIV/AIDS epidemic continues to disproportionately affect African American communities in the US, particularly those located in urban areas. Despite the fact that HIV is often transmitted from one sexual partner to another, most HIV prevention interventions have focused only on individuals, rather than couples. This five-year study investigates community-based implementation, effectiveness, and sustainability of ‘Eban II,’ an evidence-based risk reduction intervention for African-American heterosexual, serodiscordant couples. Methods/design This hybrid implementation/effectiveness implementation study is guided by organizational change theory as conceptualized in the Texas Christian University Program Change Model (PCM), a model of phased organizational change from exposure to adoption, implementation, and sustainability. The primary implementation aims are to assist 10 community-based organizations (CBOs) to implement and sustain Eban II; specifically, to partner with CBOs to expose providers to the intervention; facilitate its adoption, implementation and sustainment; and to evaluate processes and determinants of implementation, effectiveness, fidelity, and sustainment. The primary effectiveness aim is to evaluate the effect of Eban II on participant (n = 200 couples) outcomes, specifically incidents of protected sex and proportion of condom use. We will also determine the cost-effectiveness of implementation, as measured by implementation costs and potential cost savings. A mixed methods evaluation will examine implementation at the agency level; staff members from the CBOs will complete baseline measures of organizational context and climate, while key stakeholders will be interviewed periodically throughout implementation. Effectiveness of Eban II will be assessed using a randomized delayed enrollment (waitlist) control design to evaluate the impact of treatment on outcomes at posttest and three-month follow-up. Multi-level hierarchical modeling with a multi-level nested structure will be used to evaluate the effects of agency- and couples-level characteristics on couples-level outcomes (e.g., condom use). Discussion This study will produce important information regarding the value of the Eban II program and a theory-guided implementation process and tools designed for use in implementing Eban II and other evidence-based programs in demographically diverse, resource-constrained treatment settings. Trial registration NCT00644163 PMID:24950708

Community-based implementation and effectiveness in a randomized trial of a risk reduction intervention for HIV-serodiscordant couples: study protocol.

PubMed

Hamilton, Alison B; Mittman, Brian S; Williams, John K; Liu, Honghu H; Eccles, Alicia M; Hutchinson, Craig S; Wyatt, Gail E

2014-06-20

The HIV/AIDS epidemic continues to disproportionately affect African American communities in the US, particularly those located in urban areas. Despite the fact that HIV is often transmitted from one sexual partner to another, most HIV prevention interventions have focused only on individuals, rather than couples. This five-year study investigates community-based implementation, effectiveness, and sustainability of 'Eban II,' an evidence-based risk reduction intervention for African-American heterosexual, serodiscordant couples. This hybrid implementation/effectiveness implementation study is guided by organizational change theory as conceptualized in the Texas Christian University Program Change Model (PCM), a model of phased organizational change from exposure to adoption, implementation, and sustainability. The primary implementation aims are to assist 10 community-based organizations (CBOs) to implement and sustain Eban II; specifically, to partner with CBOs to expose providers to the intervention; facilitate its adoption, implementation and sustainment; and to evaluate processes and determinants of implementation, effectiveness, fidelity, and sustainment. The primary effectiveness aim is to evaluate the effect of Eban II on participant (n = 200 couples) outcomes, specifically incidents of protected sex and proportion of condom use. We will also determine the cost-effectiveness of implementation, as measured by implementation costs and potential cost savings. A mixed methods evaluation will examine implementation at the agency level; staff members from the CBOs will complete baseline measures of organizational context and climate, while key stakeholders will be interviewed periodically throughout implementation. Effectiveness of Eban II will be assessed using a randomized delayed enrollment (waitlist) control design to evaluate the impact of treatment on outcomes at posttest and three-month follow-up. Multi-level hierarchical modeling with a multi-level nested structure will be used to evaluate the effects of agency- and couples-level characteristics on couples-level outcomes (e.g., condom use). This study will produce important information regarding the value of the Eban II program and a theory-guided implementation process and tools designed for use in implementing Eban II and other evidence-based programs in demographically diverse, resource-constrained treatment settings. NCT00644163.

Multifamily psychoeducation for improvement of mental health among relatives of patients with major depressive disorder lasting more than one year: study protocol for a randomized controlled trial.

PubMed

Katsuki, Fujika; Takeuchi, Hiroshi; Watanabe, Norio; Shiraishi, Nao; Maeda, Tohru; Kubota, Yosuke; Suzuki, Masako; Yamada, Atsurou; Akechi, Tatsuo

2014-08-12

Major depressive disorder (MDD) is a long-lasting disorder with frequent relapses that have significant effects on the patient's family. Family psychoeducation is recognized as part of the optimal treatment for patients with psychotic disorder. A previous randomized controlled trial has found that family psychoeducation is effective in enhancing the treatment of MDD. Although MDD can easily become a chronic illness, there has been no intervention study on the families of patients with chronic depression. In the present study, we design a randomized controlled trial to examine the effectiveness of family psychoeducation in improving the mental health of relatives of patients with MDD lasting more than one year. Participants are patients with MDD lasting more than one year and their relatives. Individually randomized, parallel-group trial design will be employed. Participants will be allocated to one of two treatment conditions: relatives will receive (a) family psychoeducation (four, two-hour biweekly multifamily psychoeducation sessions) plus treatment-as-usual for the patient (consultation by physicians), or (b) counseling for the family (one counseling session from a nurse) plus treatment-as-usual for the patient. The primary outcome measure will be relatives' mental health as measured by K6 that was developed to screen for DSM-IV depressive and anxiety disorder. Additionally, the severity of depressive symptoms in patients measured by the Beck Depression Inventory-II (BDI-II) scale will be assessed. Data from the intention-to-treat sample will be analyzed 16 weeks after randomization. This is the first study to evaluate the effectiveness of family psychoeducation for relatives of patients with MDD lasting more than one year. If this type of intervention is effective, it could be a new method of rehabilitation for patients with MDD lasting more than one year. Clinical Trials.gov NCT01734291 (registration date: 18 October 2012).

Dietary intakes associated with successful weight loss and maintenance during the Weight Loss Maintenance Trial

PubMed Central

Champagne, Catherine M.; Broyles, Stephanie T; Moran, Laura D.; Cash, Katherine C.; Levy, Erma J.; Lin, Pao-Hwa; Batch, Bryan C.; Lien, Lillian F.; Funk, Kristine L.; Dalcin, Arlene; Loria, Catherine; Myers, Valerie H.

2011-01-01

Background Dietary components effective in weight maintenance efforts have not been adequately identified. Objective To determine impact of changes in dietary consumption on weight loss and maintenance during the Weight Loss Maintenance (WLM) clinical trial. Design WLM was a randomized controlled trial. Successful weight loss participants who completed Phase I of the trial and lost 4kg were randomized to one of three maintenance intervention arms in Phase II and followed for an additional 30 months. Participants/setting The multicenter trial was conducted from 2003–2007. This substudy included 828 successful weight loss participants. Methods Dietary Measures The Block Food Frequency Questionnaire (FFQ) was used to assess nutrient intake levels and food group servings. Carbohydrates, proteins, fats, dietary fiber and fruit/vegetable and dairy servings were utilized as predictor variables. Data collection The FFQ was collected on all participants at study entry (beginning of Phase I). Those randomized to Phase II completed the FFQ at three additional time points; randomization (beginning of Phase II), 12 and 30 months. Intervention The main intervention focused on long term maintenance of weight loss using the Dietary Approaches to Hypertension (DASH) diet. This substudy examined whether changes to specific dietary variables were associated with weight loss and maintenance. Statistical analyses performed Linear regression models that adjusted for change in total energy examined the relationship between changes in dietary intake and weight for each time period. Site, age, race, sex, and a race-sex interaction were included as covariates. Results Participants who substituted protein for fat lost, on average, 0.33 kg per 6-months during Phase I (p<0.0001) and 0.07 kg per 6-months during Phase II (p<0.0001) per 1% increase in protein. Increased intake of fruits and vegetables was associated with weight loss in Phases I and II: 0.29 kg per 6-months (p<0.0001) and 0.04 kg per 6-months (p=0.0062), respectively, per 1-serving increase. Substitution of carbohydrates for fat and protein for carbohydrates were associated with weight loss during both phases. Increasing dairy intake was associated with significant weight loss during Phase II (−0.17 kg per 6-months per 1-serving increase, p=0.0002), but not in Phase I. Dietary fiber revealed no significant findings. Conclusion Increasing fruits, vegetables, and low-fat dairy may help achieve weight loss and maintenance. PMID:22117658

The decline and fall of Type II error rates

Treesearch

Steve Verrill; Mark Durst

2005-01-01

For general linear models with normally distributed random errors, the probability of a Type II error decreases exponentially as a function of sample size. This potentially rapid decline reemphasizes the importance of performing power calculations.

Aspirin and Zileuton and Biomarker Expression in Nasal Tissue of Current Smokers | Division of Cancer Prevention

Cancer.gov

This randomized phase II trial studies the effects of aspirin and zileuton on genes related to tobacco use in current smokers. Aspirin and zileuton may interfere with genes related to tobacco use and may be useful in preventing lung cancer in current smokers. |

The Impact of a Topical Sexual Enhancement Cream on the Female Sexual Response and Its Relationship to Clitoral Blood Flow.

PubMed

Pelekanos, Michael; Stofman, Guy M; Niren, Neil

2016-12-13

The aim of this investigation was to determine, through two Investigational Review Board (IRB)-approved studies, if a new topical vasodilating cream (NTVC; Life Science Enhancement Corporation, Pittsburgh PA) could improve female sexual response. Study I subjectively evaluated sexual female response as accessed by a modification of the Female Intervention Efficacy Index (FIEI). FIEI was developed at the University of California as an immediate outcome measure of medical intervention to treat female sexual dysfunction.1 In Study II, 10 randomly selected positive responders from Study I were subsequently analyzed objectively with clitoral plethysmography in order to determine the effect of the NTVC and placebo on blood flow.2 RESULTS: In the subjective Study I (81 patients ranging in age from 18 to 63), a positive response trend for the NTVC was demonstrated compared to the placebo. In the objective Study II, 10 randomly selected patients who responded positive in Study I were objectively evaluated for response of increased blood flow in the clitoris after application of both the NTVC and placebo. The clitoral blood flow was shown to have increased with statistical significance for the NTVC in all 10 patients compared to the placebo, with the NTVC exhibiting an average 69% increase in clitoral blood flow. The female sexual response is complex. In the subjective Study I, the NTVC demonstrated positive trends for enhanced lubrication, genital sensation, intercourse, and overall sexual experience. In the objective Study II, 10 of the positive subjective responders from Study I were randomly selected to evaluate their response to the NTVC compared to the placebo. This was done via Doppler plethysmography (DP). All 10 patients demonstrated a statistically significant response rate for increase in clitoral blood flow using the NTVC compared to the placebo, with an average blood flow increase of 69%. This portion of the investigation demonstrates a significant positive end organ response to the NTVC. The positive subjective trends combined with the significant and substantial increase in clitoral blood flow may result in enhanced female sexual satisfaction.

[Subset analysis of preoperative lymphocyte ratio in stage II or III colorectal cancer patients treated with oral tegafur-uracil and protein-bound polysaccharide K].

PubMed

Totsuka, Osamu; Kawate, Susumu; Hirai, Keitaro; Ogawa, Hiroomi; Toya, Hiroyuki; Yoshinari, Daisuke; Sunose, Yutaka; Takeyoshi, Izumi

2013-12-01

We have reported, in a randomized, controlled study, that tegafur-uracil(UFT)and protein-bound polysaccharide K(PSK)combination therapy significantly improves the 5-year disease-free survival rate and reduces the risk of recurrence compared to UFT alone for Stage II or III colorectal cancer. In this study, we examined the efficacy of PSK by stratifying patients according to the preoperative lymphocyte ratio(Lym). In a randomized, controlled study, 205 patients were eligible(137 in the UFT/PSK group and 68 in the UFT group). Of these, 193 patients with available preoperative Lym data were analysed(131 in the UFT/PSK group and 62 in the UFT group). Among patients with a preoperative Lym of <35%, the relapse-free survival(RFS)rate was 76.5% in the UFT/PSK group and 55.8% in the UFT group(p=0.008). However, in patients with a preoperative Lym of ≥35%, the RFS rate did not differ between the 2 groups. Similarly, overall survival was significantly higher in the UFT/PSK group than in the UFT group in patients with a preoperative Lym of <35%, whereas no intergroup difference was found among patients with a preoperative Lym of ≥35%. This study suggests that a low preoperative Lym is a good predictor for response to PSK in patients with Stage II or III colorectal cancer.

Alveolar ridge augmentation by connective tissue grafting using a pouch method and modified connective tissue technique: A prospective study.

PubMed

Agarwal, Ashish; Gupta, Narinder Dev

2015-01-01

Localized alveolar ridge defect may create physiological and pathological problems. Developments in surgical techniques have made it simpler to change the configuration of a ridge to create a more aesthetic and more easily cleansable shape. The purpose of this study was to compare the efficacy of alveolar ridge augmentation using a subepithelial connective tissue graft in pouch and modified connective tissue graft technique. In this randomized, double blind, parallel and prospective study, 40 non-smoker individuals with 40 class III alveolar ridge defects in maxillary anterior were randomly divided in two groups. Group I received modified connective tissue graft, while group II were treated with subepithelial connective tissue graft in pouch technique. The defect size was measured in its horizontal and vertical dimension by utilizing a periodontal probe in a stone cast at base line, after 3 months, and 6 months post surgically. Analysis of variance and Bonferroni post-hoc test were used for statistical analysis. A two-tailed P < 0.05 was considered to be statistically significant. Mean values in horizontal width after 6 months were 4.70 ± 0.87 mm, and 4.05 ± 0.89 mm for group I and II, respectively. Regarding vertical heights, obtained mean values were 4.75 ± 0.97 mm and 3.70 ± 0.92 mm for group I and group II, respectively. Within the limitations of this study, connective tissue graft proposed significantly more improvement as compare to connective tissue graft in pouch.

Effect of Herbal and Fluoride Mouth Rinses on Streptococcus mutans and Dental Caries among 12–15-Year-Old School Children: A Randomized Controlled Trial

PubMed Central

Shenoy Panchmal, Ganesh; Kumar, Vijaya; Jodalli, Praveen S.; Sonde, Laxminarayan

2017-01-01

To assess and compare the effect of herbal and fluoride mouth rinses on Streptococcus mutans count and glucan synthesis by Streptococcus mutans and dental caries, a parallel group placebo controlled randomized trial was conducted among 240 schoolchildren (12–15 years old). Participants were randomly divided and allocated into Group I (0.2% fluoride group), Group II (herbal group), and Group III (placebo group). All received 10 ml of respective mouth rinses every fortnight for a period of one year. Intergroup and intragroup comparison were done for Streptococcus mutans count and glucan synthesis by Streptococcus mutans and dental caries. Streptococcus mutans count showed a statistically significant difference between Group I and Group III (p = 0.035) and also between Group II and Group III (p = 0.039). Glucan concentration levels showed a statistically significant difference (p = 0.024) between Group II and Group III at 12th month. Mean DMF scores showed no statistical difference between the three groups (p = 0.139). No difference in the level of significance was seen in the intention-to-treat and per-protocol analysis. The present study showed that both herbal and fluoride mouth rinses, when used fortnightly, were equally effective and could be recommended for use in school-based health education program to control dental caries. Trial registration number is CTRI/2015/08/006070. PMID:28352285

EEG, HRV and Psychological Correlates while Playing Bejeweled II: A Randomized Controlled Study.

PubMed

Russoniello, Carmen V; O'Brien, Kevin; Parks, Jennifer M

2009-01-01

Stress related medical disorders such as cardiovascular disease, diabetes, depression, and anxiety are serious medical issues that can cause disability and death. Interventions to prevent their development and exacerbation are needed. Casual video games (CVGs) are fun, easy to play, spontaneous and tremendously popular. People report that they play these games because they decrease their stress and improve their mood. This study tested this theory by comparing people playing Bejeweled II a popular CVG with control subjects measured under similar conditions. Electroencephalographic (EEG) changes after playing Bejeweled II were consistent with increased mood and corroborated with similar findings on psychological reports. Moreover, heart rate variability (HRV) changes consistent with autonomic nervous system relaxation or decreased physical stress were also recorded. It is concluded, therefore, that playing a CVG like Bejeweled II can increase mood and decrease stress. These finding have broad implications and include the potential development of prescriptive interventions using Bejeweled II to prevent and treat stress related medical disorders. Finally, these findings demonstrate a method using EEG, HRV and psychological correlates to understand the psychophysiological or cybernetic interconnection between participant and video game.

In vitro microleakage of glass-ionomer composite resin hybrid materials.

PubMed

Rodrigues, J A; De Magalhães, C S; Serra, M C; Rodrigues Júnior, A L

1999-01-01

The purpose of this study was to evaluate the microleakage of six glass-ionomer composite resin hybrid materials compared with a glass-ionomer cement and a composite resin. Standardized class 5 dentin cavities were prepared on root surfaces of 240 extracted human teeth that were randomly assigned to eight groups and restored using the following restorative systems: (I) Vitremer, (II) Compoglass, (III) Photac-Fil Aplicap, (IV) Variglass, (V) Dyract, (VI) Fuji II LC, (VII) Ketac-Fil Aplicap, and (VIII) Z100. The teeth were thermocycled, placed in a 2% methylene blue solution, and sectioned with diamond disks. Dye penetration was scored on a scale of 0-3. Results showed no significant differences among groups VIII, IV, I, V, VI, III, and II. There were also no significant differences among groups VI, III, II, and VII.

A Safety Run-in and Randomized Phase II Study of Cilengitide Combined with Chemoradiation for Newly Diagnosed Glioblastoma (NABTT 0306)

PubMed Central

Nabors, L. Burt; Mikkelsen, Tom; Hegi, Monika E.; Ye, Xiaubu; Batchelor, Tracy; Lesser, Glenn; Peereboom, David; Rosenfeld, Myrna R.; Olsen, Jeff; Brem, Steve; Fisher, Joy D.; Grossman, Stuart A.

2012-01-01

Background Cilengitide is a selective integrin inhibitor that is well tolerated and has demonstrated biological activity in patients with recurrent malignant glioma. The primary objectives of this randomized phase II trial were to determine safety and efficacy of cilengitide when combined with radiation and temozolomide for newly diagnosed glioblastoma (GBM) and to select a dose for comparative clinical testing. Methods A total of 112 patients were accrued. Eighteen patients received standard RT+TMZ with cilengitide in a safety run-in phase followed by a randomized phase II with ninety-four patients assigned to either 500 or 2000 mg dose groups. The trial was designed to estimate overall survival benefit when compared with the NABTT internal historical control or the published EORTC 26981 data. Results Cilengitide at all doses studied was well tolerated with radiation and temozolomide. The median survival was 19.7 months for all patients, 17.4 months for those receiving the 500 mg dose, 20.8 months for those receiving the 2000mg dose, 30 months for patients with methylated MGMT promoters and 17.4 months for unmethylated patients. For patients ages 70 and younger, the median survival and survival at 24 months was superior to that observed in the EORTC trial (20.7 months vs 14.6 months and 41% vs 27% (p=0.008) respectively). Conclusions Cilengitide is well tolerated when combined with standard chemoradiation and may improve survival for patients newly diagnosed with GBM regardless of MGMT status. From an efficacy and safety standpoint, future trials of this agent in this population should utilize the 2000 mg dose. PMID:22517399

Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. analysis and examples.

PubMed Central

Peto, R.; Pike, M. C.; Armitage, P.; Breslow, N. E.; Cox, D. R.; Howard, S. V.; Mantel, N.; McPherson, K.; Peto, J.; Smith, P. G.

1977-01-01

Part I of this report appeared in the previous issue (Br. J. Cancer (1976) 34,585), and discussed the design of randomized clinical trials. Part II now describes efficient methods of analysis of randomized clinical trials in which we wish to compare the duration of survival (or the time until some other untoward event first occurs) among different groups of patients. It is intended to enable physicians without statistical training either to analyse such data themselves using life tables, the logrank test and retrospective stratification, or, when such analyses are presented, to appreciate them more critically, but the discussion may also be of interest to statisticians who have not yet specialized in clinical trial analyses. PMID:831755

Fenoterol stimulates human erythropoietin production via activation of the renin angiotensin system

PubMed Central

Freudenthaler, S M; Schenck, T; Lucht, I; Gleiter, C H

1999-01-01

Aims The present study assessed the hypothesis that the β2 sympathomimetic fenoterol influences the production of erythropoietin (EPO) by activation of the renin angiotensin system (RAS), i.e. angiotensin II. Methods In an open, parallel, randomized study healthy volunteers received i.v. either placebo (electrolyte solution), fenoterol or fenoterol in combination with an oral dose of the AT1-receptor antagonist losartan. Results Compared with placebo treatment AUCEPO(0,24 h) was significantly increased after fenoterol application by 48% whereas no increase in the group receiving fenoterol and losartan could be detected. The rise of PRA was statistically significant under fenoterol and fenoterol plus lorsartan. Conclusions Stimulation of EPO production during fenoterol infusion appears to be angiotensin II-mediated. Thus, angiotensin II may be considered as one important physiological modulator of EPO production in humans. PMID:10583037

Fenoterol stimulates human erythropoietin production via activation of the renin angiotensin system.

PubMed

Freudenthaler, S M; Schenck, T; Lucht, I; Gleiter, C H

1999-10-01

The present study assessed the hypothesis that the beta2 sympathomimetic fenoterol influences the production of erythropoietin (EPO) by activation of the renin angiotensin system (RAS), i.e. angiotensin II. In an open, parallel, randomized study healthy volunteers received i.v. either placebo (electrolyte solution), fenoterol or fenoterol in combination with an oral dose of the AT1-receptor antagonist losartan. Compared with placebo treatment AUCEPO(0,24 h) was significantly increased after fenoterol application by 48% whereas no increase in the group receiving fenoterol and losartan could be detected. The rise of PRA was statistically significant under fenoterol and fenoterol plus lorsartan. Stimulation of EPO production during fenoterol infusion appears to be angiotensin II-mediated. Thus, angiotensin II may be considered as one important physiological modulator of EPO production in humans.

Statins as anti-arrhythmics: a systematic review part II: effects on risk of ventricular arrhythmias.

PubMed

Abuissa, Hussam; O'Keefe, James H; Bybee, Kevin A

2009-10-01

Recent studies have demonstrated that statins may possess anti-arrhythmic properties in addition to their lipid-lowering effects. Studies which reported the association of statins with the incidence of ventricular arrhythmias were identified through a systematic review of the published literature. Statins have been associated with a significant reductions in ventricular arrhythmia in cardiomyopathy patients with an implantable cardioverter defibrillator, although randomized trials have not been completed. Published data suggests that statins may possess anti-arrhythmic properties that reduce the propensity for ventricular arrhythmias. Most of this data is observational; more randomized, placebo-controlled trials are needed.

Effects of acepromazine on the incidence of vomiting associated with opioid administration in dogs.

PubMed

Valverde, Alexander; Cantwell, Shauna; Hernández, Jorge; Brotherson, Celeste

2004-01-01

To evaluate the anti-emetic properties of acepromazine in dogs receiving opioids as pre-anesthetic medication. Randomized prospective clinical study. One hundred and sixteen dogs (ASA I or II), admitted for elective surgical procedures. The dogs were a mixed population of males and females, purebreds and mixed breeds, 0.25-13.4 years of age, weighing 1.8-57.7 kg. A prospective clinical trial in which the dogs were randomly assigned to one of three groups. All groups received acepromazine (0.05 mg kg(-1) intramuscularly (i.m.)). Group I received acepromazine 15 minutes prior to opioid administration. Group II received acepromazine in combination with the opioid. Group III received acepromazine 15 minutes after opioid administration. One of three different opioids was administered i.m. to each dog: morphine sulfate at 0.5 mg kg(-1); hydromorphone hydrochloride at 0.1 mg kg(-1); or oxymorphone hydrochloride at 0.075 mg kg(-1). Dogs receiving acepromazine before the opioid (group I) had a significantly lower incidence of vomiting (18%) than dogs in groups II (45%) and III (55%). The degree of sedation was significantly lower in the dogs receiving the combination of acepromazine and the opioid (group II) than in dogs receiving the opioid as the first drug (group III). Acepromazine administered 15 minutes before the opioid lowers the incidence of vomiting induced by opioids.

A prospective, randomized therapeutic trial for schistosomal specific nephropathy.

PubMed

Sobh, M A; Moustafa, F E; Sally, S M; Foda, M A; Deelder, A M; Ghoneim, M A

1989-11-01

In this work 26 patients with schistosomal specific nephropathy were randomly distributed among three groups. Group I cases were given anti-schistosomal drugs (oxamniquine and praziquantel), group II cases were given anti-schistosomal drugs plus prednisolone, and group III cases were given anti-schistosomal drugs plus cyclosporine. The schistosomal specificity of kidney lesions was assessed by detecting the schistosomal specific antigens (CAA and CCA) and antibodies deposited in the renal glomeruli of these patients. Patients who had another etiologic cause which may explain their kidney disease were not admitted to this study. After initiation of the treatment, patients were followed up every other week in the outpatient clinic for 12 months. Follow-up showed complete remission of proteinuria in two cases in group II (duration of remission was 4 and 8 months) and in one case in group III (duration of remission was 6 months) but in none in group I. Partial remission was observed in one case in group I, in three cases in group II and in one case in group III. During the observation period, improvement in kidney function was observed in two cases in group II but deterioration in kidney function was observed in one case in group I and in one other case in group III. We conclude that in patients with schistosomal nephropathy, none of the tried therapeutic regimens produce regression of the disease if given to patients with established disease.

Child protection and adult depression: evaluating the long-term consequences of evacuating children to foster care during World War II.

PubMed

Santavirta, Nina; Santavirta, Torsten

2014-03-01

This paper combined data collected from war time government records with survey data including background characteristics, such as factors that affected eligibility, to examine the adult depression outcomes of individuals who were evacuated from Finland to temporary foster care in Sweden during World War II. Using war time government records and survey data for a random sample of 723 exposed individuals and 1321 matched unexposed individuals, the authors conducted least squares adjusted means comparison to examine the association between evacuation and adult depression (Beck Depression Inventory). The random sample was representative for the whole population of evacuees who returned to their biological families after World War II. The authors found no statistically significant difference in depressive symptoms during late adulthood between the two groups; for example, the exposed group had a 0.41 percentage points lower average Beck Depression Inventory score than the unexposed group (p = 0.907). This study provides no support for family disruption during early childhood because of the onset of sudden shocks elevating depressive symptoms during late adulthood. Copyright © 2013 John Wiley & Sons, Ltd.

Neutron Scattering Studies of Vortex Matter in Type-II Superconductors

DOE Office of Scientific and Technical Information (OSTI.GOV)

Xinsheng Ling

2012-02-02

The proposed program is an experimental study of the fundamental properties of Abrikosov vortex matter in type-II superconductors. Most superconducting materials used in applications such as MRI are type II and their transport properties are determined by the interplay between random pinning, interaction and thermal fluctuation effects in the vortex state. Given the technological importance of these materials, a fundamental understanding of the vortex matter is necessary. The vortex lines in type-II superconductors also form a useful model system for fundamental studies of a number of important issues in condensed matter physics, such as the presence of a symmetry-breaking phasemore » transition in the presence of random pinning. Recent advances in neutron scattering facilities such as the major upgrade of the NIST cold source and the Spallation Neutron Source are providing unprecedented opportunities in addressing some of the longstanding issues in vortex physics. The core component of the proposed program is to use small angle neutron scattering and Bitter decoration experiments to provide the most stringent test of the Bragg glass theory by measuring the structure factor in both the real and reciprocal spaces. The proposed experiments include a neutron reflectometry experiment to measure the precise Q-dependence of the structure factor of the vortex lattice in the Bragg glass state. A second set of SANS experiments will be on a shear-strained Nb single crystal for testing a recently proposed theory of the stability of Bragg glass. The objective is to artificially create a set of parallel grain boundaries into a Nb single crystal and use SANS to measure the vortex matter diffraction pattern as a function of the changing angle between the applied magnetic field to the grain boundaries. The intrinsic merits of the proposed work are a new fundamental understanding of type-II superconductors on which superconducting technology is based, and a firm understanding of phases and phase transitions in condensed matter systems with random pinning. The broader impact of the program includes the training of future generation of neutron scientists, and further development of neutron scattering and complementary techniques for studies of superconducting materials. The graduate and undergraduate students participating in this project will learn the state-of-the-art neutron scattering techniques, acquire a wide range of materials research experiences, and participate in the frontier research of superconductivity. This should best prepare the students for future careers in academia, industry, or government.« less

Effect of basic fibroblast growth factor and transforming growth factor β1 on the healing of reconstructed dura by carbon dioxide laser soldering in minipigs.

PubMed

Zhong, Hong-liang; Wang, Zhen-min; Yang, Zhi-jun; Zhao, Fu; Wang, Bo; Wang, Zhong-cheng; Liu, Pi-nan

2012-02-01

Carbon dioxide (CO2) laser soldering is an alternative technique for tissue bonding. Basic fibroblast growth factor (bFGF) and transforming growth factor β(1) (TGFβ(1)) are two key factors for wound healing. This study was performed to demonstrate the efficacy of CO2 laser soldering for dural reconstruction and the effect of bFGF and TGFβ(1) on healing. In Part I, 10 minipigs were randomized into two equal groups. Dural defects were reconstructed by conventional fibrin glue bonding (group I(a)) or CO2 laser soldering (group I(b)). The reconstructed dura was subjected to burst pressure (BP) measurement and immunohistochemical staining after 1 week. In Part II, 36 minipigs were randomized into three equal groups. Dural reconstruction was achieved by CO2 laser soldering. Exogenous bFGF (group II(b)) or TGFβ(1) (group II(c)) was administered while group II(a) served as a control group. The specimens were subjected to BP measurement after 1, 2, 3, and 4 weeks, respectively. In Part I, the dura specimens displayed positive staining of only bFGF in group I(a) and of both bFGF and TGFβ(1) in group I(b). Group I(b) showed higher BP than group I(a) ((98.00 ± 21.41) mmHg vs. (70.80 ± 15.09) mmHg, respectively; P < 0.05). In Part II, BP of group II(c) was significantly higher than that of group II(a) (P < 0.01). The BP of group II(a) trended toward stabilization after 3 weeks of growth, while that of groups II(b) and II(c) trended toward stabilization after 2 weeks of growth. CO2 laser soldering is a reliable technique for dural reconstruction. The superior healing of dural reconstruction by CO2 laser soldering may be related to higher expression of bFGF and TGFβ(1), and CO2 lasers may stimulate their secretion. Exogenous bFGF or TGFβ(1) may improve healing by shortening the wound healing time, and exogenous TGFβ(1) may improve the tensile strength.

A Comparison Study of the Effectiveness of the Lexia Reading Programme

ERIC Educational Resources Information Center

Ness, Mike; Couperus, Josh; Willey, Matthew

2013-01-01

This study evaluates the efficacy of the Lexia Reading (LR) programme with a cohort of 37 students in a Decile 1 primary school. The students were randomly assigned to experimental (who used LR) and control groups (who did not use LR). The WIAT-II was used to provide pre and post measures of literacy skills. Results indicated that students who…

A Study of Ontogenetic and Generational Change in Adolescent Personality by Means of Multivariate Longitudinal Sequences: Phase II. Final Report.

ERIC Educational Resources Information Center

Nesselroade, John R.; Baltes, Paul B.

Assessment of the relationship between ontogenetic (individual) and generational (historical) change in adolescent personality development was the focus of this study. The total sample included 1000 male and female adolescents (ages 13-18) randomly drawn from 32 public school systems in West Virginia following a design using longitudinal sequences…

A Phase II/III Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Ginger (Zingiber officinale) for Nausea Caused by Chemotherapy for Cancer: A Currently Accruing URCC CCOP Cancer Control Study.

PubMed

Hickok, Jane T; Roscoe, Joseph A; Morrow, Gary R; Ryan, Julie L

2007-09-01

Despite the widespread use of 5-HT3 receptor antagonist antiemetics such as ondansetron and granistron, up to 70% of patients with cancer receiving highly emetogenic chemotherapy agents experience postchemotherapy nausea and vomiting. Delayed postchemotherapy nausea (nausea that occurs >/= 24 hours after chemotherapy administration) and anticipatory nausea (nausea that develops before chemotherapy administration, in anticipation of it) are poorly controlled by currently available antiemetic agents. Scientific studies suggest that ginger (Zingiber officinale) might have beneficial effects on nausea and vomiting associated with motion sickness, surgery, and pregnancy. In 2 small studies of patients with cancer receiving chemotherapy, addition of ginger to standard antiemetic medication further reduced the severity of postchemotherapy nausea. This article describes a phase II/III randomized, dose-finding, placebo-controlled, double-blind clinical trial to assess the efficacy of ginger for nausea associated with chemotherapy for cancer. The study is currently being conducted by private practice oncology groups that are funded by the National Cancer Institute's Community Clinical Oncology Program and affiliated with the University of Rochester Cancer Center Community Clinical Oncology Program Research Base.

Study protocol for a phase II dose evaluation randomized controlled trial of cholecalciferol in critically ill children with vitamin D deficiency (VITdAL-PICU study).

PubMed

McNally, Dayre; Amrein, Karin; O'Hearn, Katharine; Fergusson, Dean; Geier, Pavel; Henderson, Matt; Khamessan, Ali; Lawson, Margaret L; McIntyre, Lauralyn; Redpath, Stephanie; Weiler, Hope A; Menon, Kusum

2017-01-01

Clinical research has recently demonstrated that vitamin D deficiency (VDD) is highly prevalent in the pediatric intensive care unit (PICU) and associated with worse clinical course. Multiple adult ICU trials have suggested that optimization of vitamin D status through high-dose supplementation may reduce mortality and improve other clinically relevant outcomes; however, there have been no trials of rapid normalization in the PICU setting. The objective of this study is to evaluate the safety and efficacy of an enteral weight-based cholecalciferol loading dose regimen in critically ill children with VDD. The VITdAL-PICU pilot study is designed as a multicenter placebo-controlled phase II dose evaluation pilot randomized controlled trial. We aim to randomize 67 VDD critically ill children using a 2:1 randomization schema to receive loading dose enteral cholecalciferol (10,000 IU/kg, maximum of 400,000 IU) or a placebo solution. Participants, caregivers and outcome assessors will be blinded to allocation. Eligibility criteria include ICU patient, aged 37 weeks to 18 years, expected ICU length of stay more than 48 h, anticipated access to bloodwork at 7 days, and VDD (blood total 25 hydroxyvitamin D < 50 nmol/L). The primary objective is to determine whether the dosing protocol normalizes vitamin D status, defined as a blood total 25(OH)D concentration above 75 nmol/L. Secondary objectives include an examination of the safety of the dosing regimen (e.g. hypercalcemia, hypercalciuria, nephrocalcinosis), measures of vitamin D axis function (e.g. calcitriol levels, immune function), and protocol feasibility (eligibility criteria, protocol deviations, blinding). Despite significant observational literature suggesting VDD to be a modifiable risk factor in the PICU setting, there is no robust clinical trial evidence evaluating the benefits of rapid normalization. This phase II clinical trial will evaluate an innovative weight-based dosing regimen intended to rapidly and safely normalize vitamin D levels in critically ill children. Study findings will be used to inform the design of a multicenter phase III trial evaluating the clinical and economic benefits to rapid normalization. Recruitment for this trial was initiated in January 2016 and is expected to continue until November 30, 2017. Clinicaltrials.gov NCT02452762.

Early initiation of beta blockade in heart failure: issues and evidence.

PubMed

Williams, Randall E

2005-09-01

Despite clinical trials demonstrating that inhibitors of the renin-angiotensin and sympathetic nervous systems can reduce the mortality and morbidity risk associated with heart failure, these drugs have remained underutilized in general clinical practice. In particular, many patients with heart failure due to left ventricular systolic dysfunction fail to receive beta blockers, although this class of drugs, as well as other antihypertensive agents such as angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, are recommended as part of routine heart failure therapy by national expert consensus guidelines. In-hospital initiation of beta-blocker therapy may improve long-term utilization by physicians and compliance by patients through obviating many of the misperceived dangers associated with beta blockade. The following review of the clinical trial data from the Randomized Evaluation of Strategies for Left Ventricular Dysfunction (RESOLVD) trial, the Metoprolol Controlled-Release Randomized Intervention Trial in Heart Failure (MERIT-HF), the Cardiac Insufficiency Bisoprolol Study II (CIBIS-II), the Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial, and the Initiation Management Predischarge Process for Assessment of Carvedilol Therapy for Heart Failure (IMPACT-HF) trial on the efficacy, safety, and tolerability of beta blockers indicates that early initiation can be safely achieved and can improve patient outcomes.

Development of the AGREE II, part 2: assessment of validity of items and tools to support application

PubMed Central

Brouwers, Melissa C.; Kho, Michelle E.; Browman, George P.; Burgers, Jako S.; Cluzeau, Françoise; Feder, Gene; Fervers, Béatrice; Graham, Ian D.; Hanna, Steven E.; Makarski, Julie

2010-01-01

Background We established a program of research to improve the development, reporting and evaluation of practice guidelines. We assessed the construct validity of the items and user’s manual in the β version of the AGREE II. Methods We designed guideline excerpts reflecting high-and low-quality guideline content for 21 of the 23 items in the tool. We designed two study packages so that one low-quality and one high-quality version of each item were randomly assigned to each package. We randomly assigned 30 participants to one of the two packages. Participants reviewed and rated the guideline content according to the instructions of the user’s manual and completed a survey assessing the manual. Results In all cases, content designed to be of high quality was rated higher than low-quality content; in 18 of 21 cases, the differences were significant (p < 0.05). The manual was rated by participants as appropriate, easy to use, and helpful in differentiating guidelines of varying quality, with all scores above the mid-point of the seven-point scale. Considerable feedback was offered on how the items and manual of the β-AGREE II could be improved. Interpretation The validity of the items was established and the user’s manual was rated as highly useful by users. We used these results and those of our study presented in part 1 to modify the items and user’s manual. We recommend AGREE II (available at www.agreetrust.org) as the revised standard for guideline development, reporting and evaluation. PMID:20513779

The impact of vitamin D in pregnancy on extraskeletal health in children: a systematic review.

PubMed

Christesen, Henrik T; Elvander, Claes; Lamont, Ronald F; Jørgensen, Jan S

2012-12-01

The impact of maternal vitamin D status in pregnancy on the extraskeletal health of the offspring has become a "hot topic" with a potential for cost-beneficial prevention. The objective of this study was to systematically review the level I and II evidence. PubMed, Embase and Cochrane databases were searched using the MeSH terms "vitamin D" AND "pregnancy" until 1 January 2012. The search was limited to randomized controlled trials (evidence level I) and observational studies (evidence level II) in humans and in the English language. Papers reporting on vitamin D supplementation in combination with other supplements, or not reporting on 25OHD or outcomes of the offspring were excluded. Six randomized controlled trials and 24 observational studies were finally included. In randomized controlled studies, vitamin D supplementation resulted in increased birthweight in one study, but showed no effect in five other studies. In cohort and case-control studies, higher vitamin D intake, or higher 25OHD, was associated with increased birthweight in large studies only, and modified by vitamin D receptor polymorphisms and by race (U-shaped in Caucasians in one unconfirmed study). The risks of HIV mother-to-child transmission, rhinitis symptoms and eczema were lower. Data were conflicting on the effect on respiratory infections and wheezing, whereas U-shaped associations to inhalant allergen-specific IgE at five years and to schizophrenia were reported in unconfirmed studies. The risk of type 1 diabetes at 15 years was lower or unchanged. It is concluded that observational studies suggest an effect of vitamin D on several outcomes. U-Shaped associations warrant caution. © 2012 The Authors Acta Obstetricia et Gynecologica Scandinavica© 2012 Nordic Federation of Societies of Obstetrics and Gynecology.

A randomized clinical trial in subjects with dry mouth evaluating subjective perceptions of an experimental oral gel, an oral rinse and a mouth spray compared to water.

PubMed

Jose, Anto; Siddiqi, Muhammad; Cronin, Matthew; DiLauro, Thomas S; Bosma, Mary Lynn

2016-02-01

This multicenter, randomized, parallel group study analyzed the effectiveness of an experimental oral gel, a commercially available oral rinse and a commercially available mouth spray versus water alone at relieving self-reported symptoms of dry mouth over a 28-day home use treatment period. The effects of the study treatments on dry mouth-related quality of life (QoL) were also investigated. Eligible subjects were stratified by dry mouth severity (mild, moderate or severe) and randomized to receive one of the study treatments. Prior to first use they completed a questionnaire designed to assess their baseline dry mouth-related QoL. Following first use and on Day 8 (2 hours post-treatment only) and Day 29, subjects completed the modified Product Performance and Attributes Questionnaire (PPAQ) I at 0.5, 1, 2 and 4 hours post-treatment. Subjects further assessed treatment performance using the PPAQ II questionnaire on Days 8 and 29 and the dry mouth-related QoL questionnaire on Day 29. In 396 randomized subjects almost all comparisons of responses to PPAQ I, including those for the primary endpoint (response to PPAQ I Question 1 'Relieving the discomfort of dry mouth' after 2 hours on Day 29), were statistically significant in favor of active treatment groups versus water (P < 0.05). All comparisons of responses to PPAQ II on Days 8 and 29 were statistically significant in favor of active treatments versus water (P < 0.05). Moreover, nearly all comparisons for dry mouth-related QoL scores on Day 29 were statistically significant in favor of the active treatments versus water. All the dry mouth management strategies in this trial were well tolerated.

Paper Tape Prevents Foot Blisters: A Randomized Prevention Trial Assessing Paper Tape in Endurance Distances II (Pre-TAPED II).

PubMed

Lipman, Grant S; Sharp, Louis J; Christensen, Mark; Phillips, Caleb; DiTullio, Alexandra; Dalton, Andrew; Ng, Pearlly; Shangkuan, Jennifer; Shea, Katherine; Krabak, Brian J

2016-09-01

To determine whether paper tape prevents foot blisters in multistage ultramarathon runners. Multisite prospective randomized trial. The 2014 250-km (155-mile) 6-stage RacingThePlanet ultramarathons in Jordan, Gobi, Madagascar, and Atacama Deserts. One hundred twenty-eight participants were enrolled: 19 (15%) from the Jordan, 35 (27%) from Gobi, 21 (16%) from Madagascar, and 53 (41%) from the Atacama Desert. The mean age was 39.3 years (22-63) and body mass index was 24.2 kg/m (17.4-35.1), with 31 (22.5%) females. Paper tape was applied to a randomly selected foot before the race, either to participants' blister-prone areas or randomly selected location if there was no blister history, with untaped areas of the same foot used as the control. Development of a blister anywhere on the study foot. One hundred six (83%) participants developed 117 blisters, with treatment success in 98 (77%) runners. Paper tape reduced blisters by 40% (P < 0.01, 95% confidence interval, 28-52) with a number needed to treat of 1.31. Most of the study participants had 1 blister (78%), with most common locations on the toes (n = 58, 50%) and heel (n = 27, 23%), with 94 (80%) blisters occurring by the end of stage 2. Treatment success was associated with earlier stages [odds ratio (OR), 74.9, P < 0.01] and time spent running (OR, 0.66, P = 0.01). Paper tape was found to prevent both the incidence and frequency of foot blisters in runners.

A Bayesian pick-the-winner design in a randomized phase II clinical trial.

PubMed

Chen, Dung-Tsa; Huang, Po-Yu; Lin, Hui-Yi; Chiappori, Alberto A; Gabrilovich, Dmitry I; Haura, Eric B; Antonia, Scott J; Gray, Jhanelle E

2017-10-24

Many phase II clinical trials evaluate unique experimental drugs/combinations through multi-arm design to expedite the screening process (early termination of ineffective drugs) and to identify the most effective drug (pick the winner) to warrant a phase III trial. Various statistical approaches have been developed for the pick-the-winner design but have been criticized for lack of objective comparison among the drug agents. We developed a Bayesian pick-the-winner design by integrating a Bayesian posterior probability with Simon two-stage design in a randomized two-arm clinical trial. The Bayesian posterior probability, as the rule to pick the winner, is defined as probability of the response rate in one arm higher than in the other arm. The posterior probability aims to determine the winner when both arms pass the second stage of the Simon two-stage design. When both arms are competitive (i.e., both passing the second stage), the Bayesian posterior probability performs better to correctly identify the winner compared with the Fisher exact test in the simulation study. In comparison to a standard two-arm randomized design, the Bayesian pick-the-winner design has a higher power to determine a clear winner. In application to two studies, the approach is able to perform statistical comparison of two treatment arms and provides a winner probability (Bayesian posterior probability) to statistically justify the winning arm. We developed an integrated design that utilizes Bayesian posterior probability, Simon two-stage design, and randomization into a unique setting. It gives objective comparisons between the arms to determine the winner.

Resistant hypertension optimal treatment trial: a randomized controlled trial.

PubMed

Krieger, Eduardo M; Drager, Luciano F; Giorgi, Dante Marcelo Artigas; Krieger, Jose Eduardo; Pereira, Alexandre Costa; Barreto-Filho, José Augusto Soares; da Rocha Nogueira, Armando; Mill, José Geraldo

2014-01-01

The prevalence of resistant hypertension (ReHy) is not well established. Furthermore, diuretics, angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers, and calcium channel blockers are largely used as the first 3-drug combinations for treating ReHy. However, the fourth drug to be added to the triple regimen is still controversial and guided by empirical choices. We sought (1) to determine the prevalence of ReHy in patients with stage II hypertension; (2) to compare the effects of spironolactone vs clonidine, when added to the triple regimen; and (3) to evaluate the role of measuring sympathetic and renin-angiotensin-aldosterone activities in predicting blood pressure response to spironolactone or clonidine. The Resistant Hypertension Optimal Treatment (ReHOT) study (ClinicalTrials.gov NCT01643434) is a prospective, multicenter, randomized trial comprising 26 sites in Brazil. In step 1, 2000 patients will be treated according to hypertension guidelines for 12 weeks, to detect the prevalence of ReHy. Medical therapy adherence will be checked by pill count monitoring. In step 2, patients with confirmed ReHy will be randomized to an open label 3-month treatment with spironolactone (titrating dose, 12.5-50 mg once daily) or clonidine (titrating dose, 0.1-0.3 mg twice daily). The primary endpoint is the effective control of blood pressure after a 12-week randomized period of treatment. The ReHOT study will disseminate results about the prevalence of ReHy in stage II hypertension and the comparison of spironolactone vs clonidine for blood pressure control in patients with ReHy under 3-drug standard regimen. © 2013 Wiley Periodicals, Inc.

A randomized trial of preoperative oral carbohydrates in abdominal surgery.

PubMed

Sada, Fatos; Krasniqi, Avdyl; Hamza, Astrit; Gecaj-Gashi, Agreta; Bicaj, Besnik; Kavaja, Floren

2014-01-01

Carbohydrate-rich liquid drinks (CRLDs) have been recommended to attenuate insulin resistance by shortening the preoperative fasting interval. The aim of our study the effect of preoperative oral administration of CRLDs on the well-being and clinical status of patients. A randomized, double blind, prospective study of patients undergoing open colorectal operations (CR) and open cholecyctectomy (CH) was conducted. Patients were divided into three groups: study, placebo, and control. Visual analogue scale (VAS) scores for seven parameters (thirst, hunger, anxiety, mouth dryness, nausea, weakness and sleep quality) were recorded and compared for two different time periods (up to 24 h postoperatively and from 36 to 48 h postoperatively). The Simplified Acute Physiology Score changes (SAPS)-II between the three groups were also studied. There were 142 patients American Society of Anesthesiology (ASA) I or II enrolled in the study (CR = 71 and CH = 71). There were no significant differences in postoperative SAPS-II scores or lengths of hospital stay (LOS) between the groups. However, in CR patients, the degree of thirst was partially improved by drinking CRLDs (P = 0.027). In CH patients, on the other hand, feelings of thirst, hunger, mouth dryness, nausea and weakness showed significant improvement (P < 0.05). Oral administration of carbohydrate-rich liquid drinks (CRLDs) improves the well-being in patients undergoing CH, but the effect is less evident in patients undergoing CR. No significant improvements were seen in clinical status or in length of hospital stay in either group. ANZCTR.org.au: ACTRN12614000995673 (registered on 16/09/2014).

Block versus Random Amphiphilic Glycopolymer Nanopaticles as Glucose-Responsive Vehicles.

PubMed

Guo, Qianqian; Zhang, Tianqi; An, Jinxia; Wu, Zhongming; Zhao, Yu; Dai, Xiaomei; Zhang, Xinge; Li, Chaoxing

2015-10-12

To explore the effect of polymer structure on their self-assembled aggregates and their unique characteristics, this study was devoted to developing a series of amphiphilic block and random phenylboronic acid-based glycopolymers by RAFT polymerization. The amphiphilic glycopolymers were successfully self-assembled into spherically shaped nanoparticles with narrow size distribution in aqueous solution. For block and random copolymers with similar monomer compositions, block copolymer nanoparticles exhibited a more regular transmittance change with the increasing glucose level, while a more evident variation of size and quicker decreasing tendency in I/I0 behavior in different glucose media were observed for random copolymer nanoparticles. Cell viability of all the polymer nanoparticles investigated by MTT assay was higher than 80%, indicating that both block and random copolymers had good cytocompatibility. Insulin could be encapsulated into both nanoparticles, and insulin release rate for random glycopolymer was slightly quicker than that for the block ones. We speculate that different chain conformations between block and random glycopolymers play an important role in self-assembled nanoaggregates and underlying glucose-sensitive behavior.

Translation, adaptation and validation of a Portuguese version of the Moorehead-Ardelt Quality of Life Questionnaire II.

PubMed

Maciel, João; Infante, Paulo; Ribeiro, Susana; Ferreira, André; Silva, Artur C; Caravana, Jorge; Carvalho, Manuel G

2014-11-01

The prevalence of obesity has increased worldwide. An assessment of the impact of obesity on health-related quality of life (HRQoL) requires specific instruments. The Moorehead-Ardelt Quality of Life Questionnaire II (MA-II) is a widely used instrument to assess HRQoL in morbidly obese patients. The objective of this study was to translate and validate a Portuguese version of the MA-II.The study included forward and backward translations of the original MA-II. The reliability of the Portuguese MA-II was estimated using the internal consistency and test-retest methods. For validation purposes, the Spearman's rank correlation coefficient was used to evaluate the correlation between the Portuguese MA-II and the Portuguese versions of two other questionnaires, the 36-item Short Form Health Survey (SF-36) and the Impact of Weight on Quality of Life-Lite (IWQOL-Lite).One hundred and fifty morbidly obese patients were randomly assigned to test the reliability and validity of the Portuguese MA-II. Good internal consistency was demonstrated by a Cronbach's alpha coefficient of 0.80, and a very good agreement in terms of test-retest reliability was recorded, with an overall intraclass correlation coefficient (ICC) of 0.88. The total sums of MA-II scores and each item of MA-II were significantly correlated with all domains of SF-36 and IWQOL-Lite. A statistically significant negative correlation was found between the MA-II total score and BMI. Moreover, age, gender and surgical status were independent predictors of MA-II total score.A reliable and valid Portuguese version of the MA-II was produced, thus enabling the routine use of MA-II in the morbidly obese Portuguese population.

Weight management for Mexican American adolescents: school-based program

USDA-ARS?s Scientific Manuscript database

The objective of the current study was to assess change in weight over time for children participating in a school-based weight management program. A total of 47 participants between the ages of 10 and 14 who exceeded the 85th percentile for BMI were randomized into an intensive intervention (II) o...

Weight change among Mexican American students involved in an intensive intervention to prevent and treat obesity

USDA-ARS?s Scientific Manuscript database

The current study examined the effects of an intensive weight management intervention for Mexican American adolescents. A total of 228 adolescents were randomized to an environmental health promotion program (EHPP) or EHPP plus intensive intervention (EHPP+II). The EHPP consisted of a school-wide in...

Embolization of the Gastroduodenal Artery Before Selective Internal Radiotherapy: A Prospectively Randomized Trial Comparing Platinum-Fibered Microcoils with the Amplatzer Vascular Plug II

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pech, Maciej, E-mail: maciej.pech@med.ovgu.de; Kraetsch, Annett; Wieners, Gero

2009-05-15

The Amplatzer Vascular Plug II (AVP II) is a novel device for transcatheter vessel occlusion, for which only limited comparative data exist. Embolotherapy of the gastroduodenal artery (GDA) is essential before internal radiotherapy (SIRT) in order to prevent radiation-induced peptic ulcerations due to migration of yttrium-90 microspheres. The purpose of this study was to compare the vascular anatomical limitations, procedure time, effectiveness, and safety of embolization of the GDA with coils versus the AVP II. Fifty patients stratified for SIRT were prospectively randomized for embolization of the GDA with either coils or the AVP II. The angle between the aortamore » and the celiac trunk, diameter of the GDA, fluoroscopy time and total time for embolization, number of embolization devices, complications, and durability of vessel occlusion at follow-up angiography for SIRT were recorded. A t-test was used for statistical analysis. Embolizations with either coils or the AVP II were technically feasible in all but two patients scheduled for embolization of the GDA with the AVP II. In both cases the plug could not be positioned due to the small celiac trunk outlet angles of 17{sup o} and 21{sup o}. The mean diameter of the GDA was 3.7 mm (range, 2.2-4.8 mm) for both groups. The procedures differed significantly in fluoroscopy time (7.8 min for coils vs. 2.6 min for the AVP II; P < 0.001) and embolization time (23.1 min for coils vs. 8.8 min for the AVP II; P < 0.001). A mean of 6.0 {+-} 3.2 coils were used for GDA embolization, while no more than one AVP II was needed for successful vessel occlusion (P < 0.001). One coil migration occurred during coil embolization, whereas no procedural complication was encountered with the use of the AVP II. Vessel reperfusion was noted in only one patient, in whom coil embolization was performed. In conclusion, embolization of the GDA with the AVP II is safe, easy, rapid, and highly effective; only an extremely sharp-angled celiac trunk outlet represented an anatomical limitation for device deployment.« less

A randomized phase II/III trial of perioperative chemotherapy with adriamycin plus ifosfamide versus gemcitabine plus docetaxel for high-grade soft tissue sarcoma: Japan Clinical Oncology Group Study JCOG1306.

PubMed

Kataoka, Kozo; Tanaka, Kazuhiro; Mizusawa, Junki; Kimura, Aya; Hiraga, Hiroaki; Kawai, Akira; Matsunobu, Tomoya; Matsumine, Akihiko; Araki, Nobuhito; Oda, Yoshinao; Fukuda, Haruhiko; Iwamoto, Yukihide

2014-08-01

A randomized Phase II/III trial was planned to commence in March 2014. Perioperative chemotherapy with adriamycin plus ifosfamide is the current standard treatment for T2bN0M0 high-grade non-round cell soft tissue sarcoma. The purpose of this study is to confirm the non-inferiority of perioperative chemotherapy with gemcitabine and docetaxel to adriamycin plus ifosfamide for patients with T2bN0M0 or any TN1M0 non-round cell soft tissue sarcoma in the extremities and body wall. A total of 140 patients will be accrued from 28 Japanese institutions over 6 years. The primary endpoint in the Phase II part is the proportion of completion of pre-operative chemotherapy without progressive disease and overall survival in the Phase III part. The secondary endpoints are progression-free survival, response rate of pre-operative chemotherapy, pathological response rate, proportion of preservation of diseased limbs, disease control rate and proportion of adverse events. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000013175 [http://www.umin.ac.jp/ctr/index.htm]. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Generalized optimal design for two-arm, randomized phase II clinical trials with endpoints from the exponential dispersion family.

PubMed

Jiang, Wei; Mahnken, Jonathan D; He, Jianghua; Mayo, Matthew S

2016-11-01

For two-arm randomized phase II clinical trials, previous literature proposed an optimal design that minimizes the total sample sizes subject to multiple constraints on the standard errors of the estimated event rates and their difference. The original design is limited to trials with dichotomous endpoints. This paper extends the original approach to be applicable to phase II clinical trials with endpoints from the exponential dispersion family distributions. The proposed optimal design minimizes the total sample sizes needed to provide estimates of population means of both arms and their difference with pre-specified precision. Its applications on data from specific distribution families are discussed under multiple design considerations. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

A Randomized, Double-Blind, Placebo-Controlled, Phase II Study of Oral ELND005 (scyllo-Inositol) in Young Adults with Down Syndrome without Dementia.

PubMed

Rafii, Michael S; Skotko, Brian G; McDonough, Mary Ellen; Pulsifer, Margaret; Evans, Casey; Doran, Eric; Muranevici, Gabriela; Kesslak, Patrick; Abushakra, Susan; Lott, Ira T

2017-01-01

ELND005 (scyllo-Inositol; cyclohexane-1,2,3,4,5,6-hexol) has been evaluated as a potential disease-modifying treatment for Alzheimer's disease (AD). Individuals with Down syndrome (DS) have an increased risk for developing AD dementia. To evaluate the safety and tolerability of ELND005 and to determine its pharmacokinetics (PK) and relationship between PK parameters, safety outcome measures, and exploratory efficacy outcome measures in young adults with DS without dementia. This was a prospective, randomized, double-blind, placebo-controlled, parallel-group, three-arm, multicenter Phase II study of the safety and pharmacokinetics of ELND005 administered orally for 4 weeks (ClinicalTrials.gov NCT01791725). Participants who met study eligibility criteria were randomly assigned in a 2 : 1:1 ratio to receive ELND005 at either 250 mg twice daily (BID) or 250 mg once daily (QD) or matching placebo for 4 weeks. There were no apparent treatment group-related trends on cognitive or behavioral measures and there were no SAEs and no deaths in the study. Overall, mean changes from baseline in clinical laboratory parameters, vital sign measurements, electrocardiogram results, and other physical findings were unremarkable. ELND005 accumulation averaged approximately 2-fold with QD dosing, and 3- to 4-fold with BID dosing. Overall, treatment of adults with DS with ELND005 at both doses was well tolerated, achieved measurable blood levels and demonstrated no safety findings. Further studies will be needed to test efficacy.

Radiofrequency ablation combined with systemic treatment versus systemic treatment alone in patients with non-resectable colorectal liver metastases: a randomized EORTC Intergroup phase II study (EORTC 40004).

PubMed

Ruers, T; Punt, C; Van Coevorden, F; Pierie, J P E N; Borel-Rinkes, I; Ledermann, J A; Poston, G; Bechstein, W; Lentz, M A; Mauer, M; Van Cutsem, E; Lutz, M P; Nordlinger, B

2012-10-01

This study investigates the possible benefits of radiofrequency ablation (RFA) in patients with non-resectable colorectal liver metastases. This phase II study, originally started as a phase III design, randomly assigned 119 patients with non-resectable colorectal liver metastases between systemic treatment (n = 59) or systemic treatment plus RFA ( ± resection) (n = 60). Primary objective was a 30-month overall survival (OS) rate >38% for the combined treatment group. The primary end point was met, 30-month OS rate was 61.7% [95% confidence interval (CI) 48.2-73.9] for combined treatment. However, 30-month OS for systemic treatment was 57.6% (95% CI 44.1-70.4), higher than anticipated. Median OS was 45.3 for combined treatment and 40.5 months for systemic treatment (P = 0.22). PFS rate at 3 years for combined treatment was 27.6% compared with 10.6% for systemic treatment only (hazard ratio = 0.63, 95% CI 0.42-0.95, P = 0.025). Median progression-free survival (PFS) was 16.8 months (95% CI 11.7-22.1) and 9.9 months (95% CI 9.3-13.7), respectively. This is the first randomized study on the efficacy of RFA. The study met the primary end point on 30-month OS; however, the results in the control arm were in the same range. RFA plus systemic treatment resulted in significant longer PFS. At present, the ultimate effect of RFA on OS remains uncertain.

Preliminary results of a randomized, equivalence trial of fluoroscopic caudal epidural injections in managing chronic low back pain: Part 2--Disc herniation and radiculitis.

PubMed

Manchikanti, Laxmaiah; Singh, Vijay; Cash, Kimberly A; Pampati, Vidyasagar; Damron, Kim S; Boswell, Mark V

2008-01-01

The pathophysiology of lumbar radicular pain is a subject of ongoing research. The prevalence of sciatica or radiculitis ranges from 1.2% to 43%. Epidural injections are one of the most commonly performed interventions in the United States in managing chronic low back and lower extremity pain secondary to disc herniation and radiculitis. There is a paucity of evidence with contemporary methodology used in performing epidural injections under fluoroscopy and based on pain relief and functional status improvement. A randomized, double-blind, equivalence trial. An interventional pain management practice, a specialty referral center, a private practice setting in the United States. To evaluate the effectiveness of caudal epidural injections with or without steroids in managing chronic low back and lower extremity pain secondary to disc herniation or radiculitis in providing effective and long-lasting pain relief and evaluate the differences between local anesthetic with or without steroids. Patients were assigned to one of 2 groups; Group I patients received caudal epidural injections with an injection of local anesthetic (lidocaine 0.5%), whereas, Group II patients received caudal epidural injections with 0.5% lidocaine 9 mL mixed with 1 mL of steroid. Randomization was performed by computer-generated random allocations sequence by simple randomization. Multiple outcome measures were utilized which included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3 months, 6 months, and 12 months post-treatment. Significant pain relief was defined as 50% or more, whereas significant improvement in disability score was defined as a reduction of 40% or more. The percentage of patients with significant pain relief of 50% or greater at 12 months was 79% in Group I and 81% in Group II. Reduction of Oswestry scores of at least 40% was seen in 83% of the patients in Group I and 91% in Group II. The overall average procedures per year were 3.9 +/- 1.26 in Group I and 3.6 +/- 1.08 in Group II with an average total relief per year of 35.2 +/- 17.18 weeks in Group I and 35.9 +/- 15.34 weeks in Group II over a period of 52 weeks. The results of this study are limited by lack of a placebo group and a preliminary report of 42 patients in each group. Caudal epidural injections with or without steroids may be effective in patients with disc herniation or radiculitis with between 79% to 91% of patients showing significant pain relief and improvement in functional status.

Fluoroscopic Caudal Epidural Injections in Managing Post Lumbar Surgery Syndrome: Two-Year Results of a Randomized, Double-Blind, Active-Control Trial

PubMed Central

Manchikanti, Laxmaiah; Singh, Vijay; Cash, Kimberly A.; Pampati, Vidyasagar; Datta, Sukdeb

2012-01-01

Study Design: A randomized, active control, double-blind trial. Objective: To evaluate the effectiveness of fluoroscopically directed caudal epidural injections with or without steroids in managing chronic low back and lower extremity pain secondary to post lumbar surgery syndrome. Summary of Background Data: There is a paucity of evidence concerning caudal epidural injections for managing chronic persistent low back pain with or without lower extremity pain caused by post lumbar surgery syndrome. Methods: This active control randomized study included 140 patients with 70 patients in each group. Group I received 0.5% lidocaine, 10 mL; Group II received 9 mL of 0.5% lidocaine mixed with 1 mL of 6 mg of nonparticulate betamethasone. The multiple outcome measures included the numeric rating scale, the Oswestry Disability Index 2.0, employment status, and opioid intake with assessments at 3, 6, 12, 18, and 24 months posttreatment. Primary outcome was defined as at least 50% improvement in pain and Oswestry Disability Index scores. Patients with a positive response to the first 2 procedures with at least 3 weeks of relief were considered to be successful. All others were considered as failures. Results: Overall in Group I, 53% and 47% of the patients and in Group II, 59% and 58% of the patients, showed significant improvement with reduction in pain scores and disability index at 12 months and 24 months. In contrast, in the successful groups, significant pain relief and improvement in function were observed in 70% and 62% of Group I at one and 2 years; in 75% and 69% of Group II at one and 2 years. The results in the successful group showed that at the end of the first year patients experienced approximately 38 weeks of relief and at the end of 2 years Group I had 62 weeks and Group II had 68 weeks of relief. Overall total relief for 2 years was 48 weeks in Group I and 54 weeks in Group II. The average procedures in the successful groups were at 4 in one year and 6 at the end of 2 years. Conclusion: Caudal epidural injections of local anesthetic with or without steroid might be effective in patients with chronic persistent low back and/or lower extremity pain in patients with post lumbar surgery syndrome. PMID:23028241

A Comparative Study of the Relationships between Conflict Management Styles and Job Satisfaction, Organizational Commitment, and Propensity to Leave the Job among Saudi and American Universities' Faculty Members

ERIC Educational Resources Information Center

Alzahrani, Mohammed

2013-01-01

This study used Rahim Organizational Conflict Inventory-II, Form C to examine the preference for conflict management styles among Saudi and American faculty members. Additionally, the study examined the relationships between conflict management styles and job satisfaction, organizational commitment, and propensity to leave the job. A random sample…

[Phosphodiesterase inhibitors in clinical practice. The present and the future. Part II].

PubMed

Baksheev, B I; Kolomiets, N M

2007-01-01

Type Sphosphodiesterase inhibitors (FDEI-5) used to be applied as the main drugs for treatment of erectile dysfunction. At present, this pharmacological group is being studied intensively in various fields of clinical medicine, such as pulmonology, cardiology, gastroenterology, gynecology etc. Part II of this system literature review is dedicated to analysis of the results of such application. In many randomized and non-randomized controlled studies sildenafil decreased pulmonary arterial pressure (independently of etiology) and pulmonary vascular resistance; it could be successfully combined with nitric oxide, illoprost, or epoprostenolol. Clinical studies have also demonstrated an increase in physical load tolerance, optimization of PAH studies according to NYHA functional classes, and good tolerance to the drug. In the recent years, antiischaemic effects of FDEI-5 and their ability to inhibit apoptosis have been proved It is possible to draw the conclusion that nature created a universal phosphodiesterase mechanism for the interconnection of biochemical processes that provide the vital activity of the cell and organism. The fact that more than 15 controlled studies of clinical application of sildenafil not for treatment of erectile dysfunction have been planned and commenced confirms the importance of further studies of this mechanism. Further analysis of the results will show how universal this mechanism is.

Breeding value accuracy estimates for growth traits using random regression and multi-trait models in Nelore cattle.

PubMed

Boligon, A A; Baldi, F; Mercadante, M E Z; Lobo, R B; Pereira, R J; Albuquerque, L G

2011-06-28

We quantified the potential increase in accuracy of expected breeding value for weights of Nelore cattle, from birth to mature age, using multi-trait and random regression models on Legendre polynomials and B-spline functions. A total of 87,712 weight records from 8144 females were used, recorded every three months from birth to mature age from the Nelore Brazil Program. For random regression analyses, all female weight records from birth to eight years of age (data set I) were considered. From this general data set, a subset was created (data set II), which included only nine weight records: at birth, weaning, 365 and 550 days of age, and 2, 3, 4, 5, and 6 years of age. Data set II was analyzed using random regression and multi-trait models. The model of analysis included the contemporary group as fixed effects and age of dam as a linear and quadratic covariable. In the random regression analyses, average growth trends were modeled using a cubic regression on orthogonal polynomials of age. Residual variances were modeled by a step function with five classes. Legendre polynomials of fourth and sixth order were utilized to model the direct genetic and animal permanent environmental effects, respectively, while third-order Legendre polynomials were considered for maternal genetic and maternal permanent environmental effects. Quadratic polynomials were applied to model all random effects in random regression models on B-spline functions. Direct genetic and animal permanent environmental effects were modeled using three segments or five coefficients, and genetic maternal and maternal permanent environmental effects were modeled with one segment or three coefficients in the random regression models on B-spline functions. For both data sets (I and II), animals ranked differently according to expected breeding value obtained by random regression or multi-trait models. With random regression models, the highest gains in accuracy were obtained at ages with a low number of weight records. The results indicate that random regression models provide more accurate expected breeding values than the traditionally finite multi-trait models. Thus, higher genetic responses are expected for beef cattle growth traits by replacing a multi-trait model with random regression models for genetic evaluation. B-spline functions could be applied as an alternative to Legendre polynomials to model covariance functions for weights from birth to mature age.

