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Sample records for short-term clinical trial

  1. Clinical trials with rasagiline: evidence for short-term and long-term effects.

    Science.gov (United States)

    Siderowf, Andrew; Stern, Matthew

    2006-05-23

    Rasagiline (N-propargyl-1 (R)-aminoindan) is a selective, potent irreversible inhibitor of MAO-B that possesses neuroprotective and anti-apoptotic properties in a variety of in vitro and in vivo animal models relevant to Parkinson's disease (PD). Several randomized controlled clinical trials have demonstrated the safety and efficacy of rasagiline as monotherapy in PD and as adjunctive therapy for patients receiving levodopa. In addition, the 1-year randomized, delayed-start analysis of the TEMPO study suggests that rasagiline may slow the rate of progression of PD. The randomized delayed-start paradigm has potential to differentiate short-term symptomatic effects from long-term effects of anti-parkinsonian agents. In the future, long-term trials to examine the potential disease-modifying effects of rasagiline, which incorporate biological markers as well as clinical endpoints, may further elucidate the role of rasagiline in the treatment of both early and advanced PD.

  2. Cerebral atrophy as outcome measure in short-term phase 2 clinical trials in multiple sclerosis

    Energy Technology Data Exchange (ETDEWEB)

    Elskamp, I.J. van den; Boden, B.; Barkhof, F. [VU University Medical Center, Department of Radiology, MS Center Amsterdam, Amsterdam (Netherlands); Dattola, V. [VU University Medical Center, Department of Radiology, MS Center Amsterdam, Amsterdam (Netherlands); University of Messina, Department of Neurosciences, Psychiatric and Anaesthesiological Sciences, Messina (Italy); Knol, D.L. [VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam (Netherlands); Filippi, M. [Scientific Institute and University Ospedale San Raffaele, Neuroimaging Research Unit, Milan (Italy); Kappos, L. [University Hospital, University of Basel, Department of Neurology, Basel (Switzerland); Fazekas, F. [Medical University of Graz, Department of Neurology, Graz (Austria); Wagner, K. [Bayer-Schering Pharma, Berlin (Germany); Pohl, C. [Bayer-Schering Pharma, Berlin (Germany); University Hospital Bonn, Department of Neurology, Bonn (Germany); Sandbrink, R. [Bayer-Schering Pharma, Berlin (Germany); Heinrich-Heine-University Dusseldorf, Department of Neurology, Dusseldorf (Germany); Polman, C.H. [VU University Medical Center, Department of Neurology, MS Center Amsterdam, Amsterdam (Netherlands); Uitdehaag, B.M.J. [VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam (Netherlands); VU University Medical Center, Department of Neurology, MS Center Amsterdam, Amsterdam (Netherlands)

    2010-10-15

    Cerebral atrophy is a compound measure of the neurodegenerative component of multiple sclerosis (MS) and a conceivable outcome measure for clinical trials monitoring the effect of neuroprotective agents. In this study, we evaluate the rate of cerebral atrophy in a 6-month period, investigate the predictive and explanatory value of other magnetic resonance imaging (MRI) measures in relation to cerebral atrophy, and determine sample sizes for future short-term clinical trials using cerebral atrophy as primary outcome measure. One hundred thirty-five relapsing-remitting multiple sclerosis patients underwent six monthly MRI scans from which the percentage brain volume change (PBVC) and the number and volume of gadolinium (Gd)-enhancing lesions, T2 lesions, and persistent black holes (PBH) were determined. By means of multiple linear regression analysis, the relationship between focal MRI variables and PBVC was assessed. Sample size calculations were performed for all patients and subgroups selected for enhancement or a high T2 lesion load at baseline. A significant atrophy occurred over 6 months (PBVC = -0.33%, SE = 0.061, p < 0.0001). The number of baseline T2 lesions (p = 0.024), the on-study Gd-enhancing lesion volume (p = 0.044), and the number of on-study PBHs (p = 0.003) were associated with an increased rate of atrophy. For a 50% decrease in rate of atrophy, the sample size calculations showed that approximately 283 patients per arm are required in an unselected sampled population and 185 patients per arm are required in a selected population. Within a 6-month period, significant atrophy can be detected and on-study associations of PBVC and PBHs emphasizes axonal loss to be a driving mechanism. Application as primary outcome measure in short-term clinical trials with feasible sample size requires a potent drug to obtain sufficient power. (orig.)

  3. Evaluation of Short-Term Changes in Serum Creatinine Level as a Meaningful End Point in Randomized Clinical Trials.

    Science.gov (United States)

    Coca, Steven G; Zabetian, Azadeh; Ferket, Bart S; Zhou, Jing; Testani, Jeffrey M; Garg, Amit X; Parikh, Chirag R

    2016-08-01

    Observational studies have shown that acute change in kidney function (specifically, AKI) is a strong risk factor for poor outcomes. Thus, the outcome of acute change in serum creatinine level, regardless of underlying biology or etiology, is frequently used in clinical trials as both efficacy and safety end points. We performed a meta-analysis of clinical trials to quantify the relationship between positive or negative short-term effects of interventions on change in serum creatinine level and more meaningful clinical outcomes. After a thorough literature search, we included 14 randomized trials of interventions that altered risk for an acute increase in serum creatinine level and had reported between-group differences in CKD and/or mortality rate ≥3 months after randomization. Seven trials assessed interventions that, compared with placebo, increased risk of acute elevation in serum creatinine level (pooled relative risk, 1.52; 95% confidence interval, 1.22 to 1.89), and seven trials assessed interventions that, compared with placebo, reduced risk of acute elevation in serum creatinine level (pooled relative risk, 0.57; 95% confidence interval, 0.44 to 0.74). However, pooled risks for CKD and mortality associated with interventions did not differ from those with placebo in either group. In conclusion, several interventions that affect risk of acute, mild to moderate, often temporary elevation in serum creatinine level in placebo-controlled randomized trials showed no appreciable effect on CKD or mortality months later, raising questions about the value of using small to moderate changes in serum creatinine level as end points in clinical trials. Copyright © 2016 by the American Society of Nephrology.

  4. Immediate and Short-Term Effects of Upper Thoracic Manipulation on Myoelectric Activity of Sternocleidomastoid Muscles in Young Women With Chronic Neck Pain: A Randomized Blind Clinical Trial.

    Science.gov (United States)

    Pires, Paulo Fernandes; Packer, Amanda Carine; Dibai-Filho, Almir Vieira; Rodrigues-Bigaton, Delaine

    2015-10-01

    The aim of this study was to assess the immediate and short-term effects of upper thoracic spine manipulation on pain intensity and myoelectric activity of the sternocleidomastoid muscles in young women with chronic neck pain. A randomized clinical trial was carried out involving 32 women with chronic neck pain (mean age, 24.8 ± 5.4 years) allocated to an experimental group and a placebo group. Three evaluations were carried out: baseline, immediate postintervention, and short-term postintervention (48-72 hours after intervention). Myoelectric activity of the right and left sternocleidomastoid muscles was assessed at rest and during isometric contractions for cervical flexion and elevation of the shoulder girdle. Neck pain intensity was assessed at rest using a visual analog scale. Comparisons of the data were performed using 2-way repeated-measures analysis of variance with the Bonferroni correction. The level of significance was set at P 0.40). No statistically significant differences were found for any of the variables analyzed in the intergroup comparisons at the different evaluation times (P > .05). No statistically significant differences were found in the intragroup or intergroup analyses of the experimental and placebo groups regarding myoelectric activity of the cervical muscles or the intensity of neck pain at rest in the immediate or short-term postintervention evaluations. Copyright © 2015 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.

  5. A randomized clinical trial of cognitive behavioural therapy versus short-term psychodynamic psychotherapy versus no intervention for patients with hypochondriasis

    DEFF Research Database (Denmark)

    Sørensen, Per; Birket-Smith, M; Wattar, U

    2011-01-01

    Hypochondriasis is common in the clinic and in the community. Cognitive behavioural therapy (CBT) has been found to be effective in previous trials. Psychodynamic psychotherapy is a treatment routinely offered to patients with hypochondriasis in many countries, including Denmark. The aim of this ......Hypochondriasis is common in the clinic and in the community. Cognitive behavioural therapy (CBT) has been found to be effective in previous trials. Psychodynamic psychotherapy is a treatment routinely offered to patients with hypochondriasis in many countries, including Denmark. The aim...... of this study was to test CBT for hypochondriasis in a centre that was not involved in its development and compare both CBT and short-term psychodynamic psychotherapy (STPP) to a waiting-list control and to each other. CBT was modified by including mindfulness and group therapy sessions, reducing the therapist...

  6. A randomized clinical trial evaluating plasma rich in growth factors (PRGF-Endoret) versus hyaluronic acid in the short-term treatment of symptomatic knee osteoarthritis.

    Science.gov (United States)

    Sánchez, Mikel; Fiz, Nicolás; Azofra, Juan; Usabiaga, Jaime; Aduriz Recalde, Enmanuel; Garcia Gutierrez, Antonio; Albillos, Javier; Gárate, Ramón; Aguirre, Jose Javier; Padilla, Sabino; Orive, Gorka; Anitua, Eduardo

    2012-08-01

    This multicenter, double-blind clinical trial evaluated and compared the efficacy and safety of PRGF-Endoret (BTI Biotechnology Institute, Vitoria-Gasteiz, Spain), an autologous biological therapy for regenerative purposes, versus hyaluronic acid (HA) as a short-term treatment for knee pain from osteoarthritis. We randomly assigned 176 patients with symptomatic knee osteoarthritis to receive infiltrations with PRGF-Endoret or with HA (3 injections on a weekly basis). The primary outcome measure was a 50% decrease in knee pain from baseline to week 24. As secondary outcomes, we also assessed pain, stiffness, and physical function using the Western Ontario and McMaster Universities Osteoarthritis Index; the rate of response using the criteria of the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI); and safety. The mean age of the patients was 59.8 years, and 52% were women. Compared with the rate of response to HA, the rate of response to PRGF-Endoret was 14.1 percentage points higher (95% confidence interval, 0.5 to 27.6; P = .044). Regarding the secondary outcome measures, the rate of response to PRGF-Endoret was higher in all cases, although no significant differences were reached. Adverse events were mild and evenly distributed between the groups. Plasma rich in growth factors showed superior short-term results when compared with HA in a randomized controlled trial, with a comparable safety profile, in alleviating symptoms of mild to moderate osteoarthritis of the knee. Level I, randomized controlled multicenter trial. Copyright © 2012 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

  7. Effects of selenium on short-term control of hyperthyroidism due to Graves' disease treated with methimazole: results of a randomized clinical trial.

    Science.gov (United States)

    Leo, M; Bartalena, L; Rotondo Dottore, G; Piantanida, E; Premoli, P; Ionni, I; Di Cera, M; Masiello, E; Sassi, L; Tanda, M L; Latrofa, F; Vitti, P; Marcocci, C; Marinò, M

    2017-03-01

    In spite of previous conflicting results, an adjuvant role of selenium in the treatment of Graves' disease (GD) hyperthyroidism has been proposed. To address this issue, a randomized clinical trial was carried out aimed at investigating whether selenium is beneficial on the short-term control of GD hyperthyroidism treated with methimazole (MMI). Thirty newly diagnosed hyperthyroid GD patients were randomly assigned to treatment with: (i) MMI or (ii) MMI plus selenium. Primary outcomes were: control of hyperthyroidism and clinical and biochemical manifestations of hyperthyroidism [heart rate, cholesterol, sex hormone-binding globulin (SHBG), hyperthyroidism symptoms] at 90 days. Baseline features of the two groups did not differ. Serum selenium at baseline was similar in the two groups and within the recommended range to define selenium sufficiency. Selenium increased with treatment in the MMI-selenium group and became significantly higher than in the MMI group. Serum malondialdehyde, a marker of oxidative stress, was similar in the two groups and decreased significantly with treatment, with no difference between groups. Administration of MMI was followed by a reduction of FT 3 and FT 4 , with no difference between groups. Heart rate, SHBG and symptoms of hyperthyroidism decreased, whereas total cholesterol increased in both groups with no difference between groups. Our study, carried out in a selenium-sufficient cohort of GD patients, failed to show an adjuvant role of selenium in the short-term control of hyperthyroidism. However, selenium might be beneficial in patients from selenium-deficient areas, as well as in the long-term outcome of antithyroid treatment.

  8. Short-term combined effects of thoracic spine thrust manipulation and cervical spine nonthrust manipulation in individuals with mechanical neck pain: a randomized clinical trial.

    Science.gov (United States)

    Masaracchio, Michael; Cleland, Joshua A; Hellman, Madeleine; Hagins, Marshall

    2013-03-01

    Randomized clinical trial. To investigate the short-term effects of thoracic spine thrust manipulation combined with cervical spine nonthrust manipulation (experimental group) versus cervical spine nonthrust manipulation alone (comparison group) in individuals with mechanical neck pain. Research has demonstrated improved outcomes with both nonthrust manipulation directed at the cervical spine and thrust manipulation directed at the thoracic spine in patients with neck pain. Previous studies have not determined if thoracic spine thrust manipulation may increase benefits beyond those provided by cervical nonthrust manipulation alone. Sixty-four participants with mechanical neck pain were randomized into 1 of 2 groups, an experimental or comparison group. Both groups received 2 treatment sessions of cervical spine nonthrust manipulation and a home exercise program consisting of active range-of-motion exercises, and the experimental group received additional thoracic spine thrust manipulations. Outcome measures were collected at baseline and at a 1-week follow-up, and included the numeric pain rating scale, the Neck Disability Index, and the global rating of change. Participants in the experimental group demonstrated significantly greater improvements (Ppain rating scale and Neck Disability Index at the 1-week follow-up compared to those in the comparison group. In addition, 31 of 33 (94%) participants in the experimental group, compared to 11 of 31 participants (35%) in the comparison group, indicated a global rating of change score of +4 or higher at the 1-week follow-up, with an associated number needed to treat of 2. Individuals with neck pain who received a combination of thoracic spine thrust manipulation and cervical spine nonthrust manipulation plus exercise demonstrated better overall short-term outcomes on the numeric pain rating scale, the Neck Disability Index, and the global rating of change.

  9. Effects of neurofeedback on the short-term memory and continuous attention of patients with moderate traumatic brain injury: A preliminary randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Reza Rostami

    2017-10-01

    Full Text Available Purpose: There are some studies which showed neurofeedback therapy (NFT can be effective in clients with traumatic brain injury (TBI history. However, randomized controlled clinical trials are still needed for evaluation of this treatment as a standard option. This preliminary study was aimed to evaluate the effect of NFT on continuous attention (CA and short-term memory (STM of clients with moderate TBI using a randomized controlled clinical trial (RCT. Methods: In this preliminary RCT, seventeen eligible patients with moderate TBI were randomly allocated in two intervention and control groups. All the patients were evaluated for CA and STM using the visual continuous attention test and Wechsler memory scale-4th edition (WMS-IV test, respectively, both at the time of inclusion to the project and four weeks later. The intervention group participated in 20 sessions of NFT through the first four weeks. Conversely, the control group participated in the same NF sessions from the fifth week to eighth week of the project. Results: Eight subjects in the intervention group and five subjects in the control group completed the study. The mean and standard deviation of participants' age were (26.75 ± 15.16 years and (27.60 ± 8.17 years in experiment and control groups, respectively. All of the subjects were male. No significant improvement was observed in any variables of the visual continuous attention test and WMS-IV test between two groups (p ≥ 0.05. Conclusion: Based on our literature review, it seems that our study is the only study performed on the effect of NFT on TBI patients with control group. NFT has no effect on CA and STM in patients with moderate TBI. More RCTs with large sample sizes, more sessions of treatment, longer time of follow-up and different protocols are recommended. Keywords: Neurofeedback, Brain injuries, Attention, Short-term memory

  10. Short-Term Effects of Kefir-Fermented Milk Consumption on Bone Mineral Density and Bone Metabolism in a Randomized Clinical Trial of Osteoporotic Patients.

    Science.gov (United States)

    Tu, Min-Yu; Chen, Hsiao-Ling; Tung, Yu-Tang; Kao, Chao-Chih; Hu, Fu-Chang; Chen, Chuan-Mu

    2015-01-01

    Milk products are good sources of calcium that may reduce bone resorption and help prevent bone loss as well as promote bone remodeling and increase bone formation. Kefir is a product made by kefir grains that degrade milk proteins into various peptides with health-promoting effects, including antithrombotic, antimicrobial and calcium-absorption enhancing bioactivities. In a controlled, parallel, double-blind intervention study over 6 months, we investigated the effects of kefir-fermented milk (1,600 mg) supplemented with calcium bicarbonate (CaCO3, 1,500 mg) and bone metabolism in 40 osteoporosis patients, and compared them with CaCO3 alone without kefir supplements. Bone turnover markers were measured in fasting blood samples collected before therapy and at 1, 3, and 6 months. Bone mineral density (BMD) values at the spine, total hip, and hip femoral neck were assessed by dual-energy x-ray absorptiometry (DXA) at baseline and at 6 months. Among patients treated with kefir-fermented milk, the relationships between baseline turnover and 6 months changes in DXA-determined BMD were significantly improved. The serum β C-terminal telopeptide of type I collagen (β-CTX) in those with T-scores > -1 patients significantly decreased after three months treatment. The formation marker serum osteocalcin (OC) turned from negative to positive after 6 months, representing the effect of kefir treatment. Serum parathyroid hormone (PTH) increased significantly after treatment with kefir, but decreased significantly in the control group. PTH may promote bone remodeling after treatment with kefir for 6 months. In this pilot study, we concluded that kefir-fermented milk therapy was associated with short-term changes in turnover and greater 6-month increases in hip BMD among osteoporotic patients. ClinicalTrials.gov NCT02361372.

  11. Short-Term Effects of Kefir-Fermented Milk Consumption on Bone Mineral Density and Bone Metabolism in a Randomized Clinical Trial of Osteoporotic Patients.

    Directory of Open Access Journals (Sweden)

    Min-Yu Tu

    Full Text Available Milk products are good sources of calcium that may reduce bone resorption and help prevent bone loss as well as promote bone remodeling and increase bone formation. Kefir is a product made by kefir grains that degrade milk proteins into various peptides with health-promoting effects, including antithrombotic, antimicrobial and calcium-absorption enhancing bioactivities. In a controlled, parallel, double-blind intervention study over 6 months, we investigated the effects of kefir-fermented milk (1,600 mg supplemented with calcium bicarbonate (CaCO3, 1,500 mg and bone metabolism in 40 osteoporosis patients, and compared them with CaCO3 alone without kefir supplements. Bone turnover markers were measured in fasting blood samples collected before therapy and at 1, 3, and 6 months. Bone mineral density (BMD values at the spine, total hip, and hip femoral neck were assessed by dual-energy x-ray absorptiometry (DXA at baseline and at 6 months. Among patients treated with kefir-fermented milk, the relationships between baseline turnover and 6 months changes in DXA-determined BMD were significantly improved. The serum β C-terminal telopeptide of type I collagen (β-CTX in those with T-scores > -1 patients significantly decreased after three months treatment. The formation marker serum osteocalcin (OC turned from negative to positive after 6 months, representing the effect of kefir treatment. Serum parathyroid hormone (PTH increased significantly after treatment with kefir, but decreased significantly in the control group. PTH may promote bone remodeling after treatment with kefir for 6 months. In this pilot study, we concluded that kefir-fermented milk therapy was associated with short-term changes in turnover and greater 6-month increases in hip BMD among osteoporotic patients.ClinicalTrials.gov NCT02361372.

  12. Effects of neurofeedback on the short-term memory and continuous attention of patients with moderate traumatic brain injury: A preliminary randomized controlled clinical trial.

    Science.gov (United States)

    Rostami, Reza; Salamati, Payman; Yarandi, Kourosh Karimi; Khoshnevisan, Alireza; Saadat, Soheil; Kamali, Zeynab Sadat; Ghiasi, Somaie; Zaryabi, Atefeh; Ghazi Mir Saeid, Seyed Shahab; Arjipour, Mehdi; Rezaee-Zavareh, Mohammad Saeid; Rahimi-Movaghar, Vafa

    2017-10-01

    There are some studies which showed neurofeedback therapy (NFT) can be effective in clients with traumatic brain injury (TBI) history. However, randomized controlled clinical trials are still needed for evaluation of this treatment as a standard option. This preliminary study was aimed to evaluate the effect of NFT on continuous attention (CA) and short-term memory (STM) of clients with moderate TBI using a randomized controlled clinical trial (RCT). In this preliminary RCT, seventeen eligible patients with moderate TBI were randomly allocated in two intervention and control groups. All the patients were evaluated for CA and STM using the visual continuous attention test and Wechsler memory scale-4th edition (WMS-IV) test, respectively, both at the time of inclusion to the project and four weeks later. The intervention group participated in 20 sessions of NFT through the first four weeks. Conversely, the control group participated in the same NF sessions from the fifth week to eighth week of the project. Eight subjects in the intervention group and five subjects in the control group completed the study. The mean and standard deviation of participants' age were (26.75 ± 15.16) years and (27.60 ± 8.17) years in experiment and control groups, respectively. All of the subjects were male. No significant improvement was observed in any variables of the visual continuous attention test and WMS-IV test between two groups (p ≥ 0.05). Based on our literature review, it seems that our study is the only study performed on the effect of NFT on TBI patients with control group. NFT has no effect on CA and STM in patients with moderate TBI. More RCTs with large sample sizes, more sessions of treatment, longer time of follow-up and different protocols are recommended. Copyright © 2017 Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Production and hosting by Elsevier B.V. All rights reserved.

  13. Vortioxetine: a meta-analysis of 12 short-term, randomized, placebo-controlled clinical trials for the treatment of major depressive disorder

    Science.gov (United States)

    Pae, Chi-Un; Wang, Sheng-Min; Han, Changsu; Lee, Soo-Jung; Patkar, Ashwin A.; Masand, Praksh S.; Serretti, Alessandro

    2015-01-01

    Background Vortioxetine was approved by the U.S. Food and Drug Administration (FDA) in September 2013 for treating major depressive disorder (MDD). Thus far, a number of randomized, double-blind, placebo-controlled clinical trials (RCTs) of vortioxetine have been conducted in patients with MDD. We performed a meta-analysis to increase the statistical power of these studies and enhance our current understanding of the role of vortioxetine in the treatment of MDD. Methods We performed an extensive search of databases and the clinical trial registry. The mean change in total scores on the 24-item Hamilton Rating Scale for Depression (HAM-D) and the Montgomery–Åsberg Depression Rating Scale (MADRS) from the baseline were the primary outcome measures. The secondary efficacy measures were the response and remission rates, as defined by a 50% or greater reduction in HAM-D/MADRS total scores and as a score of 10 or less in the MADRS and 7 or less in the HAM-D total scores at the end of treatment. Results We included 7 published and 5 unpublished short-term (6–12 wk) RCTs in our meta-analysis. Vortioxetine was significantly more effective than placebo, with an effect size (standardized mean difference [SMD]) of −0.217 (95% confidence interval [CI] −0.313 to −0.122) and with odds ratios (ORs) for response and remission of 1.652 (95% CI 1.321 to 2.067) and 1.399 (95% CI 1.104 to 1.773), respectively. Those treated with vortioxetine did not differ significantly from those treated with selective norepinephrine reuptake inhibitors/agomelatine with regard to the SMD of the primary outcome measure (0.081, −0.062 to 0.223) or for response (OR 0.815, 95% CI 0.585 to 1.135) and remission (OR 0.843, 95% CI 0.575 to 1.238) rates. Discontinuation owing to lack of efficacy (OR 0.541, 95% CI 0.308 to 0.950) was significantly less common among those treated with vortioxetine than among those who received placebo, whereas discontinuation owing to adverse events (AEs; OR 1

  14. Short term clinical outcome of children with rotavirus infection at ...

    African Journals Online (AJOL)

    Background: Rotavirus infection is the single most common cause of acute gastroenteritis in children under five years of age. Rotavirus gastroenteritis has a high morbidity and mortality in children in Kenya. Objectives: To determine the short term clinical outcome for children admitted to Kenyatta National Hospital with ...

  15. A randomized clinical trial on the effectiveness of a reintegration training program versus booster sessions after short-term inpatient psychotherapy

    NARCIS (Netherlands)

    Thunnissen, M.; Duivenvoorden, H.; Busschbach, J.; Hakkaart-van Roijen, L.; van Tilburg, W.; Verheul, R.; Trijsburg, W.

    2008-01-01

    Although several studies show symptomatic improvements in patients with personality disorders after short-term inpatient psychotherapy, reintegration remains difficult. In this study the effectiveness of a specifically designed reintegration training program is investigated. One hundred twenty-eight

  16. A randomized clinical trial on the effectiveness of a reintegration training program versus booster sessions after short-term inpatient psychotherapy

    NARCIS (Netherlands)

    M. Thunnissenl (Moniek); H.J. Duivenvoorden (Hugo); J.J. van Busschbach (Jan); L. van Hakkaart-van Roijen (Leona); W. van Tilburg (Willem); R. Verheul (Roel); W. Trijsburg (Wim)

    2008-01-01

    textabstractAlthough several studies show symptomatic improvements in patients with personality disorders after short-term inpatient psychotherapy, reintegration remains difficult. In this study the effectiveness of a specifically designed reintegration training program is investigated. One hundred

  17. An Herbal Drug, Gongjin-dan, Ameliorates Acute Fatigue Caused by Short-Term Sleep-Deprivation: A Randomized, Double-Blinded, Placebo-Controlled, Crossover Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mi Ju Son

    2018-05-01

    Full Text Available Introduction:Gongjin-dan (GJD is an herbal drug commonly used in Korea and China to combat fatigue, but there are only few clinical studies on its effectiveness and experimental studies on its mechanism of action, and no randomized controlled trial of GJD on the efficacy and mechanism of action has been reported. Here, we performed an exploratory study to evaluate both questions regarding GJD use in humans.Methods: A randomized, double-blinded, placebo-controlled, crossover clinical trial was conducted in the Republic of Korea. Healthy male participants were recruited and randomly allocated to groups receiving GJD-placebo or placebo-GJD in sequence. Fatigue was artificially induced by sleep deprivation for 2 nights. The primary outcome was a change in serum cortisol level; levels of biomarkers for stress hormones as well as oxidative stress and immunologic factors were also assessed, and questionnaires on fatigue and sleep quality were conducted.Results: Twelve and 11 participants were assigned to the GJD-placebo and placebo-GJD groups, respectively. Of all 23 participants, depending on crossover design, we analyzed a total of 20 participants for GJD, and 21 for placebo. An increase in serum cortisol appeared to be attenuated by GJD administration (p = 0.25, but the effect was not statistically significant; a similar pattern was observed in salivary cortisol levels (p = 0.14. Overall, GJD showed a tendency to reduce fatigue according to the Brief Fatigue Inventory (BFI, p = 0.07 and the Fatigue Severity Scale (FSS, p = 0.13 questionnaires. BFI and FSS scores in the first stage (before the crossover, however, were significantly improved (BFI, p = 0.02; FSS, p = 0.05 after GJD treatment (relative to placebo. GJD also seemed to improve sleep quality as assessed by the Leeds Sleep Evaluation Questionnaire (p = 0.06, with a significant improvement specifically in the condition “Getting To Sleep” (p = 0.02. Five participants experienced minor

  18. An Herbal Drug, Gongjin-dan, Ameliorates Acute Fatigue Caused by Short-Term Sleep-Deprivation: A Randomized, Double-Blinded, Placebo-Controlled, Crossover Clinical Trial.

    Science.gov (United States)

    Son, Mi Ju; Im, Hwi-Jin; Ku, Boncho; Lee, Jun-Hwan; Jung, So Young; Kim, Young-Eun; Lee, Sung Bae; Kim, Jun Young; Son, Chang-Gue

    2018-01-01

    Introduction: Gongjin-dan (GJD) is an herbal drug commonly used in Korea and China to combat fatigue, but there are only few clinical studies on its effectiveness and experimental studies on its mechanism of action, and no randomized controlled trial of GJD on the efficacy and mechanism of action has been reported. Here, we performed an exploratory study to evaluate both questions regarding GJD use in humans. Methods: A randomized, double-blinded, placebo-controlled, crossover clinical trial was conducted in the Republic of Korea. Healthy male participants were recruited and randomly allocated to groups receiving GJD-placebo or placebo-GJD in sequence. Fatigue was artificially induced by sleep deprivation for 2 nights. The primary outcome was a change in serum cortisol level; levels of biomarkers for stress hormones as well as oxidative stress and immunologic factors were also assessed, and questionnaires on fatigue and sleep quality were conducted. Results: Twelve and 11 participants were assigned to the GJD-placebo and placebo-GJD groups, respectively. Of all 23 participants, depending on crossover design, we analyzed a total of 20 participants for GJD, and 21 for placebo. An increase in serum cortisol appeared to be attenuated by GJD administration ( p = 0.25), but the effect was not statistically significant; a similar pattern was observed in salivary cortisol levels ( p = 0.14). Overall, GJD showed a tendency to reduce fatigue according to the Brief Fatigue Inventory (BFI, p = 0.07) and the Fatigue Severity Scale (FSS, p = 0.13) questionnaires. BFI and FSS scores in the first stage (before the crossover), however, were significantly improved (BFI, p = 0.02; FSS, p = 0.05) after GJD treatment (relative to placebo). GJD also seemed to improve sleep quality as assessed by the Leeds Sleep Evaluation Questionnaire ( p = 0.06), with a significant improvement specifically in the condition "Getting To Sleep" ( p = 0.02). Five participants experienced minor adverse

  19. Patterns of Change in Interpersonal Problems During and After Short-term and Long-term Psychodynamic Group Therapy: A Randomized Clinical Trial.

    Science.gov (United States)

    Fjeldstad, Anette; Høglend, Per; Lorentzen, Steinar

    2017-05-01

    In this study, we compared the patterns of change in interpersonal problems between short-term and long-term psychodynamic group therapy. A total of 167 outpatients with mixed diagnoses were randomized to 20 or 80 weekly sessions of group therapy. Interpersonal problems were assessed with the Inventory of Interpersonal Problems at six time points during the 3-year study period. Using linear mixed models, change was linearly modelled in two steps. Earlier (within the first 6 months) and later (during the last 2.5 years) changes in five subscales were estimated. Contrary to what we expected, short-term therapy induced a significantly larger early change than long-term therapy on the cold subscale and there was a trend on the socially avoidant subscale, using a Bonferroni-adjusted alpha. There was no significant difference between short-term and long-term group therapy for improving problems in the areas cold, socially avoidant, nonassertive, exploitable, and overly nurturant over the 3 years.

  20. Short-term Effects of High-Dose Caffeine on Cardiac Arrhythmias in Patients With Heart Failure: A Randomized Clinical Trial.

    Science.gov (United States)

    Zuchinali, Priccila; Souza, Gabriela C; Pimentel, Maurício; Chemello, Diego; Zimerman, André; Giaretta, Vanessa; Salamoni, Joyce; Fracasso, Bianca; Zimerman, Leandro I; Rohde, Luis E

    2016-12-01

    The presumed proarrhythmic action of caffeine is controversial. Few studies have assessed the effect of high doses of caffeine in patients with heart failure due to left ventricular systolic dysfunction at high risk for ventricular arrhythmias. To compare the effect of high-dose caffeine or placebo on the frequency of supraventricular and ventricular arrhythmias, both at rest and during a symptom-limited exercise test. Double-blinded randomized clinical trial with a crossover design conducted at the heart failure and cardiac transplant clinic of a tertiary-care university hospital. The trial included patients with chronic heart failure with moderate-to-severe systolic dysfunction (left ventricular ejection fraction capsules, in addition to 5 doses of 100 mL decaffeinated coffee at 1-hour intervals, for a total of 500 mg of caffeine or placebo during a 5-hour protocol. After a 1-week washout period, the protocol was repeated. Number and percentage of ventricular and supraventricular premature beats assessed by continuous electrocardiographic monitoring. We enrolled 51 patients (37 [74%] male; mean [SD] age, 60.6 [10.9] years) with predominantly moderate-to-severe left ventricular systolic dysfunction (mean [SD] left ventricular ejection fraction, 29% [7%]); 31 [61%] had an implantable cardioverter-defibrillator device. No significant differences between the caffeine and placebo groups were observed in the number of ventricular (185 vs 239 beats, respectively; P = .47) and supraventricular premature beats (6 vs 6 beats, respectively; P = .44), as well as in couplets, bigeminal cycles, or nonsustained tachycardia during continuous electrocardiographic monitoring. Exercise test-derived variables, such as ventricular and supraventricular premature beats, duration of exercise, estimated peak oxygen consumption, and heart rate, were not influenced by caffeine ingestion. We observed no increases in ventricular premature beats (91 vs 223 vs 207 beats, respectively

  1. Short-term effects of kinesio taping versus cervical thrust manipulation in patients with mechanical neck pain: a randomized clinical trial.

    Science.gov (United States)

    Saavedra-Hernández, Manuel; Castro-Sánchez, Adelaida M; Arroyo-Morales, Manuel; Cleland, Joshua A; Lara-Palomo, Inmaculada C; Fernández-de-Las-Peñas, César

    2012-08-01

    Randomized clinical trial. To compare the effectiveness of cervical spine thrust manipulation to that of Kinesio Taping applied to the neck in individuals with mechanical neck pain, using self-reported pain and disability and cervical range of motion as measures. The effectiveness of cervical manipulation has received considerable attention in the literature. However, because some patients cannot tolerate cervical thrust manipulation, alternative therapeutic options should be investigated. Eighty patients (36 women) were randomly assigned to 1 of 2 groups: the manipulation group, which received 2 cervical thrust manipulations, and the tape group, which received Kinesio Taping applied to the neck. Neck pain (11-point numeric pain rating scale), disability (Neck Disability Index), and cervical-range-of-motion data were collected at baseline and 1 week after the intervention by an assessor blinded to the treatment allocation of the patients. Mixed-model analyses of variance were used to examine the effects of the treatment on each outcome variable, with group as the between-subjects variable and time as the within-subjects variable. The primary analysis was the group-by-time interaction. No significant group-by-time interactions were found for pain (F = 1.892, P = .447) or disability (F = 0.115, P = .736). The group-by-time interaction was statistically significant for right (F = 7.317, P = .008) and left (F = 9.525, P = .003) cervical rotation range of motion, with the patients who received the cervical thrust manipulation having experienced greater improvement in cervical rotation than those treated with Kinesio Tape (Pcervical spine range of motion for flexion (F = 0.944, P = .334), extension (F = 0.122, P = .728), and right (F = 0.220, P = .650) and left (F = 0.389, P = .535) lateral flexion. Patients with mechanical neck pain who received cervical thrust manipulation or Kinesio Taping exhibited similar reductions in neck pain intensity and disability and similar

  2. Short-Term Effects of Kinesio Taping in Women with Pregnancy-Related Low Back Pain: A Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Kaplan, Şeyhmus; Alpayci, Mahmut; Karaman, Erbil; Çetin, Orkun; Özkan, Yasemin; İlter, Server; Şah, Volkan; Şahin, Hanım Güler

    2016-04-18

    BACKGROUND Pregnancy-related low back pain is a common condition during pregnancy. Kinesio tape is a drug-free elastic therapeutic tape used for treating various musculoskeletal problems. The aim of this study was to investigate the short-term effects of lumbar Kinesio taping on pain intensity and disability in women with pregnancy-related low back pain. MATERIAL AND METHODS A total of 65 patients with pregnancy-related low back pain were randomly allocated into either Kinesio taping (n=33) or control (n=32) groups. The intervention group was treated with paracetamol plus Kinesio taping, while the control group received only paracetamol. Kinesio taping was applied in the lumbar flexion position, and four I-shaped bands were used. Two bands were attached horizontally, with space correction technique. The remaining 2 bands, 1 on each side of the lumbar spine, were placed vertically, with inhibition technique. Low back pain intensity was measured on a 10-cm visual analogue scale (VAS), and the Roland-Morris Disability Questionnaire (RMDQ) was used for evaluation of disability. RESULTS Pain intensity and RMDQ scores improved significantly in both groups at 5 days compared with baseline. Considering the degree of treatment effect (the change from baseline to day 5), the Kinesio taping group was significantly superior than the control group in all outcome measures (for all, Plow back pain.

  3. The effect of short-term dimethylglycine treatment on oxygen consumption in cytochrome oxidase deficiency: a double-blind randomized crossover clinical trial.

    Science.gov (United States)

    Liet, Jean-Michel; Pelletier, Véronique; Robinson, Brian H; Laryea, Maurice D; Wendel, Udo; Morneau, Sylvain; Morin, Charles; Mitchell, Grant; Lacroix, Jacques

    2003-01-01

    To study the effectiveness of dimethylglycine (DMG) on oxygen consumption (VO(2)) in children with Saguenay-Lac-Saint-Jean cytochrome-c oxidase (SLSJ-COX) deficiency (OMIM 220111). In a crossover randomized double-blind clinical trial, 5 children with SLSJ-COX deficiency, who were stable and old enough to comply with VO(2) measurement, were treated with placebo or DMG for 3 days, and with the alternate treatment after a 2-week washout period. VO(2) was measured by indirect calorimetry before and after treatment. Dietary caloric intake was calculated for 3 days before each measurement. Mean caloric intakes per day were 1562 and 1342 kcal x m(-2) before and during placebo, 1,336 and 1,380 before and during DMG, respectively. DMG was well tolerated and, in all cases, resulted in markedly increased blood DMG levels (617 + 203 mmol x L(-1)), versus 0 to 2 mmol x L(-1) without treatment. Mean VO(2) was lower after administration of either DMG (-1 +/- 3 mL x min(-1) x m(-2)) or placebo (-6 +/- 4), but neither difference was statistically significant. There was no detectable effect of DMG treatment on blood levels of lactate, pyruvate, bicarbonate, or pH. VO(2) values of patients (range, 101-135 mL x min(-1) x m(-2)) were lower than published norms (150-160 mL x min(-1) x m(-2)). This study suggests that treatment with DMG does not substantially change VO(2) in children with SLSJ-COX deficiency.

  4. Short-term use of continuous glucose monitoring system adds to glycemic control in young type 1 diabetes mellitus patients in the long run: A clinical trial

    Directory of Open Access Journals (Sweden)

    Bukara-Radujković Gordana

    2011-01-01

    Full Text Available Background/Aim. Balancing strict glycemic control with setting realistic goals for each individual child and family can optimize growth, ensure normal pubertal development and emotional maturation, and control long term complications in children with type 1 diabetes (T1DM. The aim of this study was to evaluate the efficacy of short-term continuous glucose monitoring system (CGMS application in improvement of glycemic control in pediatric type 1 diabetes mellitus (T1DM patients. Methods. A total of 80 pediatric T1DM patients were randomly assigned into the experimental and the control group. The experimental group wore CGMS sensor for 72 hours at the beginning of the study. Self-monitored blood glucose (SMBG levels and hemoglobin A1c (HbA1c levels were obtained for both groups at baseline, and at 3 and 6 months. Results. There was a significant improvement in HbA1c (p < 0.001, in both the experimental and the control group, without a significant difference between the groups. Nevertheless, after 6 months the improvement of mean glycemia was noticed only in the experimental group. This finding was accompanied with a decrease in the number of hyperglycemic events and no increase in the number of hypoglycemic events in the experimental group. Conclusions. The results suggest that the CGMS can be considered as a valuable tool in treating pediatric T1DM patients, however further research is needed to more accurately estimate to what extent, if any, it outperforms intensive self-monitoring of blood glucose.

  5. Trial-to-Trial Carryover in Auditory Short-Term Memory

    Science.gov (United States)

    Visscher, Kristina M.; Kahana, Michael J.; Sekuler, Robert

    2009-01-01

    Using a short-term recognition memory task, the authors evaluated the carryover across trials of 2 types of auditory information: the characteristics of individual study sounds (item information) and the relationships between the study sounds (study set homogeneity). On each trial, subjects heard 2 successive broadband study sounds and then…

  6. Short-term clinical experience with hip resurfacing arthroplasty.

    Science.gov (United States)

    Cieliński, Łukasz; Kusz, Damian; Wojciechowski, Piotr; Dziuba, Anna

    2007-01-01

    This paper discusses the authors' experience with hip resurfacing arthroplasty. Although introduced many years ago, the method did not gain wide popularity because of poor long-term outcomes. At present, owing to the introduction of metal-on-metal bearings and hybrid fixation techniques, short- and mid-term results are very good and encourage wider use of this technique, especially in the younger and more active patients whose results with standard total hip replacements would be unsatisfactory. We performed 13 hip resurfacing arthroplasties at our institution between August 1, 2005, and May 1, 2006. Twelve patients reported for the scheduled follow-up and were included in the study. Treatment outcomes were assessed according to the Harris Hip Score. The short-term outcomes of hip resurfacing arthroplasties are encouraging. In the study group there were no intraoperative complications, infections, peripheral nerve palsy, hip dislocations or clinically overt vein thrombosis. All of the patients reported complete or major pain relief. Clinical assessment according to the Harris Hip Score revealed improvement from an average of 57.7 (20.1) points preoperatively to an average of 87.7 (12) points after the surgery. Crutches were used for a maximum of 6 weeks postoperatively. All of the patients are currently able to walk without crutches with full weight-bearing. 1) Hip resurfacing arthroplasty seems to be an advisable method of operative management of younger, active patients, in whom standard THR would be associated with a high risk of failure; it allows THR to be postponed and carried out as a revision surgery with the acetabular component already in place. 2) Despite the good short- and mid-term results, the utility of this method should be evaluated with caution due to the lack of adequate long-term follow-up data.

  7. The effect of short-term low-energy ultraviolet B irradiation on bone mineral density and bone turnover markers in postmenopausal women with osteoporosis: A randomized single-blinded controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Micić Ivan

    2013-01-01

    Full Text Available Introduction. The importance of vitamin D on bone health and osteoporosis was studied by many researchers. The main role of the Vitamin D is to absorb calcium and phosphate and increase bone mineralization. Older people are at an increased risk of the inadequate vitamin D production in the skin because of lower sun exposure and reduced ability of the skin to synthesize vitamin D. Objective. The aim of this clinical trial was to evaluate the efficacy and tolerability of short-term (2 weeks low energy UVB irradiation in postmenopausal women with osteoporosis using bone mineral density and bone turnover markers. Methods. A three-month, single-blinded, randomized, placebo-controlled clinical trial was conducted at the University hospital in Daegu, Republic of Korea. Fifty-two postmenopausal Korean women (older than 65 years with osteoporosis were randomly allocated to have either low energy UVB or placebo for 30 minutes a day for two weeks of treatment during winter. Laboratory analysis and physical examination before and 4, 8 and 12 weeks after treatment were carried out and BMD was measured before and 8 and 12 weeks after treatment. The effects of time and treatment interaction between these two groups were evaluated by repeated-measure two-factor analysis, and subgroup analysis was performed to examine UVB effect on the vitamin D insufficient group [serum 25(OHD3 concentration <30 ng/mL]. Results. In vitamin D insufficient group, the effect of UVB irradiation on vitamin D and bone ALP as well as additional benefit on bone formation was confirmed. The vitamin D insufficient group showed statistically significant increment in serum 25(OHD3 compared with the normal group (p<0.05. However, there was no significant difference between two groups in the other bone turnover markers, such as serum calcium, PTH-C, serum osteocalcin, serum CTX and BMD. Conclusion. Low-energy-short-term UVB radiation for postmenopausal women may be of use in vitamin D

  8. Steps to Health employee weight management randomized control trial: short-term follow-up results.

    Science.gov (United States)

    Østbye, Truls; Stroo, Marissa; Brouwer, Rebecca J N; Peterson, Bercedis L; Eisenstein, Eric L; Fuemmeler, Bernard F; Joyner, Julie; Gulley, Libby; Dement, John M

    2015-02-01

    To present the short-term follow-up findings of the Steps to Health study, a randomized trial to evaluate the effectiveness of two employee weight management programs offered within Duke University and the Health System. A total of 550 obese (body mass index, ≥30 kg/m2) employees were randomized 1:1 between January 2011 and June 2012 to the education-based Weight Management (WM) or the WM+ arm, which focused on behavior modification. Employees were contacted to complete a follow-up visit approximately 14 months after baseline. There were no clinically, or statistically, meaningful differences between arms, but there were modest reductions in body mass index, and positive, meaningful changes in diet and physical activity for both arms. The modest positive effects observed in this study may suggest that to achieve weight loss through the workplace more intensive interventions may be required.

  9. Dispersant trial at ANO-2: Results from a short-term trial prior to SG replacement

    International Nuclear Information System (INIS)

    Fruzzetti, K.; Frattini, P.; Robbins, P.; Miller, A.; Varrin, R.; Kreider, M.