Use of biodegradable polylactic acid barrier materials in the treatment of grade II periodontal furcation defects in humans--Part I: A multicenter investigative clinical study.

PubMed

Vernino, A R; Ringeisen, T A; Wang, H L; Derhalli, M; Rapley, J; Nechamkin, S J; Brekke, J

1998-12-01

This study evaluated two bioresorbable polylactic acid barriers (Epi-Guide and Guidor) to determine if design differences were of therapeutic significance in the treatment of Grade II furcation defects in humans. Forty patients with bilaterally matched, Grade II furcation defects in maxillary or mandibular first or second molars were treated in a multicenter study. Comprehensive initial periodontal therapy, followed by defect debridement and root preparation, preceded randomized membrane placement. Data collected from all three investigative centers were pooled and analyzed using an analysis of variance appropriate for a counterbalancing design. Both barrier types produced measurable improvements of clinical probing values. Barrier exposure scores taken through the eighth week postoperative revealed that Epi-Guide was less likely to become exposed than Guidor. The findings of this study, which was conducted over a 12-month period, demonstrated that Epi-Guide and Guidor were comparable as measured by clinical probing determinations.

Microdose GnRH Agonist Flare-Up versus Ultrashort GnRH Agonist Combined with Fixed GnRH Antagonist in Poor Responders of Assisted Reproductive Techniques Cycles

PubMed Central

Eftekhar, Maryam; Mohammadian, Farnaz; Yousefnejad, Fariba; Khani, Parisa

2013-01-01

Background: This study compares the microdose flare-up protocol to the ultrashort gonadotropinreleasing hormone (GnRH) agonist flare combined with the fixed multidose GnRH antagonist protocol in poor responders undergoing ovarian stimulation. Materials and Methods: In this randomized clinical trial, 120 women who were candidates for assisted reproductive techniques (ART) and had histories of one or more failed in vitro fertilization (IVF) cycles with three or fewer retrieved oocytes were prospectively randomized into two groups. Group I (60 patients) received the microdose flare-up regimen and group II (60 patients) received the ultrashort GnRH agonist combined with fixed GnRH antagonist. Results: There were no significant differences between the groups in the number of used gonadotropin ampoules (p=0.591), duration of stimulation (p=0.610), number of retrieved oocytes (p=0.802), fertilization rate (p=0.456), and the number of transferred embryos (p=0.954). The clinical pregnancy rates were statistically similar in group I (10%) compared with group II (13.3%, p=0.389). Conclusion: According to our results, there is no significant difference between these protocols for improving the ART outcome in poor responders. Additional prospective, randomized studies with more patients is necessary to determine the best protocol (Registration Number: IRCT201105096420N1). PMID:24520450

Vitamin K1 versus vitamin K3 for prevention of subclinical vitamin deficiency: a randomized controlled trial.

PubMed

Chawla, D; Deorari, A K; Saxena, R; Paul, V K; Agarwal, R; Biswas, A; Meena, A

2007-11-01

To compare efficacy of intramuscular phytomenadione (fat soluble vitamin K or vitamin K1) with menadione (water soluble vitamin K or vitamin K3) in prevention of subclinical vitamin K deficiency. A doubleblind randomized controlled trial. Tertiary care hospital. Healthy term neonates were randomized to receive 1 mg of either phytomenadione (Group I, n = 85) or menadione (Group II, n = 85) intramuscularly within 2 hours of birth. PIVKA-II, a sensitive and specific marker of vitamin K deficiency was measured by ELISA method (Diagnostica Stago, France). Plasma level > 2 ng/mL was labeled as detectable PIVKA-II. Birth weight (2914 +/- 318 vs 2958 +/- 312 g), gestation (38.4 +/- 1.2 vs 38.4 +/- 1.0 wk) and other baseline variables were comparable between the two groups. 48.2% (41/85) neonates in Group I and 44.7%(38/85) neonates in Group II had detectable PIVKAII levels ([Relative Risk (95% confidence interval): 1.1 (0.8-1.5); P = 0.76]). Median PIVKA-II levels in Group I and Group II were 1.99 ng/mL and 1.97 ng/mL respectively (P = 0.26). At 72 +/- 12 h of age, mean packed cell volume and mean serum bilirubin levels were comparable in the two groups. Comparable PIVKAII detection rate and PIVKAII levels in neonates receiving phytomenadione or menadione indicate their similar efficacy in prevention of vitamin K deficiency. However, high PIVKAII detection rate observed with both preparations indicates recent vitamin K deficiency and may be due to either inadequate dose of vitamin K or persistence of PIVKAII of fetal origin.

Nandrolone decanoate as anabolic therapy in chronic kidney disease: a randomized phase II dose-finding study.

PubMed

Macdonald, Jamie H; Marcora, Samuele M; Jibani, Mahdi M; Kumwenda, Mick J; Ahmed, Wasim; Lemmey, Andrew B

2007-01-01

In patients with chronic kidney disease (CKD) receiving adequate erythropoietin therapy, the ideal dose of nandrolone decanoate (ND) to enhance muscle mass is not known. In this phase II dose-finding study, 54 patients with CKD stage 5 were randomized to either low, medium or high doses of ND (50, 100 or 200 mg/week for 24 weeks, respectively, in males; doses halved in females), while 7 patients acted as non-randomized controls. The primary outcome measure was appendicular lean mass (ALM) by dual-energy X-ray absorptiometry. Fluid overload (hydration of the fat-free mass) and indicators of physical functioning were secondary measures. Harms were also recorded. Data were analysed using Quade's (1967) non-parametric analysis of covariance. ND increased ALM in a dose-responsive manner (change scores = 0.3 +/- 0.3 vs. 0.8 +/- 0.3 vs. 1.5 +/- 0.5 vs. 2.1 +/- 0.4 kg, control vs. low vs. medium vs. high dose groups, respectively, p < 0.001) with no increases in fluid overload but no consistent effect on physical functioning. The highest dose of ND (100 mg/week) was intolerable in females because of virilizing effects. If goals of future studies are to improve body composition, dosing of ND up to 200 mg/week in males and 50 mg/week in females should be investigated. However, to realize improvements in physical functioning, future phase III trials of ND may require additional interventions such as exercise training. Copyright 2007 S. Karger AG, Basel.

Tumor and circulating biomarkers in patients with second-line hepatocellular carcinoma from the randomized phase II study with tivantinib

PubMed Central

Rimassa, Lorenza; Abbadessa, Giovanni; Personeni, Nicola; Porta, Camillo; Borbath, Ivan; Daniele, Bruno; Salvagni, Stefania; Van Laethem, Jean-Luc; Van Vlierberghe, Hans; Trojan, Jörg; De Toni, Enrico N.; Weiss, Alan; Miles, Steven; Gasbarrini, Antonio; Lencioni, Monica; Lamar, Maria E.; Wang, Yunxia; Shuster, Dale; Schwartz, Brian E.; Santoro, Armando

2016-01-01

ARQ 197-215 was a randomized placebo-controlled phase II study testing the MET inhibitor tivantinib in second-line hepatocellular carcinoma (HCC) patients. It identified tumor MET as a key biomarker in HCC. Aim of this research was to study the prognostic and predictive value of tumor (MET, the receptor tyrosine kinase encoded by the homonymous MNNG-HOS transforming gene) and circulating (MET, hepatocyte growth factor [HGF], alpha-fetoprotein [AFP], vascular endothelial growth factor [VEGF]) biomarkers in second-line HCC. Tumor MET-High status was centrally assessed by immunohistochemistry. Circulating biomarkers were centrally analyzed on serum samples collected at baseline and every 4-8 weeks, using medians as cut-off to determine High/Low status. Tumor MET, tested in 77 patients, was more frequently High after (82%) versus before (40%) sorafenib. A significant interaction (p = 0.04) between tivantinib and baseline tumor MET in terms of survival was observed. Baseline circulating MET and HGF (102 patients) High status correlated with shorter survival (HR 0.61, p = 0.03, and HR 0.60, p = 0.02, respectively), while the association between AFP (104 patients) or VEGF (103 patients) status and survival was non-significant. Conclusions: Tumor MET levels were higher in patients treated with sorafenib. Circulating biomarkers such as MET and HGF may be prognostic in second-line HCC. These results need to be confirmed in larger randomized clinical trials. PMID:27579536

Telephone cognitive-behavioral therapy for subthreshold depression and presenteeism in workplace: a randomized controlled trial.

PubMed

Furukawa, Toshi A; Horikoshi, Masaru; Kawakami, Norito; Kadota, Masayo; Sasaki, Megumi; Sekiya, Yuki; Hosogoshi, Hiroki; Kashimura, Masami; Asano, Kenichi; Terashima, Hitomi; Iwasa, Kazunori; Nagasaku, Minoru; Grothaus, Louis C

2012-01-01

Subthreshold depression is highly prevalent in the general population and causes great loss to society especially in the form of reduced productivity while at work (presenteeism). We developed a highly-structured manualized eight-session cognitive-behavioral program with a focus on subthreshold depression in the workplace and to be administered via telephone by trained psychotherapists (tCBT). We conducted a parallel-group, non-blinded randomized controlled trial of tCBT in addition to the pre-existing Employee Assistance Program (EAP) versus EAP alone among workers with subthreshold depression at a large manufacturing company in Japan. The primary outcomes were depression severity as measured with Beck Depression Inventory-II (BDI-II) and presenteeism as measured with World Health Organization Health and Work Productivity Questionnaire (HPQ). In the course of the trial the follow-up period was shortened in order to increase acceptability of the study. The planned sample size was 108 per arm but the trial was stopped early due to low accrual. Altogether 118 subjects were randomized to tCBT+EAP (n = 58) and to EAP alone (n = 60). The BDI-II scores fell from the mean of 17.3 at baseline to 11.0 in the intervention group and to 15.7 in the control group after 4 months (p<0.001, Effect size = 0.69, 95%CI: 0.32 to 1.05). However, there was no statistically significant decrease in absolute and relative presenteeism (p = 0.44, ES = 0.15, -0.21 to 0.52, and p = 0.50, ES = 0.02, -0.34 to 0.39, respectively). Remote CBT, including tCBT, may provide easy access to quality-assured effective psychotherapy for people in the work force who present with subthreshold depression. Further studies are needed to evaluate the effectiveness of this approach in longer terms. The study was funded by Sekisui Chemicals Co. Ltd. ClinicalTrials.gov NCT00885014.

Rationale and design of PRIMA II: A multicenter, randomized clinical trial to study the impact of in-hospital guidance for acute decompensated heart failure treatment by a predefined NT-PRoBNP target on the reduction of readmIssion and Mortality rAtes.

PubMed

Stienen, Susan; Salah, Khibar; Moons, Andreas H M; Bakx, Adrianus L M; van Pol, Petra E; Schroeder-Tanka, Jutta M; Voogel, Albertus J; Keijer, Jan T; Kortz, R A Mikael; Dickhoff, Cathelijne; Meregalli, Paola G; Tijssen, Jan G; Pinto, Yigal M; Kok, Wouter E

2014-07-01

Hospital admissions for acute decompensated heart failure (ADHF) are frequent and are accompanied by high percentages of mortality and readmissions. Brain natriuretic peptide (BNP) and the inactive N-terminal fragment of its precursor proBNP (NT-proBNP) are currently the best predictors of prognosis in heart failure (HF) patients. In the setting of chronic HF, studies that performed guidance of therapy by NT-proBNP have had only limited success. For patients with ADHF, retrospective studies have shown that a reduction in NT-proBNP of ≤30% during admission is a significant predictor of HF readmissions and mortality. These data suggest a role for NT-proBNP guidance in the setting of ADHF admissions. The PRIMA II is an investigator-initiated, multicenter, randomized, controlled, prospective 2-arm trial that investigates the impact of inhospital guidance for ADHF treatment by a predefined NT-proBNP target (>30% reduction during admission) on the reduction of readmission and mortality rates within 180 days. Consenting ADHF patients with NT-proBNP levels of >1,700 ng/L are eligible. After achieving clinical stability, a total of 340 patients are randomized to either NT-proBNP-guided or conventional treatment (1:1). The primary end point is dual, that is, a composite of all-cause mortality and readmission for HF in 180 days and the number of days alive out of hospital in 180 days. Secondary end points are readmissions and/or mortality in 180 days, cost effectiveness of hospitalization days in 180 days, readmissions and mortality in 90 days, and quality of life. The PRIMA II trial aims at providing scientific evidence for the use of NT-proBNP-guided therapy compared with conventional treatment in patients admitted for ADHF. Copyright © 2014 Mosby, Inc. All rights reserved.

Guided tissue regeneration and platelet rich growth factor for the treatment of Grade II furcation defects: A randomized double-blinded clinical trial - A pilot study.

PubMed

Jenabian, Niloofar; Haghanifar, Sina; Ehsani, Hodis; Zahedi, Ehsan; Haghpanah, Masumeh

2017-01-01

The treatment of furcation area defects remained as a challenging issue in periodontal treatments. Regeneration treatment of furcation defects is the most discussed periodontal treatment. Although not completely hopeless in prognosis, the presence of the furcation involvement significantly increases the chance of tooth loss. The current research was conductedeto compare theeadditive effect of combined guided tissue regeneration (GTR) and platelet-rich growth factor (PRGF) on the treatment of furcation bony defects. A randomized, triple-blinded, split-mouth study was designed. It included patients with a moderate to severe chronic periodontitis with bilateral Grade II furcation involvement of first or second mandibular molars. Each side of mouth was randomly allocated for the treatment with either Bio-Gide American Society of Anesthesiologists GTR or a PRGF or PRGF by itself. Plaque index, gingival index, vertical clinical attachment level, vertical probing depth, recession depth (REC), horizontal probing depth, fornix to alveolar crest (FAC), fornix to base of defect (FBD), furcation vertical component and furcation horizontal component (FHC) were recorded. The current research was conducted to compare the additive effect of combined GTR and PRGF on treatment of furcation bony defects. Altman's nomogram, Kolmogorov-Smirnov test, Friedman test, general linear model, repeated measures, and paired t -test were used as statistical analysis in this research. P < 0.05 was considered statistically significant. Eight patients were finally enrolled for this study. Overly, general and specific clinical and furcation parameters were improved except REC that was deteriorated insignificantly and FAC improved not significantly. Intergroup comparison revealed better improvement of FHC in GTR/PRGF group ( P = 0.02). A significant improvement in the Grade II furcation defects treated with either GTR or PRGF/GTR was noticed. Further large-scale trials are needed to reveal differences of mentioned treatment in more details.

Guided tissue regeneration and platelet rich growth factor for the treatment of Grade II furcation defects: A randomized double-blinded clinical trial - A pilot study

PubMed Central

Jenabian, Niloofar; Haghanifar, Sina; Ehsani, Hodis; Zahedi, Ehsan; Haghpanah, Masumeh

2017-01-01

Background: The treatment of furcation area defects remained as a challenging issue in periodontal treatments. Regeneration treatment of furcation defects is the most discussed periodontal treatment. Although not completely hopeless in prognosis, the presence of the furcation involvement significantly increases the chance of tooth loss. The current research was conductedeto compare theeadditive effect of combined guided tissue regeneration (GTR) and platelet-rich growth factor (PRGF) on the treatment of furcation bony defects. Materials and Methods: A randomized, triple-blinded, split-mouth study was designed. It included patients with a moderate to severe chronic periodontitis with bilateral Grade II furcation involvement of first or second mandibular molars. Each side of mouth was randomly allocated for the treatment with either Bio-Gide American Society of Anesthesiologists GTR or a PRGF or PRGF by itself. Plaque index, gingival index, vertical clinical attachment level, vertical probing depth, recession depth (REC), horizontal probing depth, fornix to alveolar crest (FAC), fornix to base of defect (FBD), furcation vertical component and furcation horizontal component (FHC) were recorded. The current research was conducted to compare the additive effect of combined GTR and PRGF on treatment of furcation bony defects. Altman's nomogram, Kolmogorov–Smirnov test, Friedman test, general linear model, repeated measures, and paired t-test were used as statistical analysis in this research. P < 0.05 was considered statistically significant. Results: Eight patients were finally enrolled for this study. Overly, general and specific clinical and furcation parameters were improved except REC that was deteriorated insignificantly and FAC improved not significantly. Intergroup comparison revealed better improvement of FHC in GTR/PRGF group (P = 0.02). Conclusion: A significant improvement in the Grade II furcation defects treated with either GTR or PRGF/GTR was noticed. Further large-scale trials are needed to reveal differences of mentioned treatment in more details. PMID:29238373

Effects of an Internet-Based Cognitive Behavioral Therapy (iCBT) Program in Manga Format on Improving Subthreshold Depressive Symptoms among Healthy Workers: A Randomized Controlled Trial

PubMed Central

Imamura, Kotaro; Kawakami, Norito; Furukawa, Toshi A.; Matsuyama, Yutaka; Shimazu, Akihito; Umanodan, Rino; Kawakami, Sonoko; Kasai, Kiyoto

2014-01-01

Objective The purpose of this study was to develop a new Internet-based computerized cognitive behavior therapy (iCBT) program in Manga format, the Japanese cartoon, for workers and to examine the effects of the iCBT program on improving subthreshold depression using a randomized controlled trial (RCT) design among workers employed in private companies in Japan. Method All workers in a company (n = 290) and all workers in three departments (n = 1,500) at the headquarters of another large company were recruited by an invitation e-mail. Participants who fulfilled the inclusion criteria were randomly allocated to intervention or control groups (N = 381 for each group). A six-week, six-lesson iCBT program using Manga (Japanese comic) story was developed. The program included several CBT skills: self-monitoring, cognitive restructuring, assertiveness, problem solving, and relaxation. The intervention group studied the iCBT program at a frequency of one lesson per week. Depression (Beck Depression Inventory II; BDI-II) was assessed as a primary outcome at baseline, and three- and six-month follow-ups for both intervention and control groups were performed. Results The iCBT program showed a significant intervention effect on BDI-II (t = −1.99, p<0.05) with small effect sizes (Cohen's d: −0.16, 95% Confidence Interval: −0.32 to 0.00, at six-month follow-up). Conclusions The present study first demonstrated that a computerized cognitive behavior therapy delivered via the Internet was effective in improving depression in the general working population. It seems critical to improve program involvement of participants in order to enhance the effect size of an iCBT program. Trial Registration UMIN Clinical Trials Registry UMIN000006210 PMID:24844530

EXODUS II: A finite element data model

DOE Office of Scientific and Technical Information (OSTI.GOV)

Schoof, L.A.; Yarberry, V.R.

1994-09-01

EXODUS II is a model developed to store and retrieve data for finite element analyses. It is used for preprocessing (problem definition), postprocessing (results visualization), as well as code to code data transfer. An EXODUS II data file is a random access, machine independent, binary file that is written and read via C, C++, or Fortran library routines which comprise the Application Programming Interface (API).

Feasibility study of microwave modulation DIAL system for global CO II monitoring

NASA Astrophysics Data System (ADS)

Hirano, Yoshihito; Kameyama, Shumpei; Ueno, Shinichi; Sugimoto, Nobuo; Kimura, Toshiyoshi

2006-12-01

A new concept of DIAL (DIfferential Absorption Lidar) system for global CO II monitoring using microwave modulation is introduced. This system uses quasi-CW lights which are intensity modulated in microwave region and receives a backscattered light from the ground. In this system, ON/OFF wavelength laser lights are modulated with microwave frequencies, and received lights of two wavelengths are able to be discriminated by modulation frequencies in electrical signal domain. Higher sensitivity optical detection can be realized compared with the conventional microwave modulation lidar by using direct down conversion of modulation frequency. The system also has the function of ranging by using pseudo-random coding in modulation. Fiber-based optical circuit using wavelength region of 1.6 micron is a candidate for the system configuration. After the explanation of this configuration, feasibility study of this system on the application to global CO II monitoring is introduced.

Bayesian inference for two-part mixed-effects model using skew distributions, with application to longitudinal semicontinuous alcohol data.

PubMed

Xing, Dongyuan; Huang, Yangxin; Chen, Henian; Zhu, Yiliang; Dagne, Getachew A; Baldwin, Julie

2017-08-01

Semicontinuous data featured with an excessive proportion of zeros and right-skewed continuous positive values arise frequently in practice. One example would be the substance abuse/dependence symptoms data for which a substantial proportion of subjects investigated may report zero. Two-part mixed-effects models have been developed to analyze repeated measures of semicontinuous data from longitudinal studies. In this paper, we propose a flexible two-part mixed-effects model with skew distributions for correlated semicontinuous alcohol data under the framework of a Bayesian approach. The proposed model specification consists of two mixed-effects models linked by the correlated random effects: (i) a model on the occurrence of positive values using a generalized logistic mixed-effects model (Part I); and (ii) a model on the intensity of positive values using a linear mixed-effects model where the model errors follow skew distributions including skew- t and skew-normal distributions (Part II). The proposed method is illustrated with an alcohol abuse/dependence symptoms data from a longitudinal observational study, and the analytic results are reported by comparing potential models under different random-effects structures. Simulation studies are conducted to assess the performance of the proposed models and method.

Two Randomized Clinical Studies to Confirm Differential Plaque Removal by Sodium Bicarbonate Dentifrices in a Single Timed Brushing Model.

PubMed

Mason, Stephen; Karwal, Ritu; Bosma, Mary Lynn

2017-09-01

This study evaluated and compared plaque removal efficacy of commercially available dentifrices containing sodium bicarbonate (NaHCO3) to those without NaHCO3 in a single timed brushing clinical study model. Two randomized, examiner-blind, three-period, three-treatment, crossover studies were performed in adults with a mean Turesky modification of the Quigley-Hein Plaque Index (TPI) score of = 2.00. In Study 1, 60 subjects were randomized to commercially available dentifrices containing: (i) 67% NaHCO3 plus 1425 ppm fluoride (F) as sodium fluoride (NaF); (ii) 45% NaHCO3 plus 1425 ppm F as NaF; or (iii) 0% NaHCO3 plus silica and 1450 ppm F as NaF. In Study 2, 55 subjects were randomized to commercially available dentifrices containing: (i) 67% NaHCO3 plus 1425 ppm F as NaF; (ii) 0% NaHCO3 plus silica and 1400 ppm F as amine F/stannous F; or (iii) 0% NaHCO3 plus chlorhexidine/aluminum lactate and silica with 1360 ppm F as aluminum F. In both studies, subjects brushed their teeth for one timed minute under supervised conditions. Plaque was assessed pre- and post-brushing according to a six-site modification of the TPI. Mean TPI score was analyzed using an analysis of covariance model with treatment and study period as fixed effects, subject as a random variable, and pre-brushing score as a covariate. In both studies, mean TPI score decreased in all groups post-brushing compared with pre-brushing. In Study 1, statistically significant improvements in mean TPI score were reported with the 67% and 45% NaHCO3 dentifrices compared with the 0% NaHCO3 dentifrice (p = 0.0003 and p = 0.0005, respectively). In Study 2, improvements in mean TPI score were statistically significantly greater with the 67% NaHCO3 dentifrice compared with both 0% NaHCO3 dentifrices (p < 0.0001 for both comparisons). All dentifrices were generally well tolerated. A single timed brushing with commercially available dentifrices containing 67% or 45% NaHCO3 exerted a significantly greater effect on plaque removal than commercially available dentifrices without NaHCO3.

Refining a complex diagnostic construct: subtyping Dysthymia with the Shedler-Westen Assessment Procedure-II.

PubMed

Huprich, Steven K; Defife, Jared; Westen, Drew

2014-01-01

We sought to determine whether meaningful subtypes of Dysthymic patients could be identified when grouping them by similar personality profiles. A random, national sample of psychiatrists and clinical psychologists (n=1201) described a randomly selected current patient with personality pathology using the descriptors in the Shedler-Westen Assessment Procedure-II (SWAP-II), completed assessments of patients' adaptive functioning, and provided DSM-IV Axis I and II diagnoses. We applied Q-factor cluster analyses to those patients diagnosed with Dysthymic Disorder. Four clusters were identified-High Functioning, Anxious/Dysphoric, Emotionally Dysregulated, and Narcissistic. These factor scores corresponded with a priori hypotheses regarding diagnostic comorbidity and level of adaptive functioning. We compared these groups to diagnostic constructs described and empirically identified in the past literature. The results converge with past and current ideas about the ways in which chronic depression and personality are related and offer an enhanced means by which to understand a heterogeneous diagnostic category that is empirically grounded and clinically useful. © 2013 Published by Elsevier B.V.

Postoperative radiotherapy and tumor recurrence after complete resection of stage II/III thymic tumor: a meta-analysis of cohort studies.

PubMed

Ma, Jietao; Sun, Xin; Huang, Letian; Xiong, Zhicheng; Yuan, Meng; Zhang, Shuling; Han, Cheng-Bo

2016-01-01

Whether postoperative radiotherapy (PORT) is effective for reducing the recurrence risk in patients who received complete resection of the stage II or III thymic tumors has not been determined. A meta-analysis was performed by combining the results of all available controlled trials. PubMed, Cochrane's Library, and the Embase databases were searched for studies which compared the recurrence data for patients with complete resection of the stage II or III thymic tumors assigned to an observing group, or a PORT group. A random effect model was applied to combine the results. Nineteen studies, all designed as retrospective cohort studies were included. These studies included 663 patients of PORT group and 617 patients of observing group. The recurrence rate for the patients in PORT group and observing group were 12.4% and 11.5%, respectively. Results of our study indicated that PORT has no significant influence on recurrent risk in patients with stage II or III thymic tumor after complete resection (odds ratio 1.02, 95% confidence interval 0.55-1.90, P=0.96). When stratified by stages, our meta-analyses did not indicate any significant effects of PORT on recurrent outcomes in either the stage II or the stage III patients. Moreover, subsequent analysis limited to studies only including patients with thymoma or thymic carcinoma also did not support the benefits of PORT on recurrent outcomes. Although derived from retrospective cohort studies, current evidence did not support any benefit of PORT on recurrent risk in patients with complete resection of the stage II or III thymic tumors.

Characteristics of a random sample of emergency food program users in New York: II. Soup kitchens.

PubMed Central

Bowering, J; Clancy, K L; Poppendieck, J

1991-01-01

A random sample of soup kitchen clients in New York City was studied and specific comparisons made on various parameters including homelessness. Compared with the general population of low income persons, soup kitchen users were overwhelmingly male, disproportionately African-American, and more likely to live alone. The homeless (41 percent of the sample) were less likely to receive food stamps or free food, or to use food pantries. Fewer of them received Medicaid or had health insurance. Forty-seven percent had no income in contrast to 29 percent of the total sample. PMID:2053673

Alveolar ridge augmentation by connective tissue grafting using a pouch method and modified connective tissue technique: A prospective study

PubMed Central

Agarwal, Ashish; Gupta, Narinder Dev

2015-01-01

Background: Localized alveolar ridge defect may create physiological and pathological problems. Developments in surgical techniques have made it simpler to change the configuration of a ridge to create a more aesthetic and more easily cleansable shape. The purpose of this study was to compare the efficacy of alveolar ridge augmentation using a subepithelial connective tissue graft in pouch and modified connective tissue graft technique. Materials and Methods: In this randomized, double blind, parallel and prospective study, 40 non-smoker individuals with 40 class III alveolar ridge defects in maxillary anterior were randomly divided in two groups. Group I received modified connective tissue graft, while group II were treated with subepithelial connective tissue graft in pouch technique. The defect size was measured in its horizontal and vertical dimension by utilizing a periodontal probe in a stone cast at base line, after 3 months, and 6 months post surgically. Analysis of variance and Bonferroni post-hoc test were used for statistical analysis. A two-tailed P < 0.05 was considered to be statistically significant. Results: Mean values in horizontal width after 6 months were 4.70 ± 0.87 mm, and 4.05 ± 0.89 mm for group I and II, respectively. Regarding vertical heights, obtained mean values were 4.75 ± 0.97 mm and 3.70 ± 0.92 mm for group I and group II, respectively. Conclusion: Within the limitations of this study, connective tissue graft proposed significantly more improvement as compare to connective tissue graft in pouch. PMID:26759591

Efficacy of inhaled HYdrogen on neurological outcome following BRain Ischemia During post-cardiac arrest care (HYBRID II trial): study protocol for a randomized controlled trial.

PubMed

Tamura, Tomoyoshi; Hayashida, Kei; Sano, Motoaki; Onuki, Shuko; Suzuki, Masaru

2017-10-23

Hydrogen gas inhalation (HI) improved survival and neurological outcomes in an animal model of post-cardiac arrest syndrome (PCAS). The feasibility and safety of HI for patients with PCAS was confirmed in a pilot study. The objective of this study is to evaluate the efficacy of HI for patients with PCAS. The efficacy of inhaled HYdrogen on neurological outcome following BRain Ischemia During post-cardiac arrest care (HYBRID II) trial is an investigator-initiated, randomized, double-blind, placebo-controlled trial designed to enroll 360 adult comatose (Glasgow Coma Scale score < 8) patients who will be resuscitated following an out-of-hospital cardiac arrest of a presumed cardiac cause. The patients will be randomized (1:1) to either the HI or control group. Patients in the HI group will inhale 2% hydrogen with 24% to 50% oxygen, and those in the control group will inhale 24% to 50% oxygen for 18 h after admission via mechanical ventilation. Multidisciplinary post-arrest care, including targeted temperature management (TTM) between 33 °C and 36 °C, will be provided in accordance with the latest guidelines. The primary outcome of interest is the 90-day neurological outcome, as evaluated using the Cerebral Performance Categories scale (CPC). The secondary outcomes of interest are the 90-day survival rate and other neurological outcomes. This study will provide 80% power to detect a 15% change in the proportion of patients with good neurological outcomes (CPCs of 1 and 2), from 50% to 65%, with an overall significance level of 0.05. The first multicenter randomized trial is underway to confirm the efficacy of HI on neurological outcomes in comatose out-of-hospital cardiac arrest survivors. Our study has the potential to address HI as an appealing and innovative therapeutic strategy for PCAS in combination with TTM. University Hospital Medical Information Network (UMIN), 000019820 . Registered on 17 November 2015.

Rationale and design of the allogeneiC human mesenchymal stem cells (hMSC) in patients with aging fRAilTy via intravenoUS delivery (CRATUS) study: A phase I/II, randomized, blinded and placebo controlled trial to evaluate the safety and potential efficacy of allogeneic human mesenchymal stem cell infusion in patients with aging frailty.

PubMed

Golpanian, Samuel; DiFede, Darcy L; Pujol, Marietsy V; Lowery, Maureen H; Levis-Dusseau, Silvina; Goldstein, Bradley J; Schulman, Ivonne H; Longsomboon, Bangon; Wolf, Ariel; Khan, Aisha; Heldman, Alan W; Goldschmidt-Clermont, Pascal J; Hare, Joshua M

2016-03-15

Frailty is a syndrome associated with reduced physiological reserves that increases an individual's vulnerability for developing increased morbidity and/or mortality. While most clinical trials have focused on exercise, nutrition, pharmacologic agents, or a multifactorial approach for the prevention and attenuation of frailty, none have studied the use of cell-based therapies. We hypothesize that the application of allogeneic human mesenchymal stem cells (allo-hMSCs) as a therapeutic agent for individuals with frailty is safe and efficacious. The CRATUS trial comprises an initial non-blinded phase I study, followed by a blinded, randomized phase I/II study (with an optional follow-up phase) that will address the safety and pre-specified beneficial effects in patients with the aging frailty syndrome. In the initial phase I protocol, allo-hMSCs will be administered in escalating doses via peripheral intravenous infusion (n=15) to patients allocated to three treatment groups: Group 1 (n=5, 20 million allo-hMSCs), Group 2 (n=5, 100 million allo-hMSCs), and Group 3 (n=5, 200 million allo-hMSCs). Subsequently, in the randomized phase, allo-hMSCs or matched placebo will be administered to patients (n=30) randomly allocated in a 1:1:1 ratio to one of two doses of MSCs versus placebo: Group A (n=10, 100 million allo-hMSCs), Group B (n=10, 200 million allo-hMSCs), and Group C (n=10, placebo). Primary and secondary objectives are, respectively, to demonstrate the safety and efficacy of allo-hMSCs administered in frail older individuals. This study will determine the safety of intravenous infusion of stem cells and compare phenotypic outcomes in patients with aging frailty.

A randomized, clinical trial to assess the relative efficacy and tolerability of two doses of etoricoxib versus naproxen in patients with ankylosing spondylitis.

PubMed

Balazcs, Eva; Sieper, Joachim; Bickham, Kara; Mehta, Anish; Frontera, Nancy; Stryszak, Paul; Popmihajlov, Zoran; Peloso, Paul M

2016-10-13

This study evaluated two doses of etoricoxib (60 and 90 mg) vs. naproxen 1000 mg in subjects with ankylosing spondylitis (AS). This was a 2-part, double-blind, active comparator-controlled non-inferiority study in subjects ≥18 years of age with AS. In Part I, subjects were randomized to naproxen 1000 mg; etoricoxib 60 mg, and 90 mg. In Part II, naproxen and etoricoxib 90 mg subjects continued on the same treatment; subjects on etoricoxib 60 mg either continued on 60 mg or escalated to 90 mg. Part I (6 weeks) assessed the efficacy of A) etoricoxib 60 mg vs. naproxen and B) 90 mg vs. naproxen according to the time-weighted average change from baseline in Spinal Pain Intensity (SPI; 0-100 mm VAS) (primary endpoint). The non-inferiority margin was set at 8 mm for SPI. In Part II (20 weeks) we evaluated the potential benefit of increasing from 60 to 90 mg (predefined minimum clinically important difference = 6 mm in SPI) for inadequate responders (<50 % improvement from baseline in SPI) on etoricoxib 60 mg in Part I. In total, 1015 subjects were randomized to receive etoricoxib 60 mg (N = 702), etoricoxib 90 mg (N = 156), and naproxen 1000 mg (N = 157); 70.9 % were male and the mean age was 45.2 years. There were 919 subjects who completed Part I and all continued to Part II. In Part I, SPI change was non-inferior for both etoricoxib doses vs. naproxen. In both Part I and II, the incidence of adverse events (AEs), drug-related AEs, and serious adverse events (SAEs) were similar between the 3 treatment groups. Both doses of etoricoxib were non-inferior to naproxen. All treatments were well tolerated. Etoricoxib 60 and 90 mg effectively control pain in patients with AS, with 60 mg once daily as the lowest effective dose for most patients. Clinical Trials Registry # NCT01208207 . Registered on 22 September 2010.

RECURRENT STROKE IN THE WARFARIN VERSUS ASPIRIN IN REDUCED EJECTION FRACTION (WARCEF) TRIAL

PubMed Central

Pullicino, Patrick M.; Qian, Min; Sacco, Ralph L.; Freudenberger, Ron; Graham, Susan; Teerlink, John R.; Mann, Douglas; Di Tullio, Marco R.; Ponikowski, Piotr; Lok, Dirk J.; Anker, Stefan D.; Lip, Gregory Y.H.; Estol, Conrado J.; Levin, Bruce; Mohr, J.P.; Thompson, John L. P.; Homma, Shunichi

2014-01-01

Background and Purpose WARCEF randomized 2305 patients in sinus rhythm with ejection fraction (EF) ≤35% to warfarin (INR 2.0–3.5) or aspirin 325 mg. Warfarin reduced the incident ischemic stroke (IIS) hazard rate by 48% over aspirin in a secondary analysis. The IIS rate in heart failure (HF) is too low to warrant routine anticoagulation but epidemiologic studies show that prior stroke increases the stroke risk in HF. We here explore IIS rates in WARCEF patients with and without baseline stroke to look for risk factors for IIS and determine if a subgroup with an IIS rate high enough to give a clinically relevant stroke risk reduction can be identified. Methods We compared potential stroke risk factors between patients with baseline stroke and those without using the exact conditional score test for Poisson variables. We looked for risk factors for IIS, by comparing IIS rates between different risk factors. For EF we tried cutoff points of 10%, 15% and 20%. 15% was used as it was the highest EF that was associated with a significant increase in IIS rate. IIS and EF strata were balanced as to warfarin/aspirin assignment by the stratified randomized design. A multiple Poisson regression examined the simultaneous effects of all risk factors on IIS rate. IIS rates per hundred patient years (/100PY) were calculated in patient groups with significant risk factors. Missing values were assigned the modal value. Results Twenty of 248 (8.1%) patients with baseline stroke and 64 of 2048 (3.1%) without had IIS. IIS rate in patients with baseline stroke (2.37/100PY) was greater than patients without (0.89/100PY)(rate ratio 2.68, p<0.001). Fourteen of 219 (6.4%) patients with ejection fraction (EF)<15% and 70 of 2079 (3.4%) with EF ≥15% had IIS. In the multiple regression analysis stroke at baseline (p<0.001) and EF<15% vs. ≥15% (p=.005) remained significant predictors of IIS. IIS rate was 2.04/100PY in patients with EF<15% and 0.95/100PY in patients with EF ≥15% (p=0.009). IIS rate in patients with baseline stroke and reduced EF was 5.88/100PY with EF<15% decreasing to 2.62/100PY with EF<30%. Conclusions In a WARCEF exploratory analysis, prior stroke and EF<15% were risk factors for IIS. Further research is needed to determine if a clinically relevant stroke risk reduction is obtainable with warfarin in HF patients with prior stroke and reduced EF. PMID:25300706

Complementary and Alternative Approaches to Pain Relief During Labor

PubMed Central

Theau-Yonneau, Anne

2007-01-01

This review evaluated the effect of complementary and alternative medicine on pain during labor with conventional scientific methods using electronic data bases through 2006 were used. Only randomized controlled trials with outcome measures for labor pain were kept for the conclusions. Many studies did not meet the scientific inclusion criteria. According to the randomized control trials, we conclude that for the decrease of labor pain and/or reduction of the need for conventional analgesic methods: (i) There is an efficacy found for acupressure and sterile water blocks. (ii) Most results favored some efficacy for acupuncture and hydrotherapy. (iii) Studies for other complementary or alternative therapies for labor pain control have not shown their effectiveness. PMID:18227907

A prospective randomized trial comparing Foley catheter, oxytocin, and combination Foley catheter-oxytocin for labour induction with unfavourable cervix.

PubMed

El Khouly, Nabih I

2017-04-01

The purpose of this study was to evaluate the effectiveness and safety of transcervical Foley catheter with and without oxytocin versus oxytocin alone for labour induction with unfavourable cervix. This trial enrolled 108 women with singleton pregnancies presented for labour induction with unfavourable cervix. Patients were randomly assigned to receive Foley catheter alone (I), Foley catheter plus oxytocin (II) or oxytocin alone (III). Outcomes were analysed in terms of success of induction, induction delivery interval, route of delivery, dose and duration of oxytocin, and complications. Successful normal vaginal delivery was more common in group I (p = .02) compared to group III. Induction delivery time was statistically shorter in group II and group III (p < .001). Patients in group I required significantly less oxytocin dose and duration (p < .001). This led to our conclusion that induction of labour with Foley catheter without oxytocin increases success rate of normal vaginal delivery; however, it has a longer induction delivery interval with similar complications.

Resource Input, Service Process and Resident Activity Indicators in a Welsh National Random Sample of Staffed Housing Services for People with Intellectual Disabilities

ERIC Educational Resources Information Center

Felce, David; Perry, Jonathan

2004-01-01

Background: The aims were to: (i) explore the association between age and size of setting and staffing per resident; and (ii) report resident and setting characteristics, and indicators of service process and resident activity for a national random sample of staffed housing provision. Methods: Sixty settings were selected randomly from those…

Local Treatment of Unresectable Colorectal Liver Metastases: Results of a Randomized Phase II Trial

PubMed Central

Van Coevorden, Frits; Punt, Cornelis J. A.; Pierie, Jean-Pierre E. N.; Borel-Rinkes, Inne; Ledermann, Jonathan A.; Poston, Graeme; Bechstein, Wolf; Lentz, Marie-Ange; Mauer, Murielle; Folprecht, Gunnar; Van Cutsem, Eric; Ducreux, Michel; Nordlinger, Bernard

2017-01-01

Background: Tumor ablation is often employed for unresectable colorectal liver metastases. However, no survival benefit has ever been demonstrated in prospective randomized studies. Here, we investigate the long-term benefits of such an aggressive approach. Methods: In this randomized phase II trial, 119 patients with unresectable colorectal liver metastases (n < 10 and no extrahepatic disease) received systemic treatment alone or systemic treatment plus aggressive local treatment by radiofrequency ablation ± resection. Previously, we reported that the primary end point (30-month overall survival [OS] > 38%) was met. We now report on long-term OS results. All statistical tests were two-sided. The analyses were according to intention to treat. Results: At a median follow up of 9.7 years, 92 of 119 (77.3%) patients had died: 39 of 60 (65.0%) in the combined modality arm and 53 of 59 (89.8%) in the systemic treatment arm. Almost all patients died of progressive disease (35 patients in the combined modality arm, 49 patients in the systemic treatment arm). There was a statistically significant difference in OS in favor of the combined modality arm (hazard ratio [HR] = 0.58, 95% confidence interval [CI] = 0.38 to 0.88, P = .01). Three-, five-, and eight-year OS were 56.9% (95% CI = 43.3% to 68.5%), 43.1% (95% CI = 30.3% to 55.3%), 35.9% (95% CI = 23.8% to 48.2%), respectively, in the combined modality arm and 55.2% (95% CI = 41.6% to 66.9%), 30.3% (95% CI = 19.0% to 42.4%), 8.9% (95% CI = 3.3% to 18.1%), respectively, in the systemic treatment arm. Median OS was 45.6 months (95% CI = 30.3 to 67.8 months) in the combined modality arm vs 40.5 months (95% CI = 27.5 to 47.7 months) in the systemic treatment arm. Conclusions: This phase II trial is the first randomized study demonstrating that aggressive local treatment can prolong OS in patients with unresectable colorectal liver metastases. PMID:28376151

Local Treatment of Unresectable Colorectal Liver Metastases: Results of a Randomized Phase II Trial.

PubMed

Ruers, Theo; Van Coevorden, Frits; Punt, Cornelis J A; Pierie, Jean-Pierre E N; Borel-Rinkes, Inne; Ledermann, Jonathan A; Poston, Graeme; Bechstein, Wolf; Lentz, Marie-Ange; Mauer, Murielle; Folprecht, Gunnar; Van Cutsem, Eric; Ducreux, Michel; Nordlinger, Bernard

2017-09-01

Tumor ablation is often employed for unresectable colorectal liver metastases. However, no survival benefit has ever been demonstrated in prospective randomized studies. Here, we investigate the long-term benefits of such an aggressive approach. In this randomized phase II trial, 119 patients with unresectable colorectal liver metastases (n < 10 and no extrahepatic disease) received systemic treatment alone or systemic treatment plus aggressive local treatment by radiofrequency ablation ± resection. Previously, we reported that the primary end point (30-month overall survival [OS] > 38%) was met. We now report on long-term OS results. All statistical tests were two-sided. The analyses were according to intention to treat. At a median follow up of 9.7 years, 92 of 119 (77.3%) patients had died: 39 of 60 (65.0%) in the combined modality arm and 53 of 59 (89.8%) in the systemic treatment arm. Almost all patients died of progressive disease (35 patients in the combined modality arm, 49 patients in the systemic treatment arm). There was a statistically significant difference in OS in favor of the combined modality arm (hazard ratio [HR] = 0.58, 95% confidence interval [CI] = 0.38 to 0.88, P = .01). Three-, five-, and eight-year OS were 56.9% (95% CI = 43.3% to 68.5%), 43.1% (95% CI = 30.3% to 55.3%), 35.9% (95% CI = 23.8% to 48.2%), respectively, in the combined modality arm and 55.2% (95% CI = 41.6% to 66.9%), 30.3% (95% CI = 19.0% to 42.4%), 8.9% (95% CI = 3.3% to 18.1%), respectively, in the systemic treatment arm. Median OS was 45.6 months (95% CI = 30.3 to 67.8 months) in the combined modality arm vs 40.5 months (95% CI = 27.5 to 47.7 months) in the systemic treatment arm. This phase II trial is the first randomized study demonstrating that aggressive local treatment can prolong OS in patients with unresectable colorectal liver metastases. © The Author 2017. Published by Oxford University Press.

ABSORB II randomized controlled trial: a clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions: rationale and study design.

PubMed

Diletti, Roberto; Serruys, Patrick W; Farooq, Vasim; Sudhir, Krishnankutty; Dorange, Cecile; Miquel-Hebert, Karine; Veldhof, Susan; Rapoza, Richard; Onuma, Yoshinobu; Garcia-Garcia, Hector M; Chevalier, Bernard

2012-11-01

Currently, no data are available on the direct comparison between the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) and conventional metallic drug-eluting stents. The ABSORB II study is a randomized, active-controlled, single-blinded, multicenter clinical trial aiming to compare the second-generation Absorb BVS with the XIENCE everolimus-eluting metallic stent. Approximately 501 subjects will be enrolled on a 2:1 randomization basis (Absorb BVS/XIENCE stent) in approximately 40 investigational sites across Europe and New Zealand. Treated lesions will be up to 2 de novo native coronary artery lesions, each located in different major epicardial vessels, all with an angiographic maximal luminal diameter between 2.25 and 3.8 mm as estimated by online quantitative coronary angiography (QCA) and a lesion length of ≤48 mm. Clinical follow-up is planned at 30 and 180 days and at 1, 2, and 3 years. All subjects will undergo coronary angiography, intravascular ultrasound (IVUS) and IVUS-virtual histology at baseline (pre-device and post-device implantation) and at 2-year angiographic follow-up. The primary end point is superiority of the Absorb BVS vs XIENCE stent in terms of vasomotor reactivity of the treated segment at 2 years, defined as the QCA quantified change in the mean lumen diameter prenitrate and postnitrate administration. The coprimary end point is the noninferiority (reflex to superiority) of the QCA-derived minimum lumen diameter at 2 years postnitrate minus minimum lumen diameter postprocedure postnitrate by QCA. In addition, all subjects allocated to the Absorb BVS group will undergo multislice computed tomography imaging at 3 years. The ABSORB II randomized controlled trial (ClinicalTrials.gov NCT01425281) is designed to compare the safety, efficacy, and performance of Absorb BVS against the XIENCE everolimus-eluting stent in the treatment of de novo native coronary artery lesions. Copyright © 2012 Mosby, Inc. All rights reserved.

Side effects from intense pulsed light: Importance of skin pigmentation, fluence level and ultraviolet radiation-A randomized controlled trial.

PubMed

Thaysen-Petersen, Daniel; Erlendsson, Andres M; Nash, J F; Beerwerth, Frank; Philipsen, Peter A; Wulf, Hans C; Paasch, Uwe; Haedersdal, Merete

2017-01-01

Intense pulsed light (IPL) is a mainstream treatment for hair removal. Side effects after IPL are known, but risk factors remain to be investigated. The objective of this study was to assess the contribution of skin pigmentation, fluence level, and ultraviolet radiation (UVR) on IPL-induced side effects. The study was a blinded, randomized intra-individual controlled trial including 16 healthy subjects with Fitzpatrick Skin Types (FST) II-V. Three test areas were each divided into four sites, randomized to a single IPL exposure of 22, 34, 46 J/cm 2 or triple stacking of 46 J/cm 2 . Areas were subsequently randomized to no UVR or single solar-simulated UVR exposure of 3 Standard Erythema Dose at 30 minutes or 24 hours after IPL. Each area had a corresponding control, resulting in 15 treatment sites. Follow-up visits were scheduled up to 4 weeks after IPL. Outcome measures were: (i) blinded clinical skin reactions; (ii) objectively measured erythema and pigmentation; (iii) pain measured by visual analog scale (VAS); (iv) histology (H&E, Fontana-Masson); and (v) mRNA-expression of p53. Fifteen subjects with FST II-IV completed the protocol. IPL induced a wide range of skin reactions, including erythema (87% of subjects), purpura (27%), blisters (20%), edema (13%), crusting (13%), hyper- (60%), and hypopigmentation (20%). Darker skin pigmentation and increasing IPL fluence were determinants for IPL-induced side effects (P ≤ 0.002), while a single exposure of UVR did not exacerbate side effects (P ≥ 0.180). Clinical findings were confirmed objectively by reflectance spectrometry and qualitatively by histological changes in skin architecture, inflammatory infiltration, and pigmentation. Marker of cellular DNA damage, that is, p53, did not increase after IPL (P ≥ 0.24). Skin pigmentation and IPL fluence are major determinants of side effects after IPL exposure, while a single exposure to three SED of UVR at 30 minutes or 24 hours after IPL, does not amplify such side effects. Lasers Surg. Med. 49:88-96, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Inhibition of calcium/calmodulin kinase II alpha subunit expression results in epileptiform activity in cultured hippocampal neurons.

PubMed

Churn, S B; Sombati, S; Jakoi, E R; Severt, L; DeLorenzo, R J; Sievert, L

2000-05-09

Several models that develop epileptiform discharges and epilepsy have been associated with a decrease in the activity of calmodulin-dependent kinase II. However, none of these studies has demonstrated a causal relationship between a decrease in calcium/calmodulin kinase II activity and the development of seizure activity. The present study was conducted to determine the effect of directly reducing calcium/calmodulin-dependent kinase activity on the development of epileptiform discharges in hippocampal neurons in culture. Complimentary oligonucleotides specific for the alpha subunit of the calcium/calmodulin kinase were used to decrease the expression of the enzyme. Reduction in kinase expression was confirmed by Western analysis, immunocytochemistry, and exogenous substrate phosphorylation. Increased neuronal excitability and frank epileptiform discharges were observed after a significant reduction in calmodulin kinase II expression. The epileptiform activity was a synchronous event and was not caused by random neuronal firing. Furthermore, the magnitude of decreased kinase expression correlated with the increased neuronal excitability. The data suggest that decreased calmodulin kinase II activity may play a role in epileptogenesis and the long-term plasticity changes associated with the development of pathological seizure activity and epilepsy.

Inhibition of calcium/calmodulin kinase II alpha subunit expression results in epileptiform activity in cultured hippocampal neurons

PubMed Central

Churn, Severn B.; Sombati, Sompong; Jakoi, Emma R.; Sievert, Lawrence; DeLorenzo, Robert J.

2000-01-01

Several models that develop epileptiform discharges and epilepsy have been associated with a decrease in the activity of calmodulin-dependent kinase II. However, none of these studies has demonstrated a causal relationship between a decrease in calcium/calmodulin kinase II activity and the development of seizure activity. The present study was conducted to determine the effect of directly reducing calcium/calmodulin-dependent kinase activity on the development of epileptiform discharges in hippocampal neurons in culture. Complimentary oligonucleotides specific for the α subunit of the calcium/calmodulin kinase were used to decrease the expression of the enzyme. Reduction in kinase expression was confirmed by Western analysis, immunocytochemistry, and exogenous substrate phosphorylation. Increased neuronal excitability and frank epileptiform discharges were observed after a significant reduction in calmodulin kinase II expression. The epileptiform activity was a synchronous event and was not caused by random neuronal firing. Furthermore, the magnitude of decreased kinase expression correlated with the increased neuronal excitability. The data suggest that decreased calmodulin kinase II activity may play a role in epileptogenesis and the long-term plasticity changes associated with the development of pathological seizure activity and epilepsy. PMID:10779547

Clinical efficacy of Manasamitra Vataka (an Ayurveda medication) on generalized anxiety disorder with comorbid generalized social phobia: a randomized controlled study.

PubMed

Tubaki, Basavaraj R; Chandrashekar, Channapatna R; Sudhakar, Deverakonda; Prabha, Talakad N Sathya; Lavekar, Gandhidas S; Kutty, Bindu M

2012-06-01

Studies on alternative medicines for generalized anxiety disorder (GAD) are few. Manasamitra Vataka (an Ayurveda preparation) is explored for its efficacy in patients with GAD with comorbid generalized social phobia. Seventy-two (72) patients with GAD with comorbid social phobia meeting DSM IV TR criteria, and who were between the ages of 20 and 55 of either sex, participated in the study. They were randomly divided into three treatment groups: Group 1 (n=24) and Group II (n=24) received Manasamitra Vataka tablets (100 mg twice daily for 30 days). Group II, in addition to Manasamitra Vataka, underwent Shirodhara (therapy involving dripping of medicated oil [Brahmi tail] over the forehead) treatment for the first 7 days. Group III (n=24) received clonazepam 0.75 mg daily in divided dose for 30 days. The assessment of the study was done using the Hamilton Anxiety Rating Scale, Beck Anxiety Inventory, Beck Depression Inventory, Epworth Sleepiness Scale (ESS), World Health Organization Quality of Life BREF, and Clinical Global Impression scales (Improvement and Efficacy). Patients from all the groups showed significant reduction in clinical parameters evaluated. However, improvement in ESS was observed only in Group II. The treatment outcome was comparable between the three groups. This is the first study conducted on the efficacy of Manasamitra Vataka in anxiety disorders. The results suggest that Manasamitra Vataka is effective in the management GAD with comorbid generalized social phobia. Add-on effect of Shirodhara reduced the daytime sleepiness. Further studies on Manasamitra Vataka need to be carried out to judge its potential as a first-line treatment modality.

Gender affects renal vasoconstrictor response to Ang I and Ang II.

PubMed

Gandhi, S K; Gainer, J; King, D; Brown, N J

1998-01-01

This study tested the hypothesis that gender affects the pressor and renal vasoconstrictor responses to angiotensin (Ang) I and Ang II in salt-replete normotensive subjects. Ang I and Ang II were infused in graded doses into 9 men and 8 women in a randomized, single-blind, crossover study. There were no differences between genders in baseline blood pressure, heart rate, sodium excretion, renal plasma flow, angiotensin-converting enzyme (ACE) genotype, ACE activity, plasma renin activity, aldosterone, or Ang II levels. Although pressor responses to Ang I and Ang II were similar in men and women, there was a negative relationship between the change in mean arterial pressure and the change in heart rate during Ang I and II infusion in women only. The half-time of the pressor response after discontinuation of Ang I but not Ang II infusion was greater in men than in women (9.5+/-2.2 versus 4.3+/-2.1 minutes, P<.05). This difference in duration did not result from gender differences in the metabolism of Ang I because Ang II levels measured during Ang I infusion were identical in men and women. In contrast, the renal vasoconstrictor response to Ang I and Ang II was significantly increased in women compared with that in men (Ang I, -243+/-31 versus -138+/-13 U/1.73 m2; Ang II, -233+/-25 versus -175+/-18 U/1.73 m2; P<.03). These data suggest an effect of gender on baroreflex reactivity during angiotensin infusion. Moreover, in the setting of similar Ang II concentrations, the dramatic difference in the renal vasoconstrictor responses to Ang I and Ang II between salt-replete men and salt-replete women suggests gender differences at a pharmacodynamic level.

Effect of picroside II on hind limb ischemia reperfusion injury in rats

PubMed Central

Kılıç, Yiğit; Özer, Abdullah; Tatar, Tolga; Zor, Mustafa Hakan; Kirişçi, Mehmet; Kartal, Hakan; Dursun, Ali Doğan; Billur, Deniz; Arslan, Mustafa; Küçük, Ayşegül

2017-01-01

Introduction Many structural and functional damages are observed in cells and tissues after reperfusion of previously viable ischemic tissues. Acute ischemia reperfusion (I/R) injury of lower extremities occurs especially when a temporary cross-clamp is applied to the abdominal aorta during aortic surgery. Research regarding the treatment of I/R injury has been increasing day-by-day. In this study, we aimed to investigate the effect of picroside II on skeletal muscle of rats experiencing simulated I/R. Materials and methods Twenty-four male Wistar albino rats weighing between 210 and 300 g were used in this study. Rats were randomly divided into 4 groups of 6 rats each (control, I/R, control + picroside II, and I/R + picroside II). The infrarenal section of the abdominal aorta was occluded with an atraumatic microvascular clamp in I/R group. The clamp was removed after 120 minutes and reperfusion was provided for a further 120 minutes. Picroside II (10 mg kg−1) was administered intraperitoneally to the animals in control + picroside II and I/R + picroside II groups. At the end of the study, skeletal muscle tissue was obtained for the determination of total oxidant status (TOS) and total antioxidant status (TAS) levels. Apoptosis was evaluated by TUNEL experiment. Results TOS levels were significantly higher in I/R group than that of control and I/R + picroside II groups (P=0.014, P=0.005, respectively). TAS levels were significantly higher in I/R group than that of control and I/R + picroside II groups (P=0.007 P=0.005, respectively). TUNEL assay revealed that picroside II reduced cell necrosis. Conclusion The results of this study demonstrated that picroside II plays a critical role to prevent I/R injury. Even though our results were found to be satisfactory, it should be encouraging to those who want to conduct future research on this topic. PMID:28721011

Divergences between clinical and research methods for assessing personality disorders: implications for research and the evolution of axis II.

PubMed

Westen, D

1997-07-01

The purpose of this study was to examine the extent to which instruments for assessing axis II diverge from clinical diagnostic processes. Subjects in the first study were 52 clinicians with experience in assessment and treatment of patients with personality disorders, who were surveyed about the methods they use in clinical practice to make diagnoses and other aspects of the diagnostic process. A second study replicated the major findings with a random national sample of 1,901 experienced psychiatrists and psychologists. Whereas current instruments rely primarily on direct questions derived from DSM-IV, clinicians of every theoretical persuasion found direct questions useful for assessing axis I disorders but only marginally so for axis II. They made axis II diagnoses, instead, by listening to patients describe interpersonal interactions and observing their behavior with the interviewer. In contrast to findings with current research instruments, most patients with personality disorders in clinical practice receive only one axis II diagnosis, and if they receive more than one, one is considered primary. Clinicians reported treating a substantial number of patients for enduring personality patterns that current axis II instruments do not assess, many of which meet neither axis I nor axis II criteria, notably problems with relatedness, work, self-esteem, and chronic subclinical depressive traits. Measurements of axis II were constructed by using a model derived from axis I instruments that diverges from clinical diagnostic procedures in a way that may be problematic for the assessment of personality disorders and the development of a more clinically and empirically sound taxonomy.

Finite Birth-and-Death Models in Randomly Changing Environments.

DTIC Science & Technology

1982-02-01

7 AD-AL14 188 NAVAL POSTGRADUATE SCHOOL MONTEREY CA F/ 12/2 FINITE BIRTH-AND-DEATH MODELS IN RANDOMLY CHANGING ENVROENTS-(TC(U) FEB 82 D P 6AVER...Monterey, California DTIC $ELECTEMAY6 1982 B FINITE BIRTH-AND-DEATH MODELS IN RANDOMLY CHANGING ENVIRONMENTS by D. P. Gayer P. A. Jacobs G. Latouche February...CATALOG NUMUEi4NPS55-82-007 [iI. (. 4. TITLE (d Subtitle) S. TYPE OF REPORT A PERIOO COVERED FINITE BIRTH-AND-DEATH MODELS IN RANDOMLY Technical

The Effects of a Responsive Parenting Intervention on Parent-Child Interactions during Shared Book Reading

ERIC Educational Resources Information Center

Landry, Susan H.; Smith, Karen E.; Swank, Paul R.; Zucker, Tricia; Crawford, April D.; Solari, Emily F.

2012-01-01

This study examined mother-child shared book reading behaviors before and after participation in a random-assignment responsive parenting intervention called Play and Learning Strategies (PALS) that occurred during infancy (PALS I), the toddler-preschool (PALS II) period, or both as compared with a developmental assessment (DAS) intervention (DAS…

Efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer: a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II study.

PubMed

Yokota, T; Ogawa, T; Takahashi, S; Okami, K; Fujii, T; Tanaka, K; Iwae, S; Ota, I; Ueda, T; Monden, N; Matsuura, K; Kojima, H; Ueda, S; Sasaki, K; Fujimoto, Y; Hasegawa, Y; Beppu, T; Nishimori, H; Hirano, S; Naka, Y; Matsushima, Y; Fujii, M; Tahara, M

2017-05-05

Recent preclinical and phase I studies have reported that rebamipide decreased the severity of chemoradiotherapy-induced oral mucositis in patients with oral cancer. This placebo-controlled randomized phase II study assessed the clinical benefit of rebamipide in reducing the incidence of severe chemoradiotherapy-induced oral mucositis in patients with head and neck cancer (HNC). Patients aged 20-75 years with HNC who were scheduled to receive chemoradiotherapy were enrolled. Patients were randomized to receive rebamipide 2% liquid, rebamipide 4% liquid, or placebo. The primary endpoint was the incidence of grade ≥ 3 oral mucositis determined by clinical examination and assessed by central review according to the Common Terminology Criteria of Adverse Events version 3.0. Secondary endpoints were the time to onset of grade ≥ 3 oral mucositis and the incidence of functional impairment (grade ≥ 3) based on the evaluation by the Oral Mucositis Evaluation Committee. From April 2014 to August 2015, 97 patients with HNC were enrolled, of whom 94 received treatment. The incidence of grade ≥ 3 oral mucositis was 29% and 25% in the rebamipide 2% and 4% groups, respectively, compared with 39% in the placebo group. The proportion of patients who did not develop grade ≥ 3 oral mucositis by day 50 of treatment was 57.9% in the placebo group, whereas the proportion was 68.0% in the rebamipide 2% group and 71.3% in the rebamipide 4% group. The incidences of adverse events potentially related to the study drug were 16%, 26%, and 13% in the placebo, rebamipide 2%, and rebamipide 4% groups, respectively. There was no significant difference in treatment compliance among the groups. The present phase II study suggests that mouth washing with rebamipide may be effective and safe for patients with HNC receiving chemoradiotherapy, and 4% liquid is the optimal dose of rebamipide. ClinicalTrials.gov under the identifier NCT02085460 (the date of trial registration: March 11, 2014).

Cervical epidural injections in chronic discogenic neck pain without disc herniation or radiculitis: preliminary results of a randomized, double-blind, controlled trial.

PubMed

Manchikanti, Laxmaiah; Cash, Kimberly A; Pampati, Vidyasagar; Wargo, Bradley W; Malla, Yogesh

2010-01-01

Chronic neck pain is a common problem in the adult population with a typical 12-month prevalence of 30% to 50%. However, there is a lack of consensus regarding the causes and treatments of chronic neck pain. Despite limited evidence, cervical epidural injections are one of the commonly performed non-surgical interventions in the management of chronic neck pain. A randomized, double-blind, active control trial. An interventional pain management practice, a specialty referral center, a private practice setting in the United States. To evaluate the effectiveness of cervical interlaminar epidural injections with local anesthetic with or without steroids in the management of chronic neck pain with or without upper extremity pain in patients without disc herniation or radiculitis or facet joint pain. Patients without disc herniation or radiculitis and negative for facet joint pain by means of controlled diagnostic medial branch blocks were randomly assigned to one of 2 groups: injection of local anesthetic only or local anesthetic mixed with non-particulate betamethasone. Seventy patients were included in this analysis. Randomization was performed by computer-generated random allocation sequence by simple randomization. Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Neck Disability Index (NDI), employment status, and opioid intake with assessment at 3, 6, and 12 months post-treatment. Significant pain relief or functional status was defined as a 50% or more reduction. Significant pain relief (> or = 50%) was demonstrated in 80% of patients in both groups and functional status improvement (> or = 50%) in 69% of Group I and 80% of Group II. The overall average procedures per year were 3.9 +/- 1.01 in Group I and 3.9 +/- 0.8 in Group II with an average total relief per year of 40.3 +/- 14.1 weeks in Group I and 42.1 +/- 9.9 weeks in Group II over a period of 52 weeks in the successful group. The results of this study are limited by the lack of a placebo group and a preliminary report of 70 patients, with 35 patients in each group. Cervical interlaminar epidural injections with local anesthetic with or without steroids may be effective in patients with chronic function-limiting discogenic.

N-acetyl cysteine add-on treatment for bipolar II disorder: a subgroup analysis of a randomized placebo-controlled trial.

PubMed

Magalhães, P V; Dean, O M; Bush, A I; Copolov, D L; Malhi, G S; Kohlmann, K; Jeavons, S; Schapkaitz, I; Anderson-Hunt, M; Berk, M

2011-03-01

The evidence base for the pharmacological treatment of bipolar II disorder is limited. In bipolar disorder, there is evidence for glutathione depletion and increased oxidative stress, as well as dysregulation of glutamate; N-acetyl cysteine (NAC) has effects on both of these systems. Add-on NAC has been shown to have a significant benefit on depressive symptoms in a randomized placebo-controlled trial. In this report, we explore the effects of this compound in a subset of patients with bipolar II disorder from that trial. Individuals were randomized to NAC or placebo in addition to treatment as usual, in a double-blind fashion. Mood and functional outcomes were assessed up to 24 weeks of treatment. Fourteen individuals were available for this report, seven in each group. Six people achieved full remission of both depressive and manic symptoms in the NAC group; this was true for only two people in the placebo group (χ(2)=4.67, p=0.031). Subgroup analyses in a small subsample of patients. Not all participants had elevated depression scores at baseline. Notwithstanding all the limitations that subgroup analysis of trials carry, this data could serve as a hypothesis-generating stimulus for further clinical trials of pharmacologic treatment for bipolar II depression. Copyright © 2010 Elsevier B.V. All rights reserved.

Are written information or counseling (WOMAN-PRO II program) able to improve patient satisfaction and the delivery of health care of women with vulvar neoplasms? Secondary outcomes of a multicenter randomized controlled trial

PubMed

Gehrig, Larissa; Kobleder, Andrea; Werner, Birgit; Denhaerynck, Kris; Senn, Beate

2017-01-01

Background: Patients with vulvar neoplasms report a lack of information, missing support in self-management and a gap in delivery of health care. Aim: The aim of the study was to investigate if written information or counseling based on the WOMAN-PRO II program are able to improve patient satisfaction and the delivery of health care from the health professional's perspective of women with vulvar neoplasms. Method: Patient satisfaction and the delivery of health care have been investigated as two secondary outcomes in a multicenter randomized controlled parallel-group phase II study (Clinical Trial ID: NCT01986725). In total, 49 women, from four hospitals (CH, AUT), completed the questionnaire PACIC-S11 after written information (n = 13) and counseling (n = 36). The delivery of health care was evaluated by ten Advanced Practice Nurses (APNs) by using the G-ACIC before and after implementing counseling based on the WOMAN-PRO II program. Results: There were no significant differences between the two groups identified (p = 0.25). Only few aspects were rated highly by all women, such as the overall satisfaction (M = 80.3 %) and satisfaction with organization of care (M = 83.0 %). The evaluation of delivery of health care by APNs in women who received counseling improved significantly (p = 0.031). Conclusions: There are indications, that the practice of both interventions might have improved patient satisfaction and counseling the delivery of health care. The aspects that have been rated low in the PACIC-S11 and G-ACIC indicate possibilities to optimize the delivery of health care.

Ultrasonographic Evaluation of Zone II Partial Flexor Tendon Lacerations of the Fingers: A Cadaveric Study.

PubMed

Kazmers, Nikolas H; Gordon, Joshua A; Buterbaugh, Kristen L; Bozentka, David J; Steinberg, David R; Khoury, Viviane

2018-04-01

Accurate assessment of zone II partial flexor tendon lacerations in the finger is clinically important. Surgical repair is recommended for lacerations of greater than 50% to 60%. Our goal was to evaluate ultrasonographic test characteristics and accuracy in identifying partial flexor tendon lacerations in a cadaveric model. From fresh-frozen above-elbow human cadaveric specimens, 32 flexor digitorum profundus tendons were randomly selected to remain intact or receive low- or high-grade lacerations involving 10% to 40% and 60% to 90% of the radioulnar width within Verdan Zone II, respectively. Static and dynamic ultrasonography using a linear array 14-MHz transducer was performed by a blinded musculoskeletal radiologist. Sensitivities, specificities, and other standard test performance metrics were calculated. Actual and measured percentages of tendon laceration were compared by the paired t test. After randomization, 24 tendons were lacerated (12 low- and 12 high-grade), whereas 8 remained intact. The sensitivity and specificity in detecting the presence versus absence of a partial laceration were 0.54 and 0.75, respectively, with positive and negative likelihood ratio values of 2.17 and 0.61. For low-grade lacerations, the sensitivity and specificity were 0.25 and 0.85, compared to 0.83 and 0.85 for high-grade lacerations. Ultrasonography underestimated the percentage of tendon involvement by a mean of 18.1% for the study population as a whole (95% confidence interval, 9.0% to 27.2%; P < .001) but accurately determined the extent for correctly diagnosed high-grade lacerations (-6.7%; 95% confidence interval, -18.7% to 5.2%; P = .22). Ultrasonography was useful in identifying and characterizing clinically relevant high-grade zone II partial flexor digitorum profundus lacerations in a cadaveric model. © 2017 by the American Institute of Ultrasound in Medicine.

The Effect of Cinnamon on Glucose of Type II Diabetes Patients.

PubMed

Hasanzade, Farzaneh; Toliat, Maryam; Emami, Seyyed Ahmad; Emamimoghaadam, Zahra

2013-07-01

The incidence of type II diabetes is increasing across the world. Dietary modifications help the patients to control blood glucose. Traditional herbs and spices are commonly used for control of glucose among which cinnamon (Ròu Guì; Cinnamomum cassia) has the greatest effect. Research has shown that adding cinnamon to diet can help to lower the glucose level. The aim of this study was to determine the effect of cinnamon on the glucose level in blood. This was a Randomized clinical trial in which 70 Patients with type II diabetes were assigned randomly two groups (35 in cinnamon and 35 in placebo group). The groups were matched in terms of body mass index (BMI), HbAlc and fasting blood sugar (FBS). Patients were treated with cinnamon and the placebo group was treated with placebo in addition to their routine treatment for 60 days. FBG levels and glycosylated hemoglobin of patients on the first day, and 1 and 2 months after treatment were measured. Data were analyzed using t-test and paired t-test in Statistical Package for the Social Sciences (SPSS).16 software. The mean levels of FBS before, and 1 and 2 months after the intervention were 174 ± 59, 169 ± 43 and 177 ± 45; respectively. The levels of HbAlc before and after the intervention in the cinnamon group were (8.9 ± 1.7 and 8.9 ± 1.6). There was no significant difference in FBS and glycosylated hemoglobin levels between the two groups (P = 0.738 and P = 0.87, respectively). Results showed that using certain amount of cinnamon for 60 days did not change the glucose level of diabetic patients. So, using cinnamon to type II diabetes patients cannot be recommended and more studies are needed in future.

The Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) trial: rationale and design of a double-blind randomized trial of clomiphene citrate and letrozole for the treatment of infertility in women with polycystic ovary syndrome.

PubMed

Legro, Richard S; Kunselman, Allen R; Brzyski, Robert G; Casson, Peter R; Diamond, Michael P; Schlaff, William D; Christman, Gregory M; Coutifaris, Christos; Taylor, Hugh S; Eisenberg, Esther; Santoro, Nanette; Zhang, Heping

2012-05-01

Polycystic Ovary Syndrome (PCOS) is a common cause of female infertility and first line treatment is currently oral clomiphene citrate, a selective estrogen receptor modulator, which results in both a high nonresponse rate and multiple pregnancy rate. Aromatase inhibitors such as letrozole may have more favorable ovarian and endometrial effects. The goal of the Pregnancy in Polycystic Ovary Syndrome II (PPCOSII) study is to determine the safety and efficacy of clomiphene citrate (CC) compared to letrozole, in achieving live birth in infertile women with PCOS. The population will consist of 750 infertile women with PCOS. Additionally, the couple will have no other major infertility factor. This will be a multi-center, prospective, double-blind clinical trial of CC vs. letrozole for 5 treatment cycles (or approximately up to 25 weeks). The randomization scheme will be coordinated through the central data coordinating center (DCC) and the randomization is stratified by each participating site. After progestin withdrawal as needed, 750 women will be equally randomized to two different treatment arms: A) CC 50mg every day for 5 days (days 3-7 of cycle), or B) letrozole 2.5mg every day for 5 days (days 3-7 of cycle), for a total of 5 cycles or 25 weeks. The dose will be increased in subsequent cycles in both treatment groups for non-response or poor ovulatory response up to a maximum of 150 mg of CC a day (×5 days) or 7.5mg of letrozole a day (×5 days). The primary analysis will use an intent-to-treat approach to examine differences in the live birth rate in the two treatment arms. Copyright © 2012 Elsevier Inc. All rights reserved.

THE PREGNANCY IN POLYCYSTIC OVARY SYNDROME II (PPCOS II) TRIAL: RATIONALE AND DESIGN OF A DOUBLE-BLIND RANDOMIZED TRIAL OF CLOMIPHENE CITRATE AND LETROZOLE FOR THE TREATMENT OF INFERTILITY IN WOMEN WITH POLYCYSTIC OVARY SYNDROME

PubMed Central

Legro, Richard S.; Kunselman, Allen R.; Brzyski, Robert G.; Casson, Peter R.; Diamond, Michael P.; Schlaff, William D.; Christman, Gregory M.; Coutifaris, Christos; Taylor, Hugh S.; Eisenberg, Esther; Santoro, Nanette; Zhang, Heping

2012-01-01

Polycystic Ovary Syndrome (PCOS) is a common cause of female infertility and first line treatment is currently oral clomiphene citrate, a selective estrogen receptor modulator, which results in both a high nonresponse rate and multiple pregnancy rate. Aromatase inhibitors such as letrozole may have more favorable ovarian and endometrial effects. The goal of the Pregnancy in Polycystic Ovary Syndrome II (PPCOSII) study is to determine the safety and efficacy of clomiphene citrate (CC) compared to letrozole, in achieving live birth in infertile women with PCOS. The population will consist of 750 infertile women with PCOS. Additionally, the couple will have no other major infertility factor. This will be a multi-center, prospective, double-blind clinical trial of CC vs. letrozole for 5 treatment cycles (or approximately up to 25 weeks). The randomization scheme will be coordinated through the central data coordinating center (DCC) and the randomization is stratified by each participating site. After progestin withdrawal as needed, 750 women will be equally randomized to two different treatment arms: A) CC 50 mg every day for 5 days (day 3–7 of cycle), or B) letrozole 2.5 mg every day for 5 days (day 3–7 of cycle), for a total of 5 cycles or 25 weeks. The dose will be increased in subsequent cycles in both treatment groups for non-response or poor ovulatory response up to a maximum of 150 mg of CC a day (× 5 days) or 7.5 mg of letrozole a day (× 5 days). The primary analysis will use an intent-to-treat approach to examine differences in the live birth rate in the two treatment arms. PMID:22265923

Small-dose hypobaric lidocaine-fentanyl spinal anesthesia for short duration outpatient laparoscopy. I. A randomized comparison with conventional dose hyperbaric lidocaine.

PubMed

Vaghadia, H; McLeod, D H; Mitchell, G W; Merrick, P M; Chilvers, C R

1997-01-01

A randomized, single-blind trial of two spinal anesthetic solutions for outpatient laparoscopy was conducted to compare intraoperative conditions and postoperative recovery. Thirty women (ASA physical status I and II) were assigned to one of two groups. Group I patients received a small-dose hypobaric solution of 1% lidocaine 25 mg made up to 3 mL by the addition of fentanyl 25 micrograms. Group II patients received a conventional-dose hyperbaric solution of 5% lidocaine 75 mg (in 7.5% dextrose) made up to 3 mL by the addition of 1.5 mL 10% dextrose. All patients received 500 mL of crystalloid preloading. Spinal anesthesia was performed at L2-3 or L3-4 with a 27-gauge Quincke point needle. Surgery commenced when the level of sensory anesthesia reached T-6. Intraoperative hypotension requiring treatment with ephedrine occurred in 54% of Group II patients but not in any Group I patients. Median (range) time for full motor recovery was 50 (0-95) min in Group I patients compared to 90 (50-120) min in Group II patients (P = 0.0005). Sensory recovery also occurred faster in Group I patients (100 +/- 22 min) compared with Group II patients (140 +/- 27 min, P = 0.0001). Postoperative headache occurred in 38% of all patients and 70% of these were postural in nature. Oral analgesia was the only treatment required. Spinal anesthesia did not result in a significant incidence of postoperative backache. On follow-up, 96% said they found spinal needle insertion acceptable, 93% found surgery comfortable, and 90% said they would request spinal anesthesia for laparoscopy in future. Overall, this study found spinal anesthesia for outpatient laparoscopy to have high patient acceptance and a comparable complication rate to other studies. The small-dose hypobaric lidocaine-fentanyl technique has advantages over conventional-dose hyperbaric lidocaine of no hypotension and faster recovery.

Clinical efficacies of coracoclavicular ligament reconstruction using suture anchor versus hook plate in the treatment of distal clavicle fracture.

PubMed

Yan, H W; Li, L; Wang, R C; Yang, Y; Xie, Y; Tang, J; Shi, Z Y

2017-12-01

Comparison of clinical efficacies between coracoclavicular ligament reconstruction using autologous gracilis tendon with suture anchor and clavicular hook plate for the treatment of acute Neer type II distal clavicle fracture. Both coracoclavicular reconstruction with autologous gracilis tendon and clavicular hook plate could achieve satisfactory results for treating acute Neer type II distal clavicle fracture. Acute Neer type II distal clavicle fracture patients enrolled in this prospective randomized study were divided into the coracoclavicular ligament reconstruction group (using autologous gracilis tendon and suture anchor) and the hook plate group. Clinical outcomes were evaluated by shoulder X-ray, forward flexion, abduction and external rotation angle, Constant-Murley shoulder score and pain Visual Analogue Scale (VAS) at each follow-up for up to 24 months. The current study enrolled a total of 42 acute Neer type II distal clavicle fracture patients attended our hospital from March 2010 to December 2013. All patients had achieved complete healing and followed up for an average of 26 months (range, 24-38 months). At 3-month and 6-month follow-ups, Constant-Murley score in the ligament reconstruction group was significantly higher (93.8±2.6 vs. 88.7±8.7; 95.9±2.7 vs. 93.0±7.0, P<0.05), while VAS score was poorer than those in the hook plate group (1.6±0.8 vs. 2.5±1.9; 1.1±1.0 vs. 1.6±1.7, P<0.05). Reconstruction with autologous gracilis tendon improved VAS pain score in early postoperation follow-up; while Constant-Murley score and VAS score were significantly improved in the hook plate group after the implant was removed. These suggested that both coracoclavicular reconstruction with autologous gracilis tendon and clavicular hook plate could achieve satisfactory results. Level II, low-powered prospective randomized trial. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

mFOLFOX6 Plus Panitumumab Versus 5-FU/LV Plus Panitumumab After Six Cycles of Frontline mFOLFOX6 Plus Panitumumab: A Randomized Phase II Study of Patients With Unresectable or Advanced/Recurrent, RAS Wild-type Colorectal Carcinoma (SAPPHIRE)-Study Design and Rationale.

PubMed

Nagata, Naoki; Mishima, Hideyuki; Kurosawa, Shuichi; Oba, Koji; Sakamoto, Junichi

2017-06-01

In Japan, oxaliplatin (OXA)/5-fluorouracil (5-FU)/leucovorin (LV)-the mFOLFOX6 regimen-is the most frequently used first-line chemotherapy backbone for metastatic colorectal cancer. However, peripheral nerve disorders caused by OXA during mFOLFOX6 therapy can decrease patients' quality of life. OXA can be safely discontinued from a FOLFOX regimen after 6 cycles during first-line therapy. Also, for patients who discontinue OXA without having experienced peripheral nerve disorders, reintroducing OXA in the later stages of treatment could remain an option. The study is a phase II, multicenter, open-label, parallel-group, randomized, controlled exploratory study comparing the efficacy and safety of mFOLFOX6 plus panitumumab and 5-FU/LV plus panitumumab in patients with chemotherapy-naïve, unresectable, advanced or recurrent colorectal carcinoma of RAS wild-type (SAPPHIRE; ClinicalTrials.gov identifier, NCT02337946). Eligible patients will receive 6 cycles of mFOLFOX6 plus panitumumab combination therapy, followed by 1:1 randomization to either further treatment with mFOLFOX6 plus panitumumab or discontinuation of OXA and treatment with 5-FU/LV plus panitumumab. Up to 100 randomized patients will receive treatment for approximately 12 months or until any of the criteria for treatment discontinuation have been met. The primary endpoint is progression-free survival rate at 9 months after the day of randomization. The secondary endpoints are progression-free survival, overall survival, response rate, and interval to treatment failure. Safety will be evaluated according to the incidence and severity of adverse events, including the incidence of peripheral nerve and skin disorders. Additional endpoints will include maintenance of performance status, continuation of OXA in the mFOLFOX6 plus panitumumab group, and continuation of panitumumab in both groups. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

DYNALIST II : A Computer Program for Stability and Dynamic Response Analysis of Rail Vehicle Systems : Volume 2. User's Manual.

DOT National Transportation Integrated Search

1975-02-01

A methodology and a computer program, DYNALIST II, have been developed for computing the response of rail vehicle systems to sinusoidal or stationary random rail irregularities. The computer program represents an extension of the earlier DYNALIST pro...

DYNALIST II : A Computer Program for Stability and Dynamic Response Analysis of Rail Vehicle Systems : Volume 1. Technical Report.

DOT National Transportation Integrated Search

1975-02-01

A methodology and a computer program, DYNALIST II, have been developed for computing the response of rail vehicle systems to sinusoidal or stationary random rail irregularities. The computer program represents an extension of the earlier DYNALIST pro...

Using Empowering Processes to Create Empowered Outcomes through the Family Development Credential Program: An Empirical Study of Change in Human Service Workers

ERIC Educational Resources Information Center

Hewitt, Nicole M.

2010-01-01

This study employed a quasi-experimental non-equivalent control group design with pretest and posttest. Two waves of data were collected from a non-random sample of 180 human service professionals in Western and Central Pennsylvania using two research instruments: the Social Work Empowerment Scale and the Conditions of Work Effectiveness-II Scale.…

Aspirin in Preventing Disease Recurrence in Patients With Barrett Esophagus After Successful Elimination by Radiofrequency Ablation | Division of Cancer Prevention

Cancer.gov

This randomized phase II trial studies the safety of and how well aspirin works in preventing Barrett's esophagus from returning after it has been successfully eliminated by radiofrequency ablation. Studying samples of tissue from patients with Barrett's esophagus for the levels of a specific protein that is linked to developing Barrett's esophagus may help doctors learn

A randomized phase III trial comparing S-1 versus UFT as adjuvant chemotherapy for stage II/III rectal cancer (JFMC35-C1: ACTS-RC).

PubMed

Oki, E; Murata, A; Yoshida, K; Maeda, K; Ikejiri, K; Munemoto, Y; Sasaki, K; Matsuda, C; Kotake, M; Suenaga, T; Matsuda, H; Emi, Y; Kakeji, Y; Baba, H; Hamada, C; Saji, S; Maehara, Y

2016-07-01

Preventing distant recurrence and achieving local control are important challenges in rectal cancer treatment, and use of adjuvant chemotherapy has been studied. However, no phase III study comparing adjuvant chemotherapy regimens for rectal cancer has demonstrated superiority of a specific regimen. We therefore conducted a phase III study to evaluate the superiority of S-1 to tegafur-uracil (UFT), a standard adjuvant chemotherapy regimen for curatively resected stage II/III rectal cancer in Japan, in the adjuvant setting for rectal cancer. The ACTS-RC trial was an open-label, randomized, phase III superiority trial conducted at 222 sites in Japan. Patients aged 20-80 with stage II/III rectal cancer undergoing curative surgery without preoperative therapy were randomly assigned to receive UFT (500-600 mg/day on days 1-5, followed by 2 days rest) or S-1 (80-120 mg/day on days 1-28, followed by 14 days rest) for 1 year. The primary end point was relapse-free survival (RFS), and the secondary end points were overall survival and adverse events. In total, 961 patients were enrolled from April 2006 to March 2009. The primary analysis was conducted in 480 assigned to receive UFT and 479 assigned to receive S-1. Five-year RFS was 61.7% [95% confidence interval (CI) 57.1% to 65.9%] for UFT and 66.4% (95% CI 61.9% to 70.5%) for S-1 [P = 0.0165, hazard ratio (HR): 0.77, 95% CI 0.63-0.96]. Five-year survival was 80.2% (95% CI 76.3% to 83.5%) for UFT and 82.0% (95% CI 78.3% to 85.2%) for S-1. The main grade 3 or higher adverse events were increased alanine aminotransferase and diarrhea (each 2.3%) in the UFT arm and anorexia, diarrhea (each 2.6%), and fatigue (2.1%) in the S-1 arm. One-year S-1 treatment is superior to UFT with respect to RFS and has therefore become a standard adjuvant chemotherapy regimen for stage II/III rectal cancer following curative resection. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Randomized phase II study of cilengitide, an integrin-targeting arginine-glycine-aspartic acid peptide, in recurrent glioblastoma multiforme.

PubMed

Reardon, David A; Fink, Karen L; Mikkelsen, Tom; Cloughesy, Timothy F; O'Neill, Alison; Plotkin, Scott; Glantz, Michael; Ravin, Paula; Raizer, Jeffrey J; Rich, Keith M; Schiff, David; Shapiro, William R; Burdette-Radoux, Susan; Dropcho, Edward J; Wittemer, Sabine M; Nippgen, Johannes; Picard, Martin; Nabors, L Burt

2008-12-01

Cilengitide, an inhibitor of alphavbeta3 and alphavbeta5 integrin receptors, demonstrated minimal toxicity and durable activity across a wide range of doses administered to adults with recurrent glioblastoma multiforme (GBM) in a prior phase I study. The current multicenter phase II study was conducted to evaluate the activity and safety of cilengitide in GBM patients at first recurrence. Eligible patients were randomly assigned to receive either 500 or 2,000 mg of cilengitide twice weekly on a continuous basis. Patients were assessed every 4 weeks. The primary end point was 6-month progression-free survival (PFS) rate. Secondary end points included PFS, overall survival (OS), and radiographic response, as well as quality-of-life and pharmacokinetic assessments. Eighty-one patients were enrolled, including 41 on the 500-mg arm and 40 on the 2,000-mg arm. The safety profile of cilengitide was excellent, with no significant reproducible toxicities observed on either arm. Antitumor activity was observed in both treatment cohorts but trended more favorably among patients treated with 2,000 mg, including a 6-month PFS of 15% and a median OS of 9.9 months. Cilengitide monotherapy is well tolerated and exhibits modest antitumor activity among recurrent GBM patients. Additional studies integrating cilengitide into combinatorial regimens for GBM are warranted.

A two-stage patient enrichment adaptive design in phase II oncology trials.

PubMed

Song, James X

2014-01-01

Illustrated is the use of a patient enrichment adaptive design in a randomized phase II trial which allows the evaluation of treatment benefits by the biomarker expression level and makes interim adjustment according to the pre-specified rules. The design was applied to an actual phase II metastatic hepatocellular carcinoma (HCC) trial in which progression-free survival (PFS) in two biomarker-defined populations is evaluated at both interim and final analyses. As an extension, a short-term biomarker is used to predict the long-term PFS in a Bayesian model in order to improve the precision of hazard ratio (HR) estimate at the interim analysis. The characteristics of the extended design are examined in a number of scenarios via simulations. The recommended adaptive design is shown to be useful in a phase II setting. When a short-term maker which correlates with the long-term PFS is available, the design can be applied in smaller early phase trials in which PFS requires longer follow-up. In summary, the adaptive design offers flexibility in randomized phase II patient enrichment trials and should be considered in an overall personalized healthcare (PHC) strategy. Copyright © 2013 Elsevier Inc. All rights reserved.

Shortening the induction delivery interval with prostaglandins: a randomized controlled trial of solo or in combination

PubMed Central

Mahendru, Rajiv; Yadav, Shweta

2011-01-01

Objective To compare the efficacy and safety of misoprostol alone with dinoprostone followed by misoprostol, all inserted intravaginally in induction of labor at term and the obstetrical outcome. Material and Methods A pilot study comprising 111 primigravidae, >37 gestational weeks with singleton pregnancy in cephalic presentation having an unfavorable Bishop score admitted for labor induction, were considered and randomly allocated into two groups. In group I (n=55) with intravaginal 25mcg misoprostol 4 hourly (six doses at the most) and and group II (n=56), with dinoprostone 0.5mg followed eight hours later by 25mcg misoprostol induction to vaginal delivery time was found to be significantly different, being 14.8 h in group-I and shorter in group-II with a mean of 11.6 h. Vaginal delivery rates within 12 h (groups-I and −II: 47.2%, as compared to 60.7%, respectively) were found to be higher with dinoprostone-misoprostol induction, as well as vaginal delivery rates in 24 h, 80.0% and 91.1%. The need for oxytocin augmentation was more frequent in the misoprostol than in the dinoprostone-misoprostol group, (61.8%, and 39.3%), and all these observations were statistically significant. Abnormal foetal heart rate pattern occurred more frequently (18.2%) in group-I in contrast to 5.3% in group-II, as was the incidence rate of (18.2%) who had passage of meconium in group-I, this rate being significantly different from group-II having meconium passage in 3 cases, a rate of 5.3%. Conclusion Using dinoprostone followed by vaginal misoprostol is safe and effective for induction of labor with less need for oxytocin augmentation and shorter induction delivery interval. PMID:24591967

Efficacy and safety of Lian-Ju-Gan-Mao capsules for treating the common cold with wind-heat syndrome: study protocol for a randomized controlled trial.

PubMed

Wang, Shengjun; Jiang, Hongli; Yu, Qin; She, Bin; Mao, Bing

2017-01-05

The common cold is a common and frequent respiratory disease mainly caused by viral infection of the upper respiratory tract. Chinese herbal medicine has been increasingly prescribed to treat the common cold; however, there is a lack of evidence to support the wide utility of this regimen. This protocol describes an ongoing phase II randomized controlled clinical trial, based on the theory of traditional Chinese medicine (TCM), with the objective of evaluating the efficacy and safety of Lian-Ju-Gan-Mao capsules (LJGMC), a Chinese patent medicine, compared with placebo in patients suffering from the common cold with wind-heat syndrome (CCWHS). This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial. A total of 240 patients will be recruited and randomly assigned to a high-dose group, medium-dose group, low-dose group, and placebo-matched group in a 1:1:1:1 ratio. The treatment course is 3 consecutive days, with a 5-day follow-up. The primary outcome is time to all symptoms' clearance. Secondary outcomes include time to the disappearance of primary symptoms and each secondary symptom, time to fever relief, time to fever clearance, and change in TCM symptom and sign scores. This trial is a well-designed study according to principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide high-quality evidence on the efficacy and safety of LJGMC in treating CCWHS and help to optimize the dose for the next phase III clinical trial. Moreover, the protocol presents a detailed and practical methodology for future clinical trials of drugs developed based on TCM. Chinese Clinical Trial Registry, ChiCTR-IPR-15006504 . Registered on 4 June 2015.

Comparison of the effectiveness of whole-brain radiotherapy plus temozolomide versus whole-brain radiotherapy in treating brain metastases based on a systematic review of randomized controlled trials.

PubMed

Bai, Gui-Rong; An, Jin-Bing; Chu, Yang; Wang, Xiang-Yang; Li, Shu-Ming; Yan, Kai-Jing; Lü, Fu-Rong; Gu, Ning; Griffin, Amanda N; Sun, Bin-Yuan; Li, Wei; Wang, Guo-Cheng; Zhou, Shui-Ping; Sun, He; Liu, Chang-Xiao

2016-01-01

Temozolomide (TMZ) combination with whole-brain radiotherapy (WBRT) has been tested by many randomized controlled trials in the treatment of brain metastases (BMs) in China and other countries. We performed an up-to-date meta-analysis to determine (i) the log odds ratios (LORs) of objective response (ORR) and adverse effects (AEs) for all-grade, and (ii) the T value of mean overall survival in patients with BMs treated with WBRT combined with TMZ versus WBRT alone. PubMed, Chinese National Knowledge Infrastructure, and WanFang Data were searched for articles published up to 28 January 2015. Eligible studies were selected according to the PRISMA statement. ORR, AEs, and 95% confidence intervals were calculated using random-effects models. Eighteen studies were included in our analysis. A total of 1028 participants were enrolled. Summary LORs of ORR were 1.0239 (P<0.0001) on comparing WBRT plus TMZ with WBRT ORR (n=17). The overall mean difference of mean overall survival (n=17) between TMZ plus WBRT and WBRT was 2.2505 weeks (P=0.02185). There was a significant difference between WBRT plus TMZ and WBRT alone with a LOR of AEs for all-grade of (i) 0.923 for gastrointestinal toxicity and (ii) 0.7978 for myelosuppression. Sensitivity analysis and subgroup analysis were also performed. The 18 eligible randomized controlled trials demonstrated that the combination of WBRT and TMZ significantly improves the ORR and is statistically insignificant in prolonging the survival of patients with BMs. In addition, an increase in the incidence of gastrointestinal toxicity and myelosuppression was significant for all-grade.

Effects of a Multicomponent Life-Style Intervention on Weight, Glycemic Control, Depressive Symptoms, and Renal Function in Low-Income, Minority Patients With Type 2 Diabetes: Results of the Community Approach to Lifestyle Modification for Diabetes Randomized Controlled Trial.

PubMed

Moncrieft, Ashley E; Llabre, Maria M; McCalla, Judith Rey; Gutt, Miriam; Mendez, Armando J; Gellman, Marc D; Goldberg, Ronald B; Schneiderman, Neil

2016-09-01

Few interventions have combined life-style and psychosocial approaches in the context of Type 2 diabetes management. The purpose of this study was to determine the effect of a multicomponent behavioral intervention on weight, glycemic control, renal function, and depressive symptoms in a sample of overweight/obese adults with Type 2 diabetes and marked depressive symptoms. A sample of 111 adults with Type 2 diabetes were randomly assigned to a 1-year intervention (n = 57) or usual care (n = 54) in a parallel groups design. Primary outcomes included weight, glycosylated hemoglobin, and Beck Depression Inventory II score. Estimated glomerular filtration rate served as a secondary outcome. All measures were assessed at baseline and 6 and 12 months after randomization by assessors blind to randomization. Latent growth modeling was used to examine intervention effects on each outcome. The intervention resulted in decreased weight (mean [M] = 0.322 kg, standard error [SE] = 0.124 kg, p = .010) and glycosylated hemoglobin (M = 0.066%, SE = 0.028%, p = .017), and Beck Depression Inventory II scores (M = 1.009, SE = 0.226, p < .001), and improved estimated glomerular filtration rate (M = 0.742 ml·min·1.73 m, SE = 0.318 ml·min·1.73 m, p = .020) each month during the first 6 months relative to usual care. Multicomponent behavioral interventions targeting weight loss and depressive symptoms as well as diet and physical activity are efficacious in the management of Type 2 diabetes. This study is registered at Clinicaltrials.gov ID: NCT01739205.

Efficacy and safety of bilastine in Japanese patients with chronic spontaneous urticaria: A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II/III study.

PubMed

Hide, Michihiro; Yagami, Akiko; Togawa, Michinori; Saito, Akihiro; Furue, Masutaka

2017-04-01

Bilastine, a novel non-sedating second-generation H 1 -antihistamine, has been widely used in the treatment of allergic rhinoconjunctivitis and urticaria with a recommended dose of 20 mg once daily in most European countries since 2010. We evaluated its efficacy and safety in Japanese patients with chronic spontaneous urticaria (CSU). We conducted a multicenter, randomized, double-blind, placebo-controlled phase II/III study (trial registration No. JapicCTI-142574). Patients (age, 18-74 years) were randomly assigned to receive bilastine 20 mg, 10 mg or placebo once daily for 2 weeks. The primary efficacy endpoint was the change from baseline (Day -3 to 0) in total symptom score (TSS) at 2 weeks (Day 8-14), consisting of the itch and rash scores. A total of 304 patients were randomly allocated to bilastine 20 mg (101 patients), bilastine 10 mg (100 patients), and placebo (103 patients). The changes in TSS at 2 weeks were significantly decreased by bilastine 20 mg than did placebo (p < 0.001), demonstrating the superiority of bilastine 20 mg. Bilastine 10 mg also showed a significant difference from placebo (p < 0.001). The TSS changes for the bilastine showed significant improvement from Day 1, and were maintained during the treatment period. The Dermatology Life Quality Index scores were also improved in bilastine than in placebo. The bilastine treatments were safe and well tolerated. Two-week treatment with bilastine (20 or 10 mg) once daily was effective and tolerable in Japanese patients with CSU, demonstrating an early onset of action. Copyright © 2016 Japanese Society of Allergology. Production and hosting by Elsevier B.V. All rights reserved.

A Controlled, Randomized Double-Blind Study to Evaluate the Safety and Efficacy of Chitosan-N-Acetylcysteine for the Treatment of Dry Eye Syndrome.

PubMed

Schmidl, Doreen; Werkmeister, René; Kaya, Semira; Unterhuber, Angelika; Witkowska, Katarzyna J; Baumgartner, Renate; Höller, Sonja; O'Rourke, Maria; Peterson, Ward; Wolter, Annika; Prinz, Martin; Schmetterer, Leopold; Garhöfer, Gerhard

2017-06-01

This study was designed to evaluate the effect of chitosan-N-acetylcysteine (C-NAC) eye drops on tear film thickness (TFT) in patients with dry eye syndrome (DES). This was a controlled, randomized, double-blind clinical investigation with patients assigned to 2 cohorts. In Cohort I, 21 patients were randomized to receive 1 instillation of C-NAC eye drops in 1 eye and placebo (normal saline solution) in the contralateral eye. In Cohort II, 17 patients were randomized to receive C-NAC eye drops once (QD) or twice (BID) daily for 5 days. TFT was assessed with a custom-built ultrahigh-resolution optical coherence tomography system. In Cohort I, mean TFT increased from 3.9 ± 0.5 μm predose to 4.8 ± 1.1 μm 10 min postdose after treatment with C-NAC. The increase was significantly different from placebo over time (P < 0.0001) and remained stable until 24 h postdose. In Cohort II, TFT increased with QD and BID instillation, with no significant difference between regimens. In both groups, Ocular Surface Disease Index scores improved, fewer patients presented with corneal damage, and symptoms of ocular discomfort/conjunctival redness were reduced. A single instillation of C-NAC significantly increased mean TFT in patients with DES as early as 10 min after instillation and lasted for 24 h. The magnitude of the increase in TFT following a single instillation was comparable with that after instillation twice daily over 5 days. Corneal damage improved in >60% of patients. C-NAC could be a viable treatment option for DES.

Design of Phase II Non-inferiority Trials.

PubMed

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.

Clustering, randomness and regularity in cloud fields. I - Theoretical considerations. II - Cumulus cloud fields

NASA Technical Reports Server (NTRS)

Weger, R. C.; Lee, J.; Zhu, Tianri; Welch, R. M.

1992-01-01

The current controversy existing in reference to the regularity vs. clustering in cloud fields is examined by means of analysis and simulation studies based upon nearest-neighbor cumulative distribution statistics. It is shown that the Poisson representation of random point processes is superior to pseudorandom-number-generated models and that pseudorandom-number-generated models bias the observed nearest-neighbor statistics towards regularity. Interpretation of this nearest-neighbor statistics is discussed for many cases of superpositions of clustering, randomness, and regularity. A detailed analysis is carried out of cumulus cloud field spatial distributions based upon Landsat, AVHRR, and Skylab data, showing that, when both large and small clouds are included in the cloud field distributions, the cloud field always has a strong clustering signal.

The effects of biome and spatial scale on the Co-occurrence patterns of a group of Namibian beetles

NASA Astrophysics Data System (ADS)

Pitzalis, Monica; Montalto, Francesca; Amore, Valentina; Luiselli, Luca; Bologna, Marco A.

2017-08-01

Co-occurrence patterns (studied by C-score, number of checkerboard units, number of species combinations, and V-ratio, and by an empirical Bayes approach developed by Gotelli and Ulrich, 2010) are crucial elements in order to understand assembly rules in ecological communities at both local and spatial scales. In order to explore general assembly rules and the effects of biome and spatial scale on such rules, here we studied a group of beetles (Coleoptera, Meloidae), using Namibia as a case of study. Data were gathered from 186 sampling sites, which allowed collection of 74 different species. We analyzed data at the level of (i) all sampled sites, (ii) all sites stratified by biome (Savannah, Succulent Karoo, Nama Karoo, Desert), and (iii) three randomly selected nested areas with three spatial scales each. Three competing algorithms were used for all analyses: (i) Fixed-Equiprobable, (ii) Fixed-Fixed, and (iii) Fixed-Proportional. In most of the null models we created, co-occurrence indicators revealed a non-random structure in meloid beetle assemblages at the global scale and at the scale of biomes, with species aggregation being much more important than species segregation in determining this non-randomness. At the level of biome, the same non-random organization was uncovered in assemblages from Savannah (where the aggregation pattern was particularly strong) and Succulent Karoo, but not in Desert and Nama Karoo. We conclude that species facilitation and similar niche in endemic species pairs may be particularly important as community drivers in our case of study. This pattern is also consistent with the evidence of a higher species diversity (normalized according to biome surface area) in the two former biomes. Historical patterns were perhaps also important for Succulent Karoo assemblages. Spatial scale had a reduced effect on patterning our data. This is consistent with the general homogeneity of environmental conditions over wide areas in Namibia.

Analysis of the Japanese subgroup in LEOPOLD II: a phase 2/3 study of BAY 81-8973, a new recombinant factor VIII product.

PubMed

Fujii, Teruhisa; Hanabusa, Hideji; Shima, Midori; Morinaga, Takeshi; Fukutake, Katsuyuki

2017-03-01

BAY 81-8973, a new full length recombinant FVIII product, has been developed for prophylaxis and on-demand therapy in patients with hemophilia A. LEOPOLD II was a phase 2/3 study comparing prophylaxis versus on-demand treatment with BAY 81-8973. The analysis herein evaluated the clinical profile in Japanese subjects enrolled in LEOPOLD II. The LEOPOLD II was an open-label randomized crossover study. Our analysis evaluated the efficacy using the annualized bleeding rate, safety, and pharmacokinetics in Japanese subjects with severe hemophilia A enrolled in LEOPOLD II. The median annualized bleeding rate was 59.9/year in the on-demand group and 1.9/year in the prophylaxis group for Japanese subjects. There were no study drug-related adverse events in the Japanese subjects. None of the subjects developed FVIII inhibitors. There were no apparent clinical differences in efficacy, safety, and pharmacokinetics between the Japanese and the non-Japanese subjects. Data for the Japanese subjects showed annualized bleeding rates to be remarkably lower in the prophylaxis group compared to the on-demand group and that BAY 81-8973 exhibited a good safety profile and tolerability. These results were similar for the non-Japanese subjects. The results support adoption of BAY 81-8973 for treatment of Japanese subjects with severe hemophilia A.

Agents for facilitation of laryngeal mask airway insertion: a comparative study between thiopentone sodium and propofol.

PubMed

Sengupta, Janmejoy; Sengupta, Mohua; Nag, Tulsi

2014-01-01

Development of endotracheal intubation to avoid deleterious effect on hemodynamic responses occurring during laryngoscopy and intubation compelled researchers to venture into alternative measures of airway management with subtle hemodynamic responses. This study was carried out to compare the conditions for laryngeal mask airways LMA insertion with widely used intravenous induction agents, thiopentone sodium and propofol, and also to compare the undesired responses occurring during LMA insertion with them. The study was prospective, randomized, and double blind. All patients selected were randomly allocated into two groups: Group 1 (propofol) and group II (thiopentone). Preinduction heart rate and blood pressure were recorded. Sixty healthy adult patients of either sex belonging to age group of 20-60 years and ASA grade I or II, to undergo surgery less than 1 h, were selected for the study-Patients were randomly allocated in two groups, 30 in each group. Premedication with midazolam 0.04 mg/kg and fentanyl 2 mg/kg done in both groups. Thereafter, group 1 was induced with 2 mg/kg of propofol and group 2 with 5 mg/kg of thiopentone sodium. The study revealed that, ease of insertion of LMA, was statistically significantly greater in group 1 when compared with group 2 (P 0.05). The time required for successful insertion of LMA was lesser in group 1 patients (53.8 ± 7.77 s) than in group 2 patients (84.7 ± 16.54 s) (P 0.001). Severity of undesired responses were more in group 2, as incremental boluses of respective induction agents were required in 20% patients in thiopentone group compared to only 6% patients in propofol group and 13% of patients in thiopentone group required rescue succinylcholine.

Radiofrequency ablation combined with systemic treatment versus systemic treatment alone in patients with non-resectable colorectal liver metastases: a randomized EORTC Intergroup phase II study (EORTC 40004)

PubMed Central

Ruers, T.; Punt, C.; Van Coevorden, F.; Pierie, J. P. E. N.; Borel-Rinkes, I.; Ledermann, J. A.; Poston, G.; Bechstein, W.; Lentz, M. A.; Mauer, M.; Van Cutsem, E.; Lutz, M. P.; Nordlinger, B.

2012-01-01

Background This study investigates the possible benefits of radiofrequency ablation (RFA) in patients with non-resectable colorectal liver metastases. Methods This phase II study, originally started as a phase III design, randomly assigned 119 patients with non-resectable colorectal liver metastases between systemic treatment (n = 59) or systemic treatment plus RFA ( ± resection) (n = 60). Primary objective was a 30-month overall survival (OS) rate >38% for the combined treatment group. Results The primary end point was met, 30-month OS rate was 61.7% [95% confidence interval (CI) 48.2–73.9] for combined treatment. However, 30-month OS for systemic treatment was 57.6% (95% CI 44.1–70.4), higher than anticipated. Median OS was 45.3 for combined treatment and 40.5 months for systemic treatment (P = 0.22). PFS rate at 3 years for combined treatment was 27.6% compared with 10.6% for systemic treatment only (hazard ratio = 0.63, 95% CI 0.42–0.95, P = 0.025). Median progression-free survival (PFS) was 16.8 months (95% CI 11.7–22.1) and 9.9 months (95% CI 9.3–13.7), respectively. Conclusions This is the first randomized study on the efficacy of RFA. The study met the primary end point on 30-month OS; however, the results in the control arm were in the same range. RFA plus systemic treatment resulted in significant longer PFS. At present, the ultimate effect of RFA on OS remains uncertain. PMID:22431703

Feasibility and acceptability of a phase II randomized pharmacologic intervention for methamphetamine dependence in high-risk men who have sex with men

PubMed Central

Das, Moupali; Santos, Deirdre; Matheson, Tim; Santos, Glenn-Milo; Chu, Priscilla; Vittinghoff, Eric; Shoptaw, Steve; Colfax, Grant N.

2010-01-01

Objective To determine whether actively using, methamphetamine (meth)-dependent men who have sex with men (MSM) could be enrolled and retained in a pharmacologic intervention trial, and the degree to which participants would adhere to study procedures, including medication adherence. Study design Phase II randomized, double-blind trial of bupropion vs. placebo. Methods Thirty meth-dependent, sexually active MSM were randomized to receive daily bupropion XL 300 mg or placebo for 12 weeks. Participants received weekly substance use counseling, provided weekly urine specimens, and completed monthly audio-computer assisted self-interview (ACASI) behavioral risk assessments. Adherence was measured by medication event monitoring systems (MEMS) caps (the number of distinct MEMS cap openings divided by the number of expected doses) and self-report. Results Ninety percent completed the trial: 89% of monthly ACASIs were completed, 81% of study visits were attended, and 81% of urine samples were collected. Adherence by MEMS cap was 60% and by self-report was 81% and did not differ significantly by treatment assignment. The median number of positive urine samples was 5.5 out of a possible 11 (50%). Participants in both arms reported similar declines in the median number of sex partners (P = 0.52). No serious adverse events occurred and there were no significant differences in adverse events by treatment assignment (P = 0.11). Conclusions It is feasible to enroll and retain actively using, meth-dependent MSM in a pharmacologic intervention. Bupropion was well tolerated. Study participation and retention rates were high, however, study drug medication adherence was only moderate. Findings support a larger trial with improved adherence support to evaluate the efficacy of bupropion and other pharmacologic interventions for meth dependence in this population. PMID:20397286

The Sloan Digital Sky Survey Reverberation Mapping Project: Ensemble Spectroscopic Variability of Quasar Broad Emission Lines

NASA Astrophysics Data System (ADS)

Sun, Mouyuan; Trump, Jonathan R.; Shen, Yue; Brandt, W. N.; Dawson, Kyle; Denney, Kelly D.; Hall, Patrick B.; Ho, Luis C.; Horne, Keith; Jiang, Linhua; Richards, Gordon T.; Schneider, Donald P.; Bizyaev, Dmitry; Kinemuchi, Karen; Oravetz, Daniel; Pan, Kaike; Simmons, Audrey

2015-09-01

We explore the variability of quasars in the Mg ii and {{H}}β broad emission lines and ultraviolet/optical continuum emission using the Sloan Digital Sky Survey Reverberation Mapping project (SDSS-RM). This is the largest spectroscopic study of quasar variability to date: our study includes 29 spectroscopic epochs from SDSS-RM over 6 months, containing 357 quasars with Mg ii and 41 quasars with {{H}}β . On longer timescales, the study is also supplemented with two-epoch data from SDSS-I/II. The SDSS-I/II data include an additional 2854 quasars with Mg ii and 572 quasars with {{H}}β . The Mg ii emission line is significantly variable ({{Δ }}f/f∼ 10% on ∼100-day timescales), a necessary prerequisite for its use for reverberation mapping studies. The data also confirm that continuum variability increases with timescale and decreases with luminosity, and the continuum light curves are consistent with a damped random-walk model on rest-frame timescales of ≳ 5 days. We compare the emission-line and continuum variability to investigate the structure of the broad-line region. Broad-line variability shows a shallower increase with timescale compared to the continuum emission, demonstrating that the broad-line transfer function is not a δ-function. {{H}}β is more variable than Mg ii (roughly by a factor of ∼1.5), suggesting different excitation mechanisms, optical depths and/or geometrical configuration for each emission line. The ensemble spectroscopic variability measurements enabled by the SDSS-RM project have important consequences for future studies of reverberation mapping and black hole mass estimation of 1\\lt z\\lt 2 quasars.

Effect of the 6-week home-based exercise program on physical activity level and physical fitness in colorectal cancer survivors: A randomized controlled pilot study.

PubMed

Lee, Mi Kyung; Kim, Nam Kyu; Jeon, Justin Y

2018-01-01

Despite improvement in prognosis of colorectal cancer, colorectal cancer survivors often suffer from adverse effects of cancer treatment, including reduced health-related fitness level. Therefore, this study aimed to examine the feasibility and efficacy of the 6-week home-based exercise program on the level of physical activity and physical fitness in stage II to III colorectal cancer survivors. Seventy-two stage II to III colorectal cancer survivors were randomly assigned to either a home-based exercise (n = 38) or usual care (n = 34) group for 6 weeks. The goal of the home-based exercise program was to increase the level of exercise to 18 metabolic equivalent task hours per week. The primary and the secondary outcomes of this study were physical activity level and physical fitness, respectively. A total of 57 participants (79.2%) completed the trial. Intention-to-treat analysis indicated that moderate physical activity level increased significantly by 269.4 ± 260.6 minutes per week in the exercise group (mean between-group difference, 254.6 minutes; 95% confidence interval, 172.7-434.7; p < 0.001). Physical fitness measured by using the step test (-3.9 vs. 2.6, p = 0.012) and push-up test (3.0 vs. -1.2, p = 0.012) also improved significantly in the exercise group compared to the control group. The 6-week home-based mixed aerobic and resistance exercise program was feasible and effective for increasing physical activity level and physical fitness in stage II to III colorectal cancer survivors.

[Azilsartan Medoxomil Capabilities in Arterial Hypertension and Obesity].

PubMed

Vasyuk, Y A; Shupenina, E Y; Nesvetov, V V; Nesterova, E A; Golubkova, E I

2016-12-01

Arterial hypertension (AH) is one of the most common cardiovascular disease. Angiotensin II (AT II), the hormone of renin-angiotensin-aldosterone system, realizes its negative effects through AT 1 receptors - application point of angiotensin receptor blockers (ARB). Due to different dissociation AT 1 receptors properties some ARBs are more effective than others. Multiply multicenter randomized and observational studies approve the effectiveness and safety of azilsartan medoxomil in patients with AH 1-2 grade. Several preclinical studies have shown the additional properties of azilsartan, including increase of insulin sensitivity, cardio- and nephron protection in obesity. In our clinical case we showed the positive influence of azilsartan medoxomil on clinic and ambulatory blood pressure, 24-hour aortic stiffness parameters, longitudinal left ventricular strain in patient with AH and obesity.

Postoperative radiotherapy and tumor recurrence after complete resection of stage II/III thymic tumor: a meta-analysis of cohort studies

PubMed Central

Ma, Jietao; Sun, Xin; Huang, Letian; Xiong, Zhicheng; Yuan, Meng; Zhang, Shuling; Han, Cheng-Bo

2016-01-01

Background Whether postoperative radiotherapy (PORT) is effective for reducing the recurrence risk in patients who received complete resection of the stage II or III thymic tumors has not been determined. A meta-analysis was performed by combining the results of all available controlled trials. Methods PubMed, Cochrane’s Library, and the Embase databases were searched for studies which compared the recurrence data for patients with complete resection of the stage II or III thymic tumors assigned to an observing group, or a PORT group. A random effect model was applied to combine the results. Results Nineteen studies, all designed as retrospective cohort studies were included. These studies included 663 patients of PORT group and 617 patients of observing group. The recurrence rate for the patients in PORT group and observing group were 12.4% and 11.5%, respectively. Results of our study indicated that PORT has no significant influence on recurrent risk in patients with stage II or III thymic tumor after complete resection (odds ratio 1.02, 95% confidence interval 0.55–1.90, P=0.96). When stratified by stages, our meta-analyses did not indicate any significant effects of PORT on recurrent outcomes in either the stage II or the stage III patients. Moreover, subsequent analysis limited to studies only including patients with thymoma or thymic carcinoma also did not support the benefits of PORT on recurrent outcomes. Conclusion Although derived from retrospective cohort studies, current evidence did not support any benefit of PORT on recurrent risk in patients with complete resection of the stage II or III thymic tumors. PMID:27524907

Randomized phase II trial evaluating two paclitaxel and cisplatin-containing chemoradiation regimens as adjuvant therapy in resected gastric cancer (RTOG-0114).

PubMed

Schwartz, Gary K; Winter, Kathryn; Minsky, Bruce D; Crane, Christopher; Thomson, P John; Anne, Pramila; Gross, Howard; Willett, Christopher; Kelsen, David

2009-04-20

The investigational arm of INT0116, a fluorouracil (FU) and leucovorin-containing chemoradiotherapy regimen, is a standard treatment for patients with resected gastric cancer with a 2-year disease-free survival rate (DFS) of 52%. Toxicity is also significant. More beneficial and safer regimens are needed. We performed a randomized phase II study among 39 cancer centers to evaluate two paclitaxel and cisplatin-containing regimens, one with FU (PCF) and the other without (PC) in patients with resected gastric cancer. Patients received two cycles of postoperative chemotherapy followed by 45 Gy of radiation with either concurrent FU and paclitaxel or paclitaxel and cisplatin. The primary objective was to show an improvement in 2-year DFS to 67% as compared with INT 0116. From May 2001 to February 2004 (study closure), 78 patients entered this study, and 73 were evaluable. At the planned interim analysis of 22 patients on PCF, grade 3 or higher GI toxicity was 59%. This was significantly worse than INT0116, and this arm was closed. Accrual continued on PC. The median DFS was 14.6 months for PCF and has not been reached for PC. For PC the 2-year DFS is 52% (95% CI, 36% to 68%). Though PC appears to be safe and the median DFS favorable, the DFS failed to exceed the lower bound of 52.9% for the targeted 67% DFS at 2 years and can not be recommended as the adjuvant arm for future randomized trials.

Randomized Phase II Trial Evaluating Two Paclitaxel and Cisplatin–Containing Chemoradiation Regimens As Adjuvant Therapy in Resected Gastric Cancer (RTOG-0114)

PubMed Central

Schwartz, Gary K.; Winter, Kathryn; Minsky, Bruce D.; Crane, Christopher; Thomson, P. John; Anne, Pramila; Gross, Howard; Willett, Christopher; Kelsen, David

2009-01-01

Purpose The investigational arm of INT0116, a fluorouracil (FU) and leucovorin–containing chemoradiotherapy regimen, is a standard treatment for patients with resected gastric cancer with a 2-year disease-free survival rate (DFS) of 52%. Toxicity is also significant. More beneficial and safer regimens are needed. Patients and Methods We performed a randomized phase II study among 39 cancer centers to evaluate two paclitaxel and cisplatin–containing regimens, one with FU (PCF) and the other without (PC) in patients with resected gastric cancer. Patients received two cycles of postoperative chemotherapy followed by 45 Gy of radiation with either concurrent FU and paclitaxel or paclitaxel and cisplatin. The primary objective was to show an improvement in 2-year DFS to 67% as compared with INT 0116. Results From May 2001 to February 2004 (study closure), 78 patients entered this study, and 73 were evaluable. At the planned interim analysis of 22 patients on PCF, grade 3 or higher GI toxicity was 59%. This was significantly worse than INT0116, and this arm was closed. Accrual continued on PC. The median DFS was 14.6 months for PCF and has not been reached for PC. For PC the 2-year DFS is 52% (95% CI, 36% to 68%). Conclusion Though PC appears to be safe and the median DFS favorable, the DFS failed to exceed the lower bound of 52.9% for the targeted 67% DFS at 2 years and can not be recommended as the adjuvant arm for future randomized trials. PMID:19273696

A randomized, double-blind, placebo-controlled trial of resveratrol for Alzheimer disease.

PubMed

Turner, R Scott; Thomas, Ronald G; Craft, Suzanne; van Dyck, Christopher H; Mintzer, Jacobo; Reynolds, Brigid A; Brewer, James B; Rissman, Robert A; Raman, Rema; Aisen, Paul S

2015-10-20

A randomized, placebo-controlled, double-blind, multicenter 52-week phase 2 trial of resveratrol in individuals with mild to moderate Alzheimer disease (AD) examined its safety and tolerability and effects on biomarker (plasma Aβ40 and Aβ42, CSF Aβ40, Aβ42, tau, and phospho-tau 181) and volumetric MRI outcomes (primary outcomes) and clinical outcomes (secondary outcomes). Participants (n = 119) were randomized to placebo or resveratrol 500 mg orally once daily (with dose escalation by 500-mg increments every 13 weeks, ending with 1,000 mg twice daily). Brain MRI and CSF collection were performed at baseline and after completion of treatment. Detailed pharmacokinetics were performed on a subset (n = 15) at baseline and weeks 13, 26, 39, and 52. Resveratrol and its major metabolites were measurable in plasma and CSF. The most common adverse events were nausea, diarrhea, and weight loss. CSF Aβ40 and plasma Aβ40 levels declined more in the placebo group than the resveratrol-treated group, resulting in a significant difference at week 52. Brain volume loss was increased by resveratrol treatment compared to placebo. Resveratrol was safe and well-tolerated. Resveratrol and its major metabolites penetrated the blood-brain barrier to have CNS effects. Further studies are required to interpret the biomarker changes associated with resveratrol treatment. This study provides Class II evidence that for patients with AD resveratrol is safe, well-tolerated, and alters some AD biomarker trajectories. The study is rated Class II because more than 2 primary outcomes were designated. © 2015 American Academy of Neurology.

Effects of Metformin on Spatial and Verbal Memory in Children with ASD and Overweight Associated with Atypical Antipsychotic Use.

PubMed

Aman, Michael G; Hollway, Jill A; Veenstra-VanderWeele, Jeremy; Handen, Benjamin L; Sanders, Kevin B; Chan, James; Macklin, Eric; Arnold, L Eugene; Wong, Taylor; Newsom, Cassandra; Hastie Adams, Rianne; Marler, Sarah; Peleg, Naomi; Anagnostou, Evdokia A

2018-05-01

Studies in humans and rodents suggest that metformin, a medicine typically used to treat type 2 diabetes, may have beneficial effects on memory. We sought to determine whether metformin improved spatial or verbal memory in children with autism spectrum disorder (ASD) and overweight associated with atypical antipsychotic use. We studied the effects of metformin (Riomet ® ) concentrate on spatial and verbal memory in 51 youth with ASD, ages 6 through 17 years, who were taking atypical antipsychotic medications, had gained significant weight, and were enrolled in a trial of metformin for weight management. Phase 1 was a 16-week, randomized, double-blind, placebo-controlled, parallel-group comparison of metformin (500-850 mg given twice a day) versus placebo. During Phase 2, all participants took open-label metformin from week 17 through week 32. We assessed spatial and verbal memory using the Neuropsychological Assessment 2nd Edition (NEPSY-II) and a modified children's verbal learning task. No measures differed between participants randomized to metformin versus placebo, at either 16 or 32 weeks, after adjustment for multiple comparisons. Sixteen-week change in memory for spatial location on the NEPSY-II was nominally better among participants randomized to placebo. However, patterns of treatment response across all measures revealed no systematic differences in performance, suggesting that metformin had no effect on spatial or verbal memory in these children. Although further study is needed to support these null effects, the overall impression is that metformin does not affect memory in overweight youth with ASD who were taking atypical antipsychotic medications.

The Efficacy and Safety of Shen Guo Lao Nian Granule for Common Cold of Qi-Deficiency Syndrome: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase II Clinical Trial

PubMed Central

Fu, Juanjuan; Ding, Hong; Yang, Haimiao; Huang, Yuhong

2017-01-01

Background Common cold is one of the most frequently occurring illnesses in primary healthcare services and represents considerable disease burden. Common cold of Qi-deficiency syndrome (CCQDS) is an important but less addressed traditional Chinese medicine (TCM) pattern. We designed a protocol to explore the efficacy, safety, and optimal dose of Shen Guo Lao Nian Granule (SGLNG) for treating CCQDS. Methods/Design This is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. A total of 240 eligible patients will be recruited from five centers. Patients are randomly assigned to high-dose group, middle-dose group, low-dose group, or control group in a 1 : 1 : 1 : 1 ratio. All drugs are required to be taken 3 times daily for 5 days with a 5-day follow-up period. Primary outcomes are duration of all symptoms, total score reduction on Jackson's scale, and TCM symptoms scale. Secondary outcomes include every single TCM symptom duration and score reduction, TCM main symptoms disappearance rate, curative effects, and comparison between Jackson's scale and TCM symptom scale. Ethics and Trial Registration This study protocol was approved by the Ethics Committee of Clinical Trials and Biomedicine of West China Hospital of Sichuan University (number IRB-2014-12) and registered with the Chinese Clinical Trial Registry (ChiCTR-IPR-15006349). PMID:29430253

Mobile applications for handheld devices to screen and randomize acute stroke patients in clinical trials.

PubMed

Qureshi, Ai; Connelly, B; Abbott, Ei; Maland, E; Kim, J; Blake, J

2012-08-01

The availability of internet connectivity and mobile application software used by low-power handheld devices makes smart phones of unique value in time-sensitive clinical trials. Trial-specific applications can be downloaded by investigators from various mobile software distribution platforms or web applications delivered over HTTP. The Antihypertensive Treatment in Acute Cerebral Hemorrhage (ATACH) II investigators in collaboration with MentorMate released the ATACH-II Patient Recruitment mobile application available on iPhone, Android, and Blackberry in 2011. The mobile application provides tools for pre-screening, assessment of eligibility, and randomization of patients. Since the release of ATACH-II mobile application, the CLEAR-IVH (Clot Lysis Evaluating Accelerated Resolution of Intraventricular Hemorrhage) trial investigators have also adopted such a mobile application. The video-conferencing capabilities of the most recent mobile devices open up additional opportunities to involve central coordinating centers in the recruitment process in real time.

Circularly-symmetric complex normal ratio distribution for scalar transmissibility functions. Part I: Fundamentals

NASA Astrophysics Data System (ADS)

Yan, Wang-Ji; Ren, Wei-Xin

2016-12-01

Recent advances in signal processing and structural dynamics have spurred the adoption of transmissibility functions in academia and industry alike. Due to the inherent randomness of measurement and variability of environmental conditions, uncertainty impacts its applications. This study is focused on statistical inference for raw scalar transmissibility functions modeled as complex ratio random variables. The goal is achieved through companion papers. This paper (Part I) is dedicated to dealing with a formal mathematical proof. New theorems on multivariate circularly-symmetric complex normal ratio distribution are proved on the basis of principle of probabilistic transformation of continuous random vectors. The closed-form distributional formulas for multivariate ratios of correlated circularly-symmetric complex normal random variables are analytically derived. Afterwards, several properties are deduced as corollaries and lemmas to the new theorems. Monte Carlo simulation (MCS) is utilized to verify the accuracy of some representative cases. This work lays the mathematical groundwork to find probabilistic models for raw scalar transmissibility functions, which are to be expounded in detail in Part II of this study.

Studies in Ambulatory Care Quality Assessment in the Indian Health Service. Volume II: Appraisal of System Performance.

ERIC Educational Resources Information Center

Nutting, Paul A.; And Others

Six Indian Health Service (IHS) units, chosen in a non-random manner, were evaluated via a quality assessment methodology currently under development by the IHS Office of Research and Development. A set of seven health problems (tracers) was selected to represent major health problems, and clinical algorithms (process maps) were constructed for…

Afimoxifene in Reducing the Risk of Breast Cancer in Women With Mammographically Dense Breast | Division of Cancer Prevention

Cancer.gov

This randomized phase II trial studies how well afimoxifene works in reducing the risk of breast cancer in women with mammographically dense breast. Estrogen can cause the growth of breast cancer cells. Hormone therapy using afimoxifene may fight breast cancer by blocking the use of estrogen by the tumor cells. |

Conduct a Cost Effectiveness Study of Postgraduate Medical Education Programs. Part I, Part II (Appendixes). Final Report.

ERIC Educational Resources Information Center

Manning, Phillip R.; And Others

To gather data on the effects of different modes of instruction on physician achievement in plotting mean P, O, RS, and T receptiors in electrocardiography, researchers chose a random sample of physicians who had taken a correspondence course on electrocardiography during the previous 5 years from the University of Southern California School of…

Comparing interfertility data with random amplified microsatellites DNA (RAMS) studies in Ganoderma Karst. Taxonomy.

PubMed

Nudin, Nur Fatihah Hasan; S, Siddiquee

2012-03-01

The taxonomy of the causal pathogen of basal stem rot of oil palms, Ganoderma is somewhat problematic at present. In order to determine the genetic distance relationship between G. boninense isolates and non-boninense isolates, a random amplified microsatellites DNA (RAMS) technique was carried out. The result was then compared with interfertility data of G. boninense that had been determined in previous mating studies to confirm the species of G. boninense. Dendrogram from cluster analysis based on UPGMA of RAMS data showed that two major clusters, I and II which separated at a genetic distance of 0.7935 were generated. Cluster I consisted of all the biological species G. boninense isolates namely CNLB, GSDK 3, PER 71, WD 814, GBL 3, GBL 6, OC, GH 02, 170 SL and 348781 while all non-boninense isolates namely G. ASAM, WRR, TFRI 129, G. RES, GJ, and CNLM were grouped together in cluster II. Although the RAMS markers showed polymorphisms in all the isolates tested, the results obtained were in agreement with the interfertility data. Therefore, the RAMS data could support the interfertility data for the identification of Ganoderma isolates.

Validation of the 12-Gene Colon Cancer Recurrence Score in NSABP C-07 As a Predictor of Recurrence in Patients With Stage II and III Colon Cancer Treated With Fluorouracil and Leucovorin (FU/LV) and FU/LV Plus Oxaliplatin

PubMed Central

Yothers, Greg; O'Connell, Michael J.; Lee, Mark; Lopatin, Margarita; Clark-Langone, Kim M.; Millward, Carl; Paik, Soonmyung; Sharif, Saima; Shak, Steven; Wolmark, Norman

2013-01-01

Purpose Accurate assessments of recurrence risk and absolute treatment benefit are needed to inform colon cancer adjuvant therapy. The 12-gene Recurrence Score assay has been validated in patients with stage II colon cancer from the Cancer and Leukemia Group B 9581 and Quick and Simple and Reliable (QUASAR) trials. We conducted an independent, prospectively designed clinical validation study of Recurrence Score, with prespecified end points and analysis plan, in archival specimens from patients with stage II and III colon cancer randomly assigned to fluorouracil (FU) or FU plus oxaliplatin in National Surgical Adjuvant Breast and Bowel Project C-07. Methods Recurrence Score was assessed in 892 fixed, paraffin-embedded tumor specimens (randomly selected 50% of patients with tissue). Data were analyzed by Cox regression adjusting for stage and treatment. Results Continuous Recurrence Score predicted recurrence (hazard ratio for a 25-unit increase in score, 1.96; 95% CI, 1.50 to 2.55; P < .001), as well as disease-free and overall survival (both P < .001). Recurrence Score predicted recurrence risk (P = .001) after adjustment for stage, mismatch repair, nodes examined, grade, and treatment. Recurrence Score did not have significant interaction with stage (P = .90) or age (P = .76). Relative benefit of oxaliplatin was similar across the range of Recurrence Score (interaction P = .48); accordingly, absolute benefit of oxaliplatin increased with higher scores, most notably in patients with stage II and IIIA/B disease. Conclusion The 12-gene Recurrence Score predicts recurrence risk in stage II and stage III colon cancer and provides additional information beyond conventional clinical and pathologic factors. Incorporating Recurrence Score into the clinical context may better inform adjuvant therapy decisions in stage III as well as stage II colon cancer. PMID:24220557

Validation of the 12-gene colon cancer recurrence score in NSABP C-07 as a predictor of recurrence in patients with stage II and III colon cancer treated with fluorouracil and leucovorin (FU/LV) and FU/LV plus oxaliplatin.

PubMed

Yothers, Greg; O'Connell, Michael J; Lee, Mark; Lopatin, Margarita; Clark-Langone, Kim M; Millward, Carl; Paik, Soonmyung; Sharif, Saima; Shak, Steven; Wolmark, Norman

2013-12-20

Accurate assessments of recurrence risk and absolute treatment benefit are needed to inform colon cancer adjuvant therapy. The 12-gene Recurrence Score assay has been validated in patients with stage II colon cancer from the Cancer and Leukemia Group B 9581 and Quick and Simple and Reliable (QUASAR) trials. We conducted an independent, prospectively designed clinical validation study of Recurrence Score, with prespecified end points and analysis plan, in archival specimens from patients with stage II and III colon cancer randomly assigned to fluorouracil (FU) or FU plus oxaliplatin in National Surgical Adjuvant Breast and Bowel Project C-07. Recurrence Score was assessed in 892 fixed, paraffin-embedded tumor specimens (randomly selected 50% of patients with tissue). Data were analyzed by Cox regression adjusting for stage and treatment. Continuous Recurrence Score predicted recurrence (hazard ratio for a 25-unit increase in score, 1.96; 95% CI, 1.50 to 2.55; P < .001), as well as disease-free and overall survival (both P < .001). Recurrence Score predicted recurrence risk (P = .001) after adjustment for stage, mismatch repair, nodes examined, grade, and treatment. Recurrence Score did not have significant interaction with stage (P = .90) or age (P = .76). Relative benefit of oxaliplatin was similar across the range of Recurrence Score (interaction P = .48); accordingly, absolute benefit of oxaliplatin increased with higher scores, most notably in patients with stage II and IIIA/B disease. The 12-gene Recurrence Score predicts recurrence risk in stage II and stage III colon cancer and provides additional information beyond conventional clinical and pathologic factors. Incorporating Recurrence Score into the clinical context may better inform adjuvant therapy decisions in stage III as well as stage II colon cancer.

Perioperative antibiotic prophylaxis in the treatment of acute cholecystitis (PEANUTS II trial): study protocol for a randomized controlled trial.

PubMed

Loozen, Charlotte S; van Santvoort, Hjalmar C; van Geloven, Antoinette A W; Nieuwenhuijzen, Grard A P; de Reuver, Philip R; Besselink, Mark H G; Vlaminckx, Bart; Kelder, Johannes C; Knibbe, Catherijne A J; Boerma, Djamila

2017-08-23

The additional value of perioperative antibiotic prophylaxis in preventing infectious complications after emergency cholecystectomy for acute cholecystitis is a much-debated subject in the surgical community. Evidence-based guidelines are lacking, and consequently the use of antibiotic prophylaxis varies greatly among surgeons and hospitals. Recently, high-level evidence became available demonstrating that postoperative antibiotic prophylaxis in patients with acute cholecystitis does not reduce the risk of infectious complications. Preoperative antibiotic prophylaxis in relation to the risk of infectious complications, however, has never been studied. The PEANUTS II trial is a randomized, controlled, multicenter, open-label noninferiority trial whose aim is to determine the utility of preoperative antibiotic prophylaxis in patients undergoing emergency cholecystectomy for acute calculous cholecystitis. Patients with mild or moderate acute cholecystitis, as defined according the Tokyo Guidelines, will be randomly assigned to a single preoperative dose of antibiotic prophylaxis (2000 mg of first-generation cephalosporin delivered intravenously) or no antibiotic prophylaxis before emergency cholecystectomy. The primary endpoint is a composite endpoint consisting of all postoperative infectious complications occurring during the first 30 days after surgery. Secondary endpoints include all the individual components of the primary endpoint, all other complications, duration of hospital stay, and total costs. The hypothesis is that the absence of antibiotic prophylaxis is noninferior to the presence of antibiotic prophylaxis. A noninferiority margin of 10% is assumed. With a 1-sided risk of 2.5% and a power of 80%, a total of 454 subjects will have to be included. Analysis will be performed according to the intention-to-treat principle. The PEANUTS II trial will provide evidence-based advice concerning the utility of antibiotic prophylaxis in patients undergoing emergency cholecystectomy for acute calculous cholecystitis. Netherlands Trial Register, NTR5802 . Registered on 4 June 2016.