    2002-01-01

    Corrosion products in the secondary side of pressurized water reactor (PWR) steam generators (SGs) primarily deposit on the SG tubes. These deposits can inhibit heat transfer, lead to thermal-hydraulic instabilities through blockage of tube supports, and create occluded regions where corrosive species can concentrate along tubes and in tube-to-tube support plate crevices. The performance of the SGs is compromised not only by formation of an insulating scale, but by the removal of tubes from service due to corrosion. A potential strategy for minimizing deposition of corrosion products on SG internal surfaces is to use an online dispersant to help prevent the corrosion products from adhering to the steam generator surfaces. By inhibiting the deposition of the corrosion products, the dispersant can facilitate more effective removal from the SGs via blowdown. This type of strategy has been employed at fossil boilers for many decades. However, due to the use of inorganic (sulfur and other impurities) polymerization initiators, polymeric dispersants had not been utilized in the nuclear industry. Only recently has a poly-acrylic acid dispersant, developed by BetzDearborn (PAA), been available that meets the criteria for nuclear application. This paper summarizes the results of the short-term PAA dispersant trial in Winter/Spring 2000, lasting approximately 3 months, performed at Arkansas nuclear one unit 2 (ANO-2)-including the chronology of the trial, the increase in blowdown iron removal efficiency with use of the dispersant, and observed effects on SG performance. (authors)

  10. Dispersant trial at ANO-2: Results from a short-term trial prior to SG replacement

    Energy Technology Data Exchange (ETDEWEB)

    Fruzzetti, K.; Frattini, P. [Electric Power Research Inst., Palo Alto, CA (United States); Robbins, P. [Entergy Operations, Arkansas Nuclear One, Russellville, AR (United States); Miller, A. [Pedro Point Technology, Inc., Pacifica, CA (United States); Varrin, R.; Kreider, M. [Dominion Engineering Inc., McLean, VA (United States)

    2002-07-01

    Corrosion products in the secondary side of pressurized water reactor (PWR) steam generators (SGs) primarily deposit on the SG tubes. These deposits can inhibit heat transfer, lead to thermal-hydraulic instabilities through blockage of tube supports, and create occluded regions where corrosive species can concentrate along tubes and in tube-to-tube support plate crevices. The performance of the SGs is compromised not only by formation of an insulating scale, but by the removal of tubes from service due to corrosion. A potential strategy for minimizing deposition of corrosion products on SG internal surfaces is to use an online dispersant to help prevent the corrosion products from adhering to the steam generator surfaces. By inhibiting the deposition of the corrosion products, the dispersant can facilitate more effective removal from the SGs via blowdown. This type of strategy has been employed at fossil boilers for many decades. However, due to the use of inorganic (sulfur and other impurities) polymerization initiators, polymeric dispersants had not been utilized in the nuclear industry. Only recently has a poly-acrylic acid dispersant, developed by BetzDearborn (PAA), been available that meets the criteria for nuclear application. This paper summarizes the results of the short-term PAA dispersant trial in Winter/Spring 2000, lasting approximately 3 months, performed at Arkansas nuclear one unit 2 (ANO-2)-including the chronology of the trial, the increase in blowdown iron removal efficiency with use of the dispersant, and observed effects on SG performance. (authors)

  11. Clinical evaluation of detomidine-butorphanol-guaifenesin-ketamine as short term TIVA in Spiti ponies.

    Science.gov (United States)

    Thakur, B P S; Sharma, S K; Sharma, Arvind; Kumar, Adarsh

    2011-06-01

    Veterinarians working under remote field conditions are routinely presented with variety of surgical interventions in equines like castrations, management of wound, traumatic and congenital hernias and musculoskeletal disorders thus necessitating the use of general anaesthesia for management of these conditions. The present study was carried out to evaluate and recommend the suitable short term anaesthetic technique for Spiti ponies under field conditions. Seven clinically healthy male Spiti ponies presented for castration were evaluated for short term Total Intravenous Anaesthesia (TIVA) using detomidine (0.02 mg kg(-1)), butorphanol (0.01 mg kg(-1)), 5% guaifenesin (20 mg kg(-1)) and ketamine (2.0 mg kg(-1)). The studies conducted were open label trials and all the animals received same treatment. After proper tetanus prophylaxis and preanesthetic fasting, detomidine was administered intravenously. Subsequently at head down position the animals received butorphanol intravenously. Thereafter, guaifenesin was administered intravenously. As soon as the signs of ataxia developed, the induction of surgical anaesthesia was achieved by intravenous administration of ketamine hydrochloride. The onset of sedation was observed in 2.43 +/- 0.53 min following detomidine administration and the animals were ataxic in 1.43 +/- 0.43 min after butorphanol and guaifenesin administration when ketamine was injected. The ponies were in surgical plane of anaesthesia within 2.28 +/- 0.42 min following ketamine administration. During recovery the limb/head movement and sternal recumbency were attained in 18.71 +/- 1.98 and 26.14 +/- 1.62 min, respectively whereas standing ataxia and normal gait were seen at 29.42 +/- 3.21 and 71.14 +/- 4.74 min, respectively. There was excellent to good muscle relaxation. The surgical anaesthesia remained for 22.57 +/- 1.48 min. The recovery was smooth. Moderate to good suppression of palpebral and corneal reflexes were observed immediately after

  12. Clinical and no-clinical setting specificities in first session short-term psychotherapy psychodrama group.

    Science.gov (United States)

    Drakulić, Aleksandra Mindoljević

    2011-03-01

    Modern history of short-term group psychotherapy dates back to the late 1950-ies. From then to present day, this psychotherapeutic method has been used in various forms, from dynamic-oriented to cognitive behavioural psychotherapies. Although it has always been considered rather controversial, due its cost-effectiveness, it has been capturing more and more popularity. This paper presents the specificities of first session short-term psychotherapy psychodrama group through session work with two examined groups: a group of 20 adult women who suffer from mild or moderate forms of unipolar depression and a group of 20 students of the School of Medicine in Zagreb without any psychiatric symptomatology. The results indicate the high importance of having structure in first psychodrama session, of relating it with the previously thoroughly conducted, initial, clinical, interviews, and of the clarity and focus in terms of determining the goals of therapy, especially in a clinical context. This study also confirmed assumptions regarding the need for different approaches of warming-up in psychodrama, both in the clinical and in non-clinical samples. A psychodrama psychotherapist should have good time managing skills and capability to convert the time available into an opportunity for directly boosting the group energy and work on therapeutic alliance.

  13. Efficacy of psychodynamic short-term psychotherapy for depressed breast cancer patients: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Zwerenz Rüdiger

    2012-12-01

    Full Text Available Abstract Background There is a lack of psychotherapeutic trials of treatments of comorbid depression in cancer patients. Our study determines the efficacy of a manualized short-term psychodynamic psychotherapy and predictors of outcome by personality and quality of the therapeutic relationship. Methods/design Eligible breast cancer patients with comorbid depression are assigned to short-term psychodynamic psychotherapy (up to 20 + 5 sessions or to treatment as usual (augmented by recommendation for counseling center and physician information. We plan to recruit a total of 180 patients (90 per arm in two centers. Assessments are conducted pretreatment, after 6 (treatment termination and 12 months (follow-up. The primary outcome measures are reduction of the depression score in the Hospital Anxiety and Depression Scale and remission of depression as assessed by means of the Structured Clinical Interview for DSM IV Disorders by independent, blinded assessors at treatment termination. Secondary outcomes refer to quality of life. Discussion We investigate the efficacy of short-term psychodynamic psychotherapy in acute care and we aim to identify predictors for acceptance and success of treatment. Trial registration ISRCTN96793588

  14. Plasma HIV-1 tropism and risk of short-term clinical progression to AIDS or death

    DEFF Research Database (Denmark)

    Fontdevila, Maria Casadellà; Cozzi-Lepri, Alessandro; Phillips, Andrew

    2014-01-01

    INTRODUCTION: It is uncertain if plasma HIV-1 tropism is an independent predictor of short-term risk of clinical progression / death, in addition to the CD4 count and HIV RNA level. We conducted a nested case-control study within EuroSIDA to assess this question amongst people with current HIV RNA...

  15. Short-term effect of ultrasound-guided low-molecular-weight hyaluronic acid injection on clinical outcomes and imaging changes in patients with rheumatoid arthritis of the ankle and foot joints. A randomized controlled pilot trial.

    Science.gov (United States)

    Wang, Chien-Chih; Lee, Si-Huei; Lin, Hsiao-Yi; Liu, Fu-Wei; Chiou, Hong-Jen; Chan, Rai-Chi; Chou, Chen-Liang

    2017-11-01

    To determine whether hyaluronic acid (HA) injection into rheumatoid arthritis ankles and feet can achieve improvement in foot function and reduce synovial hyper-vascularization. Forty-four patients with RA having unilateral or bilateral painful ankle and foot involvement (N = 75) were studied. All the patients were randomized to receive HA (N = 40) or lidocaine (LI) (N = 35) injection at 2-week intervals; Clinical assessments were performed using a visual analog scale (VAS) and foot function index (FFI total ) including subscales of pain (FFI pain) before injection at baseline, 4 weeks (first evaluation) and 12 weeks (secondary evaluation). Imaging evaluation based on color Doppler ultrasound (CDUS) and synovitis scores was performed simultaneously. HA injection improved the VAS score (p = .009), FFI pain (p = .041), and FFI total (p = .032) considerably more than LI injections did at the first evaluation. The CDUS values at first evaluation (p = .005) and secondary evaluation (p injections reduced the CDUS values of more than half of the joints (54%, p = .042) while the control group exhibited no change (20%, p = .56). However, HA injection did not reduce the CDUS values more than LI injection did. Regarding the evaluation of synovial hypertrophy, no significant difference was observed between or within the groups in the synovitis scores. HA injection improved short-term foot function and pain reduction. HA injection may have a modest effect in reducing synovial hyper-vascularization. Further large-scale study is warranted to confirm this result.

  16. Dispersant trial at ANO-2: Qualification for a short-term trial prior to SG replacement

    International Nuclear Information System (INIS)

    Fruzzetti, K.; Frattini, P.; Robbins, P.; Miller, A.; Varrin, R.; Kreider, M.

    2002-01-01

    initiators, polymeric dispersants had not been utilized in the nuclear industry. Only recently has a poly-acrylic acid dispersant, developed by BetzDearborn (PAA), been available off the shelf that meets the criteria for nuclear application. This paper summarizes the qualification program designed to qualify the PAA dispersant for the short-term trial at ANO-2 prior to SG replacement. (authors)

  17. Dispersant trial at ANO-2: Qualification for a short-term trial prior to SG replacement

    Energy Technology Data Exchange (ETDEWEB)

    Fruzzetti, K.; Frattini, P. [Electric Power Research Inst., Palo Alto, CA (United States); Robbins, P. [Entergy Operations, Arkansas Nuclear One, Russellville, AR (United States); Miller, A. [Pedro Point Technology, Inc., Pacifica, CA (United States); Varrin, R.; Kreider, M. [Dominion Engineering Inc., McLean, VA (United States)

    2002-07-01

    initiators, polymeric dispersants had not been utilized in the nuclear industry. Only recently has a poly-acrylic acid dispersant, developed by BetzDearborn (PAA), been available off the shelf that meets the criteria for nuclear application. This paper summarizes the qualification program designed to qualify the PAA dispersant for the short-term trial at ANO-2 prior to SG replacement. (authors)

  18. Effect of green tea catechins in patients with high-grade prostatic intraepithelial neoplasia: Results of a short-term double-blind placebo controlled phase II clinical trial

    Directory of Open Access Journals (Sweden)

    Salvatore Micali

    2017-10-01

    Full Text Available Background and study objective: Several studies suggest a protective role of green tea catechins against prostate cancer (PCa. In order to evaluate the efficacy of green tea catechins for chemoprevention of PCa in patients with high-grade prostate intraepithelial neoplasia (HG-PIN we performed a phase II clinical trial. Methods: Sixty volunteers with HG-PIN were enrolled to carry out a double-blind randomized placebo-controlled phase II clinical trial. Treated group took daily 600 mg of green tea catechins (Categ Plus® for 1 year. Patients were screened at 6 and 12 months through prostatic biopsy and measurements of prostate-specific antigen (PSA. Results: Despite the statistically significant reduction of PSA observed in subjects who received green tea catechins for 6 and 12 months, we did not find any statistical difference in PCa incidence between the experimental groups neither after 6 nor after 12 months. However, throughout the one-year follow- up we observed very limited adverse effects induced by green tea catechins and a not significant improvement in lower urinary tract symptoms and quality of life. Conclusions: Although the small number of patients enrolled in our study and the relatively short duration of intervention, our findings seems to deny the efficacy of green tea catechins. However, results of our clinical study, mainly for its low statistical strength, suggest that the effectiveness of green tea catechins should be evaluated in both a larger cohort of men and longer trial.

  19. Social cognitive markers of short-term clinical outcome in first-episode psychosis.

    Science.gov (United States)

    Montreuil, Tina; Bodnar, Michael; Bertrand, Marie-Claude; Malla, Ashok K; Joober, Ridha; Lepage, Martin

    2010-07-01

    In psychotic disorders, impairments in cognition have been associated with both clinical and functional outcome, while deficits in social cognition have been associated with functional outcome. As an extension to a recent report on neurocognition and short-term clinical outcome in first-episode psychosis (FEP), the current study explored whether social cognitive deficits could also identify poor short-term clinical outcome among FEP patients. We defined the social-cognition domain based on the scores from the Hinting Task and the Four Factor Tests of Social Intelligence. Data were collected in 45 FEP patients and 26 healthy controls. The patients were divided into good- and poor-outcome groups based on clinical data at six months following initiation of treatment. Social cognition was compared among 27 poor-outcome, 18 good-outcome, and 26 healthy-control participants. Outcome groups significantly differed in the social cognition domain (z-scores: poor outcome=-2.0 [SD=1.4]; good outcome=-1.0 [SD=1.0]; p=0.005), with both groups scoring significantly lower than the control group (psocial cognition appears to be compromised in all FEP patients compared to healthy controls. More interestingly, significant differences in social cognitive impairments exist between good and poor short-term clinical outcome groups, with the largest effect found in the Cartoon Predictions subtest.

  20. Evaluating the short-term and long-term effects of an internet-based aural rehabilitation programme for hearing aid users in general clinical practice: a randomised controlled trial.

    Science.gov (United States)

    Malmberg, Milijana; Lunner, Thomas; Kähäri, Kim; Andersson, Gerhard

    2017-06-06

    Guided internet-based intervention beyond hearing aid (HA) fitting has been shown to be efficacious in randomised controlled trials (RCTs). However, internet interventions have rarely been applied clinically as a part of regular aural rehabilitation (AR). Our aim was to evaluate the effectiveness of internet-based AR for HA users from a clinical population. The Hearing Handicap Inventory for the Elderly (HHIE) was used as the primary outcome measure, and the Communication Strategies Scale (CSS) and the Hospital Anxiety and Depression Scale were used as secondary outcome measures. All questionnaires were administered before and directly after the intervention and at 6 months postintervention. We used a parallel group design (RCT). The data were collected in 2013-2014 at three different clinics. Seventy-four HA users were randomly assigned to receive either full internet-based AR (intervention group, n=37) or one element of the internet-based AR (control group, n=37). Data were analysed following the intention-to-treat principle. Each group showed improved HHIE scores over time and did not differ significantly from each other. The intervention group showed significantly greater improvement compared with the control group for the CSS total and the non-verbal subscale scores. The intervention group and control group were also subdivided into two age groups: 20-59 years and 60-80 years. Significantly better improvement on the CSS total and non-verbal subscale scores was found in the older group compared with the younger participants. This study indicates that participants in an internet-based intervention applied in general clinical practice showed improved self-reported communication skills compared with a control group. Receiving a full intervention was not more effective in improving self-reported hearing problems than receiving just one element of the internet-based intervention. This trial is registered at ClinicalTrals.gov, NCT01837550; results. © Article author

  1. Neonatal Pulmonary MRI of Bronchopulmonary Dysplasia Predicts Short-term Clinical Outcomes.

    Science.gov (United States)

    Higano, Nara S; Spielberg, David R; Fleck, Robert J; Schapiro, Andrew H; Walkup, Laura L; Hahn, Andrew D; Tkach, Jean A; Kingma, Paul S; Merhar, Stephanie L; Fain, Sean B; Woods, Jason C

    2018-05-23

    Bronchopulmonary dysplasia (BPD) is a serious neonatal pulmonary condition associated with premature birth, but the underlying parenchymal disease and trajectory are poorly characterized. The current NICHD/NHLBI definition of BPD severity is based on degree of prematurity and extent of oxygen requirement. However, no clear link exists between initial diagnosis and clinical outcomes. We hypothesized that magnetic resonance imaging (MRI) of structural parenchymal abnormalities will correlate with NICHD-defined BPD disease severity and predict short-term respiratory outcomes. Forty-two neonates (20 severe BPD, 6 moderate, 7 mild, 9 non-BPD controls; 40±3 weeks post-menstrual age) underwent quiet-breathing structural pulmonary MRI (ultrashort echo-time and gradient echo) in a NICU-sited, neonatal-sized 1.5T scanner, without sedation or respiratory support unless already clinically prescribed. Disease severity was scored independently by two radiologists. Mean scores were compared to clinical severity and short-term respiratory outcomes. Outcomes were predicted using univariate and multivariable models including clinical data and scores. MRI scores significantly correlated with severities and predicted respiratory support at NICU discharge (P<0.0001). In multivariable models, MRI scores were by far the strongest predictor of respiratory support duration over clinical data, including birth weight and gestational age. Notably, NICHD severity level was not predictive of discharge support. Quiet-breathing neonatal pulmonary MRI can independently assess structural abnormalities of BPD, describe disease severity, and predict short-term outcomes more accurately than any individual standard clinical measure. Importantly, this non-ionizing technique can be implemented to phenotype disease and has potential to serially assess efficacy of individualized therapies.

  2. On some verbal short-term and working memory properties in patients suffering from clinical depression

    Directory of Open Access Journals (Sweden)

    Lalović Dejan

    2012-01-01

    Full Text Available Clinical depression with verbal short-term memory relation research does not yield unequivocal results. While short-term memory (STM deficits in depressed patients are consistently displayed in working memory (WM and executive attention tasks, for STM passive memorizing tasks this holds less correct. Objective. Primary goal was to collect initial data on depressed patients treated in Serbian institutions WM/ STM. In addition, we estimated the power of WAIS IV WM subtests to discriminate depressed patients from normal subjects. Method. Depressed patients' sample was contrasted with the parallel group in WAIS' IV Arithmetic, Digit Span, and Letter- Number Sequencing; free word recall task, semantic fluency task, without and with category switching. Results. All the WM measures, with the exception of Digit Span Backward score, discriminate depressed from no depressed subjects. On the other hand, STM tasks, with the exception of short-term word free recall, fail to do the same. We suggest explanation for both the exceptions in terms of WM efficiency. WAIS IV Arithmetic, Digit Span Sequencing and Letter-Number Sequencing can be used to discriminate depressed from control subjects. Performance in STM/WM tasks is in moderate to strong negative correlation with depression severity as assessed with the Hamilton scale. Conclusion. STM deficits in the depressed are likely to be observed in tasks requiring executive attention and WM efficiency rather than in standard STM span tasks. The deficits are inertly related to depression severity.

  3. Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Barone Mark A

    2012-03-01

    self-reported residual incontinence. This trial will be conducted among 512 women with simple fistula presenting at 8 study sites for fistula repair surgery over the course of 24 months at each site. Discussion If no major safety issues are identified, the data from this trial may facilitate adoption of short-term urethral catheterization following repair of simple fistula in sub-Saharan Africa and Asia. Trial registration ClinicalTrials.gov Identifier NCT01428830.

  4. Comparing patients with spinal cord infarction and cerebral infarction: clinical characteristics, and short-term outcome

    Directory of Open Access Journals (Sweden)

    Naess H

    2011-08-01

    Full Text Available Halvor Naess, Fredrik RomiDepartment of Neurology, Haukeland University Hospital, N-5021 Bergen, NorwayBackground: To compare the clinical characteristics, and short-term outcome of spinal cord infarction and cerebral infarction.Methods: Risk factors, concomitant diseases, neurological deficits on admission, and short-term outcome were registered among 28 patients with spinal cord infarction and 1075 patients with cerebral infarction admitted to the Department of Neurology, Haukeland University Hospital, Bergen, Norway. Multivariate analyses were performed with location of stroke (cord or brain, neurological deficits on admission, and short-term outcome (both Barthel Index [BI] 1 week after symptom onset and discharge home or to other institution as dependent variables.Results: Multivariate analysis showed that patients with spinal cord infarction were younger, more often female, and less afflicted by hypertension and cardiac disease than patients with cerebral infarction. Functional score (BI was lower among patients with spinal cord infarctions 1 week after onset of symptoms (P < 0.001. Odds ratio for being discharged home was 5.5 for patients with spinal cord infarction compared to cerebral infarction after adjusting for BI scored 1 week after onset (P = 0.019.Conclusion: Patients with spinal cord infarction have a risk factor profile that differs significantly from that of patients with cerebral infarction, although there are some parallels to cerebral infarction caused by atherosclerosis. Patients with spinal cord infarction were more likely to be discharged home when adjusting for early functional level on multivariate analysis.Keywords: spinal cord infarction, cerebral infarction, risk factors, short-term outcome

  5. Short-term changes in neck pain, widespread pressure pain sensitivity, and cervical range of motion after the application of trigger point dry needling in patients with acute mechanical neck pain: a randomized clinical trial.

    Science.gov (United States)

    Mejuto-Vázquez, María J; Salom-Moreno, Jaime; Ortega-Santiago, Ricardo; Truyols-Domínguez, Sebastián; Fernández-de-Las-Peñas, César

    2014-04-01

    Randomized clinical trial. To determine the effects of trigger point dry needling (TrPDN) on neck pain, widespread pressure pain sensitivity, and cervical range of motion in patients with acute mechanical neck pain and active trigger points in the upper trapezius muscle. TrPDN seems to be effective for decreasing pain in individuals with upper-quadrant pain syndromes. Potential effects of TrPDN for decreasing pain and sensitization in individuals with acute mechanical neck pain are needed. Methods Seventeen patients (53% female) were randomly assigned to 1 of 2 groups: a single session of TrPDN or no intervention (waiting list). Pressure pain thresholds over the C5-6 zygapophyseal joint, second metacarpal, and tibialis anterior muscle; neck pain intensity; and cervical spine range-of-motion data were collected at baseline (pretreatment) and 10 minutes and 1 week after the intervention by an assessor blinded to the treatment allocation of the patient. Mixed-model analyses of variance were used to examine the effects of treatment on each outcome variable. Patients treated with 1 session of TrPDN experienced greater decreases in neck pain, greater increases in pressure pain threshold, and higher increases in cervical range of motion than those who did not receive an intervention at both 10 minutes and 1 week after the intervention (Ppain intensity and widespread pressure pain sensitivity, and also increase active cervical range of motion, in patients with acute mechanical neck pain. Changes in pain, pressure pain threshold, and cervical range of motion surpassed their respective minimal detectable change values, supporting clinically relevant treatment effects. Level of Evidence Therapy, level 1b-.

  6. Effect of whey protein supplementation on long and short term appetite: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Mollahosseini, Mehdi; Shab-Bidar, Sakineh; Rahimi, Mohammad Hossein; Djafarian, Kurosh

    2017-08-01

    Specific components of dairy, such as whey proteins may have beneficial effects on body composition by suppressing appetite, although the findings of existing studies have been inconsistent. Therefore, a meta-analysis of randomized controlled trials was performed to investigate effect of whey protein supplementation on long and short term appetite. A systematic search was conducted to identify eligible publications. Means and SDs for hunger, fullness, satiety, desire to eat and prospective consumption of food, before and after intervention, were extracted and then composite appetite score (CAS) calculated. To pool data, either a fixed-effects model or a random-effects model and for assessing heterogeneity, Cochran's Q and I 2 tests were used. Eight publications met inclusion criteria that 5 records were on short term and 3 records on long term appetite. The meta-analysis showed a significant reduction in long term appetite by 4.13 mm in combined appetite score (CAS) (95% Confidence interval (CI): -6.57, -1.96; p = 0.001). No significant reduction in short term appetite was also seen (Mean difference (MD) = -0.39 95% CI = -2.07, 1.30; p = 0.653). Subgroup analyses by time showed that compared with carbohydrate, the reduction in appetite following consumption of whey consumption was not significant (MD = -0.39, 95% CI = -2.07, 1.3, p = 0.65, I 2  = 0.0%.)A significant reduction in prospective food consumption was seen (MD = -2.17, 95% CI = -3.86, -0.48). The results of our meta-analysis showed that whey protein may reduce the long and short term appetite, but our finding did not show any significant difference in appetite reduction between whey protein and carbohydrate in short duration. Copyright © 2017 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

  7. The Impact of Short-Term Video Games on Performance among Children with Developmental Delays: A Randomized Controlled Trial

    Science.gov (United States)

    Hsieh, Ru-Lan; Lee, Wen-Chung; Lin, Jui-Hsiang

    2016-01-01

    This prospective, randomized controlled study investigated the effects of short-term interactive video game playing among children with developmental delays participating in traditional rehabilitation treatment at a rehabilitation clinic. One hundred and one boys and 46 girls with a mean age of 5.8 years (range: 3 to 12 years) were enrolled in this study. All patients were confirmed to suffer from developmental delays, and were participating in traditional rehabilitation treatment. Children participated in two periods of 4 weeks each, group A being offered intervention of eight 30-minute sessions of interactive video games in the first period, and group B in the second, in addition to the traditional rehabilitation treatment. The physical, psychosocial, and total health of the children was periodically assessed using the parent-reported Pediatric Quality of Life Inventory-Generic Core Scales (PedsQL); and the children’s upper extremity and physical function, transfer and basic mobility, sports and physical functioning, and global functioning were assessed using the Pediatric Outcomes Data Collection Instrument. Parental impact was evaluated using the PedsQL-Family Impact Module for family function, PedsQL-Health Satisfaction questionnaire for parents’ satisfaction with their children’s care and World Health Organization-Quality of Life-Brief Version for quality of life. Compared with the baseline, significant improvements of physical function were observed in both groups (5.6 ± 19.5, p = 0.013; 4.7 ± 13.8, p = 0.009) during the intervention periods. No significant improvement of psychosocial health, functional performance, or family impact was observed in children with developmental delays. Short-term interactive video game play in conjunction with traditional rehabilitation treatment improved the physical health of children with developmental delays. Trial Registration: ClinicalTrials.gov NCT02184715 PMID:26983099

  8. Short-Term Impact of a Combined Nutraceutical on Cognitive Function, Perceived Stress and Depression in Young Elderly with Cognitive Impairment: A Pilot, Double-Blind, Randomized Clinical Trial.

    Science.gov (United States)

    Cicero, A F; Bove, M; Colletti, A; Rizzo, M; Fogacci, F; Giovannini, M; Borghi, C

    2017-01-01

    The prevalence of senile dementia is increasing worldwide, especially in the developed countries. Nevertheless, drug therapy isn't often enough to treat this condition. Researchers are evaluating the possible impact of a preventive approach, based on an improvement of lifestyle and the intake of micronutrients. Moreover, there is an increasing interest for combined nutraceuticals that can act as memory and learning enhancers, with a significant and beneficial potential on the cognitive disorders. To evaluate the effects of a rational assemblage of nutraceuticals on cognitive functions in a sample of 30 elderly subjects. Double bind, cross-over designed trial versus placebo Setting: outpatient clinical practice. 30 elderly subjects with basal Mini-Mental State Examination score between 20 and 27 and self-perceived cognitive decline. Treatment with a combination of nutraceuticals based on Bacopa monnieri, L-theanine, Crocus sativus, copper, folate and vitamins of B and D group. After2 months of treatment or placebo. Patients were evaluated with Mini-Mental State Examination (MMSE), Perceived Stress Questionnaire (PSQ) and Index and Self-Rating Depression Scale (SRDS). MMSE and PSQ Index significantly improved in the active treatment arm, both versus baseline and versus the parallel arm. Both groups experienced a significant improving in the SRDS scores. We obtained a good and significant improvement of the cognitive functions tested with the MMSE, PSQ-Index and SRDS score, after 2 months of combined therapy of nutraceuticals. Further confirmation will be needed to verify these observations on the middle and long term in a larger number of subjects.

  9. The Impact of Short-Term Video Games on Performance among Children with Developmental Delays: A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Ru-Lan Hsieh

    Full Text Available This prospective, randomized controlled study investigated the effects of short-term interactive video game playing among children with developmental delays participating in traditional rehabilitation treatment at a rehabilitation clinic. One hundred and one boys and 46 girls with a mean age of 5.8 years (range: 3 to 12 years were enrolled in this study. All patients were confirmed to suffer from developmental delays, and were participating in traditional rehabilitation treatment. Children participated in two periods of 4 weeks each, group A being offered intervention of eight 30-minute sessions of interactive video games in the first period, and group B in the second, in addition to the traditional rehabilitation treatment. The physical, psychosocial, and total health of the children was periodically assessed using the parent-reported Pediatric Quality of Life Inventory-Generic Core Scales (PedsQL; and the children's upper extremity and physical function, transfer and basic mobility, sports and physical functioning, and global functioning were assessed using the Pediatric Outcomes Data Collection Instrument. Parental impact was evaluated using the PedsQL-Family Impact Module for family function, PedsQL-Health Satisfaction questionnaire for parents' satisfaction with their children's care and World Health Organization-Quality of Life-Brief Version for quality of life. Compared with the baseline, significant improvements of physical function were observed in both groups (5.6 ± 19.5, p = 0.013; 4.7 ± 13.8, p = 0.009 during the intervention periods. No significant improvement of psychosocial health, functional performance, or family impact was observed in children with developmental delays. Short-term interactive video game play in conjunction with traditional rehabilitation treatment improved the physical health of children with developmental delays.ClinicalTrials.gov NCT02184715.

  10. The Impact of Short-Term Video Games on Performance among Children with Developmental Delays: A Randomized Controlled Trial.

    Science.gov (United States)

    Hsieh, Ru-Lan; Lee, Wen-Chung; Lin, Jui-Hsiang

    2016-01-01

    This prospective, randomized controlled study investigated the effects of short-term interactive video game playing among children with developmental delays participating in traditional rehabilitation treatment at a rehabilitation clinic. One hundred and one boys and 46 girls with a mean age of 5.8 years (range: 3 to 12 years) were enrolled in this study. All patients were confirmed to suffer from developmental delays, and were participating in traditional rehabilitation treatment. Children participated in two periods of 4 weeks each, group A being offered intervention of eight 30-minute sessions of interactive video games in the first period, and group B in the second, in addition to the traditional rehabilitation treatment. The physical, psychosocial, and total health of the children was periodically assessed using the parent-reported Pediatric Quality of Life Inventory-Generic Core Scales (PedsQL); and the children's upper extremity and physical function, transfer and basic mobility, sports and physical functioning, and global functioning were assessed using the Pediatric Outcomes Data Collection Instrument. Parental impact was evaluated using the PedsQL-Family Impact Module for family function, PedsQL-Health Satisfaction questionnaire for parents' satisfaction with their children's care and World Health Organization-Quality of Life-Brief Version for quality of life. Compared with the baseline, significant improvements of physical function were observed in both groups (5.6 ± 19.5, p = 0.013; 4.7 ± 13.8, p = 0.009) during the intervention periods. No significant improvement of psychosocial health, functional performance, or family impact was observed in children with developmental delays. Short-term interactive video game play in conjunction with traditional rehabilitation treatment improved the physical health of children with developmental delays. ClinicalTrials.gov NCT02184715.

  11. Randomized cross-over trial of short-term water-only fasting: metabolic and cardiovascular consequences.

    Science.gov (United States)

    Horne, B D; Muhlestein, J B; Lappé, D L; May, H T; Carlquist, J F; Galenko, O; Brunisholz, K D; Anderson, J L

    2013-11-01

    Routine, periodic fasting is associated with a lower prevalence of coronary artery disease (CAD). Animal studies show that fasting may increase longevity and alter biological parameters related to longevity. We evaluated whether fasting initiates acute changes in biomarker expression in humans that may impact short- and long-term health. Apparently-healthy volunteers (N = 30) without a recent history of fasting were enrolled in a randomized cross-over trial. A one-day water-only fast was the intervention and changes in biomarkers were the study endpoints. Bonferroni correction required p ≤ 0.00167 for significance (p fasting intervention acutely increased human growth hormone (p = 1.1 × 10⁻⁴), hemoglobin (p = 4.8 × 10⁻⁷), red blood cell count (p = 2.5 × 10⁻⁶), hematocrit (p = 3.0 × 10⁻⁶), total cholesterol (p = 5.8 × 10⁻⁵), and high-density lipoprotein cholesterol (p = 0.0015), and decreased triglycerides (p = 1.3 × 10⁻⁴), bicarbonate (p = 3.9 × 10⁻⁴), and weight (p = 1.0 × 10⁻⁷), compared to a day of usual eating. For those randomized to fast the first day (n = 16), most factors including human growth hormone and cholesterol returned to baseline after the full 48 h, with the exception of weight (p = 2.5 × 10⁻⁴) and (suggestively significant) triglycerides (p = 0.028). Fasting induced acute changes in biomarkers of metabolic, cardiovascular, and general health. The long-term consequences of these short-term changes are unknown but repeated episodes of periodic short-term fasting should be evaluated as a preventive treatment with the potential to reduce metabolic disease risk. Clinical trial registration (ClinicalTrials.gov): NCT01059760 (Expression of Longevity Genes in Response to Extended Fasting [The Fasting and Expression of Longevity Genes during Food abstinence {FEELGOOD} Trial]). Copyright © 2012 Elsevier B.V. All rights reserved.

  12. Clinical profile of congenital adrenal hyperplasia and short-term response to treatment

    International Nuclear Information System (INIS)

    Lal, S.; Lal, S.; Jamro, B.U.; Jamro, S.

    2015-01-01

    To determine the clinical presentation of congenital adrenal hyperplasia and short- term response to treatment. Background: Congenital adrenal hyperplasia (CAH) is a genetic disorder which usually presents with life threatening emergencies. Awareness of physicians regarding these presentations is an essential for early diagnosis and lifesaving treatment. In view of the prevalence of the condition as reported from tertiary care centers within the country and other parts of the globe, we had carried out a study in the paediatric department of Shaheed Mohtrama Benazir Bhutto Medical University Larkana. Material and Methods: The study was conducted over a period of one year from July 2012 to June 2013. All infants presenting with vomiting, dehydration, shock, failure to thrive and ambiguous genitalia were examined and investigated thoroughly. The diagnosis was based upon a raised level of serum 17 OHP in a child with suggestive clinical features. Results: A total of 40 children were diagnosed to have CAH during the study period. The major presenting features were vomiting in 13 (32.5%), ambiguous genitalia 17 (42.5%), vomiting and ambiguous genitalia 10 (25%), shock 5(12.5%) and failure to thrive in 13 (32.5%) of cases. All the patients were followed up after initiation of treatment and good response was observed to short-term treatment. Conclusion: This study highlights the importance of common clinical features like vomiting, unreasonable dehydration, shock and ambiguous genitalia being the presenting features of CAH and the effectiveness of replacement therapy in amending life threatening emergencies due to this condition. (author)

  13. Clinical phase I/II trial to investigate neoadjuvant intensity-modulated short term radiation therapy (5 × 5 gy) and intraoperative radiation therapy (15 gy) in patients with primarily resectable pancreatic cancer - NEOPANC

    International Nuclear Information System (INIS)

    Roeder, Falk; Debus, Juergen; Huber, Peter E; Werner, Jens; Timke, Carmen; Saleh-Ebrahimi, Ladan; Schneider, Lutz; Hackert, Thilo; Hartwig, Werner; Kopp-Schneider, Annette; Hensley, Frank W; Buechler, Markus W

    2012-01-01

    The current standard treatment, at least in Europe, for patients with primarily resectable tumors, consists of surgery followed by adjuvant chemotherapy. But even in this prognostic favourable group, long term survival is disappointing because of high local and distant failure rates. Postoperative chemoradiation has shown improved local control and overalls survival compared to surgery alone but the value of additional radiation has been questioned in case of adjuvant chemotherapy. However, there remains a strong rationale for the addition of radiation therapy considering the high rates of microscopically incomplete resections after surgery. As postoperative administration of radiation therapy has some general disadvantages, neoadjuvant and intraoperative approaches theoretically offer benefits in terms of dose escalation, reduction of toxicity and patients comfort especially if hypofractionated regimens with highly conformal techniques like intensity-modulated radiation therapy are considered. The NEOPANC trial is a prospective, one armed, single center phase I/II study investigating a combination of neoadjuvant short course intensity-modulated radiation therapy (5 × 5 Gy) in combination with surgery and intraoperative radiation therapy (15 Gy), followed by adjuvant chemotherapy according to the german treatment guidelines, in patients with primarily resectable pancreatic cancer. The aim of accrual is 46 patients. The primary objectives of the NEOPANC trial are to evaluate the general feasibility of this approach and the local recurrence rate after one year. Secondary endpoints are progression-free survival, overall survival, acute and late toxicity, postoperative morbidity and mortality and quality of life. http://www.clinicaltrials.gov/ct2/show/NCT01372735

  14. Scaling and root planning, and locally delivered minocycline reduces the load of Prevotella intermedia in an interdependent pattern, correlating with symptomatic improvements of chronic periodontitis: a short-term randomized clinical trial

    NARCIS (Netherlands)

    Deng, S.; Wang, Y.; Sun, W.; Chen, H.; Wu, G.

    2015-01-01

    Background: To evaluate the respective or combinatory efficacy of locally delivered 2% minocycline (MO) and scaling and root planning (SRP) by assessing both clinical parameters and the loads of four main periodontal pathogens in treating chronic periodontitis (CP). Methods: Seventy adults with CP

  15. The periodontal abscess (II). Short-term clinical and microbiological efficacy of 2 systemic antibiotic regimes.

    Science.gov (United States)

    Herrera, D; Roldán, S; O'Connor, A; Sanz, M

    2000-06-01

    The aim of this short-term open parallel longitudinal clinical study was to compare the clinical and microbiological efficacy of 2 different antibiotic regimes in the treatment of acute periodontal abscesses. After patient selection, a clinical examination was carried out recording the following variables: pain, edema, redness, swelling, bleeding on probing, suppuration, tooth mobility, lymphadenopathy, and probing pocket depth. Microbiological samples were taken from the lesion and the patient was randomly assigned to one of two antibiotic regimes: azithromycin or amoxicillin/clavulanate. Clinical variables were recorded, and microbiological samples were taken, at 3-5 days, 10-12 days and 30 days. Additional mechanical treatment (debridement and scaling) was performed in the third visit (10-12 days). Blood and urine samples were collected at baseline and after 10-12 days. Microbiological samples were processed by anaerobic culturing, and isolated periodontal pathogens were tested for antibiotic susceptibility by means of the spiral gradient endpoint methodology. 15 patients took azithromycin, and 14 amoxicillin/clavulanate. Subjective clinical variables demonstrated statistically significant improvements with both antibiotic regimes, which lasted for at least 1 month (pperiodontal abscesses in periodontitis patients.

  16. Dulce Wireless Tijuana: A Randomized Control Trial Evaluating the Impact of Project Dulce and Short-Term Mobile Technology on Glycemic Control in a Family Medicine Clinic in Northern Mexico.

    Science.gov (United States)

    Anzaldo-Campos, María Cecilia; Contreras, Sonia; Vargas-Ojeda, Adriana; Menchaca-Díaz, Rufino; Fortmann, Addie; Philis-Tsimikas, Athena

    2016-04-01

    The global epidemic of diabetes calls for innovative interventions. This study evaluated the effectiveness of the Project Dulce model, with and without wireless technology, on glycemic control and other clinical and self-reported outcomes in patients with poorly controlled type 2 diabetes in Mexico. Adults with type 2 diabetes and a glycated hemoglobin A1c (HbA1c) level of ≥8% were recruited from Family Medical Unit #27 of the Instituto Mexicano del Seguro Social (IMSS) in Tijuana, México, and randomly assigned to one of three groups: Project Dulce-only (PD); Project Dulce technology-enhanced with mobile tools (PD-TE); or IMSS standard of care/control group (CG). Clinical and self-reported outcomes were assessed at baseline, Month 4, and Month 10. Time-by-group interactions and within-group changes were analyzed. HbA1c reductions from baseline to Month 10 were significantly greater in PD-TE (-3.0% [-33 mmol/mol]) and PD (-2.6% [-28.7 mmol/mol]) compared with CG (-1.3% [-14.2 mmol/mol]) (P = 0.009 and 0.001, respectively). PD-TE and PD also exhibited significant improvement in diabetes knowledge when compared with CG (P improvements were observed on other clinical and self-report indicators but did not vary significantly across groups. Project Dulce with and without wireless technology substantially improved glycemic control and diabetes knowledge in high-risk patients with type 2 diabetes in a Mexican family medical unit, suggesting that integrating peer-led education, nurse coordination, and 3G wireless technology is an effective approach for improving diabetes outcomes in high-risk populations.

  17. Age-related hip fractures in men: clinical spectrum and short-term outcomes.

    Science.gov (United States)

    Poór, G; Atkinson, E J; Lewallen, D G; O'Fallon, W M; Melton, L J

    1995-01-01

    Clinical spectrum, treatment and short-term outcomes were assessed among the 131 Rochester, Minnesota, men who contracted an initial hip fracture due to moderate trauma during 1978-89. Three-fourths of falls leading to hip fracture occurred indoors with little seasonality, and 91% of fractures were in men 65 years of age or older. The ratio of cervical to intertrochanteric femur fractures was 1.4:1, and there was a tendency toward more neurological conditions among the patients with cervical fractures. Hemiarthroplasty and total hip replacement were mostly performed for cervical fractures, while internal fixation was preferred for intertrochanteric fractures. In-hospital mortality was 11.5%, and the 30-day case fatality rate was 16.0%. Age and postoperative deterioration of mental status significantly increased the risk of early death, the latter even after adjustment in a multivariate model, while comorbidity had a suggestive but not statistically significant influence on mortality. More than half the men were discharged to nursing homes, and 79% of the patients who survived at 1 year resided in nursing homes or intermediate care facilities or were attended by home care. Only 41% of survivors recovered their prefracture level of functioning and nearly 60% of patients limped and required a cane or walker. After implementation of the prospective payment system in 1984, the length of hospital stay was reduced, but there was no change in early mortality rates, in the duration of physical therapy following fracture or in attendance at nursing homes. The results of this population-based study demonstrate the strong impact of hip fractures on short-term outcomes in men.

  18. Dulce Wireless Tijuana: A Randomized Control Trial Evaluating the Impact of Project Dulce and Short-Term Mobile Technology on Glycemic Control in a Family Medicine Clinic in Northern Mexico

    Science.gov (United States)

    Contreras, Sonia; Vargas-Ojeda, Adriana; Menchaca-Díaz, Rufino; Fortmann, Addie; Philis-Tsimikas, Athena

    2016-01-01

    Abstract Background: The global epidemic of diabetes calls for innovative interventions. This study evaluated the effectiveness of the Project Dulce model, with and without wireless technology, on glycemic control and other clinical and self-reported outcomes in patients with poorly controlled type 2 diabetes in Mexico. Subjects and Methods: Adults with type 2 diabetes and a glycated hemoglobin A1c (HbA1c) level of ≥8% were recruited from Family Medical Unit #27 of the Instituto Mexicano del Seguro Social (IMSS) in Tijuana, México, and randomly assigned to one of three groups: Project Dulce–only (PD); Project Dulce technology-enhanced with mobile tools (PD-TE); or IMSS standard of care/control group (CG). Clinical and self-reported outcomes were assessed at baseline, Month 4, and Month 10. Time-by-group interactions and within-group changes were analyzed. Results: HbA1c reductions from baseline to Month 10 were significantly greater in PD-TE (−3.0% [−33 mmol/mol]) and PD (−2.6% [−28.7 mmol/mol]) compared with CG (−1.3% [−14.2 mmol/mol]) (P = 0.009 and 0.001, respectively). PD-TE and PD also exhibited significant improvement in diabetes knowledge when compared with CG (P diabetes knowledge in high-risk patients with type 2 diabetes in a Mexican family medical unit, suggesting that integrating peer-led education, nurse coordination, and 3G wireless technology is an effective approach for improving diabetes outcomes in high-risk populations. PMID:26914371

  19. Short-Term Prospective Clinical Evaluation of Monolithic and Partially Veneered Zirconia Single Crowns.

    Science.gov (United States)

    Bömicke, Wolfgang; Rammelsberg, Peter; Stober, Thomas; Schmitter, Marc

    2017-02-01

    The purpose of this study was to prospectively evaluate the short-term clinical performance and esthetics of monolithic and partially (i.e., facially) veneered zirconia single crowns (MZC and PZC, respectively). Between September 2011 and June 2013, 68 participants received 90 MZCs and 72 PZCs. Clinical study documentation was performed at crown cementation (baseline), at the 6-month follow-up, and then yearly thereafter using standardized report forms. Eight participants with 14 single crowns (eight MZCs and six PZCs) dropped out during clinical follow-up. Thus, 60 participants (28 male, mean age 62.5 ± 13.1 years) fitted with 82 MZCs and 66 PZCs were analyzed in February 2016 (Kaplan-Meier survival; mean observation time for the restorations 35.1 ± 6.3 months). Descriptive statistics were calculated for participants' and dentists' esthetic ratings on a numerical rating scale from 0 to 10 (0 = unacceptable color and shape; 10 = excellent color and shape). Complications were predominantly biological in nature. One PZC was affected by minor chipping. Cumulative 3-year failure-free survival was 98.5% (standard error (SE), 1.5%) for both MZCs and PZCs. Three-year cumulative complication-free survival (success) was 93.6% (SE 2.8%) for MZCs and 95.5% (SE 2.6%) for PZCs. Three-year cumulative fracture-free survival was 100% for MZCs and 98.5% (SE 1.5%) for PZCs. Crowns of both types were awarded high esthetic scores by participants and dentists. Monolithic and partially veneered zirconia crowns can be used clinically with excellent short-term survival and success and without compromising esthetic appearance. Longer-term follow-up is, however, desirable. During the observation time, both monolithic and partially veneered zirconia crowns showed an outstanding low technical complication rate: only one minor chipping and three losses of retention were observed. Additionally, esthetics was excellent. Based on these results the clinical use of this kind of

  20. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... humans. What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or ...

  1. Clinical Effectiveness of Aripiprazole in Short-term Treatment of Tic Disorder in Children and Adolescents: A Naturalistic Study

    Directory of Open Access Journals (Sweden)

    Che-Sheng Ho

    2014-02-01

    Conclusion: Aripiprazole is effective for short-term treatment of TD, especially vocal tics, in children and adolescents with mild adverse effects. However, further double-blind trials against placebo or other medications are needed to verify the efficacy of aripiprazole in the pharmacotherapy of TD.

  2. Dreaming during sevoflurane or propofol short-term sedation: a randomised controlled trial.

    Science.gov (United States)

    Xu, G H; Liu, X S; Yu, F Q; Gu, E W; Zhang, J; Royse, A G; Wang, K

    2012-05-01

    Prior reports suggest that dreaming during anaesthesia is dependent on recovery time. Dreaming during sedation may impact patient satisfaction. The current study explores the incidence and content of dreaming during short-term sedation with sevoflurane or propofol and investigates whether dreaming is affected by recovery time. A total of 200 women undergoing first trimester abortion (American Society of Anesthesiologists physical status I) participated in the study. Patients were randomly assigned to receive either sevoflurane or propofol for short-term sedation. Patients were interviewed upon emergence with the modified Brice questionnaire. The results showed the incidence of dreaming was significantly different between anaesthesia groups with 60% (60/100) of the sevoflurane group and 33% (33/100) of the propofol group (P=0.000). However, recovery time did not significantly differ between groups. In the sevoflurane group, a greater number of dreamers could not recall what they had dreamed about (P=0.02) and more patients reported dreams that had no sound (P=0.03) or movement (P=0.001) compared with dreamers in the propofol group. Most participants reported dreams with positive emotional content and this did not significantly differ between groups. Anaesthesia administered had no effect on patient satisfaction. The results suggest that the incidence of dreaming was not affected by recovery time. Patient satisfaction was not influenced by choice of sedative and/or by the occurrence of dreaming during sevoflurane or propofol short-term sedation.

  3. Identifying attachment ruptures underlying severe music performance anxiety in a professional musician undertaking an assessment and trial therapy of Intensive Short-Term Dynamic Psychotherapy (ISTDP).