Milk thistle and indinavir: a randomized controlled pharmacokinetics study and meta-analysis.

PubMed

Mills, Edward; Wilson, Kumanan; Clarke, Mike; Foster, Brian; Walker, Scott; Rachlis, Beth; DeGroot, Nick; Montori, Victor M; Gold, Wayne; Phillips, Elizabeth; Myers, Stephen; Gallicano, Keith

2005-03-01

To determine whether ingestion of milk thistle affects the pharmacokinetics of indinavir. We conducted a three-period, randomized controlled trial with 16 healthy participants. We randomized participants to milk thistle or control. All participants received initial dosing of indinavir, and baseline indinavir levels were obtained (AUC(0-8)) (phase I). The active group were then given 450 mg milk-thistle extract capsules to be taken t.i.d. from day 2 to day 30. The control group received no plant extract. On day 29 and day 30, indinavir dosing and sampling was repeated in both groups as before (phase II). After a wash-out period of 7 days, indinavir dosing and sampling were repeated as before (phase III). All participants completed the trial, but two were excluded from analysis due to protocol violation. There were no significant between-group differences. Active group mean AUC(0-8) indinavir decreased by 4.4% (90% CI, -27.5% to -26%, P=0.78) from phase I to phase II in the active group, and by 17.3% (90% CI, -37.3% to +9%, P=0.25) in phase III. Control group mean AUC(0-8) decreased by 21.5% (90% CI, -43% to +8%, P=0.2) from phase I to phase II and by 38.5% (90% CI, -55.3% to -15.3%, P=0.01) of baseline at phase III. To place our findings in context, milk thistle-indinavir trials were identified through systematic searches of the literature. A meta-analysis of three milk thistle-indinavir trials revealed a non-significant pooled mean difference of 1% in AUC(0-8) (95% CI, -53% to 55%, P=0.97). Indinavir levels were not reduced significantly in the presence of milk thistle.

PacRIM II: A review of AirSAR operations and system performance

NASA Technical Reports Server (NTRS)

Moller, D.; Chu, A.; Lou, Y.; Miller, T.; O'Leary, E.

2001-01-01

In this paper we briefly review the AirSAR system, its expected performance, and quality of data obtained during that mission. We discuss the system hardware calibration methodologies, and present quantitative performance values of radar backscatter and interferometric height errors (random and systematic) from PACRIM II calibration data.

Homonyms in Context. MicroSIFT Courseware Evaluation.

ERIC Educational Resources Information Center

Northwest Regional Educational Lab., Portland, OR.

THE FOLLOWING IS THE FULL TEXT OF THIS DOCUMENT (Except for the Evaluation Summary Table): VERSION: Apple II. PRODUCER: Random House, School Division, 2970 Brandywine Road, Atlanta, Georgia 30341. EVALUATION COMPLETED: June 1982 by the staff and constituents of the Portland Public Schools, Portland, Oregon. COST: Apple II and Radio Shack TRS-80…

Effects of Exercise Training on Depressive Symptoms in Patients with Chronic Heart Failure: The HF-ACTION Randomized Trial

PubMed Central

Blumenthal, James A.; Babyak, Michael A.; O'Connor, Christopher; Keteyian, Steven; Landzberg, Joel; Howlett, Jonathan; Kraus, William; Gottlieb, Stephen; Blackburn, Gordon; Swank, Ann; Whellan, David J.

2013-01-01

Context Depression is common in cardiac patients, especially in patients with heart failure (HF), and is associated with increased risk for adverse health outcomes. There also is a growing literature to suggest that aerobic exercise may reduce depressive symptoms, but no previous study has evaluated the effects of exercise on depression in HF patients. Objective To determine if exercise training in HF patients will result in greater improvements in depressive symptoms compared with usual care. Design Multicenter, randomized (1:1) controlled trial Setting Ambulatory in 82 clinical centers in the US, Canada, and France. Participants 2,322 stable patients with a left ventricular ejection fraction (LVEF) ≤35% and NYHA class II to IV HF who completed the Beck Depression Inventory-II (BDI-II) to assess depressive symptoms (range 0-63; clinically significant ≥ 14). Interventions Supervised aerobic exercise (goal of 90 min/wk for months 1-3) followed by home exercise (goal of ≥120 min/wk for months 4-12), versus education and usual, guideline-based HF care conducted between April, 2003 and February, 2007. Main Outcome Measures Scores on the BDI-II at 3- and 12-months and the composite of death or hospitalization from any cause. Results 789 (68%) patients died or were hospitalized in the usual care (UC) arm and 759 (66%) in the aerobic exercise (AE) arm (Hazard Ratio [HR] = 0.89, 95% CI = 0.81, 0.99; p=.03) over a median follow-up period of 30 months. The median BDI-II score at study entry was 8, with 28% of the sample obtaining BDI-II scores ≥14. Compared to UC, AE resulted in lower mean BDI-II scores at 3-months, AE = 8.95 (95% CI =8.61, 9.29) vs. 9.70 (95% CI = 9.34, 10.06) for UC (difference =−0.76,95 % CI= −1.22, −0.29, p = .002), and at 12-months, AE= 8.86 (95%CI= 8.67, 9.24) vs. 9.54 (95% CI = 9.15, 9.92) for UC (difference = −0.68, 95% CI = −1.20, −0.16; p = .01). Conclusions Compared to guideline-based usual care, exercise training resulted in reduced depressive symptoms and better clinical outcomes. PMID:22851113

Inter-observer agreement for diagnostic classification of esophageal motility disorders defined in high-resolution manometry.

PubMed

Fox, M R; Pandolfino, J E; Sweis, R; Sauter, M; Abreu Y Abreu, A T; Anggiansah, A; Bogte, A; Bredenoord, A J; Dengler, W; Elvevi, A; Fruehauf, H; Gellersen, S; Ghosh, S; Gyawali, C P; Heinrich, H; Hemmink, M; Jafari, J; Kaufman, E; Kessing, K; Kwiatek, M; Lubomyr, B; Banasiuk, M; Mion, F; Pérez-de-la-Serna, J; Remes-Troche, J M; Rohof, W; Roman, S; Ruiz-de-León, A; Tutuian, R; Uscinowicz, M; Valdovinos, M A; Vardar, R; Velosa, M; Waśko-Czopnik, D; Weijenborg, P; Wilshire, C; Wright, J; Zerbib, F; Menne, D

2015-01-01

High-resolution esophageal manometry (HRM) is a recent development used in the evaluation of esophageal function. Our aim was to assess the inter-observer agreement for diagnosis of esophageal motility disorders using this technology. Practitioners registered on the HRM Working Group website were invited to review and classify (i) 147 individual water swallows and (ii) 40 diagnostic studies comprising 10 swallows using a drop-down menu that followed the Chicago Classification system. Data were presented using a standardized format with pressure contours without a summary of HRM metrics. The sequence of swallows was fixed for each user but randomized between users to avoid sequence bias. Participants were blinded to other entries. (i) Individual swallows were assessed by 18 practitioners (13 institutions). Consensus agreement (≤ 2/18 dissenters) was present for most cases of normal peristalsis and achalasia but not for cases of peristaltic dysmotility. (ii) Diagnostic studies were assessed by 36 practitioners (28 institutions). Overall inter-observer agreement was 'moderate' (kappa 0.51) being 'substantial' (kappa > 0.7) for achalasia type I/II and no lower than 'fair-moderate' (kappa >0.34) for any diagnosis. Overall agreement was somewhat higher among those that had performed >400 studies (n = 9; kappa 0.55) and 'substantial' among experts involved in development of the Chicago Classification system (n = 4; kappa 0.66). This prospective, randomized, and blinded study reports an acceptable level of inter-observer agreement for HRM diagnoses across the full spectrum of esophageal motility disorders for a large group of clinicians working in a range of medical institutions. Suboptimal agreement for diagnosis of peristaltic motility disorders highlights contribution of objective HRM metrics. © 2014 International Society for Diseases of the Esophagus.

The effect of Kombucha on post-operative intra-abdominal adhesion formation in rats.

PubMed

Maghsoudi, Hemmat; Mohammadi, Hussein Benagozar

2009-04-01

Peritoneal adhesions are fibrous bands of tissues formed between organs that are normally separated and/or between organs and the internal body wall after peritoneal injury. The aim of the study was to investigate the effect of intra-peritoneal administration of Kombucha on intra-peritoneal adhesions. Eighty Wistar rats were subjected to standardized lesion by scraping model and were randomly divided into two groups. Group I received no treatment, and Group II received 15 ml of Kombucha solution intra-peritoneally. On the post-operative 14th day adhesion intensity score, inflammatory cell reaction and number of adhesion bands were determined. In the control group, there were no rats with grade 0 and I adhesions. In the group II, there were 26 rats (78.8%) with grade 0-2 adhesions. Adhesion intensity was significantly less in group II (P<0.0001). Number of adhesion bands was significantly less in group II (P<0.001). It was concluded that intra-peritoneal administration of Kombucha might be useful for preventing peritoneal adhesions.

Does self-monitoring of blood glucose levels improve dietary compliance for obese patients with type II diabetes?

PubMed

Wing, R R; Epstein, L H; Nowalk, M P; Scott, N; Koeske, R; Hagg, S

1986-11-01

Self-monitoring of blood glucose levels is currently being recommended for obese patients with type II diabetes to improve weight loss and glycemic control. To determine whether self-monitoring of blood glucose levels improves dietary compliance in these patients, 50 obese patients with type II diabetes were randomly assigned either to a standard behavioral weight control program or to a weight control program that included self-monitoring of blood glucose levels and focused on the weight-blood glucose relationship. Both groups lost significant amounts of weight and maintained their losses for at least one year; reductions in medication could be made for 70 percent of patients. These data suggest that the behavioral weight control used in this study may be of benefit to patients with type II diabetes. However, there was no evidence that the addition of self-monitoring of blood glucose levels to the treatment program improved the outcome in terms of weight loss, reduction in medication, dietary compliance, or mood state.

An accelerated dose escalation with a grass pollen allergoid is safe and well-tolerated: a randomized open label phase II trial.

PubMed

Chaker, A M; Al-Kadah, B; Luther, U; Neumann, U; Wagenmann, M

2015-01-01

The number of injections in the dose escalation of subcutaneous immunotherapy (SCIT) is small for some currently used hypoallergenic allergoids, but can still be inconvenient to patients and can impair compliance. The aim of this trial was to compare safety and tolerability of an accelerated to the conventional dose escalation scheme of a grass pollen allergoid. In an open label phase II trial, 122 patients were 1:1 randomized for SCIT using a grass pollen allergoid with an accelerated dose escalation comprising only 4 weekly injections (Group I) or a conventional dose escalation including 7 weekly injections (Group II). Safety determination included the occurrence of local and systemic adverse events. Tolerability was assessed by patients and physicians. Treatment-related adverse events were observed in 22 (36.1 %) patients in Group I and 15 (24.6 %) in Group II. Local reactions were reported by 18 patients in Group I and 11 in Group II. Five Grade 1 systemic reactions (WAO classification) were observed in Group I and 2 in Group II. Grade 2 reactions occurred 3 times in Group I and 2 times in Group II. Tolerability was rated as "good" or "very good" by 53 (86.9 %) patients in Group I and 59 (100 %) in Group II by investigators. Forty-eight patients in Group I (80.0 %) and 54 in Group II (91.5 %) rated tolerability as "good" or "very good". The dose escalation of a grass pollen allergoid can be accelerated with safety and tolerability profiles comparable to the conventional dose escalation.

Phylogenetic analysis of different breeds of domestic chickens in selected area of Peninsular Malaysia inferred from partial cytochrome b gene information and RAPD markers.

PubMed

Yap, Fook Choy; Yan, Yap Jin; Loon, Kiung Teh; Zhen, Justina Lee Ning; Kamau, Nelly Warau; Kumaran, Jayaraj Vijaya

2010-10-01

The present investigation was carried out in an attempt to study the phylogenetic analysis of different breeds of domestic chickens in Peninsular Malaysia inferred from partial cytochrome b gene information and random amplified polymorphic DNA (RAPD) markers. Phylogenetic analysis using both neighbor-joining (NJ) and maximum parsimony (MP) methods produced three clusters that encompassed Type-I village chickens, the red jungle fowl subspecies and the Japanese Chunky broilers. The phylogenetic analysis also revealed that majority of the Malaysian commercial chickens were randomly assembled with the Type-II village chickens. In RAPD assay, phylogenetic analysis using neighbor-joining produced six clusters that were completely distinguished based on the locality of chickens. High levels of genetic variations were observed among the village chickens, the commercial broilers, and between the commercial broilers and layer chickens. In this study, it was found that Type-I village chickens could be distinguished from the commercial chickens and Type-II village chickens at the position of the 27th nucleotide of the 351 bp cytochrome b gene. This study also revealed that RAPD markers were unable to differentiate the type of chickens, but it showed the effectiveness of RAPD in evaluating the genetic variation and the genetic relationships between chicken lines and populations.

The CREST-E study of creatine for Huntington disease: A randomized controlled trial.

PubMed

Hersch, Steven M; Schifitto, Giovanni; Oakes, David; Bredlau, Amy-Lee; Meyers, Catherine M; Nahin, Richard; Rosas, Herminia Diana

2017-08-08

To investigate whether creatine administration could slow progressive functional decline in adults with early symptoms of Huntington disease. We conducted a multicenter, randomized, double-blind, placebo-controlled study of up to 40 g daily of creatine monohydrate in participants with stage I and II HD treated for up to 48 months. The primary outcome measure was the rate of change in total functional capacity (TFC) between baseline and end of follow-up. Secondary outcome measures included changes in additional clinical scores, tolerability, and quality of life. Safety was assessed by adverse events and laboratory studies. At 46 sites in North America, Australia, and New Zealand, 553 participants were randomized to creatine (275) or placebo (278). The trial was designed to enroll 650 patients, but was halted for futility after the first interim analysis. The estimated rates of decline in the primary outcome measure (TFC) were 0.82 points per year for participants on creatine, 0.70 points per year for participants on placebo, favoring placebo (nominal 95% confidence limits -0.11 to 0.35). Adverse events, mainly gastrointestinal, were significantly more common in participants on creatine. Serious adverse events, including deaths, were more frequent in the placebo group. Subgroup analysis suggested that men and women may respond differently to creatine treatment. Our data do not support the use of creatine treatment for delaying functional decline in early manifest HD. NCT00712426. This study provides Class II evidence that for patients with early symptomatic HD, creatine monohydrate is not beneficial for slowing functional decline. Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

Study protocol on comparative effectiveness of mindfulness meditation and qigong on psychophysiological outcomes for patients with colorectal cancer: a randomized controlled trial.

PubMed

Ho, Rainbow T H; Wan, Adrian H Y; Chan, Jessie S M; Ng, S M; Chung, K F; Chan, Cecilia L W

2017-08-08

Colorectal cancer imposes threats to patients' well-being. Although most physical symptoms can be managed by medication, psychosocial stressors may complicate survival and hamper quality of life. Mindfulness and Qigong, two kinds of mind-body exercise rooted in Eastern health philosophy, has been found effective in symptoms management, improving mental health, and reducing stress. With these potential benefits, a randomized controlled trial (RCT) is planned to investigate the comparative effectiveness of mindfulness and Baduanjin intervention on the bio-psychosocial wellbeing of people with colorectal cancer. A 3-arm RCT with waitlist control design will be used in this study. One hundred eighty-nine participants will be randomized into (i) Mindfulness, (ii) Baduanjin, or (iii) waitlist control groups. Participants in both the Baduanjin and mindfulness groups will receive 8-weeks of specific intervention. All three groups will undergo four assessment phases: (i) at baseline, (ii) at 4-week, (iii) at 8-week (post-intervention), and 6-month post-intervention (maintenance). All participants will be assessed in terms of cancer-related symptoms and symptom distress, mental health status, quality of life, stress level based on physiological marker. Based on prior research studies, participants in both the mindfulness and Baduanjn intervention group are expected to have better symptoms management, lower stress level, better mental health, and higher level of quality of life than the control group. This study contributes to better understanding on the common and unique effectiveness of mindfulness and Baduanjin qigong, as such patients and qualified healthcare professionals can select or provide practices which will produce maximum benefits, satisfaction, adherence, and sustainability. The trial has been registered in the Clinical Trials Centre of the University of Hong Kong ( HKCTR-2198 ) on 08 March 2017.

Randomized phase II study of sequential carboplatin plus paclitaxel and gefitinib in chemotherapy-naïve patients with advanced or metastatic non-small-cell lung cancer: Long-term follow-up results.

PubMed

Kubo, Emi; Yamamoto, Noboru; Nokihara, Hiroshi; Fujiwara, Yutaka; Horinouchi, Hidehito; Kanda, Shintaro; Goto, Yasushi; Ohe, Yuichiro

2017-01-01

The epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor gefitinib was initially approved in Japan in 2002 for the treatment of advanced or metastatic non-small-cell lung cancer (NSCLC); however, the optimal order of conventional cytotoxic chemotherapy (carboplatin and paclitaxel) and gefitinib administration has not been determined. We conducted a randomized phase II study of carboplatin and paclitaxel followed by gefitinib vs. gefitinib followed by carboplatin and paclitaxel to select a candidate for further development in a phase III study of chemotherapy-naïve patients with advanced or metastatic NSCLC, regardless of their EGFR mutation status. A total of 97 patients meeting this description were randomly assigned to arm A (carboplatin and paclitaxel followed by gefitinib; n=49) or B (gefitinib followed by carboplatin and paclitaxel; n=48) from June, 2003 to October, 2005. Carboplatin and paclitaxel were administered in 4 cycles every 3 weeks; gefitinib was continued until disease progression or development of unacceptable toxicity. The primary endpoint was overall survival; the secondary endpoints were response rate and adverse event prevalence. The median overall follow-up was 65.1 months (range, 28.7-75.1 months). The major toxicities were hematological (carboplatin and paclitaxel) or skin rash, diarrhea and hepatic dysfunction (gefitinib). Interstitial lung disease was observed in 1 patient from each arm. In arms A and B, the carboplatin and paclitaxel response rate, gefitinib response rate, and median survival durations were 34.8 and 26.5%, 33.3 and 35.7%, and 18.8 and 17.2 months, respectively. Arm A was selected for a subsequent phase III study.

Antibiotics in third molar extraction; are they really necessary: A non-inferiority randomized controlled trial

PubMed Central

Arora, Ankit; Roychoudhury, Ajoy; Bhutia, Ongkila; Pandey, Sandeep; Singh, Surender; Das, Bimal K.

2014-01-01

Introduction: Antibiotic resistance is now a serious problem, although it was not so only a few years ago. The need of the hour is to give clear evidence of the efficacy of antibiotic use, or lack thereof, to the surgeon for a procedure as common as mandibular third molar surgery. Aim: This study aimed to evaluate whether postoperative combined amoxicillin and clavulanic acid in mandibular third molar extraction is effective in preventing inflammatory complications. Study and Design: The study was structured as a prospective randomized double-blind placebo-controlled clinical trial. Materials and Methods: A study was designed wherein the 96 units (two bilaterally similar impacted mandibular third molars per head in 48 patients) were randomly assigned to two treatment groups (Group I and Group II). Each patient served as his/her own control. Each patient received 625 mg of combined amoxicillin and clavulanic acid 1 h before surgery. In the case of third molars belonging to Group I, 625 mg of combined amoxicillin and clavulanic acid TDS was continued for 3 days; in Group II, placebo in similar-looking packs was continued for 3 days. The patients were evaluated on the third and seventh postoperative days for signs of clinical infection and for microbial load evaluation. Statistical Analysis: The data between the two groups were statistically analyzed by the two-tailed Fisher's exact test, with a 95% confidence interval. Results: The difference was not statistically significant between the test group and the control group with regard to erythema, dehiscence, swelling, pain, trismus, and infection based on microbial load. The data were statistically significant for alveolar osteitis, with the occurrence of alveolar osteitis (14.58%) in the placebo group. Conclusion: Postoperative antibiotics are recommended only for patients undergoing contaminated, long-duration surgery. PMID:25937728

A new method for predicting response in complex linear systems. II. [under random or deterministic steady state excitation

NASA Technical Reports Server (NTRS)

Bogdanoff, J. L.; Kayser, K.; Krieger, W.

1977-01-01

The paper describes convergence and response studies in the low frequency range of complex systems, particularly with low values of damping of different distributions, and reports on the modification of the relaxation procedure required under these conditions. A new method is presented for response estimation in complex lumped parameter linear systems under random or deterministic steady state excitation. The essence of the method is the use of relaxation procedures with a suitable error function to find the estimated response; natural frequencies and normal modes are not computed. For a 45 degree of freedom system, and two relaxation procedures, convergence studies and frequency response estimates were performed. The low frequency studies are considered in the framework of earlier studies (Kayser and Bogdanoff, 1975) involving the mid to high frequency range.

Changeover Trial of Azilsartan and Olmesartan Comparing Effects on the Renin-Angiotensin-Aldosterone System in Patients with Essential Hypertension after Cardiac Surgery (CHAOS Study)

PubMed Central

Osaka, Shunji; Yaoita, Hiroko; Arimoto, Munehito; Hata, Hiroaki; Shiono, Motomi; Sakino, Hisakuni

2016-01-01

Background: Angiotensin II receptor blockers (ARBs) have been widely used to treat hypertension and large-scale clinical studies have shown various benefits. In this study, we compared olmesartan with azilsartan, the newest ARB. Methods: The subjects were outpatients who were clinically stable after cardiac surgery. Sixty patients were randomized to receive either azilsartan or olmesartan for 1 year and were switched to the other drug for the following 1 year. The primary endpoints were the levels of plasma renin activity, angiotensin II, and aldosterone. Results: Home blood pressure exceeded 140/90 mmHg and additional antihypertensive medication was administered to 12 patients (20 episodes) in the azilsartan group versus 4 patients (4 episodes) in the olmesartan group, with the number being significantly higher in the azilsartan group. After 1 year of treatment, both angiotensin II and aldosterone levels were significantly lower in the olmesartan group than the azilsartan group. Left ventricular mass index was also significantly lower in the olmesartan group than the azilsartan group. Conclusion: This study showed that olmesartan reduces angiotensin II and aldosterone levels more effectively than azilsartan. Accordingly, it may be effective in patients with increased renin-angiotensin-aldosterone system activity after cardiac surgery or patients with severe cardiac hypertrophy. PMID:27086671

Changeover Trial of Azilsartan and Olmesartan Comparing Effects on the Renin-Angiotensin-Aldosterone System in Patients with Essential Hypertension after Cardiac Surgery (CHAOS Study).

PubMed

Sezai, Akira; Osaka, Shunji; Yaoita, Hiroko; Arimoto, Munehito; Hata, Hiroaki; Shiono, Motomi; Sakino, Hisakuni

2016-06-20

Angiotensin II receptor blockers (ARBs) have been widely used to treat hypertension and large-scale clinical studies have shown various benefits. In this study, we compared olmesartan with azilsartan, the newest ARB. The subjects were outpatients who were clinically stable after cardiac surgery. Sixty patients were randomized to receive either azilsartan or olmesartan for 1 year and were switched to the other drug for the following 1 year. The primary endpoints were the levels of plasma renin activity, angiotensin II, and aldosterone. Home blood pressure exceeded 140/90 mmHg and additional antihypertensive medication was administered to 12 patients (20 episodes) in the azilsartan group versus 4 patients (4 episodes) in the olmesartan group, with the number being significantly higher in the azilsartan group. After 1 year of treatment, both angiotensin II and aldosterone levels were significantly lower in the olmesartan group than the azilsartan group. Left ventricular mass index was also significantly lower in the olmesartan group than the azilsartan group. This study showed that olmesartan reduces angiotensin II and aldosterone levels more effectively than azilsartan. Accordingly, it may be effective in patients with increased renin-angiotensin-aldosterone system activity after cardiac surgery or patients with severe cardiac hypertrophy.

DSM-IV Axis II personality disorders and suicide and attempted suicide in China.

PubMed

Tong, Yongsheng; Phillips, Michael R; Conner, Kenneth R

2016-10-01

There are meagre data on Axis II personality disorders and suicidal behaviour in China. To describe the prevalence of Axis II personality disorders in suicides and suicide attempts in China and to estimate risk for these outcomes associated with personality disorders. People who died by suicide (n = 151), people who attempted suicide (n = 118) and living community controls (n = 140) were randomly sampled from four Chinese counties and studied using the Structured Clinical Interviews for DSM-IV-TR Axis I Disorders (SCID-I) and Axis II Personality Disorders (SCID-II). We also determined the prevalence of subthreshold versions of ten DSM-IV personality disorders. Axis II personality disorders were present in 7% of the suicide group, 6% of the suicide attempt group and 1% of the control group. Threshold and subthreshold personality disorders had adjusted odds ratios (point estimates) in the range of 2.7-8.0 for suicide and for suicide attempts. Axis II personality disorders may confer increased risk for suicidal behaviour in China, but their low prevalence in the community and among people with suicidal behaviour suggests that other personality constructs such as select dimensional traits may be a more fruitful avenue for understanding and preventing suicide in China. © The Royal College of Psychiatrists 2016.

Hyperbaric oxygen therapy in the treatment of osteonecrosis of the femoral head: a review of the current literature.

PubMed

Uzun, Gunalp; Mutluoglu, Mesut; Ersen, Omer; Yildiz, Senol

2016-01-01

To review the current literature on the use of hyperbaric oxygen (HBO₂) therapy in the treatment of osteonecrosis of the femoral head (ONFH). We searched PubMed, Directory of Open Access Journals (DOAJ), EMBASE, Web of Science, Academic Search Complete, CINAHL and MEDLINE through April 2015. We hand-searched relevant textbooks, conference proceedings and the reference lists of review articles and clinical studies Randomized controlled trials (RCT) and observational studies (cohort study, case-control study, case series) that reported the outcome of patients who received HBO₂therapy for ONFH were included. Only English-language articles were included. Study quality was not used as an exclusion criterion. Two authors independently assessed trials for inclusion, extracted data and presented to other authors. Disagreements were resolved by consensus. We identified eight clinical studies; two randomized controlled trials (RCTs); one historically controlled study; and five case series. The majority of the studies were small-scale, heterogeneous and methodologically weak. In four of the studies HBO₂therapy was combined with other treatment modalities, making it impossible to draw firm conclusions on the specific effects of HBO₂therapy. Hip survivorship in studies wherein HBO₂therapy was used alone was 95.5% in Steinberg Stage I lesions, 89% in Steinberg Stage II lesions and 100% in Ficat Stage II lesions. There is a room for HBO₂therapy in the management ONFH. Further RCTs, however, are required to better elucidate the role of HBO₂therapy in the treatment of ONFH.

The structures of the crystalline phase and columnar mesophase of rhodium (II) heptanoate and of its binary mixture with copper (II) heptanoate probed by EXAFS

NASA Astrophysics Data System (ADS)

Inb-Elhaj, M.; Guillon, D.; Skoulios, A.; Maldivi, P.; Giroud-Godquin, A. M.; Marchon, J.-C.

1992-12-01

EXAFS was used to investigate the local structure of the polar spines of rhodium (II) soaps in the columnar liquid crystalline state. It was also used to ascertain the degree of blending of the cores in binary mixtures of rhodium (II) and copper (II) soaps. For the pure rhodium soaps, the columns are shown to result from the stacking of binuclear metal-metal bonded dirhodium tetracarboxylate units bonded to one another by apical ligation of the metal atom of each complex with one of the oxygen atoms of the adjacent molecule. Mixtures of rhodium (II) and copper (II) soaps give a hexagonal columnar mesophase in which pure rhodium and pure copper columns are randomly distributed.

Effect of Mud-Bath Therapy on Serum Biomarkers in Patients with Knee Osteoarthritis: Results from a Randomized Controlled Trial.

PubMed

Pascarelli, Nicola A; Cheleschi, Sara; Bacaro, Giovanni; Guidelli, Giacomo M; Galeazzi, Mauro; Fioravanti, Antonella

2016-01-01

Balneotherapy is one of the most commonly used non-pharmacological approaches for osteoarthritis (OA). Recent data indicate that some biomarkers could be useful to predict OA progression and to assess therapeutic response. To evaluate the effects of mud-bath therapy on serum biomarkers in patients with knee OA. The study group comprised 103 patients with primary symptomatic bilateral knee OA who were randomly assigned to receive a cycle of mud-bath therapy over a period of 2 weeks or to continue their standard therapy alone. Clinical and biochemical parameters were assessed at baseline and after 2 weeks. Clinical assessments included global pain score on a visual analogue scale (VAS) and the Western Ontario and McMaster Universities Index (WOMAC) subscores for knee OA. Cartilage oligomeric matrix protein (COMP), C-terminal cross-linked telopeptide type II collagen (CTX-II), myeloperoxidase (MPO) and high sensitivity C-reactive protein (hsCRP) serum levels were assessed by ELISA. At the end of mud-bath therapy we observed a statistically significant improvement in VAS and WOMAC subscores. Serum levels of COMP, MPO and hsCRP did not show any significant modification in either group, while a significant increase (P < 0.001) in CTX-II serum levels was observed in the mud-bath group after the treatment. A cycle of mud-bath therapy added to the usual treatment had a beneficial effect on pain and function in patients with knee OA. The evaluation of serum biomarkers showed a significant increase of CTX-II only, perhaps due to an increase of cartilage turnover induced by thermal stress.

The Comparative Reliability and Feasibility of the Past-Year Canadian Diet History Questionnaire II: Comparison of the Paper and Web Versions.

PubMed

Lo Siou, Geraldine; Csizmadi, Ilona; Boucher, Beatrice A; Akawung, Alianu K; Whelan, Heather K; Sharma, Michelle; Al Rajabi, Ala; Vena, Jennifer E; Kirkpatrick, Sharon I; Koushik, Anita; Massarelli, Isabelle; Rondeau, Isabelle; Robson, Paula J

2017-02-13

Advances in technology-enabled dietary assessment include the advent of web-based food frequency questionnaires, which may reduce costs and researcher burden but may introduce new challenges related to internet connectivity and computer literacy. The purpose of this study was to evaluate the intra- and inter-version reliability, feasibility and acceptability of the paper and web Canadian Diet History Questionnaire II (CDHQ-II) in a sub-sample of 648 adults (aged 39-81 years) recruited from Alberta's Tomorrow Project. Participants were randomly assigned to one of two groups: (1) paper, web, paper; or (2) web, paper, web over a six-week period. With few exceptions, no statistically significant differences in mean nutrient intake were found in the intra- and inter-version reliability analyses. The majority of participants indicated future willingness to complete the CDHQ-II online, and 59% indicated a preference for the web over the paper version. Findings indicate that, in this population of adults drawn from an existing cohort, the CDHQ-II may be administered in paper or web modalities (increasing flexibility for questionnaire delivery), and the nutrient estimates obtained with either version are comparable. We recommend that other studies explore the feasibility and reliability of different modes of administration of dietary assessment instruments prior to widespread implementation.

Association of tRNA methyltransferase NSUN2/IGF-II molecular signature with ovarian cancer survival.

PubMed

Yang, Jia-Cheng; Risch, Eric; Zhang, Meiqin; Huang, Chan; Huang, Huatian; Lu, Lingeng

2017-09-01

To investigate the association between NSUN2/IGF-II signature and ovarian cancer survival. Using a publicly accessible dataset of RNA sequencing and clinical follow-up data, we performed Classification and Regression Tree and survival analyses. Patients with NSUN2 high IGF-II low had significantly superior overall and disease progression-free survival, followed by NSUN2 low IGF-II low , NSUN2 high IGF-II high and NSUN2 low IGF-II high (p < 0.0001 for overall, p = 0.0024 for progression-free survival, respectively). The associations of NSUN2/IGF-II signature with the risks of death and relapse remained significant in multivariate Cox regression models. Random-effects meta-analyses show the upregulated NSUN2 and IGF-II expression in ovarian cancer versus normal tissues. The NSUN2/IGF-II signature associates with heterogeneous outcome and may have clinical implications in managing ovarian cancer.

Improvement in depression scores after 1 hour of light therapy treatment in patients with seasonal affective disorder.

PubMed

Reeves, Gloria M; Nijjar, Gagan Virk; Langenberg, Patricia; Johnson, Mary A; Khabazghazvini, Baharak; Sleemi, Aamar; Vaswani, Dipika; Lapidus, Manana; Manalai, Partam; Tariq, Muhammad; Acharya, Monika; Cabassa, Johanna; Snitker, Soren; Postolache, Teodor T

2012-01-01

The purpose of this study was to investigate possible rapid effects of light therapy on depressed mood in patients with seasonal affective disorder. Participants received 1 hour of bright light therapy and 1 hour of placebo dim red light in a randomized order crossover design. Depressed mood was measured at baseline and after each hour of light treatment using two self-report depression scales (Profile of Mood States-Depression-Dejection [POMS-D] subscale and the Beck Depression Inventory II [BDI-II]). When light effects were grouped for the two sessions, there was significantly greater reduction in self-report depression scores by -1.3 (p = 0.02) on the BDI-II and -1.2 (p = 0.02) on the POMS-D. A significant but modest improvement was detected after a single active light session. This is the first study, to our knowledge, to document an immediate improvement with light treatment using a placebo-controlled design with a clinical sample of depressed individuals.

The effect of incentive spirometry on chest expansion and breathing work in patients with chronic obstructive airway diseases: comparison of two methods.

PubMed

Ho, S C; Chiang, L L; Cheng, H F; Lin, H C; Sheng, D F; Kuo, H P; Lin, H C

2000-02-01

Chronic obstructive airway diseases (COAD), characterized by mucus hypersecretion, lead to exercise intolerance. Incentive spirometry has been used to prevent postoperative pulmonary atelectasis. To compare the efficacy of two incentive spirometers, Coach (volume-oriented) and Triflo (flow-oriented), in the work of breathing in COAD patients, 22 patients were randomized in this study: 12 patients (Triflo-II group) initially used Triflo-II for 10 minutes and then Coach for the same period. In contrast, the Coach group, including 10 patients, started with Coach followed by Triflo-II. After receiving incentive spirometry, lung expansion and work of breathing were assessed. Patients in the Coach group significantly increased chest wall expansion (p = 0.041), as compared with patients using Triflo-II. Similarly, there was also a significantly increased abdominal wall expansion in the Coach group (p = 0.0056), compared with that in the Triflo-II group. The need of accessory muscle assistance for breathing in the Coach group was significantly less than in the Triflo-II group (p = 0.047). It was easier for patients in the Coach group to start a breath (p = 0.0058) than for those in the Triflo-II group. For the entire group, 17 patients (77.3%) preferred Coach to assist their breathing, and only 4 patients (18.2%) favored Triflo-II. COAD patients achieved a larger expansion of the chest and abdomen with a Coach device. Our data provide a good rationale for an outcome study on the use of incentive spirometer in COAD patients.

[Randomized, controlled clinical trials with observational follow-up investigations for evaluating efficacy of antihyperglycaemic treatment. II. Features of and lessons from the follow-up investigations].

PubMed

Jermendy, György

2018-04-01

Although the outcomes of the follow-up investigation period of the randomized clinical studies for evaluating the efficacy of a treatment or an antidiabetic drug may be confounded or potentially biased by several factors, the results are widely accepted by the diabetes community. In line with the theory of metabolic memory or metabolic legacy, early and intensive antihyperglycaemic treatment should be provided for all diabetic patients as this strategy can result in beneficial effects even in the long run. The recent cardiovascular safety trials with new, innovative antidiabetic drugs differ in several aspects from the former efficacy studies. Ten cardiovascular safety trials were completed so far enabling to define their unique and common features. It can be anticipated that the era of randomized, controlled efficacy studies with observational follow-up investigations came to an end in diabetes research. Nowadays, cardiovascular safety trials are in the focus of clinical research in diabetology and results of several ongoing studies are expected with interest in the near future. Orv Hetil. 2018; 159(16): 615-619.

Random walks with long-range steps generated by functions of Laplacian matrices

NASA Astrophysics Data System (ADS)

Riascos, A. P.; Michelitsch, T. M.; Collet, B. A.; Nowakowski, A. F.; Nicolleau, F. C. G. A.

2018-04-01

In this paper, we explore different Markovian random walk strategies on networks with transition probabilities between nodes defined in terms of functions of the Laplacian matrix. We generalize random walk strategies with local information in the Laplacian matrix, that describes the connections of a network, to a dynamic determined by functions of this matrix. The resulting processes are non-local allowing transitions of the random walker from one node to nodes beyond its nearest neighbors. We find that only two types of Laplacian functions are admissible with distinct behaviors for long-range steps in the infinite network limit: type (i) functions generate Brownian motions, type (ii) functions Lévy flights. For this asymptotic long-range step behavior only the lowest non-vanishing order of the Laplacian function is relevant, namely first order for type (i), and fractional order for type (ii) functions. In the first part, we discuss spectral properties of the Laplacian matrix and a series of relations that are maintained by a particular type of functions that allow to define random walks on any type of undirected connected networks. Once described general properties, we explore characteristics of random walk strategies that emerge from particular cases with functions defined in terms of exponentials, logarithms and powers of the Laplacian as well as relations of these dynamics with non-local strategies like Lévy flights and fractional transport. Finally, we analyze the global capacity of these random walk strategies to explore networks like lattices and trees and different types of random and complex networks.

Genome-Enabled Studies of Anaerobic, Nitrate-Dependent Iron Oxidation in the Chemolithoautotrophic Bacterium Thiobacillus denitrificans

NASA Astrophysics Data System (ADS)

Beller, H. R.; Zhou, P.; Legler, T. C.; Chakicherla, A.; O'Day, P. A.

2013-12-01

Thiobacillus denitrificans is a chemolithoautotrophic bacterium capable of anaerobic, nitrate-dependent U(IV) and Fe(II) oxidation, both of which can strongly influence the long-term efficacy of in situ reductive immobilization of uranium in contaminated aquifers. We previously identified two c-type cytochromes involved in nitrate-dependent U(IV) oxidation in T. denitrificans and hypothesized that c-type cytochromes would also catalyze Fe(II) oxidation, as they have been found to play this role in anaerobic phototrophic Fe(II)-oxidizing bacteria. Here we report on efforts to identify genes associated with nitrate-dependent Fe(II) oxidation, namely (a) whole-genome transcriptional studies [using FeCO3, Fe2+, and U(IV) oxides as electron donors under denitrifying conditions], (b) Fe(II) oxidation assays performed with knockout mutants targeting primarily highly expressed or upregulated c-type cytochromes, and (c) random transposon-mutagenesis studies with screening for Fe(II) oxidation. Assays of mutants for 26 target genes, most of which were c-type cytochromes, indicated that none of the mutants tested were significantly defective in nitrate-dependent Fe(II) oxidation. The non-defective mutants included the c1-cytochrome subunit of the cytochrome bc1 complex (complex III), which has relevance to a previously proposed role for this complex in nitrate-dependent Fe(II) oxidation and to current concepts of reverse electron transfer. Of the transposon mutants defective in Fe(II) oxidation, one mutant with a disrupted gene associated with NADH:ubiquinone oxidoreductase (complex I) was ~35% defective relative to the wild-type strain; this strain was similarly defective in nitrate reduction with thiosulfate as the electron donor. Overall, our results indicate that nitrate-dependent Fe(II) oxidation in T. denitrificans is not catalyzed by the same c-type cytochromes involved in U(IV) oxidation, nor have other c-type cytochromes yet been implicated in the process.

Effect of angiotensin-converting enzyme (ACE) gene polymorphism on progression of renal disease and the influence of ACE inhibition in IDDM patients: findings from the EUCLID Randomized Controlled Trial. EURODIAB Controlled Trial of Lisinopril in IDDM.

PubMed

Penno, G; Chaturvedi, N; Talmud, P J; Cotroneo, P; Manto, A; Nannipieri, M; Luong, L A; Fuller, J H

1998-09-01

We examined whether the ACE gene insertion/deletion (I/D) polymorphism modulates renal disease progression in IDDM and how ACE inhibitors influence this relationship. The EURODIAB Controlled Trial of Lisinopril in IDDM is a multicenter randomized placebo-controlled trial in 530 nonhypertensive, mainly normoalbuminuric IDDM patients aged 20-59 years. Albumin excretion rate (AER) was measured every 6 months for 2 years. Genotype distribution was 15% II, 58% ID, and 27% DD. Between genotypes, there were no differences in baseline characteristics or in changes in blood pressure and glycemic control throughout the trial. There was a significant interaction between the II and DD genotype groups and treatment on change in AER (P = 0.05). Patients with the II genotype showed the fastest rate of AER progression on placebo but had an enhanced response to lisinopril. AER at 2 years (adjusted for baseline AER) was 51.3% lower on lisinopril than placebo in the II genotype patients (95% CI, 15.7 to 71.8; P = 0.01), 14.8% in the ID group (-7.8 to 32.7; P = 0.2), and 7.7% in the DD group (-36.6 to 37.6; P = 0.7). Absolute differences in AER between placebo and lisinopril at 2 years were 8.1, 1.7, and 0.8 microg/min in the II, ID, and DD groups, respectively. The significant beneficial effect of lisinopril on AER in the II group persisted when adjusted for center, blood pressure, and glycemic control, and also for diastolic blood pressure at 1 month into the study. Progression from normoalbuminuria to microalbuminuria (lisinopril versus placebo) was 0.27 (0.03-2.26; P = 0.2) in the II group, and 1.30 (0.33-5.17; P = 0.7) in the DD group (P = 0.6 for interaction). Knowledge of ACE genotype may be of value in determining the likely impact of ACE inhibitor treatment.

Regression Discontinuity and Randomized Controlled Trial Estimates: An Application to The Mycotic Ulcer Treatment Trials.

PubMed

Oldenburg, Catherine E; Venkatesh Prajna, N; Krishnan, Tiruvengada; Rajaraman, Revathi; Srinivasan, Muthiah; Ray, Kathryn J; O'Brien, Kieran S; Glymour, M Maria; Porco, Travis C; Acharya, Nisha R; Rose-Nussbaumer, Jennifer; Lietman, Thomas M

2018-08-01

We compare results from regression discontinuity (RD) analysis to primary results of a randomized controlled trial (RCT) utilizing data from two contemporaneous RCTs for treatment of fungal corneal ulcers. Patients were enrolled in the Mycotic Ulcer Treatment Trials I and II (MUTT I & MUTT II) based on baseline visual acuity: patients with acuity ≤ 20/400 (logMAR 1.3) enrolled in MUTT I, and >20/400 in MUTT II. MUTT I investigated the effect of topical natamycin versus voriconazole on best spectacle-corrected visual acuity. MUTT II investigated the effect of topical voriconazole plus placebo versus topical voriconazole plus oral voriconazole. We compared the RD estimate (natamycin arm of MUTT I [N = 162] versus placebo arm of MUTT II [N = 54]) to the RCT estimate from MUTT I (topical natamycin [N = 162] versus topical voriconazole [N = 161]). In the RD, patients receiving natamycin had mean improvement of 4-lines of visual acuity at 3 months (logMAR -0.39, 95% CI: -0.61, -0.17) compared to topical voriconazole plus placebo, and 2-lines in the RCT (logMAR -0.18, 95% CI: -0.30, -0.05) compared to topical voriconazole. The RD and RCT estimates were similar, although the RD design overestimated effects compared to the RCT.

Intrinsic Cellular Properties and Connectivity Density Determine Variable Clustering Patterns in Randomly Connected Inhibitory Neural Networks

PubMed Central

Rich, Scott; Booth, Victoria; Zochowski, Michal

2016-01-01

The plethora of inhibitory interneurons in the hippocampus and cortex play a pivotal role in generating rhythmic activity by clustering and synchronizing cell firing. Results of our simulations demonstrate that both the intrinsic cellular properties of neurons and the degree of network connectivity affect the characteristics of clustered dynamics exhibited in randomly connected, heterogeneous inhibitory networks. We quantify intrinsic cellular properties by the neuron's current-frequency relation (IF curve) and Phase Response Curve (PRC), a measure of how perturbations given at various phases of a neurons firing cycle affect subsequent spike timing. We analyze network bursting properties of networks of neurons with Type I or Type II properties in both excitability and PRC profile; Type I PRCs strictly show phase advances and IF curves that exhibit frequencies arbitrarily close to zero at firing threshold while Type II PRCs display both phase advances and delays and IF curves that have a non-zero frequency at threshold. Type II neurons whose properties arise with or without an M-type adaptation current are considered. We analyze network dynamics under different levels of cellular heterogeneity and as intrinsic cellular firing frequency and the time scale of decay of synaptic inhibition are varied. Many of the dynamics exhibited by these networks diverge from the predictions of the interneuron network gamma (ING) mechanism, as well as from results in all-to-all connected networks. Our results show that randomly connected networks of Type I neurons synchronize into a single cluster of active neurons while networks of Type II neurons organize into two mutually exclusive clusters segregated by the cells' intrinsic firing frequencies. Networks of Type II neurons containing the adaptation current behave similarly to networks of either Type I or Type II neurons depending on network parameters; however, the adaptation current creates differences in the cluster dynamics compared to those in networks of Type I or Type II neurons. To understand these results, we compute neuronal PRCs calculated with a perturbation matching the profile of the synaptic current in our networks. Differences in profiles of these PRCs across the different neuron types reveal mechanisms underlying the divergent network dynamics. PMID:27812323

s-core network decomposition: A generalization of k-core analysis to weighted networks

NASA Astrophysics Data System (ADS)

Eidsaa, Marius; Almaas, Eivind

2013-12-01

A broad range of systems spanning biology, technology, and social phenomena may be represented and analyzed as complex networks. Recent studies of such networks using k-core decomposition have uncovered groups of nodes that play important roles. Here, we present s-core analysis, a generalization of k-core (or k-shell) analysis to complex networks where the links have different strengths or weights. We demonstrate the s-core decomposition approach on two random networks (ER and configuration model with scale-free degree distribution) where the link weights are (i) random, (ii) correlated, and (iii) anticorrelated with the node degrees. Finally, we apply the s-core decomposition approach to the protein-interaction network of the yeast Saccharomyces cerevisiae in the context of two gene-expression experiments: oxidative stress in response to cumene hydroperoxide (CHP), and fermentation stress response (FSR). We find that the innermost s-cores are (i) different from innermost k-cores, (ii) different for the two stress conditions CHP and FSR, and (iii) enriched with proteins whose biological functions give insight into how yeast manages these specific stresses.

Management of atrial fibrillation in the post-cardiac surgery setting.

PubMed

Daoud, Emile G

2004-02-01

New onset postcardiac surgery AF is a prevalent problem associated with increased morbidity, hospital expense, and length of stay. Those agents that inhibit beta-adrenergic receptors (class II beta-blockers, sotalol, and amiodarone) have been demonstrated to be successful prophylaxis against postoperative AF. Furthermore, those therapies that do not inhibit beta-receptors are not effective prophylactic agents. Until comparative trials demonstrate a significant reduction in postoperative AF without additional adverse effects for sotalol or amiodarone compared with beta-blockers, class II beta-blockers are the preferred prophylactic therapy. If patients are deemed unable to take beta-blockers, amiodarone is likely the best alternative. Although prophylaxis against postoperative AF seems prudent, the impact of prophylactic therapy on length of stay and hospital costs has not been a primary objective of any randomized trial. Furthermore, no studies have compared prophylactic therapy for every patient versus therapy only for those patients who experience AF after heart surgery. In the absence of data from randomized clinical trials, postoperative AF should be managed in a similar fashion to clinical AF with attention to rate control, anticoagulation, and restoration of sinus rhythm.

Suppressed neural complexity during ketamine- and propofol-induced unconsciousness.

PubMed

Wang, Jisung; Noh, Gyu-Jeong; Choi, Byung-Moon; Ku, Seung-Woo; Joo, Pangyu; Jung, Woo-Sung; Kim, Seunghwan; Lee, Heonsoo

2017-07-13

Ketamine and propofol have distinctively different molecular mechanisms of action and neurophysiological features, although both induce loss of consciousness. Therefore, identifying a common feature of ketamine- and propofol-induced unconsciousness would provide insight into the underlying mechanism of losing consciousness. In this study we search for a common feature by applying the concept of type-II complexity, and argue that neural complexity is essential for a brain to maintain consciousness. To test this hypothesis, we show that complexity is suppressed during loss of consciousness induced by ketamine or propofol. We analyzed the randomness (type-I complexity) and complexity (type-II complexity) of electroencephalogram (EEG) signals before and after bolus injection of ketamine or propofol. For the analysis, we use Mean Information Gain (MIG) and Fluctuation Complexity (FC), which are information-theory-based measures that quantify disorder and complexity of dynamics respectively. Both ketamine and propofol reduced the complexity of the EEG signal, but ketamine increased the randomness of the signal and propofol decreased it. The finding supports our claim and suggests EEG complexity as a candidate for a consciousness indicator. Copyright © 2017 Elsevier B.V. All rights reserved.

Acculturation level and caregiver outcomes from a randomized intervention trial to enhance caregivers' health: evidence from REACH II.

PubMed

Meyer, Oanh L; Liu, Xiaoyan Lucia; Tancredi, Daniel; Ramirez, A Susana; Schulz, Richard; Hinton, Ladson

2018-06-01

Latinos comprise a growing segment of the caregiver population and vary widely in acculturation, yet little is known regarding how acculturation might affect caregiver stress or intervention outcomes. This study examined the relationship between acculturation and burden, bother, and depression in Latino dementia caregivers at baseline and following an intervention. This was a secondary data analysis of 211 Latino caregivers of older adults with dementia from Resources for Enhancing Alzheimer's Caregiver Health (REACH) II, a multisite randomized trial of caregiver interventions. Baseline and follow-up data were used to run mixed-effects models examining the main and moderating effect of acculturation on caregiver stress. No significant main effect of acculturation was found for any of the outcome measures, controlling for demographic covariates. Acculturation moderated the effect of the intervention on caregiver burden: those who were more acculturated benefited more from the intervention. Differential acculturation for Latino caregivers was not directly associated with caregiver burden, bother, or depression, but was associated with reducing burden from the intervention. Future research should explore by what mechanism acculturation influences caregiver burden following an intervention.

A Phase II, Randomized, Safety and Immunogenicity Trial of a Re-Derived, Live-Attenuated Dengue Virus Vaccine in Healthy Children and Adults Living in Puerto Rico.

PubMed

Bauer, Kristen; Esquilin, Ines O; Cornier, Alberto Santiago; Thomas, Stephen J; Quintero Del Rio, Ana I; Bertran-Pasarell, Jorge; Morales Ramirez, Javier O; Diaz, Clemente; Carlo, Simon; Eckels, Kenneth H; Tournay, Elodie; Toussaint, Jean-Francois; De La Barrera, Rafael; Fernandez, Stefan; Lyons, Arthur; Sun, Wellington; Innis, Bruce L

2015-09-01

This was a double-blind, randomized, controlled, phase II clinical trial, two dose study of re-derived, live-attenuated, tetravalent dengue virus (TDEN) vaccine (two formulations) or placebo in subjects 1-50 years of age. Among the 636 subjects enrolled, 331 (52%) were primed, that is, baseline seropositive to at least one dengue virus (DENV) type. Baseline seropositivity prevalence increased with age (10% [< 2 years], 26% [2-4 years], 60% [5-20 years], and 93% [21-50 years]). Safety profiles of TDEN vaccines were similar to placebo regardless of priming status. No vaccine-related serious adverse events (SAEs) were reported. Among unprimed subjects, immunogenicity (geometric mean antibody titers [GMT] and seropositivity rates) for each DENV increased substantially in both TDEN vaccine groups with at least 74.6% seropositive for four DENV types. The TDEN vaccine candidate showed an acceptable safety and immunogenicity profile in children and adults ranging from 1 to 50 years of age, regardless of priming status. ClinicalTrials.gov: NCT00468858. © The American Society of Tropical Medicine and Hygiene.

Contributions of Platform Motion to Simulator Training Effectiveness: Study II--Aerobatics. Interim Report for Period March 1976-November 1977.

ERIC Educational Resources Information Center

Martin, Elizabeth L.; Waag, Wayne L.

A transfer-of-training design was used to evaluate the contributions of simulator training with synergistic six-degrees-of-freedom platform motion to aerobatic skills acquisition in the novice pilot. Thirty-six undergraduate pilot trainees were randomly assigned to one of three treatment groups: motion, no-motion, and control. Those in the control…

Survey II of Public and Leadership Attitudes Toward Nuclear Power Development in the United States. Study No. 2628.

ERIC Educational Resources Information Center

Harris (Louis) and Associates, Inc., New York, NY.

This publication details a national survey done by Louis Harris and Associates, similar to one done in 1975, to assess attitudes toward nuclear power in the United States. The survey consisted of three parts. The first part was in-person, door-to-door interviews with 1,597 randomly selected households nationwide. The second part was 309…

Advanced Cancer Detection Center

DTIC Science & Technology

2007-10-01

therapy in children: A Phase II randomized double blinded cross-over study (HLMCC 0708) • Risperidone for the Treatment of Cerebellar Mutism Syndrome...each question, the participant selects the answer by using the left and right arrow keys and then pressing the Choose button. The next question is...transformed to a quantitative scale measure for transmission. Numeric responses can be entered directly or can be selected from a list of

Changes in Mobility of Children with Cerebral Palsy over Time and across Environmental Settings

ERIC Educational Resources Information Center

Tieman, Beth L.; Palisano, Robert J.; Gracely, Edward J.; Rosenbaum, Peter L.; Chiarello, Lisa A.; O'Neil, Margaret E.

2004-01-01

This study examined changes in mobility methods of children with cerebral palsy (CP) over time and across environmental settings. Sixty-two children with CP, ages 6-14 years and classified as levels II-IV on the Gross Motor Function Classification System, were randomly selected from a larger data base and followed for three to four years. On each…

An Examination of the Extent to Which School Outdoor Activities Could Enhance Senior Secondary Two Students' Achievement in Ecology

ERIC Educational Resources Information Center

Achor, Emmanuel E.; Amadu, Samuel O.

2015-01-01

This study examined the extent to which school outdoor activities could enhance senior secondary (SS) two students' achievement in ecology. Non randomized pre test post test control group Quasi-experimental design was adopted. A sample of 160 SS II students from 4 co-educational schools in Jalingo metropolis, Taraba State Nigeria was used. A 40…

Effectiveness of Antimicrobial Therapy after Extraction of Impacted Mandibular Third Molar: A Randomized Clinical Trial.

PubMed

Rabi, A; Maheshwari, Rahul; Srinivasan, Bhuvaneshwari; Warad, Lata P; Suvarna, C C; Tank, Kartik S

2018-01-01

The present study was conducted with the aim of evaluating the effectiveness of antimicrobial therapy following extraction of an impacted mandibular third molar. This randomized controlled trial was conducted on a total of 60 patients who were randomly assigned into three groups: Group I individuals were given 625 mg of combined amoxicillin and clavulanic acid tablet; 625 mg of combined amoxicillin and clavulanic acid tablet + 400 mg metronidazole tablet was given to group II individuals; whereas group III individuals were assigned no treatment. All the individuals underwent surgical extraction of impacted mandibular third molars under strict aseptic techniques, with minimal trauma to the surrounding tissues. Mouth opening in millimeters was recorded postoperatively using Vernier calipers on the 1st, 3rd, 5th, and 7th days. A 4-point visual analog scale (VAS) was used for assessing postoperative pain. Patient satisfaction was further assessed in a subjective manner using a graded scale from "very satisfied" to "very unsatisfied". The present study included individuals between the ages of 20 and 35 years. Group II individuals showed slightly better satisfaction than the other group individuals. There was no statistically significant difference between the mean age of groups. It was observed that on day 3, the number of individuals with severe pain was slightly reduced in the group I compared with group III individuals. On day 5, participants with no pain were significantly more in group II followed by group I. Furthermore, there was a statistically significant difference between the study groups with respect to mouth opening on days 3 and 5. It was concluded from this trial that the administration of postoperative antimicrobials showed no significant differences in the degree of postoperative complications that occur following the surgical extraction of impacted mandibular third molars. Antimicrobial drugs are routinely used to reduce the chances of surgical site infection, either preopera-tively or postoperatively. Therefore, the clinicians should have sound knowledge about choosing the better antimicrobial drug after the extraction of impacted third molars.

Telephone Cognitive-Behavioral Therapy for Subthreshold Depression and Presenteeism in Workplace: A Randomized Controlled Trial

PubMed Central

Furukawa, Toshi A.; Horikoshi, Masaru; Kawakami, Norito; Kadota, Masayo; Sasaki, Megumi; Sekiya, Yuki; Hosogoshi, Hiroki; Kashimura, Masami; Asano, Kenichi; Terashima, Hitomi; Iwasa, Kazunori; Nagasaku, Minoru; Grothaus, Louis C.

2012-01-01

Background Subthreshold depression is highly prevalent in the general population and causes great loss to society especially in the form of reduced productivity while at work (presenteeism). We developed a highly-structured manualized eight-session cognitive-behavioral program with a focus on subthreshold depression in the workplace and to be administered via telephone by trained psychotherapists (tCBT). Methods We conducted a parallel-group, non-blinded randomized controlled trial of tCBT in addition to the pre-existing Employee Assistance Program (EAP) versus EAP alone among workers with subthreshold depression at a large manufacturing company in Japan. The primary outcomes were depression severity as measured with Beck Depression Inventory-II (BDI-II) and presenteeism as measured with World Health Organization Health and Work Productivity Questionnaire (HPQ). In the course of the trial the follow-up period was shortened in order to increase acceptability of the study. Results The planned sample size was 108 per arm but the trial was stopped early due to low accrual. Altogether 118 subjects were randomized to tCBT+EAP (n = 58) and to EAP alone (n = 60). The BDI-II scores fell from the mean of 17.3 at baseline to 11.0 in the intervention group and to 15.7 in the control group after 4 months (p<0.001, Effect size = 0.69, 95%CI: 0.32 to 1.05). However, there was no statistically significant decrease in absolute and relative presenteeism (p = 0.44, ES = 0.15, −0.21 to 0.52, and p = 0.50, ES = 0.02, −0.34 to 0.39, respectively). Conclusion Remote CBT, including tCBT, may provide easy access to quality-assured effective psychotherapy for people in the work force who present with subthreshold depression. Further studies are needed to evaluate the effectiveness of this approach in longer terms. The study was funded by Sekisui Chemicals Co. Ltd. Trial Registration ClinicalTrials.gov NCT00885014 PMID:22532849

Comparison of Glucosamine-Chondroitin Sulfate with and without Methylsulfonylmethane in Grade I-II Knee Osteoarthritis: A Double Blind Randomized Controlled Trial.

PubMed

Lubis, Andri M T; Siagian, Carles; Wonggokusuma, Erick; Marsetyo, Aldo F; Setyohadi, Bambang

2017-04-01

Glucosamine, chondroitinsulfate are frequently used to prevent further joint degeneration in osteoarthritis (OA). Methylsulfonylmethane (MSM) is a supplement containing organic sulphur and also reported to slow anatomical joint progressivity in the knee OA. The MSM is often combined with glucosamine and chondroitin sulfate. However, there are controversies whether glucosamine-chondroitin sulfate or their combination with methylsulfonylmethane could effectively reduce pain in OA. This study is aimed to compare clinical outcome of glucosamine-chondroitin sulfate (GC), glucosamine-chondroitin sulfate-methylsulfonylmethane (GCM), and placeboin patients with knee osteoarthritis (OA) Kellgren-Lawrence grade I-II. a double blind, randomized controlled clinical trial was conducted on 147 patients with knee OA Kellgren-Lawrence grade I-II. Patients were allocated by permuted block randomization into three groups: GC (n=49), GCM (n=50), or placebo (n=48) groups. GC group received 1500 mg of glucosamine + 1200 mg of chondroitin sulfate + 500 mg of saccharumlactis; GCM group received 1500 mg of glucosamine + 1200 mg of chondroitin sulfate + 500 mg of MSM; while placebo group received three matching capsules of saccharumlactis. The drugs were administered once daily for 3 consecutive months VAS and WOMAC scores were measured before treatment, then at 4th, 8th and 12th week after treatment. on statistical analysis it was found that at the 12th week, there are significant difference between three treatment groups on the WOMAC score (p=0.03) and on the VAS score (p=0.004). When analyzed between weeks, GCM treatment group was found statistically significant on WOMAC score (p=0.01) and VAS score (p<0.001). Comparing the score difference between weeks, WOMAC score analysis showed significant difference between GC, GCM, and placebo in week 4 (p=0.049) and week 12 (p=0.01). In addition, VAS score also showed significant difference between groups in week 8 (p=0.006) and week 12 (p<0.001). combination of glucosamine-chondroitinsulfate-methylsulfonylmethane showed clinical benefit for patients with knee OAK ellgren-Lawrence grade I-II compared with GC and placebo. GC did not make clinical improvement in overall groups of patients with knee OA Kellgren Lawrence grade I-II.

Effect of local anesthetic dilution on the onset time and duration of double-injection sciatic nerve block: a prospective, randomized, blinded evaluation.

PubMed

Cappelleri, Gianluca; Ambrosoli, Andrea Luigi; Turconi, Stefania; Gemma, Marco; Ricci, Erika Basso; Cornaggia, Gabriele

2014-08-01

Among the various factors influencing the success rate, onset time, and duration of peripheral nerve blocks, the role of local anesthetics concentration remains uncertain. In this prospective, randomized, single-blinded study, we evaluated whether varying the dilution of a fixed dose of mepivacaine solution influenced onset time and duration of sciatic nerve block. Ninety ASA physical status I to II patients scheduled for foot surgery were randomly allocated to receive a double-injection Labat sciatic nerve block with 12 mL mepivacaine 2% (group concentration I = 45 patients) or 24 mL of mepivacaine 1% (group volume II = 45 patients). The nerve stimulator was initially set at 2 Hz, 0.1 millisecond, 1 mA. The total amount of local anesthetic (240 mg) was kept constant and equally divided between the peroneal and tibial nerves. All patients also received an ultrasound-guided popliteal sciatic nerve catheter for postoperative analgesia. Times to readiness for surgery, performance, and offset of local anesthetic were recorded. Our primary end point was to determine a possible difference in offset time between groups. Continuous variables were expressed as median (IQR) and compared with the Wilcoxon-Mann-Whitney U test; WMWodds are reported together with their 95% confidence interval. The overall success rate of sciatic nerve block was 99%. Time of performance was shorter in group I, 120 seconds (90-150 seconds), than that in group II, 150 seconds (120-180 seconds) (P = 0.0048; WMWodds 2.26 [1.35-4.34]). The onset time of sensory and motor sciatic nerve block was 4 minutes (2-9 minutes) in group I and 6 minutes (4-10 minutes) in group II (P = 0.41; WMWodds 1.21 [0.77-1.95]), while the duration of sensory block was 235 minutes (203-250 minutes) in group I, and 240 minutes (218-247 minutes) in group II respectively (P = 0.51; WMWodds 1.20 [0.69-2.16]). We found no evidence that varying volume and concentration while maintaining a fixed total dose of mepivacaine alters the onset time and duration of double-injection sciatic nerve block. Considering our WMWodds results, possible differences in onset time and duration comparable to differences in the performance time between groups cannot be excluded.

[The effects of a low-fat versus a low carbohydrate diet in obese adults].

PubMed

De Luis, Daniel A; Aller, Rocio; Izaola, Olatz; González Sagrado, Manuel; Conde, Rosa

2009-02-21

The aim of our study was to compare the effect of a high fat and a high protein diet vs a fat restricted diet on weight loss in obese patients. A population of 74 obesity non diabetic outpatients was analyzed in a prospective way. Patients were randomly allocated to two groups: a) diet I (low fat diet: 1500kcal/day, 52% carbohydrates, 20% proteins, 27% fats) with a distribution of fats and b) diet II (high fat and high protein diet: 1507kcal/day, 38% carbohydrates, 26% proteins, 36% fats). After three months with diet, weight, blood pressure, glucose, C reactive protein, insulin, insulin resistance, total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides were evaluated. There were randomized 35 patients (4 males and 31 females) in the group I and 39 patients (6 males and 33 females) in diet group II. In group I, systolic pressure, BMI, weight, fat free mass, fat mass total body water, intracellular body water and waist circumference decreased significantly. In group II, glucose, total cholesterol, LDL cholesterol, systolic blood, BMI, weight, fat mass, total body water and waist circumference decreased significantly. Differences among averages of parameters before treatment with both diets were not detected. No differences were detected on weight loss between a fat-restricted diet and a high fat and high protein enhanced diet.

Effect of UV irradiation on cutaneous cicatrices: a randomized, controlled trial with clinical, skin reflectance, histological, immunohistochemical and biochemical evaluations.

PubMed

Due, Eva; Rossen, Kristian; Sorensen, Lars Tue; Kliem, Anette; Karlsmark, Tonny; Haedersdal, Merete

2007-01-01

The aim of this study was to examine the effect of ultraviolet (UV) irradiation on human cutaneous cicatrices. In this randomized, controlled study, dermal punch biopsy wounds served as a wound healing model. Wounds healed by primary or second intention and were randomized to postoperative solar UV irradiation or to no UV exposure. Evaluations after 5 and 12 weeks included blinded clinical assessments, skin reflectance measurements, histology, immunohistochemistry, and biochemical analyses of the N-terminal propeptide from procollagen-1, hydroxyproline, hydroxylysine, and proline. Twelve weeks postoperatively, UV-irradiated cicatrices healing by second intention: (i) were significantly pointed out as the most disfiguring; (ii) obtained significantly higher scores of colour, infiltration and cicatrix area; and (iii) showed significantly higher increase in skin-reflectance measurements of skin-pigmentation vs. non-irradiated cicatrices. No histological, immunohistochemical or biochemical differences were found. In conclusion, postoperative UV exposure aggravates the clinical appearance of cicatrices in humans.

Evaluation of the Efficacy of Tranexamic Acid on the Surgical Field in Primary Cleft Palate Surgery on Children-A Prospective, Randomized Clinical Study.

PubMed

Durga, Padmaja; Raavula, Parvathi; Gurajala, Indira; Gunnam, Poojita; Veerabathula, Prardhana; Reddy, Mukund; Upputuri, Omkar; Ramachandran, Gopinath

2015-09-01

To assess the effect of tranexamic acid on the quality of the surgical field. Prospective, randomized, double-blind study. Institutional, tertiary referral hospital. American Society of Anesthesiologists physical status class I patients, aged 8 to 60 months with Group II or III (Balakrishnan's classification) clefts scheduled for cleft palate repair. Children were randomized into two groups. The control group received saline, and the tranexamic acid group received tranexamic acid 10 mg/kg as a bolus, 15 minutes before incision. Grade of surgical field on a 10-point scale, surgeon satisfaction, and primary hemorrhage. Significant improvements were noted in surgeon satisfaction and median grade of assessment of the surgical field (4 [interquartile range, 4 to 6] in the control group vs. 3 [interquartile range, 2 to 4] in the test group; P = .003) in the tranexamic acid group compared to the control group. Preincision administration of 10 mg/kg of tranexamic acid significantly improved the surgical field during cleft palate repair.

A 15-year randomized controlled study of a reduced shrinkage stress resin composite.

PubMed

van Dijken, Jan W V; Lindberg, Anders

2015-09-01

The aim of this randomized controlled study was to evaluate the long term effectiveness of a reduced shrinkage stress resin composite in Class II restorations. The material was compared intra-individually with a microhybrid resin composite. Each of 50 patients with at least one pair of two similar sized Class II cavities participated (22 female, 28 male, mean age 43 years, range 18-64). Each participant received in each pair, in a randomized way, one Class II restoration performed with a reduced shrinkage stress resin composite (InTen-S) and the other restoration with a microhybrid resin composite restoration (Point 4). Both restorations were placed with an etch-and-rinse bonding system and an oblique layering technique. A total of 106 restorations, 33 premolar and 73 molars, were placed. The restorations were evaluated blindly each year using modified USPHS criteria. The overall performance of the experimental restorations was tested after intra-individual comparison using the Friedmańs two-way analysis of variance test. The hypothesis was rejected at the 5% level. At 15 years, 91 restorations were evaluated. The drop out frequency was 15 restorations (5 male, 3 female participants; 2 premolar and 13 molar restorations). Except for 2 participants, who reported slight symptoms during a few weeks after placement, no post-operative sensitivity was observed at the recalls. The overall success rate at 15 years was 77%. Twenty-one non acceptable restorations were observed during the 15 years follow up, 10 InTen-S (21.7%) and 11 Point 4 (24.4%) restorations (p>0.05). Annual failure rates for the resin composites were 1.5% and 1.6%, respectively. The main reasons for failure were secondary caries (8) and resin composite fracture (7). The differences between premolar vs. molar restorations and between restorations in male vs. female participants were not significant. Significant differences were observed between 2-surface vs. 3-surface restorations. During the 15-year follow up, the reduced shrinkage stress resin composite showed a good clinical durability in Class II cavities, but not significantly better than the control microhybrid resin composite. Secondary caries and material fracture were the main reasons of failure. Copyright © 2015 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Bisoprolol for the treatment of chronic heart failure: a meta-analysis on individual data of two placebo-controlled studies--CIBIS and CIBIS II. Cardiac Insufficiency Bisoprolol Study.

PubMed

Leizorovicz, Alain; Lechat, Philippe; Cucherat, Michel; Bugnard, Françoise

2002-02-01

Despite the available evidence from randomized clinical trials, beta-blockers are often not used optimally in patients with congestive heart failure (CHF). This meta-analysis aims at providing a precise and quantitative estimate of the benefit and risks of long-term bisoprolol on major clinical events in patients with CHF, both overall and in selected subgroups. This may help clinicians in their decisions as to whether to prescribe bisoprolol for their individual patients. Meta-analysis was performed of results from the 2 randomized, controlled clinical studies in which bisoprolol was compared with placebo (Cardiac Insufficiency Bisoprolol Study [CIBIS and CIBIS II]), which included 3288 patients with proven CHF. The main outcomes were total death, cardiovascular death, sudden death, hospitalization for heart failure, and myocardial infarction. A highly significant 29.3% relative reduction of death (17%, 40%; P =.00003) was observed, as well as significant risk reduction in cardiovascular death and sudden death in favor of bisoprolol. Also, a highly significant relative reduction of 18.4% (25%, 11%; P =.00001) in hospital admission or death was observed. A similar relative reduction of death was consistently observed in selected subgroups of patients. Bisoprolol prevents major cardiovascular events in patients with CHF with a high benefit-to-risk ratio and can be recommended for these patients.

Planckian Information (Ip): A New Measure of Order in Atoms, Enzymes, Cells, Brains, Human Societies, and the Cosmos

NASA Astrophysics Data System (ADS)

Ji, Sungchul

A new mathematical formula referred to as the Planckian distribution equation (PDE) has been found to fit long-tailed histograms generated in various fields of studies, ranging from atomic physics to single-molecule enzymology, cell biology, brain neurobiology, glottometrics, econophysics, and to cosmology. PDE can be derived from a Gaussian-like equation (GLE) by non-linearly transforming its variable, x, while keeping the y coordinate constant. Assuming that GLE represents a random distribution (due to its symmetry), it is possible to define a binary logarithm of the ratio between the areas under the curves of PDE and GLE as a measure of the non-randomness (or order) underlying the biophysicochemical processes generating long-tailed histograms that fit PDE. This new function has been named the Planckian information, IP, which (i) may be a new measure of order that can be applied widely to both natural and human sciences and (ii) can serve as the opposite of the Boltzmann-Gibbs entropy, S, which is a measure of disorder. The possible rationales for the universality of PDE may include (i) the universality of the wave-particle duality embedded in PDE, (ii) the selection of subsets of random processes (thereby breaking the symmetry of GLE) as the basic mechanism of generating order, organization, and function, and (iii) the quantity-quality complementarity as the connection between PDE and Peircean semiotics.

Attachment as Moderator of Treatment Outcome in Major Depression: A Randomized Control Trial of Interpersonal Psychotherapy versus Cognitive Behavior Therapy

ERIC Educational Resources Information Center

McBride, Carolina; Atkinson, Leslie; Quilty, Lena C.; Bagby, R. Michael

2006-01-01

Anxiety and avoidance dimensions of adult attachment insecurity were tested as moderators of treatment outcome for interpersonal psychotherapy (IPT) and cognitive-behavioral therapy (CBT). Fifty-six participants with major depression were randomly assigned to these treatment conditions. Beck Depression Inventory-II, Six-Item Hamilton Rating Scale…

25 CFR 547.14 - What are the minimum technical standards for electronic random number generation?

Code of Federal Regulations, 2011 CFR

2011-04-01

... CLASS II GAMES § 547.14 What are the minimum technical standards for electronic random number generation... rules of the game. For example, if a bingo game with 75 objects with numbers or other designations has a... serial correlation (outcomes shall be independent from the previous game); and (x) Test on subsequences...

25 CFR 547.14 - What are the minimum technical standards for electronic random number generation?

Code of Federal Regulations, 2012 CFR

2012-04-01

... CLASS II GAMES § 547.14 What are the minimum technical standards for electronic random number generation... rules of the game. For example, if a bingo game with 75 objects with numbers or other designations has a... serial correlation (outcomes shall be independent from the previous game); and (x) Test on subsequences...

25 CFR 547.14 - What are the minimum technical standards for electronic random number generation?

Code of Federal Regulations, 2010 CFR

2010-04-01

... CLASS II GAMES § 547.14 What are the minimum technical standards for electronic random number generation... rules of the game. For example, if a bingo game with 75 objects with numbers or other designations has a... serial correlation (outcomes shall be independent from the previous game); and (x) Test on subsequences...

Effects of bite-jumping appliances on mandibular advancement in growing rats: A radiographic study

PubMed Central

Oksayan, Ridvan; Sokucu, Oral; Ucuncu, Neslihan

2014-01-01

Objective: The aim was to evaluate the effects of the use of mandibular advancement appliances on mandibular growth in growing rats. Materials and Methods: Twenty-four 8-week-old male Wistar albino rats were randomly divided into two experimental groups (12 rats each): Group I was a control group, and Group II was the mandibular advancement appliance group. A functional bite-jumping appliance was used in Group II to promote mandibular advancement. Anatomical changes in the condyle and mandible were evaluated by comparing radiographic results from before and after the study, with angular and linear measurements. Friedman and Mann-Whitney U-tests were used in statistical analysis. Results: According to the radiographic results, the growth of mandibles and condyles in Group II was significantly greater than with the length of the condylar process (A-B) and distance from condyle to menton (A-D) variables (P < 0.05). In addition, Group I showed greater mandibular base growth than did Group II (P < 0.05). Conclusions: We conclude that the use of an intraoral bite-jumping appliance can stimulate condylar growth and increase sagittal mandibular advancement in growing rats. PMID:25202205

Comparison of Eye Movement Desensitization Reprocessing and Cognitive Behavioral Therapy as Adjunctive Treatments for Recurrent Depression: The European Depression EMDR Network (EDEN) Randomized Controlled Trial.

PubMed

Ostacoli, Luca; Carletto, Sara; Cavallo, Marco; Baldomir-Gago, Paula; Di Lorenzo, Giorgio; Fernandez, Isabel; Hase, Michael; Justo-Alonso, Ania; Lehnung, Maria; Migliaretti, Giuseppe; Oliva, Francesco; Pagani, Marco; Recarey-Eiris, Susana; Torta, Riccardo; Tumani, Visal; Gonzalez-Vazquez, Ana I; Hofmann, Arne

2018-01-01

Background: Treatment of recurrent depressive disorders is currently only moderately successful. Increasing evidence suggests a significant relationship between adverse childhood experiences and recurrent depressive disorders, suggesting that trauma-based interventions could be useful for these patients. Objectives: To investigate the efficacy of Eye Movement Desensitization and Reprocessing therapy (EMDR) in addition to antidepressant medication (ADM) in treating recurrent depression. Design: A non-inferiority, single-blind, randomized clinical controlled trial comparing EMDR or CBT as adjunctive treatments to ADM. Randomization was carried out by a central computer system. Allocation was carried out by a study coordinator in each center. Setting: Two psychiatric services, one in Italy and one in Spain. Participants: Eighty-two patients were randomized with a 1:1 ratio to the EMDR group ( n = 40) or CBT group ( n = 42). Sixty-six patients, 31 in the EMDR group and 35 in the CBT group, were included in the completers analysis. Intervention: 15 ± 3 individual sessions of EMDR or CBT, both in addition to ADM. Participants were followed up at 6-months. Main outcome measure : Rate of depressive symptoms remission in both groups, as measured by a BDI-II score <13. Results: Sixty-six patients were analyzed as completers (31 EMDR vs. 35 CBT). No significant difference between the two groups was found either at the end of the interventions (71% EMDR vs. 48.7% CBT) or at the 6-month follow-up (54.8% EMDR vs. 42.9% CBT). A RM-ANOVA on BDI-II scores showed similar reductions over time in both groups [ F (6,59) = 22.501, p < 0.001] and a significant interaction effect between time and group [ F (6,59) = 3.357, p = 0.006], with lower BDI-II scores in the EMDR group at T1 [mean difference = -7.309 (95% CI [-12.811, -1.806]), p = 0.010]. The RM-ANOVA on secondary outcome measures showed similar improvement over time in both groups [ F (14,51) = 8.202, p < 0.001], with no significant differences between groups [ F (614,51) = 0.642, p = 0.817]. Conclusion: Although these results can be considered preliminary only, this study suggests that EMDR could be a viable and effective treatment for reducing depressive symptoms and improving the quality of life of patients with recurrent depression. ISRCTN09958202.

MSCs with ACE II gene affect apoptosis pathway of acute lung injury induced by bleomycin.

PubMed

Zhang, Xiaomiao; Gao, Fengying; Li, Qian; Dong, Zhixia; Sun, Bo; Hou, Lili; Li, Zhuozhe; Liu, Zhenwei

2015-02-01

The aim of this study was to evaluate the effect and related mechanisms of Mesenchymal stem cells (MSCs) and Angiotensin converting enzyme II (ACE II) on acute lung injury (ALI). MSCs were separated from umbilical cord cells, and the changes of phenotype before and after ACE II silence were observed using Flow Cytometer. ALI model was induced by 10 mg/mL bleomycin in 60 Balb/c mice, and the rest 8 mice were regarded as the baseline group. The mice were randomly divided into four groups (n = 15): control, ACE II, stem, and stem + ACE II. The apoptotic index (AI) was calculated using TUNEL, and the detection of protein and mRNA of Bax, Bak and p53, Bcl-2, Grp78, CHOP and Caspase 12 were used by western-blot and RT-PCR, respectively. The umbilical cord cells differentiated into stable MSCs about 14 days, and ACE II transfection reached a peak at the 5th day after transfection. ACE II silence did not affect the phenotype of MSCs. All the proteins and mRNAs expression except Bcl-2 in the stem and stem + ACE II were significantly lower than those in control from 8 h (p < 0.05, p < 0.01), while Bcl-2 exhibited an opposite trend. Stem + ACE II performed a better effect than single stem in most indexes, including AI (p < 0.05, p < 0.01). The co-administration of MSCs and ACE II can significantly suppress apoptosis in ALI mice, and may be an effective clinical treatment for ALI.

A Phase II, Randomized, Double-Blind Clinical Study Evaluating the Safety, Tolerability, and Efficacy of a Topical Minocycline Foam, FMX103, for the Treatment of Facial Papulopustular Rosacea.

PubMed

Mrowietz, Ulrich; Kedem, Tal Hetzroni; Keynan, Rita; Eini, Meir; Tamarkin, Dov; Rom, Dror; Shirvan, Mitchell

2018-06-01

Our objective was to demonstrate the safety, tolerability, and efficacy of a minocycline foam, FMX103, in the treatment of moderate-to-severe facial papulopustular rosacea. This was a phase II, randomized, double-blind, multicenter study. Healthy subjects aged ≥ 18 years with moderate-to-severe rosacea that had been diagnosed ≥ 6 months previously and with ≥ 12 inflammatory facial lesions were randomized (1:1:1) to receive once-daily 1.5% FMX103, 3% FMX103, or vehicle for 12 weeks. The primary endpoint was the absolute change in inflammatory lesion count at week 12. Other assessments included grade 2 or higher Investigator's Global Assessment (IGA) improvement, IGA "clear" or "almost clear" (IGA 0/1), clinical erythema, and safety/tolerability. Safety and efficacy were evaluated at weeks 2, 4, 8, and 12, with a safety follow-up at week 16. A total of 232 subjects were randomized; 213 completed the study. At week 12, inflammatory lesion count reduction was significantly greater for the 1.5 and 3% FMX103 doses than for vehicle (21.1 and 19.1 vs. 7.8, respectively; both p < 0.001). Both doses were significantly better than vehicle for achieving grade 2 or higher IGA improvement and assessment of "clear" or "almost clear." Both doses appeared generally safe and well tolerated. In total, 11 (4.7%) subjects reported treatment-related treatment-emergent adverse events (TEAEs); all but one (eye discharge) were dermal related, and all resolved by study end. No treatment-related systemic TEAEs were reported. Four subjects discontinued the study because of TEAEs (3% FMX103, n = 3; vehicle, n = 1). Topical minocycline foam, FMX103, appeared to be an effective, safe, and well tolerated treatment for moderate-to-severe papulopustular rosacea. These results support further investigation in larger clinical trials. CLINICALTRIALS. NCT02601963.

The effect of extremely low frequency pulsed electromagnetic field on in vitro fertilization success rate in N MRI mice.

PubMed

Hafizi, Leili; Sazgarnia, Ameneh; Mousavifar, Nezhat; Karimi, Mohammad; Ghorbani, Saleh; Kazemi, Mohammad Reza; Emami Meibodi, Neda; Hosseini, Golkoo; Mostafavi Toroghi, Hesam

2014-01-01

The effects of exposure to electromagnetic fields (EMF) on reproduction systems have been widely debated. In this study, we aimed to investigate whether low frequency EMF could ameliorate the in vitro fertilization success rate in Naval medical research institute (NMRI) Mice. In this randomized comparative animal study, ten NMRI mice were randomly divided into 2 equal groups (control and experimental). 10 IU of human chorionic gonadotropin (hCG) was injected intraperitoneally to both groups in order to stimulate ovulating, and ovums were then aspirated and kept in KSOM (modified version of sequential simplex optimization medium with a higher K(+) concentration) culture medium. Metaphase II ovums were separated, and sperms obtained by "swim out" method were added to metaphase II ovums in the culture medium. The experimental group was exposed to 1.3 millitesla pulsed electromagnetic field at 4 kilohertz frequency for 5 hours. To assess the efficacy, we considered the identification of two-pronuclear zygote (2PN) under microscope as fertilizing criterion. Total number of collected ovums in the control and experimental groups was 191 and 173, respectively, from which 58 (30.05%) and 52 (30.36%) ovums were collected from metaphase II, respectively. In vitro fertilization (IVF) success rate was 77% in extremely low frequency- pulsed electromagnetic field (ELFPEMF) for exposed group (experimental), whereas the rate was 68% for control group. Despite increased percentile of IVF success rate in exposed group, there was no statistically significant difference between 2 groups, but this hypothesis has still been stated as a question. Further studies with larger sample sizes and different EMF designs are suggested.

Allergy immunotherapy with a hypoallergenic recombinant birch pollen allergen rBet v 1-FV in a randomized controlled trial.

PubMed

Klimek, Ludger; Bachert, Claus; Lukat, Karl-Friedrich; Pfaar, Oliver; Meyer, Hanns; Narkus, Annemie

2015-01-01

Pollen extracts and chemically modified allergoids are used successfully in allergen immunotherapy (AIT). Recombinant extracts offer potential advantages with respect to pharmaceutical quality, standardization and dosing. A hypoallergenic recombinant folding variant of the major birch pollen allergen (rBet v 1-FV) was compared with an established native birch preparation. A pre-seasonal, randomized, actively controlled phase II study was performed in birch pollen allergic rhino-conjunctivitis with or without asthma, GINA I/ II. 51 patients (24 rBet v 1-FV, 27 native extract) started therapy with subcutaneous allergen immunotherapy (SCIT). Primary end-point was a combined symptom medication score (SMS), changes in nasal provocation test, visual rating score and specific antibody responses secondary end-points. After one pre-seasonal treatment course the combined SMS was 5.86 (median; IQR: 14.02) for the rBet v 1-FV group versus 12.40 (median; IQR: 9.32) for the comparator during the three weeks pollen season (p = 0.330). After treatment in the second year, scores were 3.00 (median; IQR: 6.50) and 2.93 (4.86) respectively. Allergen tolerance in a nasal provocation test improved to a comparable extent in both groups. Significant increases in birch pollen-specific IgG1 and IgG4 were observed in both treatment groups following the first treatment phase and remained significantly raised until the end of the study. In this first in man, proof of concept phase II trial no statistical difference between rBet v 1-FV and an established natural pollen extract could be observed. rBet v 1-FV could be administered in higher doses than the native protein with no increase in adverse effects. The study was registered in clinicalTrials.gov (NCT00266526).

Mid- and Long-Term Efficacy of Non-Invasive Ventilation in Obesity Hypoventilation Syndrome: The Pickwick's Study.

PubMed

López-Jiménez, María José; Masa, Juan F; Corral, Jaime; Terán, Joaquín; Ordaz, Estrella; Troncoso, Maria F; González-Mangado, Nicolás; González, Mónica; Lopez-Martínez, Soledad; De Lucas, Pilar; Marín, José M; Martí, Sergi; Díaz-Cambriles, Trinidad; Díaz-de-Atauri, Josefa; Chiner, Eusebi; Aizpuru, Felipe; Egea, Carlos; Romero, Auxiliadora; Benítez, José M; Sánchez-Gómez, Jesús; Golpe, Rafael; Santiago-Recuerda, Ana; Gómez, Silvia; Barbe, Ferrán; Bengoa, Mónica

2016-03-01

The Pickwick project was a prospective, randomized and controlled study, which addressed the issue of obesity hypoventilation syndrome (OHS), a growing problem in developed countries. OHS patients were divided according to apnea-hypopnea index (AHI) ≥30 and <30 determined by polysomnography. The group with AHI≥30 was randomized to intervention with lifestyle changes, noninvasive ventilation (NIV) or continuous positive airway pressure (CPAP); the group with AHI<30 received NIV or lifestyle changes. The aim of the study was to evaluate the efficacy of NIV treatment, CPAP and lifestyle changes (control) in the medium and long-term management of patients with OHS. The primary variables were PaCO2 and days of hospitalization, and operating variables were the percentage of dropouts for medical reasons and mortality. Secondary medium-term objectives were: (i)to evaluate clinical-functional effectiveness on quality of life, echocardiographic and polysomnographic variables; (ii)to investigate the importance of apneic events and leptin in the pathogenesis of daytime alveolar hypoventilation and change according to the different treatments; (ii)to investigate whether metabolic, biochemical and vascular endothelial dysfunction disorders depend on the presence of apneas and hypopneasm and (iv)changes in inflammatory markers and endothelial damage according to treatment. Secondary long-term objectives were to evaluate: (i)clinical and functional effectiveness and quality of life with NIV and CPAP; (ii)changes in leptin, inflammatory markers and endothelial damage according to treatment; (iii)changes in pulmonary hypertension and other echocardiographic variables, as well as blood pressure and incidence of cardiovascular events, and (iv)dropout rate and mortality. Copyright © 2015 SEPAR. Published by Elsevier Espana. All rights reserved.

DDD versus VVIR versus VVI mode in patients with indication to dual-chamber stimulation: a prospective, randomized, controlled, single-blind study.

PubMed

Moro, Eugenio; Caprioglio, Francesco; Berton, Giuseppe; Marcon, Carlo; Riva, Umberto; Corbucci, Giorgio; Delise, Pietro

2005-09-01

The aim of this study was to compare VVI, VVIR and DDD modes in patients with indication to dual-chamber stimulation, depending on left ventricular function. Two groups of patients were implanted with a DDD pacemaker: Group I with ejection fraction > 40% and Group II with ejection fraction < 40%. Patients with a history of atrial arrhythmia or retrograde conduction were excluded. At follow-up (1 month each) quality of life (QoL), patient preference and echo parameters were collected. At hospital discharge all patients were programmed in DDD for 1 month and then randomized to VVI or VVIR mode. At the end of the period in VVI or VVIR mode each patient underwent a control period in DDD and then was programmed in VVIR or VVI mode. Seventeen patients out of 23 preferred DDD mode and 6 did not perceive any subjective difference among DDD, VVI and VVIR modes (4/9 in Group I and 2/14 in Group II, p = 0.0017). QoL was significantly different between the two groups and at each follow-up showed the best values in DDD. The correlation between QoL and Tei index was 0.62 in Group I (p < 0.001) and 0.35 in Group II (p = 0.001). Neither ejection fraction nor fractional shortening showed any significant difference during the three phases of the study. Most patients preferred the DDD mode. The Tei index showed a good correlation with QoL and both QoL and Tei index significantly improved with DDD mode as compared to VVI and VVIR.

A phase I/II randomized, controlled, clinical trial for assessment of the efficacy and safety of β-D-mannuronic acid in rheumatoid arthritis patients.

PubMed

Ahmadi, Hossein; Jamshidi, Ahmad Reza; Gharibdoost, Farhad; Mahmoudi, Mahdi; Rastkari, Noushin; Mostafaei, Shayan; Fattahi, Mohammad Javad; Vojdanian, Mahdi; Cuzzocrea, Salvatore; Rehm, Bernd H A; Matsuo, Hidenori; Hosseini, Mostafa; Aghazadeh, Zahra; Mortazavi-Jahromi, Seyed Shahabeddin; Mirshafiey, Abbas

2018-06-01

Following the potent efficacy of β-D-mannuronic acid (M2000) in phase I/II trial in ankylosing spondylitis patients, the present clinical trial was conducted to evaluate the efficacy, safety, and tolerability of this novel drug in rheumatoid arthritis (RA) patients who had inadequate response to conventional therapy. The study was a 12-week randomized, controlled, phase I/II clinical trial with two treatment arms: M2000 and conventional treatment. Patients who had RA according to the modified American College of Rheumatology (ACR) criteria, with active disease at baseline also inadequate response to conventional therapy, were enrolled in this study. M2000 was administrated at a dose of two capsules (500 mg) per day orally during a period of 12 weeks. The primary endpoint was the proportion of patients fulfilling the ACR 20% improvement criteria after 12 weeks of M2000 therapy. Moreover, the patients were also followed up for safety. There were no statistically significant differences between treatment and conventional groups at baseline characteristics. The ACR20 response rate was significantly higher among M2000-treated patients than conventional-treated control, so that 74% of patients in treatment group showed an ACR20 response after 12 weeks of M2000 therapy (74 versus 16%; P = 0.011). 10% of M2000-treated patients and 57.1% of conventional-treated patient's adverse events occurred during this study. Treatment with M2000 in combination with conventional therapy showed a significantly superior efficacy along with a high safety profile compared to conventional-treated patients. Thereby, M2000 might be suggested as a suitable option in the treatment of RA.

Longitudinal study of health, disease and access to care in rural Victoria: the Crossroads-II study: methods.

PubMed

Glenister, Kristen M; Bourke, Lisa; Bolitho, Leslie; Wright, Sian; Roberts, Stuart; Kemp, William; Rhode, Leigh; Bhat, Ravi; Tremper, Sönke; Magliano, Dianna J; Morgan, Mike; Mariño, Rodrigo; Adam, William; Simmons, David

2018-05-30

High quality, contemporary data regarding patterns of chronic disease is essential for planning by health services, policy makers and local governments, but surprisingly scarce, including in rural Australia. This dearth of data occurs despite the recognition that rural Australians live with high rates of ill health, poor health behaviours and restricted access to health services. Crossroads-II is set in the Goulburn Valley, a rural region of Victoria, Australia 100-300 km north of metropolitan Melbourne. It is primarily an irrigated agricultural area. The aim of the study is to identify changes in the prevalence of key chronic health conditions including the extent of undiagnosed and undermanaged disease, and association with access to care, over a 15 year period. This study is a 15 year follow up from the 2000-2003 Crossroads-I study (2376 households participated). Crossroads-II includes a similar face to face household survey of 3600 randomly selected households across four towns of sizes 6300 to 49,800 (50% sampled in the larger town with the remainder sampled equally from the three smaller towns). Self-reported health, health behaviour and health service usage information is verified and supplemented in a nested sub-study of 900 randomly selected adult participants in 'clinics' involving a range of additional questionnaires and biophysical measurements. The study is expected to run from October 2016 to December 2018. Besides providing epidemiological and health service utilisation information relating to different diseases and their risk factors in towns of different sizes, the results will be used to develop a composite measure of health service access. The importance of access to health services will be investigated by assessing the correlation of this measure with rates of undiagnosed and undermanaged disease at the mesh block level. Results will be shared with partner organisations to inform service planning and interventions to improve health outcomes for local people.

Effects of Icariside II on Corpus Cavernosum and Major Pelvic Ganglion Neuropathy in Streptozotocin-Induced Diabetic Rats

PubMed Central

Bai, Guang-Yi; Zhou, Feng; Hui, Yu; Xu, Yong-De; Lei, Hong-En; Pu, Jin-Xian; Xin, Zhong-Cheng

2014-01-01

Diabetic erectile dysfunction is associated with penile dorsal nerve bundle neuropathy in the corpus cavernosum and the mechanism is not well understood. We investigated the neuropathy changes in the corpus cavernosum of rats with streptozotocin-induced diabetes and the effects of Icariside II (ICA II) on improving neuropathy. Thirty-six 8-week-old Sprague-Dawley rats were randomly distributed into normal control group, diabetic group and ICA-II treated group. Diabetes was induced by a one-time intraperitoneal injection of streptozotocin (60 mg/kg). Three days later, the diabetic rats were randomly divided into 2 groups including a saline treated placebo group and an ICA II-treated group (5 mg/kg/day, by intragastric administration daily). Twelve weeks later, erectile function was measured by cavernous nerve electrostimulation with real time intracorporal pressure assessment. The penis was harvested for the histological examination (immunofluorescence and immunohistochemical staining) and transmission electron microscopy detecting. Diabetic animals exhibited a decreased density of dorsal nerve bundle in penis. The neurofilament of the dorsal nerve bundle was fragmented in the diabetic rats. There was a decreased expression of nNOS and NGF in the diabetic group. The ICA II group had higher density of dorsal nerve bundle, higher expression of NGF and nNOS in the penis. The pathological change of major pelvic nerve ganglion (including the microstructure by transmission electron microscope and the neurite outgrowth length of major pelvic nerve ganglion tissue cultured in vitro) was greatly attenuated in the ICA II-treated group (p < 0.01). ICA II treatment attenuates the diabetes-related impairment of corpus cavernosum and major pelvic ganglion neuropathy in rats with Streptozotocin-Induced Diabetes. PMID:25517034

Test-retest reliability and minimal detectable change of the Beck Depression Inventory and the Taiwan Geriatric Depression Scale in patients with Parkinson's disease

PubMed Central

Huang, Sheau-Ling; Hsieh, Ching-Lin; Wu, Ruey-Meei

2017-01-01

Background The Beck Depression Inventory II (BDI-II) and the Taiwan Geriatric Depression Scale (TGDS) are self-report scales used for assessing depression in patients with Parkinson’s disease (PD) and geriatric people. The minimal detectable change (MDC) represents the least amount of change that indicates real difference (i.e., beyond random measurement error) for a single subject. Our aim was to investigate the test-retest reliability and MDC of the BDI-II and the TGDS in people with PD. Methods Seventy patients were recruited from special clinics for movement disorders at a medical center. The patients’ mean age was 67.7 years, and 63.0% of the patients were male. All patients were assessed with the BDI-II and the TGDS twice, 2 weeks apart. We used the intraclass correlation coefficient (ICC) to determine the reliability between test and retest. We calculated the MDC based on standard error of measurement. The MDC% was calculated (i.e., by dividing the MDC by the possible maximal score of the measure). Results The test-retest reliabilities of the BDI-II/TGDS were high (ICC = 0.86/0.89). The MDCs (MDC%s) of the BDI-II and TGDS were 8.7 (13.8%) and 5.4 points (18.0%), respectively. Both measures had acceptable to nearly excellent random measurement errors. Conclusions The test-retest reliabilities of the BDI-II and the TGDS are high. The MDCs of both measures are acceptable to nearly excellent in people with PD. These findings imply that the BDI-II and the TGDS are suitable for use in a research context and in clinical settings to detect real change in a single subject. PMID:28945776

Tube thorocostomy: management and outcome in patients with penetrating chest trauma.

PubMed

Muslim, Muhammad; Bilal, Amer; Salim, Muhammad; Khan, Muhammad Abid; Baseer, Abdul; Ahmed, Manzoor

2008-01-01

Penetrating chest trauma is common in this part of the world due to present situation in tribal areas. The first line of management after resuscitation in these patients is tube thoracostomy combined with analgesia and incentive spirometry. After tube thoracostomy following surgery or trauma there are two schools of thought one favours application of continuous low pressure suction to the chest tubes beyond the water seal while other are against it. We studied the application of continuous low pressure suction in patients with penetrating chest trauma. This Randomized clinical controlled trial was conducted in the department of thoracic surgery Post Graduate Medical Institute Lady Reading Hospital Peshawar from July 2007 to March 2008. The objectives of study were to evaluate the effectiveness of continuous low pressure suction in patients with penetrating chest trauma for evacuation of blood, expansion of lung and prevention of clotted Haemothorax. One hundred patients who underwent tube thoracostomy after penetrating chest trauma from fire arm injury or stab wounds were included in the study. Patients with multiple trauma, blunt chest trauma and those intubated for any pulmonary or pleural disease were excluded from the study. After resuscitation, detailed examination and necessary investigations patients were randomized to two groups. Group I included patients who had continuous low pressure suction applied to their chest drains. Group II included those patients whose chest drains were placed on water seal only. Lung expansion development of pneumothorax or clotted Haemothorax, time to removal of chest drain and hospital stay was noted in each group. There were fifty patients in each group. The two groups were not significantly different from each other regarding age, sex, pre-intubation haemoglobin and pre intubation nutritional status. Full lung expansion was achieved in forty six (92%) patients in group I and thirty seven (74%) in group II. Partial lung expansion or pneumothorax was present in three (60%) in group I and 10 (20%) in group II. One patient in group I and three (6%) patients in group II had no response. The mean time to removal of chest drains were 8.2 +/- 3.14 days in group I and 12.6 +/- 4.20 days in group II. The length of hospital stay was 7.2 +/- 2.07 days and 12.4 +/- 3.63 days in group I and II respectively. Clotted Haemothorax requiring surgery developed in three (6%) patients in group I and 8 (16%) patients in group II. Placing chest tubes on continuous low pressure suction after penetrating chest trauma helps evacuation of blood, expansion of lung and prevents the development of clotted Haemothorax. It also reduces the time to removal of chest drains, the hospital stay and the chances of surgery for clotted Haemothorax or Empyema.

Effect of cooling of cooked white rice on resistant starch content and glycemic response.

PubMed

Sonia, Steffi; Witjaksono, Fiastuti; Ridwan, Rahmawati

2015-01-01

Cooling of cooked starch is known to cause starch retrogradation which increases resistant starch content. This study aimed to determine the effect of cooling of cooked white rice on resistant starch content and glycemic response in healthy subjects. Resistant starch contents were analyzed on freshly cooked white rice (control rice), cooked white rice cooled for 10 hours at room temperature (test rice I), and cooked white rice cooled for 24 hours at 4°C then reheated (test rice II). The results showed that resistant starch contents in control rice, test rice I, and test rice II were 0.64 g/100 g, 1.30 g/100 g, and 1.65 g/100 g, respectively. Test rice II had higher resistant starch content than test rice I, hence used in the clinical study along with control rice to characterize glycemic response in 15 healthy adults. The clinical study was a randomized, single-blind crossover study. In the clinical study, test rice II significantly lowered glycemic response compared with control rice (125±50.1 vs 152±48.3 mmol.min/L, respectively; p=0.047). In conclusion, cooling of cooked white rice increased resistant starch content. Cooked white rice cooled for 24 hours at 4°C then reheated lowered glycemic response compared with freshly cooked white rice.

Comparison of ADM and Connective Tissue Graft as the Membrane in Class II Furcation Defect Regeneration: A Randomized Clinical Trial

PubMed Central

Esfahanian, Vahid; Farhad, Shirin; Sadighi Shamami, Mehrnaz

2014-01-01

Background and aims. Furcally-involved teeth present unique challenges to the success of periodontal therapy and influence treatment outcomes. This study aimed to assess to compare use of ADM and connective tissue membrane in class II furcation defect regeneration. Materials and methods. 10 patient with 2 bilaterally class II furcation defects in first and/or second maxilla or man-dibular molar without interproximal furcation involvement, were selected. Four weeks after initial phase of treatment, before and thorough the surgery pocket depth (PD), clinical attachment level to stent (CAL-S), free gingival margin to stent(FGM-S) , crestal bone to stent (Crest-S), horizontal defect depth to stent (HDD-S) and vertical defect depth to stent (VDD-S) and crestal bone to defect depth measured from stent margin. Thereafter, one side randomly treated using connective tissue and DFDBA (study group) and opposite side received ADM and DFDBA (control group). After 6 months, soft and hard tissue parameters measured again in re-entry. Results. Both groups presented improvements after therapies (P & 0.05). No inter-group differences were seen in PD re-duction (P = 0.275), CAL gain (P = 0.156), free gingival margin (P = 0.146), crest of the bone (P = 0.248), reduction in horizontal defects depth (P = 0.139) and reduction in vertical defects depth (P = 0.149). Conclusion. Both treatments modalities have potential of regeneration without any adverse effect on healing process. Connective tissue grafts did not have significant higher bone fill compared to that of ADM. PMID:25093054

Land Plus Aquatic Therapy Versus Land-Based Rehabilitation Alone for the Treatment of Balance Dysfunction in Parkinson Disease: A Randomized Controlled Study With 6-Month Follow-Up.

PubMed

Palamara, Grazia; Gotti, Francesco; Maestri, Roberto; Bera, Rossana; Gargantini, Roberto; Bossio, Fabiola; Zivi, Ilaria; Volpe, Daniele; Ferrazzoli, Davide; Frazzitta, Giuseppe

2017-06-01

To assess whether a specific land-based physical intervention with the inclusion of aquatic therapy is more effective than land-based rehabilitation alone for the treatment of balance dysfunction in patients with Parkinson disease (PD), immediately after therapy and at 6 months' follow-up. Randomized controlled study with 6-month follow-up. A PD and brain injury rehabilitation department in a general hospital. Patients (N=34) with moderate-stage PD. Seventeen patients underwent a land-based rehabilitation protocol called multidisciplinary intensive rehabilitation treatment (MIRT), and 17 underwent MIRT plus aquatic therapy (MIRT-AT). The primary outcome measure was the Berg Balance Scale (BBS); secondary outcome measures were the Unified Parkinson Disease Rating Scale parts II and III (UPDRS II/III) and the Timed Up and Go (TUG) test. These measures were assessed in both groups at admission, at discharge, and after 6 months. BBS improved after treatment in both groups. Even though no statistically significant difference between groups was observed at each observation time, BBS scores at follow-up were significantly higher than at baseline in MIRT-AT patients. Both groups also showed an improvement in UPDRS II/III and TUG at the end of treatment compared with baseline, but these findings were lost at the 6-month follow-up. Aquatic therapy added to land-based rehabilitation could provide a contribution to the treatment of balance dysfunction in patients with moderate-stage PD. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Is immediate adjunctive CBT more beneficial than delayed CBT in treating depression?: A Pilot Study.

PubMed

Rizvi, Sakina J; Zaretsky, Ari; Schaffer, Ayal; Levitt, Anthony

2015-03-01

Cognitive-behavioral therapy (CBT) is an efficacious first-line therapy for patients with major depressive disorder (MDD). Due to the limited accessibility of CBT, long wait lists result in delayed treatment, which may affect treatment outcomes. The goal of this pilot study was to obtain preliminary data from a randomized controlled trial to determine whether delayed CBT reduces the effectiveness of the therapy compared to immediate CBT in patients with MDD receiving pharmacotherapy. Patients were randomized to receive immediate CBT (n=18) or to begin CBT after 6 months (n=20) and received 14 weekly sessions, followed by two additional booster sessions. During the active treatment months, patients in the immediate group demonstrated reductions in scores on the Beck Depression Inventory II (BDI-II) that were similar to those in the delayed CBT group. However, when the analysis was performed using only data from patients in the delayed group who were still in a depressive episode, there was an overall greater decrease in BDI-II scores in the immediate group vs. the delayed group over the active treatment months, but not specifically at the 6-month endpoint. These findings suggest delays in depression treatment, similar to what occurs with real-world wait list times, may not have a significant impact on the effectiveness of CBT in patients who are already receiving treatment as usual. However, such delays may affect the effectiveness of CBT in those patients who remain depressed during the time delay. A larger trial is necessary to confirm these findings. (Journal of Psychiatric Practice 2015;21:107-113).

Phase II of the International Study of Asthma and Allergies in Childhood (ISAAC II): rationale and methods.

PubMed

Weiland, S K; Björkstén, B; Brunekreef, B; Cookson, W O C; von Mutius, E; Strachan, D P

2004-09-01

International comparative studies, investigating whether disease incidence or prevalence rates differ between populations and, if so, which factors explain the observed differences, have made important contributions to the understanding of disease aetiology in many areas. In Phase I of the International Study of Asthma and Allergies in Childhood (ISAAC), the prevalence rates of symptoms of asthma, allergic rhinitis and atopic eczema in 13-14-yr-olds, assessed by standardised questionnaires, were found to differ >20-fold between the 155 study centres around the world. Phase II of ISAAC aims to identify determinants of these differences by studying informative populations. A detailed study protocol was developed for use in community-based random samples of children aged 9-11 yrs. The study modules include standardised questionnaires with detailed questions on the occurrence and severity of symptoms of asthma, allergic rhinitis and atopic eczema, their clinical management, and a broad range of previous and current exposure conditions. In addition, standardised protocols were applied for examination of flexural dermatitis, skin-prick testing, bronchial challenge with hypertonic saline, blood sampling for immunoglobulin E analyses and genotyping, and dust sampling for assessment of indoor exposures to allergens and endotoxin. To date, ISAAC II field work had been completed or started in 30 study centres in 22 countries. The majority of centres are in countries that participated in International Study of Asthma and Allergies in Childhood Phase I and reflect almost the full range of the observed variability in Phase I prevalence rates.

New film-coated tablet formulation of deferasirox is well tolerated in patients with thalassemia or lower-risk MDS: Results of the randomized, phase II ECLIPSE study.

PubMed

Taher, Ali T; Origa, Raffaella; Perrotta, Silverio; Kourakli, Alexandra; Ruffo, Giovan Battista; Kattamis, Antonis; Goh, Ai-Sim; Cortoos, Annelore; Huang, Vicky; Weill, Marine; Merino Herranz, Raquel; Porter, John B

2017-05-01

Once-daily deferasirox dispersible tablets (DT) have a well-defined safety and efficacy profile and, compared with parenteral deferoxamine, provide greater patient adherence, satisfaction, and quality of life. However, barriers still exist to optimal adherence, including gastrointestinal tolerability and palatability, leading to development of a new film-coated tablet (FCT) formulation that can be swallowed with a light meal, without the need to disperse into a suspension prior to consumption. The randomized, open-label, phase II ECLIPSE study evaluated the safety of deferasirox DT and FCT formulations over 24 weeks in chelation-naïve or pre-treated patients aged ≥10 years, with transfusion-dependent thalassemia or IPSS-R very-low-, low-, or intermediate-risk myelodysplastic syndromes. One hundred seventy-three patients were randomized 1:1 to DT (n = 86) or FCT (n = 87). Adverse events (overall), consistent with the known deferasirox safety profile, were reported in similar proportions of patients for each formulation (DT 89.5%; FCT 89.7%), with a lower frequency of severe events observed in patients receiving FCT (19.5% vs. 25.6% DT). Laboratory parameters (serum creatinine, creatinine clearance, alanine aminotransferase, aspartate aminotransferase and urine protein/creatinine ratio) generally remained stable throughout the study. Patient-reported outcomes showed greater adherence and satisfaction, better palatability and fewer concerns with FCT than DT. Treatment compliance by pill count was higher with FCT (92.9%) than with DT (85.3%). This analysis suggests deferasirox FCT offers an improved formulation with enhanced patient satisfaction, which may improve adherence, thereby reducing frequency and severity of iron overload-related complications. © 2017 Wiley Periodicals, Inc.

Effectiveness of multimodal pain management after bipolar hemiarthroplasty for hip fracture: a randomized, controlled study.

PubMed

Kang, Hyun; Ha, Yong-Chan; Kim, Jin-Yun; Woo, Young-Cheol; Lee, Jae-Sung; Jang, Eui-Chan

2013-02-20

Appropriate pain management affects outcome after hip fracture surgery. Although multimodal pain management is commonly used for pain control for patients undergoing elective surgery, few studies have evaluated its use in those undergoing hip fracture surgery. This prospective randomized study was designed to determine the clinical value of multimodal pain management with preemptive pain medication and intraoperative periarticular multimodal drug injections in patients undergoing bipolar hip hemiarthroplasty. Of eighty-two cognitively intact elderly patients about to undergo bipolar hemiarthroplasty after a hip fracture, forty-three were randomly assigned to receive preemptive pain medication and intraoperative periarticular injections (Group I) and thirty-nine were assigned to not receive preemptive medication and injections (Group II). These two groups were compared with regard to the pain level on postoperative days one, four, and seven; at discharge; and when they started walking and standing exercises. Total amounts of fentanyl used, the frequency of use of patient-controlled analgesia, patient satisfaction at discharge, and perioperative complications were recorded. Group I had a lower pain level than Group II on postoperative days one and four, but no intergroup difference in pain level was observed on postoperative day seven. The total amount of fentanyl used and the frequency of use of patient-controlled analgesia were also lower in Group I. Patient satisfaction at discharge was higher in Group I. No significant intergroup differences were found in the times until the patients walked or performed standing exercises or in the complications. Multimodal pain management provides additional pain relief until the fourth postoperative day, improves patient satisfaction at discharge, and reduces total narcotic consumption for postoperative pain management after hip hemiarthroplasty for hip fractures.

One year treatment effects of the eruption guidance appliance in 7- to 8-year-old children: a randomized clinical trial.

PubMed

Myrlund, Rita; Dubland, Mari; Keski-Nisula, Katri; Kerosuo, Heidi

2015-04-01

The eruption guidance appliance (EGA) aims to correct sagittal and vertical occlusal relations concomitantly with alignment of the incisors. Few reports have been published on treatment effects with the EGA but no randomized studies have been available. The aim was to find out if 1 year active treatment time with EGA was sufficient for achieving normal occlusal relationships and dental alignment in 7- to 8-year-old children. Eligibility criteria for participants were: fully erupted upper central incisors, and Angle's Class I or Class II molar relationship combined with any of the following traits: deep bite, increased overjet ≥5mm, moderate anterior crowding with overjet ≥4mm. After screening of 148 children, 48 7- to 8-year-old children were recruited in the study. The participants were randomly assigned into a treatment group (N = 25) and a control group (N = 23). Children in the treatment group received treatment with the EGA for 1 year. The controls had no orthodontic treatment. Changes in overjet, overbite, Angle's Class, and crowding were used as primary outcome measures. Occlusal assessments were performed on dental casts obtained from all subjects at start of the study (T1) and after 1 year (T2). Lateral cephalograms were obtained from all subjects at T1 and from the treatment group at T2. All measurements on dental casts and cephalograms were carried out blinded. Forty-six children completed the study. Mean overjet and overbite decreased significantly in the treated subjects during 1 year, in contrast to a slight increase in the controls. Class II molar relationship decreased from 46 to 4 per cent in the treatment group, with no significant change in the control group. Mandibular anterior crowding decreased significantly in the treated subjects, while the controls showed a slight increase. In short term, the EGA seems to be effective in correcting increased overjet and overbite, Class II malocclusion, and lower anterior crowding in the early mixed dentition. Follow-up data are needed to assess long-term effects of this treatment. This study was not registered. © The Author 2014. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Once-Weekly Administration of Sustained-Release Growth Hormone in Korean Prepubertal Children with Idiopathic Short Stature: A Randomized, Controlled Phase II Study.

PubMed

Hwang, Jin Soon; Lee, Hae Sang; Lee, Kee-Hyoung; Yoo, Han-Wook; Lee, Dae-Yeol; Suh, Byung-Kyu; Ko, Cheol Woo; Chung, Woo Yeong; Jin, Dong-Kyu; Shin, Choong Ho; Han, Heon-Seok; Han, Song; Kim, Ho-Seong

2018-06-20

To determine the optimal dose of LB03002, a sustained-release, once-weekly formulation of recombinant human growth hormone (rhGH), and to compare its efficacy and safety with daily rhGH in children with idiopathic short stature (ISS). This multicenter, randomized, open-label, phase II study included GH-naïve, prepubertal children with ISS, randomized to receive daily rhGH 0.37 mg/kg/week (control, n = 16), LB03002 0.5 mg/kg/week (n = 14), or LB03002 0.7 mg/kg/week (n = 16). The primary endpoint was height velocity (HV) change at week 26. At week 26, the least square (LS) means for HV change (cm/year) with control, LB03002 0.5 mg/kg/week, and LB03002 0.7 mg/kg/week were 5.08, 3.65, and 4.38, and the LS means for the change in height standard deviation score were 0.65, 0.49, and 0.58, respectively. The lower bound of the 90% confidence interval for the difference between LB03002 0.7 mg/kg/week and the control in the LS mean for HV change (-1.72) satisfied the noninferiority margin (-1.75). Adverse events were generally mild and short-lived. A once-weekly regimen of LB03002 0.7 mg/kg demonstrated noninferiority to the daily regimen of rhGH 0.37 mg/kg/week in terms of HV increments. LB03002 was well tolerated and its safety profile was comparable with that of daily rhGH. © 2018 S. Karger AG, Basel.

Effectiveness of the addition of citicoline to patching in the treatment of amblyopia around visual maturity: A randomized controlled trial

PubMed Central

Pawar, Prachee Vasant; Mumbare, Sachin S; Patil, Mrunal Suresh; Ramakrishnan, Seema

2014-01-01

Aim: To study the effectiveness of the addition of citicoline to patching in the treatment of amblyopia in the age group of 4-13 years. Materials and Methods: A randomized controlled trial, which included patients who were randomly divided into two groups. Both the groups received patching therapy till plateau was achieved in phase 1 of the study. Then in phase 2, group I received citicoline plus patching and group II continued to receive only patching. Outcome Measures: Outcome was measured by the visual acuity in logMAR every month in phase 1 till plateau was achieved and then for 12 months in phase 2. Results: No significant difference was found in the mean visual acuities in these two groups in phase 1 till plateau was reached. In phase 2, for the initial four months, there was no significant difference in the visual acuities in these two groups, at the respective intervals. However, five months onward, up to 12 months, there was a significant difference in the visual acuities in these groups. The result was the same in younger patients (< seven years of age) as well as in older patients (> seven years of age). In phase 2, the mean proportional improvement in group I was significantly more than that in group II, at two months and onward, at the respective intervals. Conclusion: The improvement in visual acuity with citicoline plus patching was significantly more than that with patching alone, in one year of treatment. PMID:24618483

A randomized, double-blind, cross-over, phase IV trial of oros-methylphenidate (CONCERTA(®)) and generic novo-methylphenidate ER-C (NOVO-generic).

PubMed

Fallu, Angelo; Dabouz, Farida; Furtado, Melissa; Anand, Leena; Katzman, Martin A

2016-08-01

Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral disorder with onset during childhood. Multiple aspects of a child's development are hindered, in both home and school settings, with negative impacts on social, emotional, and cognitive functioning. If left untreated, ADHD is commonly associated with poor academic achievement and low occupational status, as well as increased risk of substance abuse and delinquency. The objective of this study was to evaluate adult ADHD subject reported outcomes when switched from a stable dose of CONCERTA(®) to the same dose of generic Novo-methylphenidate ER-C(®). Randomized, double-blind, cross-over, phase IV trial consisted of two phases in which participants with a primary diagnosis of ADHD were randomized in a 1:1 ratio to 3 weeks of treatment with CONCERTA or generic Novo-Methylphenidate ER-C. Following 3 weeks of treatment, participants were crossed-over to receive the other treatment for an additional 3 weeks. Primary efficacy was assessed through the use of the Treatment Satisfaction Questionnaire for Medication, Version II (TSQM-II). Participants with ADHD treated with CONCERTA were more satisfied in terms of efficacy and side effects compared to those receiving an equivalent dose of generic Novo-Methylphenidate ER-C. All participants chose to continue with CONCERTA treatment at the conclusion of the study. Although CONCERTA and generic Novo-Methylphenidate ER-C have been deemed bioequivalent, however the present findings demonstrate clinically and statistically significant differences between generic and branded CONCERTA. Further investigation of these differences is warranted.

Feasibility and Efficacy of the Nintendo Wii Gaming System to Improve Balance Performance Post-Stroke: Protocol of a Phase II Randomized Controlled Trial in an Inpatient Rehabilitation Setting.

PubMed

Bower, Kelly J; Clark, Ross A; McGinley, Jennifer L; Martin, Clarissa L; Miller, Kimberly J

2013-04-01

Balance deficits following stroke are common and debilitating. Commercially available gaming systems, such as the Nintendo(®) (Kyoto, Japan) Wii™, have been widely adopted clinically; however, there is limited evidence supporting their feasibility and efficacy for improving balance performance following stroke. The aim of this trial is to investigate the clinical feasibility and efficacy of using the Nintendo Wii gaming system as an adjunct to standard care to improve balance performance following stroke in an inpatient rehabilitation setting. Thirty participants undergoing inpatient stroke rehabilitation will be recruited into this Phase II, single-blind, randomized controlled trial. Participants will be allocated into a Balance or Upper Limb Group, and both groups will perform activities using the Nintendo Wii in addition to their standard care. Participants will attend three 45-minute sessions per week, for a minimum of 2 and a maximum of 4 weeks. The main focus of the study is to investigate the feasibility of the intervention protocol. This will be evaluated through recruitment, retention, adherence, acceptability, and safety. The Step Test and Functional Reach Test will be the primary efficacy outcomes. Secondary outcomes will include force platform, mobility, and upper limb measures. Assessments will occur at baseline, 2 weeks, and 4 weeks after study entry. To the authors' knowledge, this will be the largest randomized clinical trial to investigate the feasibility and efficacy of the Nintendo Wii gaming system for improving balance performance in a stroke population. The results will inform the design of a Phase III multicenter trial.

Polyurethane on titanium unconstrained disc arthroplasty versus anterior discectomy and fusion for the treatment of cervical disc disease: a review of level I-II randomized clinical trials including clinical outcomes.

PubMed

Aragonés, María; Hevia, Eduardo; Barrios, Carlos

2015-12-01

To contrast the clinical and radiologic outcomes and adverse events of anterior cervical discectomy and fusion (ACDF) with a single cervical disc arthroplasty design, the polyurethane on titanium unconstrained cervical disc (PTUCD). This is a systematic review of randomized clinical trials (RCT) with evidence level I-II reporting clinical outcomes. After a search on different databases including PubMed, Cochrane Central Register of Controlled Trials, and Ovid MEDLINE, a total of 10 RCTs out of 51 studies found were entered in the study. RTCs were searched from the earliest available records in 2005 to November 2014. Out of a total of 1101 patients, 562 were randomly assigned into the PTUCD arthroplasty group and 539 into the ACDF group. The mean follow-up was 30.9 months. Patients undergoing arthroplasty had lower Neck Disability Index, and better SF-36 Physical component scores than ACDF patients. Patients with PTUCD arthroplasty had also less radiological degenerative changes at the upper adjacent level. Overall adverse events were twice more frequent in patients with ACDF. The rate of revision surgery including both adjacent and index level was slightly higher in patients with ACDF, showing no statistically significant difference. According to this review, PTUCD arthroplasty showed a global superiority to ACDF in clinical outcomes. The impact of both surgical techniques on the cervical spine (radiological spine deterioration and/or complications) was more severe in patients undergoing ACDF. However, the rate of revision surgeries at any cervical level was equivalent for ACDF and PTUCD arthroplasty.

Likelihood-Based Random-Effect Meta-Analysis of Binary Events.

PubMed

Amatya, Anup; Bhaumik, Dulal K; Normand, Sharon-Lise; Greenhouse, Joel; Kaizar, Eloise; Neelon, Brian; Gibbons, Robert D

2015-01-01

Meta-analysis has been used extensively for evaluation of efficacy and safety of medical interventions. Its advantages and utilities are well known. However, recent studies have raised questions about the accuracy of the commonly used moment-based meta-analytic methods in general and for rare binary outcomes in particular. The issue is further complicated for studies with heterogeneous effect sizes. Likelihood-based mixed-effects modeling provides an alternative to moment-based methods such as inverse-variance weighted fixed- and random-effects estimators. In this article, we compare and contrast different mixed-effect modeling strategies in the context of meta-analysis. Their performance in estimation and testing of overall effect and heterogeneity are evaluated when combining results from studies with a binary outcome. Models that allow heterogeneity in both baseline rate and treatment effect across studies have low type I and type II error rates, and their estimates are the least biased among the models considered.

Genome-enabled studies of anaerobic, nitrate-dependent iron oxidation in the chemolithoautotrophic bacterium Thiobacillus denitrificans

PubMed Central

Beller, Harry R.; Zhou, Peng; Legler, Tina C.; Chakicherla, Anu; Kane, Staci; Letain, Tracy E.; A. O’Day, Peggy

2013-01-01

Thiobacillus denitrificans is a chemolithoautotrophic bacterium capable of anaerobic, nitrate-dependent U(IV) and Fe(II) oxidation, both of which can strongly influence the long-term efficacy of in situ reductive immobilization of uranium in contaminated aquifers. We previously identified two c-type cytochromes involved in nitrate-dependent U(IV) oxidation in T. denitrificans and hypothesized that c-type cytochromes would also catalyze Fe(II) oxidation, as they have been found to play this role in anaerobic phototrophic Fe(II)-oxidizing bacteria. Here we report on efforts to identify genes associated with nitrate-dependent Fe(II) oxidation, namely (a) whole-genome transcriptional studies [using FeCO3, Fe2+, and U(IV) oxides as electron donors under denitrifying conditions], (b) Fe(II) oxidation assays performed with knockout mutants targeting primarily highly expressed or upregulated c-type cytochromes, and (c) random transposon-mutagenesis studies with screening for Fe(II) oxidation. Assays of mutants for 26 target genes, most of which were c-type cytochromes, indicated that none of the mutants tested were significantly defective in nitrate-dependent Fe(II) oxidation. The non-defective mutants included the c1-cytochrome subunit of the cytochrome bc1 complex (complex III), which has relevance to a previously proposed role for this complex in nitrate-dependent Fe(II) oxidation and to current concepts of reverse electron transfer. A transposon mutant with a disrupted gene associated with NADH:ubiquinone oxidoreductase (complex I) was ~35% defective relative to the wild-type strain; this strain was similarly defective in nitrate reduction with thiosulfate as the electron donor. Overall, our results indicate that nitrate-dependent Fe(II) oxidation in T. denitrificans is not catalyzed by the same c-type cytochromes involved in U(IV) oxidation, nor have other c-type cytochromes yet been implicated in the process. PMID:24065960

Seven lessons from manyfield inflation in random potentials

NASA Astrophysics Data System (ADS)

Dias, Mafalda; Frazer, Jonathan; Marsh, M. C. David

2018-01-01

We study inflation in models with many interacting fields subject to randomly generated scalar potentials. We use methods from non-equilibrium random matrix theory to construct the potentials and an adaption of the `transport method' to evolve the two-point correlators during inflation. This construction allows, for the first time, for an explicit study of models with up to 100 interacting fields supporting a period of `approximately saddle-point' inflation. We determine the statistical predictions for observables by generating over 30,000 models with 2–100 fields supporting at least 60 efolds of inflation. These studies lead us to seven lessons: i) Manyfield inflation is not single-field inflation, ii) The larger the number of fields, the simpler and sharper the predictions, iii) Planck compatibility is not rare, but future experiments may rule out this class of models, iv) The smoother the potentials, the sharper the predictions, v) Hyperparameters can transition from stiff to sloppy, vi) Despite tachyons, isocurvature can decay, vii) Eigenvalue repulsion drives the predictions. We conclude that many of the `generic predictions' of single-field inflation can be emergent features of complex inflation models.

Randomized controlled trial of uncut Roux-en-Y vs Billroth II reconstruction after distal gastrectomy for gastric cancer: Which technique is better for avoiding biliary reflux and gastritis?

PubMed

Yang, Dong; He, Liang; Tong, Wei-Hua; Jia, Zhi-Fang; Su, Tong-Rong; Wang, Quan

2017-09-14

To identify which technique is better for avoiding biliary reflux and gastritis between uncut Roux-en-Y and Billroth II reconstruction. A total of 158 patients who underwent laparoscopy-assisted distal gastrectomy for gastric cancer at the First Hospital of Jilin University (Changchun, China) between February 2015 and February 2016 were randomized into two groups: uncut Roux-en-Y (group U) and Billroth II group (group B). Postoperative complications and relevant clinical data were compared between the two groups. According to the randomization table, each group included 79 patients. There was no significant difference in postoperative complications between groups U and B (7.6% vs 10.1%, P = 0.576). During the postoperative period, group U stomach pH values were lower than 7 and group B pH values were higher than 7. After 1 year of follow-up, group B presented a higher incidence of biliary reflux and alkaline gastritis. However, histopathology did not show a significant difference in gastritis diagnosis ( P = 0.278), and the amount of residual food and gain of weight between the groups were also not significantly different. At 3 mo there was no evidence of partial recanalization of uncut staple line, but at 1 year the incidence was 13%. Compared with Billroth II reconstruction, uncut Roux-en-Y reconstruction is secure and feasible, and can effectively reduce the incidence of alkaline reflux, residual gastritis, and heartburn. Despite the incidence of recanalization, uncut Roux-en-Y should be widely applied.

Racial and Ethnic Differences in the Delivery of the Resources for Enhancing Alzheimer's Caregiver Health II Intervention.

PubMed

Graham-Phillips, Anita; Roth, David L; Huang, Jin; Dilworth-Anderson, Peggye; Gitlin, Laura N

2016-08-01

To determine whether there are racial and ethnicity group differences in Resources for Enhancing Alzheimer's Caregiver Health (REACH II) intervention delivery. Randomized controlled trial. Community-based intervention delivered at five sites across the United States. Family caregivers of persons with dementia who were randomized to the active intervention condition (N = 323). Nine in-home sessions (90 minutes each) and three telephone sessions (30 minutes each) were intended to be delivered and designed to reduce caregiver burden and depression, improve caregiver self-care and social support, and help caregivers manage behavior problems in persons with dementia. Interventionists recorded the type of intervention (home or telephone), start and stop times, and whether specific intervention content modules (e.g., stress management, social support) were administered in each session. Overall, REACH II intervention delivery was high, with more than 80% of randomized caregivers completing at least five in-home sessions and receiving eight or more hours of intervention contact, but black caregivers completed fewer in-home sessions (mean 6.98) than Hispanics (mean 7.84) or whites (mean 8.25) and received less total intervention contact time (mean 683 minutes) than Hispanics (mean 842 minutes) or whites (mean 798 minutes). No significant differences in exposure to content according to race or ethnicity were found after controlling for demographic covariates. Blacks in REACH II received significantly less intervention contact. Similar multicomponent interventions should examine whether there are systematic differences in intervention delivery across specific demographic subgroups and explore implications for treatment outcomes. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Assessment of type II diabetes mellitus using irregularly sampled measurements with missing data.

PubMed

Barazandegan, Melissa; Ekram, Fatemeh; Kwok, Ezra; Gopaluni, Bhushan; Tulsyan, Aditya

2015-04-01

Diabetes mellitus is one of the leading diseases in the developed world. In order to better regulate blood glucose in a diabetic patient, improved modelling of insulin-glucose dynamics is a key factor in the treatment of diabetes mellitus. In the current work, the insulin-glucose dynamics in type II diabetes mellitus can be modelled by using a stochastic nonlinear state-space model. Estimating the parameters of such a model is difficult as only a few blood glucose and insulin measurements per day are available in a non-clinical setting. Therefore, developing a predictive model of the blood glucose of a person with type II diabetes mellitus is important when the glucose and insulin concentrations are only available at irregular intervals. To overcome these difficulties, we resort to online sequential Monte Carlo (SMC) estimation of states and parameters of the state-space model for type II diabetic patients under various levels of randomly missing clinical data. Our results show that this method is efficient in monitoring and estimating the dynamics of the peripheral glucose, insulin and incretins concentration when 10, 25 and 50% of the simulated clinical data were randomly removed.

The large-scale placebo-controlled beta-blocker studies in systolic heart failure revisited: results from CIBIS-II, COPERNICUS and SENIORS-SHF compared with stratified subsets from MERIT-HF.

PubMed

Wikstrand, J; Wedel, H; Castagno, D; McMurray, J J V

2014-02-01

The four pivotal beta-blocker trials in heart failure (HF) had different inclusion criteria, making comparison difficult without patient stratifying. The aim of this study was to compare, in similar patients, the effects of bisoprolol, metoprolol controlled release/extended release (CR/XL), carvedilol and nebivolol on (i) total mortality, (ii) all-cause mortality or hospitalization due to cardiovascular causes (time to first event), (iii) all-cause mortality or hospitalization because of HF and (iv) tolerability, defined as discontinuation of randomized treatment. We compared stratified (s ) subsets in MERIT-HF with patients in CIBIS-II [New York Heart Association (NYHA) class III/IV and ejection fraction (EF) ≤ 35%] and COPERNICUS (NYHA III/IV and EF <25%) and in patients with systolic HF in SENIORS-SHF (age ≥ 70 years and EF ≤ 35%). The annual mortality rates in the placebo and beta-blocker arms were: (i) CIBIS-II (n = 2647), 13.2% vs. 8.8% (relative risk reduction 34%, 95% CI: 19-46, P < 0.0001) and MERIT-HFs (n = 2002), 14.8% vs. 8.6% (relative risk reduction 42%, 95% CI: 24-56, P < 0.0001); (ii) COPERNICUS (n = 2289), 19.7% vs. 12.8% (relative risk reduction 35%, 95% CI: 19-48, P = 0.0014) and MERIT-HFs (n = 795), 19.1% vs. 11.7% (relative risk reduction 39%; 95% CI: 11-58, P = 0.0086); (iii) SENIORS-SHF (n = 1359), 11.3% vs. 9.7% (relative risk reduction 16%, NS) and MERIT-HFs (n = 985), 14.8% vs. 10.1% (relative risk reduction 32%, 95% CI: 2-53, P = 0.038). The effects on the other outcomes assessed were similar. Analyses indicated fewer discontinuations from randomized treatment on beta-blockers compared with placebo in COPERNICUS and the MERIT-HFs subsets. The efficacy and tolerability of bisoprolol, carvedilol and metoprolol CR/XL are similar in patients with systolic HF, irrespective of NYHA class or ejection fraction. Nebivolol is less effective and not better tolerated. © 2013 The Association for the Publication of the Journal of Internal Medicine.

A 12-week randomized, double-blind, placebo-controlled multicenter study of choline-stabilized orthosilicic acid in patients with symptomatic knee osteoarthritis.

PubMed

Geusens, Piet; Pavelka, Karel; Rovensky, Jozef; Vanhoof, Johan; Demeester, Nathalie; Calomme, Mario; Vanden Berghe, Dirk

2017-01-05

The aim of this study was to assess the efficacy of choline-stabilized orthosilicic acid (ch-OSA) in patients with symptomatic knee osteoarthritis (OA). In a multicenter, double-blind, placebo-controlled study, 211 patients with knee OA (Kellgren and Lawrence grade II or III) and moderate to moderately severe pain were randomly allocated to ch-OSA or placebo for 12 weeks. The primary outcome was the change in the WOMAC pain subscale from baseline to week 12. Secondary outcomes were changes from baseline to week 12 in WOMAC total, WOMAC stiffness, WOMAC physical function, Subject Global Assessment and levels of cartilage degradation biomarkers C-terminal telopeptide of collagen type II (CTX-II) and cartilage oligomeric matrix protein (COMP). Pre-specified subgroup analyses included the effect of gender. A total of 166 (120 women, 46 men) patients were included in the analysis (87 and 79 in the ch-OSA and placebo group, respectively). In the total study population, no differences were observed between the two treatment groups for the different outcomes but significant treatment x gender interactions were found. In men taking ch-OSA, a significant improvement in WOMAC total, WOMAC stiffness and WOMAC physical function as well as a lower increase in biomarker levels of cartilage degradation was observed, but not in women. The change in WOMAC pain showed a similar positive trend in men taking ch-OSA. After 12 weeks of treatment, no effect was found of ch-OSA in the total study population on clinical parameters and biomarkers, but a gender interaction was observed. In men, ch-OSA was found effective in reducing symptoms of knee OA, which was associated with a slight but significant reduction of biomarkers that are related to cartilage degradation. The study was registered retrospectively: ISRCTN88583133 . Registration date: 2015-10-07.

Combination Therapy with Atorvastatin and Amlodipine Suppresses Angiotensin II-Induced Aortic Aneurysm Formation

PubMed Central

Takahashi, Kikuyo; Matsumoto, Yasuharu; Do.e, Zhulanqiqige; Kanazawa, Masanori; Satoh, Kimio; Shimizu, Takuya; Sato, Akira; Fukumoto, Yoshihiro; Shimokawa, Hiroaki

2013-01-01

Background Abdominal aortic aneurysm (AAA) is a life-threatening vascular disease. It is controversial whether statin and calcium channel blockers (CCBs) has an inhibitory effect on the expansion of AAA. Some studies reported that CCBs have an inhibitory effect on Rho-kinase activity. Rho-kinase plays an important role in the pathogenesis of various cardiovascular diseases. However, there is no study reporting of the association between Rho-kinase and human AAAs. Methods and Results Experimental AAA was induced in Apolipoprotein E-deficient (ApoE-/-) mice infused with angiotensin II (AngII) for 28 days. They were randomly divided into the following 5 groups; saline infusion alone (sham), AngII infusion alone, AngII infusion plus atorvastatin (10 mg/kg/day), AngII infusion plus amlodipine (1 mg/kg/day), and AngII infusion plus combination therapy with atorvastatin (10 mg/kg/day) and amlodipine (1 mg/kg/day). The combination therapy significantly suppressed AngII-induced increase in maximal aortic diameter as compared with sham, whereas each monotherapy had no inhibitory effects. The combination therapy significantly reduced AngII-induced apoptosis and elastin degradation at the AAA lesion, whereas each monotherapy did not. Moreover, Rho-kinase activity, as evaluated by the extent of phosphorylation of myosin-binding subunit (a substrate of Rho-kinase) and matrix metalloproteinase activity were significantly increased in the AngII-induced AAA lesion as compared with sham, both of which were again significantly suppressed by the combination therapy. In human aortic samples, immunohistochemistory revealed that the activity and expression of Rho-kinase was up-regulated in AAA lesion as compared with abdominal aorta from control subjects. Conclusions Rho-kinase is up-regulated in the aortic wall of human AAA. The combination therapy with amlodipine and Atorvastatin, but not each monotherapy, suppresses AngII-induced AAA formation in mice in vivo, for which Rho-kinase inhibition may be involved. PMID:23967318

Effect of Oral Voriconazole on Fungal Keratitis in the Mycotic Ulcer Treatment Trial II (MUTT II): A Randomized Clinical Trial.