    Science.gov (United States)

    Kenny, Dianna T; Arthey, Stephen; Abbass, Allan

    2016-01-01

    Kenny has proposed that severe music performance anxiety that is unresponsive to usual treatments such as cognitive-behaviour therapy may be one manifestation of unresolved attachment ruptures in early life. Intensive Short-Term Dynamic Psychotherapy specifically targets early relationship trauma. Accordingly, a trial of Intensive Short-Term Dynamic Psychotherapy with severely anxious musicians was implemented to assess whether resolution of attachment ruptures resulted in clinically significant relief from music performance anxiety. Volunteer musicians participating in a nationally funded study were screened for MPA severity. Those meeting the critical cut-off score on the Kenny Music Performance Anxiety Inventory were offered a trial of Intensive Short-Term Dynamic Psychotherapy. In this paper, we present the theoretical foundations and rationale for the treatment approach, followed by sections of a verbatim transcript and process analysis of the assessment phase of treatment that comprised a 3-h trial therapy session. The 'case' was a professional orchestral musician (male, aged 55) who had suffered severe music performance anxiety over the course of his entire career, which spanned more than 30 years at the time he presented for treatment following his failure to secure a position at audition. The participant was able to access the pain, rage and grief associated with unresolved attachment ruptures with both parents that demonstrated the likely nexus between early attachment trauma and severe music performance anxiety. Intensive Short-Term Dynamic Psychotherapy is a potentially cost-effective treatment for severe music performance anxiety. Further research using designs with higher levels of evidence are required before clinical recommendations can be made for the use of this therapy with this population.

  4. Clinical Trials

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    Full Text Available ... questions and clinical trials. Optimizing our Clinical Trials Enterprise NHLBI has a strong tradition of supporting clinical ... multi-pronged approach to Optimize our Clinical Trials Enterprise that will make our clinical trials enterprise even ...

  5. The anticaries effect of a food extract (shiitake) in a short-term clinical study

    NARCIS (Netherlands)

    Lingström, P.; Zaura, E.; Hassan, H.; Buijs, M.J.; Hedelin, P.; Pratten, J.; Spratt, D.; Daglia, M.; Karbowiak, A.; Signoretto, C.; Rosema, M.; van der Weijden, F.; Wilson, M.

    2012-01-01

    The main objective was to investigate whether low-molecular-weight fraction of edible mushroom shiitake extract (Lentinus edodes) possesses caries-preventive properties. The study was designed as a double-blind, three-leg, cross-over, randomized, controlled clinical trial carried out on two series

  6. Clinical Trials

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    Full Text Available ... clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a ... will be done during the clinical trial and why. Each medical center that does the study uses ...

  7. Clinical Trials

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    Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ...

  8. Short-term effects of customized arch support insoles on symptomatic flexible flatfoot in children: A randomized controlled trial.

    Science.gov (United States)

    Hsieh, Ru-Lan; Peng, Hui-Ling; Lee, Wen-Chung

    2018-05-01

    Limited evidence is available regarding the effects of insoles on pediatric flexible flatfoot because of the heterogeneity and low methodological quality of previous studies. The purpose of this prospective trial is to examine the short-term effects of customized arch support insoles on symptomatic flexible flatfoot in children by using the International Classification of Functioning, randomized controlled Disability, and Health (ICF) framework. This study was conducted in a rehabilitation outpatient clinic of a teaching hospital. Fifty-two children with symptomatic flexible flatfoot were included. The children in the treatment group wore customized arch support insoles for 12 weeks, whereas those in the control group did not wear the insoles. Both clinical and radiographic measurements, including the navicular drop, foot posture index, Beighton hypermobility score, talonavicular coverage angle, calcaneal inclination angle, and calcaneal-first metatarsal angle, were used for diagnosing flexible flatfoot. Physical activity (10-m normal and fast walking, stair ascent, stair descent, and chair rising), physical function, and psychometric properties (Pediatric Outcome Data Collection Instrument and Pediatric Quality of Life Inventory) were evaluated at the baseline and 12 weeks after the intervention. Compared with the control group, the treatment group exhibited significant improvement in pain/comfort (P = .048), physical health (P = .035), stair ascent time (P = .015), upper extremity and physical function (P = .016), and transfer and basic mobility (P = .042) during the intervention period. Children with flexible flatfoot who wore customized arch support insoles for 12 weeks exhibited significantly improved pain/comfort, physical health, stair ascent time, upper extremity and physical function, and transfer and basic mobility. These variables belong to the domains of body functions and structures and activity and participation in the ICF

  9. Phase II trial of short-term neoadjuvant docetaxel and complete androgen blockade in high-risk prostate cancer

    Science.gov (United States)

    Mellado, B; Font, A; Alcaraz, A; Aparicio, L A; Veiga, F J G; Areal, J; Gallardo, E; Hannaoui, N; Lorenzo, J R M; Sousa, A; Fernandez, P L; Gascon, P

    2009-01-01

    Background: The low probability of curing high-risk prostate cancer (PC) with local therapy suggests the need to study modality of therapeutic approaches. To this end, a prospective phase II trial of neoadjuvant docetaxel (D) and complete androgen blockade (CAB) was carried out in high-risk PC patients. The primary end point was to detect at least 10% of pCRs after chemohormonal treatment. Methods: Patients with T1c–T2 clinical stage with prostate-specific antigen (PSA) >20 ng ml−1 and/or Gleason score ⩾7 (4+3) and T3 were included. Treatment consisted of three cycles of D 36 mg m−2 on days 1, 8 and 15 every 28 days concomitant with CAB, followed by radical prostatectomy (RP). Results: A total of 57 patients were included. Clinical stage was T1c, 11 patients (19.3%); T2, 30 (52.6%) and T3, 16 (28%) patients. Gleason score was ⩾7 (4+3) in 44 (77%) patients and PSA >20 ng ml−1 in 15 (26%) patients. Treatment was well tolerated with 51 (89.9%) patients completing neoadjuvant therapy together with RP. The rate of pCR was 6% (three patients). Three (6%) additional patients had microscopic residual tumour (near pCR) in prostate specimen. With a median follow-up of 35 months, 18 (31.6%) patients presented PSA relapse. Conclusion: Short-term neoadjuvant D and CAB induced a 6% pCR rate, which is close to what would be expected with ADT alone. The combination was generally well tolerated. PMID:19755998

  10. Clinical Trials

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    Full Text Available ... Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance ...

  11. A pilot randomized crossover trial assessing the safety and short-term effects of pomegranate supplementation in hemodialysis patients.

    Science.gov (United States)

    Rivara, Matthew B; Mehrotra, Rajnish; Linke, Lori; Ruzinski, John; Ikizler, T Alp; Himmelfarb, Jonathan

    2015-01-01

    Oxidative stress and systemic inflammation are highly prevalent in patients undergoing maintenance hemodialysis (MHD) and are linked to excess cardiovascular risk. This study examined whether short-term supplementation with pomegranate juice and extract is safe and well tolerated by MHD patients. The secondary aim was to assess the effect of pomegranate supplementation on oxidative stress, systemic inflammation, monocyte function, and blood pressure. Prospective, randomized, crossover, pilot clinical trial (NCT01562340). The study was conducted from March to October 2012 in outpatient dialysis facilities in the Seattle metropolitan area. Twenty-four patients undergoing MHD (men, 64%; mean age, 61 ± 14 years) were randomly assigned to receive pomegranate juice or extract during a 4-week intervention period. After a washout period, all patients received the alternative treatment during a second 4-week intervention period. Patients assigned to receive pomegranate juice received 100 mL of juice before each dialysis session. Patients assigned to receive pomegranate extract were given 1,050 mg of extract daily. The main outcome measures were safety and tolerability of pomegranate juice and extract. Additional secondary outcomes assessed included serum lipids, laboratory biomarkers of inflammation (C-reactive protein and interleukin 6) and oxidative stress (plasma F2 isoprostanes and isofurans), monocyte cytokine production, and predialysis blood pressure. Both pomegranate juice and extract were safe and well tolerated by study participants. Over the study period, neither treatment had a significant effect on lipid profiles, plasma C-reactive protein, interleukin 6, F2-isoprostane or isofuran concentrations, predialysis systolic or diastolic blood pressure nor changed the levels of monocyte cytokine production. Both pomegranate juice and extract are safe and well tolerated by patients undergoing MHD but do not influence markers of inflammation or oxidative stress

  12. Clinical Trials

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    Full Text Available ... take part in a clinical trial. When researchers think that a trial's potential risks are greater than ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

  13. Clinical Trials

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    Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are ... earlier than they would be in general medical practice. This is because late-phase trials have large ...

  14. The effects of long- and short-term interdisciplinary treatment approaches in women with fibromyalgia: a randomized controlled trial.

    Science.gov (United States)

    Saral, Ilknur; Sindel, Dilsad; Esmaeilzadeh, Sina; Sertel-Berk, Hanife Ozlem; Oral, Aydan

    2016-10-01

    We investigated the effects of long- and short-term interdisciplinary treatment approaches for reducing symptoms and improving health-related quality of life (HRQoL) and physical functions of patients with fibromyalgia and compared the effects of two different interdisciplinary treatment approaches. We conducted a prospective, randomized, controlled trial involving 66 women with fibromyalgia eligible for the study at a university hospital setting. The patients were randomized into three groups (allocation ratio 1:1:1) using a computer-generated random numbers: a long-term interdisciplinary treatment group (LG, n = 22) that participated in 10 sessions (3-h once-weekly session for 10 weeks) of cognitive behavioral therapy (CBT) together with exercise training and other fibromyalgia related educational programs (two full days); a short-term interdisciplinary treatment group (SG, n = 22) that received two full days of educational, exercise, and CBT programs; and a control group (CG, n = 22). The patients were evaluated at baseline and 6 months after treatment using the visual analog scale (pain, fatigue, and sleep), Fibromyalgia Impact Questionnaire, Beck Depression Inventory, Short Form-36, tender point numbers, and pressure algometry as primary outcomes. The statistical analysis was confined to the 'per-protocol' set. No blinding was performed. The number of patients analyzed was 21 in the LG, 19 in the SG, and 19 in the CG. The intensity of pain (p treatment approaches when compared with controls; the long-term treatment was found more effective in reducing pain than the short-term. Both, long- and short-term interdisciplinary treatments were effective in reducing the severity of some symptoms and disease activity in patients with fibromyalgia. The short-term program well meets the needs of women with fibromyalgia particularly in relation to pain and health status as measured using FIQ; however, a long-term program may be beneficial in reducing fatigue and

  15. Short term effects of kinesiotaping on acromiohumeral distance in asymptomatic subjects: a randomised controlled trial.

    Science.gov (United States)

    Luque-Suarez, A; Navarro-Ledesma, S; Petocz, P; Hancock, M J; Hush, J

    2013-12-01

    The first aim of this study was to investigate whether kinesiotaping (KT) can increase the acromiohumeral distance (AHD) in asymptomatic subjects in the short term. The second aim was to investigate whether the direction of kinesiotaping application influences AHD. In recent years, the use of KT has become increasingly popular for a range of musculoskeletal conditions and for sport injuries. To date, we are unaware of any research investigating the effect of kinesiotaping on AHD. Moreover, it is unknown whether the direction of kinesiotaping application for the shoulder is important. Forty nine participants were randomly assigned to one of three groups: kinesiotaping group 1 (KT1), kinesiotaping group 2 (KT2) and sham kinesiotaping (KT3). AHD ultrasound measurements at 0° and 60° of shoulder elevation were collected at baseline and immediately after kinesiotape application. The results showed significant improvements in AHD after kinesiotaping, compared with sham taping. The mean difference in AHD between KT1 and KT3 groups was 1.28 mm (95% CI: 0.55, 2.03), and between KT2 and KT3 was 0.98 mm (95% CI: 0.23, 1.74). Comparison of KT1 and KT2 groups, which was performed to identify whether the direction of taping influences the AHD, indicated there were no significant differences. KT increases AHD in healthy individuals immediately following application, compared with sham kinesiotape. No differences were found with respect to the direction in which KT was applied. Copyright © 2013 Elsevier Ltd. All rights reserved.

  16. Clinical effectiveness of aripiprazole in short-term treatment of tic disorder in children and adolescents: a naturalistic study.

    Science.gov (United States)

    Ho, Che-Sheng; Chiu, Nan-Chang; Tseng, Chih-Fan; Huang, Yuan-Ling

    2014-02-01

    The purpose of this study was to evaluate the effectiveness and tolerability of aripiprazole in short-term treatment of children and adolescents with tic disorder (TD). This was a 14-week, prospective, open-label flexible dose trial of aripiprazole. We enrolled patients with TD aged between 4 years and 18 years. They received aripiprazole (dose: 2.5 mg/day) initially, which was then adjusted according to clinical response. The severity was assessed by the Yale Global Tic Severity Score (YGTSS) at 0, 2, 6, 10, and 14 weeks. The linear mixed models were used for evaluation of the YGTSSs at each follow-up, which were compared with baseline scores. Eighty-one patients were enrolled in this study. Nine patients withdrew from the study with complaints of adverse side effects. Of the remaining 72 patients, 15 patients discontinued medications prematurely due to being free of symptoms for over 2 weeks. Two patients discontinued medications due to no significant improvement. The mean scores had significantly decreased since the 2nd week (p tic scores, 67.1% in the vocal tic scores, and 70.0% in the total YGTSSs. The common adverse effects were sedation (32.1%) and increased appetite (22.2%). A slight increase in average body weight was noted, from 32.7 to 33.7 kg (+1.0 kg, p tics, in children and adolescents with mild adverse effects. However, further double-blind trials against placebo or other medications are needed to verify the efficacy of aripiprazole in the pharmacotherapy of TD. Copyright © 2013. Published by Elsevier B.V.

  17. Description of Common Clinical Presentations and Associated Short-Term Physical Therapy Clinical Outcomes in Patients With Neck Pain.

    Science.gov (United States)

    Horn, Maggie E; Brennan, Gerard P; George, Steven Z; Harman, Jeffrey S; Bishop, Mark D

    2015-10-01

    To determine the effect of clinical presentations of neck pain on short-term physical therapy outcomes. Retrospective analysis of pair-matched groups from a clinical cohort. Thirteen outpatient physical therapy clinics in 1 health care system. Patients (N=1069) grouped by common clinical presentations of neck pain: nonspecific neck pain (NSNP) with duration 4 weeks; neck pain with arm pain; neck pain with headache; and neck pain from whiplash. Conservative interventions provided by physical therapists. Neck Disability Index (NDI) and numerical pain rating scale (NPRS) recorded at the initial and last visits. The main outcome of interest was achieving recovery status on the NDI. Changes in NDI and NPRS were compared between clinical presentation groups. Compared with patients presenting with NSNP >4 weeks, patients with NSNP neck pain and arm pain demonstrated an increased odds of achieving recovery status on the NDI (P=.04) compared with patients presenting with NSNP >4 weeks. Treating patients with NSNP within <4 weeks of onset of symptoms may lead to improved clinical outcomes from physical therapy compared with other common clinical presentations. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  18. Clinical Trials

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    Full Text Available ... to-kol). This plan explains how the trial will work. The trial is led by a principal ... for the clinical trial. The protocol outlines what will be done during the clinical trial and why. ...

  19. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

  20. Excess sudden cardiac deaths after short-term clarithromycin administration in the CLARICOR trial

    DEFF Research Database (Denmark)

    Winkel, Per; Hilden, J; Hansen, Jørgen Fischer

    2011-01-01

    Objectives: To elucidate potential mechanisms for the clarithromycin-induced excess mortality observed in the CLARICOR trial during 2.6 year follow-up of patients with stable coronary artery disease. Methods: Cox analyses using out-of-hospital death as a proxy for sudden death compared to in-hospital...... CV death in patients not on statins at trial entry (HR: 2.61, 95% CI: 1.69–4.05, p administration was significantly associated with increased risk of sudden CV death in stable...

  1. Clinical Trials

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    Full Text Available ... Trial Protocol Each clinical trial has a master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The trial ... clinical trial; and detailed information about the treatment plan. Eligibility Criteria A clinical trial's protocol describes what ...

  2. Clinical Trials

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    Full Text Available ... clinical trials are vital to the process of improving medical care. Many people volunteer because they want ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

  3. Clinical Trials

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    Full Text Available ... or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  4. Clinical Trials

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    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human ...

  5. Clinical Trials

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    Full Text Available ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...

  6. Short-term efficacy of physical interventions in osteoarthritic knee pain. A systematic review and meta-analysis of randomised placebo-controlled trials

    Directory of Open Access Journals (Sweden)

    Bogen Bård

    2007-06-01

    Full Text Available Abstract Background Treatment efficacy of physical agents in osteoarthritis of the knee (OAK pain has been largely unknown, and this systematic review was aimed at assessing their short-term efficacies for pain relief. Methods Systematic review with meta-analysis of efficacy within 1–4 weeks and at follow up at 1–12 weeks after the end of treament. Results 36 randomised placebo-controlled trials (RCTs were identified with 2434 patients where 1391 patients received active treatment. 33 trials satisfied three or more out of five methodological criteria (Jadad scale. The patient sample had a mean age of 65.1 years and mean baseline pain of 62.9 mm on a 100 mm visual analogue scale (VAS. Within 4 weeks of the commencement of treatment manual acupuncture, static magnets and ultrasound therapies did not offer statistically significant short-term pain relief over placebo. Pulsed electromagnetic fields offered a small reduction in pain of 6.9 mm [95% CI: 2.2 to 11.6] (n = 487. Transcutaneous electrical nerve stimulation (TENS, including interferential currents, electro-acupuncture (EA and low level laser therapy (LLLT offered clinically relevant pain relieving effects of 18.8 mm [95% CI: 9.6 to 28.1] (n = 414, 21.9 mm [95% CI: 17.3 to 26.5] (n = 73 and 17.7 mm [95% CI: 8.1 to 27.3] (n = 343 on VAS respectively versus placebo control. In a subgroup analysis of trials with assumed optimal doses, short-term efficacy increased to 22.2 mm [95% CI: 18.1 to 26.3] for TENS, and 24.2 mm [95% CI: 17.3 to 31.3] for LLLT on VAS. Follow-up data up to 12 weeks were sparse, but positive effects seemed to persist for at least 4 weeks after the course of LLLT, EA and TENS treatment was stopped. Conclusion TENS, EA and LLLT administered with optimal doses in an intensive 2–4 week treatment regimen, seem to offer clinically relevant short-term pain relief for OAK.

  7. Extended vs short-term buprenorphine-naloxone for treatment of opioid-addicted youth: a randomized trial.

    Science.gov (United States)

    Woody, George E; Poole, Sabrina A; Subramaniam, Geetha; Dugosh, Karen; Bogenschutz, Michael; Abbott, Patrick; Patkar, Ashwin; Publicker, Mark; McCain, Karen; Potter, Jennifer Sharpe; Forman, Robert; Vetter, Victoria; McNicholas, Laura; Blaine, Jack; Lynch, Kevin G; Fudala, Paul

    2008-11-05

    The usual treatment for opioid-addicted youth is detoxification and counseling. Extended medication-assisted therapy may be more helpful. To evaluate the efficacy of continuing buprenorphine-naloxone for 12 weeks vs detoxification for opioid-addicted youth. Clinical trial at 6 community programs from July 2003 to December 2006 including 152 patients aged 15 to 21 years who were randomized to 12 weeks of buprenorphine-naloxone or a 14-day taper (detox). Patients in the 12-week buprenorphine-naloxone group were prescribed up to 24 mg per day for 9 weeks and then tapered to week 12; patients in the detox group were prescribed up to 14 mg per day and then tapered to day 14. All were offered weekly individual and group counseling. Opioid-positive urine test result at weeks 4, 8, and 12. The number of patients younger than 18 years was too small to analyze separately, but overall, patients in the detox group had higher proportions of opioid-positive urine test results at weeks 4 and 8 but not at week 12 (chi(2)(2) = 4.93, P = .09). At week 4, 59 detox patients had positive results (61%; 95% confidence interval [CI] = 47%-75%) vs 58 12-week buprenorphine-naloxone patients (26%; 95% CI = 14%-38%). At week 8, 53 detox patients had positive results (54%; 95% CI = 38%-70%) vs 52 12-week buprenorphine-naloxone patients (23%; 95% CI = 11%-35%). At week 12, 53 detox patients had positive results (51%; 95% CI = 35%-67%) vs 49 12-week buprenorphine-naloxone patients (43%; 95% CI = 29%-57%). By week 12, 16 of 78 detox patients (20.5%) remained in treatment vs 52 of 74 12-week buprenorphine-naloxone patients (70%; chi(2)(1) = 32.90, P < .001). During weeks 1 through 12, patients in the 12-week buprenorphine-naloxone group reported less opioid use (chi(2)(1) = 18.45, P < .001), less injecting (chi(2)(1) = 6.00, P = .01), and less nonstudy addiction treatment (chi(2)(1) = 25.82, P < .001). High levels of opioid use occurred in both groups at follow-up. Four of 83 patients who tested

  8. Eficácia a curto prazo do laser de baixa intensidade em pacientes com osteoartrite do joelho: ensaio clínico aleatório, placebo-controlado e duplo-cego Short-term efficacy of low-level laser therapy in patients with knee osteoarthritis: a randomized placebo-controlled, double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    Vanessa Ovanessian Fukuda

    2011-10-01

    Full Text Available OBJETIVO: Este estudo foi designado para avaliar a eficácia a curto prazo da laserterapia de baixa intensidade (LBI na melhora da dor e função em pacientes portadores de osteoartrite (OA do joelho. MÉTODOS: Participaram deste ensaio clínico aleatório, duplo-cego e controlado 47 pacientes (79 joelhos de ambos os sexos portadores de OA do joelho, que foram distribuídos aleatoriamente em dois grupos; grupo laser com 25 pacientes (41 joelhos e grupo placebo com 22 pacientes (38 joelhos. A LBI foi realizada três vezes por semana totalizando nove sessões, com uso do laser AsGa de 904nm, 60mW de potência média e 0,5cm² de área do feixe, sendo irradiados nove pontos no joelho com energia de 3,0J por ponto. O grupo placebo foi tratado com o mesmo aparelho de laser, porém com uma caneta selada. As avaliações Lequesne, escala visual numérica (EVN, Timed Up and Go (TUG, goniometria e dinamometria foram realizadas antes do início do tratamento e após as nove sessões da LBI. RESULTADOS: Foi encontrada melhora significante da dor e função para todas as avaliações aplicadas no grupo laser. Quando comparado o grupo laser ao grupo placebo encontrou-se diferença significante para as avaliações EVN-Repouso e Lequesne. CONCLUSÃO: O tratamento com a LBI melhora a dor e função a curto prazo de pacientes portadores de OA do joelho.OBJECTIVE: This study was designed to evaluate the short-term efficacy of low-level laser therapy (LLLT for improving pain and function in patients with knee osteoarthritis. METHODS: Forty-seven patients with knee osteoarthritis (79 knees, of both genders, participated in this randomized controlled double-blind clinical trial. They were randomly allocated to two groups: laser group with 25 patients (41 knees and placebo group with 22 patients (38 knees. LLLT was performed three times a week, totaling nine sessions, using a AsGa 904 nm laser with mean power of 60 mW and beam area of 0.5 cm². Nine points were

  9. Effectiveness and short-term safety of modified sodium hyaluronic acid-carboxymethylcellulose at cesarean delivery: a randomized trial.

    Science.gov (United States)

    Kiefer, Daniel G; Muscat, Jolene C; Santorelli, Jarrett; Chavez, Martin R; Ananth, Cande V; Smulian, John C; Vintzileos, Anthony M

    2016-03-01

    The rising cesarean birth rate has drawn attention to risks associated with repeat cesarean birth. Prevention of adhesions with adhesion barriers has been promoted as a way to decrease operative difficulty. However, robust data demonstrating effectiveness of such interventions are lacking. We report data from a multicenter trial designed to evaluate the short-term safety and effectiveness of a modified sodium hyaluronic acid (HA)-carboxymethylcellulose (CMC) absorbable adhesion barrier for reduction of adhesions following cesarean delivery. Patients who underwent primary or repeat cesarean delivery were included in this multicenter, single-blinded (patient), randomized controlled trial. Patients were randomized into either HA-CMC (N = 380) or no treatment (N = 373). No other modifications to their treatment were part of the protocol. Short-term safety data were collected following randomization. The location and density of adhesions (primary outcome) were assessed at their subsequent delivery using a validated tool, which can also be used to derive an adhesion score that ranges from 0-12. No differences in baseline characteristics, postoperative course, or incidence of complications between the groups following randomization were noted. Eighty patients from the HA-CMC group and 92 controls returned for subsequent deliveries. Adhesions in any location were reported in 75.6% of the HA-CMC group and 75.9% of the controls (P = .99). There was no significant difference in the median adhesion score; 2 (range 0-10) for the HA-CMC group vs 2 (range 0-8) for the control group (P = .65). One third of the HA-CMC patients met the definition for severe adhesions (adhesion score >4) compared to 15.5% in the control group (P = .052). There were no significant differences in the time from incision to delivery (P = .56). Uterine dehiscence in the next pregnancy was reported in 2 patients in HA-CMC group vs 1 in the control group (P = .60). Although we did not identify any short-term

  10. Efficacy of short-term high-dose statin in preventing contrast-induced nephropathy: a meta-analysis of seven randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Yongchuan Li

    Full Text Available A few studies focused on statin therapy as specific prophylactic measures of contrast-induced nephropathy have been published with conflicting results. In this meta-analysis of randomized controlled trials, we aimed to assess the effectiveness of short-term high-dose statin treatment for the prevention of CIN and clinical outcomes and re-evaluate of the potential benefits of statin therapy.We searched PubMed, OVID, EMBASE, Web of science and the Cochrane Central Register of Controlled Trials databases for randomized controlled trials comparing short-term high-dose statin treatment versus low-dose statin treatment or placebo for preventing CIN. Our outcome measures were the risk of CIN within 2-5 days after contrast administration and need for dialysis.Seven randomized controlled trials with a total of 1,399 patients were identified and analyzed. The overall results based on fixed-effect model showed that the use of short-term high-dose statin treatment was associated with a significant reduction in risk of CIN (RR =0.51, 95% CI 0.34-0.76, p =0.001; I(2 = 0%. The incidence of acute renal failure requiring dialysis was not significant different after the use of statin (RR = 0.33, 95% CI 0.05-2.10, p = 0.24; I(2 = 0%. The use of statin was not associated with a significant decrease in the plasma C-reactive protein level (SMD -0.64, 95% CI: -1.57 to 0.29, P = 0.18, I(2 = 97%.Although this meta-analysis supports the use of statin to reduce the incidence of CIN, it must be considered in the context of variable patient demographics. Only a limited recommendation can be made in favour of the use of statin based on current data. Considering the limitations of included studies, a large, well designed trial that incorporates the evaluation of clinically relevant outcomes in participants with different underlying risks of CIN is required to more adequately assess the role for statin in CIN prevention.

  11. Efficacy of a probiotic and chlorhexidine mouth rinses: A short-term clinical study

    Directory of Open Access Journals (Sweden)

    Harini P

    2010-09-01

    Full Text Available Introduction: Probiotic technology represents a breakthrough approach to maintaining oral health by utilizing natural beneficial bacteria commonly found in healthy mouths to provide a natural defense against those bacteria thought to be harmful to teeth and gums. However, data are still sparse on the probiotic action in the oral cavity. The review article on probiotics in children published by Twetman and Stecksen- Blicks in 2008 showed only one study of dental interest on probiotics in children. Aim and Objectives: The present study evaluated clinically the efficacy of a probiotic and chlorhexidine mouth rinses on plaque and gingival accumulation in children. The trial design is a double-blind parallel group, 14 days comparative study between a probiotic mouth rinse and a chlorhexidine mouth rinse, which included 45 healthy children in the age group of 6-8 years. Results: The Probiotic and Chlorhexidine groups had less plaque accumulations compared with the Control group at the end of 14 years (P < 0.001 and P < 0.001, respectively. But, unlike the plaque score, there was a significant difference in the Gingival Index between the Probiotic and the Chlorhexidine groups (P = 0.009, Probiotic group being better than the Chlorhexidine group (mean = 0.2300 and 0.6805, respectively. Conclusion: The Probiotic mouth rinse was found effective in reducing plaque accumulation and gingival inflammation. Therefore, probiotic mouth rinse obviously has a potential therapeutic value and further long-term study is recommended to determine its efficacy.

  12. The Anticaries Effect of a Food Extract (Shiitake in a Short-Term Clinical Study

    Directory of Open Access Journals (Sweden)

    Peter Lingström

    2012-01-01

    Full Text Available The main objective was to investigate whether low-molecular-weight fraction of edible mushroom shiitake extract (Lentinus edodes possesses caries-preventive properties. The study was designed as a double-blind, three-leg, cross-over, randomized, controlled clinical trial carried out on two series of volunteers at the University of Gothenburg, and the Academic Centre for Dentistry Amsterdam. Volunteers rinsed twice daily with a solution containing low-molecular-weight fraction of edible mushroom, placebo (negative control without active ingredients, or Meridol (positive control, AmF-SnF2 for two weeks, with a two-week washout period between each rinsing period. Changes in the acidogenicity of dental plaque before and after a sucrose challenge, shifts in microbial composition, and plaque scores were determined. Frequent rinses with shiitake reduced the metabolic activity of dental plaque. No reduction of plaque scores and no inhibition of the production of organic acids in plaque was found. Minor differences in microbial composition between test sessions were found. To conclude, the results indicate that shiitake extract has anticariogenic potential, but not to the same extent as the positive control.

  13. The Anticaries Effect of a Food Extract (Shiitake) in a Short-Term Clinical Study

    Science.gov (United States)

    Lingström, Peter; Zaura, Egija; Hassan, Haidar; Buijs, Mark J.; Hedelin, Pamie; Pratten, Jonathan; Spratt, David; Daglia, Maria; Karbowiak, Aneta; Signoretto, Caterina; Rosema, Martijn; van der Weijden, Fridus; Wilson, Michael

    2012-01-01

    The main objective was to investigate whether low-molecular-weight fraction of edible mushroom shiitake extract (Lentinus edodes) possesses caries-preventive properties. The study was designed as a double-blind, three-leg, cross-over, randomized, controlled clinical trial carried out on two series of volunteers at the University of Gothenburg, and the Academic Centre for Dentistry Amsterdam. Volunteers rinsed twice daily with a solution containing low-molecular-weight fraction of edible mushroom, placebo (negative control without active ingredients), or Meridol (positive control, AmF-SnF2) for two weeks, with a two-week washout period between each rinsing period. Changes in the acidogenicity of dental plaque before and after a sucrose challenge, shifts in microbial composition, and plaque scores were determined. Frequent rinses with shiitake reduced the metabolic activity of dental plaque. No reduction of plaque scores and no inhibition of the production of organic acids in plaque was found. Minor differences in microbial composition between test sessions were found. To conclude, the results indicate that shiitake extract has anticariogenic potential, but not to the same extent as the positive control. PMID:22500081

  14. Clinical Trials

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    Full Text Available ... protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. This means ... study before you agree to take part. Randomization Most clinical trials that have comparison groups use randomization. ...

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    Full Text Available ... more information about eligibility criteria, go to "How Do Clinical Trials Work?" Some trials enroll people who ... for adults. For more information, go to "How Do Clinical Trials Protect Participants?" For more information about ...

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... study? How might this trial affect my daily life? Will I have to be in the hospital? ...

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... from a study at any time, for any reason. Also, during the trial, you have the right ...

  18. Clinical Trials

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    Full Text Available ... need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in ... Maryland, runs clinical trials. Many other clinical trials take place in medical centers and ... trial can have many benefits. For example, you may gain access to new treatments before ...

  19. Clinical Trials

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    Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key ... Enterprise NHLBI has a strong tradition of supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

  20. Symptom profile and short term outcome of catatonia: an exploratory clinical study.

    Science.gov (United States)

    Worku, Benyam; Fekadu, Abebaw

    2015-07-22

    Catatonia is a potentially life-threatening but treatable neuropsychiatric condition. Although considered more common in low income countries, data is particularly sparse in these settings. In this study we explore the symptomatology, treatment, and short-term outcome of catatonia in Ethiopia, a low income country. The study was a prospective evaluation of patients admitted with a DSM-IV diagnosis of catatonia. Diagnosis of Catatonia and its severity were further assessed with the Bush-Francis Catatonia Rating Scale (BFCRS). Twenty participants, 5 male and 15 female, were included in the study: 15 patients (75 %) had underlying mood disorders, 4 patients (20 %) had schizophrenia and 1 patient (5 %) had general medical condition. The most common catatonic symptoms, occurring in over two-thirds of participants, were mutism, negativism, staring and immobility (stupor). Eighteen (90 %) of the twenty patients were on multiple medications. Antipsychotics were the most commonly prescribed medications. ECT was required in seven patients (35.0 %). Dehydration, requiring IV rehydration, and infections were the most important complications ascribed to the catatonia. These occurred in seven patients (25 %). Almost all patients (n = 19/20) were discharged with significant improvement. This study supports the growing consensus that catatonia is most often associated with mood disorders. Overall prognosis appears very good although the occurrence of life-threatening complications underlines the serious nature of catatonia. This has implication for "task-shifted" service scale up plans, which aim to improve treatment coverage by training non-specialist health workers to provide mental health care in low income countries. Further larger scale studies are required to clarify the nature and management, as well as, service requirements for catatonia.

  1. Portion controlled ready-to-eat meal replacement is associated with short term weight loss: a randomised controlled trial.

    Science.gov (United States)

    Kuriyan, Rebecca; Lokesh, Deepa P; D'Souza, Ninoshka; Priscilla, Divya J; Peris, Chandni Halcyon; Selvam, Sumithra; Kurpad, Anura V

    2017-01-01

    Strategies to prevent and treat overweight/obesity are urgently needed. This study assessed the effect of a short-term intake of ready-to-eat cereal on body weight and waist circumference of overweight/obese individuals in comparison to a control group. A randomized, controlled 2-arm trial was carried out on 101 overweight/obese (Body Mass Index - 29.2±2.4 kg/m2) females aged 18 to 44 years, at St. John's Medical College Hospital. The intervention group received a low fat, ready to eat cereal, replacing two meals/day for two weeks. The control group was provided with standard dietary guidelines for weight loss and energy requirements for both groups were calculated similarly. Anthropometric, dietary, appetite and health status assessments were carried out at baseline and at the end of two weeks. At the end of two weeks, the mean reductions in body weight and waist circumference were significantly greater in the intervention group, -0.53 kg; 95% CI (-0.86 to -0.19) for body weight and -1.39 cm; 95% CI (-1.78, -0.99) for waist circumference. The intervention group had a significantly higher increase in dietary intakes of certain vitamins, fiber and sugar, and significantly higher reductions in total and polyunsaturated fats and sodium intakes, as compared to the control group (peat cereal could be effective for short-term weight loss, with some improvements in the nutrient intake profile. However, studies of longer duration are needed.

  2. Clinical Trials

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    Full Text Available ... Working at the NHLBI Contact and FAQs Accessible Search Form Search the NHLBI, use the drop down list to ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

  3. Clinical Trials

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    Full Text Available ... comparison groups by chance, rather than choice. This method helps ensure that any differences observed during a ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

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    Full Text Available ... these results are important because they advance medical knowledge and help improve patient care. Sponsorship and Funding ... All types of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical ...

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    Full Text Available ... clinical trials. If you're thinking about taking part in a clinical trial, find out ahead of time about costs and coverage. You should learn about the risks and benefits of any clinical trial before you agree to take part in the trial. Talk with your doctor about ...

  6. Short-term effect of cocoa product consumption on lipid profile: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Jia, Lei; Liu, Xuan; Bai, Yong Yi; Li, Shao Hua; Sun, Kai; He, Chen; Hui, Rutai

    2010-07-01

    The effect of cocoa products on lipid changes is controversial. We aimed to identify and quantify the effect of cocoa on total cholesterol, LDL cholesterol, and HDL cholesterol. A comprehensive literature search was conducted for relevant trials of cocoa on lipid profile. Weighted mean differences were calculated for net changes in lipid concentrations by using fixed-effects or random-effects models. Previously defined subgroup analyses were performed to identify the source of heterogeneity. Eight trials (involving 215 participants) were included and evaluated. Because there was only one relatively longer-term study, we focused on the short-term data to evaluate the effects of cocoa on plasma lipid. Cocoa consumption significantly lowered LDL cholesterol by 5.87 mg/dL (95% CI: -11.13, -0.61; P consumption significantly reduced blood cholesterol, but the changes were dependent on the dose of cocoa consumption and the healthy status of participants. There was no dose response and no effect in healthy participants. Future high-quality studies are needed to determine the efficiency of moderate cocoa consumption on lipid profile in long-term intervention and in subjects with other cardiometabolic risk factors.

  7. Effects of a manualized short-term treatment of internet and computer game addiction (STICA: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jäger Susanne

    2012-04-01

    Full Text Available Abstract Background In the last few years, excessive internet use and computer gaming have increased dramatically. Salience, mood modification, tolerance, withdrawal symptoms, conflict, and relapse have been defined as diagnostic criteria for internet addiction (IA and computer addiction (CA in the scientific community. Despite a growing number of individuals seeking help, there are no specific treatments of established efficacy. Methods/design This clinical trial aims to determine the effect of the disorder-specific manualized short-term treatment of IA/CA (STICA. The cognitive behavioural treatment combines individual and group interventions with a total duration of 4 months. Patients will be randomly assigned to STICA treatment or to a wait list control group. Reliable and valid measures of IA/CA and co-morbid mental symptoms (for example social anxiety, depression will be assessed prior to the beginning, in the middle, at the end, and 6 months after completion of treatment. Discussion A treatment of IA/CA will establish efficacy and is desperately needed. As this is the first trial to determine efficacy of a disorder specific treatment, a wait list control group will be implemented. Pros and cons of the design were discussed. Trial Registration ClinicalTrials (NCT01434589

  8. Effects of a manualized short-term treatment of internet and computer game addiction (STICA): study protocol for a randomized controlled trial

    Science.gov (United States)

    2012-01-01

    Background In the last few years, excessive internet use and computer gaming have increased dramatically. Salience, mood modification, tolerance, withdrawal symptoms, conflict, and relapse have been defined as diagnostic criteria for internet addiction (IA) and computer addiction (CA) in the scientific community. Despite a growing number of individuals seeking help, there are no specific treatments of established efficacy. Methods/design This clinical trial aims to determine the effect of the disorder-specific manualized short-term treatment of IA/CA (STICA). The cognitive behavioural treatment combines individual and group interventions with a total duration of 4 months. Patients will be randomly assigned to STICA treatment or to a wait list control group. Reliable and valid measures of IA/CA and co-morbid mental symptoms (for example social anxiety, depression) will be assessed prior to the beginning, in the middle, at the end, and 6 months after completion of treatment. Discussion A treatment of IA/CA will establish efficacy and is desperately needed. As this is the first trial to determine efficacy of a disorder specific treatment, a wait list control group will be implemented. Pros and cons of the design were discussed. Trial Registration ClinicalTrials (NCT01434589) PMID:22540330

  9. Comparison between the effects of trigger point mesotherapy versus acupuncture points mesotherapy in the treatment of chronic low back pain: a short term randomized controlled trial.

    Science.gov (United States)

    Di Cesare, Annalisa; Giombini, Arrigo; Di Cesare, Mariachiara; Ripani, Maurizio; Vulpiani, Maria Chiara; Saraceni, Vincenzo Maria

    2011-02-01

    The goal of this study was to compare the effects of trigger point (TRP) mesotherapy and acupuncture (ACP) mesotherapy in the treatment of patients with chronic low back pain. Short term randomized controlled trial. 62 subjects with chronic low back pain were recruited at outpatients Physical Medicine and Rehabilitation Clinic at the University of Rome "La Sapienza" in the period between July 2006 and May 2008. Study subjects were assigned to receive 4 weeks treatments with either trigger point mesotherapy (TRP mesotherapy, n=29) or acupoints mesotherapy (ACP mesotherapy, n=33). Pain intensity with a pain visual analogic scale (VAS) and verbal rating scale (VRS) and pain disability with McGill Pain Questionnaire Short Form (SFMPQ), Roland Morris Disability Questionnaire (RMQ) and Oswestry Low Back Pain Disability Questionaire (ODQ). ACP mesotherapy shows a more effective results in VRS and VAS measures in the follow-up (p(VRS)=mesotherapy group. Our results suggest that the response to ACP mesotherapy may be greater than the response to TRP mesotherapy in the short term follow-up. This technique could be nevertheless a viable option as an adjunct treatment in an overall treatment planning of CLBP. Copyright © 2010 Elsevier Ltd. All rights reserved.

  10. Clinical Trials

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    Full Text Available ... resources to the strategies and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, you may get tests or treatments in a hospital, clinic, or doctor's office. In some ways, taking part in a clinical trial is different ...

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    Full Text Available ... Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don't know ...

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    Full Text Available ... about your health or fill out forms about how you feel. Some people will need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in Bethesda, Maryland, runs clinical trials. Many other clinical trials take place ...

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    Full Text Available ... child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials. Clinical trials for children have the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ...

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    Full Text Available ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment options. Together, you can make the ... more about, or taking part in, clinical trials, talk with your doctor. He or she may know about ... clinical trials. NIH Clinical Research Studies ...

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    Full Text Available ... you agree to take part in the trial. Talk with your doctor about specific trials you're ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment ...

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    Full Text Available ... any clinical trial before you agree to take part in the trial. Talk with your doctor about specific trials you're interested in. For a list of questions to ask your doctor and the ...

  17. Short-Term Memory and Auditory Processing Disorders: Concurrent Validity and Clinical Diagnostic Markers

    Science.gov (United States)

    Maerlender, Arthur

    2010-01-01

    Auditory processing disorders (APDs) are of interest to educators and clinicians, as they impact school functioning. Little work has been completed to demonstrate how children with APDs perform on clinical tests. In a series of studies, standard clinical (psychometric) tests from the Wechsler Intelligence Scale for Children, Fourth Edition…

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    Full Text Available ... medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key research tool for ... other for moderate persistent asthma. The results provided important treatment information for doctors and patients. The results ...

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    Full Text Available ... Entire Site NHLBI Entire Site Health Topics News & Resources Intramural Research ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ...

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    Full Text Available ... sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, ... and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including the NHLBI) usually ...

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    Full Text Available ... decisionmaking. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards ... otherwise. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards ...

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    Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... medical strategy, treatment, or device is safe and effective for humans. These studies also may show which ...

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... care providers might be part of your treatment team. They will monitor your health closely. You may ...

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute of Health ...

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... include factors such as a patient's age and gender, the type and stage of disease, and whether ...

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    Full Text Available ... needed. For safety purposes, clinical trials start with small groups of patients to find out whether a ... phase I clinical trials test new treatments in small groups of people for safety and side effects. ...

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    Full Text Available ... organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ...

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    Full Text Available ... risks that outweigh any possible benefits. Clinical Trial Phases Clinical trials of new medicines or medical devices are done in phases. These phases have different purposes and help researchers ...

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    Full Text Available ... clinical trials. An IRB is an independent committee created by the institution that sponsors a clinical trial. ... have not only shaped medical practice around the world, but have improved the health of millions of ...

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    Full Text Available ... at the smallest dose and for the shortest time possible. Clinical trials, like the two described above, ... in a clinical trial, find out ahead of time about costs and coverage. You should learn about ...

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    Full Text Available ... Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... and advance medical care. They also can help health care decisionmakers direct resources to the strategies and treatments ...

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    Full Text Available ... whether a new approach causes any harm. In later phases of clinical trials, researchers learn more about ... other National Institutes of Health (NIH) Institutes and Centers sponsor clinical trials. Many other groups, companies, and ...

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    Full Text Available ... Some companies and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ...

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    Full Text Available ... and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial ... volunteer because they want to help others. Possible Risks Clinical trials do have risks and some downsides, ...

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  8. A short-term clinical evaluation of IPS Empress 2 crowns.

    Science.gov (United States)

    Toksavul, Suna; Toman, Muhittin

    2007-01-01

    The aim of this study was to evaluate the clinical performance of all-ceramic crowns made with the IPS Empress 2 system after an observation period of 12 to 60 months. Seventy-nine IPS Empress 2 crowns were placed in 21 patients. The all-ceramic crowns were evaluated clinically, radiographically, and using clinical photographs. The evaluations took place at baseline (2 days after cementation) and at 6-month intervals for 12 to 60 months. Survival rate of the crowns was determined using Kaplan-Meier statistical analysis. Based on the US Public Health Service criteria, 95.24% of the crowns were rated satisfactory after a mean follow-up period of 58 months. Fracture was registered in only 1 crown. One endodontically treated tooth failed as a result of fracture at the cervical margin area. In this in vivo study, IPS Empress 2 crowns exhibited a satisfactory clinical performance during an observation period ranging from 12 to 60 months.

  9. Effects of a manualized short-term treatment of internet and computer game addiction (STICA): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Jäger, Susanne; Müller, Kai W; Ruckes, Christian; Wittig, Tobias; Batra, Anil; Musalek, Michael; Mann, Karl; Wölfling, Klaus; Beutel, Manfred E

    2012-04-27

    In the last few years, excessive internet use and computer gaming have increased dramatically. Salience, mood modification, tolerance, withdrawal symptoms, conflict, and relapse have been defined as diagnostic criteria for internet addiction (IA) and computer addiction (CA) in the scientific community. Despite a growing number of individuals seeking help, there are no specific treatments of established efficacy. This clinical trial aims to determine the effect of the disorder-specific manualized short-term treatment of IA/CA (STICA). The cognitive behavioural treatment combines individual and group interventions with a total duration of 4 months. Patients will be randomly assigned to STICA treatment or to a wait list control group. Reliable and valid measures of IA/CA and co-morbid mental symptoms (for example social anxiety, depression) will be assessed prior to the beginning, in the middle, at the end, and 6 months after completion of treatment. A treatment of IA/CA will establish efficacy and is desperately needed. As this is the first trial to determine efficacy of a disorder specific treatment, a wait list control group will be implemented. Pros and cons of the design were discussed. ClinicalTrials (NCT01434589).

  10. The effect of short-term workshop on improving clinical reasoning skill of medical students.

    Science.gov (United States)

    Yousefichaijan, Parsa; Jafari, Farshad; Kahbazi, Manijeh; Rafiei, Mohammad; Pakniyat, AbdolGhader

    2016-01-01

    Clinical reasoning process leads clinician to get purposeful steps from signs and symptoms toward diagnosis and treatment. This research intends to investigate the effect of teaching clinical reasoning on problem-solving skills of medical students. This research is a semi-experimental study. Nineteen Medical student of the pediatric ward as case group participated in a two-day workshop for training clinical reasoning. Before the workshop, they filled out Diagnostic Thinking Inventory (DTI) questionnaires. Fifteen days after the workshop the DTI questionnaire completed and "key feature" (KF) test and "clinical reasoning problem" (CRP) test was held. 23 Medical student as the control group, without passing the clinical reasoning workshop DTI questionnaire completed, and KF test and CRP test was held. The average score of the DTI questionnaire in the control group was 162.04 and in the case group before the workshop was 153.26 and after the workshop was 181.68. Compare the average score of the DTI questionnaire before and after the workshop there is a significant difference. The difference between average KF test scores in the control and the case group was not significant but between average CRP test scores was significant. Clinical reasoning workshop is effectiveness in promoting problem-solving skills of students.