PubMed

Prajna, N Venkatesh; Krishnan, Tiruvengada; Rajaraman, Revathi; Patel, Sushila; Srinivasan, Muthiah; Das, Manoranjan; Ray, Kathryn J; O'Brien, Kieran S; Oldenburg, Catherine E; McLeod, Stephen D; Zegans, Michael E; Porco, Travis C; Acharya, Nisha R; Lietman, Thomas M; Rose-Nussbaumer, Jennifer

2016-12-01

To compare oral voriconazole with placebo in addition to topical antifungals in the treatment of filamentous fungal keratitis. The Mycotic Ulcer Treatment Trial II (MUTT II), a multicenter, double-masked, placebo-controlled, randomized clinical trial, was conducted in India and Nepal, with 2133 individuals screened for inclusion. Patients with smear-positive filamentous fungal ulcers and visual acuity of 20/400 (logMAR 1.3) or worse were randomized to receive oral voriconazole vs oral placebo; all participants received topical antifungal eyedrops. The study was conducted from May 24, 2010, to November 23, 2015. All trial end points were analyzed on an intent-to-treat basis. Study participants were randomized to receive oral voriconazole vs oral placebo; a voriconazole loading dose of 400 mg was administered twice daily for 24 hours, followed by a maintenance dose of 200 mg twice daily for 20 days, with dosing altered to weight based during the trial. All participants received topical voriconazole, 1%, and natamycin, 5%. The primary outcome of the trial was rate of corneal perforation or the need for therapeutic penetrating keratoplasty (TPK) within 3 months. Secondary outcomes included microbiologic cure at 6 days, rate of re-epithelialization, best-corrected visual acuity and infiltrate and/or scar size at 3 weeks and 3 months, and complication rates associated with voriconazole use. A total of 2133 patients in India and Nepal with smear-positive ulcers were screened; of the 787 who were eligible, 240 (30.5%) were enrolled. Of the 119 patients (49.6%) in the oral voriconazole treatment group, 65 were male (54.6%), and the median age was 54 years (interquartile range, 42-62 years). Overall, no difference in the rate of corneal perforation or the need for TPK was determined for oral voriconazole vs placebo (hazard ratio, 0.82; 95% CI, 0.57-1.18; P = .29). In prespecified subgroup analyses comparing treatment effects among organism subgroups, there was some suggestion that Fusarium species might have a decreased rate of perforation or TPK in the oral voriconazole-treated arm; however, this was not a statistically significant finding after Holms-Šidák correction for multiple comparisons (effect coefficient, 0.49; 95% CI, 0.26-0.92; P = .03). Patients receiving oral voriconazole experienced a total of 58 adverse events (48.7%) compared with 28 adverse events (23.1%) in the placebo group (P < .001 after Holms-Šidák correction for multiple comparisons). There appears to be no benefit to adding oral voriconazole to topical antifungal agents in the treatment of severe filamentous fungal ulcers. All patients in this study were enrolled in India and Nepal; therefore, it is possible that organisms in this region may exhibit characteristics different from those in other regions of the world. clinicaltrials.gov Identifier: NCT00996736.

The Circularization of Amyloid Fibrils Formed by Apolipoprotein C-II

PubMed Central

Hatters, Danny M.; MacRaild, Christopher A.; Daniels, Rob; Gosal, Walraj S.; Thomson, Neil H.; Jones, Jonathan A.; Davis, Jason J.; MacPhee, Cait E.; Dobson, Christopher M.; Howlett, Geoffrey J.

2003-01-01

Amyloid fibrils have historically been characterized by diagnostic dye-binding assays, their fibrillar morphology, and a “cross-β” x-ray diffraction pattern. Whereas the latter demonstrates that amyloid fibrils have a common β-sheet core structure, they display a substantial degree of morphological variation. One striking example is the remarkable ability of human apolipoprotein C-II amyloid fibrils to circularize and form closed rings. Here we explore in detail the structure of apoC-II amyloid fibrils using electron microscopy, atomic force microscopy, and x-ray diffraction studies. Our results suggest a model for apoC-II fibrils as ribbons ∼2.1-nm thick and 13-nm wide with a helical repeat distance of 53 nm ± 12 nm. We propose that the ribbons are highly flexible with a persistence length of 36 nm. We use these observed biophysical properties to model the apoC-II amyloid fibrils either as wormlike chains or using a random-walk approach, and confirm that the probability of ring formation is critically dependent on the fibril flexibility. More generally, the ability of apoC-II fibrils to form rings also highlights the degree to which the common cross-β superstructure can, as a function of the protein constituent, give rise to great variation in the physical properties of amyloid fibrils. PMID:14645087

Comparison of temporomandibular joint and ramus morphology between class II and class III cases before and after bi-maxillary osteotomy.

PubMed

Iguchi, Ran; Yoshizawa, Kunio; Moroi, Akinori; Tsutsui, Takamitsu; Hotta, Asami; Hiraide, Ryota; Takayama, Akihiro; Tsunoda, Tatsuya; Saito, Yuki; Sato, Momoko; Baba, Nana; Ueki, Koichiro

2017-12-01

The purpose of this study was to compare changes in temporomandibular joint (TMJ) and ramus morphology between class II and III cases before and after sagittal split ramus osteotomy (SSRO) and Le Fort I osteotomy. The subjects were 39 patients (78 sides) who underwent bi-maxillary surgery. They consisted of 2 groups (18 class II cases and 21 class III cases), and were selected randomly from among patients who underwent surgery between 2012 and 2016. The TMJ disc tissue and joint effusion were assessed by magnetic resonance imaging (MRI) and the TMJ space, condylar height, ramus height, ramus inclination and condylar square were assessed by computed tomography (CT), pre- and post-operatively. The number of joints with anterior disc displacement in class II was significantly higher than that in class III (p < 0.0001). However, there were no significant differences between the two classes regarding ratio of joint symptoms and ratio of joint effusion pre- and post-operatively. Class II was significantly better than class III regarding reduction ratio of condylar height (p < 0.0001) and square (p = 0.0005). The study findings suggest that condylar morphology could change in both class II and III after bi-maxillary surgery. The findings of the numerical analysis also demonstrated that reduction of condylar volume occurred frequently in class II, although TMJ disc position classification did not change significantly, as previously reported. Copyright © 2017 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

AT-rich sequence elements promote nascent transcript cleavage leading to RNA polymerase II termination

PubMed Central

White, Eleanor; Kamieniarz-Gdula, Kinga; Dye, Michael J.; Proudfoot, Nick J.

2013-01-01

RNA Polymerase II (Pol II) termination is dependent on RNA processing signals as well as specific terminator elements located downstream of the poly(A) site. One of the two major terminator classes described so far is the Co-Transcriptional Cleavage (CoTC) element. We show that homopolymer A/T tracts within the human β-globin CoTC-mediated terminator element play a critical role in Pol II termination. These short A/T tracts, dispersed within seemingly random sequences, are strong terminator elements, and bioinformatics analysis confirms the presence of such sequences in 70% of the putative terminator regions (PTRs) genome-wide. PMID:23258704

Results from clinical trials of a selective ionotropic glutamate receptor 5 (iGluR5) antagonist, LY5454694 tosylate, in 2 chronic pain conditions.

PubMed

Chappell, Amy S; Iyengar, Smriti; Lobo, Evelyn D; Prucka, William R

2014-06-01

This article reports results of 2 studies investigating LY545694 in pain due to osteoarthritis (OA) of the knee and diabetic peripheral neuropathic pain (DPNP). Study I randomized patients to either of 2 doses of LY545694 or to placebo, and study II randomized patients to either of 3 doses of LY545694, to pregabalin, or to placebo. No significant differences between LY545694 groups and placebo were observed on the primary (average pain severity) or secondary efficacy measures in either study. Notably, study I lacked an active control, and, in study II, pregabalin, did not separate from placebo. Treatment-emergent nausea, vomiting, and dizziness were significantly more frequent in the LY545694 groups in both trials (P⩽.05), and significantly more LY545694-treated patients discontinued because of adverse events (P<.001). Steady-state concentrations of LY545694 were comparable in patients in both studies but were lower than exposures required for efficacy in animal models of pain behavior. Because the active control did not separate from placebo in the DPNP study, the study was potentially failed, rather than negative. Without an active control, it is unknown whether the OA study was negative or failed. Consequently, efficacy of selective ionotropic glutamate receptor antagonism in chronic pain conditions may warrant further investigation. Future trials should consider different pain conditions, contain a positive control with larger patient numbers per arm, and be conducted within a single region. Copyright © 2014 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Time scale of random sequential adsorption.

PubMed

Erban, Radek; Chapman, S Jonathan

2007-04-01

A simple multiscale approach to the diffusion-driven adsorption from a solution to a solid surface is presented. The model combines two important features of the adsorption process: (i) The kinetics of the chemical reaction between adsorbing molecules and the surface and (ii) geometrical constraints on the surface made by molecules which are already adsorbed. The process (i) is modeled in a diffusion-driven context, i.e., the conditional probability of adsorbing a molecule provided that the molecule hits the surface is related to the macroscopic surface reaction rate. The geometrical constraint (ii) is modeled using random sequential adsorption (RSA), which is the sequential addition of molecules at random positions on a surface; one attempt to attach a molecule is made per one RSA simulation time step. By coupling RSA with the diffusion of molecules in the solution above the surface the RSA simulation time step is related to the real physical time. The method is illustrated on a model of chemisorption of reactive polymers to a virus surface.

Modeling Laser Damage Thresholds Using the Thompson-Gerstman Model

DTIC Science & Technology

2014-10-01

Gerstman model was intended to be a modular tool fit for integration into other computational models. This adds usability to the standalone code...Advanced Study Institute, Series A – Life Sciences, Vol. 34, pp. 77-97. New York: Plenum Press . 4. Birngruber, R., V.-P. Gabel and F. Hillenkamp...Random granule placement - varies with melnum. ; ii. Depth averaging or shadowing - varies with melnum. ; iii. T(r,t) single granule calc

Abbreviated Breast MRI and Digital Tomosynthesis Mammography in Screening Women With Dense Breasts | Division of Cancer Prevention

Cancer.gov

This randomized phase II trial studies how well abbreviated breast magnetic resonance imaging (MRI) and digital tomosynthesis mammography work in detecting cancer in women with dense breasts. Abbreviated breast MRI is a low cost procedure in which radio waves and a powerful magnet linked to a computer and used to create detailed pictures of the breast in less than 10 minutes.

Agricultural Workers in Central California. Volume 1: In 1989; Volume 2: Phase II, 1990-91. California Agricultural Studies, 90-8 and 91-5.

ERIC Educational Resources Information Center

Alvarado, Andrew J.; And Others

Two surveys developed profiles of seasonal agricultural workers and their working conditions in central California. In 1989, a random sample of 347 seasonal workers was interviewed. The sample was 30 percent female and 87 percent Mexican-born. Average age was 35 years and average educational attainment was 5.9 years. Most had parents, spouses, or…

Role of Omega-3 Fatty Acids on Lipid Profile in Diabetic Dyslipidaemia: Single Blind, Randomised Clinical Trial.

PubMed

Chauhan, Shaylika; Kodali, Hanish; Noor, Jawad; Ramteke, Karuna; Gawai, Vidisha

2017-03-01

Diabetic dyslipidaemia is characterised by hypertriglyceridaemia, low High Density Lipoprotein (HDL), postprandial lipimea, small and dense LDL particles is considered to be a major predisposing factor for various macrovascular complications. Omega-3 fatty acids are fish oil derivative introduced in the market for dyslipidaemia associated with increased triglyceride level. To study the effect of omega-3 fatty acids on lipid profile in Type II diabetes patients. This study was prospective, single blind, randomized comparative trial. Hundred patients were randomized into three groups. Group I received metformin 500 mg twice daily and placebo, Group II received metformin 500 mg twice daily and omega-3 fatty acids (1 gram) once daily and the Group III received metformin 500 mg twice daily and omega-3 fatty acids (1 gram) twice daily. ANOVA test was applied for analysis. Group II was effective in reducing the triglyceride level from 144.59±14.18 mg/dl to 101±13.31 mg/dl which was significant as compared to Group I from 147.67±18.57 mg/dl to 145.8±19.86 mg/dl respectively. Group III containing 1 g of omega-3 fatty acids twice daily showed decrease from 144.83±22.17 mg/dl to 86±17.46 mg/dl and was more effective in reducing triglyceride levels than Group II containing 1 gram of omega-3 fatty acids once daily. Omega-3 fatty acids can be given in conjunction with metformin to reduce triglyceride levels in diabetic dyslipidaemia without any adverse drug reactions or any drug interaction. Omega-3 fatty acids were effective in reducing the triglyceride level significantly as compared to placebo. Two grams of omega-3 fatty acids were more effective than 1 gram of omega-3 fatty acids in reducing triglyceride levels.

Postoperative analgesia in children when using clonidine in addition to fentanyl with bupivacaine given caudally.

PubMed

Jarraya, Anouar; Elleuch, Sahar; Zouari, Jawhar; Smaoui, Mohamed; Laabidi, Sofiene; Kolsi, Kamel

2016-01-01

The aim of the study was to evaluate the efficacy of clonidine in association with fentanyl as an additive to bupivacaine 0.25% given via single shot caudal epidural in pediatric patients for postoperative pain relief. In the present prospective randomized double blind study, 40 children of ASA-I-II aged 1-5 years scheduled for infraumblical surgical procedures were randomly allocated to two groups to receive either bupivacaine 0.25% (1 ml/kg) with fentanyl 1 μg/kg and clonidine 1μg/kg (group I) or bupivacaine 0.25% (1 ml/kg) with fentanyl 1 μg/kg (group II). Caudal block was performed after the induction of general anesthesia. Postoperatively patients were observed for analgesia, sedation, hemodynamic parameters, and side effects or complications. Both the groups were similar with respect to patient and various block characteristics. Heart rate and blood pressure were not different in 2 groups. Significantly prolonged duration of post-operative analgesia was observed in group I (P<0.05). Side effects such as respiratory depression, vomiting and bradycardia were similar in both groups. The adjunction of clonidine to fentanyl as additives to bupivacaine in single shot caudal epidural in children may provide better and longer analgesia after infraumblical surgical procedures.

Emtonjeni—A Structural Intervention to Integrate Sexual and Reproductive Health into Public Sector HIV Care in Cape Town, South Africa: Results of a Phase II Study

PubMed Central

Mantell, J. E.; Cooper, D.; Exner, T. M.; Moodley, J.; Hoffman, S.; Myer, L.; Leu, C.-S.; Bai, D.; Kelvin, E. A.; Jennings, K.; Stein, Z. A.; Constant, D.; Zweigenthal, V.; Cishe, N.; Nywagi, N.

2016-01-01

Integration of sexual and reproductive health within HIV care services is a promising strategy for increasing access to family planning and STI services and reducing unwanted pregnancies, perinatal HIV transmission and maternal and infant mortality among people living with HIV and their partners. We conducted a Phase II randomized futility trial of a multi-level intervention to increase adherence to safer sex guidelines among those wishing to avoid pregnancy and adherence to safer conception guidelines among those seeking conception in newly-diagnosed HIV-positive persons in four public-sector HIV clinics in Cape Town. Clinics were pair-matched and the two clinics within each pair were randomized to either a three-session provider-delivered enhanced intervention (EI) (onsite contraceptive services and brief milieu intervention for staff) or standard-of-care (SOC) provider-delivered intervention. The futility analysis showed that we cannot rule out the possibility that the EI intervention has a 10 % point or greater success rate in improving adherence to safer sex/safer conception guidelines than does SOC (p = 0.573), indicating that the intervention holds merit, and a larger-scale confirmatory study showing whether the EI is superior to SOC has merit. PMID:27807792

Effect of pH adjustment by mixing steroid for venous pain in colorectal cancer patients receiving oxaliplatin through peripheral vein: a multicenter randomized phase II study (APOLLO).

PubMed

Hata, Taishi; Honda, Michitaka; Kobayashi, Michiya; Toyokawa, Akihiro; Tsuda, Masahiro; Tokunaga, Yukihiko; Takase, Kozo; Miyake, Masakazu; Morita, Satoshi; Nagata, Naoki; Sakamoto, Junichi; Gosho, Masahiko; Mishima, Hideyuki

2015-12-01

The aim of this phase II clinical trial was to evaluate the preventive effect of dexamethasone mixing injection for venous pain in patients with colorectal cancer during chemotherapy. Patients were randomized to receive a 2-h intravenous infusion of oxaliplatin 130 mg/m(2) on day 1 followed by capecitabine 1000 mg/m(2) (or S-1 40-60 mg/m(2)) twice daily on days 1 through 14 of every 3 weeks with or without dexamethasone 1.65 mg at the infusion on day 1. A total of 53 patients were enrolled. The analysis population consisted of 49 patients (arm A, with dexamethasone N = 24; arm B, without dexamethasone N = 25). The incidence of venous pain ≥grade 2 based on the CTCAE version 4.0 was 33.3 % in arm A and 56.0 % in arm B (relative risk 0.60; 95 % CI 0.31-1.16). The incidences based on the verbal rating scale for arms A and B were 50.0 and 64.0 %, respectively (relative risk 0.78; 95 % CI 0.48-1.28). The primary endpoint was not met in this preliminary study.

Continuous-Time Random Walk Models of DNA Electrophoresis in a Post Array: II. Mobility and Sources of Band Broadening

PubMed Central

Olson, Daniel W.; Dutta, Sarit; Laachi, Nabil; Tian, Mingwei; Dorfman, Kevin D.

2011-01-01

Using the two-state, continuous-time random walk model, we develop expressions for the mobility and the plate height during DNA electrophoresis in an ordered post array that delineate the contributions due to (i) the random distance between collisions and (ii) the random duration of a collision. These contributions are expressed in terms of the means and variances of the underlying stochastic processes, which we evaluate from a large ensemble of Brownian dynamics simulations performed using different electric fields and molecular weights in a hexagonal array of 1 μm posts with a 3 μm center-to-center distance. If we fix the molecular weight, we find that the collision frequency governs the mobility. In contrast, the average collision duration is the most important factor for predicting the mobility as a function of DNA size at constant Péclet number. The plate height is reasonably well-described by a single post rope-over-pulley model, provided that the extension of the molecule is small. Our results only account for dispersion inside the post array and thus represent a theoretical lower bound on the plate height in an actual device. PMID:21290387

Effect of Daikenchuto (TJ-100) on gastrointestinal symptoms following laparoscopic colectomy in patients with colon cancer: study protocol for a randomized controlled trial.

PubMed

Hoshino, Nobuaki; Kawada, Kenji; Hida, Koya; Wada, Toshiaki; Takahashi, Ryo; Yoshitomi, Mami; Sakai, Yoshiharu

2017-11-21

Postoperative paralytic ileus can be a difficult complication for both surgeons and patients. Causes and treatments have been discussed for more than two centuries, but have not yet been fully resolved. Daikenchuto (TJ-100, DKT) is a traditional Japanese herbal medicine. Recently, some beneficial mechanisms of DKT to relieve paralytic ileus have been reported. DKT can suppress inflammation, increase intestinal blood flow, and accelerate bowel movements. Therefore, we have designed a randomized controlled trial to investigate the effects of DKT on postoperative gastrointestinal symptoms following laparoscopic colectomy in patients with left-sided colon cancer at a single institution. As primary endpoints, the following outcomes will be evaluated: (i) grade of abdominal pain determined using the numeric rating scale (NRS), (ii) grade of abdominal distention determined using the NRS, and (iii) quality of life determined using the Gastrointestinal Quality Life Index (GIQLI). As secondary endpoints, the following will be evaluated: (i) postoperative nutritional status (Onodera's Prognostic Nutritional Index (PNI) and the Controlling Nutritional Status score (CONUT score)), (ii) duration to initial flatus, (iii) duration to initial defecation, (iv) bowel gas volume, (v) character of stool (Bristol Stool Form Scale), (vi) defecation frequency per day, (vii) postoperative complications (Clavien-Dindo classification), (viii) length of postoperative hospital stay, and (ix) metabolites in the stool and blood. This trial is an open-label study, and needs to include 40 patients (20 patients per group) and is expected to span 2 years. To our knowledge, this is the first randomized controlled trial to investigate the effects of DKT on postoperative subjective outcomes (i.e., postoperative quality of life) following laparoscopic colectomy as primary endpoints. Exploratory metabolomics analysis of metabolites in stool and blood will be conducted in this trial, which previously has only been performed in a few human studies. The study aims to guide a future full-scale pragmatic randomized trial to assess the overall effectiveness of DKT to improve the postoperative quality of life following laparoscopic colectomy. UMIN-CTR (Japan), UMIN000023318 . Registered on 25 July 2016.

Blockade of AT1 type receptors for angiotensin II prevents cardiac microvascular fibrosis induced by chronic stress in Sprague-Dawley rats.

PubMed

Firoozmand, Lília Taddeo; Sanches, Andrea; Damaceno-Rodrigues, Nilsa Regina; Perez, Juliana Dinéia; Aragão, Danielle Sanches; Rosa, Rodolfo Mattar; Marcondes, Fernanda Klein; Casarini, Dulce Elena; Caldini, Elia Garcia; Cunha, Tatiana Sousa

2018-04-20

To test the effects of chronic-stress on the cardiovascular system, the model of chronic mild unpredictable stress (CMS) has been widely used. The CMS protocol consists of the random, intermittent, and unpredictable exposure of laboratory animals to a variety of stressors, during 3 consecutive weeks. In this study, we tested the hypothesis that exposure to the CMS protocol leads to left ventricle microcirculatory remodeling that can be attenuated by angiotensin II receptor blockade. Male Sprague-Dawley rats were randomly assigned into four groups: Control, Stress, Control + losartan, and Stress + losartan (N = 6, each group, losartan: 20 mg/kg/day). The rats were euthanized 15 days after CMS exposure, and blood samples and left ventricle were collected. Rats submitted to CMS presented increased glycemia, corticosterone, noradrenaline and adrenaline concentration, and losartan reduced the concentration of the circulating amines. Cardiac angiotensin II, measured by high-performance liquid chromatography (HPLC), was significantly increased in the CMS group, and losartan treatment reduced it, while angiotensin 1-7 was significantly higher in the CMS losartan-treated group as compared with CMS. Histological analysis, verified by transmission electron microscopy, showed that rats exposed to CMS presented increased perivascular collagen and losartan effectively prevented the development of this process. Hence, CMS induced a state of microvascular disease, with increased perivascular collagen deposition, that may be the trigger for further development of cardiovascular disease. In this case, CMS fibrosis is associated with increased production of catecholamines and with a disruption of renin-angiotensin system balance, which can be prevented by angiotensin II receptor blockade.

Comparative trial of the use of antiplatelet and oral anticoagulant in thrombosis prophylaxis in patients undergoing total cavopulmonary operation with extracardiac conduit: echocardiographic, tomographic, scintigraphic, clinical and laboratory analysis.

PubMed

Pessotti, Cristiane Felix Ximenes; Jatene, Marcelo Biscegli; Jatene, Ieda Biscegli; Oliveira, Patrícia Marques; Succi, Fabiana Moreira Passos; Moreira, Valeria de Melo; Lopes, Rafael Willain; Pedra, Simone Rolim Fernandes Fontes

2014-01-01

To compare the efficacy of aspirin and warfarin for prophylaxis of thrombosis in patients undergoing total cavopulmonary anastomosis. Evaluate whether coagulation factors (VII, VIII and protein C), clinical data, fenestration or hemodynamic factors, interfere with postoperative thrombosis. A prospective, randomized study of 30 patients, randomized into Group I (Warfarin) and Group II (AAS), underwent total cavopulmonary shunt with extracardiac conduit, between 2008 and 2011, with follow-up by clinical visits to evaluate side effects and adhesion. Performed transesophageal echocardiography in post operatory time, 3, 6,12 and 24 months; angiotomography at 6, 12 and 24 months to evaluate changes in the internal tube wall or thrombi and pulmonary scintigraphy to evaluate possible PTE. Two deaths in group I; 33.3% of patients had thrombus (46.7% in Group II). The previous occurrence of thrombus and low levels of coagulation protein C were the only factors that influenced the time free of thrombus (P=0.035 and 0.047). Angiotomographic evaluation: 35.7% in group II presented material accumulation greater than 2 mm (P=0.082). Scintigraphy: two patients had PTE in group II. Five patients had difficulty to comply with the treatment, 4 in group I with INR ranging from 1 to 6.4. The previous occurrence of thrombus is a risk factor for thrombosis in the postoperative period. Patients using AAS tend to deposit material in the tube wall. The small sample size did not allow to conclude which is the most effective drug in the prevention of thrombosis in this population.

Phase I/randomized phase II study of afatinib, an irreversible ErbB family blocker, with or without protracted temozolomide in adults with recurrent glioblastoma.

PubMed

Reardon, David A; Nabors, Louis B; Mason, Warren P; Perry, James R; Shapiro, William; Kavan, Petr; Mathieu, David; Phuphanich, Surasak; Cseh, Agnieszka; Fu, Yali; Cong, Julie; Wind, Sven; Eisenstat, David D

2015-03-01

This phase I/II trial evaluated the maximum tolerated dose (MTD) and pharmacokinetics of afatinib plus temozolomide as well as the efficacy and safety of afatinib as monotherapy (A) or with temozolomide (AT) vs temozolomide monotherapy (T) in patients with recurrent glioblastoma (GBM). Phase I followed a traditional 3 + 3 dose-escalation design to determine MTD. Treatment cohorts were: afatinib 20, 40, and 50 mg/day (plus temozolomide 75 mg/m(2)/day for 21 days per 28-day cycle). In phase II, participants were randomized (stratified by age and KPS) to receive A, T or AT; A was dosed at 40 mg/day and T at 75 mg/m(2) for 21 of 28 days. Primary endpoint was progression-free survival rate at 6 months (PFS-6). Participants were treated until intolerable adverse events (AEs) or disease progression. Recommended phase II dose was 40 mg/day (A) + T based on safety data from phase I (n = 32). Most frequent AEs in phase II (n = 119) were diarrhea (71% [A], 82% [AT]) and rash (71% [A] and 69% [AT]). Afatinib and temozolomide pharmacokinetics were unaffected by coadministration. Independently assessed PFS-6 rate was 3% (A), 10% (AT), and 23% (T). Median PFS was longer in afatinib-treated participants with epidermal growth factor receptor (EFGR) vIII-positive tumors versus EGFRvIII-negative tumors. Best overall response included partial response in 1 (A), 2 (AT), and 4 (T) participants and stable disease in 14 (A), 14 (AT), and 21 (T) participants. Afatinib has a manageable safety profile but limited single-agent activity in unselected recurrent GBM patients. © The Author(s) 2014. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Post dural puncture headache after spinal anaesthesia for caesarean section: a comparison of 25 g Quincke, 27 g Quincke and 27 g Whitacre spinal needles.

PubMed

Shaikh, Jan Muhammad; Memon, Amna; Memon, Muhammad Ali; Khan, Majida

2008-01-01

To compare the frequency and severity of post dural puncture headache in obstetric patients using 25G Quincke, 27G Quincke and 27G Whitacre spinal needles. Comparative, randomized, double-blind, interventional study. Liaquat University Hospital Hyderabad from October 2005 to December 2006. 480 ASA I-II full term pregnant women, 18 to 45 years of age, scheduled for elective Caesarean section, under spinal anaesthesia, were randomized into three groups: Group I (25G Quincke spinal needle: n=168), Group II (27G Quincke spinal needle: n=160) and Group III (27G Whitacre spinal needle: n=152). Spinal anaesthesia was performed with 1.5-2.0 ml 0.75% hyperbaric bupivacaine using 25G Quincke spinal needle (Group I), 27G Quincke spinal needle (Group II) and 27G Whitacre spinal needle (Group III) at L3-4 inter-vertebral space. Each patient was assessed daily for four consecutive days following Caesarean section. Frequency and severity and of postdural puncture headache (PDPH) were recorded. Data were analyzed using SPSS-11. Frequency of PDPH following the use of 25G Quincke (Group I), 27G Quincke (Group II) and 27G Whitacre (Group III) spinal needles was 8.3% (14/168), 3.8% (6/160) and 2.0% (3/152) respectively. In Group I, PDPH was mild in 5 patients, moderate in 7 patients and severe in 2 patients. In Group II, it was mild in 2, moderate in 3 and severe in 1 patient. In group III, it was mild in 2 and moderate in 1 patient. Severe PDPH did not occur in Group III. Most of the patients with PDPH developed it on 1st and 2nd postoperative day. When using a 27G Whitacre spinal needle, the frequency and severity of PDPH was significantly lower than when a 25G Quincke or 27G Quincke needle was used.

The effects of intravenous, enteral and combined administration of glutamine on malnutrition in sepsis: a randomized clinical trial.

PubMed

Koksal, Guniz Meyancı; Erbabacan, Emre; Tunali, Yusuf; Karaoren, Gulsah; Vehid, Suphi; Oz, Huseyin

2014-01-01

Our aim was to compare the effects of intravenous, enteral, and enteral plus intravenous supplemented glutamine on plasma transferrin, nitrogen balance, and creatinine/height index in septic patients with malnutrition. Blood and urine samples were collected for transferrin, urea and creatinine measurements. Samples, SOFA score and protein-calorie intake values were repeated on days 7 and 15. Patients (n:120) were randomly divided into 4 groups. Group I received 30 g/day IV glutamine, group II received 30 g/day enteral glutamine, group III received 15 g/day IV and 15 g/day enteral glutamine. Group IV received only enteral feeding as a control group. Transferrin levels decreased in group IV (p<0.01 0-7 days, p<0.01 7-15 days, p<0.01 0-15 days). Nitrogen balance levels were highest in group IV when compared with group I (p<0.05, p<0.001), group II (p<0.001), and group III (p<0.05, p<0.001) on days 7-15. Creatinine/height indexes increased in group I (p<0.001), group II (p<0.001), group III (p<0.001), and group IV (p<0.05) on day 15. In group III the creatinine/height index was higher than in groups I and II (p<0.05). In group IV, creatinine/height index was lower than in group I (p<0.01) and group II (p<0.001). Protein-calorie intake in group IV was higher than others on day 7 (p<0.05). SOFA scores of group IV were higher than the other groups on day 15 (p<0.05). This study demonstrated, that combined route of gln supplementation resulted in the most positive outcome to transferrin, creatine/height index and nitrogen balance (on days 7 and 15) during the catabolic phase of septic patients with malnutrition.

Efficacy and safety of sacubitril/valsartan (LCZ696) in Japanese patients with chronic heart failure and reduced ejection fraction: Rationale for and design of the randomized, double-blind PARALLEL-HF study.

PubMed

Tsutsui, Hiroyuki; Momomura, Shinichi; Saito, Yoshihiko; Ito, Hiroshi; Yamamoto, Kazuhiro; Ohishi, Tomomi; Okino, Naoko; Guo, Weinong

2017-09-01

The prognosis of heart failure patients with reduced ejection fraction (HFrEF) in Japan remains poor, although there is growing evidence for increasing use of evidence-based pharmacotherapies in Japanese real-world HF registries. Sacubitril/valsartan (LCZ696) is a first-in-class angiotensin receptor neprilysin inhibitor shown to reduce mortality and morbidity in the recently completed largest outcome trial in patients with HFrEF (PARADIGM-HF trial). The prospectively designed phase III PARALLEL-HF (Prospective comparison of ARNI with ACE inhibitor to determine the noveL beneficiaL trEatment vaLue in Japanese Heart Failure patients) study aims to assess the clinical efficacy and safety of LCZ696 in Japanese HFrEF patients, and show similar improvements in clinical outcomes as the PARADIGM-HF study enabling the registration of LCZ696 in Japan. This is a multicenter, randomized, double-blind, parallel-group, active controlled study of 220 Japanese HFrEF patients. Eligibility criteria include a diagnosis of chronic HF (New York Heart Association Class II-IV) and reduced ejection fraction (left ventricular ejection fraction ≤35%) and increased plasma concentrations of natriuretic peptides [N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥600pg/mL, or NT-proBNP ≥400pg/mL for those who had a hospitalization for HF within the last 12 months] at the screening visit. The study consists of three phases: (i) screening, (ii) single-blind active LCZ696 run-in, and (iii) double-blind randomized treatment. Patients tolerating LCZ696 50mg bid during the treatment run-in are randomized (1:1) to receive LCZ696 100mg bid or enalapril 5mg bid for 4 weeks followed by up-titration to target doses of LCZ696 200mg bid or enalapril 10mg bid in a double-blind manner. The primary outcome is the composite of cardiovascular death or HF hospitalization and the study is an event-driven trial. The design of the PARALLEL-HF study is aligned with the PARADIGM-HF study and aims to assess the efficacy and safety of LCZ696 in Japanese HFrEF patients. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Pharmacological Treatment of Insomnia Symptoms in Individuals with Substance Use Disorders in Spain: A Quasi-Experimental Study.

PubMed

Grau-López, L; Grau-López, L; Daigre, C; Palma-Álvarez, R F; Rodriguez-Cintas, L; Ros-Cucurull, E; Roncero, C

2018-07-03

Pharmacological treatment of insomnia in patients with addictions has been hardly investigated and there are few researches about it in an inpatient detoxification. The aim of this study was to describe the outcomes of the pharmacological treatment of insomnia in SUD patients admitted to a detoxification unit in Spain, with a focus on the primary substance of abuse and co-occurring mental disorders. A quasi-experimental study was conducted in 481 addicted in patients, who were admitted for substances detoxification in Vall d´Hebron University Hospital, Barcelona, Spain, from 2010 to 2015. The patients underwent systematic evaluation of axes I and II psychiatric disorders (SCID-I, SCID-II, and CAADID). Insomnia was evaluated using a night time sleep log. Substance-dependent patients, who had insomnia during hospital detoxification, received a psychotropic medication with hypnotic effect, keeping the regular clinical practice without randomization. At discharge, insomnia was considered to have been alleviated in 63.8% (n = 204) of patients while 36.2% (n = 116) of patients remained with insomnia disturbances. Comparing hypnotic treatments it was observed that mirtazapine and clotiapine were the treatment that corrected the insomnia more frequently. Since insomnia is not corrected in all patients, it should be further investigated in medications with hypnotic purpose. Based on the results of this work, randomized clinical trials might be proposed.

The Comparative Reliability and Feasibility of the Past-Year Canadian Diet History Questionnaire II: Comparison of the Paper and Web Versions

PubMed Central

Lo Siou, Geraldine; Csizmadi, Ilona; Boucher, Beatrice A.; Akawung, Alianu K.; Whelan, Heather K.; Sharma, Michelle; Al Rajabi, Ala; Vena, Jennifer E.; Kirkpatrick, Sharon I.; Koushik, Anita; Massarelli, Isabelle; Rondeau, Isabelle; Robson, Paula J.

2017-01-01

Advances in technology-enabled dietary assessment include the advent of web-based food frequency questionnaires, which may reduce costs and researcher burden but may introduce new challenges related to internet connectivity and computer literacy. The purpose of this study was to evaluate the intra- and inter-version reliability, feasibility and acceptability of the paper and web Canadian Diet History Questionnaire II (CDHQ-II) in a sub-sample of 648 adults (aged 39–81 years) recruited from Alberta’s Tomorrow Project. Participants were randomly assigned to one of two groups: (1) paper, web, paper; or (2) web, paper, web over a six-week period. With few exceptions, no statistically significant differences in mean nutrient intake were found in the intra- and inter-version reliability analyses. The majority of participants indicated future willingness to complete the CDHQ-II online, and 59% indicated a preference for the web over the paper version. Findings indicate that, in this population of adults drawn from an existing cohort, the CDHQ-II may be administered in paper or web modalities (increasing flexibility for questionnaire delivery), and the nutrient estimates obtained with either version are comparable. We recommend that other studies explore the feasibility and reliability of different modes of administration of dietary assessment instruments prior to widespread implementation. PMID:28208819

Axitinib dose titration: analyses of exposure, blood pressure and clinical response from a randomized phase II study in metastatic renal cell carcinoma.

PubMed

Rini, B I; Melichar, B; Fishman, M N; Oya, M; Pithavala, Y K; Chen, Y; Bair, A H; Grünwald, V

2015-07-01

In a randomized, double-blind phase II trial in patients with metastatic renal cell carcinoma (mRCC), axitinib versus placebo titration yielded a significantly higher objective response rate. We evaluated pharmacokinetic and blood pressure (BP) data from this study to elucidate relationships among axitinib exposure, BP change, and efficacy. Patients received axitinib 5 mg twice daily during a lead-in period. Patients who met dose-titration criteria were randomized 1:1 to stepwise dose increases with axitinib or placebo. Patients ineligible for randomization continued without dose increases. Serial 6-h and sparse pharmacokinetic sampling were carried out; BP was measured at clinic visits and at home in all patients, and by 24-h ambulatory BP monitoring (ABPM) in a subset of patients. Area under the plasma concentration-time curve from 0 to 24 h throughout the course of treatment (AUCstudy) was higher in patients with complete or partial responses than those with stable or progressive disease in the axitinib-titration arm, but comparable between these groups in the placebo-titration and nonrandomized arms. In the overall population, AUCstudy and efficacy outcomes were not strongly correlated. Mean BP across the population was similar when measured in clinic, at home, or by 24-h ABPM. Weak correlations were observed between axitinib steady-state exposure and diastolic BP. When grouped by change in diastolic BP from baseline, patients in the ≥10 and ≥15 mmHg groups had longer progression-free survival. Optimal axitinib exposure may differ among patients with mRCC. Pharmacokinetic or BP measurements cannot be used exclusively to guide axitinib dosing. Individualization of treatment with vascular endothelial growth factor receptor tyrosine kinase inhibitors, including axitinib, is thus more complex than anticipated and cannot be limited to a single clinical factor. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Randomized Evaluation of the Effectiveness of a Structured Educational Program for Patients With Essential Hypertension.

PubMed

Perl, Sabine; Niederl, Ella; Kos, Cornelia; Mrak, Peter; Ederer, Herbert; Rakovac, Ivo; Beck, Peter; Kraler, Elisabeth; Stoff, Ingrid; Klima, Gert; Pieske, Burkert M; Pieber, Thomas R; Zweiker, Robert

2016-07-01

Adherence to medication and lifestyle interventions are essential keys for the management of hypertension. In this respect, a structured educational program for hypertensive patients has got remarkable merits (herz.leben). In order to determine the isolated effect of participation in the educational program, neglecting the possible impact of more intense care, this prospective multicenter randomized controlled study was designed (NCT00453037). A total of 256 patients in 13 centers were enrolled and randomly assigned to 2 groups (G). G-I (n = 137) underwent the educational program immediately (T-0), G-II (n = 119) after 6 months (T-6). Follow-up visits were done after 6 (T-6) and 12 (T-12) months. Primary endpoint was a difference in office blood pressure (BP) at T-6, when only G-I had undergone the educational program. Patients' baseline characteristics were comparable. At T-6, systolic office and home BP were significantly lower in G-I compared to G-II: office BP systolic 139 (134-150) mm Hg vs. 150 (135-165) mm Hg (P < 0.01); diastolic 80 (76-85) mm Hg vs. 84 (75-90) mm Hg (ns); home BP systolic 133 (130-140) mm Hg vs. 142 (132-150) mm Hg (P < 0.01); diastolic 80 (75-85) mm Hg vs. 80 (76-89) mm Hg (ns)). At T-12, when all patients had undergone the educational program differences in BP disappeared. The results of this multicenter randomized controlled study provide significant evidence for benefit by participation in a structured educational program. Positive effects seem to be mediated by better adherence and life style changes due to higher levels of information and patient empowerment. Therefore, educational strategies should be considered as standard of care for hypertensive patients. © American Journal of Hypertension, Ltd 2015. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Selective aldosterone blockade prevents angiotensin II/salt-induced vascular inflammation in the rat heart.

PubMed

Rocha, Ricardo; Martin-Berger, Cynthia L; Yang, Pochang; Scherrer, Rachel; Delyani, John; McMahon, Ellen

2002-12-01

We studied the role of aldosterone (aldo) in myocardial injury in a model of angiotensin (Ang) II-hypertension. Wistar rats were given 1% NaCl (salt) to drink and randomized into one of the following groups (n = 10; treatment, 21 d): 1) vehicle control (VEH); 2) Ang II infusion (25 ng/min, sc); 3) Ang II infusion plus the selective aldo blocker, eplerenone (epl, 100 mg/kg.d, orally); 4) Ang II infusion in adrenalectomized (ADX) rats; and 5) Ang II infusion in ADX rats with aldo treatment (20 micro g/kg.d, sc). ADX rats received also dexamethasone (12 micro g/kg.d, sc). Systolic blood pressure increased with time in all treatment groups except the VEH group (VEH, 136 +/- 6; Ang II/NaCl, 203 +/- 12; Ang II/NaCl/epl, 196 +/- 10; Ang II/NaCl/ADX, 181 +/- 7; Ang II/NaCl/ADX/aldo, 236 +/- 8 mm Hg). Despite similar levels of hypertension, epl and ADX attenuated the increase in heart weight/body weight induced by Ang II. Histological examination of the hearts evidenced myocardial and vascular injury in the Ang II/salt (7 of 10 hearts with damage, P < 0.05 vs. VEH) and Ang II/salt/ADX/aldo groups (10 of 10 hearts with damage, P < 0.05). Injury included arterial fibrinoid necrosis, perivascular inflammation (primarily macrophages), and focal infarctions. Vascular lesions were associated with expression of the inflammatory mediators cyclooxygenase 2 (COX-2) and osteopontin in the media of coronary arteries. Myocardial injury, COX-2, and osteopontin expression were markedly attenuated by epl treatment (1 of 10 hearts with damage, P < 0.05 vs. Ang II/salt) and adrenalectomy (2 of 10 hearts with damage, P < 0.05 vs. Ang II/salt). Our data indicate that aldo plays a major role in Ang II-induced vascular inflammation in the heart and implicate COX-2 and osteopontin as potential mediators of the damage.

Mucosal integrity and inflammatory markers in the female lower genital tract as potential screening tools for vaginal microbicides.

PubMed

Su, H Irene; Schreiber, Courtney A; Fay, Courtney; Parry, Sam; Elovitz, Michal A; Zhang, Jian; Shaunik, Alka; Barnhart, Kurt

2011-11-01

In the female genital tract, vaginal colposcopy, endometrial mucosal integrity and inflammatory mediators are potential in vivo biomarkers of microbicide and contraceptive safety. A randomized, blinded crossover trial of 18 subjects comparing effects of nonoxynol-9 vaginal gel (Gynol II; putative inflammatory gel), hydroxyethyl cellulose gel (HEC; putative inert gel) and no gel exposure on endometrial and vaginal epithelial integrity and endometrial and vaginal inflammatory markers [interleukin (IL) 1β, IL-6, IL-8, MCP-1, MIP-1α, MIP-1β, RANTES, tumor necrosis factor α, IL-1RA, IL-10, SLPI). Gynol II was associated with more vaginal lesions. No endometrial disruptions were observed across conditions. In the vagina, RANTES (p=.055) and IL-6 (p=.04) were higher after HEC exposure than at baseline. In the endometrium, IL-1β (p=.003) and IL-8 (p=.025) were lower after Gynol II cycles than after no gel. Gynol II and HEC may modulate inflammatory markers in the vagina and endometrium. How these changes relate to infection susceptibility warrants further study. Copyright © 2011 Elsevier Inc. All rights reserved.

Randomized Multicenter Phase II Study of Modified Docetaxel, Cisplatin, and Fluorouracil (DCF) Versus DCF Plus Growth Factor Support in Patients With Metastatic Gastric Adenocarcinoma: A Study of the US Gastric Cancer Consortium.

PubMed

Shah, Manish A; Janjigian, Yelena Y; Stoller, Ronald; Shibata, Stephen; Kemeny, Margaret; Krishnamurthi, Smitha; Su, Yungpo Bernard; Ocean, Allyson; Capanu, Marinela; Mehrotra, Bhoomi; Ritch, Paul; Henderson, Charles; Kelsen, David P

2015-11-20

Docetaxel, cisplatin, and fluorouracil (DCF) is a standard first-line three-drug chemotherapy regimen for advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma and is associated with significant toxicity. We examined the safety and efficacy of a modified DCF (mDCF) regimen in a randomized multicenter phase II study. Previously untreated patients with metastatic gastric or GEJ adenocarcinoma were randomly assigned to receive either mDCF (fluorouracil 2,000 mg/m2 intravenously [IV] over 48 hours, docetaxel 40 mg/m2 IV on day 1, cisplatin 40 mg/m2 IV on day 3, every 2 weeks) or parent DCF (docetaxel 75 mg/m2, cisplatin 75 mg/m2, and fluorouracil 750 mg/m2 IV over 5 days with granulocyte colony-stimulating factor, every 3 weeks). The study had 90% power to differentiate between 6-month progression-free survival of 26% and 43%, with type I and II error rates of 10% each. An early stopping rule for toxicity was included, defined as grade 3 to 4 adverse event rate > 70% in the first 3 months. From November 2006 to June 2010, 85 evaluable patients were enrolled (male, n = 61; female, n = 24; median age, 58 years; Karnofsky performance status, 90%; GEJ, n = 28; gastric, 57). mDCF (n = 54) toxicity rates included 54% grade 3 to 4 toxicity (22% hospitalized) within the first 3 months and 76% grade 3 to 4 toxicity over the course of treatment. The DCF arm (n = 31) closed early because of toxicity, with rates of 71% grade 3 to 4 toxicity (52% hospitalized) within 3 months and 90% grade 3 to 4 toxicity over the course of treatment. Six-month PFS was 63% (95% CI, 48% to 75%) for mDCF and 53% (95% CI, 34% to 69%) for DCF. Median overall survival was improved for mDCF (18.8 v 12.6 months; P = .007). mDCF is less toxic than parent DCF, even when supported with growth factors, and is associated with improved efficacy. mDCF should be considered a standard first-line option for patients with metastatic gastric or GEJ adenocarcinoma.

A randomized, placebo-controlled, double-blind, prospective trial to evaluate the effect of vildagliptin in new-onset diabetes mellitus after kidney transplantation.

PubMed

Haidinger, Michael; Werzowa, Johannes; Voigt, Hans-Christian; Pleiner, Johannes; Stemer, Gunar; Hecking, Manfred; Döller, Dominik; Hörl, Walter H; Weichhart, Thomas; Säemann, Marcus D

2010-10-06

New-onset diabetes mellitus after transplantation (NODAT), a frequent and serious complication after transplantation, is associated with decreased graft and patient survival. Currently, it is diagnosed and treated primarily according to existing guidelines for type II diabetes. To date, only a few trials have studied antidiabetic drugs in patients with NODAT. Vildagliptin is a novel dipeptidyl peptidase-4 (DPP-4) inhibitor that improves pancreatic islet function by enhancing both α- and β-cell responsiveness to increased blood glucose. Experimental data show potential protective effects of DPP-4 inhibitors on islet function after exogenous stress stimuli including immunosuppressants. Therefore, the therapy of NODAT with this class of compounds seems attractive. At present, vildagliptin is used to treat type II diabetes as monotherapy or in combination with other antidiabetic drugs, since that it efficiently decreases glycated hemoglobin (HbA1c) values. Additionally, vildagliptin has been shown to be safe in patients with moderately impaired kidney function. This study will evaluate the safety and efficacy of vildagliptin monotherapy in renal transplant recipients with recently diagnosed NODAT. This study is a randomized, placebo-controlled, double-blind, prospective phase II trial. Using the results of routinely performed oral glucose tolerance tests (OGTT) in stable renal transplant patients at our center, we will recruit patients without a history of diabetes and a 2 h glucose value surpassing 200 mg/dl (11.1 mmol/l). They are randomized to receive either 50 mg vildagliptin or placebo once daily. A total of 32 patients with newly diagnosed NODAT will be included. The primary endpoint is the difference in the 2 h glucose value between baseline and the repeated OGTT performed 3 months after treatment start, compared between the vildagliptin- and the placebo-group. Secondary endpoints include changes in HbA1c and fasting plasma glucose (FPG). The safety of vildagliptin in renal transplant patients will be assessed by the number of symptomatic hypoglycemic episodes (glucose <72 mg/dl or 4 mmol/l), the number of adverse events, and possible medication-associated side-effects. NODAT is a severe complication after kidney transplantation. Few trials have assessed the safety and efficacy of antidiabetic drugs for these patients. The purpose of this study is to assess the safety and efficacy of vildagliptin in renal transplant patients with NODAT. ClinicalTrials.gov NCT00980356.

Platelet-rich plasma in arthroscopic rotator cuff repair: a meta-analysis of randomized controlled trials.

PubMed

Zhao, Jia-Guo; Zhao, Li; Jiang, Yan-Xia; Wang, Zeng-Liang; Wang, Jia; Zhang, Peng

2015-01-01

The purpose of this study was to appraise the retear rate and clinical outcomes of platelet-rich plasma use in patients undergoing arthroscopic full-thickness rotator cuff repair. We searched the Cochrane Library, PubMed, and EMBASE databases for randomized controlled trials comparing the outcomes of arthroscopic rotator cuff surgery with or without the use of platelet-rich plasma. Methodological quality was assessed by the Detsky quality scale. When there was no high heterogeneity, we used a fixed-effects model. Dichotomous variables were presented as risk ratios (RRs) with 95% confidence intervals (CIs), and continuous data were measured as mean differences with 95% CIs. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system was used to assess the quality of evidence for each individual outcome. Eight randomized controlled trials were included, with the sample size ranging from 28 to 88. Overall methodological quality was high. Fixed-effects analysis showed that differences were not significant between the 2 groups in retear rate (RR, 0.94; 95% CI, 0.70 to 1.25; P = .66), Constant score (mean difference, 1.12; 95% CI, -1.38 to 3.61; P = .38), and University of California at Los Angeles (UCLA) score (mean difference, -0.68; 95% CI, -2.00 to 0.65; P = .32). The strength of GRADE evidence was categorized respectively as low for retear, moderate for Constant score, and low for UCLA shoulder score. Our meta-analysis does not support the use of platelet-rich plasma in the arthroscopic repair of full-thickness rotator cuff tears over repairs without platelet-rich plasma because of similar retear rates and clinical outcomes. Level II, meta-analysis of Level I and II randomized controlled trials. Copyright © 2015 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

A randomized, double-blinded, placebo-controlled phase II trial of recombinant human leukemia inhibitory factor (rhuLIF, emfilermin, AM424) to prevent chemotherapy-induced peripheral neuropathy.

PubMed

Davis, Ian D; Kiers, Lynette; MacGregor, Lachlan; Quinn, Michael; Arezzo, Joseph; Green, Michael; Rosenthal, Mark; Chia, Michael; Michael, Michael; Bartley, Peter; Harrison, Leonie; Daly, Michael

2005-03-01

To determine whether recombinant human leukemia inhibitory factor (rhuLIF, AM424, emfilermin) can prevent or ameliorate the development of chemotherapy-induced peripheral neuropathy (CIPN) after treatment with carboplatin (AUC 6) and paclitaxel (175 mg/m(2) over 3 hours). Randomized double-blind placebo-controlled phase II clinical trial. Eligible patients had solid tumors for which treatment with carboplatin/paclitaxel was appropriate. The primary end point was a standardized composite peripheral nerve electrophysiology (CPNE) score, based on nerve velocities and amplitudes, measured at baseline and after four cycles of chemotherapy. Secondary efficacy end points included CPNE score at last cycle and at exit evaluation, vibration perception threshold, H-reflex latency, symptom scores, and quantitative assessment of neurologic signs. Study drug was given s.c. daily for 7 days starting the day before chemotherapy. Patients were randomized to receive low-dose rhuLIF (2 microg/kg), high-dose rhuLIF (4 microg/kg), or placebo. Patients (n = 117) were randomized across seven neurology test centers. Thirty-six patients received low dose rhuLIF (2 microg/kg), 39 received high dose rhuLIF (4 microg/kg) and 42 received placebo. rhuLIF was well tolerated with 95% compliance and no adverse effects on quality of life. No differences between groups in CPNE or any of the individual neurologic testing variables were observed between baseline and cycle 4 or by the secondary efficacy variables. rhuLIF is not effective in preventing CIPN caused by carboplatin and paclitaxel. CPNE is a reliable and valid tool that was sensitive to the onset and progression of CIPN.

Transcutaneous tibial nerve stimulation in the treatment of lower urinary tract symptoms and its impact on health-related quality of life in patients with Parkinson disease: a randomized controlled trial.

PubMed

Perissinotto, Maria Carolina; DʼAncona, Carlos Arturo Levi; Lucio, Adélia; Campos, Renata Martins; Abreu, Anelyssa

2015-01-01

A randomized controlled trial study was performed to evaluate the efficacy of transcutaneous tibial nerve stimulation (TTNS) and sham TTNS, in patients with Parkinson disease (PD) with lower urinary tract symptoms (LUTS). Randomized controlled trial. Thirteen patients with a diagnosis of PD and bothersome LUTS were randomly allocated to one of the following groups: Group I: TTNS group (n = 8) and group II: Sham group (n = 5). Both groups attended twice a week during 5 weeks; each session lasted 30 minutes. Eight patients received TTNS treatment and 5 subjects allocated to group II were managed with sham surface electrodes that delivered no electrical stimulation. Assessments were performed before and after the treatment; they included a 3-day bladder diary, Overactive Bladder Questionnaire (OAB-V8), and the International Consultation on Incontinence Quality of Life Questionnaire Short Form (ICIQ-SF), and urodynamic evaluation. Following 5 weeks of treatment, patients allocated to TTNS demonstrated statistically significant reductions in the number of urgency episodes (P = .004) and reductions in nocturia episodes (P < .01). Participants allocated to active treatment also showed better results after treatment in the OAB-V8 and ICIQ-SF scores (P < .01, respectively). Urodynamic testing revealed that patients in the active treatment group showed improvements in intravesical volume at strong desire to void (P < .05) and volume at urgency (P < .01) when compared to subjects in the sham treatment group. These findings suggest that TTNS is effective in the treatment of LUTS in patients with PD, reducing urgency and nocturia episodes and improving urodynamic parameters as well as symptom scores measured by the OAB-V8 and health-related quality-of-life scores measured by the ICIQ-SF.

Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial.

PubMed

Benzies, Karen M; Shah, Vibhuti; Aziz, Khalid; Isaranuwatchai, Wanrudee; Palacio-Derflingher, Luz; Scotland, Jeanne; Larocque, Jill; Mrklas, Kelly; Suter, Esther; Naugler, Christopher; Stelfox, Henry T; Chari, Radha; Lodha, Abhay

2017-10-10

Every year, about 15 million of the world's infants are born preterm (before 37 weeks gestation). In Alberta, the preterm birth rate was 8.7% in 2015, the second highest among Canadian provinces. Approximately 20% of preterm infants are born before 32 weeks gestation (early preterm), and require care in a Level III neonatal intensive care unit (NICU); 80% are born moderate (32 weeks and zero days [32 0/7 ] to 33 6/7 weeks) and late preterm (34 0/7 to 36 6/7 weeks), and require care in a Level II NICU. Preterm birth and experiences in the NICU disrupt early parent-infant relationships and induce parental psychosocial distress. Family Integrated Care (FICare) shows promise as a model of care in Level III NICUs. The purpose of this study is to evaluate length of stay, infant and maternal clinical outcomes, and costs following adaptation and implementation of FICare in Level II NICUs. We will conduct a pragmatic, cluster randomized controlled trial (cRCT) in ten Alberta Level II NICUs allocated to one of two groups: FICare or standard care. The FICare Alberta model involves three theoretically-based, standardized components: information sharing, parenting education, and family support. Our sample size of 181 mother-infant dyads per group is based on the primary outcome of NICU length of stay, 80% participation, and 80% retention at follow-up. Secondary outcomes (e.g., infant clinical outcomes and maternal psychosocial distress) will be assessed shortly after admission to NICU, at discharge and 2 months corrected age. We will conduct economic analysis from two perspectives: the public healthcare payer and society. To understand the utility, acceptability, and impact of FICare, qualitative interviews will be conducted with a subset of mothers at the 2-month follow-up, and with hospital administrators and healthcare providers near the end of the study. Results of this pragmatic cRCT of FICare in Alberta Level II NICUs will inform policy decisions by providing evidence about the clinical effectiveness and costs of FICare. ClinicalTrials.gov, ID: NCT02879799 . Registered on 27 May 2016. Protocol version: 9 June 2016; version 2.

Effectiveness of adjunctive antimicrobial photodynamic therapy in reducing peri-implant inflammatory response in individuals vaping electronic cigarettes: A randomized controlled clinical trial.

PubMed

Al Rifaiy, Mohammed Q; Qutub, Osama A; Alasqah, Mohammed N; Al-Sowygh, Zeyad H; Mokeem, Sameer A; Alrahlah, Ali

2018-06-01

There are no studies that have assessed the effectiveness of antimicrobial photodynamic therapy (aPDT) in reducing peri-implant inflammatory response in individuals vaping electronic cigarettes (e-cigs). This study explored the effectiveness of aPDT as an adjunct to mechanical debridement (MD) in the treatment of peri-implant mucositis (p-iM) in individuals vaping e-cigs. Vaping individuals with p-iM were divided into 2 groups: (a) Group-I: receiving MD with aPDT (test group); and (b) Group-II: MD only (control group). Peri-implant inflammatory parameters including plaque index (PI), bleeding on probing (BoP), and pocket depth (PD) were assessed at baseline and 12-weeks follow-up. Inter- and intra-group comparisons were made using Mann-Whitney U test and Wilcoxon signed ranks test. P-value < 0.05 was considered significant. Thirty-eight male patients (20 in Group-I and 18 in Group-II) were included. The mean age of vaping individuals in groups I and II were 33.6 ± 2.8 and 35.4 ± 2.1 years, respectively. Mean daily frequency of vaping e-cigs in groups I and II was 7.3 ± 0.9 and 5.9 ± 1.0 whereas mean duration of vaping e-cigs was 4.8 ± 1.5 and 4.1 ± 1.3 years respectively. There was no significant difference between groups at baseline. There was significant improvement in PI (p < 0.001) and PD (p < 0.001) at 12-weeks follow-up with respect to the baseline visit in both groups. There was a significant reduction in PI (p < 0.001) and PD (p < 0.001) for group-I as compared to group-II at follow-up. There was no statistically significant difference for BoP between groups at follow-up. Antimicrobial PDT is more effective compared to MD alone in the treatment of p-iM in individuals vaping e-cigs. The findings of the present study should be considered preliminary and interpreted with caution. Further randomized clinical trials should be performed in order to obtain strong conclusions. Copyright © 2018 Elsevier B.V. All rights reserved.

Dose-finding study of carbamylated monomeric allergoid tablets in grass-allergic rhinoconjunctivitis patients.

PubMed

Mösges, Ralph; Rohdenburg, Christina; Eichel, Andrea; Zadoyan, Gregor; Kasche, Elena-Manja; Shah-Hosseini, Kija; Lehmacher, Walter; Schmalz, Petra; Compalati, Enrico

2017-11-01

To determine the optimal effective and safe dose of sublingual immunotherapy tablets containing carbamylated monomeric allergoids in patients with grass pollen-induced allergic rhinoconjunctivitis. In this prospective, randomized, double-blind, active-controlled, multicenter, Phase II study, four different daily doses were applied preseasonally for 12 weeks. Of 158 randomized adults, 155 subjects (safety population) received 300 units of allergy (UA)/day (n = 36), 600 UA/day (n = 43), 1000 UA/day (n = 39), or 2000 UA/day (n = 37). After treatment, 54.3, 47.6, 59.0 and 51.4% of patients, respectively, ceased to react to the highest allergen concentration in a conjunctival provocation test. Furthermore, the response threshold improved in 70.4, 62.9, 76.7 and 66.7% of patients, respectively. No serious adverse events occurred. This study found 1000 UA/day to be the optimal effective and safe dose.

Novel therapies for resistant focal segmental glomerulosclerosis (FONT) phase II clinical trial: study design.

PubMed

Trachtman, Howard; Vento, Suzanne; Gipson, Debbie; Wickman, Larysa; Gassman, Jennifer; Joy, Melanie; Savin, Virginia; Somers, Michael; Pinsk, Maury; Greene, Tom

2011-02-10

The lack of adequate randomized clinical trials (RCT) has hindered identification of new therapies that are safe and effective for patients with primary focal segmental glomerulosclerosis (FSGS), especially in patients who fail to respond to corticosteroids and immunosuppressive therapies. Recent basic science advances have led to development of alternative treatments that specifically target aberrant pathways of fibrosis which are relevant to disease progression in FSGS. There is a need for a flexible Phase II study design which will test such novel antifibrotic strategies in order to identify agents suitable for phase III testing. The Novel Therapies for Resistant Focal Segmental Glomerulosclerosis (FONT) project is a multicenter Phase I/II RCT designed to investigate the potential efficacy of novel therapies for resistant FSGS. Adalimumab and galactose will be evaluated against conservative therapy consisting of the combination of lisinopril, losartan and atorvastatin. The sample size is defined to assure that if one of the treatments has a superior response rate compared to that of the other treatments, it will be selected with high probability for further evaluation. Comparison of primary and secondary endpoints in each study arm will enable a choice to be made of which treatments are worthy of further study in future Phase III RCT. This report highlights the key features of the FONT II RCT including the two-step outcome analysis that will expedite achievement of the study objectives. The proposed phase II study design will help to identify promising agents for further testing while excluding ineffective agents. This staged approach can help to prevent large expenditures on unworthy therapeutic agents in the management of serious but rare kidney diseases.

Pre-exercise glycerol hydration improves cycling endurance time

NASA Technical Reports Server (NTRS)

Montner, P.; Stark, D. M.; Riedesel, M. L.; Murata, G.; Robergs, R.; Timms, M.; Chick, T. W.

1996-01-01

The effects of glycerol ingestion (GEH) on hydration and subsequent cycle ergometer submaximal load exercise were examined in well conditioned subjects. We hypothesized that GEH would reduce physiologic strain and increase endurance. The purpose of Study I (n = 11) was to determine if pre-exercise GEH (1.2 gm/kg glycerol in 26 ml/kg solution) compared to pre-exercise placebo hydration (PH) (26 ml/kg of aspartame flavored water) lowered heart rate (HR), lowered rectal temperature (Tc), and prolonged endurance time (ET) during submaximal load cycle ergometry. The purpose of Study II (n = 7) was to determine if the same pre-exercise regimen followed by carbohydrate oral replacement solution (ORS) during exercise also lowered HR, Tc, and prolonged ET. Both studies were double-blind, randomized, crossover trials, performed at an ambient temperature of 23.5-24.5 degrees C, and humidity of 25-27%. Mean HR was lower by 2.8 +/- 0.4 beats/min (p = 0.05) after GEH in Study I and by 4.4 +/- 1.1 beats/min (p = 0.01) in Study II. Endurance time was prolonged after GEH in Study I (93.8 +/- 14 min vs. 77.4 +/- 9 min, p = 0.049) and in Study II (123.4 +/- 17 min vs. 99.0 +/- 11 min, p = 0.03). Rectal temperature did not differ between hydration regimens in both Study I and Study II. Thus, pre-exercise glycerol-enhanced hyperhydration lowers HR and prolongs ET even when combined with ORS during exercise. The regimens tested in this study could potentially be adapted for endurance activities.

Failure of antioxidants to protect against angiotensin II-induced aortic rupture in aged apolipoprotein(E)-deficient mice.

PubMed

Jiang, F; Jones, G T; Dusting, G J

2007-11-01

Oxidative stress may be involved in the development of abdominal aortic aneurysms (AAAs). Previous studies indicate that antioxidants protect against AAA formation during chronic angiotensin (Ang) II infusion in apolipoprotein E-deficient (ApoE(0)) mice. We here examine if these protective effects also occurred in aged ApoE(0) mice. Male ApoE(0) mice (50-60 weeks) were randomly divided into 4 groups: saline, Ang II (1000 ng kg(-1) min(-1) for 4 weeks), Ang II plus antioxidants (0.1% vitamin E in food plus 0.1% vitamin C in drinking water), and Ang II plus losartan (30 mg kg(-1) day(-1)). Exogenous Ang II increased systolic blood pressure by 40 mmHg and resulted in the formation of pseudoaneurysms (rupture and extramural haematoma) in the abdominal aorta in 50% of animals. True aneurysmal dilatation was rarely observed. Antioxidants decreased systemic oxidative stress (plasma malondialdehyde), but had only minor effects on aortic rupture, relative to the complete prevention by losartan. Immunohistochemistry revealed strong matrix metalloproteinase-9 (MMP-9) expression in atherosclerotic plaques and at the sites of rupture. Antioxidants did not affect tumour necrosis factor-alpha-stimulated MMP-9 release from U937 cells. In addition, antioxidants had little effects on Ang II-induced renal dysfunction. In contrast to previous findings in younger mice, antioxidants had only minor effects on Ang II-induced aortic rupture in aged mice. Our results demonstrate that the pathological features of the aneurysmal remodelling induced by Ang II in old ApoE(0) mice are distinct from those of human AAA.

Adjunctive Oral Voriconazole Treatment of Fusarium Keratitis: A Secondary Analysis From the Mycotic Ulcer Treatment Trial II.

PubMed

Prajna, N Venkatesh; Krishnan, Tiruvengada; Rajaraman, Revathi; Patel, Sushila; Shah, Ranjeet; Srinivasan, Muthiah; Devi, Lumbini; Das, Manoranjan; Ray, Kathryn J; O'Brien, Kieran S; Oldenburg, Catherine E; McLeod, Stephen D; Zegans, Michael E; Acharya, Nisha R; Lietman, Thomas M; Rose-Nussbaumer, Jennifer

2017-06-01

Fusarium keratitis is common and often results in poor outcomes. No new treatments since natamycin have become available. To explore the role of adjuvant oral voriconazole on clinical outcomes in Fusarium keratitis. In this prespecified subgroup analysis of a multicenter, double-masked, placebo-controlled randomized clinical trial, 240 patients from the Aravind Eye Care System in India, the Lumbini Eye Hospital and Bharatpur Eye Hospital in Nepal, and the University of California, San Francisco, who had culture-positive fungal ulcer and baseline visual acuity of 20/400 or worse were randomized to receive oral voriconazole vs placebo. Enrollment started May 24, 2010, and the last patient study visit was November 23, 2015. All patients received topical voriconazole, 1%, and after the results of the Mycotic Ulcer Treatment Trial (MUTT) II became available, topical natamycin, 5%, was added for all patients. Data analysis was performed from September 2 to October 28, 2016. The primary outcome of the trial was the rate of corneal perforation or the need for therapeutic penetrating keratoplasty. Secondary outcomes included rate of reepithelialization, best spectacle-corrected visual acuity, and infiltrate or scar size at 3 months. Of the 240 study participants, 72 (30.4%) were culture positive for Fusarium species (41 [56.9%] male and 31 [43.1%] female; median [interquartile range] age, 50 [45-57] years). Of these, 33 (45.8%) were randomized to oral voriconazole and 39 (54.2%) to placebo. Fusarium ulcers randomized to oral voriconazole had a 0.43-fold decreased hazard of perforation or therapeutic penetrating keratoplasty compared with placebo after controlling for baseline infiltrate depth (95% CI, 0.22-fold to 0.84-fold; P = .01). Multiple linear regression revealed a 1.89-mm decreased infiltrate and/or scar size at 3 weeks (95% CI, -2.69 to -1.09 mm; P < .001) and a 0.83-mm decreased infiltrate and/or scar size at 3 months after correcting for baseline values (95% CI, -1.33 to -0.32 mm; P = .001) in eyes randomized to oral voriconazole vs placebo. Eyes treated with oral voriconazole also had a mean 0.29 decreased logMAR (improved) (Snellen equivalent 20/40) visual acuity at 3 months after controlling for baseline visual acuity, although this finding was not statistically significant (95% CI, -0.57 to 0.002; P = .052). Although MUTT II could not find a benefit for all corneal ulcers, Fusarium keratitis may benefit from the addition of oral voriconazole to topical natamycin, and physicians should consider prescribing oral voriconazole in these cases. clinicaltrials.gov Identifier: NCT00996736.

Sprint interval training (SIT) substantially reduces depressive symptoms in major depressive disorder (MDD): A randomized controlled trial.

PubMed

Minghetti, Alice; Faude, Oliver; Hanssen, Henner; Zahner, Lukas; Gerber, Markus; Donath, Lars

2018-07-01

Continuous aerobic exercise training (CAT) is considered a complementary treatment option in patients with major depressive disorder (MDD). Intermittent exercise training protocols, such as sprint interval training (SIT) have gained increasing popularity, but no studies on depressive symptoms following SIT in patients with MDD are available. Fifty-nine in-patients with MDD were randomly assigned to a SIT or CAT group. Medication was counterbalanced in both intervention arms. Both intervention groups received 3 weekly training sessions for 4-weeks (12 sessions in total). SIT comprised 25 bouts of 30 seconds at 80% of maximal power, whereas CAT consisted of 20 minutes of physical activity at 60% of maximal power. The training protocols were isocalorically designed. Maximal bicycle ergometer exercise testing yielded maximal and submaximal physical fitness parameters. The Beck-Depression-Inventory-II (BDI-II) was filled out by the patients before and after the intervention period. BDI-II scores substantially decreased in both groups with an effect size pointing towards a large effect (p < 0.001, η p ² = 0.70) while submaximal (0.07 < d < 0.89) and maximal (0.05 < d < 0.85) fitness variables improved in both groups. Short-term SIT leads to similar results as CAT in patients with MDD and can be regarded as a time-efficient and promising exercise-based treatment strategy. Copyright © 2018 Elsevier B.V. All rights reserved.

What is the best reconstruction method after distal gastrectomy for gastric cancer?

PubMed

Lee, Moon-Soo; Ahn, Sang-Hoon; Lee, Ju-Hee; Park, Do Joong; Lee, Hyuk-Joon; Kim, Hyung-Ho; Yang, Han-Kwang; Kim, Nayoung; Lee, Won Woo

2012-06-01

We performed this prospective randomized study to evaluate what is the best reconstruction method after distal gastrectomy for gastric cancer. One hundred fifty-nine patients who underwent laparoscopy-assisted or open gastrectomy for gastric cancer were analyzed from March 2006 to August 2007. Billroth I (B-I) anastomosis, Billroth II (B-II) with Braun anastomosis, and Roux-en-Y (R-Y) anastomosis were applied randomly. Additionally, the patients were divided into two groups based on treatment type: laparoscopic and open operation. Endoscopy and hepatobiliary scans were performed to investigate gastric stasis and enterogastric reflux. The Gastrointestinal Quality of Life Index (GIQLI) was used to evaluate postoperative quality of life, and the hematologic test was used to assess nutritional aspect. Endoscopy revealed that reflux after the R-Y anastomosis procedure was significantly less frequent than after the other anastomosis types at 12 months. Comparison of the GIQLI and the nutritional parameters between the reconstruction types revealed that there were no differences, but a significantly higher GIQLI score was observed in the laparoscopic group immediately following the procedure (P = 0.042). R-Y anastomosis is superior to B-I and B-II with Braun anastomosis in terms of frequency of bile reflux, despite the fact that there is no difference in the postoperative quality-of-life index and nutritional status between reconstructive procedures. The laparoscopic approach is the better option than open surgery in terms of QOL in the immediate postoperative period.

A randomized, phase 3 trial of naltrexone SR/bupropion SR on weight and obesity-related risk factors (COR-II).

PubMed

Apovian, Caroline M; Aronne, Louis; Rubino, Domenica; Still, Christopher; Wyatt, Holly; Burns, Colleen; Kim, Dennis; Dunayevich, Eduardo

2013-05-01

To examine the effects of naltrexone/bupropion (NB) combination therapy on weight and weight-related risk factors in overweight and obese participants. CONTRAVE Obesity Research-II (COR-II) was a double-blind, placebo-controlled study of 1,496 obese (BMI 30-45 kg/m(2) ) or overweight (27-45 kg/m(2) with dyslipidemia and/or hypertension) participants randomized 2:1 to combined naltrexone sustained-release (SR) (32 mg/day) plus bupropion SR (360 mg/day) (NB32) or placebo for up to 56 weeks. The co-primary endpoints were percent weight change and proportion achieving ≥ 5% weight loss at week 28. Significantly (P < 0.001) greater weight loss was observed with NB32 versus placebo at week 28 (-6.5% vs. -1.9%) and week 56 (-6.4% vs. -1.2%). More NB32-treated participants (P < 0.001) experienced ≥ 5% weight loss versus placebo at week 28 (55.6% vs. 17.5%) and week 56 (50.5% vs. 17.1%). NB32 produced greater improvements in various cardiometabolic risk markers, participant-reported weight-related quality of life, and control of eating. The most common adverse event with NB was nausea, which was generally mild to moderate and transient. NB was not associated with increased events of depression or suicidality versus placebo. NB represents a novel pharmacological approach to the treatment of obesity, and may become a valuable new therapeutic option. Copyright © 2013 The Obesity Society.

Randomized Multicenter Phase II Trial Comparing Two Schedules of Etirinotecan Pegol (NKTR-102) in Women With Recurrent Platinum-Resistant/Refractory Epithelial Ovarian Cancer

PubMed Central

Vergote, Ignace B.; Garcia, Agustin; Micha, John; Pippitt, Charles; Bendell, Johanna; Spitz, Daniel; Reed, Nicholas; Dark, Graham; Fracasso, Paula M.; Ibrahim, Emad N.; Armenio, Vincent A.; Duska, Linda; Poole, Chris; Gennigens, Christine; Dirix, Luc Y.; Leung, Abraham C.F.; Zhao, Carol; Soufi-Mahjoubi, Raoudha; Rustin, Gordon

2013-01-01

Purpose Etirinotecan pegol (NKTR-102) is a unique, long-acting topoisomerase-I inhibitor with prolonged systemic exposure to SN38 (7-ethyl-10-hydroxycamptothecin), the active metabolite of irinotecan. This randomized phase II trial investigated two dosing schedules of etirinotecan pegol in patients with platinum-resistant/refractory ovarian carcinoma. Patients and Methods A total of 71 eligible patients were randomly assigned to receive etirinotecan pegol 145 mg/m2 every 14 or 21 days until progression or unacceptable adverse events (AEs). The primary end point was objective response rate (ORR) by RECIST (version 1.0). Secondary end points included response by Gynecologic Cancer Intergroup criteria, duration of ORR, progression-free survival (PFS), and overall survival (OS). Results The overall confirmed ORR was 20% (95% CI, 10% to 30%): 20% for once every 14 days, and 19% for once every 21 days. Median response duration was 4.1 months for once every 14 days and 4.0 months for once every 21 days. Median PFS for every 14 and every 21 days was 4.1 and 5.3 months, respectively, and median OS was 10.0 and 11.7 months, respectively. Etirinotecan pegol was well tolerated, with the most common grade 3 to 4 AEs being dehydration (24%) and diarrhea (23%). Diarrhea, dehydration, nausea, and neutropenia were less frequent with the schedule of once every 21 days than with that of once every 14 days. Conclusion Both schedules of etirinotecan pegol showed activity in patients with heavily pretreated ovarian cancer, with encouraging ORR and PFS rates. The schedule of once every 21 days was better tolerated and had slightly longer PFS and OS rates. The treatment schedule of etirinotecan pegol 145 mg/m2 once every 21 days was selected for the expanded phase II study and is preferred for future phase III studies. These findings provide support to directly compare etirinotecan pegol versus one of the approved drugs (eg, pegylated liposomal doxorubicin or topotecan) in platinum-resistant ovarian cancer. PMID:24081946

Item Randomized-Response Models for Measuring Noncompliance: Risk-Return Perceptions, Social Influences, and Self-Protective Responses

ERIC Educational Resources Information Center

Bockenholt, Ulf; Van Der Heijden, Peter G. M.

2007-01-01

Randomized response (RR) is a well-known method for measuring sensitive behavior. Yet this method is not often applied because: (i) of its lower efficiency and the resulting need for larger sample sizes which make applications of RR costly; (ii) despite its privacy-protection mechanism the RR design may not be followed by every respondent; and…

1981 Image II Conference Proceedings.

DTIC Science & Technology

1981-11-01

rapid motion of terrain detail across the display requires fast display processors. Other difficulties are perceptual: the visual displays must convey...has been a continuing effort by Vought in the last decade. Early systems were restricted by the unavailability of video bulk storage with fast random...each photograph. The calculations aided in the proper sequencing of the scanned scenes on the tape recorder and eventually facilitated fast random

Random Measurement Error Does Not Bias the Treatment Effect Estimate in the Regression-Discontinuity Design. II. When an Interaction Effect Is Present.

ERIC Educational Resources Information Center

Trochim, William M. K.; And Others

1991-01-01

The regression-discontinuity design involving a treatment interaction effect (TIE), pretest-posttest functional form specification, and choice of point-of-estimation of the TIE are examined. Formulas for controlling the magnitude of TIE in simulations can be used for simulating the randomized experimental case where estimation is not at the…

Efficacy of exercise as an adjunct treatment for clinically depressed inpatients during the initial stages of antidepressant pharmacotherapy: An open randomized controlled trial.

PubMed

Legrand, Fabien D; Neff, Elise M

2016-02-01

Physical exercise as adjunctive treatment for hospitalized patients with major depressive disorder (MDD) has been of increasing interest in the past few years. While preliminary findings are promising, these prior studies have been plagued by inclusion of participants at different stages of medication use at study entry. The present study evaluates the effects of a short (10-days) add-on endurance-training intervention in hospitalized MDD patients on antidepressant medication for less than two weeks. Thirty-five participants were randomly assigned to one of three study groups: aerobic exercise (n=14), placebo (stretching) exercise (n=11), or no intervention (control; n=10). The study outcome was the change in the Beck Depression Inventory (BDI-II) total score from baseline to the end of the study period. The intent-to-treat analysis showed significant improvements in BDI-II scores for both the aerobic and the stretching groups. However, comparing pre- to post-study depression changes in these two groups, we found a large effect size in favor of aerobic exercise (Cohen's d=-1.06). No significant change in depressive symptoms was found in the control group. The nature of the intervention (i.e., exercise) meant blinding participants to treatments was not possible. Precise information on medication dosage was not available, and the short duration of interventions and lack of follow-up assessment were all limitations. Endurance-training can be a helpful adjunct treatment for hospitalized patients with severe affective disorders in the initial stages of pharmacotherapy. Copyright © 2015 Elsevier B.V. All rights reserved.

Acetylsalicylic Acid Compared to Placebo in Treating High-Risk Patients With Subsolid Lung Nodules | Division of Cancer Prevention

Cancer.gov

This randomized phase II trial studies acetylsalicylic acid compared to placebo in treating high-risk patients with subsolid lung nodules. A nodule is a growth or lump that may be malignant (cancer) or benign (not cancer). Chemoprevention is the use of drugs to keep cancer from forming or coming back. The use of acetylsalicylic acid may keep cancer from forming in patients

The Effect of Pre-Emptive Administration of Dextromethorphan on Postoperative Pain in Patients Undergoing Interval Laparoscopic Tubal Sterilization

DTIC Science & Technology

2001-10-01

requirements following surgery. Dextromethorphan , a readily available nonopioid antitussive in clinical use for more than 40 years, is one such NMDA...receptor Anticosti. This prospective, randomized, double blind pilot study compared the effects over time when patients received dextromethorphan versus...groups. Group I received 60 mg of dextromethorphan orally, and Group II received an oral placebo. Postoperative pain was assessed using an 11 point

National Assessment of Title I: Interim Report. Volume II: Closing the Reading Gap: First Year Findings from a Randomized Trial of Four Reading Interventions for Striving Readers

ERIC Educational Resources Information Center

Torgesen, Joseph; Myers, David; Schirm, Allen; Stuart, Elizabeth; Vartivarian, Sonya; Mansfield, Wendy; Stancavage, Fran; Durno, Donna; Javorsky, Rosanne; Haan, Cinthia

2006-01-01

According to the National Assessment of Educational Progress, nearly 4 in 10 fourth graders read below the basic level. These literacy problems get worse as students advance through school and are exposed to progressively more complex concepts and courses. The purpose of this study was to assess the effectiveness of four remedial reading programs…

Biased ligand of the angiotensin II type 1 receptor in patients with acute heart failure: a randomized, double-blind, placebo-controlled, phase IIB, dose ranging trial (BLAST-AHF).

PubMed

Pang, Peter S; Butler, Javed; Collins, Sean P; Cotter, Gad; Davison, Beth A; Ezekowitz, Justin A; Filippatos, Gerasimos; Levy, Phillip D; Metra, Marco; Ponikowski, Piotr; Teerlink, John R; Voors, Adriaan A; Bharucha, David; Goin, Kathleen; Soergel, David G; Felker, G Michael

2017-08-07

Currently, no acute heart failure (AHF) therapy definitively improves outcomes. Reducing morbidity and mortality from acute heart failure (AHF) remains an unmet need. TRV027 is a novel 'biased' ligand of the angiotensin II type 1 receptor (AT1R), selectively antagonizing the negative effects of angiotensin II, while preserving the potential pro-contractility effects of AT1R stimulation. BLAST-AHF was designed to determine the safety, efficacy, and optimal dose of TRV027 to advance into future studies. BLAST-AHF was a multi-centre, international, randomized, double-blind, placebo-controlled, parallel group, phase IIb dose-ranging study, enrolling patients with AHF into 4 groups: placebo, 1, 5, or 25 mg/h of TRV027. Treatment was by IV infusion for 48-96 h. The primary composite endpoint was comprised of the following: (i) time from baseline to death through day 30, (ii) time from baseline to heart failure re-hospitalization through day 30, (iii) the first assessment time point following worsening heart failure through day 5, (iv) change in dyspnea visual analogue scale (VAS) score calculated as the area under the curve (AUC) representing the change from baseline over time from baseline through day 5, and (v) length of initial hospital stay (in days) from baseline. Analyses were by modified intention-to-treat. Overall, 621 patients were enrolled. After 254 patients, a pre-specified interim analysis resulted in several protocol changes, including a lower blood pressure inclusion criterion as well as a new allocation scheme of 2:1:2:1, overweighting both placebo, and the 5 mg/h dose. TRV027 did not confer any benefit over placebo at any dose with regards to the primary composite endpoint or any of the individual components. There were no significant safety issues with TRV027. In this phase IIb dose-ranging AHF study, TRV027 did not improve clinical status through 30-day follow-up compared with placebo. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

Sequential causal inference: Application to randomized trials of adaptive treatment strategies

PubMed Central

Dawson, Ree; Lavori, Philip W.

2009-01-01

SUMMARY Clinical trials that randomize subjects to decision algorithms, which adapt treatments over time according to individual response, have gained considerable interest as investigators seek designs that directly inform clinical decision making. We consider designs in which subjects are randomized sequentially at decision points, among adaptive treatment options under evaluation. We present a sequential method to estimate the comparative effects of the randomized adaptive treatments, which are formalized as adaptive treatment strategies. Our causal estimators are derived using Bayesian predictive inference. We use analytical and empirical calculations to compare the predictive estimators to (i) the ‘standard’ approach that allocates the sequentially obtained data to separate strategy-specific groups as would arise from randomizing subjects at baseline; (ii) the semi-parametric approach of marginal mean models that, under appropriate experimental conditions, provides the same sequential estimator of causal differences as the proposed approach. Simulation studies demonstrate that sequential causal inference offers substantial efficiency gains over the standard approach to comparing treatments, because the predictive estimators can take advantage of the monotone structure of shared data among adaptive strategies. We further demonstrate that the semi-parametric asymptotic variances, which are marginal ‘one-step’ estimators, may exhibit significant bias, in contrast to the predictive variances. We show that the conditions under which the sequential method is attractive relative to the other two approaches are those most likely to occur in real studies. PMID:17914714

Does immobilization after arthroscopic rotator cuff repair increase tendon healing? A systematic review and meta-analysis.

PubMed

Shen, Chong; Tang, Zhi-Hong; Hu, Jun-Zu; Zou, Guo-Yao; Xiao, Rong-Chi; Yan, Dong-Xue

2014-09-01

To determine whether immobilization after arthroscopic rotator cuff repair improved tendon healing compared with early passive motion. A systematic electronic literature search was conducted to identify randomized controlled trials (RCTs) comparing early passive motion with immobilization after arthroscopic rotator cuff repair. The primary outcome assessed was tendon healing in the repaired cuff. Secondary outcome measures were range of motion (ROM) and American Shoulder and Elbow Surgeons (ASES) shoulder scale, Simple Shoulder Test (SST), Constant, and visual analog scale (VAS) for pain scores. Pooled analyses were performed using a random effects model to obtain summary estimates of treatment effect with 95% confidence intervals. Heterogeneity among included studies was quantified. Three RCTs examining 265 patients were included. Meta-analysis revealed no significant difference in tendon healing in the repaired cuff between the early-motion and immobilization groups. A significant difference in external rotation at 6 months postoperatively favored early motion over immobilization, but no significant difference was observed at 1 year postoperatively. In one study, Constant scores were slightly higher in the early-motion group than in the immobilization group. Two studies found no significant difference in ASES, SST, or VAS score between groups. We found no evidence that immobilization after arthroscopic rotator cuff repair was superior to early-motion rehabilitation in terms of tendon healing or clinical outcome. Patients in the early-motion group may recover ROM more rapidly. Level II; systematic review of levels I and II studies.

The effect of ondansetron on analgesic efficacy of acetaminophen after hysterectomy: A randomized double blinded placebo controlled trial.

PubMed

Koyuncu, Onur; Leung, Steve; You, Jing; Oksar, Menekse; Turhanoglu, Selim; Akkurt, Cagla; Dolapcioglu, Kenan; Sahin, Hanifi; Sessler, Daniel I; Turan, Alparslan

2017-08-01

To determine that perioperative ondansetron reduces the analgesic efficacy of acetaminophen. Randomized, double-blinded study. 120 patients ASA I-II who underwent abdominal hysterectomy. All the patients were given 1g acetaminophen at skin closure. Patients were divided into two groups; ondansetron HCl (8mg, 2ml IV) (Group I, N=60) and saline (2ml IV) (Group II, N=60) at the skin closure. Postoperative pain scores (VAS) while resting in bed and sitting, total opioid consumption were noted. Patients randomized to ondansetron had significantly worse pain scores upon arrival to the recovery unit [by 1.7 (99.7% CI: 0.75, 2.59) cm] and at 1h [by 1.3 (0.5, 2.1) cm] while resting in bed. Pain scores while sitting were also significantly greater in ondansetron group at arrival in PACU by 0.6 (99.7% CI: 0.1, 1.0) cm. Thereafter, pain scores did not differ significantly. Median total opioid (tramadol) consumption was 441 [Q1, Q3: 280, 578] mg in the ondansetron group and 412 [309, 574] mg in the placebo group, P=0.95. Ondansetron significantly decreased the analgesic effect of acetaminophen during the initial postoperative period. Our results thus confirm that acetaminophen analgesia is partially mediated by serotonin receptors. However, the reduction was of marginal clinical importance and short-lived. Copyright © 2017 Elsevier Inc. All rights reserved.

Text4Heart II - improving medication adherence in people with heart disease: a study protocol for a randomized controlled trial.

PubMed

Maddison, Ralph; Stewart, Ralph; Doughty, Rob; Scott, Tony; Kerr, Andrew; Benatar, Jocelyne; Whittaker, Robyn; Rawstorn, Jonathan C; Rolleston, Anna; Jiang, Yannan; Estabrooks, Paul; Sullivan, Rachel Karen; Bartley, Hannah; Pfaeffli Dale, Leila

2018-01-25

Cardiac rehabilitation (CR) is an essential component of contemporary management for patients with coronary heart disease, including following an acute coronary syndrome (ACS). CR typically involves education and support to assist people following an ACS to make lifestyle changes and prevent subsequent events. Despite its benefits, uptake and participation in tradition CR programs is low. The use of mobile technologies (mHealth) offers the potential to improve reach, access, and delivery of CR support. We aim to determine the effectiveness and cost-effectiveness of a text-messaging intervention (Text4Heart II) to improve adherence to medication and lifestyle change in addition to usual care in people following an ACS. A second aim is to use the RE-AIM framework to inform the potential implementation of Text4Heart II within health services in New Zealand. Text4Heart II is a two-arm, parallel, superiority randomized controlled trial conducted in two large metropolitan hospitals in Auckland, New Zealand. Three hundred and thirty participants will be randomized to either a 24-week theory- and evidence-based personalized text message program to support self-management in addition to usual CR, or usual CR alone (control). Outcomes are assessed at 6 and 12 months. The primary outcome is the proportion of participants adhering to medication at 6 months as measured by dispensed records. Secondary outcomes include medication adherence at 12 months, the proportion of participants adhering to self-reported healthy behaviors (physical activity, fruit and vegetable consumption, moderating alcohol intake and smoking status) measured using a composite health behavior score, self-reported medication adherence, cardiovascular risk factors (lipids, blood pressure), readmissions and related hospital events at 6 and 12 months. A cost-effectiveness analysis will also be conducted. Using the RE-AIM framework, we will determine uptake and sustainability of the intervention. The Text4Heart II trial will determine the effectiveness of a text-messaging intervention to improve adherence to medication and lifestyle behaviors at both 6 and 12 months. Using the RE-AIM framework this trial will provide much needed data and insight into the potential implementation of Text4Heart II. This trial addresses many limitations/criticisms of previous mHealth trials; it builds on our Text4Heart pilot trial, it is adequately powered, has sufficient duration to elicit behavior change, and the follow-up assessments (6 and 12 months) are long enough to determine the sustained effect of the intervention. Australian New Zealand Clinical Trials Registry, ID: ACTRN12616000422426 . Registered retrospectively on 1 April 2016.

Rayleigh approximation to ground state of the Bose and Coulomb glasses

PubMed Central

Ryan, S. D.; Mityushev, V.; Vinokur, V. M.; Berlyand, L.

2015-01-01

Glasses are rigid systems in which competing interactions prevent simultaneous minimization of local energies. This leads to frustration and highly degenerate ground states the nature and properties of which are still far from being thoroughly understood. We report an analytical approach based on the method of functional equations that allows us to construct the Rayleigh approximation to the ground state of a two-dimensional (2D) random Coulomb system with logarithmic interactions. We realize a model for 2D Coulomb glass as a cylindrical type II superconductor containing randomly located columnar defects (CD) which trap superconducting vortices induced by applied magnetic field. Our findings break ground for analytical studies of glassy systems, marking an important step towards understanding their properties. PMID:25592417

Active transport on disordered microtubule networks: the generalized random velocity model.

PubMed

Kahana, Aviv; Kenan, Gilad; Feingold, Mario; Elbaum, Michael; Granek, Rony

2008-11-01

The motion of small cargo particles on microtubules by means of motor proteins in disordered microtubule networks is investigated theoretically using both analytical tools and computer simulations. Different network topologies in two and three dimensions are considered, one of which has been recently studied experimentally by Salman [Biophys. J. 89, 2134 (2005)]. A generalization of the random velocity model is used to derive the mean-square displacement of the cargo particle. We find that all cases belong to the class of anomalous superdiffusion, which is sensitive mainly to the dimensionality of the network and only marginally to its topology. Yet in three dimensions the motion is very close to simple diffusion, with sublogarithmic corrections that depend on the network topology. When details of the thermal diffusion in the bulk solution are included, no significant change to the asymptotic time behavior is found. However, a small asymmetry in the mean microtubule polarity affects the corresponding long-time behavior. We also study a three-dimensional model of the microtubule network in living animal cells. Three first-passage-time problems of intracellular transport are simulated and analyzed for different motor processivities: (i) cargo that originates near the nucleus and has to reach the membrane, (ii) cargo that originates from the membrane and has to reach the nucleus, and (iii) cargo that leaves the nucleus and has to reach a specific target in the cytoplasm. We conclude that while a higher motor processivity increases the transport efficiency in cases (i) and (ii), in case (iii) it has the opposite effect. We conjecture that the balance between the different network tasks, as manifested in cases (i) and (ii) versus case (iii), may be the reason for the evolutionary choice of a finite motor processivity.

Effect of Group Positive Psychotherapy on Improvement of Life Satisfaction and The Quality of Life in Infertile Woman.

PubMed

Seyedi Asl, Seyed Teymur; Sadeghi, Kheirollah; Bakhtiari, Mitra; Ahmadi, Seyed Mojtaba; Nazari Anamagh, Alireza; Khayatan, Tayebeh

2016-01-01

Positive psychotherapy is one of the new approaches in psychology which is innovated for treating psychological disorders and enhancing positive emotions. The aim of this study is to investigate the effectiveness of the group positive psychotherapy on elevation of life satisfaction and quality of life in infertile women. In a randomized trial study, Beck Depression Inventory II (BDI-II) and clinical interview were used in a pre-test post-test control group design. After analyzing the result of the questionnaire, 36 infertile women who showed signs of mild to moderate depression were randomly placed into two following groups: control (n=18) and intervention (n=18). Before the treatment, the members of both groups answered BDI-II, Satisfaction With Life Scale (SWLS) and 12 item Short Form Health Survey (SF-12). The intervention group received six sessions of group positive psychotherapy, but the treatment of the control group began six weeks after the intervention group. The results showed that the life satisfaction scores of the intervention group were significantly elevated from 22.66 in pre-test to 26.13 in post-test (P<0.001), while this improvement was not significant in the control group (P=0.405). The difference between life satisfaction scores of the intervention and the control groups was also significant (F=8.92, P=0.006). However, no significant change in the quality of life level of the intervention and control groups was observed (P=0.136). Thus it can be deduced from the findings that this treatment method could be introduced as solution to increase the life satisfaction in infertile women, but not as a treatment for elevating their quality of life (Registration Number: IRCT2013042810063N3).

Predictors of long-term weight loss in adults with modest initial weight loss, by sex and race.

PubMed

Svetkey, Laura P; Ard, Jamy D; Stevens, Victor J; Loria, Catherine M; Young, Deb Y; Hollis, Jack F; Appel, Lawrence J; Brantley, Phillip J; Kennedy, Betty M; Kumanyika, Shiriki K; Batch, Bryan C; Corsino, Leonor; Lien, Lillian F; Vollmer, William M

2012-09-01

Effective weight management interventions could reduce race-sex disparities in cardiovascular disease (CVD), yet little is known about factors associated with successful weight loss maintenance in race-sex subgroups. In the Weight Loss Maintenance trial (WLM), overweight/obese (BMI 25-45 kg/m(2)) adults who lost ≥4 kg in a 6-month behavioral weight loss intervention (phase I) were randomized into one of three 30-month maintenance interventions (phase II). To investigate predictors in subgroups, randomized groups were combined for this analysis. Of 1,685 phase I participants, 1,032 (61%) entered phase II, including 12% black men (BM), 26% black women (BW), 25% white men (WM), and 37% white women (WW). Weight change over the 36-month study ranged from -2.3% (95% confidence interval = -3.1 to -1.5%) in BW to -4.5% (95% confidence interval = -5.7 to -4.0%) in WM, the result of differential weight loss during phase I. Within race, men lost significantly more weight than women, but within sex group, weight loss did not differ significantly between races. Although participants regained weight during phase II, regain did not differ by race-sex group, and mean weight at the end of the study was significantly lower than phase I entry weight for each subgroup. In regression models, phase I weight loss predicted overall 36-month weight loss in all race-sex groups. Healthy dietary pattern at entry, improvement in dietary pattern, or both were predictive in three of four race-sex groups. Few other variables other than initial weight loss and dietary pattern were predictive. Future research should identify additional modifiable influences on long-term maintenance after a modest weight loss.

The Influence of Disease Severity of Preceding Clinical Cases on Pathologists' Medical Decision Making.

PubMed

Frederick, Paul D; Nelson, Heidi D; Carney, Patricia A; Brunyé, Tad T; Allison, Kimberly H; Weaver, Donald L; Elmore, Joann G

2017-01-01

Medical decision making may be influenced by contextual factors. We evaluated whether pathologists are influenced by disease severity of recently observed cases. Pathologists independently interpreted 60 breast biopsy specimens (one slide per case; 240 total cases in the study) in a prospective randomized observational study. Pathologists interpreted the same cases in 2 phases, separated by a washout period of >6 months. Participants were not informed that the cases were identical in each phase, and the sequence was reordered randomly for each pathologist and between phases. A consensus reference diagnosis was established for each case by 3 experienced breast pathologists. Ordered logit models examined the effect the pathologists' diagnoses on the preceding case or the 5 preceding cases had on their diagnosis for the subsequent index case. Among 152 pathologists, 49 provided interpretive data in both phases I and II, 66 from only phase I, and 37 from phase II only. In phase I, pathologists were more likely to indicate a more severe diagnosis than the reference diagnosis when the preceding case was diagnosed as ductal carcinoma in situ (DCIS) or invasive cancer (proportional odds ratio [POR], 1.28; 95% confidence interval [CI], 1.15-1.42). Results were similar when considering the preceding 5 cases and for the pathologists in phase II who interpreted the same cases in a different order compared with phase I (POR, 1.17; 95% CI, 1.05-1.31). Physicians appear to be influenced by the severity of previously interpreted test cases. Understanding types and sources of diagnostic bias may lead to improved assessment of accuracy and better patient care. © The Author(s) 2016.

Randomized Phase Ib/II Trial of Rilotumumab or Ganitumab with Panitumumab versus Panitumumab Alone in Patients with Wild-type KRAS Metastatic Colorectal Cancer

PubMed Central

Cutsem, Eric Van; Eng, Cathy; Nowara, Elzbieta; Świeboda-Sadlej, Anna; Tebbutt, Niall C.; Mitchell, Edith; Davidenko, Irina; Stephenson, Joe; Elez, Elena; Prenen, Hans; Deng, Hongjie; Tang, Rui; McCaffery, Ian; Oliner, Kelly S.; Chen, Lisa; Gansert, Jennifer; Loh, Elwyn; Smethurst, Dominic; Tabernero, Josep

2015-01-01

Purpose Panitumumab, a fully human anti-epidermal growth factor receptor monoclonal antibody (mAb), has demonstrated efficacy in patients with wild-type KRAS metastatic colorectal cancer (mCRC). Rilotumumab and ganitumab are investigational, fully human mAbs against hepatocyte growth factor (HGF)/scatter factor and IGF1R, respectively. Here we evaluate combining rilotumumab or ganitumab with panitumumab in previously treated patients with wild-type KRAS mCRC. Experimental Design Part 1 was a phase Ib dose-finding study of panitumumab plus rilotumumab. The primary endpoint was the incidence of dose-limiting toxicities (DLT). Part 2 was a randomized phase II trial of panitumumab in combination with rilotumumab, ganitumab, or placebo. The primary endpoint was objective response rate (ORR); safety, progression-free survival (PFS), and overall survival (OS) were secondary endpoints. Archival tissue specimens were collected for exploratory correlative work. Results In part 1, no DLTs were reported. A recommended phase II dose of 10 mg/kg rilotumumab was selected. In part 2, for the panitumumab plus rilotumumab (n = 48), panitumumab plus ganitumab (n = 46), and panitumumab plus placebo arms (n = 48), the ORRs were 31%, 22%, and 21%, respectively. The median PFS was 5.2, 5.3, and 3.7 months and median OS 13.8,10.6, and 11.6 months, respectively. Adverse events were tolerable. Exploratory biomarker analyses, including MET and IGF-related protein expression, failed to indicate conclusive predictive evidence on efficacy endpoints. Conclusions Panitumumab plus rilotumumab met the prespecified criterion for improvement in ORR whereas ganitumab did not. This is the first study to suggest a benefit for combining an HGF inhibitor (rilotumumab) with panitumumab in previously treated patients with wild-type KRAS mCRC. PMID:24919569

Enhanced removal of Enterococcus faecalis biofilms in the root canal using sodium hypochlorite plus photon-induced photoacoustic streaming: an in vitro study.

PubMed

Al Shahrani, Mohammed; DiVito, Enrico; Hughes, Christopher V; Nathanson, Dan; Huang, George T-J

2014-05-01

The purpose of this study was to determine the effectiveness of laser-activated irrigation by photon-induced photoacoustic streaming (PIPS) using Er:YAG laser energy in decontaminating heavily colonized root canal systems in vitro. Extracted single-rooted human teeth (n=60) were mechanically and chemically prepared, sterilized, inoculated with Enterococcus faecalis for 3 weeks, and randomly assigned to four groups (n=15): Group I (control, no decontamination), Group II (PIPS+6% NaOCl), Group III (PIPS+saline), and Group IV (6% NaOCl). PIPS settings were all preset to 50 μsec pulse, 20 mJ, 15 Hz, for an average power of 0.3 W. After decontamination, the remaining live microbes from all specimens were collected and recovered via plate counting of the colony-forming units (CFUs). Randomized root canal surfaces were examined with scanning electron microscopy and confocal laser microscopy. Mean variance and Dunnett's t test (post-hoc test) comparisons were used to compare mean scores for the three groups with the control group. The CFU analysis showed the following measurements (mean±SE): Group I (control), 336.8±1.8; Group II (PIPS+NaOCl), 0.27±0.21; Group III (PIPS+saline), 225.0±21; and Group IV (NaOCl), 46.9±20.29. Group II had significantly lower CFUs than any other groups (p<0.05). Both imaging analyses confirmed levels of remaining bacteria on examined root surfaces. The use of the PIPS system along with NaOCl showed the most efficient eradication of the bacterial biofilm. It appears that laser-activated irrigation (LAI) utilizing PIPS may enhance the disinfection of the root canal system.

Enhanced Removal of Enterococcus faecalis Biofilms in the Root Canal Using Sodium Hypochlorite Plus Photon-Induced Photoacoustic Streaming: An In Vitro Study

PubMed Central

Al Shahrani, Mohammed; DiVito, Enrico; Hughes, Christopher V.; Nathanson, Dan

2014-01-01

Abstract Objective: The purpose of this study was to determine the effectiveness of laser-activated irrigation by photon-induced photoacoustic streaming (PIPS) using Er:YAG laser energy in decontaminating heavily colonized root canal systems in vitro. Materials and methods: Extracted single-rooted human teeth (n=60) were mechanically and chemically prepared, sterilized, inoculated with Enterococcus faecalis for 3 weeks, and randomly assigned to four groups (n=15): Group I (control, no decontamination), Group II (PIPS+6% NaOCl), Group III (PIPS+saline), and Group IV (6% NaOCl). PIPS settings were all preset to 50 μsec pulse, 20 mJ, 15 Hz, for an average power of 0.3 W. After decontamination, the remaining live microbes from all specimens were collected and recovered via plate counting of the colony-forming units (CFUs). Randomized root canal surfaces were examined with scanning electron microscopy and confocal laser microscopy. Mean variance and Dunnett's t test (post-hoc test) comparisons were used to compare mean scores for the three groups with the control group. Results: The CFU analysis showed the following measurements (mean±SE): Group I (control), 336.8±1.8; Group II (PIPS+NaOCl), 0.27±0.21; Group III (PIPS+saline), 225.0±21; and Group IV (NaOCl), 46.9±20.29. Group II had significantly lower CFUs than any other groups (p<0.05). Both imaging analyses confirmed levels of remaining bacteria on examined root surfaces. Conclusions: The use of the PIPS system along with NaOCl showed the most efficient eradication of the bacterial biofilm. It appears that laser-activated irrigation (LAI) utilizing PIPS may enhance the disinfection of the root canal system. PMID:24717113

Routine Sub-hepatic Drainage versus No Drainage after Laparoscopic Cholecystectomy: Open, Randomized, Clinical Trial.

PubMed

Shamim, Muhammad

2013-02-01

Surgeons are still following the old habit of routine subhepatic drainage following laparoscopic cholecystectomy (LC). This study aims to compare the outcome of subhepatic drainage with no drainage after LC. This prospective study was conducted in two phases. Phase I was open, randomized controlled trial (RCT), conducted in Civil Hospital Karachi, from August 2004 to June 2005. Phase II was descriptive case series, conducted in author's practice hospitals of Karachi, from July 2005 to December 2009. In phase I, 170 patients with chronic calculous cholecystitis underwent LC. Patients were divided into two groups, subhepatic drainage (group A: 79 patients) or no drainage (group B: 76 patients). The rest 15 patients were excluded either due to conversion or elective subhepatic drainage. In phase II, 218 consecutive patients were enrolled, who underwent LC with no subhepatic drainage. Duration of operation, character, and amount of drain fluid (if placed), postoperative ultrasound for subhepatic collection, postoperative chest X-ray for the measurement of subdiaphragmatic air, postoperative pain, postoperative nausea/vomiting, duration of hospital stay, and preoperative or postoperative complications were noted and analyzed. Duration of operation and hospital stay was slightly longer in group A patients (P values 0.002 and 0.029, respectively); postoperative pain perception, nausea/vomiting, and postoperative complications were nearly same in both groups (P value 0.064, 0.078, and 0.003, respectively). Subhepatic fluid collection was more in group A (P = 0.002), whereas subdiaphragmatic air collection was more in group B (P = 0.003). Phase II results were nearly similar to group B patients in phase I. Routine subhepatic drainage after LC is not necessary in uncomplicated cases.

Antioxidant status, metabolic profile and immune response of lambs supplemented with tannin rich Ficus infectoria leaf meal.

PubMed

Dey, Avijit; Dutta, Narayan; Pattanaik, Ashok Kumar; Sharma, Kusumakar

2015-02-01

To study the effect of supplementation of tanniferous tree leaves Ficus infectoria on antioxidant status and immune response, twenty four lambs were randomly divided into four groups of six each in a completely randomized design and fed either a conventional supplement (CON) or experimental supplements (FILM-I, FILM-II and FILM-III) containing 1.0, 1.5 and 2.0% condensed tannins (CT), respectively by replacement of wheat bran of supplement CON with Ficus infectoria leaf meal (FILM). Blood biochemical profile was monitored in all lambs at 0, 45, 90, 135, 180 days of feeding. Although haemato-biochemical parameters remained similar, there was significant (p < 0.05) improvement in catalase activity, total thiol and protein thiol groups with reduction in lipid peroxidation (LPO) in lambs fed FILM diet irrespective of levels. However, intracellular status of reduced glutathione, and superoxide dismutase activity was improved (p < 0.05) only in FILM-II and FILM-III supplemented lambs. The cell-mediated immune response was significantly (p < 0.05) improved in all the lambs fed FILM supplemented diets. Improved antioxidant status and immunity in FILM supplemented lambs increased voluntary feed intake irrespective of level. However, the average daily gain for a period of 180 d showed a significant (p < 0.05) increase by the supplementation of FILM-II diet containing 1.5% CT. The present study reveals that the supplementation of Ficus infectoria leaf meal up to 21.2% in the concentrate mixture could improve the antioxidant status and immunity in lambs. However, as feed efficiency was reduced at higher levels due to presence of CT, 15.9% supplementation containing 1.5% condensed tannins in concentrate mixture is suggested to improve the health and production performance of lambs.

Biologic determinants of tumor recurrence in stage II colon cancer: validation study of the 12-gene recurrence score in cancer and leukemia group B (CALGB) 9581.

PubMed

Venook, Alan P; Niedzwiecki, Donna; Lopatin, Margarita; Ye, Xing; Lee, Mark; Friedman, Paula N; Frankel, Wendy; Clark-Langone, Kim; Millward, Carl; Shak, Steven; Goldberg, Richard M; Mahmoud, Najjia N; Warren, Robert S; Schilsky, Richard L; Bertagnolli, Monica M

2013-05-10

A greater understanding of the biology of tumor recurrence should improve adjuvant treatment decision making. We conducted a validation study of the 12-gene recurrence score (RS), a quantitative assay integrating stromal response and cell cycle gene expression, in tumor specimens from patients enrolled onto Cancer and Leukemia Group B (CALGB) 9581. CALGB 9581 randomly assigned 1,713 patients with stage II colon cancer to treatment with edrecolomab or observation and found no survival difference. The analysis reported here included all patients with available tissue and recurrence (n = 162) and a random (approximately 1:3) selection of nonrecurring patients. RS was assessed in 690 formalin-fixed paraffin-embedded tumor samples with quantitative reverse transcriptase polymerase chain reaction by using prespecified genes and a previously validated algorithm. Association of RS and recurrence was analyzed by weighted Cox proportional hazards regression. Continuous RS was significantly associated with risk of recurrence (P = .013) as was mismatch repair (MMR) gene deficiency (P = .044). In multivariate analyses, RS was the strongest predictor of recurrence (P = .004), independent of T stage, MMR, number of nodes examined, grade, and lymphovascular invasion. In T3 MMR-intact (MMR-I) patients, prespecified low and high RS groups had average 5-year recurrence risks of 13% (95% CI, 10% to 16%) and 21% (95% CI, 16% to 26%), respectively. The 12-gene RS predicts recurrence in stage II colon cancer in CALGB 9581. This is consistent with the importance of stromal response and cell cycle gene expression in colon tumor recurrence. RS appears to be most discerning for patients with T3 MMR-I tumors, although markers such as grade and lymphovascular invasion did not add value in this subset of patients.

Active transport on disordered microtubule networks: The generalized random velocity model

NASA Astrophysics Data System (ADS)

Kahana, Aviv; Kenan, Gilad; Feingold, Mario; Elbaum, Michael; Granek, Rony

2008-11-01

The motion of small cargo particles on microtubules by means of motor proteins in disordered microtubule networks is investigated theoretically using both analytical tools and computer simulations. Different network topologies in two and three dimensions are considered, one of which has been recently studied experimentally by Salman [Biophys. J. 89, 2134 (2005)]. A generalization of the random velocity model is used to derive the mean-square displacement of the cargo particle. We find that all cases belong to the class of anomalous superdiffusion, which is sensitive mainly to the dimensionality of the network and only marginally to its topology. Yet in three dimensions the motion is very close to simple diffusion, with sublogarithmic corrections that depend on the network topology. When details of the thermal diffusion in the bulk solution are included, no significant change to the asymptotic time behavior is found. However, a small asymmetry in the mean microtubule polarity affects the corresponding long-time behavior. We also study a three-dimensional model of the microtubule network in living animal cells. Three first-passage-time problems of intracellular transport are simulated and analyzed for different motor processivities: (i) cargo that originates near the nucleus and has to reach the membrane, (ii) cargo that originates from the membrane and has to reach the nucleus, and (iii) cargo that leaves the nucleus and has to reach a specific target in the cytoplasm. We conclude that while a higher motor processivity increases the transport efficiency in cases (i) and (ii), in case (iii) it has the opposite effect. We conjecture that the balance between the different network tasks, as manifested in cases (i) and (ii) versus case (iii), may be the reason for the evolutionary choice of a finite motor processivity.

The comparative effects of 0.12% chlorhexidine and herbal oral rinse on dental plaque-induced gingivitis: A randomized clinical trial

PubMed Central

Bhate, Devaki; Jain, Sanjay; Kale, Rahul; Muglikar, Sangeeta

2015-01-01

Background: Chlorhexidine (CHX) is considered as a gold standard of antimicrobial rinses. Various herbal oral rinses are available in the market. However, little is known of its effectiveness. Aim: The aim of this study was to evaluate the clinical changes after the usage of herbal oral rinse and 0.12% CHX. Materials and Methods: In a randomized clinical trial, 76 patients with dental plaque-induced gingivitis were assigned to Group I (Herbal Oral Rinse - Hiora®) and 76 patients with dental plaque-induced gingivitis to Group II (0.12% Chlorhexidine-Peridex®). Gingival index and Plaque index scores were recorded at baseline and 21 days after scaling. Results: Intragroup comparison in both groups showed that plaque index and gingival index scores were statistically significant after 21 days as compared to baseline. Intergroup comparison showed that plaque index scores and gingival index scores were statistically significant in Group II as compared to Group I. Conclusion: When herbal oral rinse was compared to 0.12% CHX, 0.12% CHX mouth rinse effectively reduced the clinical symptoms of plaque-induced gingivitis. PMID:26392686

Comparison of effectiveness of Calendula officinalis extract gel with lycopene gel for treatment of tobacco-induced homogeneous leukoplakia: A randomized clinical trial

PubMed Central

Singh, Manisha; Bagewadi, Anjana

2017-01-01

Aim: The aim of the study is to assess the efficacy of Calendula officinalis gel as cost-effective treatment modality in comparison to lycopene gel in the treatment of leukoplakia. Materials and Methods: The study comprised of sixty patients of clinically diagnosed and histopathologically confirmed cases of homogeneous leukoplakia which were divided into Group I and Group II with thirty patients each. Group I patients were dispensed C. officinalis extract gel whereas Group II patients were given lycopene gel. The therapy was instituted for 1 month to assess the change in the size of the lesion at the baseline and posttreatment. Results: The results revealed a statistically significant difference in both Group I and Group II when the pre- and post-treatment results were compared in the same group. The mean difference in the reduction in size before and after treatment for Group I was 2.0% ±1.0 cm while for the Group II, it was 1.57% ±0.87 cm. The intergroup comparison for the evaluation of reduction in the size of the lesion did not reveal statistically significant results. Conclusion: C. officinalis extract gel can be effectively used as an alternative to conventional treatment modality. PMID:28929051

Combination of Probiotics and Antibiotics in the Prevention of Recurrent Urinary Tract Infection in Children

PubMed Central

Mohseni, Mohammad-Javad; Aryan, Zahra; Emamzadeh-Fard, Sahra; Paydary, Koosha; Mofid, Vahid; Joudaki, Hasan; Kajbafzadeh, Abdol-Mohammad

2013-01-01

Objective We examined the preventive effect of probiotic and antibiotics versus antibiotics alone, in children with recurrent urinary tract infections (RUTI) in a preliminary randomized clinical trial. Methods Between March 2007 and April 2011, children with the history of RUTI and unilateral vesicoureteral reflux (VUR) were randomly assigned to receive concomitant probiotic and antibiotics (Lactobacillus acidophilus and bifidobacterium lactis, 107/ml, as 0.25 ml/kg three times a day regimen in addition to Nitrofurantoin, 1mg/kg daily (group I). In group II, all children received conventional prophylactic antibiotics alone (Nitrofurantoin, 1 mg/kg daily). Randomization was performed via using the random numerals table in a 1:1 manner with stratification by sex, age and grade of reflux. The urine examinations were done monthly and the incidence of UTI was evaluated in these two groups. Findings Forty-one children (age: 8.3±3.1 years) in group I and 44 children (age: 8.0±3.0 years) in group II were compared. During the course of three years, 39% in group I and 50% of participants in group II experienced RUTIs (P=0.4). Incidences of UTI - febrile and afebrile - reduced in both groups without any significant differences after two years of prophylaxis. Also, incidence of afebrile UTIs did not significantly differ (0.51±1.30 and 0.81±1.41 respectively, P =0.3); however, the incidence of febrile UTIs in particular were lower in group I (0.00±0.00 versus 0.13±0.40, P =0.03) in the last year. Conclusion The consumption of probiotic and antibiotics in children with RUTI is safe and more effective in reducing the incidence of febrile UTI in comparison to prophylactic antibiotics alone. PMID:24427497

Combination of probiotics and antibiotics in the prevention of recurrent urinary tract infection in children.

PubMed

Mohseni, Mohammad-Javad; Aryan, Zahra; Emamzadeh-Fard, Sahra; Paydary, Koosha; Mofid, Vahid; Joudaki, Hasan; Kajbafzadeh, Abdol-Mohammad

2013-08-01

We examined the preventive effect of probiotic and antibiotics versus antibiotics alone, in children with recurrent urinary tract infections (RUTI) in a preliminary randomized clinical trial. Between March 2007 and April 2011, children with the history of RUTI and unilateral vesicoureteral reflux (VUR) were randomly assigned to receive concomitant probiotic and antibiotics (Lactobacillus acidophilus and bifidobacterium lactis, 10(7)/ml, as 0.25 ml/kg three times a day regimen in addition to Nitrofurantoin, 1mg/kg daily (group I). In group II, all children received conventional prophylactic antibiotics alone (Nitrofurantoin, 1 mg/kg daily). Randomization was performed via using the random numerals table in a 1:1 manner with stratification by sex, age and grade of reflux. The urine examinations were done monthly and the incidence of UTI was evaluated in these two groups. Forty-one children (age: 8.3±3.1 years) in group I and 44 children (age: 8.0±3.0 years) in group II were compared. During the course of three years, 39% in group I and 50% of participants in group II experienced RUTIs (P=0.4). Incidences of UTI - febrile and afebrile - reduced in both groups without any significant differences after two years of prophylaxis. Also, incidence of afebrile UTIs did not significantly differ (0.51±1.30 and 0.81±1.41 respectively, P =0.3); however, the incidence of febrile UTIs in particular were lower in group I (0.00±0.00 versus 0.13±0.40, P =0.03) in the last year. The consumption of probiotic and antibiotics in children with RUTI is safe and more effective in reducing the incidence of febrile UTI in comparison to prophylactic antibiotics alone.

A randomized phase II study of gemcitabine and carboplatin with or without cediranib as first-line therapy in advanced non-small-cell lung cancer: North Central Cancer Treatment Group Study N0528.

PubMed

Dy, Grace K; Mandrekar, Sumithra J; Nelson, Garth D; Meyers, Jeffrey P; Adjei, Araba A; Ross, Helen J; Ansari, Rafat H; Lyss, Alan P; Stella, Philip J; Schild, Steven E; Molina, Julian R; Adjei, Alex A

2013-01-01

The purpose of this study was to assess the safety and efficacy of gemcitabine and carboplatin with (arm A) or without (arm B) daily oral cediranib as first-line therapy for advanced non-small-cell lung cancer. A lead-in phase to determine the tolerability of gemcitabine 1000 mg/m on days 1 and 8, and carboplatin on day 1 at area under curve 5 administered every 21 days with cediranib 45 mg once daily was followed by a 2 (A):1 (B) randomized phase II study. The primary end point was confirmed overall response rate (ORR) with 6-month progression-free survival (PFS6) rate in arm A as secondary end point. Polymorphisms in genes encoding cediranib targets and transport were correlated with treatment outcome. On the basis of the safety assessment, cediranib 30 mg daily was used in the phase II portion. A total of 58 and 29 evaluable patients were accrued to arms A and B. Patients in A experienced more grade 3+ nonhematologic adverse events, 71% versus 45% (p = 0.01). The ORR was 19% (A) versus 20% (B) (p = 1.0). PFS6 in A was 48% (95% confidence interval: 35%-62%), thus meeting the protocol-specified threshold of at least 40%. The median overall survival was 12.0 versus 9.9 months (p = 0.10). FGFR1 rs7012413, FGFR2 rs2912791, and VEGFR3 rs11748431 polymorphisms were significantly associated with decreased overall survival (hazard ratio 2.78-5.01, p = 0.0002-0.0095). The trial did not meet its primary end point of ORR but met its secondary end point of PFS6. The combination with cediranib 30 mg daily resulted in increased toxicity. Pharmacogenetic analysis revealed an association of FGFR and VEGFR variants with survival.

Community-based Randomized Controlled Trial of Non-pharmacological Interventions in Prevention and Control of Hypertension among Young Adults.

PubMed

Saptharishi, Lg; Soudarssanane, Mb; Thiruselvakumar, D; Navasakthi, D; Mathanraj, S; Karthigeyan, M; Sahai, A

2009-10-01

Hypertension is a major chronic lifestyle disease. Several non-pharmacological interventions are effective in bringing down the blood pressure (BP). This study focuses on the effectiveness of such interventions among young adults. To measure the efficacy of physical exercise, reduction in salt intake, and yoga, in lowering BP among young (20-25) pre-hypertensives and hypertensives, and to compare their relative efficacies. The study was done in the urban service area of JIPMER. Pre-hypertensives and hypertensives, identified from previous studies, constituted the universe. The participants were randomized into one control and three interventional groups. A total of 113 subjects: 30, 28, 28 and 27 in four groups respectively participated for eight weeks: control (I), physical exercise (II) - brisk walking for 50-60 minutes, four days/week, salt intake reduction (III) - to at least half of their previous intake, and practice of yoga (IV) - for 30-45 minutes/day on at least five days/week. Efficacy was assessed using paired t test and ANOVA with Games Howell post hoc test. An intention to treat analysis was also performed. A total of 102 participants (29, 27, 25 and 21 in groups I, II, III and IV) completed the study. All three intervention groups showed a significant reduction in BP (SBP/DBP: 5.3/6.0 in group II, 2.6/3.7 in III, and 2.0/2.6 mm Hg in IV respectively). There was no significant change (SBP/DBP: 0.2/0.5 mmHg) of BP in control group (I). Physical exercise was most effective (considered individually); salt intake reduction and yoga were also effective. Physical exercise, salt intake reduction, and yoga are effective non-pharmacological interventions in significantly reducing BP among young hypertensives and pre-hypertensives. These can therefore be positively recommended for hypertensives. There is also a case to deploy these interventions in the general population.

Enhancing superconducting critical current by randomness

NASA Astrophysics Data System (ADS)

Wang, Y. L.; Thoutam, L. R.; Xiao, Z. L.; Shen, B.; Pearson, J. E.; Divan, R.; Ocola, L. E.; Crabtree, G. W.; Kwok, W. K.

2016-01-01

The key ingredient of high critical currents in a type-II superconductor is defect sites that pin vortices. Contrary to earlier understanding on nanopatterned artificial pinning, here we show unequivocally the advantages of a random pinscape over an ordered array in a wide magnetic field range. We reveal that the better performance of a random pinscape is due to the variation of its local density of pinning sites (LDOPS), which mitigates the motion of vortices. This is confirmed by achieving even higher enhancement of the critical current through a conformally mapped random pinscape, where the distribution of the LDOPS is further enlarged. The demonstrated key role of LDOPS in enhancing superconducting critical currents gets at the heart of random versus commensurate pinning. Our findings highlight the importance of random pinscapes in enhancing the superconducting critical currents of applied superconductors.

Autoshaping, random control, and omission training in the rat1

PubMed Central

Locurto, Charles; Terrace, H. S.; Gibbon, John

1976-01-01

The role of the stimulus-reinforcer contingency in the development and maintenance of lever contact responding was studied in hooded rats. In Experiment I, three groups of experimentally naive rats were trained either on autoshaping, omission training, or a random-control procedure. Subjects trained by the autoshaping procedure responded more consistently than did either random-control or omission-trained subjects. The probability of at least one lever contact per trial was slightly higher in subjects trained by the omission procedure than by the random-control procedure. However, these differences were not maintained during extended training, nor were they evident in total lever-contact frequencies. When omission and random-control subjects were switched to the autoshaping condition, lever contacts increased in all animals, but a pronounced retardation was observed in omission subjects relative to the random-control subjects. In addition, subjects originally exposed to the random-control procedure, and later switched to autoshaping, acquired more rapidly than naive subjects that were exposed only on the autoshaping procedure. In Experiment II, subjects originally trained by an autoshaping procedure were exposed either to an omission, a random-control, or an extinction procedure. No differences were observed among the groups either in the rate at which lever contacts decreased or in the frequency of lever contacts at the end of training. These data implicate prior experience in the interpretation of omission-training effects and suggest limitations in the influence of stimulus-reinforcer relations in autoshaping. PMID:16811960

Autoshaping, random control, and omission training in the rat.

PubMed

Locurto, C; Terrace, H S; Gibbon, J

1976-11-01

The role of the stimulus-reinforcer contingency in the development and maintenance of lever contact responding was studied in hooded rats. In Experiment I, three groups of experimentally naive rats were trained either on autoshaping, omission training, or a random-control procedure. Subjects trained by the autoshaping procedure responded more consistently than did either random-control or omission-trained subjects. The probability of at least one lever contact per trial was slightly higher in subjects trained by the omission procedure than by the random-control procedure. However, these differences were not maintained during extended training, nor were they evident in total lever-contact frequencies. When omission and random-control subjects were switched to the autoshaping condition, lever contacts increased in all animals, but a pronounced retardation was observed in omission subjects relative to the random-control subjects. In addition, subjects originally exposed to the random-control procedure, and later switched to autoshaping, acquired more rapidly than naive subjects that were exposed only on the autoshaping procedure. In Experiment II, subjects originally trained by an autoshaping procedure were exposed either to an omission, a random-control, or an extinction procedure. No differences were observed among the groups either in the rate at which lever contacts decreased or in the frequency of lever contacts at the end of training. These data implicate prior experience in the interpretation of omission-training effects and suggest limitations in the influence of stimulus-reinforcer relations in autoshaping.

Progressive Elaboration and Cross-Validation of a Latent Class Typology of Adolescent Alcohol Involvement in a National Sample

PubMed Central

Donovan, John E.; Chung, Tammy

2015-01-01

Objective: Most studies of adolescent drinking focus on single alcohol use behaviors (e.g., high-volume drinking, drunkenness) and ignore the patterning of adolescents’ involvement across multiple alcohol behaviors. The present latent class analyses (LCAs) examined a procedure for empirically determining multiple cut points on the alcohol use behaviors in order to establish a typology of adolescent alcohol involvement. Method: LCA was carried out on six alcohol use behavior indicators collected from 6,504 7th through 12th graders who participated in Wave I of the National Longitudinal Study of Adolescent Health (AddHealth). To move beyond dichotomous indicators, a “progressive elaboration” strategy was used, starting with six dichotomous indicators and then evaluating a series of models testing additional cut points on the ordinal indicators at progressively higher points for one indicator at a time. Analyses were performed on one random half-sample, and confirmatory LCAs were performed on the second random half-sample and in the Wave II data. Results: The final model consisted of four latent classes (never or non–current drinkers, low-intake drinkers, non–problem drinkers, and problem drinkers). Confirmatory LCAs in the second random half-sample from Wave I and in Wave II support this four-class solution. The means on the four latent classes were also generally ordered on an array of measures reflecting psychosocial risk for problem behavior. Conclusions: These analyses suggest that there may be four different classes or types of alcohol involvement among adolescents, and, more importantly, they illustrate the utility of the progressive elaboration strategy for moving beyond dichotomous indicators in latent class models. PMID:25978828

Study in Parkinson Disease of Exercise (SPARX): Translating high-intensity exercise from animals to humans

PubMed Central

Moore, Charity G.; Schenkman, Margaret; Kohrt, Wendy M.; Delitto, Anthony; Hall, Deborah A.; Corcos, Daniel

2013-01-01

A burgeoning literature suggests that exercise has a therapeutic benefit in persons with Parkinson disease (PD) and in animal models of PD, especially when animals exercise at high intensity. If exercise is to be prescribed as “first-line” or “add-on” therapy in patients with PD, we must demonstrate its efficacy and dose-response effects through testing phases similar to those used in the testing of pharmacologic agents. The SPARX Trial is a multicenter, randomized, controlled, single-blinded, Phase II study that we designed to test the feasibility of using high-intensity exercise to modify symptoms of PD and to simultaneously test the nonfutility of achieving a prespecified change in patients’ motor scores on the Unified Parkinson Disease Rating Scale (UPDRS). The trial began in May 2102 and is in the process of screening, enrolling, and randomly assigning 126 patients with early-stage PD to 1 of 3 groups: usual care (wait-listed controls), moderate-intensity exercise (4 days/week at 60%–65% maximal heart rate [HRmax]), or high-intensity exercise (4 days/week at 80%–85% HRmax). At 6-month follow-up, the trial is randomly reassigning usual care participants to a moderate-intensity or high-intensity exercise group for the remaining 6 months. The goals of the Phase II trial are to determine if participants can exercise at moderate and high intensities; to determine if either exercise yields benefits consistent with meaningful clinical change (nonfutility); and to document safety and attrition. The advantage of using a non-futility approach allows us to efficiently determine if moderate- or high-intensity exercise warrants further large-scale investigation in PD. PMID:23770108

Multicenter, randomized, open-label Phase II study comparing S-1 alternate-day oral therapy with the standard daily regimen as a first-line treatment in patients with unresectable advanced pancreatic cancer.

PubMed

Yamaue, Hiroki; Shimizu, Atsushi; Hagiwara, Yasuhiro; Sho, Masayuki; Yanagimoto, Hiroaki; Nakamori, Shoji; Ueno, Hideki; Ishii, Hiroshi; Kitano, Masayuki; Sugimori, Kazuya; Maguchi, Hiroyuki; Ohkawa, Shinichi; Imaoka, Hiroshi; Hashimoto, Daisuke; Ueda, Kazuki; Nebiki, Hiroko; Nagakawa, Tatsuya; Isayama, Hiroyuki; Yokota, Isao; Ohashi, Yasuo; Shirasaka, Tetsuhiko

2017-04-01

Non-inferiority for overall survival (OS) following alternate-day treatment with the oral anticancer drug S-1 compared with standard daily treatment was assessed in Japanese patients with unresectable advanced pancreatic cancer in a multicenter, randomized, phase II study. This trial was registered at the UMIN Clinical Trials Registry (no. 000008604). Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were randomly assigned 2:1 to treatment with alternate-day (twice daily on alternate days from days 1 through 42 of a 42-day cycle) or daily (twice daily on days 1 through 28 of a 42-day cycle) treatment with S-1. The primary endpoint was OS. Secondary endpoints were progression-free survival (PFS), time to treatment failure, response rate, quality of life assessments, and safety. A total of 190 patients were enrolled, of which 185 were included in the final analysis (alternate-day: 121; daily: 64). Median OS was 9.4 for the alternate-day group and 10.4 months for the daily group [hazard ratio (HR), 1.19; 95% credible interval, 0.86 to 1.64], indicating that non-inferiority of alternate-day treatment to daily treatment was not demonstrated. Median PFS was 3.0 for the alternate-day group and 4.2 months for the daily group (HR, 1.65; 95% credible interval, 1.20-2.29). The incidence of anorexia, fatigue, neutrophils, pigmentation, and pneumonitis was lower in alternate-day treatment compared with daily treatment. S-1 for advanced pancreatic cancer should be taken daily as recommended, based on the decreased OS and PFS and marginal improvement in safety observed in the alternate-day group.

Nivolumab for Metastatic Renal Cell Carcinoma: Results of a Randomized Phase II Trial

PubMed Central

Motzer, Robert J.; Rini, Brian I.; McDermott, David F.; Redman, Bruce G.; Kuzel, Timothy M.; Harrison, Michael R.; Vaishampayan, Ulka N.; Drabkin, Harry A.; George, Saby; Logan, Theodore F.; Margolin, Kim A.; Plimack, Elizabeth R.; Lambert, Alexandre M.; Waxman, Ian M.; Hammers, Hans J.

2015-01-01

Purpose Nivolumab is a fully human immunoglobulin G4 programmed death–1 immune checkpoint inhibitor antibody that restores T-cell immune activity. This phase II trial assessed the antitumor activity, dose-response relationship, and safety of nivolumab in patients with metastatic renal cell carcinoma (mRCC). Patients and Methods Patients with clear-cell mRCC previously treated with agents targeting the vascular endothelial growth factor pathway were randomly assigned (blinded ratio of 1:1:1) to nivolumab 0.3, 2, or 10 mg/kg intravenously once every 3 weeks. The primary objective was to evaluate the dose-response relationship as measured by progression-free survival (PFS); secondary end points included objective response rate (ORR), overall survival (OS), and safety. Results A total of 168 patients were randomly assigned to the nivolumab 0.3- (n = 60), 2- (n = 54), and 10-mg/kg (n = 54) cohorts. One hundred eighteen patients (70%) had received more than one prior systemic regimen. Median PFS was 2.7, 4.0, and 4.2 months, respectively (P = .9). Respective ORRs were 20%, 22%, and 20%. Median OS was 18.2 months (80% CI, 16.2 to 24.0 months), 25.5 months (80% CI, 19.8 to 28.8 months), and 24.7 months (80% CI, 15.3 to 26.0 months), respectively. The most common treatment-related adverse event (AE) was fatigue (24%, 22%, and 35%, respectively). Nineteen patients (11%) experienced grade 3 to 4 treatment-related AEs. Conclusion Nivolumab demonstrated antitumor activity with a manageable safety profile across the three doses studied in mRCC. No dose-response relationship was detected as measured by PFS. These efficacy and safety results in mRCC support study in the phase III setting. PMID:25452452

Nivolumab for Metastatic Renal Cell Carcinoma: Results of a Randomized Phase II Trial.

PubMed

Motzer, Robert J; Rini, Brian I; McDermott, David F; Redman, Bruce G; Kuzel, Timothy M; Harrison, Michael R; Vaishampayan, Ulka N; Drabkin, Harry A; George, Saby; Logan, Theodore F; Margolin, Kim A; Plimack, Elizabeth R; Lambert, Alexandre M; Waxman, Ian M; Hammers, Hans J

2015-05-01

Nivolumab is a fully human immunoglobulin G4 programmed death-1 immune checkpoint inhibitor antibody that restores T-cell immune activity. This phase II trial assessed the antitumor activity, dose-response relationship, and safety of nivolumab in patients with metastatic renal cell carcinoma (mRCC). Patients with clear-cell mRCC previously treated with agents targeting the vascular endothelial growth factor pathway were randomly assigned (blinded ratio of 1:1:1) to nivolumab 0.3, 2, or 10 mg/kg intravenously once every 3 weeks. The primary objective was to evaluate the dose-response relationship as measured by progression-free survival (PFS); secondary end points included objective response rate (ORR), overall survival (OS), and safety. A total of 168 patients were randomly assigned to the nivolumab 0.3- (n = 60), 2- (n = 54), and 10-mg/kg (n = 54) cohorts. One hundred eighteen patients (70%) had received more than one prior systemic regimen. Median PFS was 2.7, 4.0, and 4.2 months, respectively (P = .9). Respective ORRs were 20%, 22%, and 20%. Median OS was 18.2 months (80% CI, 16.2 to 24.0 months), 25.5 months (80% CI, 19.8 to 28.8 months), and 24.7 months (80% CI, 15.3 to 26.0 months), respectively. The most common treatment-related adverse event (AE) was fatigue (24%, 22%, and 35%, respectively). Nineteen patients (11%) experienced grade 3 to 4 treatment-related AEs. Nivolumab demonstrated antitumor activity with a manageable safety profile across the three doses studied in mRCC. No dose-response relationship was detected as measured by PFS. These efficacy and safety results in mRCC support study in the phase III setting. © 2014 by American Society of Clinical Oncology.