  11. Clinical Trials

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    Full Text Available ... give permission for their child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials. Find a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  12. The coping with depression course: Short term outcomes and mediating effects of a randomized controlled trial in the treatment of subclinical depression

    NARCIS (Netherlands)

    Allart-van Dam, E.; Hosman, C.M.H.; Hoogduin, C.A.L.; Schaap, C.P.D.R.

    2003-01-01

    This article reports on a randomized controlled trial investigating the short-term effectiveness of the Coping With Depression course in a sample of adults seriously at risk of developing major depression. In addition, possible mediating properties of several proximal outcome variables were

  13. The Coping with Depression course : Short-term outcomes and mediating effects of a randomized controlled trial in the treatment of subclinical depression

    NARCIS (Netherlands)

    Allart-van Dam, E; Hosman, CMH; Hoogduin, CAL; Schaap, CPDR

    2003-01-01

    This article reports on a randomized controlled trial investigating the short-term effectiveness of the Coping With Depression course in a sample of adults seriously at risk of developing major depression. In addition, possible mediating properties of several proximal outcome variables were

  14. Pediatric-onset Takayasu's arteritis: clinical features and short-term outcome.

    Science.gov (United States)

    Misra, Durga Prasanna; Aggarwal, Amita; Lawrence, Able; Agarwal, Vikas; Misra, Ramnath

    2015-10-01

    The aim of this was to assess clinical features and outcome in pediatric-onset Takayasu's arteritis (TA). Retrospective data analysis of patients diagnosed with TA over last 13 years with onset before 18 years of age was done. Their presenting features, activity (by NIH criteria, ITAS2010, ITAS-A), disease extent (by DEI.Tak) and angiographic findings were retrieved from clinic files. Treatment received and follow-up data on disease activity and damage by TA damage score (TADS) were also analyzed. Wherever repeated angiography data were available, the same was analyzed. Values are expressed as median with interquartile range in brackets. There were 29 patients (19 females) with median age at diagnosis of 14 (13-16) years and delay to diagnosis of 1 (0.4-2) year. Common presenting symptoms were pulse loss (23/29) and hypertension (22/29). Patients had extensive disease at presentation with median DEI.Tak of 12 (9.5-15); 23/29 had elevated acute-phase reactants, and 28/29 were active at presentation [median ITAS2010 13 (8-15.5), ITAS-A 14 (10-17)]. Numano's type V was the commonest angiographic type (22/29). At a median follow-up of 2.4 (1.5-5.1) years, 2/20 were active whereas all had sustained damage despite a majority (17/20) being on immunosuppression. The median TADS was 8 (6.3-9.8) with pulse loss, claudication and hypertension being the commonest damage item. Two needed renal artery stenting to control hypertension. Angiographic assessment at least 2 years apart demonstrated disease progression in 5 of 6 patients despite immunosuppression. Significant damage accrued on follow-up despite immunosuppression and control of disease activity. Hypertension remains the major long-term morbidity.

  15. Does short-term virologic failure translate to clinical events in antiretroviral-naïve patients initiating antiretroviral therapy in clinical practice?

    NARCIS (Netherlands)

    Mugavero, Michael J; May, Margaret; Harris, Ross; Saag, Michael S; Costagliola, Dominique; Egger, Matthias; Phillips, Andrew; Günthard, Huldrych F; Dabis, Francois; Hogg, Robert; de Wolf, Frank; Fatkenheuer, Gerd; Gill, M John; Justice, Amy; D'Arminio Monforte, Antonella; Lampe, Fiona; Miró, Jose M; Staszewski, Schlomo; Sterne, Jonathan A C; Niesters, Bert

    2008-01-01

    OBJECTIVE: To determine whether differences in short-term virologic failure among commonly used antiretroviral therapy (ART) regimens translate to differences in clinical events in antiretroviral-naïve patients initiating ART. DESIGN: Observational cohort study of patients initiating ART between

  16. Risk factors associated with short-term post-treatment outcomes of clinical mastitis.

    Science.gov (United States)

    Pinzón-Sánchez, C; Ruegg, P L

    2011-07-01

    The objectives of this study were to characterize 60-d outcomes after treatment of mild (abnormal milk) and moderate (abnormal milk and abnormal udder) cases of clinical mastitis (CM) occurring in a single quarter of cows on Wisconsin farms (n=4) and to determine risk factors associated with those outcomes. Duplicate milk samples were collected from the affected quarter of each cow for microbiological analysis at the onset of CM (PRE) and 21 d later (POST). Cows were treated only in the affected quarter using an intramammary product containing 125 mg of ceftiofur. Bacteriological cure was defined as absence of pathogens in the POST sample obtained from the enrolled quarter. Recurrence was defined for the cow when CM occurred after the milk-withholding period for the enrolled case of CM. Retention in the herd was defined when a cow was retained within the herd for the 60-d follow-up period. Somatic cell count reduction (SCCR) was defined at the cow level as somatic cell count (SCC) below 200,000 cells/mL at the Dairy Herd Improvement Association test day occurring between 21 to 55 d post-treatment. The effects of farm, days in milk, parity, severity, microbiological diagnosis at PRE, previous milk yield, previous SCC, previous occurrence of CM and treatment duration on selected post-treatment outcomes were assessed using Chi-squared analysis and logistic regression. Microbiological results at PRE were distributed as: Escherichia coli (n=14), Klebsiella spp. (n=11), Enterobacter spp. (n=8), Serratia spp. (n=7), other gram-negative species (n=3), Streptococcus spp. (n=25), coagulase-negative staphylococci (n=4); Staphylococcus aureus (n=1); Streptococcus agalactiae (n=1), other gram-positive species (n=9), and culture negative (n=60). Treated quarters were more likely to experience bacteriological cure when the cow experienced CM for the first time in the lactation and when no pathogen was recovered from PRE milk samples obtained from the enrolled quarter. Parity and

  17. Clinical Trials

    Medline Plus

    Full Text Available ... more screening tests to see which test produces the best results. Some companies and groups sponsor clinical trials that test the ... and Drug Administration (FDA) oversees these clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All ...

  18. Effect of short-term estrogen therapy on endothelial function: a double-blinded, randomized, controlled trial.

    Science.gov (United States)

    Hurtado, R; Celani, M; Geber, S

    2016-10-01

    To evaluate the effect of short-term hormone replacement therapy with 0.625 mg conjugated estrogens daily on endothelial function of healthy postmenopausal women, using flow-mediated dilation (FMD) of the brachial artery. We performed a double-blinded, randomized, controlled trial over 3 years. Randomization was performed using computer-generated sorting. All participants were blinded to the use of conjugated equine estrogens (CEE) or placebo and FMD was assessed by a blinded examiner, before and after 28 days of medication. A total of 64 healthy postmenopausal women were selected and randomly assigned into two groups of treatment: 0.625 mg of CEE or placebo. FMD values were statistically different between the groups (p = 0.025): the group receiving CEE showed a FMD value of 0.011 compared to the placebo group (FMD = -0.082). The two groups were additionally evaluated for homogeneity through the Shapiro-Wilk test in respect to variables that could interfere with endothelial function such as age (p = 0.729), body mass index (p = 0.891), and time since menopause (p = 0.724). Other variables were excluded during selection of the participants such as chronic vascular conditions, smoking, and sedentary lifestyle. Our results demonstrate that the administration of 0.625 mg CEE for 28 days is effective in improving vascular nitric oxide-dependent dilation assessed by FMD of the brachial artery in postmenopausal women. NCT01482416.

  19. The impact of short term clinical placement in a developing country on nursing students: A qualitative descriptive study.

    Science.gov (United States)

    Ulvund, Ingeborg; Mordal, Elin

    2017-08-01

    Offering nursing students' international clinical placement during the educational program is one response to meet the need of cultural competence among nurses. This paper provides insight into the impact of clinical placement, in a developing country, on third year nursing students. In the study we investigated how short term international clinical placement impacted Norwegian nursing students' development of cultural competency. In this study we utilised a qualitative descriptive design and used individual interviews with eighteen Norwegian nursing students who had all participated in an international clinical placement. The data were analysed using the principles of systematic text condensation. In spite the international clinical placement only was four weeks, the findings suggested that real life experience culturally awakened the students and forced an ongoing process developing cultural competence. However, it is important to give students time to reflection. Although increased cultural awareness and a growing cultural competence was identified by the students undertaking international clinical placement, further research is required. It is important to investigate the best methods to support the students' reflection such that the experiences lead to learning. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. Prevention of colonic neoplasia with polyethylene glycol: A short term randomized placebo-controlled double-blinded trial.

    Science.gov (United States)

    Wali, Ramesh K; Bianchi, Laura; Kupfer, Sonia; De La Cruz, Mart; Jovanovic, Borko; Weber, Christopher; Goldberg, Michael J; Rodriguez, L M; Bergan, Raymond; Rubin, David; Tull, Mary Beth; Richmond, Ellen; Parker, Beth; Khan, Seema; Roy, Hemant K

    2018-01-01

    Chemoprevention represents an attractive modality against colorectal cancer (CRC) although widespread clinical implementation of promising agents (e.g. aspirin/NSAIDS) have been stymied by both suboptimal efficacy and concerns over toxicity. This highlights the need for better agents. Several groups, including our own, have reported that the over-the-counter laxative polyethylene glycol (PEG) has remarkable efficacy in rodent models of colon carcinogenesis. In this study, we undertook the first randomized human trial to address the role of PEG in prevention of human colonic neoplasia. This was a double-blind, placebo-controlled, three-arm trial where eligible subjects were randomized to 8g PEG-3350 (n = 27) or 17g PEG-3350 (n = 24), or placebo (n = 24; maltodextrin) orally for a duration of six months. Our initial primary endpoint was rectal aberrant crypt foci (ACF) but this was changed during protocol period to rectal mucosal epidermal growth factor receptor (EGFR). Of the 87 patients randomized, 48 completed study primary endpoints and rectal EGFR unchanged PEG treatment. Rectal ACF had a trend suggesting potentially reduction with PEG treatment (pre-post change 1.7 in placebo versus -0.3 in PEG 8+ 17g doses, p = 0.108). Other endpoints (proliferation, apoptosis, expression of SNAIL and E-cadherin), previously noted to be modulated in rodent models, appeared unchanged with PEG treatment in this clinical trial. We conclude that PEG was generally well tolerated with the trial failing to meet primary efficacy endpoints. However, rectal ACFs demonstrated a trend (albeit statistically insignificant) for suppression with PEG. Moreover, all molecular assays including EGFR were unaltered with PEG underscoring issues with lack of translatability of biomarkers from preclinical to clinical trials. This data may provide the impetus for future clinical trials on PEG using more robust biomarkers of chemoprevention. ClinicalTrials.gov NCT00828984.

  1. Clinical Trials

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    Full Text Available ... you to explore NIH Clinical Center for patient recruitment and clinical trial information. For more information, please email the NIH Clinical Center Office of Patient Recruitment at cc-prpl@cc.nih.gov or call ...

  2. Clinical Trials

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    Full Text Available ... the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ... based on what is known to work in adults. To improve clinical care of children, more studies ...

  3. Clinical Trials

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    Full Text Available ... groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments ... sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of ...

  4. Clinical Trials

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    Full Text Available ... Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including ... our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...

  5. Clinical Trials

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    Full Text Available ... identified earlier than they would be in general medical practice. This is because late-phase trials have large ... supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

  6. Clinical Trials

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    Full Text Available ... the past, clinical trial participants often were White men. Researchers assumed that trial results were valid for ... different ethnic groups sometimes respond differently than White men to the same medical approach. As a result, ...

  7. Clinical Trials

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    Full Text Available ... or strategies work best for certain illnesses or groups of people. Some clinical trials show a positive result. For example, the National Heart, Lung, and Blood Institute (NHLBI) sponsored a trial of two different ...

  8. Clinical Trials

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    Full Text Available ... healthy people to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial participants ... DSMBs for large trials comparing alternative strategies for diagnosis or treatment. In addition, the NIH requires DSMBs ...

  9. Clinical Trials

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    Full Text Available ... well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All ...

  10. Clinical Trials

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    Full Text Available ... trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... they advance medical knowledge and help improve patient care. Sponsorship and Funding The National Heart, Lung, and ...

  11. Clinical Trials

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    Full Text Available ... including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study explored ... risks. Other examples of clinical trials that test principles or strategies include studies that explore whether surgery ...

  12. The effect of perioperative probiotics treatment for colorectal cancer: short-term outcomes of a randomized controlled trial.

    Science.gov (United States)

    Yang, Yongzhi; Xia, Yang; Chen, Hongqi; Hong, Leiming; Feng, Junlan; Yang, Jun; Yang, Zhe; Shi, Chenzhang; Wu, Wen; Gao, Renyuan; Wei, Qing; Qin, Huanlong; Ma, Yanlei

    2016-02-16

    This study was designed to mainly evaluate the anti-infective effects of perioperative probiotic treatment in patients receiving confined colorectal cancer (CRC) respective surgery. From November 2011 to September 2012, a total of 60 patients diagnosed with CRC were randomly assigned to receive probiotic (n = 30) or placebo (n = 30) treatment. The operative and post-operative clinical results including intestinal cleanliness, days to first - flatus, defecation, fluid diet, solid diet, duration of pyrexia, average heart rate, length of intraperitoneal drainage, length of antibiotic therapy, blood index changes, rate of infectious and non-infectious complications, postoperative hospital stay, and mortality were investigated. The patient demographics were not significantly different (p > 0.05) between the probiotic treated and the placebo groups. The days to first flatus (3.63 versus 3.27, p = 0.0274) and the days to first defecation (4.53 versus 3.87, p = 0.0268) were significantly improved in the probiotic treated patients. The incidence of diarrhea was significantly lower (p = 0.0352) in probiotics group (26.67%, 8/30) compared to the placebo group (53.33%, 16/30). There were no statistical differences (p > 0.05) in other infectious and non-infectious complication rates including wound infection, pneumonia, urinary tract infection, anastomotic leakage, and abdominal distension. In conclusion, for those patients undergoing confined CRC resection, perioperative probiotic administration significantly influenced the recovery of bowel function, and such improvement may be of important clinical significance in reducing the short-term infectious complications such as bacteremia.

  13. The effects of short-term alpha-ketoisocaproic acid supplementation on exercise performance: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Yarrow Joshua F

    2007-07-01

    Full Text Available Abstract Background This study examined the efficacy of short-term alpha-ketoisocaproic acid (KIC monotherapy supplementation immediately prior to moderate- and high-intensity single bout exercise performance. Methods Thirteen resistance trained men (22.8 ± 2.5 years; 81.6 ± 12.6 kg participated in a prospective, randomized, double blind, placebo controlled crossover experiment. Each subject completed one familiarization and four experimental trials with either 1.5 g or 9.0 g of either KIC or isocaloric placebo control (CONT, following an overnight fast. During the experimental trials, subjects consumed the supplement regimen and then completed leg and chest press repetitions to failure and 30 s of repeated maximal vertical jumping (VJ on a force plate. Results In this treatment regimen, no significant differences (p > 0.05 were observed between dosages or conditions for leg press (low CONT = 19.8 ± 0.4 SEM, low KIC = 21.0 ± 0.5, high CONT = 20.1 ± 0.3, high KIC = 22.4 ± 0.6 or chest press (low CONT = 18.1 ± 0.2, low KIC = 18.5 ± 0.3, high CONT = 17.8 ± 0.3, high KIC = 18.0 ± 0.3 repetitions to failure. Additionally, no significant differences were observed for peak or mean VJ performance (low CONT = 34.6 ± 2.2 cm and 28.6 ± 1.8 cm; low KIC = 35.6 ± 2.0 cm and 29.4 ± 1.6 cm; high CONT = 35.7 ± 2.1 cm and 29.4 ± 1.7 cm; high KIC = 34.8 ± 2.3 cm and 28.3 ± 1.7 cm, respectively. Conclusion Based on our results, we conclude that acute KIC ingestion by itself with no other ergogenic supplement, immediately prior to exercise, did not alter moderate- nor high-intensity single-bout exercise performance in young resistance-trained males. This study addressed single-dose single-bout performance events; the efficacy of KIC monotherapy supplementation on repeated high-intensity exercise bouts and long-term exercise training remains unknown.

  14. Comparative short-term effects of two thoracic spinal manipulation techniques in subjects with chronic mechanical neck pain: a randomized controlled trial.

    Science.gov (United States)

    Casanova-Méndez, Amaloha; Oliva-Pascual-Vaca, Angel; Rodriguez-Blanco, Cleofás; Heredia-Rizo, Alberto Marcos; Gogorza-Arroitaonandia, Kristobal; Almazán-Campos, Ginés

    2014-08-01

    Spinal Manipulation (SM) has been purported to decrease pain and improve function in subjects with non-specific neck pain. Previous research has investigated which individuals with non-specific neck pain will be more likely to benefit from SM. It has not yet been proven whether or not the effectiveness of thoracic SM depends on the specific technique being used. This double-blind randomized trial has compared the short-term effects of two thoracic SM maneuvers in subjects with chronic non-specific neck pain. Sixty participants were distributed randomly into two groups. One group received the Dog technique (n = 30), with the subject in supine position, and the other group underwent the Toggle-Recoil technique (n = 30), with the participant lying prone, T4 being the targeted area in both cases. Evaluations were made of self-reported neck pain (Visual Analogue Scale); neck mobility (Cervical Range of Motion); and pressure pain threshold at the cervical and thoracic levels (C4 and T4 spinous process) and over the site described for location of tense bands of the upper trapezius muscle. Measurements were taken before intervention, immediately afterward, and 20 min later. Both maneuvers improved neck mobility and mechanosensitivity and reduced pain in the short term. No major or clinical differences were found between the groups. In the between-groups comparison slightly better results were observed in the Toggle-Recoil group only for cervical extension (p = 0.009), right lateral flexion (p = 0.004) and left rotation (p < 0.05). Copyright © 2014 Elsevier Ltd. All rights reserved.

  15. Secondary Prevention of Chronic PTSD by Early and Short-Term Administration of Escitalopram: A Prospective Randomized, Placebo-Controlled, Double-Blind Trial.

    Science.gov (United States)

    Zohar, Joseph; Fostick, Leah; Juven-Wetzler, Alzabeta; Kaplan, Zeev; Shalev, Hadar; Schreiber, Gavriel; Miroshnik, Natalie; Shalev, Arieh Y; Stein, Dan J; Seedat, Soraya; Suliman, Sharain; Klein, Ehud

    Prospective studies have not identified a viable pharmacologic strategy for secondary prevention of posttraumatic stress disorder (PTSD). The authors examined whether preventive intervention via early and short-term administration of a selective serotonin reuptake inhibitor (SSRI), within 1 month of exposure to a traumatic event (before diagnosis of PTSD could be made), may reduce the severity of PTSD symptoms according to DSM-IV at 13 months' follow-up. Over 25,000 screening calls to patients referred to an emergency department for a traumatic event performed between June 2006 and December 2008 yielded 353 participants who were recruited within the month following a traumatic event . Participants were randomly assigned in a double-blind design to escitalopram (n = 176) or placebo (n = 177). The per-protocol analysis comprised 198 participants (escitalopram, n = 102; placebo, n = 96) who received treatment for 12 to 24 weeks and were available for follow-up at week 56. The primary outcome measure, the Clinician Administered PTSD Scale (CAPS), revealed no prevention effect. However, a secondary outcome, the Pittsburgh Sleep Quality Inventory (PSQI), showed better results for the SSRI group than for the placebo group. For a subset of participants who experienced intentional trauma (missile attacks, rape, or physical assault; n = 50), the prevention effect was found on both primary and secondary measures (CAPS, PSQI and measures of depression and global illness severity). Early and short-term administration of escitalopram was not shown to prevent PTSD, although it did improve sleep quality. In a subgroup of participants who experienced intentional trauma, however, this early-treatment approach may be effective as secondary prevention. This large study is the first to investigate the preventive effect of early administration of escitalopram on PTSD. It highlights the relevance of the type of trauma (intentional vs unintentional) to the outcome. ClinicalTrials

  16. Clinical Trials

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    Full Text Available ... benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials ... child to enroll. Also, children aged 7 and older often must agree (assent) to ... as clinical trials for adults. For more information, go to "How Do Clinical ...

  17. Clinical Trials

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    Full Text Available ... part. Randomization Most clinical trials that have comparison groups use randomization. This involves assigning patients to different comparison groups by chance, rather than choice. This ...

  18. Short-term soy isoflavone intervention in patients with localized prostate cancer: a randomized, double-blind, placebo-controlled trial.

    Directory of Open Access Journals (Sweden)

    Jill M Hamilton-Reeves

    Full Text Available We describe the effects of soy isoflavone consumption on prostate specific antigen (PSA, hormone levels, total cholesterol, and apoptosis in men with localized prostate cancer.We conducted a double-blinded, randomized, placebo-controlled trial to examine the effect of soy isoflavone capsules (80 mg/d of total isoflavones, 51 mg/d aglucon units on serum and tissue biomarkers in patients with localized prostate cancer. Eighty-six men were randomized to treatment with isoflavones (n=42 or placebo (n=44 for up to six weeks prior to scheduled prostatectomy. We performed microarray analysis using a targeted cell cycle regulation and apoptosis gene chip (GEArrayTM. Changes in serum total testosterone, free testosterone, total estrogen, estradiol, PSA, and total cholesterol were analyzed at baseline, mid-point, and at the time of radical prostatectomy. In this preliminary analysis, 12 genes involved in cell cycle control and 9 genes involved in apoptosis were down-regulated in the treatment tumor tissues versus the placebo control. Changes in serum total testosterone, free testosterone, total estrogen, estradiol, PSA, and total cholesterol in the isoflavone-treated group compared to men receiving placebo were not statistically significant.These data suggest that short-term intake of soy isoflavones did not affect serum hormone levels, total cholesterol, or PSA.ClinicalTrials.gov NCT00255125.

  19. Clinical Holistic Medicine (Mindful, Short-Term Psychodynamic Psychotherapy Complemented with Bodywork in the Treatment of Experienced Impaired Sexual Functioning

    Directory of Open Access Journals (Sweden)

    Søren Ventegodt

    2007-01-01

    Full Text Available In this clinical follow-up study, we examined the effect of clinical holistic medicine (psychodynamic short-term therapy complemented with bodywork on patients with poor self-assessed sexual functioning and found that this problem could be solved in 41.67% of the patients ((95% CI: 27.61–56.7%; 1.75 < NNT < 3.62, p = 0.05. The bodywork was inspired by the Marion Rosen method and helped the patients to confront painful emotions from childhood trauma(s, and thus accelerated and deepened the therapy. The goal of therapy was the healing of the whole life of the patient through Antonovsky-salutogenesis. In this process, rehabilitation of the character and purpose of life of the patient was essential, and assisted the patient to recover his or her sense of coherence (existential coherence. We conclude that clinical holistic medicine is the treatment of choice if the patient is ready to explore and assume responsibility for his or her existence (true self, and willing to struggle emotionally in the therapy to reach this important goal. When the patient heals existentially, quality of life, health, and ability to function in general are improved at the same time. The therapy was “mindful” in its focus on existential and spiritual issues. The patients received in average 14.8 sessions at the cost of 1,188 EURO.

  20. Does short-term virologic failure translate to clinical events in antiretroviral-naïve patients initiating antiretroviral therapy in clinical practice?

    DEFF Research Database (Denmark)

    NN, NN; Mugavero, Michael J; May, Margaret

    2008-01-01

    , nevirapine, lopinavir/ritonavir, nelfinavir, or abacavir as third drugs in combination with a zidovudine and lamivudine nucleoside reverse transcriptase inhibitor backbone. MAIN OUTCOME MEASURES: Short-term (24-week) virologic failure (>500 copies/ml) and clinical events within 2 years of ART initiation.......58-2.22), lopinavir/ritonavir (1.32, 95% CI = 1.12-1.57), nelfinavir (3.20, 95% CI = 2.74-3.74), and abacavir (2.13, 95% CI = 1.82-2.50). However, the rate of clinical events within 2 years of ART initiation appeared higher only with nevirapine (adjusted hazard ratio for composite outcome measure 1.27, 95% CI = 1......OBJECTIVE: To determine whether differences in short-term virologic failure among commonly used antiretroviral therapy (ART) regimens translate to differences in clinical events in antiretroviral-naïve patients initiating ART. DESIGN: Observational cohort study of patients initiating ART between...

  1. Short Term Analgesic Effects of 5% Dextrose Epidural Injections for Chronic Low Back Pain: A Randomized Controlled Trial.

    Science.gov (United States)

    Maniquis-Smigel, Liza; Dean Reeves, Kenneth; Jeffrey Rosen, Howard; Lyftogt, John; Graham-Coleman, Cassie; Cheng, An-Lin; Rabago, David

    2017-02-01

    Hypertonic dextrose injection (prolotherapy) is reported to reduce pain including non-surgical chronic low back pain (CLBP), and subcutaneous injection of 5% dextrose is reported to reduce neurogenic pain, hyperalgesia and allodynia. The mechanism in both cases is unclear, though a direct effect of dextrose on neurogenic pain has been proposed. This study assessed the short-term analgesic effects of epidural 5% dextrose injection compared with saline for non-surgical CLBP. Randomized double-blind (injector, participant) controlled trial. Adults with moderate-to-severe non-surgical low back pain with radiation to gluteal or leg areas for at least 6 months received a single epidurogram-confirmed epidural injection of 10 mL of 5% dextrose or 0.9% saline using a published vertical caudal injection technique. The primary outcome was change in a numerical rating scale (NRS, 0 - 10 points) pain score between baseline and 15 minutes; and 2, 4, and 48 hours and 2 weeks post-injection. The secondary outcome was percentage of participants achieving 50% or more pain improvement at 4 hours. No baseline differences existed between groups; 35 participants (54 ± 10.7 years old; 11 female) with moderate-to-severe CLBP (6.7 ± 1.3 points) for 10.6 ± 10.5 years. Dextrose participants reported greater NRS pain score change at 15 minutes (4.4 ± 1.7 vs 2.4 ± 2.8 points; P = 0.015), 2 hours (4.6 ± 1.9 vs 1.8 ± 2.8 points; P = 0.001), 4 hours (4.6 ± 2.0 vs 1.4 ± 2.3 points; P dextrose recipients and 19% (3/16) of saline recipients reported ≥ 50% pain reduction at 4 hours (P dextrose on pain at the dorsal root level; waning pain control at 2 weeks suggests the need to assess the effect of serial dextrose epidural injections in a long-term study with robust outcome assessment.

  2. Clinical Trials

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    Full Text Available ... Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in ... Possible Benefits Taking part in a clinical trial can have many benefits. For example, you may gain ...

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    Full Text Available ... you may get tests or treatments in a hospital, clinic, or doctor's office. In some ways, taking ... people will need to travel or stay in hospitals to take part in clinical trials. For example, ...

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    Full Text Available ... the clinical trial you take part in, the information gathered can help others and add to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care. Many people volunteer because ...

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    Full Text Available ... from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative ... safe a treatment is or how well it works. Children (aged 18 and younger) get ... legal consent for their child to take part in a clinical trial. When ...

  6. Clinical Trials

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    Full Text Available ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ... clinical trials are vital to the process of improving medical care. Many people ... participants, it may not work for you. A new treatment may have side ...

  7. Clinical Trials

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    Full Text Available ... Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ... phase II clinical trials. The risk of side effects might be even greater for ... treatments. Health insurance and health care providers don't always ...

  8. Clinical Trials

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    Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, talk with your doctor. He or she may know about studies going on in your area. You can visit the following website to learn more about ...

  9. Clinical Trials

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    Full Text Available ... products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ... cancer also increased. As a result, the U.S. Food and Drug Administration now recommends never using HT ... Clinical Trials Work If you take ...

  10. Short-term effects of the "Together at School" intervention program on children's socio-emotional skills: a cluster randomized controlled trial.

    Science.gov (United States)

    Kiviruusu, Olli; Björklund, Katja; Koskinen, Hanna-Leena; Liski, Antti; Lindblom, Jallu; Kuoppamäki, Heini; Alasuvanto, Paula; Ojala, Tiina; Samposalo, Hanna; Harmes, Nina; Hemminki, Elina; Punamäki, Raija-Leena; Sund, Reijo; Santalahti, Päivi

    2016-05-26

    Together at School is a universal intervention program designed to promote socio-emotional skills among primary-school children. It is based on a whole school approach, and implemented in school classes by teachers. The aim of the present study is to examine the short-term effects of the intervention program in improving socio-emotional skills and reducing psychological problems among boys and girls. We also examine whether these effects depend on grade level (Grades 1 to 3) and intervention dosage. This cluster randomized controlled trial design included 79 Finnish primary schools (40 intervention and 39 control) with 3 704 children. The outcome measures were the Strengths and Difficulties Questionnaire (SDQ) and the Multisource Assessment of Social Competence Scale (MASCS) with teachers as raters. The intervention dosage was indicated by the frequencies six central tools were used by the teachers. The data was collected at baseline and 6 months later. Intervention effects were analyzed using multilevel modeling. When analyzed across all grades no intervention effect was observed in improving children's socio-emotional skills or in reducing their psychological problems at 6-month follow-up. Among third (compared to first) graders the intervention decreased psychological problems. Stratified analyses by gender showed that this effect was significant only among boys and that among them the intervention also improved third graders' cooperation skills. Among girls the intervention effects were not moderated by grade. Implementing the intervention with intended intensity (i.e. a high enough dosage) had a significant positive effect on cooperation skills. When analyzed separately among genders, this effect was significant only in girls. These first, short-term results of the Together at School intervention program did not show any main effects on children's socio-emotional skills or psychological problems. This lack of effects may be due to the relatively short follow

  11. Effects of Short-Term Cognitive Remediation on Cognitive Dysfunction in Partially or Fully Remitted Individuals with Bipolar Disorder: Results of a Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Kirsa M Demant

    Full Text Available Cognitive dysfunction is common in bipolar disorder (BD but is not sufficiently addressed by current treatments. Cognitive remediation (CR may improve cognitive function in schizophrenia but no randomised controlled trial has investigated this intervention in BD. The present study aimed to investigate the effects of CR on persistent cognitive dysfunction in BD.Patients with BD in partial remission with cognitive complaints were randomised to 12 weeks group-based CR (n=23 or standard treatment (ST (n=23. Outcomes were improved verbal memory (primary, sustained attention, executive and psychosocial function (secondary and additional measures of cognitive and psychosocial function (tertiary. Participants were assessed at baseline and weeks 12 and 26.Of the 46 randomised participants five dropped out and one was excluded after baseline. CR (n=18 had no effect on primary or secondary measures of cognitive or psychosocial function compared with ST (n=22. However, CR improved subjective sharpness at week 12, and quality of life and verbal fluency at week 26 follow-up (tertiary outcomes. Although the trial turned out to have suboptimal statistical power for the primary outcome analysis, calculation of the 95% confidence interval showed that it was highly unlikely that an increase in sample size would have rendered any beneficial effects of CR vs. ST on the verbal memory.Short-term group-based CR did not seem to improve overall cognitive or psychosocial function in individuals with BD in full or partial remission. The present findings suggest that that longer-term, more intensive and individualised CR may be necessary to improve cognition in BD.ClinicalTrials.gov NCT01457235.

  12. Are intragastric N-nitroso compounds elevated after short-term acid suppression?

    NARCIS (Netherlands)

    Houben, G.M.P.; Hooi, J.D.; Brummer, R.J.M.; Stobberingh, E.E.; Stockbrügger, R.W.

    1996-01-01

    Are intragastric N-nitroso compounds elevated after short-term acid suppression? Houben GM, Hooi J, Brummer RJ, Stobberingh EE, Stockbrugger RW. Department of Gastroenterolgy, Academic Hospital Maastricht, The Netherlands. Publication Types: Clinical Trial Randomized Controlled Trial

  13. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  14. Short-term clinical implications of the accessory left hepatic artery in patients undergoing radical gastrectomy for gastric cancer.

    Directory of Open Access Journals (Sweden)

    Chang-Ming Huang

    Full Text Available BACKGROUND: To evaluate the prevalence of the accessory left hepatic artery (ALHA; defined as a vessel arising from the left gastric artery, which, together with a typical left hepatic artery, supplies blood to the left lobe of the liver and its short-term clinical implications in patients undergoing radical gastrectomy for gastric cancer. METHODS: Clinical data of 1173 patients with gastric cancer who underwent laparoscopy-assisted radical gastrectomy were retrospectively analyzed. Groups of patients with and without ALHA were compared to identify differences in intraoperative and postoperative variables and changes in liver function. RESULTS: Of the 1173 patients, 135 (11.5% had an ALHA and 1038 (88.5% did not. There were no significant between-group differences in clinicopathological and intraoperative characteristics, postoperative recovery, and morbidity and mortality rates (P>0.05 each. None of the patients had postoperative symptoms associated with impaired liver function. Glutamic oxaloacetic transaminase (GOT, glutamic pyruvic transaminase (GPT and total bilirubin (TBIL concentrations were similar preoperatively. TBIL concentrations on postoperative days 1, 3, and 7 were similar (P>0.05, while GOT and GPT activities were higher in the ALHA than in the non-ALHA group on days 1 and 7 (P<0.05, with all three markers similar in the two groups on day 14. In patients without chronic liver disease (CLD, GOT, GPT and TBIL concentrations were similar in patients with and without ALHA; whereas, in patients with CLD, GOT and GPT concentrations on days 1 and 3 and GOT on day 7 were higher in patients with than without ALHA. CONCLUSION: ALHA is a common anomaly that was found in 11.5% of patients. It can be safely severed during radical gastrectomy in patients without CLD, but should be left intact in patients with CLD to prevent liver dysfunction. If severed in the latter, the patient should be monitored and liver-protecting therapy may be

  15. Clinical Trials

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    Full Text Available ... trial found that one of the combinations worked much better than the other for moderate persistent asthma. The results provided important treatment information for doctors and patients. The results from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI ...

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    Full Text Available ... other expenses (for example, travel and child care)? Who will be in charge of my care? What will happen after the trial? Taking part in a clinical trial is your decision. Talk with your doctor about all of your treatment ...

  17. Effect of a participatory organizational-level occupational health intervention on short-term sickness absence: a cluster randomized controlled trial.

    Science.gov (United States)

    Framke, Elisabeth; Sørensen, Ole Henning; Pedersen, Jacob; Rugulies, Reiner

    2016-05-01

    The aim of this study was to examine whether employees in pre-schools that implemented a participatory organizational-level intervention focusing on the core task at work had a lower incidence of short-term sickness absence compared to employees in the control group. The cluster randomized controlled trial (RCT) comprised 78 pre-schools that were allocated to the intervention (44 pre-schools with 1760 employees) or control (34 pre-schools with 1279 employees) group. The intervention lasted 25 months and followed a stepwise and structured approach, consisting of seminars, workshops, and workplace-directed intervention activities focusing on the core task at work. Using Poisson regression, we tested differences in incidence rates in short-term sickness absence between the intervention and control groups during a 29-months follow-up. Estimated short-term sickness absence days per person-year during follow-up were 8.68 and 9.17 in the intervention and control groups, respectively. The rate ratio (RR) for comparing incident sickness absence in the intervention to control groups during follow-up was 0.93 [95% confidence interval (95% CI) 0.86-1.00] in the crude analysis and 0.89 (95% CI 0.83-0.96) when adjusting for age, sex, job group, type and size of workplace, and workplace average level of previous short-term sickness absence. A supplementary analysis showed that the intervention also was associated with a reduced risk of long-term sickness absence with a crude RR of 0.83 (95% CI 0.69-0.99) and an adjusted RR of 0.84 (95% CI 0.69-1.01). Pre-school employees participating in an organizational-level occupational health intervention focusing on the core task at work had a lower incidence of short-term sickness absence during a 29-month follow-up compared with control group employees.

  18. Clinical Trials

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    Full Text Available ... and compare new treatments with other available treatments. Steps To Avoid Bias The researchers doing clinical trials take steps to avoid bias. "Bias" means that human choices ...

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    Full Text Available ... gathered can help others and add to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care. Many people volunteer because they want to help others. ...

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    Full Text Available ... materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of Health ( ... III clinical trial is required to have a Data and Safety Monitoring Board (DSMB). This board consists ...

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    ... of Personal Stories Peers Celebrating Art Peers Celebrating Music Be Vocal Support Locator DBSA In-Person Support ... by participating in a clinical trial is to science first and to the patient second. More About ...

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    Full Text Available ... Usually, a computer program makes the group assignments. Masking The term "masking" refers to not telling the clinical trial participants which treatment they're getting. Masking, or "blinding," helps avoid bias. For this reason, ...

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    Full Text Available ... Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood ... of estrogen and progestin, the risk of breast cancer also increased. As a result, the U.S. Food ...

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    Full Text Available ... Science Science Home Blood Disorders and Blood Safety Sleep Science and Sleep Disorders Lung Diseases Heart and Vascular Diseases Precision ... women and that are ethnically diverse. Children also need clinical trials that focus on them, as medical ...

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    Full Text Available ... Events About NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ...

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    Full Text Available ... NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory Committees Budget ... always, parents must give legal consent for their child to take part in a clinical trial. When ...

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    Full Text Available ... records can quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines ... and materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of ...

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    Full Text Available ... women and that are ethnically diverse. Children also need clinical trials that focus on them, as medical ... often differ for children. For example, children may need lower doses of certain medicines or smaller medical ...

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    Full Text Available ... care providers might be part of your treatment team. They will monitor your health closely. You may ... taking part in a clinical trial. Your treatment team also may ask you to do other tasks. ...

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    Full Text Available ... new treatments in small groups of people for safety and side effects. Phase II clinical trials look at how well treatments work and further review these treatments for safety. Phase ...

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    Full Text Available ... Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood ... these results are important because they advance medical knowledge and help improve patient care. Sponsorship and Funding ...

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    Full Text Available ... and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense ... FOIA) Accessibility Copyright and Usage No FEAR Act Grants and Funding Building 31 31 Center Drive Bethesda, ...

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    Full Text Available ... as the U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes ... for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, ...

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    Full Text Available ... combination of estrogen and progestin, the risk of breast cancer also increased. As a result, the U.S. Food ... to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial participants often were ...

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    Full Text Available ... from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. ( ...

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    Full Text Available ... always, parents must give legal consent for their child to take part in a clinical trial. When ... minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

  6. A randomized controlled trial to establish effects of short-term rapamycin treatment in 24 middle-aged companion dogs.

    Science.gov (United States)

    Urfer, Silvan R; Kaeberlein, Tammi L; Mailheau, Susan; Bergman, Philip J; Creevy, Kate E; Promislow, Daniel E L; Kaeberlein, Matt

    2017-04-01

    Age is the single greatest risk factor for most causes of morbidity and mortality in humans and their companion animals. As opposed to other model organisms used to study aging, dogs share the human environment, are subject to similar risk factors, receive comparable medical care, and develop many of the same age-related diseases humans do. In this study, 24 middle-aged healthy dogs received either placebo or a non-immunosuppressive dose of rapamycin for 10 weeks. All dogs received clinical and hematological exams before, during, and after the trial and echocardiography before and after the trial. Our results showed no clinical side effects in the rapamycin-treated group compared to dogs receiving the placebo. Echocardiography suggested improvement in both diastolic and systolic age-related measures of heart function (E/A ratio, fractional shortening, and ejection fraction) in the rapamycin-treated dogs. Hematological values remained within the normal range for all parameters studied; however, the mean corpuscular volume (MCV) was decreased in rapamycin-treated dogs. Based on these results, we will test rapamycin on a larger dog cohort for a longer period of time in order to validate its effects on cardiac function and to determine whether it can significantly improve healthspan and reduce mortality in companion dogs.

  7. Efficacy and short-term safety of topical Dwarf Elder (Sambucus ebulus L.) versus diclofenac for knee osteoarthritis: A randomized, double-blind, active-controlled trial.

    Science.gov (United States)

    Jabbari, Marzie; Hashempur, Mohammad Hashem; Razavi, Seyede Zahra Emami; Shahraki, Hadi Raeisi; Kamalinejad, Mohammad; Emtiazy, Majid

    2016-07-21

    Sambucus ebulus L. (S. ebulus) has had long-standing application in Traditional Persian Medicine for joint pain and for a variety of bone and joint disorders. According to traditional use of S. ebulus and its relevant pharmacologic properties, this study was designed to evaluate the efficacy and short-term safety of topical use of S. ebulus in patients with knee osteoarthritis (OA). Seventy nine patients with knee OA were randomly enrolled in 2 parallel arms of a pilot randomized, double-blind, active-controlled clinical trial. The patients were treated by topical S. ebulus gel or 1% diclofenac gel, three times a day, as much as a fingertip unit for 4 weeks. Patients were assessed prior to enrollment and, then, 2 and 4 weeks subsequent to the intervention, in terms of scores of visual analogue scale (VAS) for self-grading of their knee joint pain, and according to 3 different domains of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Any observed adverse effects were also scrutinized. The mean values of WOMAC pain score, total WOMAC score and VAS score for pain of the S. ebulus group were significantly lower compared with the diclofenac group (P=0.004, P=0.04, and P<0.001, respectively). In addition, no serious adverse effect was reported. This pilot study showed that topical treatment with S. ebulus gel can be recommended for alleviating symptoms of patients with knee OA. However, longer trials involving larger samples size, are needed for achieving a comprehensive understanding about the efficacy and safety of S. ebulus in knee OA. Copyright © 2016. Published by Elsevier Ireland Ltd.

  8. Short-term effects of a rights-based sexuality education curriculum for high-school students: a cluster-randomized trial.

    Science.gov (United States)

    Constantine, Norman A; Jerman, Petra; Berglas, Nancy F; Angulo-Olaiz, Francisca; Chou, Chih-Ping; Rohrbach, Louise A

    2015-03-26

    An emerging model for sexuality education is the rights-based approach, which unifies discussions of sexuality, gender norms, and sexual rights to promote the healthy sexual development of adolescents. A rigorous evaluation of a rights-based intervention for a broad population of adolescents in the U.S. has not previously been published. This paper evaluates the immediate effects of the Sexuality Education Initiative (SEI) on hypothesized psychosocial determinants of sexual behavior. A cluster-randomized trial was conducted with ninth-grade students at 10 high schools in Los Angeles. Classrooms at each school were randomized to receive either a rights-based curriculum or basic sex education (control) curriculum. Surveys were completed by 1,750 students (N = 934 intervention, N = 816 control) at pretest and immediate posttest. Multilevel regression models examined the short-term effects of the intervention on nine psychosocial outcomes, which were hypothesized to be mediators of students' sexual behaviors. Compared with students who received the control curriculum, students receiving the rights-based curriculum demonstrated significantly greater knowledge about sexual health and sexual health services, more positive attitudes about sexual relationship rights, greater communication about sex and relationships with parents, and greater self-efficacy to manage risky situations at immediate posttest. There were no significant differences between the two groups for two outcomes, communication with sexual partners and intentions to use condoms. Participation in the rights-based classroom curriculum resulted in positive, statistically significant effects on seven of nine psychosocial outcomes, relative to a basic sex education curriculum. Longer-term effects on students' sexual behaviors will be tested in subsequent analyses. ClinicalTrials.gov NCT02009046.

  9. Randomised controlled trial evaluating the short-term analgesic effect of topical diclofenac on chronic Achilles tendon pain: a pilot study.

    Science.gov (United States)

    Bussin, Erin Rebecca; Cairns, Brian; Bovard, Jim; Scott, Alexander

    2017-05-04

    To determine if a topically applied non-steroidal anti-inflammatory drug (diclofenac) can provide short-term pain relief for chronic Achilles tendinopathy (CAT), in order to inform the development of a new rehabilitation protocol. Pilot double-blind, cross-over randomised controlled trial providing participants with tertiary care. The study was conducted at a single research centre in Vancouver, BC. Sixteen adults with unilateral CAT and three adults with bilateral CAT participated. Participants received two successive treatments (10% diclofenac gel or placebo gel) in random order over a 3-day period. There was a 1-week washout period between the treatments. Allocation was by simple randomisation, and the participants as well as the assessing/treating researcher were blinded to treatment allocation. The primary outcome measure was pain level (0-10) during tendon loading (hopping). Secondary outcome measures included pain at rest, pressure pain threshold of the Achilles tendon and symptom improvement. Nineteen adults participated in the study, and all were included in the analysis. Diclofenac gel significantly reduced the average pain during tendon loading (pdiclofenac. Pain at rest was decreased and pressure pain threshold increased with diclofenac treatment, but not with placebo gel. There were no observed or reported side effects of either treatment. In this small, short-term study, diclofenac was able to improve symptoms and reduce pain during tendon loading in participants with CAT, whereas placebo gel was not. A future study of diclofenac as a supplement to rehabilitation, with longer follow-up and powered to detect a difference between diclofenac and placebo, is indicated. ISRCTN60151284, http://www.isrctn.com/ISRCTN60151284 ETHICS: UBC Clinical Research Ethics Board approval was obtained for this research. The certificate number of the ethics certificate of approval to conduct research is H15-00999. © Article author(s) (or their employer(s) unless otherwise

  10. Friction massage versus kinesiotaping for short-term management of latent trigger points in the upper trapezius: a randomized controlled trial.

    Science.gov (United States)

    Mohamadi, Marzieh; Piroozi, Soraya; Rashidi, Iman; Hosseinifard, Saeed

    2017-01-01

    Latent trigger points in the upper trapezius muscle may disrupt muscle movement patterns and cause problems such as cramping and decreased muscle strength. Because latent trigger points may spontaneously become active trigger points, they should be addressed and treated to prevent further problems. In this study we compared the short-term effect of kinesiotaping versus friction massage on latent trigger points in the upper trapezius muscle. Fifty-eight male students enrolled with a stratified sampling method participated in this single-blind randomized clinical trial (Registration ID: IRCT2016080126674N3) in 2016. Pressure pain threshold was recorded with a pressure algometer and grip strength was recorded with a Collin dynamometer. The participants were randomly assigned to two different treatment groups: kinesiotape or friction massage. Friction massage was performed daily for 3 sessions and kinesiotape was used for 72 h. One hour after the last session of friction massage or removal of the kinesiotape, pressure pain threshold and grip strength were evaluated again. Pressure pain threshold decreased significantly after both friction massage (2.66 ± 0.89 to 2.25 ± 0.76; P  = 0.02) and kinesiotaping (2.00 ± 0.74 to 1.71 ± 0.65; P  = 0.01). Grip strength increased significantly after friction massage (40.78 ± 9.55 to 42.17 ± 10.68; P  = 0.03); however there was no significant change in the kinesiotape group (39.72 ± 6.42 to 40.65 ± 7.3; P  = 0.197). There were no significant differences in pressure pain threshold (2.10 ± 0.11 & 1.87 ± 0.11; P  = 0.66) or grip strength (42.17 ± 10.68 & 40.65 ± 7.3; P  = 0.53) between the two study groups. Friction massage and kinesiotaping had identical short-term effects on latent trigger points in the upper trapezius. Three sessions of either of these two interventions did not improve latent trigger points. Registration ID in IRCT: IRCT2016080126674N3.