Cardiac ischemia in patients with septic shock randomized to vasopressin or norepinephrine

PubMed Central

2013-01-01

Introduction Cardiac troponins are sensitive and specific biomarkers of myocardial necrosis. We evaluated troponin, CK, and ECG abnormalities in patients with septic shock and compared the effect of vasopressin (VP) versus norepinephrine (NE) on troponin, CK, and ECGs. Methods This was a prospective substudy of a randomized trial. Adults with septic shock randomly received, blinded, a low-dose infusion of VP (0.01 to 0.03 U/min) or NE (5 to 15 μg/min) in addition to open-label vasopressors, titrated to maintain a mean blood pressure of 65 to 75 mm Hg. Troponin I/T, CK, and CK-MB were measured, and 12-lead ECGs were recorded before study drug, and 6 hours, 2 days, and 4 days after study-drug initiation. Two physician readers, blinded to patient data and drug, independently interpreted ECGs. Results We enrolled 121 patients (median age, 63.9 years (interquartile range (IQR), 51.1 to 75.3), mean APACHE II 28.6 (SD 7.7)): 65 in the VP group and 56 in the NE group. At the four time points, 26%, 36%, 32%, and 21% of patients had troponin elevations, respectively. Baseline characteristics and outcomes were similar between patients with positive versus negative troponin levels. Troponin and CK levels and rates of ischemic ECG changes were similar in the VP and the NE groups. In multivariable analysis, only APACHE II was associated with 28-day mortality (OR, 1.07; 95% CI, 1.01 to 1.14; P = 0.033). Conclusions Troponin elevation is common in adults with septic shock. We observed no significant differences in troponin, CK, and ECGs in patients treated with vasopressin and norepinephrine. Troponin elevation was not an independent predictor of mortality. Trial registration Controlled-trials.com ISRCTN94845869 PMID:23786655

FemZone trial: a randomized phase II trial comparing neoadjuvant letrozole and zoledronic acid with letrozole in primary breast cancer patients

PubMed Central

2014-01-01

Background The objective of this prospectively randomized phase II trial (Trial registration: EUCTR2004-004007-37-DE) was to compare the clinical response of primary breast cancer patients to neoadjuvant therapy with letrozole alone (LET) or letrozole and zoledronic acid (LET + ZOL). Methods Patients were randomly assigned to receive either LET 2.5 mg/day (n = 79) or the combination of LET 2.5 mg/day and a total of seven infusions of ZOL 4 mg every 4 weeks (n = 89) for 6 months. Primary endpoint was clinical response rate as assessed by mammogram readings. The study was terminated prematurely due to insufficient recruitment. We report here on an exploratory analysis of this data. Results Central assessment of tumor sizes during the treatment period was available for 131 patients (66 LET, 65 LET + ZOL). Clinical responses (complete or partial) were seen in 54.5% (95% CI: 41.8-66.9) of the patients in the LET arm and 69.2% (95% CI: 56.6-80.1) of those in the LET + ZOL arm (P = 0.106). A multivariate model showed an OR of 1.72 (95% CI: 0.83-3.59) for the experimental arm. Conclusion No increase in the clinical response rate was observed with the addition of ZOL to a neoadjuvant treatment regimen with LET. However a trend towards a better reponse in the LET + ZOL arm could be observed. This trend is consistent with previous studies that have investigated the addition of ZOL to chemotherapy, and it may support the evidence for a direct antitumor action of zoledronic acid. PMID:24499441

AIO LQ-0110: a randomized phase II trial comparing oral doxycycline versus local administration of erythromycin as preemptive treatment strategies of panitumumab-mediated skin toxicity in patients with metastatic colorectal cancer.

PubMed

Kripp, Melanie; Prasnikar, Nicole; Vehling-Kaiser, Ursula; Quidde, Julia; Al-Batran, Salah-Eddin; Stein, Alexander; Neben, Kai; Hannig, Carla Verena; Tessen, Hans Werner; Trarbach, Tanja; Hinke, Axel; Hofheinz, Ralf-Dieter

2017-12-01

Dermatologic toxicities, especially akne-like skin rash, are the most common side-effects associated with anti-epidermal growth factor receptor (EGFR) therapy. Preemptive treatment with oral tetracyclines is recommended as a standard. Topical prophylactic options have thus far not been compared to tetracyclines. In the current study, we sought to establish an alternative topical treatment. In this multicentre, randomized, open-label phase II study patients with (K)Ras-wildtype colorectal cancer receiving panitumumab were randomized (1:1) to receive either doxycycline 100 mg b.i.d. (standard arm) or erythromycin ointment 2% followed by doxycycline in case of insufficient activity. The primary endpoint was the percentage of patients developing no skin toxicity ≥ grade 2 at any time during the first 8 weeks of panitumumab treatment. Skin toxicity was assessed using the NCI CTCAE v 4.0. Secondary endpoints comprised the assessment of skin toxicity using a more thorough grading system (WoMo score), evaluation of skin-related (DLQI) and global quality of life (EORTC QLQ C30). In total, 88 patients were included in this trial. 69% of the patients in the erythromycin arm suffered from skin toxicity of grade ≥ 2 versus 63% in the standard arm ( P = n.s .). However, as per WoMo score significantly more patients in the erythromycin arm developed moderate or severe skin toxicity at earlier time points. Skin related and overall quality of life was comparable between both arms. Based on this data erythromycin cannot be regarded as an alternative to doxycycline as prevention of EGFR-related skin toxicity.

Efficacy of different therapy regimes of low-power laser in painful osteoarthritis of the knee: a double-blind and randomized-controlled trial.

PubMed

Gur, Ali; Cosut, Abdulkadir; Sarac, Aysegul Jale; Cevik, Remzi; Nas, Kemal; Uyar, Asur

2003-01-01

A prospective, double-blind, randomized, and controlled trial was conducted in patients with knee osteoarthritis (OA) to evaluate the efficacy of infrared low-power Gallium-Arsenide (Ga-As) laser therapy (LPLT) and compared two different laser therapy regimes. Ninety patients were randomly assigned to three treatment groups by one of the nontreating authors by drawing 1 of 90 envelopes labeled 'A' (Group I: actual LPLT consisted of 5 minutes, 3 J total dose + exercise; 30 patients), 'B' (Group II: actual LPLT consisted of 3 minutes, 2 J total dose + exercise; 30 patients), and 'C' (Group III: placebo laser group + exercise; 30 patients). All patients received a total of 10 treatments, and exercise therapy program was continued during study (14 weeks). Subjects, physician, and data analysts were unaware of the code for active or placebo laser until the data analysis was complete. All patients were evaluated with respect to pain, degree of active knee flexion, duration of morning stiffness, painless walking distance and duration, and the Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC) at week 0, 6, 10, and 14. Statistically significant improvements were indicated in respect to all parameters such as pain, function, and quality of life (QoL) measures in the post-therapy period compared to pre-therapy in both active laser groups (P < 0.01). Improvements in all parameters of the Group I and in parameters, such as pain and WOMAC of the Group II, were more statistically significant when compared with placebo laser group (P < 0.05). Our study demonstrated that applications of LPLT in different dose and duration have not affected results and both therapy regimes were a safe and effective method in treatment of knee OA. Copyright 2003 Wiley-Liss, Inc.

Comparison between group and personal rehabilitation for dementia in a geriatric health service facility: single-blinded randomized controlled study.

PubMed

Tanaka, Shigeya; Honda, Shin; Nakano, Hajime; Sato, Yuko; Araya, Kazufumi; Yamaguchi, Haruyasu

2017-05-01

The aim of this study was to compare the effects of rehabilitation involving group and personal sessions on demented participants. This single-blinded randomized controlled trial included 60 elderly participants with dementia in a geriatric health service facility, or R oken. Staff members, who did not participate in the intervention, examined cognitive function, mood, communication ability, severity of dementia, objective quality of life, vitality, and daily behaviour. After a baseline assessment, participants were randomly divided into three groups: (i) group intervention; (ii) personal intervention; and (iii) control. The 1-h group intervention (3-5 subjects) and 20-min personal intervention (one staff member per participant) were performed twice a week for 12 weeks (24 total sessions). The cognitive rehabilitation programme consisted of reminiscence, reality orientation, and physical exercise, and it was based on five principles of brain-activating rehabilitation; (i) pleasant atmosphere; (ii) communication; (iii) social roles; (iv) praising; and (v) errorless support. Data were analyzed after the second assessment. Outcome measures were analyzed in 43 participants-14 in the control group, 13 in group intervention, and 16 in personal intervention. Repeated measure ancova showed a significant interaction for cognitive function score (Mini-Mental State Examination) between group intervention and controls ( F  = 5.535, P = 0.029). In the post-hoc analysis, group intervention showed significant improvement (P = 0.016). Global severity of dementia tended to improve (P = 0.094) in group intervention compared to control (Mann-Whitney U -test). There were no significant interactions or improvements for other measurements. Group rehabilitation for dementia is more effective for improving cognitive function and global severity of dementia than personal rehabilitation in Roken. © 2016 Japanese Psychogeriatric Society.

Effect of Eischens Yoga During Radiation Therapy on Prostate Cancer Patient Symptoms and Quality of Life: A Randomized Phase II Trial.

PubMed

Ben-Josef, Avital Mazar; Chen, Jerry; Wileyto, Paul; Doucette, Abigail; Bekelman, Justin; Christodouleas, John; Deville, Curtiland; Vapiwala, Neha

2017-08-01

A randomized phase II study was performed to measure the potential therapeutic effects of yoga on fatigue, erectile dysfunction, urinary incontinence, and overall quality of life (QOL) in prostate cancer (PCa) patients undergoing external beam radiation therapy (RT). The participants were randomized to yoga and no-yoga cohorts (1:1). Twice-weekly yoga interventions were offered throughout the 6- to 9-week courses of RT. Comparisons of standardized assessments were performed between the 2 cohorts for the primary endpoint of fatigue and the secondary endpoints of erectile dysfunction, urinary incontinence, and QOL before, during, and after RT. From October 2014 to January 2016, 68 eligible PCa patients underwent informed consent and agreed to participate in the study. Of the 68 patients, 18 withdrew early, mostly because of treatment schedule-related time constraints, resulting in 22 and 28 patients in the yoga and no-yoga groups, respectively. Throughout treatment, those in the yoga arm reported less fatigue than those in the control arm, with global fatigue, effect of fatigue, and severity of fatigue subscales showing statistically significant interactions (P<.0001). The sexual health scores (International Index of Erectile Function Questionnaire) also displayed a statistically significant interaction (P=.0333). The International Prostate Symptom Score revealed a statistically significant effect of time (P<.0001) but no significant effect of treatment (P=.1022). The QOL measures had mixed results, with yoga having a significant time by treatment effect on the emotional, physical, and social scores but not on functional scores. A structured yoga intervention of twice-weekly classes during a course of RT was associated with a significant reduction in pre-existing and RT-related fatigue and urinary and sexual dysfunction in PCa patients. Copyright © 2017 Elsevier Inc. All rights reserved.

Preoperative chemoradiation with paclitaxel-carboplatin or with fluorouracil-oxaliplatin-folinic acid (FOLFOX) for resectable esophageal and junctional cancer: the PROTECT-1402, randomized phase 2 trial.

PubMed

Messager, Mathieu; Mirabel, Xavier; Tresch, Emmanuelle; Paumier, Amaury; Vendrely, Véronique; Dahan, Laetitia; Glehen, Olivier; Vasseur, Frederique; Lacornerie, Thomas; Piessen, Guillaume; El Hajbi, Farid; Robb, William B; Clisant, Stéphanie; Kramar, Andrew; Mariette, Christophe; Adenis, Antoine

2016-05-18

Often curative treatment for locally advanced resectable esophageal or gastro-esophageal junctional cancer consists of concurrent neoadjuvant radiotherapy and chemotherapy followed by surgery. Currently, one of the most commonly used chemotherapy regimens in this setting is a combination of a fluoropyrimidin and of a platinum analogue. Due to the promising results of the recent CROSS trial, another regimen combining paclitaxel and carboplatin is also widely used by European and American centers. No clinical study has shown the superiority of one treatment over the other. The objective of this Phase II study is to clarify clinical practice by comparing these two chemotherapy treatments. Our aim is to evaluate, in operable esophageal and gastro-esophageal junctional cancer, the complete resection rate and severe postoperative morbidity rate associated with these two neoadjuvant chemotherapeutic regimens (carboplatin-paclitaxel or fluorouracil-oxaliplatin-folinic acid) when each is combined with the radiation regime utilized in the CROSS trial. PROTECT is a prospective, randomized, multicenter, open arms, phase II trial. Eligible patients will have a histologically confirmed adenocarcinoma or squamous cell carcinoma and be treated with neoadjuvant radiochemotherapy followed by surgery for stage IIB or stage III resectable esophageal cancer. A total of 106 patients will be randomized to receive either 3 cycles of FOLFOX combined to concurrent radiotherapy (41.4 Grays) or carboplatin and paclitaxel with the same radiation regimen, using a 1:1 allocation ratio. This ongoing trial offers the unique opportunity to compare two standards of chemotherapy delivered with a common regimen of preoperative radiation, in the setting of operable locally advanced esophageal or gastro-esophageal junctional tumors. NCT02359968 (ClinicalTrials.gov) (registration date: 9 FEB 2015), EudraCT: 2014-000649-62 (registration date: 10 FEB 2014).

Socket preservation by beta-tri-calcium phosphate with collagen compared to platelet-rich fibrin: A clinico-radiographic study

PubMed Central

Das, Swati; Jhingran, Rajesh; Bains, Vivek Kumar; Madan, Rohit; Srivastava, Ruchi; Rizvi, Iram

2016-01-01

Objectives: This study was primarily designed to determine the clinico-radiographic efficacy of platelet-rich fibrin (PRF) and beta-tri-calcium phosphate with collagen (β-TCP-Cl) in preserving extraction sockets. Materials and Methods: For Group I (PRF), residual sockets (n = 15) were filled with autologous PRF obtained from patients' blood; and for Group II (β-TCP-Cl), residual sockets (n = 15) were filled with β-TCP-Cl. For the sockets randomly selected for Group II (β-TCP-Cl), the reshaped Resorbable Tissue Replacement cone was inserted into the socket. Results: Clinically, there was a significantly greater decrease in relative socket depth, but apposition in midcrestal height in Group II (β-TCP-Cl) as compared to Group I (PRF), whereas more decrease in buccolingual width of Group I (PRF) than Group II (β-TCP-Cl) after 6 months. Radiographically, the mean difference in socket height, residual ridge, and width (coronal, middle, and apical third of socket) after 6 months was higher in Group I (PRF) as compared to Group II (β-TCP-Cl). The mean density (in Hounsfield Units) at coronal, middle, and apical third of socket was higher in Group I (PRF) as compared to Group II (β-TCP-Cl). There were statistically significant apposition and resorption for Group I (PRF) whereas nonsignificant resorption and significant apposition for Group II (β-TCP-Cl) in buccal and lingual/palatal cortical plate, respectively, at 6 months on computerized tomography scan. Conclusion: The use of either autologous PRF or β-TCP-Cl was effective in socket preservation. Results obtained from PRF were almost similar to β-TCP-Cl; therefore being autologous, nonimmune, cost-effective, easily procurable regenerative biomaterial, PRF proves to be an insight into the future biofuel for regeneration. PMID:27095909

Socket preservation by beta-tri-calcium phosphate with collagen compared to platelet-rich fibrin: A clinico-radiographic study.

PubMed

Das, Swati; Jhingran, Rajesh; Bains, Vivek Kumar; Madan, Rohit; Srivastava, Ruchi; Rizvi, Iram

2016-01-01

This study was primarily designed to determine the clinico-radiographic efficacy of platelet-rich fibrin (PRF) and beta-tri-calcium phosphate with collagen (β-TCP-Cl) in preserving extraction sockets. For Group I (PRF), residual sockets (n = 15) were filled with autologous PRF obtained from patients' blood; and for Group II (β-TCP-Cl), residual sockets (n = 15) were filled with β-TCP-Cl. For the sockets randomly selected for Group II (β-TCP-Cl), the reshaped Resorbable Tissue Replacement cone was inserted into the socket. Clinically, there was a significantly greater decrease in relative socket depth, but apposition in midcrestal height in Group II (β-TCP-Cl) as compared to Group I (PRF), whereas more decrease in buccolingual width of Group I (PRF) than Group II (β-TCP-Cl) after 6 months. Radiographically, the mean difference in socket height, residual ridge, and width (coronal, middle, and apical third of socket) after 6 months was higher in Group I (PRF) as compared to Group II (β-TCP-Cl). The mean density (in Hounsfield Units) at coronal, middle, and apical third of socket was higher in Group I (PRF) as compared to Group II (β-TCP-Cl). There were statistically significant apposition and resorption for Group I (PRF) whereas nonsignificant resorption and significant apposition for Group II (β-TCP-Cl) in buccal and lingual/palatal cortical plate, respectively, at 6 months on computerized tomography scan. The use of either autologous PRF or β-TCP-Cl was effective in socket preservation. Results obtained from PRF were almost similar to β-TCP-Cl; therefore being autologous, nonimmune, cost-effective, easily procurable regenerative biomaterial, PRF proves to be an insight into the future biofuel for regeneration.

Effects of aerobic exercise training on ACE and ADRB2 gene expression, plasma angiotensin II level, and flow-mediated dilation: a study on obese postmenopausal women with prehypertension.

PubMed

Azadpour, Noushin; Tartibian, Bakhtyar; Koşar, Şükran Nazan

2017-03-01

The purpose of this study is to determine the effect of 10 weeks of moderate-intensity aerobic exercise training (MIET) on blood pressure (BP), angiotensin-converting enzyme (ACE) and β2-adrenergic receptor (ADRB2) gene expression in leukocytes, plasma angiotensin II (Ang II), and flow-mediated dilation (FMD) in obese postmenopausal women (PMW) with prehypertension. Twenty-four obese prehypertensive PMW (aged 50-70 y; body mass index ≥30 kg/m) randomly assigned to control (n = 12) and exercise (n = 12) groups. Exercise group performed MIET (25-40 min/d, 3 d/wk at 50%-70% of heart rate reserve) for 10 weeks. Control group maintained their normal daily physical activity level. Body composition, VO2max, BP, ACE and ADRB2 gene expression, plasma Ang II, and FMD were measured before and after the training program. After MIET, systolic and diastolic BPs decreased by 4.6% and 2.4%, respectively (P < 0.001). Plasma Ang II level decreased by 45.7%, whereas FMD increased by 86% in the exercise group (P < 0.001). Exercise training resulted in a threefold increase in ADRB2 and a fourfold decrease in ACE gene expressions (P < 0.05). Training-induced changes in BP inversely associated with the changes in FMD and ADRB2 (r values range -0.55 to -0.78), and positively associated with Ang II and ACE (r values range 0.68-0.86) (P < 0.001). Ten weeks of MIET modulates ACE and ADRB2 gene expression, decreases Ang II plasma levels, and improves endothelial function in obese PMW, and these alterations are associated with reduction in BP.

Practical management of patients with myelofibrosis receiving ruxolitinib.

PubMed

Harrison, Claire; Mesa, Ruben; Ross, David; Mead, Adam; Keohane, Clodagh; Gotlib, Jason; Verstovsek, Srdan

2013-10-01

Myelofibrosis (MF) is characterized by bone marrow fibrosis, progressive anemia and extramedullary hematopoiesis, primarily manifested as splenomegaly. Patients also experience debilitating constitutional symptoms, including sequelae of splenomegaly, night sweats and fatigue. Ruxolitinib (INC424, INCB18424, Jakafi, Jakavi), a JAK1 and JAK2 inhibitor, was approved in November 2011 by the US FDA for the treatment of intermediate- or high-risk MF, and more recently in Europe and Canada for the treatment of MF-related splenomegaly or symptoms. These approvals were based on data from two randomized Phase III studies: COMFORT-I randomized against placebo, and COMFORT-II randomized against best available therapy. In these studies, ruxolitinib rapidly improved multiple disease manifestations of MF, reducing splenomegaly and improving quality of life of patients and potentially prolonging survival. However, as with other chemotherapies, ruxolitinib therapy is associated with some adverse events, such as anemia and thrombocytopenia. The aims of this article are to provide a brief overview of ruxolitinib therapy, to discuss some common adverse events associated with ruxolitinib therapy and to provide clinical management recommendations to maximize patients' benefit from ruxolitinib.

Antibiotic prophylaxis at elective cesarean section: a randomized controlled trial in a low resource setting.

PubMed

Kandil, Mohamed; Sanad, Zakaria; Gaber, Wael

2014-04-01

To determine the best time to administer prophylactic antibiotics at Cesarean delivery in order to reduce the postoperative maternal infectious morbidity in a low resource setting. One hundred term primigravidae with singleton pregnancy were recruited and randomly allocated to two equal groups. Each woman received 2 g intravenous Cefazoline. Women in Group I received it prior to skin incision while those in Group II had it immediately after cord clamping. We measured the following outcome parameters: (1) Surgical site wound infection; (2) Endometritis and (3) Urinary tract infection. There was no significant difference in any of the patients' characteristics between both groups. In Group I, three cases developed surgical site infections but four in Group II (p > 0.05). In Group I, the infected cases had Cesarean because of malpresentations while in Group II, two cases had Cesarean because of patients' request, one because of maternal heart disease and one due to intra-uterine growth restriction. Seven and nine cases had urinary tract infection in Groups I and II, respectively, (p > 0.05). Prophylactic antibiotic administration either prior to surgery or after cord clamping is probably equally effective in reducing the postoperative infectious morbidity after Cesarean in low resource settings.

Rationale, study design, and implementation of the ACS1 study: effect of azilsartan on circadian and sleep blood pressure as compared with amlodipine.

PubMed

Kario, Kazuomi; Hoshide, Satoshi

2014-06-01

The ACS1 (Azilsartan Circadian and Sleep Pressure - the first study) is a multicenter, randomized, open-label, two parallel-group study carried out to investigate the efficacy of an 8-week oral treatment with azilsartan 20 mg in comparison with amlodipine 5 mg. The patients with stage I or II primary hypertension will be randomly assigned to either an azilsartan group (n=350) or an amlodipine group (n=350). The primary endpoint is a change in nocturnal systolic blood pressure (BP) as measured by ambulatory BP monitoring at the end of follow-up relative to the baseline level during the run-in period. In addition, we will carry out the same analysis after dividing four different nocturnal BP dipping statuses (extreme-dippers, dippers, nondipper, and risers). The findings of this study will help in establishing an appropriate antihypertensive treatment for hypertensive patients with a disrupted circadian BP rhythm.

Rationale, study design, and implementation of the ACS1 study: effect of azilsartan on circadian and sleep blood pressure as compared with amlodipine

PubMed Central

Hoshide, Satoshi

2014-01-01

Objective The ACS1 (Azilsartan Circadian and Sleep Pressure – the first study) is a multicenter, randomized, open-label, two parallel-group study carried out to investigate the efficacy of an 8-week oral treatment with azilsartan 20 mg in comparison with amlodipine 5 mg. Materials and methods The patients with stage I or II primary hypertension will be randomly assigned to either an azilsartan group (n=350) or an amlodipine group (n=350). The primary endpoint is a change in nocturnal systolic blood pressure (BP) as measured by ambulatory BP monitoring at the end of follow-up relative to the baseline level during the run-in period. In addition, we will carry out the same analysis after dividing four different nocturnal BP dipping statuses (extreme-dippers, dippers, nondipper, and risers). Conclusion The findings of this study will help in establishing an appropriate antihypertensive treatment for hypertensive patients with a disrupted circadian BP rhythm. PMID:24637789

Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (II) Physiological and Symptomatic Responses of Early-Postmenopausal Women to Standardized doses of Maca in Double Blind, Randomized, Placebo-Controlled, Multi-Centre Clinical Study.

PubMed

Meissner, H O; Mscisz, A; Reich-Bilinska, H; Kapczynski, W; Mrozikiewicz, P; Bobkiewicz-Kozlowska, T; Kedzia, B; Lowicka, A; Barchia, I

2006-12-01

This was a double-blind, randomized, placebo-corrected, outpatient, multi-centre (five sites) clinical study, in which a total of 168 Caucasian early-postmenopausal women volunteers (age>49 years) participated after fulfilling the criteria: follicle stimulating hormone (FSH) >30 IU/ml and estrogen (E2) <40 pg/ml levels at admission. They were randomly allocated to Placebo and Pre-Gelatinized Organic Maca (Maca-GO) treatment, according to different monthly treatment sequences scheduled for each site. Two 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/day) during three (Trial I; n=102) or four (Trial II; n=66) months study periods. At the baseline and follow- up monthly intervals, blood levels of FSH, E2, progesterone (PRG) and lutinizing hormone (LH), as well as serum cholesterol (CHOL), triglycerides (TRG), high- and low density lipoproteins (HDL and LDL) were measured. Menopausal symptoms were assessed according to Greene's Score (GMS) and Kupperman's Index (KMI). Data were analyzed using multivariate technique on blocs of monthly results in one model and Maca versus Placebo contrast in another model. A total of 124 women concluded the study. Maca-GO significantly stimulated production of E2 (P<0.001) with a simultaneous suppression (P<0.05) of blood FSH, increase (P<0.05) in HDL. Maca-GO significantly reduced both frequency and severity of individual menopausal symptoms (hot flushes and night sweating in particular) resulting in significant (P<0.001) alleviation of KMI (from 22 to 10), thus, offering an attractive non-hormonal addition to the choices available to early-postmenopausal women in the form of a natural plant alternative to Hormone Replacement Therapy (HRT) - hence, reducing dependence on hormone therapy programs.

Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (II) Physiological and Symptomatic Responses of Early-Postmenopausal Women to Standardized doses of Maca in Double Blind, Randomized, Placebo-Controlled, Multi-Centre Clinical Study

PubMed Central

Meissner, H. O.; Mscisz, A.; Reich-Bilinska, H.; Kapczynski, W.; Mrozikiewicz, P.; Bobkiewicz-Kozlowska, T.; Kedzia, B.; Lowicka, A.; Barchia, I.

2006-01-01

This was a double-blind, randomized, placebo-corrected, outpatient, multi-centre (five sites) clinical study, in which a total of 168 Caucasian early-postmenopausal women volunteers (age>49 years) participated after fulfilling the criteria: follicle stimulating hormone (FSH) >30 IU/ml and estrogen (E2) <40 pg/ml levels at admission. They were randomly allocated to Placebo and Pre-Gelatinized Organic Maca (Maca-GO) treatment, according to different monthly treatment sequences scheduled for each site. Two 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/day) during three (Trial I; n=102) or four (Trial II; n=66) months study periods. At the baseline and follow- up monthly intervals, blood levels of FSH, E2, progesterone (PRG) and lutinizing hormone (LH), as well as serum cholesterol (CHOL), triglycerides (TRG), high- and low density lipoproteins (HDL and LDL) were measured. Menopausal symptoms were assessed according to Greene’s Score (GMS) and Kupperman’s Index (KMI). Data were analyzed using multivariate technique on blocs of monthly results in one model and Maca versus Placebo contrast in another model. A total of 124 women concluded the study. Maca-GO significantly stimulated production of E2 (P<0.001) with a simultaneous suppression (P<0.05) of blood FSH, increase (P<0.05) in HDL. Maca-GO significantly reduced both frequency and severity of individual menopausal symptoms (hot flushes and night sweating in particular) resulting in significant (P<0.001) alleviation of KMI (from 22 to 10), thus, offering an attractive non-hormonal addition to the choices available to early-postmenopausal women in the form of a natural plant alternative to Hormone Replacement Therapy (HRT) – hence, reducing dependence on hormone therapy programs. PMID:23675005

The effects of sour tea (Hibiscus sabdariffa) on hypertension in patients with type II diabetes.

PubMed

Mozaffari-Khosravi, H; Jalali-Khanabadi, B-A; Afkhami-Ardekani, M; Fatehi, F; Noori-Shadkam, M

2009-01-01

To compare the antihypertensive effectiveness of sour tea (ST; Hibiscus sabdariffa) with black tea (BT) infusion in diabetic patients, this double-blind randomized controlled trial was carried out. Sixty diabetic patients with mild hypertension, without taking antihypertensive or antihyperlipidaemic medicines, were recruited in the study. The patients were randomly allocated to the ST and BT groups and instructed to drink ST and BT infusions two times a day for 1 month. Their blood pressure (BP) was measured on days 0, 15 and 30 of the study. The mean of systolic BP (SBP) in the ST group decreased from 134.4+/-11.8 mm Hg at the beginning of the study to 112.7+/-5.7 mm Hg after 1 month (P-value <0.001), whereas this measure changed from 118.6+/-14.9 to 127.3+/-8.7 mm Hg (P-value=0.002) in the BT group during the same period. The intervention had no statistically significant effect on the mean of diastolic BP (DBP) in either the ST or BT group. The mean pulse pressure (PP) of the patients in the ST group decreased from 52.2+/-12.2 to 34.5+/-9.3 mm Hg (P-value <0.001) during the study, whereas in the BT group, it increased from 41.9+/-11.7 to 47.3+/-9.6 mm Hg (P-value=0.01). In conclusion, consuming ST infusion had positive effects on BP in type II diabetic patients with mild hypertension. This study supports the results of similar studies in which antihypertensive effects have been shown for ST.

CHBPR: ANGIOTENSIN II, INDEPENDENT OF PLASMA RENIN ACTIVITY, CONTRIBUTES TO THE HYPERTENSION OF AUTONOMIC FAILURE

PubMed Central

Arnold, Amy C.; Okamoto, Luis E.; Gamboa, Alfredo; Shibao, Cyndya; Raj, Satish R.; Robertson, David; Biaggioni, Italo

2013-01-01

At least half of primary autonomic failure patients exhibit supine hypertension, despite profound impairments in sympathetic activity. While the mechanisms underlying this hypertension are unknown, plasma renin activity is often undetectable suggesting renin-angiotensin pathways are not involved. However, because aldosterone levels are preserved, we tested the hypothesis that angiotensin II is intact and contributes to the hypertension of autonomic failure. Indeed, circulating angiotensin II was paradoxically increased in hypertensive autonomic failure patients (52±5 pg/ml, n=11) compared to matched healthy controls (27±4 pg/ml, n=10; p=0.002), despite similarly low renin activity (0.19±0.06 versus 0.34±0.13 ng/ml/hr, respectively; p=0.449). To determine the contribution of angiotensin II to supine hypertension in these patients, we administered the AT1 receptor blocker losartan (50 mg) at bedtime in a randomized, double-blind, placebo-controlled study (n=11). Losartan maximally reduced systolic blood pressure by 32±11 mmHg at 6 hours after administration (p<0.05), decreased nocturnal urinary sodium excretion (p=0.0461), and did not worsen morning orthostatic tolerance. In contrast, there was no effect of the captopril on supine blood pressure in a subset of these patients. These findings suggest that angiotensin II formation in autonomic failure is independent of plasma renin activity, and perhaps angiotensin converting enzyme. Furthermore, these studies suggest that elevations in angiotensin II contribute to the hypertension of autonomic failure, and provide rationale for the use of AT1 receptor blockers for treatment of these patients. PMID:23266540

Transgenic mice overexpressing insulin-like growth factor-II in β cells develop type 2 diabetes

PubMed Central

Devedjian, Jean-Christophe; George, Monica; Casellas, Alba; Pujol, Anna; Visa, Joana; Pelegrín, Mireia; Gros, Laurent; Bosch, Fatima

2000-01-01

During embryonic development, insulin-like growth factor-II (IGF-II) participates in the regulation of islet growth and differentiation. We generated transgenic mice (C57BL6/SJL) expressing IGF-II in β cells under control of the rat Insulin I promoter in order to study the role of islet hyperplasia and hyperinsulinemia in the development of type 2 diabetes. In contrast to islets from control mice, islets from transgenic mice displayed high levels of IGF-II mRNA and protein. Pancreases from transgenic mice showed an increase in β-cell mass (about 3-fold) and in insulin mRNA levels. However, the organization of cells within transgenic islets was disrupted, with glucagon-producing cells randomly distributed throughout the core. We also observed enhanced glucose-stimulated insulin secretion and glucose utilization in islets from transgenic mice. These mice displayed hyperinsulinemia, mild hyperglycemia, and altered glucose and insulin tolerance tests, and about 30% of these animals developed overt diabetes when fed a high-fat diet. Furthermore, transgenic mice obtained from the N1 backcross to C57KsJ mice showed high islet hyperplasia and insulin resistance, but they also developed fatty liver and obesity. These results indicate that local overexpression of IGF-II in islets might lead to type 2 diabetes and that islet hyperplasia and hypersecretion of insulin might occur early in the pathogenesis of this disease. PMID:10727441

A Phase II Randomized Trial (GO27827) of First‐Line FOLFOX Plus Bevacizumab with or Without the MET Inhibitor Onartuzumab in Patients with Metastatic Colorectal Cancer

PubMed Central

Hochster, Howard; Hart, Lowell L.; Firdaus, Irfan; Mace, Joseph R.; McFarlane, Joshua J.; Kozloff, Mark; Catenacci, Daniel; Hsu, Jessie J.; Hack, Stephen P.; Shames, David S.; Phan, See‐Chun; Koeppen, Hartmut; Cohn, Allen L.

2017-01-01

Abstract Background. Dysregulated hepatocyte growth factor/mesenchymal‐epithelial transition (MET) signaling is associated with poor prognosis and resistance to vascular endothelial growth factor inhibition in metastatic colorectal cancer (mCRC). We report outcomes from a double‐blind, multicenter phase II trial of the MET inhibitor onartuzumab in combination with mFOLFOX‐6 and bevacizumab for mCRC (GO27827; NCT01418222). Materials and Methods. Patients were randomized 1:1 to receive onartuzumab (10 mg/kg intravenously [IV]) or placebo plus mFOLFOX‐6 and bevacizumab (5 mg/kg IV). Oxaliplatin was given for 8–12 cycles; other agents were continued until disease progression, unacceptable toxicity, or death. The primary endpoint was progression‐free survival (PFS) in the intent‐to‐treat (ITT) and MET immunohistochemistry (IHC) expression‐positive populations. Results. Between September 2011 and November 2012, 194 patients were enrolled. In September 2013, an interim analysis recommended stopping onartuzumab treatment due to lack of efficacy. At the time of the final analysis in February 2014, no significant improvement in PFS was seen with onartuzumab versus placebo in either the ITT or MET IHC‐positive populations. An improvement in PFS was noted in the MET IHC‐negative population. Neither overall survival nor response rate was improved with onartuzumab. The incidence of fatigue, peripheral edema, and deep vein thrombosis was increased with onartuzumab relative to placebo. Conclusion. Onartuzumab combined with mFOLFOX‐6 and bevacizumab did not significantly improve efficacy outcomes in either the ITT or MET IHC‐positive populations. MET expression by IHC was not a predictive biomarker in this setting. Implications for Practice. The addition of onartuzumab to mFOLFOX‐6 plus bevacizumab did not improve outcomes in patients with previously untreated metastatic colorectal cancer in this randomized, phase II study. Although initial results with onartuzumab were promising, a number of phase II/III clinical trials have reported a lack of improvement in efficacy with onartuzumab combined with standard‐of‐care therapies in several tumor types. Furthermore, negative study data have been published for rilotumumab and ficlatuzumab, both of which block hepatocyte growth factor binding to the mesenchymal‐epithelial transition (MET) receptor. MET immunohistochemistry was not a predictive biomarker. It remains to be seen if other biomarkers or small molecule inhibitors may be more appropriate for inhibiting this oncogenic pathway. PMID:28209746

Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop.

PubMed

Chambrone, Leandro; Tatakis, Dimitris N

2015-02-01

This paper aims to create a "bridge" between research and practice by developing a practical, extensive, and clinically relevant study that translates evidence-based findings on soft tissue root coverage (RC) of recession-type defects to daily clinical practice. This review is prepared in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement based on the proposed focused questions. A literature search with no restrictions regarding status or the language of publication was performed for MEDLINE and EMBASE databases up to and including June 2013. Systematic reviews (SRs), randomized clinical trials, controlled clinical trials, case series, and case reports evaluating recession areas that were treated by means of RC procedures were considered eligible for inclusion through the three parts of the study (part I, an overview of the base of SRs; part II, an alternative random-effects meta-analyses on mean percentage of RC and sites exhibiting complete RC; and part III, an SR of non-randomized trials exploring other conditions not extensively evaluated by previous SRs). Data on Class I, II, III, and IV recessions, type of histologic attachment achieved with treatment, recipient- and donor-site anatomic characteristics, smoking-related outcomes, root surface conditions, tooth type and location, long-term effectiveness outcomes, unusual conditions that may be reported during conventional daily practice, and patient-centered outcomes were assessed as well. Of the 2,456 potentially eligible trials, 234 were included. Data on Class I, II, III, and IV gingival recessions, histologic attachment achieved after treatment, recipient- and donor-site anatomic characteristics, smoking-related outcomes, root surface conditions/biomodification, tooth type and location, long-term effectiveness outcomes and unusual conditions that may be reported during conventional daily practice, and patient-centered outcomes (i.e., esthetic, visual analog scale, complications, hypersensitivity, patients perceptions) were assessed. Subepithelial connective tissue (CT)-based procedures and coronally advanced flap plus acellular dermal matrix grafts, enamel matrix derivative, or collagen matrix led to the best improvements of recession depth, clinical attachment level (CAL) gain, and keratinized tissue (KT). Some conditions, such as smoking and use of magnification, may affect RC outcomes. All RC procedures can provide significant reduction in recession depth and CAL gain for Miller Class I and II recession-type defects. Subepithelial CT graft-based procedures provided the best outcomes for clinical practice because of their superior percentages of mean and complete RC, as well as significant increase of KT.

Effect of fluoroscopically guided caudal epidural steroid or local anesthetic injections in the treatment of lumbar disc herniation and radiculitis: a randomized, controlled, double blind trial with a two-year follow-up.

PubMed

Manchikanti, Laxmaiah; Singh, Vijay; Cash, Kimberly A; Pampati, Vidyasagar; Damron, Kim S; Boswell, Mark V

2012-01-01

Lumbar disc herniation and radiculitis are common elements of low back and lower extremity pain. Among minimally invasive treatments, epidural injections are one of the most commonly performed interventions. However, the literature is mixed about their effectiveness in managing low back and lower extremity pain. In general, individual studies and systematic reviews of epidural steroid injections have been hampered by their study design, baseline differences between treatment groups, inadequate sample sizes, highly controlled settings, lack of validated outcome measures, and the inability to confirm the injectate location because fluoroscopy was not used. A randomized, controlled, double blind, active control trial. A private, interventional pain management practice, specialty referral center in the United States. To assess the effectiveness of fluoroscopically directed caudal epidural injections with local anesthetic with or without steroids in managing chronic low back and lower extremity pain in patients with disc herniation and radiculitis. One hundred twenty patients were randomized to two groups: Group I received 10 mL caudal epidural injections of local anesthetic, lidocaine 0.5%; Group II patients received caudal epidural injections of 0.5% lidocaine, 9 mL, mixed with 1 mL of steroid. Multiple outcome measures were utilized. The primary outcome measures were Numeric Rating Scale (NRS) and the Oswestry Disability Index 2.0 (ODI). Secondary outcome measures were employment status and opioid intake. Significant pain relief improvement was defined as 50% or more improvement in NRS and ODI scores. In the successful category, 77% of Group I had significant pain relief of >/= 50% and functional status improvement of >/= 50% reduction in ODI scores; in Group II it was 76%, whereas overall it was 60% and 65% in Groups I and II. Over the two years, Group I had an average number of procedures of 5.5 ± 2.8; Group II was 5.3 ± 2.4. Even though there was no significant difference in overall relief between the two groups, the average relief for each procedure was superior for steroids. Presumed limitations of this evaluation include lack of a placebo group. Caudal epidural injections of local anesthetic with or without steroids might be an effective therapy for patients with disc herniation or radiculitis. The present evidence illustrates the potential superiority of steroids compared with local anesthetic at two year follow up based on average relief per procedure. NCT00370799.

A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Every year in Europe about 25,000 infants are born extremely preterm. These infants have a 20% mortality rate, and 25% of survivors have severe long-term cerebral impairment. Preventative measures are key to reduce mortality and morbidity in an extremely preterm population. The primary objective of the SafeBoosC phase II trial is to examine if it is possible to stabilize the cerebral oxygenation of extremely preterm infants during the first 72 hours of life through the application of cerebral near-infrared spectroscopy (NIRS) oximetry and implementation of an clinical treatment guideline based on intervention thresholds of cerebral regional tissue saturation rStO2. Methods/Design SafeBoosC is a randomized, blinded, multinational, phase II clinical trial. The inclusion criteria are: neonates born more than 12 weeks preterm; decision to conduct full life support; parental informed consent; and possibility to place the cerebral NIRS oximeter within 3 hours after birth. The infants will be randomized into one of two groups. Both groups will have a cerebral oximeter monitoring device placed within three hours of birth. In the experimental group, the cerebral oxygenation reading will supplement the standard treatment using a predefined treatment guideline. In the control group, the cerebral oxygenation reading will not be visible and the infant will be treated according to the local standards. The primary outcome is the multiplication of the duration and magnitude of rStO2 values outside the target ranges of 55% to 85%, that is, the ‘burden of hypoxia and hyperoxia’ expressed in ‘%hours’. To detect a 50% difference between the experimental and control group in %hours, 166 infants in total must be randomized. Secondary outcomes are mortality at term date, cerebral ultrasound score, and interburst intervals on an amplitude-integrated electroencephalogram at 64 hours of life and explorative outcomes include neurodevelopmental outcome at 2 years corrected age, magnetic resonance imaging at term, blood biomarkers at 6 and 64 hours after birth, and adverse events. Discussion Cerebral oximetry guided interventions have the potential to improve neurodevelopmental outcome in extremely preterm infants. It is a logical first step to test if it is possible to reduce the burden of hypoxia and hyperoxia. Trial registration ClinicalTrial.gov, NCT01590316 PMID:23782447

Early Intervention for Symptomatic Youth at Risk for Bipolar Disorder: A Randomized Trial of Family-Focused Therapy

ERIC Educational Resources Information Center

Miklowitz, David J.; Schneck, Christopher D.; Singh, Manpreet K.; Taylor, Dawn O.; George, Elizabeth L.; Cosgrove, Victoria E.; Howe, Meghan E.; Dickinson, L. Miriam; Garber, Judy; Chang, Kiki D.

2013-01-01

Objective: Depression and brief periods of (hypo)mania are linked to an increased risk of progression to bipolar I or II disorder (BD) in children of bipolar parents. This randomized trial examined the effects of a 4-month family-focused therapy (FFT) program on the 1-year course of mood symptoms in youth at high familial risk for BD, and explored…

Randomized Phase II Trial of High-Dose Melatonin and Radiation Therapy for RPA Class 2 Patients With Brain Metastases (RTOG 0119)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Berk, Lawrence; Berkey, Brian; Rich, Tyvin

Purpose: To determine if high-dose melatonin for Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) Class 2 patients with brain metastases improved survival over historical controls, and to determine if the time of day melatonin was given affected its toxicity or efficacy. RTOG 0119 was a phase II randomized trial for this group of patients. Methods and Materials: RTOG RPA Class 2 patients with brain metastases were randomized to 20 mg of melatonin, given either in the morning (8-9 AM) or in the evening (8-9 PM). All patients received radiation therapy (30 Gy in 10 fractions) in the afternoon.more » Melatonin was continued until neurologic deterioration or death. The primary endpoint was overall survival time. Neurologic deterioration, as reflected by the Mini-Mental Status Examination, was also measured. Results: Neither of the randomized groups had survival distributions that differed significantly from the historic controls of patients treated with whole-brain radiotherapy. The median survivals of the morning and evening melatonin treatments were 3.4 and 2.8 months, while the RTOG historical control survival was 4.1 months. Conclusions: High-dose melatonin did not show any beneficial effect in this group of patients.« less

Insights from computational analysis of full-length β-ketoacyl-[ACP] synthase-II cDNA isolated from American and African oil palms

PubMed Central

Bhore, Subhash J.; Cha, Thye S.; Amelia, Kassim; Shah, Farida H.

2014-01-01

Background: Palm oil derived from fruits (mesocarp) of African oil palm (Elaeis guineensis Jacq. Tenera) and American oil palm (E. oleifera) is important for food industry. Due to high yield, Elaeis guineensis (Tenera) is cultivated on commercial scale, though its oil contains high (~54%) level of saturated fatty acids. The rate-limiting activity of beta-ketoacyl-[ACP] synthase-II (KAS-II) is considered mainly responsible for the high (44%) level of palmitic acid (C16:0) in the oil obtained from E. guineensis. Objective: The objective of this study was to annotate KAS-II cDNA isolated from American and African oil palms. Materials and Methods: The full-length E. oleifera KAS-II (EoKAS-II) cDNA clone was isolated using random method of gene isolation. Whereas, the E. guineensis KAS-II (EgTKAS-II) cDNA was isolated using reverse transcriptase polymerase chain reaction (RT-PCR) technique; and missing ends were obtained by employing 5’and 3’ RACE technique. Results: The results show that EoKAS-II and EgTKAS-II open reading frames (ORFs) are of 1689 and 1721 bp in length, respectively. Further analysis of the both EoKAS-II and EgTKAS-II predicted protein illustrates that they contains conserved domains for ‘KAS-I and II’, ‘elongating’ condensing enzymes, ‘condensing enzymes super-family’, and ‘3-oxoacyl-[ACP] synthase II’. The predicted protein sequences shows 95% similarity with each other. Consecutively, the three active sites (Cys, His, and His) were identified in both proteins. However, difference in positions of two active Histidine (His) residues was noticed. Conclusion: These insights may serve as the foundation in understanding the variable activity of KAS-II in American and African oil palms; and cDNA clones could be useful in the genetic engineering of oil palms. PMID:24678202

Improved self-management skills in Chinese diabetes patients through a comprehensive health literacy strategy: study protocol of a cluster randomized controlled trial.

PubMed

Xu, Wang Hong; Rothman, Russell L; Li, Rui; Chen, Yingyao; Xia, Qinghua; Fang, Hong; Gao, Junling; Yan, Yujie; Zhou, Peng; Jiang, Yu; Liu, Yinan; Zhou, Fangjia; Wang, Wei; Chen, Minling; Liu, Xiao Yu; Liu, Xiao Na

2014-12-20

Diabetes self-management often involves the interpretation and application of oral, written, or quantitative information. Numerous diabetes patients in China have limited health literacy, which likely leads to poorer clinical outcomes. This study is designed to examine the efficacy and cost-effectiveness of addressing health literacy to improve self-management skills and glycemic control in Chinese diabetes patients. This is a cluster randomized controlled trial (RCT) conducted in 20 community healthcare sites in Shanghai, China. Overall, 800 diabetes patients will be randomized into intervention and control arms and will have a baseline hemoglobin A1c (HbA1c) assay and undergo a baseline survey which includes measures of health literacy and diabetes numeracy using revised Chinese versions of the Health Literacy Management Scale and Diabetes Numeracy Test Scale. During the 1-year period of intervention, while the control group will receive usual care, the intervention group will be supplemented with a comprehensive health literacy strategy which includes i) training healthcare providers in effective health communication skills that address issues related to low literacy, and ii) use of an interactive Diabetes Education Toolkit to improve patient understanding and behaviors. Assessments will be conducted at both patient and healthcare provider levels, and will take place upon admission and after 3, 6, 12, and 24 months of intervention. The primary outcome will be the improvement in HbA1c between Intervention group and Control group patients. Secondary outcomes at the patient level will include improvement in i) clinical outcomes (blood pressure, fasting lipids, body mass index, weight, smoking status), ii) patient reported self-management behaviors, and iii) patient-reported self-efficacy. Outcomes at the provider level will include: i) provider satisfaction and ii) intensity and type of care provided. The effects of the intervention will be examined in multivariable general linear models. Both cost-effectiveness and cost-utility analyses will be performed. The main strengths of this study are its large sample size and RCT design, involvement of both patients and healthcare providers, and the long term follow-up (24-months). This project will help to demonstrate the value of addressing health literacy and health communication to improve self-management and clinical outcomes among Chinese diabetes patients. ISRCTN76130594, Registration date: Sept 22, 2014.

Group patient visits for Parkinson disease: a randomized feasibility trial.

PubMed

Dorsey, E R; Deuel, L M; Beck, C A; Gardiner, I F; Scoglio, N J; Scott, J C; Marshall, F J; Biglan, K M

2011-05-03

Group patient visits are medical appointments shared among patients with a common medical condition. This care delivery method has demonstrated benefits for individuals with chronic conditions but has not been evaluated for Parkinson disease (PD). We conducted a 12-month, randomized trial of group patient visits vs usual (one-on-one) care for patients with PD. Visits were led by one of 3 study physicians, included patients and caregivers, and lasted approximately 90 minutes. Those receiving group visits had 4 sessions over 12 months. The primary outcome measure was feasibility as measured by the ability to recruit participants and by the proportion of participants who completed the study. The primary efficacy outcome was quality of life as measured by the PD Questionnaire-39. Thirty patients and 27 caregivers enrolled in the study. Thirteen of the 15 patients randomized to group patient visits and 14 of the 15 randomized to usual care completed the study. Quality of life measured 12 months after baseline between the 2 groups was not different (25.9 points for group patient visits vs 26.0 points for usual care; p = 0.99). Group patient visits may be a feasible means of providing care to individuals with PD and may offer an alternative or complementary method of care delivery for some patients and physicians. This study provides Class II evidence that group patient visits did not improve quality of life for individuals with PD over a 1-year period.

Phase II study of the tetrahydropyranyl adriamycin-cyclophosphamide, vincristine, and prednisolone regimen combined with rituximab as first-line treatment for elderly patients with diffuse large B-cell lymphoma.

PubMed

Kasahara, Senji; Hara, Takeshi; Tsurumi, Hisashi; Goto, Naoe; Kitagawa, Jun-Ichi; Kanemura, Nobuhiro; Yoshikawa, Takeshi; Goto, Hideko; Fukuno, Kenji; Yamada, Toshiki; Sawada, Michio; Takahashi, Takeshi; Takami, Tsuyoshi; Moriwaki, Hisataka

2011-04-01

The anthracycline drug pirarubicin (tetrahydropyranyl adriamycin; THP) apparently has fewer cardiotoxic effects than doxorubicin. We previously described the benefit of the THP-COP regimen comprising cyclophosphamide, THP, vincristine, and prednisolone for elderly patients with diffuse large B-cell lymphoma (DLBCL). However, that study was completed before rituximab (R) was introduced into clinical practice. Here we report a phase II study of the THP-COP regimen combined with R (R-THP-COP) every 3 weeks. The complete response and 3-year overall survival rates was 63% and 53%, respectively, and no deaths were related to the regimen. We conclude that the R-THP-COP regimen is safe and effective for patients with DLBCL. Based on these results, a randomized controlled trial of rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) and R-THP-COP as a phase III study is ongoing.

Comparison of total oxidant/antioxidant status in unconjugated hyperbilirubinemia of newborn before and after conventional and LED phototherapy: A prospective randomized controlled trial.

PubMed

Demirel, Gamze; Uras, Nurdan; Celik, Istemi H; Aksoy, Hatice T; Oguz, Serife S; Erdeve, Omer; Erel, Ozcan; Dilmen, Ugur

2010-10-01

We evaluated and compared the oxidant and antioxidant status of hyperbilirubinemic infants before and after the two forms of phototherapy: conventional and LED phototherapy, in order to identify the optimal treatment method. Thirty newborns exposed to conventional (Group I) phototherapy and 30 infants exposed to LED phototherapy (Group II) were studied. The serum total antioxidant capacity (TAC) and the total oxidant status (TOS) were assessed by EREL's method. There were no statistically significant differences in TAC or TOS levels between Group I and Group II prior to phototherapy, and no statistically significant difference in TAC levels between the two groups after phototherapy; however, TOS levels were significantly lower in Group II compared to Group I after phototherapy. Oxidative stress index (OSI) increased after conventional phototherapy (p < 0.05) The increase in TOS following conventional phototherapy was not not observed following LED phototherapy. This difference should be considered when using phototherapy.

Comparison of Eye Movement Desensitization Reprocessing and Cognitive Behavioral Therapy as Adjunctive Treatments for Recurrent Depression: The European Depression EMDR Network (EDEN) Randomized Controlled Trial

PubMed Central

Ostacoli, Luca; Carletto, Sara; Cavallo, Marco; Baldomir-Gago, Paula; Di Lorenzo, Giorgio; Fernandez, Isabel; Hase, Michael; Justo-Alonso, Ania; Lehnung, Maria; Migliaretti, Giuseppe; Oliva, Francesco; Pagani, Marco; Recarey-Eiris, Susana; Torta, Riccardo; Tumani, Visal; Gonzalez-Vazquez, Ana I.; Hofmann, Arne

2018-01-01

Background: Treatment of recurrent depressive disorders is currently only moderately successful. Increasing evidence suggests a significant relationship between adverse childhood experiences and recurrent depressive disorders, suggesting that trauma-based interventions could be useful for these patients. Objectives: To investigate the efficacy of Eye Movement Desensitization and Reprocessing therapy (EMDR) in addition to antidepressant medication (ADM) in treating recurrent depression. Design: A non-inferiority, single-blind, randomized clinical controlled trial comparing EMDR or CBT as adjunctive treatments to ADM. Randomization was carried out by a central computer system. Allocation was carried out by a study coordinator in each center. Setting: Two psychiatric services, one in Italy and one in Spain. Participants: Eighty-two patients were randomized with a 1:1 ratio to the EMDR group (n = 40) or CBT group (n = 42). Sixty-six patients, 31 in the EMDR group and 35 in the CBT group, were included in the completers analysis. Intervention: 15 ± 3 individual sessions of EMDR or CBT, both in addition to ADM. Participants were followed up at 6-months. Main outcome measure: Rate of depressive symptoms remission in both groups, as measured by a BDI-II score <13. Results: Sixty-six patients were analyzed as completers (31 EMDR vs. 35 CBT). No significant difference between the two groups was found either at the end of the interventions (71% EMDR vs. 48.7% CBT) or at the 6-month follow-up (54.8% EMDR vs. 42.9% CBT). A RM-ANOVA on BDI-II scores showed similar reductions over time in both groups [F(6,59) = 22.501, p < 0.001] and a significant interaction effect between time and group [F(6,59) = 3.357, p = 0.006], with lower BDI-II scores in the EMDR group at T1 [mean difference = –7.309 (95% CI [–12.811, –1.806]), p = 0.010]. The RM-ANOVA on secondary outcome measures showed similar improvement over time in both groups [F(14,51) = 8.202, p < 0.001], with no significant differences between groups [F(614,51) = 0.642, p = 0.817]. Conclusion: Although these results can be considered preliminary only, this study suggests that EMDR could be a viable and effective treatment for reducing depressive symptoms and improving the quality of life of patients with recurrent depression. Trial registration: ISRCTN09958202. PMID:29487548

Modified Angle's Classification for Primary Dentition.

PubMed

Chandranee, Kaushik Narendra; Chandranee, Narendra Jayantilal; Nagpal, Devendra; Lamba, Gagandeep; Choudhari, Purva; Hotwani, Kavita

2017-01-01

This study aims to propose a modification of Angle's classification for primary dentition and to assess its applicability in children from Central India, Nagpur. Modification in Angle's classification has been proposed for application in primary dentition. Small roman numbers i/ii/iii are used for primary dentition notation to represent Angle's Class I/II/III molar relationships as in permanent dentition, respectively. To assess applicability of modified Angle's classification a cross-sectional preschool 2000 children population from central India; 3-6 years of age residing in Nagpur metropolitan city of Maharashtra state were selected randomly as per the inclusion and exclusion criteria. Majority 93.35% children were found to have bilateral Class i followed by 2.5% bilateral Class ii and 0.2% bilateral half cusp Class iii molar relationships as per the modified Angle's classification for primary dentition. About 3.75% children had various combinations of Class ii relationships and 0.2% children were having Class iii subdivision relationship. Modification of Angle's classification for application in primary dentition has been proposed. A cross-sectional investigation using new classification revealed various 6.25% Class ii and 0.4% Class iii molar relationships cases in preschool children population in a metropolitan city of Nagpur. Application of the modified Angle's classification to other population groups is warranted to validate its routine application in clinical pediatric dentistry.

Quasi-experimental study designs series-paper 2: complementary approaches to advancing global health knowledge.

PubMed

Geldsetzer, Pascal; Fawzi, Wafaie

2017-09-01

Quasi-experiments have been infrequently used in the health sciences. Focusing on health systems implementation research, this article details key advantages of quasi-experiments and argues that they can complement (but not replace) randomized evaluations. Specifically, it may be possible to use a quasi-experiment to study the causal effect of an intervention that cannot feasibly be randomized or that would be unethical (e.g., because the intervention has become the standard of care) to test in a randomized controlled trial (RCT). In addition, because they usually take advantage of routinely collected data, quasi-experiments may be feasible when it is too costly (either financially or in terms of the required time) to carry out a RCT - an important advantage in research on health systems, which vary widely between settings. Nonetheless, we argue that RCTs will continue to be indispensable for implementation research because i) the assumptions needed to establish causality with a quasi-experiment are often unverifiable, ii) available data frequently do not allow for a rigorous quasi-experiment, and iii) randomized designs tend to lend themselves more to informing policy makers of causal effects prior to (or during) the full-scale rollout of an intervention than quasi-experiments. Copyright © 2017 Elsevier Inc. All rights reserved.

Temporomandibular disorders in growing patients after treatment of class II and III malocclusion with orthopaedic appliances: a systematic review.

PubMed

Jiménez-Silva, Antonio; Carnevali-Arellano, Romano; Venegas-Aguilera, Matías; Tobar-Reyes, Julio; Palomino-Montenegro, Hernán

2018-05-01

To determine if the use of orthopaedic appliances in growing patients applied to correct Class II and III malocclusion is related to the development of temporomandibular disorders (TMD). A systematic review was conducted between 1960 and July 2017, based on electronic databases: PubMed, Cochrane Library, Embase, Medline, Scopus, EBSCOhost, Scielo, Lilacs and Bireme. Controlled clinical trials (CCTs) and randomized controlled trials (RCTs) were identified. The articles were selected and analyzed by two authors independently. The quality of the evidence was determined according to the guidelines of the Cochrane Risk Bias Assessment Tool and the Cochrane Quality Study Guide. Seven articles were included, four CCTs and three RCTs. The studies were grouped according to malocclusion treatment in (a) class II appliances (n = 4) and (b) class III appliances (n = 3). The quality of evidence was low due to the high risk of bias, independent of the association reported. All studies concluded that the use of orthopaedic appliances would not contribute to the development of TMD. The quality of evidence available is insufficient to establish definitive conclusions, since the studies were very heterogeneous and presented a high risk of bias. However, it is suggested that the use of orthopaedic appliances to correct class II and III malocclusion in growing patients would not be considered as a risk factor for the development of TMD. High-quality RCTs are required to draw any definitive conclusions.

Efficacy of a Cream Containing Ceramides and Magnesium in the Treatment of Mild to Moderate Atopic Dermatitis: A Randomized, Double-blind, Emollient- and Hydrocortisone-controlled Trial.

PubMed

Koppes, Sjors A; Charles, Frank; Lammers, Laureen; Frings-Dresen, Monique; Kezic, Sanja; Rustemeyer, Thomas

2016-11-02

The aim of this randomized controlled trial was to assess the efficacy of a cream containing ceramides and magnesium (Cer-Mg) in the treatment of mild to moderate atopic dermatitis and to compare it with hydrocortisone and a commonly used emollient (unguentum leniens; cold cream). A total of 100 patients, randomized into 2 groups, were treated for 6 weeks simultaneously (left vs. right side of the body) with either Cer-Mg and hydrocortisone (group I) or Cer-Mg and emollient (group II). The primary outcome was a reduction in severity of lesions as assessed by (local) SCORAD (SCORing Atopic Dermatitis). Levels of trans-epidermal water loss (TEWL), skin hydration, and natural moisturizing factors (NMF) were then measured. After 6 weeks, group I showed comparable significant improvement in SCORAD and TEWL, while in group II, the decrease in SCORAD and TEWL was significantly greater after Cer-Mg compared with emollient. Finally, Cer-Mg cream was more effective in improving skin hydration and maintenance of levels of NMF than hydrocortisone and emollient.

Study protocol: implementation of a computer-assisted intervention for autism in schools: a hybrid type II cluster randomized effectiveness-implementation trial.

PubMed

Pellecchia, Melanie; Beidas, Rinad S; Marcus, Steven C; Fishman, Jessica; Kimberly, John R; Cannuscio, Carolyn C; Reisinger, Erica M; Rump, Keiran; Mandell, David S

2016-11-25

The number of children diagnosed with autism has rapidly outpaced the capacities of many public school systems to serve them, especially under-resourced, urban school districts. The intensive nature of evidence-based autism interventions, which rely heavily on one-to-one delivery, has caused schools to turn to computer-assisted interventions (CAI). There is little evidence regarding the feasibility, effectiveness, and implementation of CAI in public schools. While CAI has the potential to increase instructional time for students with autism, it may also result in unintended consequences such as reduction in the amount of interpersonal (as opposed to computerized) instruction students receive. The purpose of this study is to test the effectiveness of one such CAI-TeachTown-its implementation, and its effects on teachers' use of other evidence-based practices. This study protocol describes a type II hybrid cluster randomized effectiveness-implementation trial. We will train and coach 70 teachers in autism support classrooms in one large school district in the use of evidence-based practices for students with autism. Half of the teachers then will be randomly selected to receive training and access to TeachTown: Basics, a CAI for students with autism, for the students in their classrooms. The study examines: (1) the effectiveness of TeachTown for students with autism; (2) the extent to which teachers implement TeachTown the way it was designed (i.e., fidelity); and (3) whether its uptake increases or reduces the use of other evidence-based practices. This study will examine the implementation of new technology for children with ASD in public schools and will be the first to measure the effectiveness of CAI. As importantly, the study will investigate whether adding a new technology on top of existing practices increases or decreases their use. This study presents a unique method to studying both the implementation and exnovation of evidence-based practices for children with autism in school settings. NCT02695693 . Retrospectively registered on July 8, 2016.

Magnetic-epichlorohydrin crosslinked chitosan schiff's base (m-ECCSB) as a novel adsorbent for the removal of Cu(II) ions from aqueous environment.

PubMed

Gutha, Yuvaraja; Zhang, Yaping; Zhang, Weijiang; Jiao, Xu

2017-04-01

Metal ions cause a serious public health problem. It is a great challenge to find an effective and efficient adsorbent to remove heavy metals from wastewater. Chitosan-based adsorbents are potential and effective for heavy metal ion removal. Hence a novel m-ECCSB was synthesized, characterized and utilized as an adsorbent for the removal of Cu(II) ions from aqueous solution. Various factors affecting the uptake behavior such as pH, adsorbent dosage, contact time, initial concentration of Cu(II) and temperature effect were investigated. Maximum adsorption capability (123.10mg/g) was obtained at pH=6, adsorbent dose of=250mg, rotational speed=200rpm, contact time=60min, and temperature of 323K. The result of the kinetic study shows that the adsorption of Cu(II) could be described by the pseudo-second-order equation. Equilibrium data were analysed with the Langmuir, Freundlich and Dubinin-Radushkevich isotherms and Langmuir model was found to provide the best fit of the experimental data. The thermodynamic parameters showed that the adsorption of Cu(II) onto m-ECCSB was spontaneous (ΔG°=-8.990, -10.00 and -10.593kJ/mol), endothermic (ΔH°=15.674, 15.478 and 15.699kJ/mol) and ΔS° (0.0814J/molK) suggests an increased randomness at the solid/solution interface under the studied conditions. Copyright © 2017 Elsevier B.V. All rights reserved.

Comparison of various treatment modalities for acute tinnitus.

PubMed

Shim, Hyun Joon; Song, Seong Jun; Choi, A Young; Hyung Lee, Rae; Yoon, Sang Won

2011-12-01

Because in most cases the development of tinnitus is triggered by cochlear damage, there exists the opportunity to eliminate tinnitus while the cochlear lesion is still reversible. Therefore, we evaluated the therapeutic effects of various treatment modalities on acute subjective idiopathic tinnitus (SIT) and investigated prognostic factors affecting the treatment outcome. Prospective, controlled, double-blind trial. A total 107 patients who underwent treatment for unilateral SIT that had developed within the previous 3 months completed the study. The patients were randomly assigned into three groups according to the treatment modality: group I (n = 32), alprazolam orally for 3 months; group II (n = 35), as for group I plus four intratympanic dexamethasone (ITD) injections; and group III (n = 40), as for group II plus four intravenous injections of lipo-prostaglandin E(1) . The improvement rate of group II (75.8%) was significantly higher than that of group I (40.3%; P < .05), and there was no significant difference in the improvement rate of group III (50.0%) compared with groups I and II (P > .05). The cure rates of group II (25.8%) and group III (20.0%) were significantly higher than that of group I (9.8%; P < .05). There was a significant correlation between the cure rate and duration of symptoms. The results of the present study indicate that ITD injection plus alprazolam medication is the best treatment choice for acute SIT within 3 months of development. Copyright © 2011 The American Laryngological, Rhinological, and Otological Society, Inc.

Low-dose levobupivacaine plus fentanyl combination for spinal anesthesia in anorectal surgery.

PubMed

Honca, Mehtap; Dereli, Necla; Kose, Emine Arzu; Honca, Tevfik; Kutuk, Selcen; Unal, Selma Savas; Horasanli, Eyup

2015-01-01

the aim of this study was to investigate the effects of spinal anesthesia using two different doses of fentanyl combined with low-dose levobupivacaine in anorectal surgery. in this prospective, double-blind study, 52 American Society of Anaesthesiologists I-II patients scheduled for elective anorectal surgery were randomized into two groups. The patients in group I received intrathecal 2.5mg hyperbaric levobupivacaine plus 12.5 μg fentanyl and in group II received intrathecal 2.5mg hyperbaric levobupivacaine plus 25 μg fentanyl. All the patients remained in the seated position for 5 min after completion of the spinal anesthesia. Sensory block was evaluated with pin-prick test and motor block was evaluated with a modified Bromage scale. motor block was not observed in both of the groups. The sensory block was limited to the S2 level in group I, and S1 level in group II. None of the patients required additional analgesics during the operation. Time to two-segment regression was shorter in group I compared with group II (p<0.01). One patient in group I and 5 patients in group II had pruritus. Hemodynamic parameters were stable during the operation in both of the groups. spinal saddle block using hyperbaric levobupivacaine with both 12.5 μg and 25 μg fentanyl provided good quality of anesthesia without motor block for anorectal surgery in the prone position. Copyright © 2014 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.