  11. Clinical Features, Short-Term Mortality, and Prognostic Risk Factors of Septic Patients Admitted to Internal Medicine Units

    Science.gov (United States)

    Mazzone, Antonino; Dentali, Francesco; La Regina, Micaela; Foglia, Emanuela; Gambacorta, Maurizia; Garagiola, Elisabetta; Bonardi, Giorgio; Clerici, Pierangelo; Concia, Ercole; Colombo, Fabrizio; Campanini, Mauro

    2016-01-01

    Abstract Only a few studies provided data on the clinical history of sepsis within internal Medicine units. The aim of the study was to assess the short-term mortality and to evaluate the prognostic risk factors in a large cohort of septic patients treated in internal medicine units. Thirty-one internal medicine units participated to the study. Within each participating unit, all admitted patients were screened for the presence of sepsis. A total of 533 patients were included; 78 patients (14.6%, 95%CI 11.9, 18.0%) died during hospitalization; mortality rate was 5.5% (95% CI 3.1, 9.6%) in patients with nonsevere sepsis and 20.1% (95%CI 16.2, 28.8%) in patients with severe sepsis or septic shock. Severe sepsis or septic shock (OR 4.41, 95%CI 1.93, 10.05), immune system weakening (OR 2.10, 95%CI 1.12, 3.94), active solid cancer (OR 2.14, 95% CI 1.16, 3.94), and age (OR 1.03 per year, 95% CI 1.01, 1.06) were significantly associated with an increased mortality risk, whereas blood culture positive for Escherichia coli was significantly associated with a reduced mortality risk (OR 0.46, 95%CI 0.24, 0.88). In-hospital mortality of septic patients treated in internal medicine units appeared similar to the mortality rate obtained in recent studies conducted in the ICU setting. PMID:26825876

  12. [Dual insertion paths design characteristics and short-term clinical observation of rotational path removable partial dentures].

    Science.gov (United States)

    Li, Jian; Jiang, Ting; Li, Sai; Chen, Wei

    2013-02-18

    To investigate design methods of dual insertion paths and observe a short-term clinic overview of rotational path removable partial dentures (RPDs). In the study, 40 patients with partial edentulous arches were included and divided into two groups. The patients in group one were restored with rotational path RPDs (10 Kennedy class III and 10 Kennedy class IV respectively). The patients in group two (20 patients), whose edentulous area was matched with the patients' in group one, were restored with the linear path RPDs. After surveying and simulative preparation on diagnostic casts, the basic laws of designing rotational path RPDs were summarized. The oral preparation was accurately performed under the guidance of indices made on diagnostic casts after simulative preparation. The 40 dentures were recalled two weeks and one year after the insertion. The evaluations of the clinic outcome, including retention, stability, mastication function, esthetics and wearing convenience, were marked out as good, acceptable, and poor. The comparison of the evaluation results was performed between the two groups. In the rotational path design for Kennedy class III or IV RPDs, the angles (α) of dual insertion paths should be designed within a scope, approximate 10°-15°.When the angle (α) became larger, the denture retention turned to be better, but accordingly the posterior abutments needed more preparation. In the clinical application, the first insertions of the 40 dentures were all favorably accomplished. When the rotational path RPDs were compared to linear path RPDs, the time consuming on first insertion had no statistical difference[(32±8) min and (33±8) min respectively, P>0.05]. Recalled two weeks and one year after the insertion, in the esthetics evaluation, 20 rotational path RPDs were all evaluated as "A", but only 7(two weeks after) and 6 (one year after) linear path RPDs were evaluated as "A"(P<0.05). There was no significant difference in other evaluation results

  13. Clinical Trials

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    Full Text Available ... Wide Range of Audiences The Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, ...

  14. Short-term effectiveness of web-based guided self-help for phobic outpatients: randomized controlled trial.

    Science.gov (United States)

    Kok, Robin N; van Straten, Annemieke; Beekman, Aartjan T F; Cuijpers, Pim

    2014-09-29

    Internet-based guided self-help has been successfully used in the general population, but it is unknown whether this method can be effectively used in outpatient clinics for patients waiting for face-to-face psychotherapy for phobias. The aim was to assess the clinical effectiveness of Phobias Under Control, an Internet-based intervention based on exposure therapy with weekly guidance. We conducted a randomized controlled trial, recruiting 212 outpatients scheduled to receive face-to-face psychotherapy for any type of phobia at an outpatient clinic. Participants suffering from at least 1 DSM-IV or ICD-10 classified phobia (social phobia, agoraphobia with or without panic disorder, and/or specific phobia as ascertained by a telephone interview at baseline) were randomly allocated to either a 5-week Internet-based guided self-help program based on exposure therapy with weekly student support followed by face-to-face psychotherapy (n=105) or a wait-list control group followed by face-to-face psychotherapy (n=107). Primary outcome was the Fear Questionnaire (FQ). Secondary outcomes were the Beck Anxiety Inventory (BAI) and Center of Epidemiological Studies-Depression scale (CES-D). Assessments took place by telephone at baseline (T0) and on the Internet at posttest (T1, self-assessment at 5 weeks after baseline). Missing data at T1 were imputed. At posttest, analysis of covariance on the intention-to-treat sample showed significant but small effect sizes between intervention and control groups on the FQ (d=0.35, P=.02), CES-D (d=0.34, P=.03), and a nonsignificant effect size on the BAI (d=0.28. P=.05). Although initial acceptance was good, high nonresponse was observed, with 86 of 212 participants (40.5%) lost to follow-up at T1 and only 14 of 105 (13.3%) intervention participants finishing all 5 weeks. Phobias Under Control is modestly effective in lowering phobic and depressive symptoms in a relatively short period and may be clinically beneficial when implemented in

  15. Comparative Short-Term Clinical Outcomes of Mediastinum Tumor Excision Performed by Conventional VATS and Single-Port VATS

    OpenAIRE

    Wu, Ching-Feng; Gonzalez-Rivas, Diego; Wen, Chih-Tsung; Liu, Yun-Hen; Wu, Yi-Cheng; Chao, Yin-Kai; Hsieh, Ming-Ju; Wu, Ching-Yang; Chen, Wei-Hsun

    2015-01-01

    Abstract Single-port video-assisted thoracoscopic surgery (VATS) has been widely applied recently. However, there are still only few reports describing its use in mediastinum tumor resection. We present the technique of single-port video-assisted thoracoscopic mediastinum tumor resection and compare it with conventional VATS with regard to short-term outcome. We retrospectively enrolled 105 patients who received mediastinum surgery in Chang Gung Memorial Hospital. Sixteen patients received st...

  16. The effect of short term neo-adjuvant androgen deprivation on erectile function in patients treated with external beam radiotherapy for localised prostate cancer: an analysis of the 4- versus 8-month randomised trial (Irish Clinical Oncology Research Group 97-01).

    LENUS (Irish Health Repository)

    Daly, Patricia E

    2012-07-01

    Erectile dysfunction is a common consequence of external beam radiotherapy (EBRT) for prostate cancer. The addition of neo-adjuvant androgen deprivation (NAD) has an indeterminate additive effect. We examined the long-term effect on erectile function (EF) of two durations (4 months: arm 1 and 8 months: arm 2) of NAD prior to radiation (RT) for patients with localised prostate cancer from the Irish Clinical Oncology Research Group (ICORG 97-01) 4- versus 8-month trial. In this study we aimed to (1) analyse the overall effect on EF of NAD in an EBRT population, (2) compare the probability of retained EF over time in an EBRT population treated with either 4 or 8 months of NAD and (3) identify any variables such as risk group and age which may have an additive detrimental effect. This analysis provides unique long term follow up data.

  17. Clinical Trials

    Medline Plus

    Full Text Available ... an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment team. ...

  18. Clinical Trials

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    Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep ...

  19. Clinical Trials

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    Full Text Available ... treatments produce better results for certain illnesses or groups of people; look at the best age and frequency for doing screening tests, such as mammography; and compare two or more screening tests to see which test ... Some companies and groups sponsor clinical trials that test the safety of ...

  20. Clinical Trials

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    Full Text Available ... patient has had certain treatments or has other health problems. Eligibility criteria ensure that new approaches are tested ... public. What to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ...

  1. Clinical Trials

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    Full Text Available ... This shows how the approach affects a living body and whether it's harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start ...

  2. Clinical Trials

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    Full Text Available ... to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep Science and ...

  3. Clinical Trials

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    Full Text Available ... protect patients and help produce reliable study results. Clinical trials are one of the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ...

  4. Clinical Trials

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    Full Text Available ... benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials ... child to enroll. Also, children aged 7 and older often must agree (assent) to take part ... about how you feel. Some people will need to travel or stay in hospitals ...

  5. Clinical Trials

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    Full Text Available ... safe a treatment is or how well it works. Children (aged 18 and younger) get special protection as research subjects. Almost always, parents must give legal consent for their child to take part in a clinical trial. When ...

  6. Clinical Trials

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    Full Text Available ... As a result, the U.S. Food and Drug Administration now recommends never using HT to prevent heart disease. When HT is used for menopausal symptoms, it should be taken only at the smallest dose and for the shortest time possible. Clinical trials, like the two described above, ...

  7. Clinical Trials

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    Full Text Available ... approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start with small groups of patients to find out whether a ...

  8. Short-term tibolone does not interfere with endothelial function: a double-blinded, randomized, controlled trial.

    Science.gov (United States)

    Celani, M F S; Hurtado, R; Brandão, A H F; Maciel da Fonseca, A M R; Geber, S

    2016-06-01

    Objective To evaluate the effect of short-term hormone replacement therapy with tibolone 2.5 mg daily on endothelial function of healthy postmenopausal women, using flow-mediated dilation (FMD) of the brachial artery. Methods We performed a randomized, double-blinded, placebo-controlled study. A total of 100 healthy postmenopausal women were randomly allocated to receive tibolone (n = 50) or placebo (n = 50) for 28 days. Measurement of the FMD of the brachial artery was performed before and after the use of tibolone and placebo. Results A total of 31 women completed the study in the tibolone group, and 32 women completed the study in the control group. The results of the FMD measurements obtained from the women in the two groups before treatment were similar (0.018 and 0.091, for tibolone and placebo, p = 0.57). The values of the FMD in women who used tibolone and placebo, before and after the treatment, were similar in both groups. The numbers of women who presented an increase in the values of the FMD in both groups were also similar. Conclusion Our results demonstrate that the administration of 2.5 mg tibolone to healthy postmenopausal women for 28 days does not promote endothelial-dependent vasodilation, measured by FMD of the brachial artery.

  9. Acute and Short-Term Toxicities of Conventionally Fractionated Versus Hypofractionated Whole Breast Irradiation in a Prospective, Randomized Trial

    Science.gov (United States)

    Shaitelman, Simona F.; Schlembach, Pamela J.; Arzu, Isidora; Ballo, Matthew; Bloom, Elizabeth S.; Buchholz, Daniel; Chronowski, Gregory M.; Dvorak, Tomas; Grade, Emily; Hoffman, Karen E.; Kelly, Patrick; Ludwig, Michelle; Perkins, George H.; Reed, Valerie; Shah, Shalin; Stauder, Michael C.; Strom, Eric A.; Tereffe, Welela; Woodward, Wendy A.; Ensor, Joe; Baumann, Donald; Thompson, Alastair M.; Amaya, Diana; Davis, Tanisha; Guerra, William; Hamblin, Lois; Hortobagyi, Gabriel; Hunt, Kelly K.; Buchholz, Thomas A.; Smith, Benjamin D.

    2015-01-01

    IMPORTANCE The most appropriate dose-fractionation for whole breast irradiation (WBI) remains uncertain. OBJECTIVE To assess acute and six-month toxicity and quality of life (QoL) with conventionally fractionated WBI (CF-WBI) versus hypofractionated WBI (HF-WBI). DESIGN Unblinded randomized trial of CF-WBI (n=149; 50 Gy/25 fractions + boost [10–14 Gy/5–7 fractions]) versus HF-WBI (n=138; 42.56 Gy/16 fractions + boost [10–12.5 Gy/4–5 fractions]). SETTING Community-based and academic cancer centers. PARTICIPANTS 287 women age ≥ 40 years with stage 0–II breast cancer treated with breast-conserving surgery for whom whole breast irradiation without addition of a third field was recommended. 76% (n=217) were overweight or obese. Patients were enrolled from February 2011 through February 2014. INTERVENTION(S) FOR CLINICAL TRIALS CF-WBI versus HF-WBI. MAIN OUTCOME MEASURES Physician-reported acute and six-month toxicities using NCICTCv4.0 and patient-reported QoL using the FACT-B version 4. All analyses were intention-to-treat, with outcomes compared using chi-square, Cochran-Armitage test, and ordinal logistic regression. Patients were followed for a minimum of 6 months. RESULTS Treatment arms were well-matched for baseline characteristics including FACT-B total score (P=0.46) and individual QoL items such as lack of energy (P=0.86) and trouble meeting family needs (P=0.54). Maximal physician-reported acute dermatitis (P<0.001), pruritus (P<0.001), breast pain (P=0.001), hyperpigmentation (P=0.002), and fatigue (P=0.02) during radiation were lower in patients randomized to HF-WBI. Overall grade ≥2 acute toxicity was less with HF-WBI vs. CF-WBI (47% vs. 78%; P<0.001). Six months after radiation, physicians reported less fatigue in patients randomized to HF-WBI (P=0.01), and patients randomized to HF-WBI reported less lack of energy (P<0.001) and less trouble meeting family needs (P=0.01). Multivariable regression confirmed the superiority of HF-WBI in terms

  10. Impact of age, sex, therapeutic intent, race and severity of advanced heart failure on short-term principal outcomes in the MOMENTUM 3 trial.

    Science.gov (United States)

    Goldstein, Daniel J; Mehra, Mandeep R; Naka, Yoshifumi; Salerno, Christopher; Uriel, Nir; Dean, David; Itoh, Akinobu; Pagani, Francis D; Skipper, Eric R; Bhat, Geetha; Raval, Nirav; Bruckner, Brian A; Estep, Jerry D; Cogswell, Rebecca; Milano, Carmelo; Fendelander, Lahn; O'Connell, John B; Cleveland, Joseph

    2018-01-01

    Primary outcomes analysis of the Multicenter Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3 (MOMENTUM 3) trial short-term cohort demonstrated a higher survival rate free of debilitating stroke and reoperation to replace/remove the device (primary end-point) in patients receiving the HeartMate 3 (HM3) compared with the HeartMate (HMII). In this study we sought to evaluate the individual and interactive effects of pre-specified patient subgroups (age, sex, race, therapeutic intent [bridge to transplant/bridge to candidacy/destination therapy] and severity of illness) on primary end-point outcomes in MOMENTUM 3 patients implanted with HM3 and HMII devices. Cox proportional hazard models were used to analyze patients enrolled in the "as-treated cohort" (n = 289) of the MOMENTUM 3 trial to: (1) determine interaction of various subgroups on primary end-point outcomes; and (2) identify independent variables associated with primary end-point success. Baseline characteristics were well balanced among HM3 (n = 151) and HMII (n = 138) cohorts. No significant interaction between the sub-groups on primary end-point outcomes was observed. Cox multivariable modeling identified age (≤65 years vs >65 years, hazard ratio 0.42 [95% confidence interval 0.22 to 0.78], p = 0.006]) and pump type (HM3 vs HMII, hazard ratio 0.53 [95% confidence interval 0.30 to 0.96], p = 0.034) to be independent predictors of primary outcomes success. After adjusting for age, no significant impact of sex, race, therapeutic intent and INTERMACS profiles on primary outcomes were observed. This analysis of MOMENTUM 3 suggests that younger age (≤65 years) at implant and pump choice are associated with a greater likelihood of primary end-point success. These findings further suggest that characterization of therapeutic intent into discrete bridge-to-transplant and destination therapy categories offers no clear clinical advantage, and should ideally be abandoned. Copyright

  11. Short-term effects of an anti-inflammatory treatment on clinical parameters and serum levels of C-reactive protein and proinflammatory cytokines in subjects with periodontitis.

    Science.gov (United States)

    Renvert, Stefan; Lindahl, Christel; Roos-Jansåker, Ann-Marie; Lessem, Jan

    2009-06-01

    Periodontal disease is the most common multifactorial disease, afflicting a very large proportion of the adult population. Periodontal disease secondarily causes increases in the serum levels of C-reactive protein (CRP) and other markers of inflammation. An increased level of CRP reflects an increased risk for cardiovascular disease. The aim of the current randomized clinical trial was to evaluate the short-term effect of a combination of dipyridamole and prednisolone (CRx-102) on the levels of high-sensitivity (hs)-CRP, proinflammatory markers in blood, and clinical signs of periodontal disease. Fifty-seven patients with >/=10 pockets with probing depths >/=5 mm were randomized into two groups in this masked single-center placebo-controlled study: CRx-102 (n = 28) and placebo (n = 29). hs-CRP levels, inflammatory markers (interleukin [IL]-6, -1beta, -8, and -12, tumor necrosis factor-alpha, and interferon-gamma [IFN-gamma]), bleeding on probing (BOP), and changes in probing depths were evaluated. The subjects received mechanical non-surgical therapy after 42 days, and the study was completed after 49 days. At day 42, the differences in the hs-CRP, IFN-gamma, and IL-6 levels between the two groups were statistically significant (P <0.05), whereas no difference was found for the other inflammatory markers. There was no change in probing depth or BOP between the two groups. The administration of CRx-102 resulted in significant decreases in hs-CRP, IFN-gamma, and IL-6, but it did not significantly change BOP or probing depths.

  12. A randomised comparative study of the short term clinical and biological effects of intravenous pulse methylprednisolone and infliximab in patients with active rheumatoid arthritis despite methotrexate treatment

    OpenAIRE

    Durez, P; Nzeusseu, T; Lauwerys, B; Manicourt, D; Verschueren, P; Westhovens, R; Devogelaer, J; Houssiau, F

    2004-01-01

    OBJECTIVES: To compare the short term clinical and biological effects of intravenous (i.v.) pulse methylprednisolone (MP) and infliximab (IFX) in patients with severe active rheumatoid arthritis (RA) despite methotrexate (MTX) treatment. METHODS: Patients with active RA despite MTX treatment were randomly allocated to receive a single i.v. infusion of MP (1 g) or three i.v. infusions of IFX (3 mg/kg) on weeks 0, 2, and 6. Patients were "blindly" evaluated for disease activity measures. Qualit...

  13. Acute heart failure with mid-range left ventricular ejection fraction: clinical profile, in-hospital management, and short-term outcome.

    Science.gov (United States)

    Farmakis, Dimitrios; Simitsis, Panagiotis; Bistola, Vasiliki; Triposkiadis, Filippos; Ikonomidis, Ignatios; Katsanos, Spyridon; Bakosis, George; Hatziagelaki, Erifili; Lekakis, John; Mebazaa, Alexandre; Parissis, John

    2017-05-01

    Heart failure with mid-range left ventricular ejection fraction (HFmrEF) is a poorly characterized population as it has been studied either in the context of HF with reduced (HFrEF) or preserved (HFpEF) left ventricular ejection fraction (LVEF) depending on applied LVEF cutoffs. We sought to investigate the clinical profile, in-hospital management, and short-term outcome of HFmrEF patients in comparison with those with HFrEF or HFpEF in a large acute HF cohort. The Acute Heart Failure Global Registry of Standard Treatment (ALARM-HF) included 4953 patients hospitalized for HF in nine countries in Europe, Latin America, and Australia. Baseline characteristics, clinical presentation, in-hospital therapies, and short-term mortality (all-cause in-hospital or 30-day mortality, whichever first) were compared among HFrEF (LVEF chronic renal disease (p = 0.003), more hospitalizations for acute coronary syndrome (p < 0.001), or infection (p = 0.003), and were more frequently treated with intravenous vasodilators compared to HFrEF or HFpEF. Adjusted short-term mortality in HFmrEF was lower than HFrEF [hazard ratio (HR) = 0.635 (0.419, 0.963), p = 0.033] but similar to HFpEF [HR = 1.026 (0.605, 1.741), p = 0.923]. Hospitalized HFmrEF patients represent a demographically and clinically diverse group with many intermediate features compared to HFrEF and HFpEF and carry a lower risk of short-term mortality than HFrEF but a similar risk with HFpEF.

  14. Associations between symptoms, clinical findings and the short-term prognosis among children with otitis media: A cohort study

    DEFF Research Database (Denmark)

    Ryborg, Christina Trankjær; Søndergaard, Jens; Lous, Jørgen

    2013-01-01

    -related factors influence the course of OM. The aim of this study was to analyze to what extent symptoms at the time of initial diagnosis are associated with the short-term course of otitis media. Methods: Cohort study in general practice comprising 747 children between 0 and 7 years with a new ear symptom......Objective: Otitis media (OM) is a common childhood disease and a frequent reason for seeking medical care in general practice. Only few studies have focused on what happens after diagnosis and initial treatment of OM. In particular, there is a lack of research on how different patient- and disease....... At the first consultation the GPs registered symptoms, results of otoscopy and tympanometry, together with diagnosis and treatment. The children were followed up four weeks later. Results: Sleep problems at inclusion are statistically significant associated with having one or more symptom after four weeks...

  15. Short-term effectiveness of web-based guided self-help for phobic outpatients: Randomized controlled trial.

    NARCIS (Netherlands)

    Kok, R.N.; van Straten, A.; Beekman, A.T.F.; Cuijpers, P.

    2014-01-01

    Background: Internet-based guided self-help has been successfully used in the general population, but it is unknown whether this method can be effectively used in outpatient clinics for patients waiting for face-to-face psychotherapy for phobias. Objective: The aim was to assess the clinical

  16. Short-term effectiveness of low dose liraglutide in combination with metformin versus high dose liraglutide alone in treatment of obese PCOS: randomized trial.

    Science.gov (United States)

    Jensterle, Mojca; Kravos, Nika Aleksandra; Goričar, Katja; Janez, Andrej

    2017-01-31

    Liraglutide 3 mg was recently approved as an anti-obesity drug. Metformin is weight neutral, yet it could enhance the therapeutic index of GLP-1 agonist. We compared weight-lowering potential of liraglutide 1.2 mg in combination with metformin to liraglutide 3 mg monotherapy in obese PCOS. Thirty obese women with PCOS (aged 33.1 ± 6.1 years, BMI 38.3 ± 5.4 kg/m 2 ) were randomized to combination (COMBO) of metformin (MET) 1000 mg BID and liraglutide 1.2 mg QD (N = 15) or liraglutide 3 mg (LIRA3) QD alone (N = 15) for 12 weeks. The primary outcome was change in anthropometric measures of obesity. Both treatments led to significant weight loss (-3.6 ± 2.5 kg, p = 0.002 in COMBO vs -6.3 ± 3.7 kg, p = 0.001 in LIRA3). BMI and waist circumference reduction in LIRA3 was greater than in COMBO (-2.2 ± 1.3 vs -1.3 ± 0.9 kg/m 2 , p = 0.05 and -4.2 ± 3.4 vs -2.2 ± 6.2 cm, p = 0.014, respectively). Both interventions resulted in a significant decrease of post-OGTT glucose levels. COMBO significantly reduced total testosterone and was associated with less nausea. Short-term interventions with COMBO and LIRA3 both led to significant improvement of measures of obesity in obese PCOS, LIRA3 being superior to COMBO. However, COMBO further improved androgen profile beyond weight reduction and was associated with better tolerability. The study was retrospectively registered with ClinicalTrials.gov ( NCT02909933 ) on 16 th of September 2016.

  17. Short-term and long-term effects of dipeptidyl peptidase-4 inhibitors in type 2 diabetes mellitus patients with renal impairment: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Li, Ruifei; Wang, Rui; Li, Haixia; Sun, Sihao; Zou, Meijuan; Cheng, Gang

    2016-09-01

    To assess the short-term and long-term effects of dipeptidyl peptidase-4 (DPP-4) inhibitors in type 2 diabetes mellitus patients with renal impairment, a meta-analysis of randomized clinical trials of DPP-4 inhibitor interventions in type 2 diabetes mellitus patients with renal impairment was performed. PubMed, Embase, Cochrane Library and ClinicalTrials.gov were searched through the end of March 2015. Randomized clinical trials were selected if (1) DPP-4 inhibitors were compared with a placebo or other active-comparators, (2) the treatment duration was ≥12 weeks and (3) data regarding changes in haemoglobin A1c (HbA1c ), changes in fasting plasma glucose or hypoglycaemia and other adverse events were reported. Of 790 studies, ten studies on eight randomized clinical trials were included. Compared with the control group, DPP-4 inhibitors were associated with a greater HbA1c reduction in both the short-term [mean differences (MD) = -0.45, 95% confidence intervals (-0.57, -0.33), p 1] and long-term [MD = -0.33, 95% confidence intervals (-0.63, -0.03), p = 0.03] treatments. However, the long-term greater reduction in HbA1c with DPP-4 inhibitor treatment was only significant when the control treatment comprised placebo plus stable background treatment, but not glipizide plus stable background treatment. DPP-4 inhibitors were associated with a greater fasting plasma glucose reduction [MD = -12.59, 95% confidence intervals (-22.01, -3.17), p = 0.009] over the short-term; however, this effect was not present over the long-term. Regarding the hypoglycaemia adverse events assessment, the long-term treatment data indicated there was no increased risk of hypoglycaemia compared with placebo or active-controlled anti-diabetic drugs. The present meta-analysis confirms that DPP-4 inhibitors are effective and equivalent to other agents in type 2 diabetes mellitus patients with renal impairment. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015

  18. Short-Term Effect of Laser Acupuncture on Lower Back Pain: A Randomized, Placebo-Controlled, Double-Blind Trial

    Directory of Open Access Journals (Sweden)

    Jae-Young Shin

    2015-01-01

    Full Text Available Purpose. This trial was performed to investigate the efficacy of laser acupuncture for the alleviation of lower back pain. Methods. This was a randomized, placebo-controlled, double-blind trial. Fifty-six participants were randomly assigned to either the laser acupuncture group (n=28 or the sham laser acupuncture group (n=28. Participants in both groups received three treatment sessions over the course of one week. Thirteen acupuncture points were selected. The visual analogue scale for pain, pressure pain threshold, Patient Global Impression of Change, and Euro-Quality-of-Life Five Dimensions questionnaire (Korean version were used to evaluate the effect of laser acupuncture treatment on lower back pain. Results. There were no significant differences in any outcome between the two groups, although the participants in both groups showed a significant improvement in each assessed parameter relative to the baseline values. Conclusion. Although there was no significant difference in outcomes between the two groups, the results suggest that laser acupuncture can provide effective pain alleviation and can be considered an option for relief from lower back pain. Further studies using long-term intervention, a larger sample size, and rigorous methodology are required to clarify the effect of laser acupuncture on lower back pain.

  19. Reconstruction After Hemipelvectomy With the Ice-Cream Cone Prosthesis: What Are the Short-term Clinical Results?

    Science.gov (United States)

    Barrientos-Ruiz, Irene; Ortiz-Cruz, Eduardo José; Peleteiro-Pensado, Manuel

    2017-03-01

    Reconstruction after internal hemipelvectomy resection likely provides better function than hindquarter amputation. However, many reconstruction methods have been used, complications with these approaches are common, and function often is poor; because of these issues, it seems important to investigate alternative implants and surgical techniques. The purposes of this study were (1) to identify the frequency of surgical site complications and infection associated with the use of the Ice-Cream Cone prosthesis for reconstruction after hemipelvectomy for oncological indications; (2) to evaluate the Musculoskeletal Tumor Society (MSTS) outcomes scores in a small group of patients treated with this implant in the short term; and (3) to quantify the surgical margins and frequency of local recurrence in the short term in this group of patients. Between 2008 and 2013, one center performed a total of 27 internal hemipelvectomies for oncological indications. Of those, 23 (85%) were treated with reconstruction. Our general indications for reconstruction were patients whose pelvic stability was affected by the resection and whose general condition was sufficiently strong to tolerate the reconstructive procedure. Of those patients undergoing reconstruction, 14 (61%) were treated with an Ice-Cream Cone-style implant (Coned ® ; Stanmore Worldwide Ltd, Elstree, UK; and Socincer ® custom-made implant for the pelvis, Gijón, Spain), whereas nine others were treated with other implants or allografts. The indications during this time for using the Ice-Cream Cone implant were pelvic tumors affecting the periacetabular area without iliac wing involvement. Of those 14, 10 were available for followup at a minimum of 2 years (median, 3 years; range, 2-5 years) unless a study endpoint (wound complication, infection, or local recurrence) was observed earlier. Study endpoints were ascertained by chart review performed by one of the authors. Surgical site complications occurred in five

  20. Short-term memory

    Science.gov (United States)

    Toulouse, G.

    This is a rather bold attempt to bridge the gap between neuron structure and psychological data. We try to answer the question: Is there a relation between the neuronal connectivity in the human cortex (around 5,000) and the short-term memory capacity (7±2)? Our starting point is the Hopfield model (Hopfield 1982), presented in this volume by D.J. Amit.

  1. Comparative Short-Term Clinical Outcomes of Mediastinum Tumor Excision Performed by Conventional VATS and Single-Port VATS: Is It Worthwhile?

    Science.gov (United States)

    Wu, Ching-Feng; Gonzalez-Rivas, Diego; Wen, Chih-Tsung; Liu, Yun-Hen; Wu, Yi-Cheng; Chao, Yin-Kai; Hsieh, Ming-Ju; Wu, Ching-Yang; Chen, Wei-Hsun

    2015-11-01

    Single-port video-assisted thoracoscopic surgery (VATS) has been widely applied recently. However, there are still only few reports describing its use in mediastinum tumor resection. We present the technique of single-port video-assisted thoracoscopic mediastinum tumor resection and compare it with conventional VATS with regard to short-term outcome.We retrospectively enrolled 105 patients who received mediastinum surgery in Chang Gung Memorial Hospital. Sixteen patients received sternotomy or thoracotomy, 29 patients received single-port VATS, and 60 patients received conventional VATS (3 ports). The operative time, blood loss, postoperation day 1 pain score, discharge day pain score, and postoperative hospital stay were compared. In order to establish a well balanced cohort study, we also use propensity scores match (1:1) to compare the short-term clinical outcome in 2 groups.No operative deaths occurred in this study. Single-port VATS was associated with shorter operative time, lower postoperation day 1 pain score, and shorter postoperation hospital stay in our cohort study (P = 0.001, short-term outcome not inferior to conventional VATS in our cohort study. The long-term oncology outcome may require time and more enrolled patients to be further evaluated.

  2. Textbook of clinical trials

    National Research Council Canada - National Science Library

    Day, Simon; Machin, David; Green, Sylvan B

    2006-01-01

    ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 The Development of Clinical Trials Simon...

  3. Clinical Trials

    Medline Plus

    Full Text Available ... criteria differ from trial to trial. They include factors such as a patient's age and gender, the ... bias. "Bias" means that human choices or other factors not related to the protocol affect the trial's ...

  4. Clinical Trials

    Medline Plus

    Full Text Available ... under way. For example, some trials are stopped early if benefits from a strategy or treatment are ... stop a trial, or part of a trial, early if the strategy or treatment is having harmful ...

  5. Effects of modafinil on attention performance, short-term memory and executive function in university students: a randomized trial.

    Science.gov (United States)

    Fernández, Alejandro; Mascayano, Franco; Lips, Walter; Painel, Andrés; Norambuena, Jonathan; Madrid, Eva

    2015-06-30

    Modafinil is a drug developed and used for the treatment of excessive lethargy. Even though very effective for sleep disorders, it is still controversial whether modafinil can improve performance in high-order cognitive processes such as memory and executive function. This randomized, double-blind, placebo-controlled, crossover trial was designed to evaluate the effect of modafinil (compared to placebo) on the cognitive functions of healthy students. 160 volunteers were recruited and allocated randomly to modafinil or placebo group, and were assessed using the Stroop Test, BCET test and Digit span test. We found a significant difference in favor of modafinil compared to placebo in the proportion of correct answers of Stroop Test in congruent situation. A significant shorter latency of modafinil group in the incongruent situation of Stroop test was also found. No differences were found in Digit Span, or BCET tests. The study demonstrated that modafinil does not enhance the global cognitive performance of healthy non-sleep deprived students, except regarding non-demanding tasks. In particular, this drug does not seem to have positive effects on mental processes that sustain studying tasks in the college population under normal conditions. We expect these findings to demystify the use of this drug and help decision making concerning pharmacological public policies.

  6. Enriched enteral nutrition may improve short-term survival in stage IV gastric cancer patients: A randomized, controlled trial.

    Science.gov (United States)

    Klek, Stanislaw; Scislo, Lucyna; Walewska, Elzbieta; Choruz, Ryszard; Galas, Aleksander

    2017-04-01

    The aim of the study was to determine whether the postoperative use of enteral nutrition enriched with arginine, glutamine, and omega-3 fatty acids influences survival in patients diagnosed with stomach cancer. For the purpose of the study, the second wave of the trial performed in 2003 to 2009 was done. Ninety-nine patients who underwent surgery for gastric cancer (27 F, 72 M, mean age: 62.9 y) met the inclusion criteria. Of those, 54 were randomized to standard and 45 to enriched enteral nutrition (EEN). In all patients, short- and long-term (5 y) survival was analyzed. Analysis of the overall survival time did not reveal differences between groups (P = 0.663). Until the end of the third month, however, there were nine deaths in the standard enteral nutrition group and no deaths in the EEN group (16.7% versus 0.0%, P = 0.004). The univariate analyses suggested that the EEN group may have lower risk, especially during the first year after intervention. A significant reduction in the risk of death was seen during the early period after surgery (first 6 mo) in the EEN group in stage IV patients (hazard ratio = 0.25, P = 0.049). The use of enriched enteral diet did not influence, however, the risk of dying when patients were analyzed together. The study does not support the beneficial effect of enriched enteral nutrition in long-term survival; however, the positive impact on the stage IV patients suggests the need for further, more detailed studies. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Effects of a short-term parental education program on childhood atopic dermatitis: a randomized controlled trial.

    Science.gov (United States)

    Futamura, Masaki; Masuko, Ikuyo; Hayashi, Keiichi; Ohya, Yukihiro; Ito, Komei

    2013-01-01

    Parental education is important in managing childhood atopic dermatitis (AD). We evaluated the long-term effects of a 2-day parental education program (PEP) on childhood AD. In an investigator-blinded, randomized controlled trial, 59 children age 6 months to 6 years with moderate to severe AD and their mothers were recruited in Japan. Participants were given a booklet about AD and received conventional treatment alone or in combination with a 2-day PEP comprising three lectures, three practical sessions, and a group discussion. The primary outcome was evaluation of eczema severity using SCORing Atopic Dermatitis (SCORAD) at 6 months. Secondary outcomes included changes in symptom scores, amount of corticosteroid used, parental quality of life as determined according to the Dermatitis Family Impact questionnaire, and change in parental anxiety regarding the use of corticosteroids in their children. Participants in the PEP group had a significantly lower SCORAD score than those in the control group at 6 months (mean difference 10.0, 95% confidence interval [CI] = 2.3-17.7, p = 0.01) and objective SCORAD score (mean difference 7.1, 95% CI = 0.8-13.5, p = 0.03). The sleeplessness symptom score (mean difference 1.6, 95% CI = 0.0-3.1, p = 0.048) and corticosteroid anxiety score (p = 0.02) in the PEP group were significantly better than in the control group at 6 months. There was no significant difference between groups in the amount of corticosteroid used or quality of life. The PEP had positive long-term effects on eczema severity and parental anxiety about corticosteroid usage. © 2013 Wiley Periodicals, Inc.

  8. Clinical Holistic Medicine (Mindful,Short-Term Psychodynamic Psychotherapy Complemented with Bodywork in the Treatment of Experienced Mental Illness

    Directory of Open Access Journals (Sweden)

    Søren Ventegodt

    2007-01-01

    Full Text Available Short-term psychodynamic psychotherapy (STPP complemented with bodywork improved 31 of 54 patients (57.4%, 95% CI: 43.21–70.77% who rated themselves mentally ill before treatment. Calculated from this we find 1.41 500. Of the 54 patients, 40% had already had traditional treatment that did not help them. Bodywork helped the patients to confront repressed painful feelings from childhood and this seemingly accelerated and improved the therapy. The patients received in average 20 sessions over 14 months at a cost of 1600 EURO. For the treatment responders, all measured aspects of life (on a five point Likert Scale improved significantly, simultaneously, and radically: somatic health (from 2.9 to 2.3, self-esteem/relationship to self (from 3.5 to 2.3, relationship to partner (from 4.7 to 2.9 [no partner was rated as “6”], relationship to friends (from 2.5 to 2.0, ability to love (from 3.8 to 2.4, self-assessed sexual ability (from 3.5 to 2.4, self-assessed social ability (from 3.2 to 2.1, self-assessed working ability (from 3.3 to 2.4, and self-assessed quality of life (from 4.0 to 2.3. Quality of life as measured with QOL5 improved (from 3.6 to 2.3 on a scale from 1 to 5; p < 0.001. This general improvement strongly indicated that the patient had healed existentially, i.e., had experienced what Aaron Antonovsky (1923–1994 called “salutogenesis”, defined as the process exactly the opposite of pathogenesis. For the treatment responders, the treatment provided lasting benefits, without the negative side effects of drugs. A lasting, positive effect might also prevent many different types of problems in the future.

  9. Influence of a history of smoking on short term (six month) clinical and angiographic outcome after successful coronary angioplasty

    NARCIS (Netherlands)

    A.G. Violaris (Andonis); A. Thury (Attila); R. Melkert (Rein); P.W.J.C. Serruys (Patrick); E.S. Regar (Eveline)

    2000-01-01

    textabstractOBJECTIVES: To assess the influence of smoking on restenosis after coronary angioplasty. DESIGN AND PATIENTS: The incidence of smoking on restenosis was investigated in 2948 patients. They were prospectively enrolled in four major restenosis trials in which quantitative

  10. Comparative randomized open-label trial on efficacy and safety of Persen® and Persen® Night herbal extracts in patients with short-term insomnia

    Directory of Open Access Journals (Sweden)

    A. P. Rachin

    2016-01-01

    Full Text Available Herbal sedatives serve an alternative to antipsychotics and hypnotics aimed to alleviate symptoms of anxious disorders and insomnia. Valeriana officinalis L., Mentha piperita L. and Melissa officinalis are most widely used in neurology as sedatives of herbal origin. We present the results of a randomized open-label trial on efficiency and safety of Persen® and Persen® Night containing extracts of the above mentioned plants in patients with short-term insomnia. The study consisted of 60 subjects of 18–65 y.o. (mean 42.4 ± 6.9 y.o. with short-term insomnia due to adjustment disorder or mixed anxiety-depressive disorders: 30 of them got Persen® 2 tablets a day and 30 – Persen® Night, 1 capsule 30–60 min before sleep during 4 weeks. The majority (76.5 % of patients referred the onset of insomnia with psychosocial traumatic stressor. Persen® Night’s main action was found on superficial sleep, number of night awakenings, sleep onset rate. At the end of the therapy with this substance 39.7 % of patients fell asleep in 10–15 min, and 92.2 % – in 30 min, accordingly, while for Persen® at 17.4 and 80.3 % accordingly (р < 0.05. In the meantime Persen® decreased the bad sleep perception at awakening and day somnolence, mostly attributed to the mood improvement and decrease of anxiety. Levels of efficacy and safety for both substances were significant, allowing to regard them as potential phytotherapeutic agent in the treatment of insomnia and mixed anxiety-depressive disorders.

  11. Clinical Trials

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    Full Text Available ... people who fit the patient traits for that study (the eligibility criteria). Eligibility criteria differ from trial to trial. They include factors such as a patient's age and gender, the type and stage of disease, and whether ...

  12. Clinical Trials

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    Full Text Available ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ...

  13. Clinical Trials

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    Full Text Available ... trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT ...

  14. Clinical Trials

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    Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A ...

  15. Clinical Trials

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    Full Text Available ... sponsored a trial of two different combinations of asthma treatments. The trial found that one of the ... much better than the other for moderate persistent asthma. The results provided important treatment information for doctors ...

  16. Clinical Trials

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    Full Text Available ... Sponsors also may stop a trial, or part of a trial, early if the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight ...

  17. Clinical Holistic Medicine (Mindful, Short-Term Psychodynamic Psychotherapy Complemented with Bodywork in the Treatment of Experienced Physical Illness and Chronic Pain

    Directory of Open Access Journals (Sweden)

    Søren Ventegodt

    2007-01-01

    Full Text Available We investigated the treatment effect of psychodynamic short-term therapy complemented with bodywork on patients who presented with physical illness at the Research Clinic for Holistic Medicine in Copenhagen. Psychodynamic short-term therapy was complemented with bodywork (Marion Rosen to help patients confront old emotional pain from childhood trauma(s. Patients were measured with a five-item quality of life and health questionnaire (QOL5, a one-item questionnaire of self-assessed quality of life (QOL1, and four questions on self-rated ability to love and to function sexually, socially, and at work (ability to sustain a full-time job. Most of the patients had chronic pain that could not be alleviated with drugs. Results showed that 31 patients with the experience of being severely physically ill (mostly from chronic pain, in spite of having consulted their own general practitioner, entered the study. The holistic approach and body therapy accelerated the therapy dramatically and no significant side effects were detected. After the intervention, 38.7% did not feel ill (1.73 < NNT < 4.58 (p = 0.05. Psychodynamic short-term therapy complemented with bodywork can help patients. When the patients responded to the therapy, the self-assessed mental health, relationship with partner, ability to work, self-assessed quality of life, relationships in general, measured QOL (with the validated questionnaire QOL5, and life's total state (mean of health, QOL and ability were significantly improved, statistically and clinically. Most importantly, all aspects of life were improved simultaneously, due to induction of Antonovsky-salutogenesis. The patients received in average 20 sessions over 14 months at a cost of 1600 EURO. For the treatment responders, the treatment seemingly provided lasting benefits.

  18. Clinical research on radioiodine addition of low-doses of lithium carbonate in short-term treatment of Graves hyperthyroidism

    International Nuclear Information System (INIS)

    Zha Jinshun; Jiang Yan; Xu Yuan; Lin Qinxiu; Huang Chunling; Jiang Tingyin

    2014-01-01

    after therapy (t fT3 =5.23, t fT4 =10.14 in group Ⅰ, t fT3 =5.12, t fT4 =9.98 in group Ⅱ, all P<0.01), then decreased gradually to the normal ranges. The fT 3 and fT 4 values in group Ⅱ were much lower than those in group Ⅰ (t fT3 =8.22, t fT4 =19.18, all P<0.01) 30 days after therapy, no significance were found in other time periods. Cure rate of hyperthyroidism was achieved in 36 of the 50 patients (72%) in group Ⅰ and in 38 of the 50 patients (76%) in group Ⅱ without significant difference. There were no significant differences in curative effect of the two groups (χ 2 =0.21, P>0.05). Conclusion: For patients withdrawing of ATD and those with short effective half-time, as well as those intolerant or invalid, the short term addition of lithium to 131 I allows for a better control of thyrotoxia and the completeness of treatment. But there have not been observed that lithium carbonate plus 131 I can improve the long term cure rate of Graves hyperthyroidism. (authors)

  19. A randomised comparative study of the short term clinical and biological effects of intravenous pulse methylprednisolone and infliximab in patients with active rheumatoid arthritis despite methotrexate treatment.

    Science.gov (United States)

    Durez, P; Nzeusseu Toukap, A; Lauwerys, B R; Manicourt, D H; Verschueren, P; Westhovens, R; Devogelaer, J-P; Houssiau, F A

    2004-09-01

    To compare the short term clinical and biological effects of intravenous (i.v.) pulse methylprednisolone (MP) and infliximab (IFX) in patients with severe active rheumatoid arthritis (RA) despite methotrexate (MTX) treatment. Patients with active RA despite MTX treatment were randomly allocated to receive a single i.v. infusion of MP (1 g) or three i.v. infusions of IFX (3 mg/kg) on weeks 0, 2, and 6. Patients were "blindly" evaluated for disease activity measures. Quality of life (QoL) was evaluated through the SF-36 health survey. Serum matrix metalloproteinase-3 (MMP-3) titres were measured at baseline, weeks 2 and 6. Compared with baseline, significant improvement was noted in all activity measures, including serum C reactive protein (CRP) titres, in the IFX group only. At week 14, 6/9 (67%) and 4/9 (44%) IFX patients met the ACR20 and 50 response criteria, while this was the case in only 1/12 (8%) and 0/12 (0%) MP patients, respectively (ptreatment, whereas some did so in the IFX group. Serum MMP-3 titres significantly decreased (41% drop) at week 6 in the IFX group, while no changes were seen in patients given MP. This short term randomised comparative study demonstrates that TNF blockade is better than MP pulse therapy in a subset of patients with severe refractory RA, with improvement in not only clinical parameters of disease activity but also biological inflammatory indices, such as serum CRP and MMP-3 titres.

  20. Short-term biological variation of clinical chemical values in dumeril's monitors (Varanus dumerili)

    DEFF Research Database (Denmark)

    Bertelsen, Mads Frost; Kjelgaard-Hansen, Mads Jens; Howell, Jennifer R.

    2007-01-01

    Plasma biochemical values are routinely used in the medical management of ill reptiles, and for monitoring the health of clinically normal animals. Laboratory tests, including clinical biochemical values, are subject to biological and analytical variation, the magnitude of which determines the ut...

  1. Plasma HIV-1 Tropism and the Risk of Short-Term Clinical Progression to AIDS or Death

    DEFF Research Database (Denmark)

    Casadellà, Maria; Cozzi-Lepri, Alessandro; Phillips, Andrew

    2017-01-01

    OBJECTIVE: To investigate if plasma HIV-1 tropism testing could identify subjects at higher risk for clinical progression and death in routine clinical management. DESIGN: Nested case-control study within the EuroSIDA cohort. METHODS: Cases were subjects with AIDS or who died from any cause...

  2. Clinical Trials

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    Full Text Available ... the NHLBI's Children and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to ...

  3. Clinical Trials

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    Full Text Available ... Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often ... participants. Children and Clinical Studies Learn about the importance of children in clinical studies and get answers ...

  4. Clinical Trials

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    Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and health ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A DSMB's ...

  5. A preliminary case series evaluating the safety and immediate to short-term clinical benefits of joint mobilization in hemophilic arthritis of the lower limb.

    Science.gov (United States)

    Scaddan, Emma; Rowell, John; O'Leary, Shaun

    2017-09-01

    Arthritis resulting from recurrent intra-articular bleeding in individuals with hemophilia can be severely debilitating due to joint pain and stiffness with subsequent loss of mobility and function. Very limited studies have investigated the potential benefits of joint mobilization for this condition. This case series is a preliminary investigation of safety, as well as immediate and short-term clinical benefits, associated with gentle knee and ankle joint mobilization in people with hemophilic arthropathy. A single intervention of joint mobilization was applied to the affected knees and/or ankles of 16 individuals with severe or moderate hemophilia within a public hospital setting. Adverse events, as well as immediate (pain-free passive joint range, Timed Up and Go Test with maximum pain numerical rating scale) and short-term (Lower Extremity Functional Scale) effects of the intervention were evaluated with a repeated measures ANOVA. There were no adverse events. An immediate significant increase was observed in pain-free passive ankle joint range of motion ( p  < 0.05) following the joint mobilization intervention. The findings of this case series suggest that gentle joint mobilization techniques may be safely considered as part of a multimodal management approach for hemophilic arthropathy.

  6. Clinical holistic medicine (mindful, short-term psychodynamic psychotherapy complemented with bodywork) in the treatment of experienced physical illness and chronic pain.

    Science.gov (United States)

    Ventegodt, Søren; Thegler, Suzette; Andreasen, Tove; Struve, Flemming; Enevoldsen, Lars; Bassaine, Laila; Torp, Margrethe; Merrick, Joav

    2007-03-02

    We investigated the treatment effect of psychodynamic short-term therapy complemented with bodywork on patients who presented with physical illness at the Research Clinic for Holistic Medicine in Copenhagen. Psychodynamic short-term therapy was complemented with bodywork (Marion Rosen) to help patients confront old emotional pain from childhood trauma(s). Patients were measured with a five-item quality of life and health questionnaire (QOL5), a one-item questionnaire of self-assessed quality of life (QOL1), and four questions on self-rated ability to love and to function sexually, socially, and at work (ability to sustain a full-time job). Most of the patients had chronic pain that could not be alleviated with drugs. Results showed that 31 patients with the experience of being severely physically ill (mostly from chronic pain), in spite of having consulted their own general practitioner, entered the study. The holistic approach and body therapy accelerated the therapy dramatically and no significant side effects were detected. After the intervention, 38.7% did not feel ill (1.73 treatment responders, the treatment seemingly provided lasting benefits.

  7. Assessing and comparing the short-term effects of TPB only and TPB plus implementation intentions interventions on snacking behavior in Iranian adolescent girls: a cluster randomized trial.

    Science.gov (United States)

    Karimi-Shahanjarini, Akram; Rashidian, Arash; Omidvar, Nasrin; Majdzadeh, Reza

    2013-01-01

    The evidence for the effectiveness of theory of planned behavior (TPB)-based interventions is mixed. There is also mixed evidence on the effectiveness of adding implementation intentions to TPB-based interventions. In this study we assessed and compared the short-term effects of TPB-only intervention and TPB plus implementation intentions intervention on snacking behavior and intention to consume unhealthy snacks in Iranian adolescent girls. Three-arm cluster randomized controlled trial. Ten middle schools in Tehran (Iran). A total of 29 classes included 739 female adolescents (age range: 12-15 years). Intervention. Two brief interventions including TPB-only intervention and TPB plus implementation intentions intervention. Food frequency questionnaire and intentions at baseline, 10 days, and 3 months measuring snacking behavior and cognitions about unhealthy snack consumption, respectively. Hierarchical linear modeling to assess the interventions' effects. Both interventions successfully decreased intention to consume and consumption of unhealthy snacks at postintervention. Calculation of the effect sizes revealed that the TPB plus implementation intentions intervention was more effective than the TPB-only intervention. The effects remained significant at 3-month follow-up in the TPB plus implementation intentions intervention group only, although the effect size decreased. Overall, the study suggests that adding implementation intentions on top of TPB-based persuasive messages improves effectiveness and sustainability of desirable changes.

  8. Clinical Trials

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    Full Text Available ... include factors such as a patient's age and gender, the type and stage of disease, and whether ... How long will the trial last? Who will pay for the tests and treatments I receive? Will ...

  9. Clinical Trials

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    Full Text Available ... medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these ... trials are a key research tool for advancing medical knowledge and patient care. ...

  10. Clinical Trials

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    Full Text Available ... Masking, or "blinding," helps avoid bias. For this reason, researchers also may not be told which treatments ... from a study at any time, for any reason. Also, during the trial, you have the right ...

  11. Clinical Trials

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    Full Text Available ... get special protection as research subjects. Almost always, parents must give legal consent for their child to ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. ...

  12. Clinical Trials

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    Full Text Available ... risk of heart disease in the first few years, and HT also increased the risk of stroke ... a safety measure. They ensure a trial excludes any people for whom the protocol has known risks ...

  13. Clinical Trials

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    Full Text Available ... Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT was already in common use for the treatment of menopausal symptoms. It also ...

  14. Clinical Trials

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    Full Text Available ... risk of heart disease in the first few years, and HT also increased the risk of stroke ... master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The ...

  15. Clinical Trials

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    Full Text Available ... treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug ... life? Will I have to be in the hospital? How long will the trial last? Who will ...

  16. Clinical Trials

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    Full Text Available ... procedures painful? What are the possible risks, side effects, and benefits of taking part in the study? How might this trial affect my daily life? Will I have to be in the hospital? ...

  17. Clinical Trials

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    Full Text Available ... Blood Safety Sleep Science and Sleep Disorders Lung Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, ... whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT ...

  18. Clinical Trials

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    Full Text Available ... are ethical and that the participants' rights are protected. The IRB reviews the trial's protocol before the ... may know about studies going on in your area. You can visit the following website to learn ...

  19. Clinical Trials

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    Full Text Available ... a laboratory (lab), where scientists first develop and test new ideas. If an approach seems promising, the ... Centers (including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study ...

  20. Clinical Trials

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    Full Text Available ... whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT ... also was increasingly being used for prevention of heart disease.) The study found that HT increased the risk ...

  1. Clinical Trials

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    Full Text Available ... trials optimization . Building 31 31 Center Drive Bethesda, MD 20892 Learn more about getting to NIH Get ... and Funding Building 31 31 Center Drive Bethesda, MD 20892 Learn more about getting to NIH Connect ...

  2. Clinical Trials

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    Full Text Available ... that the participants' rights are protected. The IRB reviews the trial's protocol before the study begins. An IRB will only approve research that deals with medically important questions ...

  3. Clinical Trials

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    Full Text Available ... to preexisting differences between the patients. Usually, a computer program makes the group assignments. Masking The term " ... under way. For example, some trials are stopped early if benefits from a strategy or treatment are ...

  4. Clinical Trials

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    Full Text Available ... treatment of menopausal symptoms. It also was increasingly being used for prevention of heart disease.) The study ... a trial are due to the different strategies being used, not to preexisting differences between the patients. ...

  5. Clinical Trials

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    Full Text Available ... Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies Women’s Health All Science A- ... assumed that trial results were valid for other populations as well. Researchers now realize that women and ...

  6. Short-term memory across eye blinks.

    Science.gov (United States)

    Irwin, David E

    2014-01-01

    The effect of eye blinks on short-term memory was examined in two experiments. On each trial, participants viewed an initial display of coloured, oriented lines, then after a retention interval they viewed a test display that was either identical or different by one feature. Participants kept their eyes open throughout the retention interval on some blocks of trials, whereas on others they made a single eye blink. Accuracy was measured as a function of the number of items in the display to determine the capacity of short-term memory on blink and no-blink trials. In separate blocks of trials participants were instructed to remember colour only, orientation only, or both colour and orientation. Eye blinks reduced short-term memory capacity by approximately 0.6-0.8 items for both feature and conjunction stimuli. A third, control, experiment showed that a button press during the retention interval had no effect on short-term memory capacity, indicating that the effect of an eye blink was not due to general motoric dual-task interference. Eye blinks might instead reduce short-term memory capacity by interfering with attention-based rehearsal processes.

  7. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  8. Efficacy of Denture Cleansers in Reducing Microbial Counts from Removable Partial Dentures: A Short-Term Clinical Evaluation

    OpenAIRE

    Lucena-Ferreira,Silvia Carneiro de; Cavalcanti,Indira Moraes Gomes; Cury,Altair Antoninha Del Bel

    2013-01-01

    This clinical study investigated if daily immersion in denture cleansers reduces microbial counts on removable partial denture's (RPD) biofilm. Twenty-five RPD wearer volunteers were selected and instructed to complement the hygiene of their dentures by immersing them in an enzymatic peroxide-based denture cleanser (Polident® 3 minute) once a day for 3 min for a period of 15 days. The biofilm was collected from RPD surfaces with a swab immediately before (baseline) and after the experimental ...

  9. Photodynamic therapy in non-surgical treatment of chronic periodontitis: short term randomized clinical trial study

    Science.gov (United States)

    Russo, C.; Palaia, G.; Loskutova, E.; Libotte, F.; Kornblit, R.; Gaimari, G.; Tenore, G.; Romeo, U.

    2016-03-01

    Introduction: Periodontitis is a chronic inflammatory disease due to exposition to plaque and tartar. Conventional treatments consist of scaling and root planing (SRP) and antibiotics administration. Among them encouraging results have been obtained using alternative protocols, like the antimicrobial photodynamic therapy (PDT). Aim of the Study: Evaluation of PDT effects added to conventional methods. Materials and Methods: 11 patients (4M/7F, 37-67 years aged, non-smoking) affected by untreated chronic periodontal disease, with >3mm pockets in at least 4 teeth were divided in two groups, test and control group. Each patient had to made full-intraoral before and after the treatment. The test group received SRP+PDT, while the control group was subjected to SRP. The PDT was performed through the HELBO®TheraLite (Bredent Medical), diode laser battery powered 670nm with an output of 75mW/cm2. The Helbo Blue photosensitizer, containing methylene blue, was used. The exposure time to the laser effect was of 10'' for each site, for a total of 60'' at 3J/cm2. Results: Both groups had a significant improvement in the reduction of pocket depth (PD), above all in the test group. Statistical analysis was performed through the T-test, evaluating PD between the two groups p=0.96 (p> 0.05), resulting not statistically significant. Conclusion: PDT is a promising support to SRP, achieving a significant reduction in the pocket depth, but more cases are needed to confirm the validity of the used protocol.

  10. Understanding Clinical Trials

    Science.gov (United States)

    Watch these videos to learn about some basic aspects of cancer clinical trials such as the different phases of clinical trials, methods used to protect patient safety, and how the costs of clinical trials are covered.

  11. Plasma HIV-1 Tropism and the Risk of Short-Term Clinical Progression to AIDS or Death

    DEFF Research Database (Denmark)

    Casadellà, Maria; Cozzi-Lepri, Alessandro; Phillips, Andrew

    2017-01-01

    -naïve. Baseline factors independently associated with clinical progression or death were female gender (OR = 2.13 vs. male, 95CI = 1.04, 4.36), p = 0.038), CD4+T-cell count (OR = 0.90 (95CI = 0.80, 1.00) per 100 cells/mm3 higher, p = 0.058), being on ART (OR = 2.72 vs. being off-ART (95CI = 1.15, 6.41), p = 0...

  12. Using modified polyetheretherketone (PEEK) as an alternative material for endocrown restorations: A short-term clinical report.

    Science.gov (United States)

    Zoidis, Panagiotis; Bakiri, Eleonora; Polyzois, Gregory

    2017-03-01

    A modified polyetheretherketone (PEEK) framework material veneered with indirect light-polymerized composite resin was used as an alternative material for the fabrication of an endocrown restoration for an extensively damaged molar. The elastic modulus of the polyetheretherketone framework (4 GPa) veneered with indirect composite resin could dampen the occlusal forces protecting tooth structures better than ceramic materials. This is important in the restoration of extensively damaged molars with weak roots. Long-term clinical evidence is required before recommending the application as a substitute material. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  13. Articular congruity is associated with short-term clinical outcomes of operatively treated SER IV ankle fractures.

    Science.gov (United States)

    Berkes, Marschall B; Little, Milton T M; Lazaro, Lionel E; Pardee, Nadine C; Schottel, Patrick C; Helfet, David L; Lorich, Dean G

    2013-10-02

    With regard to supination-external rotation type-IV (SER IV) ankle fractures, there is no consensus regarding which patient, injury, and treatment variables most strongly influence clinical outcome. The purpose of this investigation was to examine the impact of articular surface congruity on the functional outcomes of operatively treatment of SER IV ankle fractures. A prospectively generated database consisting of operatively treated SER IV ankle fractures was reviewed. Postoperative computed tomography (CT) scans were used to assess ankle joint congruity. Ankles were considered incongruent in the presence of >2 mm of articular step-off, intra-articular loose bodies, or an articular surface gap of >2 mm (despite an otherwise anatomic reduction) due to joint impaction and comminution. Patients with at least one year of clinical follow-up were eligible for analysis. The primary and secondary outcome measures were the Foot and Ankle Outcome Score (FAOS) and ankle motion. One hundred and eight SER IV fractures met our inclusion criteria. The average duration of follow-up was twenty-one months. Seventy-two patients (67%) had a congruent ankle joint, and thirty-six (33%) had elements of articular surface incongruity on postoperative CT scanning. These two groups were similar with regard to comorbidities and injury and treatment variables. At the time of the final follow-up, the group with articular incongruity had a significantly worse FAOS with regard to symptoms (p = 0.012), pain (p = 0.004), and activities of daily living (p = 0.038). Those with articular incongruity had worse average scores in the FAOS sport domain as well. No significant differences in ankle motion were found between the two groups. In this population of patients with an operatively treated SER IV ankle fracture, the presence of postoperative articular incongruity correlated with inferior early clinical outcomes. Orthopaedic surgeons should scrutinize ankle fracture reductions and strive for

  14. Clinical Trials

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    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... the NHLBI's Children and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and ...

  15. Clinical Trials

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    Full Text Available ... go to the NHLBI's Children and Clinical Studies Web page. Children and Clinical Studies Learn more about ... Protections The U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) oversees ...

  16. Clinical Trials

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    Full Text Available ... Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often ... rights that help protect them. Scientific Oversight Institutional Review Board Institutional review boards (IRBs) help provide scientific ...

  17. Clinical Trials

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    Full Text Available ... taking the same treatment the same way. These patients are closely watched by Data and Safety Monitoring Boards. Even if you don't directly ... risk procedures (such as gene therapy) or vulnerable patients (such as ... trial for safety problems or differences in results among different groups. ...

  18. Clinical Trials

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    Full Text Available ... edge approaches, such as gene therapy or new biological treatments. Health insurance and health care providers don't ... of a trial, early if the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and ...

  19. Clinical Trials

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    Full Text Available ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the ...

  20. Clinical Trials

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    Full Text Available ... Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep ... Activity Population and Epidemiology Studies Women’s Health All Science A-Z Grants ... in the Press Research Features All Events Past Events Upcoming ...

  1. Clinical Trials

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    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... include factors such as a patient's age and gender, the type and stage of disease, ... helps ensure that any differences observed during a trial are due to the ...

  2. Clinical Trials

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    Full Text Available ... an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

  3. Short-term effects of instruction in home heating on indoor temperature and blood pressure in elderly people: a randomized controlled trial.

    Science.gov (United States)

    Saeki, Keigo; Obayashi, Kenji; Kurumatani, Norio

    2015-11-01

    Increased mortality from cardiovascular disease in winter is partly explained by increased blood pressure (BP) caused by cold exposure. For physicians, instruction in home heating is feasible option to reduce cold exposure, but the effectiveness remains unknown. To determine whether instruction in home heating increases indoor temperatures and decreases ambulatory BP among elderly people, we conducted an open-label, simply randomized, controlled trial in the winters. As an intervention, the participants were asked to set the heating device in the living room to start 1 h before estimated rising time with target temperature at 24°C, and to stay in the living room until 2 h after rising as long as possible. Repeatedly measured ambulatory BP, physical activity, and indoor temperatures until 4 h after rising were assessed using multilevel linear regression model with random intercept among individual. A total of 359 eligible participants (mean age ± standard deviation: 71.6 ± 6.6) were randomly allocated to the control group (n = 173) and intervention group (n = 186). Intervention significantly increased living room temperature by 2.09°C (95% confidence interval 1.28-2.90), and significantly decreased SBP and DBP by 4.43/2.33 mmHg (95% confidence interval 0.97-7.88/0.08-4.58 mmHg) after adjusting for confounders including age, sex, antihypertensive medication, household income, and physical activity. Short-term effect of instruction in home heating showed larger increase of indoor temperature than that of insulation intervention. Significant reduction of BPsuggests the effectiveness on preventing cardiovascular incidence in winter. To summarize, instruction in heating significantly decreased BP.

  4. Short-term influence of cataract surgery on circadian biological rhythm and related health outcomes (CLOCK-IOL trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Saeki, Keigo; Obayashi, Kenji; Nishi, Tomo; Miyata, Kimie; Maruoka, Shinji; Ueda, Tetsuo; Okamoto, Masahiro; Hasegawa, Taiji; Matsuura, Toyoaki; Tone, Nobuhiro; Ogata, Nahoko; Kurumatani, Norio

    2014-12-29

    activity and wrist skin temperature, and urinary melatonin metabolite. Chronotype and visual function will be assessed using the 'morningness-eveningness' questionnaire, the Munich chronotype questionnaire, and the National Eye Institute Visual Function Questionnaire. Although there are potential limitations due to the difference in duration from baseline survey to outcome measurements between two groups, any seasonal effect on the outcome measurement will be balanced as a result of continuous inclusion of participants through the year, and outcomes will be adjusted for day length at outcome measurements at analysis. UMIN000014559, UMIN Clinical Trials Registry, registered on 15 July 2014.

  5. Clinical Trials

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    Full Text Available ... and useful results, which in turn will improve public health. We offer a variety of funding mechanisms tailored to planning and conducting clinical ... Privacy Policy Freedom of Information Act (FOIA) Accessibility ...

  6. Clinical Trials

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    Full Text Available ... and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical Studies ... have not only shaped medical practice around the world, but have improved the health of millions of ...

  7. Clinical Trials

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    Full Text Available ... the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical ...

  8. Clinical Trials

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    Full Text Available ... harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight ... of research studies at the NIH Clinical Center, America's research hospital, located on the NIH campus in ...

  9. Clinical aspects of intraoperative radiotherapy in early breast cancer: short-term complications after IORT in women treated with low energy x-rays

    International Nuclear Information System (INIS)

    Tuschy, Benjamin; Berlit, Sebastian; Romero, Simone; Sperk, Elena; Wenz, Frederik; Kehl, Sven; Sütterlin, Marc

    2013-01-01

    To assess postoperative complications, clinical outcome and histological findings in patients undergoing intraoperative radiotherapy with low energy x-rays for early breast cancer. We retrospectively analysed data of 208 women who underwent intraoperative irradiation during breast conserving surgery (BCS) between 2002 and 2007. Demographic, clinical and surgical parameters as well as short-term complications within the first postoperative week and histological findings were evaluated. Toxicities were assessed using the CTC/EORTC Score. Postoperative complications were rare and the immediate toxicity low, without any grade 3/4 acute toxicity. The most frequent postoperative side effects were suggillation (24%) and palpable seroma (17.3%). In 78.6% of the axillary seroma and in 25% of the breast seroma a needle aspiration was inevitable. Erythema grade I-II of the breast was found in 27 women (13%); whereas in 7 patients (3.4%), mastitis was confirmed. In 57.7% of the cases, the pathological assessment revealed ductal invasive breast cancer and tumour size ranged between 0.1 and 4.5 cm (mean = 1.6 cm). IORT using Intrabeam ® during BCS is safe, although it is associated with postoperative adverse events such as seroma. These should be mentioned and explained to women in detail during the preoperative discussion. This explicitly clinical description is useful for daily clinical practice; especially for giving a detailed analysis of the postoperative side effects during preoperative counselling

  10. Clinical Trials

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    Full Text Available ... seems promising, the next step may involve animal testing. This shows how the approach affects a living body and whether it's harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical ...

  11. Clinical Trials

    Medline Plus

    Full Text Available ... the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ideas. If an approach seems ... Thus, research in humans is needed. For safety purposes, clinical ...

  12. Short-term clinical outcomes of laser supported periodontal treatment concept using Er,Cr:YSGG (2780nm) and diode (940 nm): a pilot study

    Science.gov (United States)

    Odor, Alin A.; Violant, Deborah; Badea, Victoria; Gutknecht, Norbert

    2016-03-01

    Backgrounds: Er,Cr:YSGG (2780nm) and diode (940 nm) lasers can be used adjacent to the conventional periodontal treatment as minimally invasive non-surgical devices. Aim: To describe the short-term clinical outcomes by combining Er,Cr:YSGG (2780nm) and diode 940 nm lasers in non-surgical periodontal treatment. Materials and methods: A total of 10 patients with periodontal disease (mild, moderate, severe) - 233 teeth and 677 periodontal pockets ranging from 4 mm to 12 mm - were treated with Er,Cr:YSGG (2780nm) and diode (940 nm) lasers in adjunct to manual and piezoelectric scaling and root planning (SRP). Periodontal parameters such as mean probing depth (PD), mean clinical attachment level (CAL) and mean bleeding on probing (BOP) were evaluated at baseline and 6 months after the laser treatment using an electronic periodontal chart. Results: At baseline, the mean PD was 4.06 ± 1.06 mm, mean CAL was 4.56 ± 1.43 mm, and mean BOP was 43.8 ± 23.84 %. At 6 months after the laser supported periodontal treatments the mean PD was 2.6 ± 0.58 mm (p laser wavelengths in adjunct to SRP offers significant improvements of periodontal clinical parameters such as PD, CAL and BOP. Keywords: Laser supported periodontal treatment concept, Er,Cr:YSGG and diode 940nm lasers, Scaling and root planning, Minimally invasive non-surgical device

  13. Clinical trial methodology

    National Research Council Canada - National Science Library

    Peace, Karl E; Chen, Ding-Geng

    2011-01-01

    ... in the pharmaceutical industry, Clinical trial methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research...

  14. The Short-term Effects of ASPIRA: A Web-based, Multimedia Smoking Prevention Program for Adolescents in Romania: A Cluster Randomized Trial.

    Science.gov (United States)

    Nădăşan, Valentin; Foley, Kristie L; Pénzes, Melinda; Paulik, Edit; Mihăicuţă, Ștefan; Ábrám, Zoltán; Bálint, Jozsef; Csibi, Monika; Urbán, Robert

    2017-08-01

    Although web-based, multimedia smoking prevention programs have been tested in several high-income countries, their efficacy in Central and Eastern Europe is unknown. The aim of this trial was to assess the short-term effects of ASPIRA, among Romanian and Hungarian speaking ninth graders in Tirgu Mures, Romania. ASPIRA is the Romanian acronym for the translated and adapted version of ASPIRE, "A Smoking Prevention Interactive Experience," an evidence-based smoking prevention program originally developed to prevent tobacco use among high school students in the United States. Sixteen high schools in Tirgu Mures, Romania were randomized to receive five weekly sessions of the ASPIRA web-based, multimedia program or to a control condition. Socio-demographic data, psychosocial characteristics, and smoking behavior were collected from students at baseline and at 6 months. A hierarchical logistic regression analysis was conducted to test the efficacy of the intervention on smoking initiation and current smoking among 1369 students. Never-smoker students in the intervention arm were 35% less likely to report smoking initiation 6 months after the baseline assessment (OR = 0.65, 95%CI: 0.44-0.97). Reduced smoking initiation was observed most notably among students who were exposed to at least 75% of the ASPIRA program. There was no statistically significant effect of the intervention on current tobacco use (OR = 0.80, 95%CI: 0.44-1.46). ASPIRA, an adapted version of the evidence-based, multimedia ASPIRE program that was originally developed and tested in the United States may decrease smoking initiation among multi-ethnic adolescents in Central and Eastern Europe. (1). Web-based, multimedia smoking prevention programs may be effective tools to prevent smoking initiation among multi-ethnic adolescent communities in Central and Eastern Europe. (2). The degree of exposure is critical, only high exposure to the multimedia smoking prevention program is associated with reduced

  15. Efficacy and cost-effectiveness of an experimental short-term inpatient Dialectical Behavior Therapy (DBT) program: study protocol for a randomized controlled trial.

    Science.gov (United States)

    van den Bosch, Louisa M C; Sinnaeve, Roland; Hakkaart-van Roijen, Leona; van Furth, Eric F

    2014-05-01

    outpatient patients can pose a dilemma for mental health care professionals. Although hospitalization seems inevitable under some circumstances, it has proven to be harmful in its own right. This paper outlines the background and methods of a randomized trial evaluating the possible surplus value of a short-term inpatient DBT program.

  16. Short-term androgen priming by use of aromatase inhibitor and hCG before controlled ovarian stimulation for IVF. A randomized controlled trial

    DEFF Research Database (Denmark)

    Lossl, K; Andersen, C Yding; Loft, A

    2008-01-01

    Temporary exposure of follicles to increased levels of androgens may augment follicular responsiveness. The present study tested whether short-term androgen priming by aromatase inhibitor and human chorionic gonadotrophin (hCG) before controlled ovarian stimulation (COS) increases the number of top......-quality embryos after IVF/ICSI....

  17. Effects of short-term isokinetic training with reciprocal knee extensors agonist and antagonist muscle actions : A controlled and randomized trial

    NARCIS (Netherlands)

    Cunha, Rafael; Carregaro, Rodrigo L.; Martorelli, André; Vieira, Amilton; Oliveira, Ana B.; Bottaro, Martim

    Background: Previous studies have shown that preloading an antagonist muscle may increase the acute agonist neuromuscular performance. In addition, studies have suggested that very short-term resistance exercise (RE) programs may also be useful to increase strength and muscular performance.

  18. Short-term population-based and spatiotemporal nonlinear concentration-response associations between fine particulate matter and children's respiratory clinic visits

    Science.gov (United States)

    Yu, Hwa-Lung; Chien, Lung-Chang

    2014-05-01

    Advert health impacts associated with the PM2.5 exposure have been confirmed in mortality and cardiovascular diseases; however, findings of the influence of PM2.5 on respiratory diseases investigated among previous studies are still inconsistent. We investigated the short-term population-based associations between the respiratory clinic visits of children population and the PM2.5 exposure levels with considering both the spatiotemporal distributions of the ambient pollution and clinic visit data. We applied a spatiotemporal structured additive regression model to examine the concentration-response (C-R) association between daily children's respiratory clinic visits and PM2.5 concentrations. The analysis was performed separately on the four selected respiratory disease categories of the population-based dataset, obtained from Taiwan National Health Insurance database, covering the 41 districts in Taipei area during the period of 2005 to 2007. This study reveals a strong nonlinear C-R pattern that the PM2.5 increment can significantly affect respiratory health at PM2.5 concentration ≤ 18.17µg/m3 for both preschool children and schoolchildren. The elevated risks are especially present in the category of acute respiratory infections. PM2.5 increase is mostly non-significant to the more severe respiratory diseases, e.g., COPD and pneumonia, over the ranges of 8.85-92.45µg/m3. The significantly higher relative rate of respiratory clinic visit most likely concentrated at populated areas. We highlight the nonlinearity of the respiratory health impacts of PM2.5 on children's populations from the first study, to our knowledge, to investigate this population-based association. The strong nonlinearity can possibly cause the inconsistency of PM2.5 health impact assessments with linear assumptions.

  19. A short-term increase in cancer risk associated with daytime napping is likely to reflect pre-clinical disease: prospective cohort study.

    Science.gov (United States)

    Cairns, B J; Travis, R C; Wang, X-S; Reeves, G K; Green, J; Beral, V

    2012-07-24

    Sleep disturbance, a correlate of which is daytime napping, has been hypothesised to be associated with risk of breast and other cancers. We estimated relative risks (RR) of breast and other invasive cancers by the reported frequency of daytime napping in a large prospective cohort of middle-aged women in the UK. During an average of 7.4 years of follow-up, 20 058 breast cancers and 31 856 other cancers were diagnosed. Over the first 4 years of follow-up, daytime napping (sometimes/usually vs rarely/never) was associated with slightly increased risks of breast cancer (RR=1.10, 95% CI 1.06-1.15) and of other cancers (RR=1.12, 1.08-1.15), but the RRs decreased significantly with increasing follow-up time (P=0.001 and P=0.01, respectively, for trend). Four or more years after baseline, there was no elevated risk of breast cancer (RR=1.00, 0.96-1.05), and only marginally greater risk of other cancers (RR=1.04, 1.01-1.07). The effect of pre-clinical disease is a likely explanation for the short-term increased risk of breast and other cancers associated with daytime napping. © 2012 Cancer Research UK

  20. Association of short-term exposure to ground-level ozone and respiratory outpatient clinic visits in a rural location – Sublette County, Wyoming, 2008–2011

    Energy Technology Data Exchange (ETDEWEB)

    Pride, Kerry R., E-mail: hgp3@cdc.gov [Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, GA (United States); Wyoming Department of Health, 6101 Yellowstone Road, Suite 510, Cheyenne, WY 82002 (United States); Peel, Jennifer L. [Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO 80523 (United States); Robinson, Byron F. [Scientific Education and Professional Development Program Office, Office of Surveillance, Epidemiology and Laboratory Services, Centers for Disease Control and Prevention, 1600 Clifton Rd, NE, E-92, Atlanta, GA 30333 (United States); Busacker, Ashley [Field Support Branch, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Wyoming Department of Health, 6101 Yellowstone Road, Suite 510, Cheyenne, WY 82002 (United States); Grandpre, Joseph [Chronic Disease Epidemiologist, Wyoming Department of Health, 6101 Yellowstone Road, Suite 510, Cheyenne, WY 82002 (United States); Bisgard, Kristine M. [Scientific Education and Professional Development Program Office, Office of Surveillance, Epidemiology and Laboratory Services, Centers for Disease Control and Prevention, 600 Clifton Road, NE, E-92, Atlanta, GA 30333 (United States); Yip, Fuyuen Y. [Air Pollution and Respiratory Disease Branch, Centers for Disease Control and Prevention, 600 Clifton Rd, NE, E-92, Atlanta, GA 30333 (United States); Murphy, Tracy D. [Wyoming Department of Health, 101 Yellowstone Road, Suite 510, Cheyenne, WY 82002 (United States)

    2015-02-15

    Objective: Short-term exposure to ground-level ozone has been linked to adverse respiratory and other health effects; previous studies typically have focused on summer ground-level ozone in urban areas. During 2008–2011, Sublette County, Wyoming (population: ~10,000 persons), experienced periods of elevated ground-level ozone concentrations during the winter. This study sought to evaluate the association of daily ground-level ozone concentrations and health clinic visits for respiratory disease in this rural county. Methods: Clinic visits for respiratory disease were ascertained from electronic billing records of the two clinics in Sublette County for January 1, 2008–December 31, 2011. A time-stratified case-crossover design, adjusted for temperature and humidity, was used to investigate associations between ground-level ozone concentrations measured at one station and clinic visits for a respiratory health concern by using an unconstrained distributed lag of 0–3 days and single-day lags of 0 day, 1 day, 2 days, and 3 days. Results: The data set included 12,742 case-days and 43,285 selected control-days. The mean ground-level ozone observed was 47±8 ppb. The unconstrained distributed lag of 0–3 days was consistent with a null association (adjusted odds ratio [aOR]: 1.001; 95% confidence interval [CI]: 0.990–1.012); results for lags 0, 2, and 3 days were consistent with the null. However, the results for lag 1 were indicative of a positive association; for every 10-ppb increase in the 8-h maximum average ground-level ozone, a 3.0% increase in respiratory clinic visits the following day was observed (aOR: 1.031; 95% CI: 0.994–1.069). Season modified the adverse respiratory effects: ground-level ozone was significantly associated with respiratory clinic visits during the winter months. The patterns of results from all sensitivity analyzes were consistent with the a priori model. Conclusions: The results demonstrate an association of increasing ground

  1. Association of short-term exposure to ground-level ozone and respiratory outpatient clinic visits in a rural location – Sublette County, Wyoming, 2008–2011

    International Nuclear Information System (INIS)

    Pride, Kerry R.; Peel, Jennifer L.; Robinson, Byron F.; Busacker, Ashley; Grandpre, Joseph; Bisgard, Kristine M.; Yip, Fuyuen Y.; Murphy, Tracy D.

    2015-01-01

    Objective: Short-term exposure to ground-level ozone has been linked to adverse respiratory and other health effects; previous studies typically have focused on summer ground-level ozone in urban areas. During 2008–2011, Sublette County, Wyoming (population: ~10,000 persons), experienced periods of elevated ground-level ozone concentrations during the winter. This study sought to evaluate the association of daily ground-level ozone concentrations and health clinic visits for respiratory disease in this rural county. Methods: Clinic visits for respiratory disease were ascertained from electronic billing records of the two clinics in Sublette County for January 1, 2008–December 31, 2011. A time-stratified case-crossover design, adjusted for temperature and humidity, was used to investigate associations between ground-level ozone concentrations measured at one station and clinic visits for a respiratory health concern by using an unconstrained distributed lag of 0–3 days and single-day lags of 0 day, 1 day, 2 days, and 3 days. Results: The data set included 12,742 case-days and 43,285 selected control-days. The mean ground-level ozone observed was 47±8 ppb. The unconstrained distributed lag of 0–3 days was consistent with a null association (adjusted odds ratio [aOR]: 1.001; 95% confidence interval [CI]: 0.990–1.012); results for lags 0, 2, and 3 days were consistent with the null. However, the results for lag 1 were indicative of a positive association; for every 10-ppb increase in the 8-h maximum average ground-level ozone, a 3.0% increase in respiratory clinic visits the following day was observed (aOR: 1.031; 95% CI: 0.994–1.069). Season modified the adverse respiratory effects: ground-level ozone was significantly associated with respiratory clinic visits during the winter months. The patterns of results from all sensitivity analyzes were consistent with the a priori model. Conclusions: The results demonstrate an association of increasing ground

  2. Effect of Sucrose Analgesia, for Repeated Painful Procedures, on Short-term Neurobehavioral Outcome of Preterm Neonates: A Randomized Controlled Trial.

    Science.gov (United States)

    Banga, Shreshtha; Datta, Vikram; Rehan, Harmeet Singh; Bhakhri, Bhanu Kiran

    2016-04-01

    Safety of oral sucrose, commonly used procedural analgesic in neonates, is questioned. To evaluate the effect of sucrose analgesia, for repeated painful procedures, on short-term neurobehavioral outcome of preterm neonates. Stable preterm neonates were randomized to receive either sucrose or distilled water orally, for every potentially painful procedure during the first 7 days after enrollment. Neurodevelopmental status at 40 weeks postconceptional age (PCA) measured using the domains of Neurobehavioral Assessment of Preterm Infants scale. A total of 93 newborns were analyzed. The baseline characteristics of the groups were comparable. No statistically significant difference was observed in the assessment at 40 weeks PCA, among the groups. Use of sucrose analgesia, for repeated painful procedures on newborns, does not lead to any significant difference in the short-term neurobehavioral outcome. © The Author [2015]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  3. Research Areas - Clinical Trials

    Science.gov (United States)

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  4. Clinical trial methodology

    National Research Council Canada - National Science Library

    Peace, Karl E; Chen, Ding-Geng

    2011-01-01

    "Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide...

  5. Randomized controlled trial evaluating the temporal effects of high-intensity exercise on learning, short-term and long-term memory, and prospective memory.

    Science.gov (United States)

    Frith, Emily; Sng, Eveleen; Loprinzi, Paul D

    2017-11-01

    The broader purpose of this study was to examine the temporal effects of high-intensity exercise on learning, short-term and long-term retrospective memory and prospective memory. Among a sample of 88 young adult participants, 22 were randomized into one of four different groups: exercise before learning, control group, exercise during learning, and exercise after learning. The retrospective assessments (learning, short-term and long-term memory) were assessed using the Rey Auditory Verbal Learning Test. Long-term memory including a 20-min and 24-hr follow-up assessment. Prospective memory was assessed using a time-based procedure by having participants contact (via phone) the researchers at a follow-up time period. The exercise stimulus included a 15-min bout of progressive maximal exertion treadmill exercise. High-intensity exercise prior to memory encoding (vs. exercise during memory encoding or consolidation) was effective in enhancing long-term memory (for both 20-min and 24-h follow-up assessments). We did not observe a differential temporal effect of high-intensity exercise on short-term memory (immediate post-memory encoding), learning or prospective memory. The timing of high-intensity exercise may play an important role in facilitating long-term memory. © 2017 Federation of European Neuroscience Societies and John Wiley & Sons Ltd.

  6. A Randomized Double-Blind Controlled Trial Comparing Davanloo Intensive Short-Term Dynamic Psychotherapy as Internet-Delivered Vs Treatment as Usual for Medically Unexplained Pain: A 6-Month Pilot Study.

    Science.gov (United States)

    Chavooshi, Behzad; Mohammadkhani, Parvaneh; Dolatshahi, Behrouz

    2016-01-01

    Research has shown that Intensive Short-Term Dynamic Psychotherapy (ISTDP) can effectively decrease pain intensity and improve quality of life in patients with medically unexplained pain. Understanding that not all patients with medically unexplained pain have access to in-person ISTDP, this study aims to investigate the efficacy of an Internet-delivered ISTDP for individuals with medically unexplained pain using Skype in comparison with treatment as usual. In this randomized controlled trial, 100 patients were randomly allocated into Internet-delivered ISTDP (n = 50) and treatment-as- usual (n = 50) groups. Treatment intervention consisted of 16 weekly, hour-long therapy sessions. The primary outcome was perceived pain assessed using the Numeric Pain Rating Scale. The secondary outcome included Depression Anxiety Stress Scale-21, Emotion Regulation Questionnaire, Mindful Attention Awareness Scale, and Quality-of-Life Inventory. Blind assessments were conducted at the baseline, posttreatment, and at a 6-month follow-up. In the intention-to-treat analysis, pain symptoms in the intervention group were significantly reduced (p Skype can significantly improve pain intensity and clinical symptoms of medically unexplained pain. Copyright © 2016 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

  7. Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation: multicentre randomised controlled trial and economic evaluation of antimicrobial- and antiseptic-impregnated urethral catheters (the CATHETER trial).

    Science.gov (United States)

    Pickard, R; Lam, T; Maclennan, G; Starr, K; Kilonzo, M; McPherson, G; Gillies, K; McDonald, A; Walton, K; Buckley, B; Glazener, C; Boachie, C; Burr, J; Norrie, J; Vale, L; Grant, A; N'dow, J

    2012-11-01

    Catheter-associated urinary tract infection (CAUTI) is a major preventable cause of harm for patients in hospital and incurs significant costs for health-care providers such as the UK NHS. Many preventative strategies and measures have been introduced to minimise CAUTI risk, including the use of antimicrobial catheters. However, there is considerable uncertainty regarding their usefulness in terms of reducing symptomatic CAUTI, and whether or not they are cost-effective. Do antimicrobial catheters reduce the rate of symptomatic urinary tract infection (UTI) during short-term hospital use and is their use cost-effective for the UK NHS? A pragmatic multicentre UK randomised controlled trial comparing three catheters as they would be used in the UK NHS: antimicrobial-impregnated (nitrofurazone) and antiseptic-coated (silver alloy) catheters with the standard polytetrafluoroethylene (PTFE)-coated catheters. Economic evaluation used a decision model populated with data from the trial. Sensitivity analysis was used to explore uncertainty. Relevant clinical departments in 24 NHS hospitals throughout the UK. Adults requiring temporary urethral catheterisation for a period of between 1 and 14 days as part of their care, predominantly as a result of elective surgery. Eligible participants were randomised 1 : 1 : 1 to one of three types of urethral catheter in order to make the following pragmatic comparisons: nitrofurazone-impregnated silicone catheter compared with standard PTFE-coated latex catheter; and silver alloy-coated hydrogel latex catheter compared with standard PTFE-coated latex catheter. The primary outcome for clinical effectiveness was the incidence of UTI at any time up to 6 weeks post randomisation. This was defined as any symptom reported during catheterisation, up to 3 days or 1 or 2 weeks post catheter removal or 6 weeks post randomisation combined with a prescription of antibiotics, at any of these times, for presumed symptomatic UTI. The primary economic

  8. Clinical Features, Short-Term Mortality, and Prognostic Risk Factors of Septic Patients Admitted to Internal Medicine Units: Results of an Italian Multicenter Prospective Study.

    Science.gov (United States)

    Mazzone, Antonino; Dentali, Francesco; La Regina, Micaela; Foglia, Emanuela; Gambacorta, Maurizia; Garagiola, Elisabetta; Bonardi, Giorgio; Clerici, Pierangelo; Concia, Ercole; Colombo, Fabrizio; Campanini, Mauro

    2016-01-01

    Only a few studies provided data on the clinical history of sepsis within internal Medicine units. The aim of the study was to assess the short-term mortality and to evaluate the prognostic risk factors in a large cohort of septic patients treated in internal medicine units. Thirty-one internal medicine units participated to the study. Within each participating unit, all admitted patients were screened for the presence of sepsis. A total of 533 patients were included; 78 patients (14.6%, 95%CI 11.9, 18.0%) died during hospitalization; mortality rate was 5.5% (95% CI 3.1, 9.6%) in patients with nonsevere sepsis and 20.1% (95%CI 16.2, 28.8%) in patients with severe sepsis or septic shock. Severe sepsis or septic shock (OR 4.41, 95%CI 1.93, 10.05), immune system weakening (OR 2.10, 95%CI 1.12, 3.94), active solid cancer (OR 2.14, 95% CI 1.16, 3.94), and age (OR 1.03 per year, 95% CI 1.01, 1.06) were significantly associated with an increased mortality risk, whereas blood culture positive for Escherichia coli was significantly associated with a reduced mortality risk (OR 0.46, 95%CI 0.24, 0.88). In-hospital mortality of septic patients treated in internal medicine units appeared similar to the mortality rate obtained in recent studies conducted in the ICU setting.

  9. Traditional Chinese Herbal Patch for Short-Term Management of Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Xuezong Wang

    2012-01-01

    Full Text Available Objective. To assess the short-term efficacy and safety of two kinds of Traditional Chinese herbal patches, Fufang Nanxing Zhitong Gao (FNZG and Shangshi Jietong Gao (SJG, for painful knee osteoarthritis (OA. Methods. Patients were randomly enrolled in a double-blind, placebo-controlled study to receive FNZG (n=60, SJG (n=60, or placebo patch (n=30 for 7 days. Outcome measures included visual analogue scale (VAS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, and Traditional Chinese Medicine Syndrome Questionnaire (TCMSQ subscale. Results. Although there was no significant difference among, three groups in short-term pain management, patients receiving FNZG got significant improvement in symptom of fear of coldness as compared with placebo patch (P=0.029. The most common local adverse events of rash, itching, erythema, and slightly damaged skin were observed in 7% of participants. Conclusions. FNZG may be a useful treatment for symptom of knee OA and merits long-term study in broader populations.

  10. Short-term supervised inpatient physiotherapy exercise protocol improves cardiac autonomic function after coronary artery bypass graft surgery--a randomised controlled trial.

    Science.gov (United States)

    Mendes, Renata Gonçalves; Simões, Rodrigo Polaquini; De Souza Melo Costa, Fernando; Pantoni, Camila Bianca Falasco; Di Thommazo, Luciana; Luzzi, Sérgio; Catai, Aparecida Maria; Arena, Ross; Borghi-Silva, Audrey

    2010-01-01

    Coronary artery bypass grafting (CABG) is accompanied by severe impairment of cardiac autonomous regulation (CAR). This study aimed to determine whether a short-term physiotherapy exercise protocol post-CABG, during inpatient cardiac rehabilitation (CR), might improve CAR. Seventy-four patients eligible for CABG were recruited and randomised into physiotherapy exercise group (EG) or physiotherapy usual care group (UCG). EG patients underwent a short-term supervised inpatient physiotherapy exercise protocol consisting of an early mobilisation with progressive exercises plus usual care (respiratory exercises). UCG only received respiratory exercises. Forty-seven patients (24 EG and 23 UGC) completed the study. Outcome measures of CAR included linear and non-linear measures of heart rate variability (HRV) assessed before discharge. By hospital discharge, EG presented significantly higher parasympathetic HRV values [rMSSD, high frequency (HF), SD1)], global power (STD RR, SD2), non-linear HRV indexes [detrended fluctuation analysis (DFA)alpha1, DFAalpha2, approximate entropy (ApEn)] and mean RR compared to UCG (pexercise protocol during inpatient CR improves CAR at the time of discharge. Thus, exercise-based inpatient CR might be an effective non-pharmacological tool to improve autonomic cardiac tone in patient's post-CABG.

  11. Achievement of Virtual and Real Objects Using a Short-Term Motor Learning Protocol in People with Duchenne Muscular Dystrophy: A Crossover Randomized Controlled Trial.

    Science.gov (United States)

    Massetti, Thais; Fávero, Francis Meire; Menezes, Lilian Del Ciello de; Alvarez, Mayra Priscila Boscolo; Crocetta, Tânia Brusque; Guarnieri, Regiani; Nunes, Fátima L S; Monteiro, Carlos Bandeira de Mello; Silva, Talita Dias da

    2018-04-01

    To evaluate whether people with Duchenne muscular dystrophy (DMD) practicing a task in a virtual environment could improve performance given a similar task in a real environment, as well as distinguishing whether there is transference between performing the practice in virtual environment and then a real environment and vice versa. Twenty-two people with DMD were evaluated and divided into two groups. The goal was to reach out and touch a red cube. Group A began with the real task and had to touch a real object, and Group B began with the virtual task and had to reach a virtual object using the Kinect system. ANOVA showed that all participants decreased the movement time from the first (M = 973 ms) to the last block of acquisition (M = 783 ms) in both virtual and real tasks and motor learning could be inferred by the short-term retention and transfer task (with increasing distance of the target). However, the evaluation of task performance demonstrated that the virtual task provided an inferior performance when compared to the real task in all phases of the study, and there was no effect for sequence. Both virtual and real tasks promoted improvement of performance in the acquisition phase, short-term retention, and transfer. However, there was no transference of learning between environments. In conclusion, it is recommended that the use of virtual environments for individuals with DMD needs to be considered carefully.

  12. Long-term Diet and Biomarker Changes after a Short-term Intervention among Hispanic Breast Cancer Survivors: The ¡Cocinar Para Su Salud! Randomized Controlled Trial.

    Science.gov (United States)

    Greenlee, Heather; Ogden Gaffney, Ann; Aycinena, A Corina; Koch, Pam; Contento, Isobel; Karmally, Wahida; Richardson, John M; Shi, Zaixing; Lim, Emerson; Tsai, Wei-Yann; Santella, Regina M; Blaner, William S; Clugston, Robin D; Cremers, Serge; Pollak, Susan; Sirosh, Iryna; Crew, Katherine D; Maurer, Matthew; Kalinsky, Kevin; Hershman, Dawn L

    2016-11-01

    Among Hispanic breast cancer survivors, we examined the long-term effects of a short-term culturally based dietary intervention on increasing fruits/vegetables (F/V), decreasing fat, and changing biomarkers associated with breast cancer recurrence risk. Spanish-speaking women (n = 70) with a history of stage 0-III breast cancer who completed treatment were randomized to ¡Cocinar Para Su Salud! (n = 34), a culturally based 9-session program (24 hours over 12 weeks, including nutrition education, cooking classes, and food-shopping field trips), or a control group (n = 36, written dietary recommendations for breast cancer survivors). Diet recalls, fasting blood, and anthropometric measures were collected at baseline, 6, and 12 months. We report changes between groups at 12 months in dietary intake and biomarkers using 2-sample Wilcoxon t tests and generalized estimating equation (GEE) models. At 12 months, the intervention group compared with the control group reported higher increases in mean daily F/V servings (total: +2.0 vs. -0.4; P Salud! program was effective at increasing long-term F/V intake in Hispanic breast cancer survivors and changed biomarkers associated with breast cancer recurrence risk. It is possible for short-term behavioral interventions to have long-term effects on behaviors and biomarkers in minority cancer patient populations. Results can inform future study designs. Cancer Epidemiol Biomarkers Prev; 25(11); 1491-502. ©2016 AACR. ©2016 American Association for Cancer Research.

  13. No effect of short-term amino acid supplementation on variables related to skeletal muscle damage in 100 km ultra-runners - a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rosemann Thomas

    2011-04-01

    Full Text Available Abstract Background The purpose of this study was to investigate the effect of short-term supplementation of amino acids before and during a 100 km ultra-marathon on variables of skeletal muscle damage and muscle soreness. We hypothesized that the supplementation of amino acids before and during an ultra-marathon would lead to a reduction in the variables of skeletal muscle damage, a decrease in muscle soreness and an improved performance. Methods Twenty-eight experienced male ultra-runners were divided into two groups, one with amino acid supplementation and the other as a control group. The amino acid group was supplemented a total of 52.5 g of an amino acid concentrate before and during the 100 km ultra-marathon. Pre- and post-race, creatine kinase, urea and myoglobin were determined. At the same time, the athletes were asked for subjective feelings of muscle soreness. Results Race time was not different between the groups when controlled for personal best time in a 100 km ultra-marathon. The increases in creatine kinase, urea and myoglobin were not different in both groups. Subjective feelings of skeletal muscle soreness were not different between the groups. Conclusions We concluded that short-term supplementation of amino acids before and during a 100 km ultra-marathon had no effect on variables of skeletal muscle damage and muscle soreness.

  14. Short term effects of exercise training on exercise capacity and quality of life in patients with pulmonary arterial hypertension: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Gain Kevin

    2011-05-01

    Full Text Available Abstract Background Advances in the understanding and management of pulmonary arterial hypertension have enabled earlier diagnosis and improved prognosis. However, despite best available therapy, symptoms of exertional dyspnoea and fatigue are commonly reported and result in a reduced capacity to perform daily activities and impaired quality of life. Exercise training has demonstrated efficacy in individuals with other respiratory and cardiovascular diseases. Historically, however, exercise training has not been utilised as a form of therapy in pulmonary arterial hypertension due to the perceived risk of sudden cardiac death and the theoretical possibility that exercise would lead to worsening pulmonary vascular haemodynamics and deterioration in right heart function. Now, with the advances in pharmaceutical management, determining the safety and benefits of exercise training in this population has become more relevant. Only three studies of supervised exercise training in pulmonary arterial hypertension have been published. These studies demonstrated improvements in exercise capacity and quality of life, in the absence of adverse events or clinical deterioration. However, these studies have not utilised an outpatient-based, whole body exercise training program, the most common format for exercise programs within Australia. It is uncertain whether this form of training is beneficial and capable of producing sustained benefits in exercise capacity and quality of life in this population. Design/Methods This randomised controlled trial will determine whether a 12 week, outpatient-based, supervised, whole body exercise training program, followed by a home-based exercise program, is safe and improves exercise capacity and quality of life in individuals with pulmonary arterial hypertension. This study aims to recruit 34 subjects who will be randomly allocated to the exercise group (supervised exercise training 3 times a week for 12 weeks, followed by

  15. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... and Public Home » Hepatitis C » Treatment Decisions Viral Hepatitis Menu Menu Viral Hepatitis Viral Hepatitis Home For ... can I find out about participating in a hepatitis C clinical trial? Many trials are being conducted ...

  16. Extracorporeal shockwave therapy versus exercise program in patients with low back pain: short-term results of a randomised controlled trial.

    Science.gov (United States)

    Notarnicola, A; Maccagnano, G; Gallone, M F; Mastromauro, L; Rifino, F; Pesce, V; Covelli, I; Moretti, B

    2018-01-01

    The physiotherapy treatment of low back pain (LBP) with physical stimulation offers different possibilities of application. Until now, the physical therapies used in LBP are laser therapy, ultrasonotherapy and currents. We conducted a clinical trial in order to verify whether shockwave therapy, which is very effective in treating tendinopathies and fracture consolidation delays, leads to clinical and electromyographic improvement in patients affected by LBP. We randomized thirty patients affected by LBP treated with shock waves (shockwave group) or a standard protocol characterized by rehabilitative exercises (control group). At one and three months, the patients treated with shockwave therapy showed clinical improvement measured by VAS scales (p=0.002; p= 0.02), and disability evaluated with Roland scales (p=0.002; p=0.002) and Oswestry (p=0.002; p=0.002). At three months, the patients treated with shock waves, showed a significant improvement in terms of values of amplitude of the sensory nerve conduction velocity (SNCV) of the plantar medialis nerve (left: p=0.007; right: p=0.04), the motor nerve muscular conduction (MNCV) of the deep peroneal nerve (left: p=0.28; right: p=0.01) and recruitment of motor units of finger brevis extensor (left: p = 0.02; right: p=0.006). In the control group, there was a trend to increase the clinical and electromyographic results without statistical significance. The preliminary results suggest a good applicability of shockwave therapy in the treatment of LBP, in accordance with the antiinflammatory, antalgic, decontracting effects and remodeling of the nerve fiber damage verified in previous studies conducted on other pathological models. Future research will allow us to verify the integration of this therapy into a rehabilitation protocol combined with other physical therapies.

  17. Managing clinical trials

    Directory of Open Access Journals (Sweden)

    Kenyon Sara

    2010-07-01

    Full Text Available Abstract Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field. For the past three decades, trialists have invented and reinvented the trial management wheel. We suggest that to improve the successful, timely delivery of important clinical trials for patient benefit, it is time to produce standard trial management guidelines and develop robust methods of evaluation.

  18. Effectiveness of a Web-Based Guided Self-help Intervention for Outpatients With a Depressive Disorder: Short-term Results From a Randomized Controlled Trial.

    Science.gov (United States)

    Kenter, Robin Maria Francisca; Cuijpers, Pim; Beekman, Aartjan; van Straten, Annemieke

    2016-03-31

    Research has convincingly demonstrated that symptoms of depression can be reduced through guided Internet-based interventions. However, most of those studies recruited people form the general population. There is insufficient evidence for the effectiveness when delivered in routine clinical practice in outpatient clinics. The objective of this randomized controlled trial was to study patients with a depressive disorder (as defined by the Diagnostic and Statistical Manual of Disorders, fourth edition), as assessed by trained interviewers with the Composite International Diagnostic Interview, who registered for treatment at an outpatient mental health clinic. We aimed to examine the effectiveness of guided Internet-based self-help before starting face-to-face treatment. We recruited 269 outpatients, aged between 18 and 79 years, from outpatient clinics and randomly allocated them to Internet-based problem solving therapy (n=136), with weekly student support, or to a control condition, who remained on the waitlist with a self-help booklet (control group; n=133). Participants in both conditions were allowed to take up face-to-face treatment at the outpatient clinics afterward. We measured the primary outcome, depressive symptoms, by Center for Epidemiological Studies Depression scale (CES-D). Secondary outcome measures were the Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A), Insomnia Severity Index questionnaire (ISI), and EuroQol visual analog scale (EQ-5D VAS). All outcomes were assessed by telephone at posttest (8 weeks after baseline). Posttest measures were completed by 184 (68.4%) participants. We found a moderate to large within-group effect size for both the intervention (d=0.75) and the control (d=0.69) group. However, the between-group effect size was very small (d=0.07), and regression analysis on posttreatment CES-D scores revealed no significant differences between the groups (b=1.134, 95% CI -2.495 to 4.763). The per-protocol analysis (

  19. Short-term hypertension management in community is associated with long-term risk of stroke and total death in China: A community controlled trial.

    Science.gov (United States)

    Wang, Zengwu; Hao, Guang; Wang, Xin; Wang, Wen; Chen, Weiwei; Zhu, Manlu

    2016-11-01

    It is not fully clear whether the effect of short-term management in community can reduce the long-term risk of stroke OBJECTIVES:: To evaluate whether short-term hypertension management is associated with long-term incidence of stroke and total death in community health centers in China. Community controlled trail. Six community health centers (4 active, 2 control) in China, patients with hypertension. Patients were treated with normally therapy method. Patients were treated oriented by the Guideline for hypertension management. Two centers (Hebei and Zhejiang) from the Hypertension Control in Community (HCC) Project, which was conducted from 2005 to 2008, were randomly selected for this study. Four thousand hypertensive patients from these centers, who were under management for one year in the baseline, were followed up in 2013. The electronic health record system (2005-2008) was used to identify 2000 hypertensive patients, who were not included in HCC but lived in comparable community health center in the same province, as the control group. All baseline and follow-up data were collected using standardized questionnaires for stroke outcomes. Stroke. Of the 6000 participants, 3787 (63.1%) were eligible for analysis. At the time of follow-up, the average BP was kept in the lower level than that in baseline, and the control rate was 59.3%. After propensity-score matching, 110 strokes (2.0% vs 4.6%) and 141 deaths (1.4% vs 3.8%) were noted in the matched intervention and control groups (1078 pairs), respectively. Patients in the intervention group were less likely to experience a stroke or die than those in the control group (hazard ratio [HR] = 0.40, 95% confidence interval [CI]: 0.26-0.62, P stroke in hypertensive patients.

  20. A Short Term Analogue Memory

    DEFF Research Database (Denmark)

    Shah, Peter Jivan

    1992-01-01

    A short term analogue memory is described. It is based on a well-known sample-hold topology in which leakage currents have been minimized partly by circuit design and partly by layout techniques. Measurements on a test chip implemented in a standard 2.4 micron analogue CMOS process show a droop...

  1. Types of Cancer Clinical Trials

    Science.gov (United States)

    Information about the several types of cancer clinical trials, including treatment trials, prevention trials, screening trials, supportive and palliative care trials. Each type of trial is designed to answer different research questions.

  2. Short term benefits for laparoscopic colorectal resection.

    Science.gov (United States)

    Schwenk, W; Haase, O; Neudecker, J; Müller, J M

    2005-07-20

    Colorectal resections are common surgical procedures all over the world. Laparoscopic colorectal surgery is technically feasible in a considerable amount of patients under elective conditions. Several short-term benefits of the laparoscopic approach to colorectal resection (less pain, less morbidity, improved reconvalescence and better quality of life) have been proposed. This review compares laparoscopic and conventional colorectal resection with regards to possible benefits of the laparoscopic method in the short-term postoperative period (up to 3 months post surgery). We searched MEDLINE, EMBASE, CancerLit, and the Cochrane Central Register of Controlled Trials for the years 1991 to 2004. We also handsearched the following journals from 1991 to 2004: British Journal of Surgery, Archives of Surgery, Annals of Surgery, Surgery, World Journal of Surgery, Disease of Colon and Rectum, Surgical Endoscopy, International Journal of Colorectal Disease, Langenbeck's Archives of Surgery, Der Chirurg, Zentralblatt für Chirurgie, Aktuelle Chirurgie/Viszeralchirurgie. Handsearch of abstracts from the following society meetings from 1991 to 2004: American College of Surgeons, American Society of Colorectal Surgeons, Royal Society of Surgeons, British Assocation of Coloproctology, Surgical Association of Endoscopic Surgeons, European Association of Endoscopic Surgeons, Asian Society of Endoscopic Surgeons. All randomised-controlled trial were included regardless of the language of publication. No- or pseudorandomised trials as well as studies that followed patient's preferences towards one of the two interventions were excluded, but listed separately. RCT presented as only an abstract were excluded. Results were extracted from papers by three observers independently on a predefined data sheet. Disagreements were solved by discussion. 'REVMAN 4.2' was used for statistical analysis. Mean differences (95% confidence intervals) were used for analysing continuous variables. If

  3. Fall Preventive Exercise With or Without Behavior Change Support for Community-Dwelling Older Adults: A Randomized Controlled Trial With Short-Term Follow-up.

    Science.gov (United States)

    Arkkukangas, Marina; Söderlund, Anne; Eriksson, Staffan; Johansson, Ann-Christin

    2017-02-27

    In Western countries, falls and fall-related injuries are a well-known threat to health in the aging population. Studies indicate that regular exercise improves strength and balance and can therefore decrease the incidence of falls and fall-related injuries. The challenge, however, is to provide exercise programs that are safe, effective, and attractive to the older population. The aim of this study was to investigate the short-term effect of a home-based exercise program with or without motivational interviewing (MI) compared with standard care on physical performance, fall self-efficacy, balance, activity level, handgrip strength, adherence to the exercise, and fall frequency. A total of 175 older adults participated in this randomized controlled study. They were randomly allocated for the Otago Exercise Program (OEP) (n = 61), OEP combined with MI (n = 58), or a control group (n = 56). The participants' mean age was 83 years. The recruitment period was from October 2012 to May 2015. Measurements of physical performance, fall self-efficacy, balance, activity level, handgrip strength, adherence to the exercise, and fall frequency were done before and 12 weeks after randomization. A total of 161 participants were followed up, and there were no significant differences between groups after a period of 12 weeks of regular exercise. Within the OEP + MI group, physical performance, fall self-efficacy, physical activity level, and handgrip strength improved significantly; likewise, improved physical performance and fall self-efficacy were found in the control group. A corresponding difference did not occur in the OEP group. Adherence to the exercise was generally high in both exercise groups. In the short-term perspective, there were no benefits of an exercise program with or without MI regarding physical performance, fall self-efficacy, activity level, handgrip strength, adherence to the exercise, and fall frequency in comparison to a control group. However, some small

  4. Home noninvasive positive pressure ventilation with built-in software in stable hypercapnic COPD: a short-term prospective, multicenter, randomized, controlled trial.

    Science.gov (United States)

    Zhou, Luqian; Li, Xiaoying; Guan, Lili; Chen, Jianhua; Guo, Bingpeng; Wu, Weiliang; Huo, Yating; Zhou, Ziqing; Liang, Zhenyu; Zhou, Yuqi; Tan, Jie; Chen, Xin; Song, Yuanlin; Chen, Rongchang

    2017-01-01

    The benefits of noninvasive positive pressure ventilation (NPPV) in patients with hypercapnic COPD are controversial. It is presumed that methodology and appropriate use of NIV ventilator might be crucial for the outcomes. With the new built-in software, the performance of NIV can be monitored at home, which can guarantee the compliance and appropriate use. This study investigated effects of home use of NIV in hypercapnia in COPD patients using the NIV ventilator with built-in software for monitoring. The current multicenter prospective, randomized, controlled trial enrolled patients with stable GOLD stages III and IV hypercapnic COPD. Patients were randomly assigned via a computer-generated randomization sequence, with a block size of four patients, to continue optimized treatment (control group) or to receive additional NPPV (intervention group) for 3 months. The primary outcome was arterial carbon dioxide pressure (PaCO 2 ). Data were derived from built-in software and analyzed every 4 weeks. Analysis was carried out with the intention to treat. This study is registered with ClinicalTrials.gov, number NCT02499718. Patients were recruited from 20 respiratory units in China from October 1, 2015, and recruitment was terminated with a record of the vital statistics on May 31, 2016. A total of 115 patients were randomly assigned to the NPPV group (n=57) or the control group (n=58). Patients complied well with NPPV therapy (mean [± standard deviation] day use 5.6±1.4 h). The mean estimation of leaks was 37.99±13.71 L/min. The changes in PaCO 2 (-10.41±0.97 vs -4.32±0.68 mmHg, P =0.03) and 6-min walk distance (6MWD) (38.2% vs 18.2%, P =0.02) were statistically significant in the NPPV group versus the control group. COPD assessment test (CAT) showed a positive trend ( P =0.06) in favor of the NPPV group. Pulmonary function and dyspnea were not different between groups. Ventilators equipped with built-in software provided methodology for monitoring NIV use at home

  5. Excess sudden cardiac deaths after short-term clarithromycin administration in the CLARICOR trial: why is this so, and why are statins protective?

    DEFF Research Database (Denmark)

    Winkel, Per; Hilden, Jørgen; Fischer Hansen, Jørgen

    2011-01-01

    To elucidate potential mechanisms for the clarithromycin-induced excess mortality observed in the CLARICOR trial during 2.6 year follow-up of patients with stable coronary artery disease.......To elucidate potential mechanisms for the clarithromycin-induced excess mortality observed in the CLARICOR trial during 2.6 year follow-up of patients with stable coronary artery disease....

  6. [Principles of controlled clinical trials].

    Science.gov (United States)

    Martini, P

    1962-01-01

    The recovery of the patient should be facilitated as the result of therapeutic research. The basic rule for every therapeutic-clinical trial mist involve a comparison of therapeutic approaches. In acute conditions, such as acute infectious diseases, infarcts, etc., comparisons should be made between two or more groups: the collective therapeutic comparison = the between patients trial. The formation of groups, to be compared one with the other can be justified only if one is reasonably sure that a pathogenic condition indeed exists. In chronic diseases, which extend essentially unchanged over a lengthy period but are nevertheless reversible, therapeutic comparisons may be made between two or more time intervals within the course of the disease in the same individual. This type of therapeutic trial rests primarily upon a (refined!) type of specious reasoning and secondarily, upon modified statistics: the individual therapeutic comparison = the within patient trial. The collective therapeutic comparison, on the one hand, and the individual therapeutic comparison on the other, overlap somewhat in scope. The immediate therapeutic effect is not always an indication of its true value, which may become evident only upon long-term treatment. The short-term trials of therapeutic regimens in an individual must, therefore, be frequently supplemented by long-term trials which can only be carried out by comparing two groups. For many clinical investigations, therefore, the joint efforts of numerous hospitals are absolutely necessary. The second basic rule of therapeutic research is the elimination of secondary causes. The difficulties introduced by these secondary considerations are far greater in therapeutic trials carried out on ambulatory patients than has been hitherto realized. In order to remove subjective secondary causes, the author demanded, in 1931, the use of hidden or illusory media (placebos, dummies) that is, unconscious causative agents. The double blind

  7. Clinical trials of homoeopathy.

    Science.gov (United States)

    Kleijnen, J; Knipschild, P; ter Riet, G

    1991-01-01

    OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURES--Results of the trials with the best methodological quality. Trials of classical homoeopathy and several modern varieties were considered separately. RESULTS--In 14 trials some form of classical homoeopathy was tested and in 58 trials the same single homoeopathic treatment was given to patients with comparable conventional diagnosis. Combinations of several homoeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homoeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homoeopathy. CONCLUSIONS--At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials. PMID:1825800

  8. An Internet- and mobile-based tailored intervention to enhance maintenance of physical activity after cardiac rehabilitation: short-term results of a randomized controlled trial.

    Science.gov (United States)

    Antypas, Konstantinos; Wangberg, Silje C

    2014-03-11

    (Kolmogorov-Smirnov Z=0.823, P=.38, r=.17). At 3 months after discharge, the tailored intervention group (n=7) had a significantly higher median level of overall physical activity (median 5613.0, IQR 2828.0) than the control group (n=12, median 1356.0, IQR 2937.0; Kolmogorov-Smirnov Z=1.397, P=.02, r=.33). The median adherence was 45.0 (95% CI 0.0-169.8) days for the tailored group and 111.0 (95% CI 45.1-176.9) days for the control group; however, the difference was not significant (P=.39). There were no statistically significant differences between the 2 groups in stage of change, self-efficacy, social support, perceived tailoring, anxiety, or depression. Because of the small sample size and the high attrition rate at the follow-up visits, we cannot make conclusions regarding the efficacy of our approach, but the results indicate that the tailored version of the intervention may have contributed to the long-term higher physical activity maintained after cardiac rehabilitation by participants receiving the tailored intervention compared with those receiving the nontailored intervention. ClinicalTrials.gov: NCT01223170; http://clinicaltrials.gov/show/NCT01223170 (Archived by WebCite at http://www.webcitation.org/6Nch4ldcL).

  9. Fundamentals of clinical trials

    CERN Document Server

    Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

    2015-01-01

    This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

  10. Prophylactic Mesh Placement During Formation of an End-colostomy Reduces the Rate of Parastomal Hernia: Short-term Results of the Dutch PREVENT-trial

    NARCIS (Netherlands)

    Brandsma, H.T.; Hansson, B.M.; Aufenacker, T.J.; Geldere, D. van; Lammeren, F.M. van; Mahabier, C.; Makai, P.; Steenvoorde, P.; Vries Reilingh, T.S. de; Wiezer, M.J.; Wilt, J.H.W. de; Bleichrodt, R.P.; Rosman, C.

    2017-01-01

    OBJECTIVE: The aim of this study was to investigate the incidence of parastomal hernias (PSHs) after end-colostomy formation using a polypropylene mesh in a randomized controlled trial versus conventional colostomy formation. BACKGROUND: A PSH is the most frequent complication after stoma formation.

  11. Outcome of transcutaneous electrical nerve stimulation in chronic pain: short-term results of a double-blind, randomised, placebo-controlled trial.

    NARCIS (Netherlands)

    Oosterhof, J.; Boo, T.M. de; Oostendorp, R.A.B.; Wilder-Smith, O.H.G.; Crul, B.J.P.

    2006-01-01

    The aim of this study was to test the efficacy of shortterm transcutaneous electrical nerve stimulation (TENS) treatment in chronic pain with respect to pain intensity and patients' satisfaction with treatment results. We therefore performed a randomised controlled trial comparing TENS and sham

  12. Assessment of the short-term safety and tolerability of a quantified 80 % ethanol extract from the stem bark of Nauclea pobeguinii (PR 259 CT1) in healthy volunteers: a clinical phase I study.

    Science.gov (United States)

    Mesia, Kahunu; Cimanga, Kanyanga; Tona, Lutete; Mampunza, Ma Miezi; Ntamabyaliro, Nsengi; Muanda, Tsobo; Muyembe, Tamfum; Totté, Jozef; Mets, Tony; Pieters, Luc; Vlietinck, Arnold

    2011-01-01

    The aim of this study was to evaluate the short-term safety and tolerability of an antimalarial herbal medicinal product (PR 259 CT1) consisting of a quantified 80 % ethanol extract from the stem bark of Nauclea pobeguinii when given orally to healthy adult male volunteers. The amount of the major alkaloid strictosamide in the extract was determined by a validated HPLC method and was shown to be 5.6 %. The herbal preparation was formulated in a gelatine capsule form containing 500 mg of PCR 259 CT1. A sample of 15 healthy male volunteers, selected using the Lot Quality Assurance of Sampling (LQAS) method, was eligible for inclusion after fulfillment of the inclusion criteria and clinical examination by a physician. The volunteers were treated in an outpatient clinic with a drug regimen of two 500 mg capsules three times daily (each eight hours) for seven days, during meals. Safety and tolerability were monitored clinically, haematologically, biochemically and by electrocardiographic (ECG) examination at days 0, 1, 3, 7 and 14. Adverse effects were recorded by self-reporting of the participants or by detection of abnormalities in clinical examinations by a physician. The oral administration of PR 259 CT1 at high doses of 2 × 500 mg/capsule/day for 7 days was found to induce no significant changes in the concentration levels of all investigated haematological, biochemical, electrocardiogram and vital sign parameters and physical characteristics after 14 days of treatment compared to those seen in the baseline data. The concentration levels of all evaluated parameters were within the normal limits as reported in the literature. All adverse events noted were mild and self-resolving including increase of appetite (33 %), headache (20 %) and nausea (20 %). Other minor side effects were insomnia, somnolence and asthenia (7 %). Thus, PR 259 CT1 presented a significant safety and tolerability in healthy volunteers to allow its further development by starting a phase II

  13. ClinicalTrials.gov

    Data.gov (United States)

    U.S. Department of Health & Human Services — Provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases...

  14. Cancer clinical trials

    International Nuclear Information System (INIS)

    Scheurlen, A.; Kay, R.; Baum, M.

    1988-01-01

    This book contains the proceedings on Cancer clinical trials: A critical appraisal. Topics covered include: Scientific fundamentals; Heterogeneous treatment effects; On combining information: Historical controls, overviews, and comprehensive cohort studies; and assessment of quality of life

  15. Effects of short-term isokinetic training with reciprocal knee extensors agonist and antagonist muscle actions: A controlled and randomized trial

    Directory of Open Access Journals (Sweden)

    Rafael Cunha

    2013-04-01

    Full Text Available BACKGROUND: Previous studies have shown that preloading an antagonist muscle may increase the acute agonist neuromuscular performance. In addition, studies have suggested that very short-term resistance exercise (RE programs may also be useful to increase strength and muscular performance. OBJECTIVES: To evaluate the effects of three days of RE using a reciprocal action method on the muscular performance of healthy men and to compare these effects with those of a traditional RE group. METHOD: Thirty-three men (21.1 ± 2.3 years were randomly assigned to one of three groups: 1 reciprocal (REC; knee flexion immediately followed by a knee extension exercise; 2 traditional (TRA; non-preload; a concentric knee extension exercise; and 3 control (CON; no exercise. The REC and TRA subjects performed four sets of 10 repetitions at 60º/s with one minute of rest. The pre- and post-RE tests included two sets of four maximal concentric repetitions at 60º/s and 180º/s. A 3x2 ANOVA with Tukey post-hoc was used to analyze the differences in peak torque (PT, rating of acceleration development (RAD and time to peak torque (TIMEtorque. RESULTS: A significant PT increase was found for REC and TRA (p CONTEXTUALIZAÇÃO: Estudos demonstraram que a pré-ativação de músculos antagonistas pode aumentar o desempenho neuromuscular agonista. Além disso, estudos sugerem que programas de exercício resistido (ER de curta duração podem ser úteis para aumentar a força muscular e o desempenho. OBJETIVOS: Avaliar os efeitos de três sessões de ER por meio do método de ações recíprocas no desempenho muscular de homens sadios e comparar com um grupo de ER tradicional. MÉTODO: Trinta e três homens (21,1 ± 2,3 anos foram randomicamente alocados em três grupos: Recíproco (REC: uma repetição de flexão do joelho imediatamente seguida por uma de extensão do joelho; Tradicional (TRA: exercício concêntrico de extensão do joelho e Controle (CON: não realizaram

  16. Falsificationism and clinical trials.

    Science.gov (United States)

    Senn, S J

    1991-11-01

    The relevance of the philosophy of Sir Karl Popper to the planning, conduct and analysis of clinical trials is examined. It is shown that blinding and randomization can only be regarded as valuable for the purpose of refuting universal hypotheses. The purpose of inclusion criteria is also examined. It is concluded that a misplaced belief in induction is responsible for many false notions regarding clinical trials.

  17. Short-term role of the dietary total antioxidant capacity in two hypocaloric regimes on obese with metabolic syndrome symptoms: the RESMENA randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lopez-Legarrea Patricia

    2013-02-01

    Full Text Available Abstract Background Dietary strategies seem to be the most prescribed therapy in order to counteract obesity regarding not only calorie restriction, but also bioactive ingredients and the composition of the consumed foods. Dietary total antioxidant capacity (TAC is gaining importance in order to assess the quality of the diet. Methods Ninety-six obese adults presenting metabolic syndrome (MetS symptoms completed an 8-week intervention trial to evaluate the effects of a novel dietary program with changes in the nutrient distribution and meal frequency and to compare it with a dietary pattern based on the American Heart Association (AHA guidelines. Anthropometric and biochemical parameters were assessed at baseline and at the endpoint of the study, in addition to 48-hours food dietary records. Results Both diets equally (p > 0.05 improved MetS manifestations. Dietary TAC was the component which showed the major influence on body weight (p = 0.034, body mass index (p = 0.026, waist circumference (p = 0.083 and fat mass (p = 0.015 reductions. Transaminases (ALT and AST levels (p = 0.062 and p = 0.004, respectively were associated with lower TAC values. Conclusion RESMENA diet was as effective as AHA pattern for reducing MetS features. Dietary TAC was the most contributing factor involved in body weight and obesity related markers reduction. Trial registration http://www.clinicaltrials.gov; NCT01087086

  18. Fixed Full Arches Supported by Tapered Implants with Knife-Edge Thread Design and Nanostructured, Calcium-Incorporated Surface: A Short-Term Prospective Clinical Study

    Directory of Open Access Journals (Sweden)

    Soheil Bechara

    2017-01-01

    Full Text Available Purpose. To evaluate implant survival, peri-implant bone loss, and complications affecting fixed full-arch (FFA restorations supported by implants with a knife-edge thread design and nanostructured, calcium-incorporated surface. Methods. Between January 2013 and December 2015, all patients referred for implant-supported FFA restorations were considered for enrollment in this study. All patients received implants with a knife-edge thread design and nanostructured calcium-incorporated surface (Anyridge®, Megagen, South Korea were restored with FFA restorations and enrolled in a recall program. The final outcomes were implant survival, peri-implant bone loss, biologic/prosthetic complications, and “complication-free” survival of restorations. Results. Twenty-four patients were selected. Overall, 215 implants were inserted (130 maxilla, 85 mandible, 144 in extraction sockets and 71 in healed ridges. Thirty-six FFAs were delivered (21 maxilla, 15 mandible: 27 were immediately loaded and 9 were conventionally loaded. The follow-up ranged from 1 to 3 years. Two fixtures failed, yielding an implant survival rate of 95.9% (patient-based. A few complications were registered, for a “complication-free” survival of restorations of 88.9%. Conclusions. FFA restorations supported by implants with a knife-edge thread design and nanostructured, calcium-incorporated surface are successful in the short term, with high survival and low complication rates; long-term studies are needed to confirm these outcomes.

  19. Short-term treatment outcomes of children starting antiretroviral ...

    African Journals Online (AJOL)

    Short-term treatment outcomes of children starting antiretroviral therapy in the intensive care unit, general medical wards and outpatient HIV clinics at Red Cross War Memorial Children's Hospital, Cape Town, South Africa: A retrospective cohort study.

  20. Conducting clinical trials in Singapore.

    Science.gov (United States)

    Woo, K T

    1999-04-01

    All clinical trials in Singapore will now have to conform to the Medicines (Clinical Trials) Amended Regulations 1998 and the Singapore Good Clinical Practice (GCP) Guidelines 1998. The Medical Clinical Research Committee (MCRC) has been established to oversee the conduct of clinical drug trials in Singapore and together with the legislations in place, these will ensure that clinical trials conducted in Singapore are properly controlled and the well-being of trial subjects are safe guarded. All clinical drug trials require a Clinical Trial Certificate from the MCRC before the trial can proceed. The hospital ethics committee (EC) vets the application for a trial certificate before it is sent to MCRC. The drug company sponsoring the trial has to indemnify the trial investigators and the hospital for negligence arising from the trial. The MCRC, apart from ensuring the safety of trial subjects, has to provide continuing review of the clinical trial and monitors adverse events in the course of the trial. The EC will conduct continuing review of clinical trials. When a non-drug clinical trial is carried out, the EC will ensure that the proposed protocol addresses ethical concerns and meets regulatory requirements for such trials. There is great potential for pharmaceutical Research & Development (R&D) in Singapore. We must develop our skills and infrastructure in clinical trials to enable Singapore to be a regional hub for R&D of drugs in Asia.

  1. Efficacy of short-term versus long-term chest tube drainage following talc slurry pleurodesis in patients with malignant pleural effusions: a randomised trial.

    Science.gov (United States)

    Goodman, Anna; Davies, Christopher W H

    2006-10-01

    Talc pleurodesis is commonly used in the palliative treatment of malignant pleural effusions but the shortest and most effective regime has not been determined. In particular, it is not clear when the intercostal drain should be removed following the insertion of sclerosant. We conducted a single-centre, randomised, open trial of drain removal at 24 h versus 72 h following talc slurry pleurodesis. The primary outcome measure was success of pleurodesis (no recurrence of effusion on chest radiograph at 1-month follow-up) and secondary outcome measures included length of hospital stay and mortality. We found no difference between recurrence of pleural effusion in those randomised to drain removal at 24 h and those randomised to drain removal at 72 h (p>0.5). However, length of stay was significantly reduced when the chest drain was removed at 24 h (4 days versus 8 days; p<0.01). Mortality did not differ between the two groups. We conclude that this shorter pleurodesis regime is safe and effective.

  2. Peri-apatite coating decreases uncemented tibial component migration: long-term RSA results of a randomized controlled trial and limitations of short-term results.

    Science.gov (United States)

    Van Hamersveld, Koen T; Marang-Van De Mheen, Perla J; Nelissen, Rob G H H; Toksvig-Larsen, Sören

    2018-05-09

    Background and purpose - Biological fixation of uncemented knee prostheses can be improved by applying hydroxyapatite coating around the porous surface via a solution deposition technique called Peri-Apatite (PA). The 2-year results of a randomized controlled trial, evaluating the effect of PA, revealed several components with continuous migration in the second postoperative year, particularly in the uncoated group. To evaluate whether absence of early stabilization is diagnostic of loosening, we now present long-term follow-up results. Patients and methods - 60 patients were randomized to PA-coated or uncoated (porous only) total knee arthroplasty of which 58 were evaluated with radiostereometric analysis (RSA) performed at baseline, at 3 months postoperatively and at 1, 2, 5, 7, and 10 years. A linear mixed-effects model was used to analyze the repeated measurements. Results - PA-coated components had a statistically significantly lower mean migration at 10 years of 0.94 mm (95% CI 0.72-1.2) compared with the uncoated group showing a mean migration of 1.72 mm (95% CI 1.4-2.1). Continuous migration in the second postoperative year was seen in 7 uncoated components and in 1 PA-coated component. All of these implants stabilized after 2 years except for 2 uncoated components. Interpretation - Peri-apatite enhances stabilization of uncemented components. The number of components that stabilized after 2 years emphasizes the importance of longer follow-up to determine full stabilization and risk of loosening in uncemented components with biphasic migration profiles.

  3. Absence of gender disparity in short-term clinical outcomes in patients with acute ST-segment elevation myocardial infarction undergoing sirolimus-eluting stent based primary coronary intervention: a report from Shanghai Acute Coronary Event (SACE) Registry.

    Science.gov (United States)

    Zhang, Qi; Qiu, Jian-Ping; Zhang, Rui-Yan; Li, Yi-Gang; He, Ben; Jin, Hui-Gen; Zhang, Jun-Feng; Wang, Xiao-Long; Jiang, Li; Liao, Min-Lei; Hu, Jian; Shen, Wei-Feng

    2010-04-05

    Randomized, controlled trials have demonstrated the superiority of sirolimus-eluting stent (SES) implantation during primary percutaneous coronary intervention (PCI), as opposed to bare-metal stents, in patients with ST-elevation myocardial infarction (STEMI). This study aimed to test the hypothesis that clinical benefits of SES treatment were independent of gender in this setting. A total of 2042 patients with STEMI undergoing SES-based primary PCI were prospectively enrolled into Shanghai Acute Coronary Event (SACE) registry (1574 men and 468 women). Baseline demographics, angiographic and PCI features, and in-hospital and 30-day major adverse cardiac events (MACE) were analyzed as a function of gender. Compared with men, women were older and more frequently had hypertension, diabetes, and hypercholesterolemia. Use of platelet glycoprotein IIb/IIIa receptor inhibitor (GPI, 65.5% vs. 62.2%, P = 0.10) and procedural success rate (95.0% vs. 94.2%, P = 0.52) were similar in both genders. In-hospital death and MACE occurred in 3.8% and 7.6%, and 4.5% and 8.1% in the male and female patients, respectively (all P > 0.05). At 30-day follow-up, survival (94.3% vs. 93.8%, P = 0.66) and MACE-free survival (90.2% vs. 89.3%, P = 0.52) did not significantly differ between men and women. After adjustment for differences in patient demographics, angiographic and procedural features, there were no significant difference in either in-hospital (OR = 0.77, 95%CI of 0.48 to 1.22, P = 0.30) or 30-day mortality (OR = 1.28, 95%CI of 0.73 to 2.23, P = 0.38) between women and men. Despite more advanced age and clustering of risk factors in women, female patients with STEMI treated by SES-based primary PCI had similar in-hospital and short-term clinical outcomes as their male counterparts.

  4. The short-term safety and efficacy of fluoxetine in depressed adolescents with alcohol and cannabis use disorders: a pilot randomized placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Lingler Jacqui

    2009-03-01

    Full Text Available Abstract Background The objective of this study was to examine whether fluoxetine was superior to placebo in the acute amelioration of depressive symptomatology in adolescents with depressive illness and a comorbid substance use disorder. Methods Eligible subjects ages 12–17 years with either a current major depressive disorder (MDD or a depressive disorder that were also suffering from a comorbid substance-related disorder were randomized to receive either fluoxetine or placebo in this single site, 8-week double-blind, placebo-controlled study. The primary outcome analysis was a random effects mixed model for repeated measurements of Children's Depression Rating Scale-Revised (CDRS-R scores compared between treatment groups across time. Results An interim analysis was performed after 34 patients were randomized. Based on the results of a futility analysis, study enrollment was halted. Twenty-nine males and 5 females were randomized to receive fluoxetine (n = 18 or placebo (n = 16. Their mean age was 16.5 (1.1 years. Overall, patients who received fluoxetine and placebo had a reduction in CDRS-R scores. However, there was no significant difference in mean change in CDRS-R total score in those subjects treated with fluoxetine and those who received placebo (treatment difference = 0.19, S.E. = 0.58, F = 0.14, p = .74. Furthermore, there was not a significant difference in rates of positive urine drug toxicology results between treatment groups at any post-randomization visit (F = 0.22, df = 1, p = 0.65. The main limitation of this study is its modest sample size and resulting low statistical power. Other significant limitations to this study include, but are not limited to, the brevity of the trial, high placebo response rate, limited dose range of fluoxetine, and the inclusion of youth who met criteria for depressive disorders other than MDD. Conclusion Fluoxetine was not superior to placebo in alleviating depressive symptoms or in decreasing

  5. Onboard Short Term Plan Viewer

    Science.gov (United States)

    Hall, Tim; LeBlanc, Troy; Ulman, Brian; McDonald, Aaron; Gramm, Paul; Chang, Li-Min; Keerthi, Suman; Kivlovitz, Dov; Hadlock, Jason

    2011-01-01

    Onboard Short Term Plan Viewer (OSTPV) is a computer program for electronic display of mission plans and timelines, both aboard the International Space Station (ISS) and in ISS ground control stations located in several countries. OSTPV was specifically designed both (1) for use within the limited ISS computing environment and (2) to be compatible with computers used in ground control stations. OSTPV supplants a prior system in which, aboard the ISS, timelines were printed on paper and incorporated into files that also contained other paper documents. Hence, the introduction of OSTPV has both reduced the consumption of resources and saved time in updating plans and timelines. OSTPV accepts, as input, the mission timeline output of a legacy, print-oriented, UNIX-based program called "Consolidated Planning System" and converts the timeline information for display in an interactive, dynamic, Windows Web-based graphical user interface that is used by both the ISS crew and ground control teams in real time. OSTPV enables the ISS crew to electronically indicate execution of timeline steps, launch electronic procedures, and efficiently report to ground control teams on the statuses of ISS activities, all by use of laptop computers aboard the ISS.

  6. The Short-Term Effects of Transcranial Direct Current Stimulation on Electroencephalography in Children with Autism: A Randomized Crossover Controlled Trial

    Directory of Open Access Journals (Sweden)

    Anuwat Amatachaya

    2015-01-01

    Full Text Available Abnormal synaptic maturation and connectivity are possible etiologies of autism. Previous studies showed significantly less alpha activity in autism than normal children. Therefore, we studied the effects of anodal tDCS on peak alpha frequency (PAF related to autism treatment evaluation checklist (ATEC. Twenty male children with autism were randomly assigned in a crossover design to receive a single session of both active and sham tDCS stimulation (11 mA over F3 (left dorsolateral prefrontal cortex. Pre- to postsession changes in a measure of cortical activity impacted by tDCS (PAF and ATEC were compared between groups. We also examined the associations between pre- and postsession changes in the PAF and ATEC. The results show significant pre- to postsession improvements in two domains of ATEC (social and health/behavior domains following active tDCS, relative to sham treatment. PAF also significantly increased at the stimulation site, and an increase in PAF was significantly associated with improvements in the two domains of ATEC impacted by tDCS. The findings suggest that a single session of anodal tDCS over the F3 may have clinical benefits in children with autism and that those benefits may be related to an increase in PAF.

  7. Effect of mindfulness meditation on short-term weight loss and eating behaviors in overweight and obese adults: A randomized controlled trial.

    Science.gov (United States)

    Spadaro, Kathleen C; Davis, Kelliann K; Sereika, Susan M; Gibbs, Bethany B; Jakicic, John M; Cohen, Susan M

    2017-12-05

    Background There is a significant health crisis with rates of obesity continuing to increase despite research and clinical standard behavioral weight loss programs (SBWP). Mindfulness meditation (MM), with demonstrated benefits on physical, psychological health, and self-regulation behaviors was explored with SBWP. Methods Forty-six adults (BMI=32.5±3.7 kg/m2; age=45.2±8.2 years, 87 % female, 21.7 % African American) were randomly assigned to a 6-month SBWP only (n=24) or SBWP+MM (n=22) at a university-based physical activity and weight management research center in a northeastern US city. Participants were instructed to decrease intake (1200-1500 kcal/day), increase physical activity (300 min/wk), and attend weekly SBWP or SBWP+MM sessions. SBWP+MM had the same SBWP lessons with addition of focused MM training. Outcome measures collected at 0, 3, and 6 months included: weight, Block Food Frequency Questionnaire, Eating Behavior Inventory, Eating Inventory and Paffenbarger Physical Activity Questionnaire. Data were analyzed using linear mixed modeling for efficacy analysis of weight (primary) and eating, exercise and mindfulness (secondary outcomes). Results Retention rate was 76.1 % (n=35). A significant group by time interaction (p=0.03) was found for weight, with weight loss favoring SBWP+MM (-6.9 kg+2.9) over SBWP (-4.1 kg+2.8). Eating behaviors (p=0.02) and dietary restraint (p=0.02) improved significantly in SBWP+MM, compared to SBWP. MM enhanced weight loss by 2.8 kg potentially through greater improvements in eating behaviors and dietary restraint. Conclusions These findings support further study into the use of MM strategies with overweight and obese adults. The use of this low-cost, portable strategy with standard behavioral interventions could improve weight management outcomes.

  8. Is the adjuvant albendazole treatment really needed with PAIR in the management of liver hydatid cysts? A prospective, randomized trial with short-term follow-up results.

    Science.gov (United States)

    Akhan, Okan; Yildiz, Adalet Elcin; Akinci, Devrim; Yildiz, Baris Dogu; Ciftci, Turkmen

    2014-12-01

    The purpose of this study was to determine the safety and efficacy of adjuvant albendazole medication in percutaneous liver hydatid cyst treatment with puncture, aspiration, injection, and reaspiration (PAIR) method. Between November 2007 and May 2011, total of 39 patients with newly diagnosed liver hydatid cyst (total of 77 cysts) were prospectively randomized and enrolled in 3 groups. In the first group, cysts (n = 14) were treated with PAIR without albendazole. In the second (n = 16) and third groups (n = 47), cysts were treated with PAIR with albendazole 1 week before and 1 month after the procedure, with albendazole 1 week before and 3 months after the procedure respectively. Technical and clinical success rates were 100 and 96.1% respectively. In 3 of 77 cysts (3.9%), findings of recurrence were detected on US imaging. All recurrent cysts were in group 1 and recurrence rates in this group were statistically different from cysts of second and third groups (p = 0.005). Side effects of albendazole were detected in 7 of 29 patients (24.1%), and no statistically significant difference was observed between the second (15.3%) and third (38.4%) groups (p = 0.378). Use of albendazole medication as an adjuvant to percutaneous treatment of liver hydatid cyst decreases the recurrence rate. Although there is no statistically significant difference between groups 2 and 3 in terms of efficacy and recurrence rate, patients in group 3 had a higher rate of side effect. Therefore, we conclude that albendazole treatment 1 week before and 1 month after PAIR treatment is sufficient to reduce/prevent recurrences.

  9. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Kraus, V B; Blanco, F J; Englund, M

    2015-01-01

    The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from...

  10. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    McAlindon, T. E.; Driban, J. B.; Henrotin, Y.

    2015-01-01

    The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct...

  11. Narcissism and the Strategic Pursuit of Short-Term Mating

    DEFF Research Database (Denmark)

    Schmitt, David P.; Alcalay, Lidia; Allik, Jüri

    2017-01-01

    Previous studies have documented links between sub-clinical narcissism and the active pursuit of short-term mating strategies (e.g., unrestricted sociosexuality, marital infidelity, mate poaching). Nearly all of these investigations have relied solely on samples from Western cultures. In the curr...... limitations of these cross-culturally universal findings and presents suggestions for future research into revealing the precise psychological features of narcissism that facilitate the strategic pursuit of short-term mating....

  12. Ethics of clinical trials.

    Science.gov (United States)

    Palter, S F

    1996-05-01

    The modern clinical trial is a form of human experimentation. There is a long history of disregard for individual rights of the patient in this context, and special attention must be paid to ethical guidelines for these studies. Clinical trials differ in basic ways from clinical practice. Foremost is the introduction of outside interests, beyond those of the patient's health, into the doctor-patient therapeutic alliance. Steps must be taken to protect the interests of the patient when such outside influence exists. Kantian moral theory and the Hippocratic oath dictate that the physician must respect the individual patient's rights and hold such interests paramount. These principles are the basis for informed consent. Randomization of patients is justified when a condition of equipoise exists. The changing nature of health care delivery in the United States introduces new outside interests into the doctor-patient relationship.

  13. A Low-Intensity Mobile Health Intervention With and Without Health Counseling for Persons With Type 2 Diabetes, Part 1: Baseline and Short-Term Results From a Randomized Controlled Trial in the Norwegian Part of RENEWING HEALTH.

    Science.gov (United States)

    Torbjørnsen, Astrid; Jenum, Anne Karen; Småstuen, Milada Cvancarova; Arsand, Eirik; Holmen, Heidi; Wahl, Astrid Klopstad; Ribu, Lis

    2014-12-11

    Self-management support for people with type 2 diabetes is essential in diabetes care. Thus, mobile health technology with or without low-intensity theory-based health counseling could become an important tool for promoting self-management. The aim was to evaluate whether the introduction of technology-supported self-management using the Few Touch Application (FTA) diabetes diary with or without health counseling improved glycated hemoglobin (HbA1c) levels, self-management, behavioral change, and health-related quality of life, and to describe the sociodemographic, clinical, and lifestyle characteristics of the participants after 4 months. A 3-armed randomized controlled trial was conducted in Norway during 2011-2013. In the 2 intervention groups, participants were given a mobile phone for 1 year, which provided access to the FTA diary, a self-help tool that recorded 5 elements: blood glucose, food habits, physical activity, personal goal setting, and a look-up system for diabetes information. One of the intervention groups was also offered theory-based health counseling with a specialist diabetes nurse by telephone for 4 months from baseline. Both intervention groups and the control group were provided usual care according to the national guidelines. Adults with type 2 diabetes and HbA1c ≥7.1% were included (N=151). There were 3 assessment points: baseline, 4 months, and 1 year. We report the short-term findings after 4 months. HbA1c was the primary outcome and the secondary outcomes were self-management (Health Education Impact Questionnaire, heiQ), behavioral change (diet and physical activity), and health-related quality of life (SF-36 questionnaire). The data were analyzed using univariate methods (ANOVA), multivariate linear, and logistic regression. Data were analyzed from 124 individuals (attrition rate was 18%). The groups were well balanced at baseline. There were no differences in HbA1c between groups after 4 months, but there was a decline in all

  14. The association of clinical and microbiologic parameters with histologic observations in relatively healthy peri-implant conditions- a preliminary short-term in vivo study

    NARCIS (Netherlands)

    Brakel, R. van; Meijer, G.J.; Putter, C. de; Verhoeven, J.W.; Jansen, J.A.; Cune, M.S.

    2014-01-01

    PURPOSE: To determine whether clinical findings-bleeding on probing, pocket depth, recession, and bacterial sampling-correlate with histologic outcomes in relatively healthy peri-implant soft tissues in people. MATERIALS AND METHODS: In this cross-sectional study, a convenience sample of 20

  15. Exogenous Attention Influences Visual Short-Term Memory in Infants

    Science.gov (United States)

    Ross-Sheehy, Shannon; Oakes, Lisa M.; Luck, Steven J.

    2011-01-01

    Two experiments examined the hypothesis that developing visual attentional mechanisms influence infants' Visual Short-Term Memory (VSTM) in the context of multiple items. Five- and 10-month-old infants (N = 76) received a change detection task in which arrays of three differently colored squares appeared and disappeared. On each trial one square…

  16. Proactive Interference in Short-Term Recognition and Recall Memory

    Science.gov (United States)

    Dillon, Richard F.; Petrusic, William M.

    1972-01-01

    Purpose of study was to (a) compare the rate of increase of proactive interference over the first few trials under recall and recognition memory test conditions, (2) determine the effects of two types of distractors on short-term recognition, and (3) test memory after proactive interference had reached a stable level under each of three test…

  17. Elevated levels of endothelial cell-derived microparticles following short-term withdrawal of continuous positive airway pressure in patients with obstructive sleep apnea: data from a randomized controlled trial.

    Science.gov (United States)

    Ayers, Lisa; Stoewhas, Anne-Christin; Ferry, Berne; Stradling, John; Kohler, Malcolm

    2013-01-01

    Obstructive sleep apnea has been associated with impaired endothelial function; however, the mechanisms underlying this association are not completely understood. Cell-derived microparticles may provide a link between obstructive sleep apnea and endothelial dysfunction. This randomized controlled trial aimed to examine the effect of a 2-week withdrawal of continuous positive airway pressure (CPAP) therapy on levels of circulating microparticles. Forty-one obstructive sleep apnea patients established on CPAP treatment were randomized to either CPAP withdrawal (subtherapeutic CPAP) or continuing therapeutic CPAP, for 2 weeks. Polysomnography was performed and circulating levels of microparticles were analyzed by flow cytometry at baseline and 2 weeks. CPAP withdrawal led to a recurrence of obstructive sleep apnea. Levels of CD62E+ endothelium-derived microparticles increased significantly in the CPAP withdrawal group compared to the continuing therapeutic CPAP group (median difference in change +32.4 per µl; 95% CI +7.3 to +64.1 per µl, p = 0.010). CPAP withdrawal was not associated with a statistically significant increase in granulocyte, leukocyte, and platelet-derived microparticles when compared with therapeutic CPAP. Short-term withdrawal of CPAP therapy leads to a significant increase in endothelium-derived microparticles, suggesting that microparticle formation may be causally linked to obstructive sleep apnea and may promote endothelial activation. Copyright © 2012 S. Karger AG, Basel.

  18. External validation of the simple clinical score and the HOTEL score, two scores for predicting short-term mortality after admission to an acute medical unit.

    Science.gov (United States)

    Stræde, Mia; Brabrand, Mikkel

    2014-01-01

    Clinical scores can be of aid to predict early mortality after admission to a medical admission unit. A developed scoring system needs to be externally validated to minimise the risk of the discriminatory power and calibration to be falsely elevated. We performed the present study with the objective of validating the Simple Clinical Score (SCS) and the HOTEL score, two existing risk stratification systems that predict mortality for medical patients based solely on clinical information, but not only vital signs. Pre-planned prospective observational cohort study. Danish 460-bed regional teaching hospital. We included 3046 consecutive patients from 2 October 2008 until 19 February 2009. 26 (0.9%) died within one calendar day and 196 (6.4%) died within 30 days. We calculated SCS for 1080 patients. We found an AUROC of 0.960 (95% confidence interval [CI], 0.932 to 0.988) for 24-hours mortality and 0.826 (95% CI, 0.774-0.879) for 30-day mortality, and goodness-of-fit test, χ(2) = 2.68 (10 degrees of freedom), P = 0.998 and χ(2) = 4.00, P = 0.947, respectively. We included 1470 patients when calculating the HOTEL score. Discriminatory power (AUROC) was 0.931 (95% CI, 0.901-0.962) for 24-hours mortality and goodness-of-fit test, χ(2) = 5.56 (10 degrees of freedom), P = 0.234. We find that both the SCS and HOTEL scores showed an excellent to outstanding ability in identifying patients at high risk of dying with good or acceptable precision.

  19. Short term clinical disease progression in HIV-1 positive patients taking combination antiretroviral therapy : The EuroSIDA risk-score

    DEFF Research Database (Denmark)

    Mocroft, A; Ledergerber, B; Zilmer, K

    2007-01-01

    /death in patients taking cART. A score was derived for 4169 patients from EuroSIDA and validated on 5150 patients from the Swiss HIV Cohort Study (SHCS). RESULTS: In EuroSIDA, 658 events occurred during 22 321 person-years of follow-up: an incidence rate of 3.0/100 person-years of follow-up [95% confidence interval...... (CI), 2.7-3.3]. Current levels of viral load, CD4 cell count, CD4 cell slope, anaemia, and body mass index all independently predicted new AIDS/death, as did age, exposure group, a prior AIDS diagnosis, prior antiretroviral treatment and stopping all antiretroviral drugs. The EuroSIDA risk...... in the risk-score was associated with a 2.70 times higher incidence of clinical progression (95% CI, 2.56-2.84) in EuroSIDA and 2.88 (95% CI, 2.75-3.02) in SHCS. CONCLUSIONS: A clinically relevant prognostic score was derived in EuroSIDA and validated within the SHCS, with good agreement. The EuroSIDA risk...

  20. External Validation of the Simple Clinical Score and the HOTEL Score, Two Scores for Predicting Short-Term Mortality after Admission to an Acute Medical Unit

    DEFF Research Database (Denmark)

    Stræde, Mia; Brabrand, Mikkel

    2014-01-01

    with the objective of validating the Simple Clinical Score (SCS) and the HOTEL score, two existing risk stratification systems that predict mortality for medical patients based solely on clinical information, but not only vital signs. METHODS: Pre-planned prospective observational cohort study. SETTING: Danish 460.......932 to 0.988) for 24-hours mortality and 0.826 (95% CI, 0.774-0.879) for 30-day mortality, and goodness-of-fit test, χ2 = 2.68 (10 degrees of freedom), P = 0.998 and χ2 = 4.00, P = 0.947, respectively. We included 1470 patients when calculating the HOTEL score. Discriminatory power (AUROC) was 0.931 (95......% CI, 0.901-0.962) for 24-hours mortality and goodness-of-fit test, χ2 = 5.56 (10 degrees of freedom), P = 0.234. CONCLUSION: We find that both the SCS and HOTEL scores showed an excellent to outstanding ability in identifying patients at high risk of dying with good or acceptable precision....

  1. Short-term Clinical Course of Knee Pain in Children and Adolescents: A Feasibility Study Using Electronic Methods of Data Collection.

    Science.gov (United States)

    Swain, Michael S; Kamper, Steven J; Maher, Chris G; Latimer, Jane; Broderick, Carolyn; McKay, Damien; Henschke, Nicholas

    2017-10-01

    Musculoskeletal disorders, such as knee pain, are common in children and adolescents, but there is a lack of high quality research that evaluates the clinical course of these conditions. The objective of this study was to evaluate the feasibility of conducting a prospective study of children and adolescents with knee pain using electronic methods of data collection. Children and adolescents with knee pain that presented to primary care physiotherapy clinics were enrolled and followed-up on a weekly basis via short messaging service (SMS) until their knee pain had recovered (i.e. two consecutive weeks of no pain). Feasibility was assessed in terms of recruitment, retention and response rates to SMS and an online questionnaire. Baseline and 6-month follow-up measures included pain, disability, physical function, physical activity and health related quality of life. Kaplan-Meier survival analysis was used to estimate the median time to knee pain recovery. Thirty participants (mean age 13.0 ± 2.2 years, 53% boys) were recruited over 26 months. The overall response rate to weekly SMS follow-up was 71.3% (809 received/1135 sent). One third of participants stopped responding to SMS prior to recovery, and these participants typically had a much lower response rate during the time they remained in the study. At 6-month follow-up, 80% of the cohort completed the final online questionnaire, and 29% of participants still reported current knee pain (≥1/10 VAS). The median time for knee pain recovery was 8 weeks (95%CI: 5, 10). Electronic data collection alone seems insufficient to track pain recovery in young people and may need to be supplemented with more traditional data collection methods. Researchers should consider further measures to address slow recruitment rates and high attrition when designing large prospective studies of children and adolescents in the future. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  2. Clinical Holistic Medicine (Mindful, Short-Term Psychodynamic Psychotherapy Complemented with Bodywork Improves Quality of Life, Health, and Ability by Induction of Antonovsky-Salutogenesis

    Directory of Open Access Journals (Sweden)

    Søren Ventegodt

    2007-01-01

    Full Text Available We had a success rate of treating low, self-assessed, global quality of life (measured by QOL1: How would you assess the quality of your life now? with clinical holistic medicine of 56.4% (95% CI: 42.3–69.7% and calculated from this the Number Needed to Treat (NNT as 1.43–2.36. We found that during treatment, (in average 20 sessions of psychodynamic psychotherapy complemented with bodywork at a cost of 1600 EURO, the patients entered a state of Antonovsky-salutogenesis (holistic, existential healing, which also improved their self-assessed health and general ability one whole step up a 5-point Likert Scale. The treatment responders radically improved their self-assessed physical health (0.6 step, self-assessed mental health (1.6 step, their relation to self (1.2 step, friends (0.3 step, and partner (2.1 step on a 6-step scale, and their ability to love (1.2 step and work (0.8 step, and to function socially (1.0 step and sexually (0.8 step. It seems that treatment with clinical holistic medicine is the cure of choice when the patients (1 present the triad of low quality of life, poor self-assessed physical and/or mental health, and poor ability to function; and (2 are willing to suffer during the therapy by confronting and integrating old emotional problems and trauma(s from the past. For these patients, the treatment provided lasting benefits, without the negative side effects of drugs. A lasting, positive effect might also prevent many different types of problems in the future. The therapy was “mindful” in its focus on existential and spiritual issues.

  3. Immediate loading of mandibular overdentures supported by one-piece, direct metal laser sintering mini-implants: a short-term prospective clinical study.

    Science.gov (United States)

    Mangano, Francesco G; Caprioglio, Alberto; Levrini, Luca; Farronato, Davide; Zecca, Piero A; Mangano, Carlo

    2015-02-01

    Only a few studies have dealt with immediately loaded, unsplinted mini-implants supporting ball attachment-retained mandibular overdentures (ODs). The aim of this study is to evaluate treatment outcomes of ball attachment-retained mandibular ODs supported by one-piece, unsplinted, immediately loaded, direct metal laser sintering (DMLS) mini-implants. Over a 4-year period (2009 to 2012), all patients referred to the Dental Clinic, University of Varese, and to a private practice for treatment with mandibular ODs were considered for inclusion in this study. Each patient received three or four DMLS mini-implants. Immediately after implant placement, a mandibular OD was connected to the implants. At each annual follow-up session, clinical and radiographic parameters were assessed, including the following outcome measures: 1) implant failures; 2) peri-implant marginal bone loss; and 3) complications. Statistical analysis was conducted using a life-table analysis. A total of 231 one-piece DMLS mini-implants were inserted in 62 patients. After 4 years of loading, six implants failed, giving an overall cumulative survival rate of 96.9%. The mean distance between the implant shoulder and the first visible bone-to-implant contact was 0.38 ± 0.25 and 0.62 ± 0.20 mm at the 1- and 4-year follow-up examinations, respectively. An incidence of 6.0% of biologic complications was reported; prosthetic complications were more frequent (12.9%). Within the limits of this study, it can be concluded that the immediate loading of one-piece, unsplinted, DMLS titanium mini-implants by means of ball attachment-supported mandibular ODs is a successful treatment procedure. Long-term follow-up studies are needed to confirm these results.

  4. Short-term efficacy of calcium fructoborate on subjects with knee discomfort: a comparative, double-blind, placebo-controlled clinical study

    Directory of Open Access Journals (Sweden)

    Pietrzkowski Z

    2014-06-01

    Full Text Available Zbigniew Pietrzkowski,1 Michael J Phelan,2 Robert Keller,3 Cynthia Shu,1 Ruby Argumedo,1 Tania Reyes-Izquierdo11FutureCeuticals, Inc., Applied BioClinical Laboratory; 2Department of Statistics, School of Information and Computer Science, University of California at Irvine; 3NutraClinical Inc., Irvine, CA, USAAbstract: Calcium fructoborate (CFB at a dose of 110 mg twice per day was previously reported to improve knee discomfort during the first 14 days of treatment. In this study, 60 participants with self-reported knee discomfort were randomized into two groups receiving CFB or placebo. Initial levels of knee discomfort were evaluated by Western Ontario and McMaster Universities Arthritis Index (WOMAC and McGill Pain Questionnaire (MPQ scores at the beginning of the study and also at 7 and 14 days after treatment. Results showed that supplementation with CFB significantly improved knee discomfort in the study subjects; significant reductions of mean within-subject change in WOMAC and MPQ scores were observed for the CFB group compared to the placebo group at both 7 and 14 days after treatment. Estimated treatment differences for the MPQ score were -5.8 (P=0.0009 and -8.9 (P<0.0001 at Day 7 and 14, respectively. Estimated differences for the WOMAC score were -5.3 (P=0.06 and -13.73 (P<0.0001 at Day 7 and 14, respectively. Negative values indicate greater reductions in reported discomfort. On both Day 7 and Day 14, the trend was toward greater improvement in the CFB group. The placebo group did not exhibit any change in the WOMAC and MPQ scores. In conclusion, supplementation with 110 mg CFB twice per day was associated with improving knee discomfort during the 2 weeks of intake.Keywords: CFB, joint discomfort, WOMAC score, McGill pain score

  5. The Demonstration of Short-Term Consolidation.

    Science.gov (United States)

    Jolicoeur, Pierre; Dell'Acqua, Roberto

    1998-01-01

    Results of seven experiments involving 112 college students or staff using a dual-task approach provide evidence that encoding information into short-term memory involves a distinct process termed short-term consolidation (STC). Results suggest that STC has limited capacity and that it requires central processing mechanisms. (SLD)

  6. Short-Term Intercultural Psychotherapy: Ethnographic Inquiry

    Science.gov (United States)

    Seeley, Karen M.

    2004-01-01

    This article examines the challenges specific to short-term intercultural treatments and recently developed approaches to intercultural treatments based on notions of cultural knowledge and cultural competence. The article introduces alternative approaches to short-term intercultural treatments based on ethnographic inquiry adapted for clinical…

  7. Short-term Clinical Results of Manipulation Under Ultrasound-Guided Brachial Plexus Block in Patients with Idiopathic Frozen Shoulder and Diabetic Secondary Frozen Shoulder.

    Science.gov (United States)

    Ando, Akira; Hamada, Junichiro; Hagiwara, Yoshihiro; Sekiguchi, Takuya; Koide, Masashi; Itoi, Eiji

    2018-01-01

    This study examined the effectiveness of manipulation under ultrasound-guided brachial plexus block in patients with recalcitrant idiopathic frozen shoulder and diabetic secondary frozen shoulder (diabetic frozen shoulder). Forty-four idiopathic frozen shoulders and 10 diabetic frozen shoulders with failed conservative treatment for at least 3 months were included in this study. The manipulation was performed under ultrasound-guided brachial plexus block and visual analogue scale, range of motion, and Constant scores were measured before manipulation and at the last follow-up examination. No major complications were observed during the procedure. Sufficient improvement was not obtained in two patients during the procedure and to avoid complications, the procedure was discontinued and subsequently arthroscopic capsular release was performed. Visual analogue scale, range of motion towards all directions, and Constant scores were significantly improved after the manipulation in both the idiopathic frozen shoulder and diabetic frozen shoulder groups, however the diabetic group showed inferior results compared with those of the idiopathic group. This manipulation was effective and shortened the duration of symptoms in most of the idiopathic and diabetic frozen shoulders without major complications during the procedure. Diabetic frozen shoulder showed inferior clinical results and difficulty in recovery in range of motion, which indicated that diabetic frozen shoulder should be discussed as a different entity.

  8. Conservative treatment of idiopathic scoliosis according to FITS concept: presentation of the method and preliminary, short term radiological and clinical results based on SOSORT and SRS criteria

    Science.gov (United States)

    2011-01-01

    Background Conservative scoliosis therapy according to the FITS Concept is applied as a unique treatment or in combination with corrective bracing. The aim of the study was to present author's method of diagnosis and therapy for idiopathic scoliosis FITS-Functional Individual Therapy of Scoliosis and to analyze the early results of FITS therapy in a series of consecutive patients. Methods The analysis comprised separately: (1) single structural thoracic, thoracolumbar or lumbar curves and (2) double structural scoliosis-thoracic and thoracolumbar or lumbar curves. The Cobb angle and Risser sign were analyzed at the initial stage and at the 2.8-year follow-up. The percentage of patients improved (defined as decrease of Cobb angle of more than 5 degrees), stable (+/- 5 degrees), and progressed (increase of Cobb angle of more than 5 degrees) was calculated. The clinical assessment comprised: the Angle of Trunk Rotation (ATR) initial and follow-up value, the plumb line imbalance, the scapulae level and the distance from the apical spinous process of the primary curve to the plumb line. Results In the Group A: (1) in single structural scoliosis 50,0% of patients improved, 46,2% were stable and 3,8% progressed, while (2) in double scoliosis 50,0% of patients improved, 30,8% were stable and 19,2% progressed. In the Group B: (1) in single scoliosis 20,0% of patients improved, 80,0% were stable, no patient progressed, while (2) in double scoliosis 28,1% of patients improved, 46,9% were stable and 25,0% progressed. Conclusion Best results were obtained in 10-25 degrees scoliosis which is a good indication to start therapy before more structural changes within the spine establish. PMID:22122964

  9. Conservative treatment of idiopathic scoliosis according to FITS concept: presentation of the method and preliminary, short term radiological and clinical results based on SOSORT and SRS criteria

    Directory of Open Access Journals (Sweden)

    Białek Marianna

    2011-11-01

    Full Text Available Abstract Background Conservative scoliosis therapy according to the FITS Concept is applied as a unique treatment or in combination with corrective bracing. The aim of the study was to present author's method of diagnosis and therapy for idiopathic scoliosis FITS-Functional Individual Therapy of Scoliosis and to analyze the early results of FITS therapy in a series of consecutive patients. Methods The analysis comprised separately: (1 single structural thoracic, thoracolumbar or lumbar curves and (2 double structural scoliosis-thoracic and thoracolumbar or lumbar curves. The Cobb angle and Risser sign were analyzed at the initial stage and at the 2.8-year follow-up. The percentage of patients improved (defined as decrease of Cobb angle of more than 5 degrees, stable (+/- 5 degrees, and progressed (increase of Cobb angle of more than 5 degrees was calculated. The clinical assessment comprised: the Angle of Trunk Rotation (ATR initial and follow-up value, the plumb line imbalance, the scapulae level and the distance from the apical spinous process of the primary curve to the plumb line. Results In the Group A: (1 in single structural scoliosis 50,0% of patients improved, 46,2% were stable and 3,8% progressed, while (2 in double scoliosis 50,0% of patients improved, 30,8% were stable and 19,2% progressed. In the Group B: (1 in single scoliosis 20,0% of patients improved, 80,0% were stable, no patient progressed, while (2 in double scoliosis 28,1% of patients improved, 46,9% were stable and 25,0% progressed. Conclusion Best results were obtained in 10-25 degrees scoliosis which is a good indication to start therapy before more structural changes within the spine establish.

  10. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2007-12-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Intergrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 249553, 2-Methoxyestradiol; Abatacept, Adalimumab, Adefovir dipivoxil, Agalsidase beta, Albinterferon alfa-2b, Aliskiren fumarate, Alovudine, Amdoxovir, Amlodipine besylate/atorvastatin calcium, Amrubicin hydrochloride, Anakinra, AQ-13, Aripiprazole, AS-1404, Asoprisnil, Atacicept, Atrasentan; Belimumab, Bevacizumab, Bortezomib, Bosentan, Botulinum toxin type B, Brivaracetam; Catumaxomab, Cediranib, Cetuximab, cG250, Ciclesonide, Cinacalcet hydrochloride, Curcumin, Cypher; Darbepoetin alfa, Denosumab, Dihydrexidine; Eicosapentaenoic acid/docosahexaenoic acid, Entecavir, Erlotinib hydrochloride, Escitalopram oxalate, Etoricoxib, Everolimus, Ezetimibe; Febuxostat, Fenspiride hydrochloride, Fondaparinux sodium; Gefitinib, Ghrelin (human), GSK-1562902A; HSV-tk/GCV; Iclaprim, Imatinib mesylate, Imexon, Indacaterol, Insulinotropin, ISIS-112989; L-Alanosine, Lapatinib ditosylate, Laropiprant; Methoxy polyethylene glycol-epoetin-beta, Mipomersen sodium, Motexafin gadolinium; Natalizumab, Nimotuzumab; OSC, Ozarelix; PACAP-38, Paclitaxel nanoparticles, Parathyroid Hormone-Related Protein-(1-36), Pasireotide, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Picoplatin, Pimecrolimus, Pitavastatin calcium, Plitidepsin; Ranelic acid distrontium salt, Ranolazine, Recombinant human relaxin H2, Regadenoson, RFB4(dsFv)-PE38, RO-3300074, Rosuvastatin calcium; SIR-Spheres, Solifenacin succinate, Sorafenib, Sunitinib malate; Tadalafil, Talabostat, Taribavirin hydrochloride, Taxus, Temsirolimus, Teriparatide, Tiotropium bromide, Tipifarnib, Tirapazamine, Tocilizumab; UCN-01, Ularitide

  11. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2005-04-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity. prous.com. This issue focuses on the following selection of drugs: ABX-IL-8, Acclaim, adalimumab, AGI-1067, alagebrium chloride, alemtuzumab, Alequel, Androgel, anti-IL-12 MAb, AOD-9604, aripiprazole, atomoxetine hydrochloride; Biphasic insulin aspart, bosentan, botulinum toxin type B, bovine lactoferrin, brivudine; Cantuzumab mertansine, CB-1954, CDB-4124, CEA-TRICOM, choriogonadotropin alfa, cilansetron, CpG-10101, CpG-7909, CTL-102, CTL-102/CB-1954; DAC:GRF, darbepoetin alfa, davanat-1, decitabine, del-1 Genemedicine, dexanabinol, dextofisopam, dnaJP1, dronedarone hydrochloride, dutasteride; Ecogramostim, eletriptan, emtricitabine, EPI-hNE-4, eplerenone, eplivanserin fumarate, erlotinib hydrochloride, ertapenem sodium, escitalopram oxalate, esomeprazole magnesium, etoricoxib, ezetimibe; Falecalcitriol, fingolimod hydrochloride; Gepirone hydrochloride; HBV-ISS, HSV-2 theracine, human insulin; Imatinib mesylate, Indiplon, insulin glargine, ISAtx-247; L612 HuMAb, levodopa/carbidopa/entacapone, lidocaine/prilocaine, LL-2113AD, lucinactant, LY-156735; Meclinertant, metelimumab, morphine hydrochloride, morphine-6-glucuronide; Natalizumab, nimotuzumab, NX-1207, NYVAC-HIV C; Omalizumab, onercept, osanetant; PABA, palosuran sulfate, parathyroid hormone (human recombinant), parecoxib sodium, PBI-1402, PCK-3145, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, pimecrolimus, PINC, pregabalin; Ramelteon, rasagiline mesilate, rasburicase, rimonabant hydrochloride, RO-0098557, rofecoxib, rosiglitazone maleate/metformin hydrochloride; Safinamide mesilate, SHL-749, sitaxsentan sodium, sparfosic acid, SprayGel, squalamine, St. John's Wort

  12. Clinical trials in India.

    Science.gov (United States)

    Maiti, Rituparna; M, Raghavendra

    2007-07-01

    The concept of outsourcing for the development and global studies on new drugs has become widely accepted in the pharmaceutical industry due to its cost and uncertainty. India is going to be the most preferred location for contract pharma research and development due to its huge treatment naïve population, human resources, technical skills, adoption/amendment/implementation of rules/laws by regulatory authorities, and changing economic environment. But still 'miles to go' to fulfill the pre-requisites to ensure India's success. In spite of all the pitfalls, the country is ambitious and optimist to attract multinational pharmaceutical companies to conduct their clinical trials in India.

  13. [Maraviroc: clinical trials results].

    Science.gov (United States)

    Chidiac, C; Katlama, C; Yeni, P

    2008-03-01

    Just over a decade after identification of chemokine receptors CCR5 and CXCR4 as coreceptors for HIV, maraviroc (Celsentri), the first CCR5 antagonist, has recently obtained its Marketing Authorization in the United States and Europe, for treatment of treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable. CCR5 antagonists, after fusion inhibitor enfuvirtide available since 2003, also belong to entry inhibitors. These molecules, unlike previous antiretrovirals, do not target the virus but its target cell by blocking viral penetration. Maraviroc has shown its clinical efficacy in patients failing other antiretroviral classes. Its safety profile was similar to placebo in two large phase III trials. However, careful assessment of both hepatic and immunologic safety of this new therapeutic class is needed. Viral tropism testing has to be investigated before using maraviroc in the clinic, because CCR5 antagonists are not active against CXCR4 viruses. For the moment indicated for the treatment-experienced patient population, maraviroc could in the future benefit to other types of patients, depending on ongoing trials results.

  14. Short term memory in echo state networks

    OpenAIRE

    Jaeger, H.

    2001-01-01

    The report investigates the short-term memory capacity of echo state recurrent neural networks. A quantitative measure MC of short-term memory capacity is introduced. The main result is that MC 5 N for networks with linear Output units and i.i.d. input, where N is network size. Conditions under which these maximal memory capacities are realized are described. Several theoretical and practical examples demonstrate how the short-term memory capacities of echo state networks can be exploited for...

  15. Short-Term High-Dose Vitamin E to Prevent Contrast Medium-Induced Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Elective Coronary Angiography: A Randomized Placebo-Controlled Trial.

    Science.gov (United States)

    Rezaei, Yousef; Khademvatani, Kamal; Rahimi, Behzad; Khoshfetrat, Mehran; Arjmand, Nasim; Seyyed-Mohammadzad, Mir-Hossein

    2016-03-15

    Contrast medium-induced acute kidney injury (CIAKI) is a leading cause of acquired renal impairment. The effects of antioxidants have been conflicting regarding the prevention of CIAKI. We performed a study of vitamin E use to decrease CIAKI in patients undergoing elective coronary angiography. In a placebo-controlled randomized trial at 2 centers in Iran, 300 patients with chronic kidney disease-defined as estimated glomerular filtration rate vitamin E 12 hours before plus 400 mg vitamin E 2 hours before coronary angiography or to receive placebo. The primary end point was the development of CIAKI, defined as an increase ≥0.5 mg/dL or ≥25% in serum creatinine that peaked within 72 hours. Based on an intention-to-treat analysis, CIAKI developed in 10 (6.7%) and 21 (14.1%) patients in the vitamin E and placebo groups, respectively (P=0.037). Change in white blood cell count from baseline to peak value was greater in the vitamin E group compared with the placebo group (-500 [-1500 to 200] versus 100 [-900 to 600]×10(3)/mL, P=0.001). In multivariate analysis, vitamin E (odds ratio 0.408, 95% CI 0.170-0.982, P=0.045) and baseline Mehran score (odds ratio 1.257, 95% CI 1.007-1.569; P=0.043) predicted CIAKI. Prophylactic short-term high-dose vitamin E combined with 0.9% saline infusion is superior to placebo for prevention of CIAKI in patients undergoing elective coronary angiography. URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02070679. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  16. [Clinical trials in nursing journals].

    Science.gov (United States)

    Di Giulio, Paola; Campagna, Sara; Dimonte, Valerio

    2014-01-01

    Clinical trials are pivotal for the development of nursing knowledge. To describe the clinical trials published in nursing journals in the last two years and propose some general reflections on nursing research. A search with the key-word trial was done on PubMed (2009-2013) on Cancer Nursing, European Journal of Oncology Nursing, International Journal of Nursing Studies, Journal of Advanced Nursing, Journal of Clinical Nursing and Nursing Research. Of 228 trials identified, 104 (45.8%) were published in the last 2 years. Nurses from Asian countries published the larger number of trials. Educational and supportive interventions were the most studied (61/104 trials), followed by clinical interventions (33/104). Samples were limited and most trials are monocentric. A growing number of trials is published, on issues relevant for the nursing profession, however larger samples and multicentric studies would be necessary.

  17. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2006-10-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issues focuses on the following selection of drugs: (-)-Epigallocatechin gallate, (-)-gossypol, 2-deoxyglucose, 3,4-DAP, 7-monohydroxyethylrutoside; Ad5CMV-p53, adalimumab, adefovir dipivoxil, ADH-1, alemtuzumab, aliskiren fumarate, alvocidib hydrochloride, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, amrubicin hydrochloride, AN-152, anakinra, anecortave acetate, antiasthma herbal medicine intervention, AP-12009, AP-23573, apaziquone, aprinocarsen sodium, AR-C126532, AR-H065522, aripiprazole, armodafinil, arzoxifene hydrochloride, atazanavir sulfate, atilmotin, atomoxetine hydrochloride, atorvastatin, avanafil, azimilide hydrochloride; Bevacizumab, biphasic insulin aspart, BMS-214662, BN-83495, bortezomib, bosentan, botulinum toxin type B; Caspofungin acetate, cetuximab, chrysin, ciclesonide, clevudine, clofarabine, clopidogrel, CNF-1010, CNTO-328, CP-751871, CX-717, Cypher; Dapoxetine hydrochloride, darifenacin hydrobromide, dasatinib, deferasirox, dextofisopam, dextromethorphan/quinidine sulfate, diclofenac, dronedarone hydrochloride, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Edaravone, efaproxiral sodium, emtricitabine, entecavir, eplerenone, epratuzumab, erlotinib hydrochloride, escitalopram oxalate, etoricoxib, ezetimibe, ezetimibe/simvastatin; Finrozole, fipamezole hydrochloride, fondaparinux sodium, fulvestrant; Gabapentin enacarbil, gaboxadol, gefitinib, gestodene, ghrelin (human); Human insulin, human papillomavirus vaccine; Imatinib mesylate, immunoglobulin intravenous (human), indiplon, insulin detemir, insulin glargine, insulin glulisine, intranasal insulin, istradefylline, i.v. gamma

  18. The effect of the publication of a major clinical trial in a high impact journal on clinical practise: the ORACLE Trial experience.

    Science.gov (United States)

    Kenyon, Sara; Taylor, David J

    2002-12-01

    To estimate the short term effect of the publication of a major clinical trial on clinical practise. Questionnaire survey of clinical practise. UK. All maternity units in the UK. A self-administered questionnaire completed by lead consultants on delivery suite of maternity units. Changes in antibiotic prescription. Within six months of publication, approximately 50% of maternity units had changed their guidelines for the care of women with preterm prelabour rupture of the fetal membranes. Publication of a major clinical trial does impact on clinical practise but the impact is heterogeneous in terms of time and consistency.

  19. Fast Weight Long Short-Term Memory

    OpenAIRE

    Keller, T. Anderson; Sridhar, Sharath Nittur; Wang, Xin

    2018-01-01

    Associative memory using fast weights is a short-term memory mechanism that substantially improves the memory capacity and time scale of recurrent neural networks (RNNs). As recent studies introduced fast weights only to regular RNNs, it is unknown whether fast weight memory is beneficial to gated RNNs. In this work, we report a significant synergy between long short-term memory (LSTM) networks and fast weight associative memories. We show that this combination, in learning associative retrie...

  20. Comparison of the Impact of Wikipedia, UpToDate, and a Digital Textbook on Short-Term Knowledge Acquisition Among Medical Students: Randomized Controlled Trial of Three Web-Based Resources.

    Science.gov (United States)

    Scaffidi, Michael A; Khan, Rishad; Wang, Christopher; Keren, Daniela; Tsui, Cindy; Garg, Ankit; Brar, Simarjeet; Valoo, Kamesha; Bonert, Michael; de Wolff, Jacob F; Heilman, James; Grover, Samir C

    2017-10-31

    Web-based resources are commonly used by medical students to supplement curricular material. Three commonly used resources are UpToDate (Wolters Kluwer Inc), digital textbooks, and Wikipedia; there are concerns, however, regarding Wikipedia's reliability and accuracy. The aim of this study was to evaluate the impact of Wikipedia use on medical students' short-term knowledge acquisition compared with UpToDate and a digital textbook. This was a prospective, nonblinded, three-arm randomized trial. The study was conducted from April 2014 to December 2016. Preclerkship medical students were recruited from four Canadian medical schools. Convenience sampling was used to recruit participants through word of mouth, social media, and email. Participants must have been enrolled in their first or second year of medical school at a Canadian medical school. After recruitment, participants were randomized to one of the three Web-based resources: Wikipedia, UpToDate, or a digital textbook. During testing, participants first completed a multiple-choice questionnaire (MCQ) of 25 questions emulating a Canadian medical licensing examination. During the MCQ, participants took notes on topics to research. Then, participants researched topics and took written notes using their assigned resource. They completed the same MCQ again while referencing their notes. Participants also rated the importance and availability of five factors pertinent to Web-based resources. The primary outcome measure was knowledge acquisition as measured by posttest scores. The secondary outcome measures were participants' perceptions of importance and availability of each resource factor. A total of 116 medical students were recruited. Analysis of variance of the MCQ scores demonstrated a significant interaction between time and group effects (P<.001, η g 2 =0.03), with the Wikipedia group scoring higher on the MCQ posttest compared with the textbook group (P<.001, d=0.86). Access to hyperlinks, search

  1. Short-term outcomes following laparoscopic resection for colon cancer.

    LENUS (Irish Health Repository)

    Kavanagh, Dara O

    2011-03-01

    Laparoscopic resection for colon cancer has been proven to have a similar oncological efficacy compared to open resection. Despite this, it is performed by a minority of colorectal surgeons. The aim of our study was to evaluate the short-term clinical, oncological and survival outcomes in all patients undergoing laparoscopic resection for colon cancer.

  2. Histo-morphological findings and preliminary clinical findings after pre-operative short-term irradiation of squamous cell carcinomas of the floor of the mouth using telecobalt sources

    International Nuclear Information System (INIS)

    Dieckmann, J.; Morgenroth, K.; Hering, K.; Will, C.

    1981-01-01

    In a clinical investigation, the preoperative short-term telecobalt irradiation of patients with carcinoma of the floor of the mouth was tested. On 50 patients, the preoperative irradiation was applied after identifying the tumour by PE and fast cesion examination. Within 3 days, a focal dose of 15 to 20 Gy was applied. On the 4th day, the radical operation took place. 2-3 weeks after the operation, the saturation irradiation was carried out. For the purpose of testing, 100 patients under our usual combined treatment with radical operation plus postoperative curative telecobalt irradiation were refined to. The tissue sample before irradiation was histologically compared to the preoperatively irradiated tumour. The examinations revealed definitively a letal damage of the tumour cells. Up to the moment, the clinical results could not be received statistically because the investigation had just been finished when the draft of the speech was in preparation. But we can state, as a preliminary result, that there is a trend recognizable in which the mortality in the patients group seems to be appr. 8% lower. It is noteworthy, however, that the relapse and metastase behaviour in the group of preirradiated tumours seems to be significantly better than in the group irradiated only surgically and postoperatively: it is seen that the tumour-caused mortality in the first group is 18% less than in the latter. (orig.) [de

  3. SHORT-TERM MEMORY IS INDEPENDENT OF BRAIN PROTEIN SYNTHESIS

    Energy Technology Data Exchange (ETDEWEB)

    Davis, Hasker P.; Rosenzweig, Mark R.; Jones, Oliver W.

    1980-09-01

    Male Swiss albino CD-1 mice given a single injection of a cerebral protein synthesis inhibitor, anisomycin (ANI) (1 mg/animal), 20 min prior to single trial passive avoidance training demonstrated impaired retention at tests given 3 hr, 6 hr, 1 day, and 7 days after training. Retention was not significantly different from saline controls when tests were given 0.5 or 1.5 hr after training. Prolonging inhibition of brain protein synthesis by giving either 1 or 2 additional injections of ANI 2 or 2 and 4 hr after training did not prolong short-term retention performance. The temporal development of impaired retention in ANI treated mice could not be accounted for by drug dosage, duration of protein synthesis inhibition, or nonspecific sickness at test. In contrast to the suggestion that protein synthesis inhibition prolongs short-term memory (Quinton, 1978), the results of this experiment indicate that short-term memory is not prolonged by antibiotic drugs that inhibit cerebral protein synthesis. All evidence seems consistent with the hypothesis that short-term memory is protein synthesis independent and that the establishment of long-term memory depends upon protein synthesis during or shortly after training. Evidence for a role of protein synthesis in memory maintenance is discussed.

  4. Short-term intensive psychodynamic group therapy versus cognitive-behavioral group therapy in day treatment of anxiety disorders and comorbid depressive or personality disorders: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Suszek, Hubert; Holas, Paweł; Wyrzykowski, Tomasz; Lorentzen, Steinar; Kokoszka, Andrzej

    2015-07-29

    Psychodynamic and cognitive-behavioral group therapies are frequently applied in day hospitals for the treatment of anxiety disorders and comorbid depressive or personality disorders in Poland and other Eastern European countries. Yet there is not enough evidence as to their effectiveness in this environment; this study addresses this gap. The aim of the study is to determine the effectiveness of these two kinds of day treatment care consisting of intensive, short-term group psychodynamic and cognitive-behavioral therapy, for patients with anxiety disorders and/or comorbid depressive or personality disorders. Our objectives are to: 1) show the effectiveness of each treatment in a day-care setting relative to the wait-list control group; 2) demonstrate the relative short- and long-term effectiveness of the two active treatments; 3) carry out a preliminary examination of the predictors and moderators of treatment response; 4) carry out a preliminary examination of the mediators of therapeutic change; and 5) compare the impact of both methods of treatment on the outcome of the measures used in this study. In this randomized controlled trial, a total of 199 patients with anxiety disorders and comorbid depressive and/or personality disorders will be assigned to one of three conditions: 1) psychodynamic group therapy; 2) cognitive-behavioral group therapy; or 3) wait-list control group. The therapy will last 12 weeks. Both treatments will be manualized (the manuals will address comorbidity). Primary outcome measures will include self-reported symptoms of anxiety, observer-rated symptoms of anxiety, global improvement, and recovery rate. Secondary outcome measures will include the number of pathological personality traits, depression, self-esteem, defense mechanisms, beliefs about self and others, interpersonal problems, object relations, parental bonding, meta-cognition, and quality of life. Measures will be taken at baseline, post-treatment, and at six months following

  5. Cross-Over Clinical Trials?

    Directory of Open Access Journals (Sweden)

    Latif Gachkar

    2017-01-01

    Full Text Available Abstract Cross-Over Clinical Trials in comparison with Parallel groups clinical trials have some advantages such as control of confounding variables, small sample size, and short time to implement the research project. But this type of research has few essential limitations that discusses in this monogram.

  6. DupuytrEn Treatment EffeCtiveness Trial (DETECT): a protocol for prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of collagenase clostridium histolyticum, percutaneous needle fasciotomy and limited fasciectomy as short-term and long-term treatment strategies in Dupuytren's contracture.

    Science.gov (United States)

    Räisänen, Mikko P; Karjalainen, Teemu; Göransson, Harry; Reito, Aleksi; Kautiainen, Hannu; Malmivaara, Antti; Leppänen, Olli V

    2018-03-28

    Dupuytren's contracture (DC) is a chronic fibroproliferative disorder of the palmar fascia which leads to flexion contracture in one or more fingers. There is no definitive cure for DC, and treatment aims at relieving symptoms by releasing the contracture using percutaneous or operative techniques. We planned a prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of (1) collagenase clostridium histolyticum injection followed by limited fasciectomy in non-responsive cases, (2) percutaneous needle fasciotomy followed by limited fasciectomy in non-responsive cases and (3) primary limited fasciectomy during short-term and long-term follow-up for Tubiana I-III stages DC. We will recruit participants from seven national centres in Finland. Primary outcome is the rate of success in the treatment arm at 5 years after recruitment. Success is a composite outcome comprising (1) at least 50% contracture release from the date of recruitment and (2) participants in a patient-accepted symptom state (PASS). Secondary outcomes are (1) angle of contracture, (2) quick disabilities of the arm, a shoulder and hand outcome measure (QuickDASH), (3) perceived hand function, (4) EQ-5D-3L, (5) rate of major adverse events, (6) patient's trust of the treatment, (7) global rating, (8) rate of PASS, (9) rate of minimal clinically important improvement, (10) expenses, (11) progression of disease, (12) progression-free survival, (13) favoured treatment modality, (14) patients achieving full contracture release and >50% improvement and (15) patient satisfaction with the treatment effect. Predictive factors for achieving the PASS will also be analysed. The protocol was approved by the Tampere University Hospital Institutional Review Board and Finnish Medicine Agency. The study will be performed according to the principles of good clinical practice. The results of the trial will be disseminated as

  7. EFFECT OF SHORT-TERM ART INTERRUPTION ON LEVELS OF INTEGRATED HIV DNA.

    Science.gov (United States)

    Strongin, Zachary; Sharaf, Radwa; VanBelzen, D Jake; Jacobson, Jeffrey M; Connick, Elizabeth; Volberding, Paul; Skiest, Daniel J; Gandhi, Rajesh T; Kuritzkes, Daniel R; O'Doherty, Una; Li, Jonathan Z

    2018-03-28

    Analytic treatment interruption (ATI) studies are required to evaluate strategies aimed at achieving ART-free HIV remission, but the impact of ATI on the viral reservoir remains unclear. We validated a DNA size selection-based assay for measuring levels of integrated HIV DNA and applied it to assess the effects of short-term ATI on the HIV reservoir. Samples from participants from four AIDS Clinical Trials Group (ACTG) ATI studies were assayed for integrated HIV DNA levels. Cryopreserved PBMCs were obtained for 12 participants with available samples pre-ATI and approximately 6 months after ART resumption. Four participants also had samples available during the ATI. The median duration of ATI was 12 weeks. Validation of the HIV Integrated DNA size-Exclusion (HIDE) assay was performed using samples spiked with unintegrated HIV DNA, HIV-infected cell lines, and participant PBMCs. The HIDE assay eliminated 99% of unintegrated HIV DNA species and strongly correlated with the established Alu- gag assay. For the majority of individuals, integrated DNA levels increased during ATI and subsequently declined upon ART resumption. There was no significant difference in levels of integrated HIV DNA between the pre- and post-ATI time points, with the median ratio of post:pre-ATI HIV DNA levels of 0.95. Using a new integrated HIV DNA assay, we found minimal change in the levels of integrated HIV DNA in participants who underwent an ATI followed by 6 months of ART. This suggests that short-term ATI can be conducted without a significant impact on levels of integrated proviral DNA in the peripheral blood. IMPORTANCE Interventions aimed at achieving sustained antiretroviral therapy (ART)-free HIV remission require treatment interruption trials to assess their efficacy. However, these trials are accompanied by safety concerns related to the expansion of the viral reservoir. We validated an assay that uses an automated DNA size-selection platform for quantifying levels of integrated

  8. The selective treatment of clinical mastitis based on on-farm culture results: I. Effects on antibiotic use, milk withholding time, and short-term clinical and bacteriological outcomes.

    Science.gov (United States)

    Lago, A; Godden, S M; Bey, R; Ruegg, P L; Leslie, K

    2011-09-01

    The objective of this multi-state, multi-herd clinical trial was to evaluate the efficacy of using an on-farm culture system to guide strategic treatment decisions in cows with clinical mastitis. The study was conducted in 8 commercial dairy farms ranging in size from 144 to 1,795 cows from Minnesota, Wisconsin, and Ontario, Canada. A total of 422 cows affected with mild or moderate clinical mastitis in 449 quarters were randomly assigned to either (1) a positive-control treatment program or (2) an on-farm, culture-based treatment program. Quarter cases assigned to the positive-control group received immediate on-label intramammary treatment with cephapirin sodium. Quarters assigned to the culture-based treatment program were cultured on-farm and treated with cephapirin sodium after 18 to 24h of incubation if they had gram-positive growth or a mixed infection. Quarters with gram-negative or no growth did not receive intramammary therapy. The proportion of quarter cases assigned to positive-control and culture-based treatments that received intramammary antibiotic therapy because of study assignment was 100 and 44%, respectively; the proportion of cases that received secondary antibiotic therapy was 36 and 19%, respectively; and the proportion of cases that received intramammary antibiotic therapy because of study assignment or secondary therapy was 100 and 51%, respectively. A tendency existed for a decrease in the number of days in which milk was discarded from cows assigned to the culture-based treatment program versus cows assigned to the positive-control group (5.9 vs. 5.2 d). No statistically significant differences existed between cases assigned to the positive-control and cases assigned to the culture-based treatment program in days to clinical cure (2.7 vs. 3.2 d), bacteriological cure risk within 21 d of enrollment (71 vs. 60%), new intramammary infection risk within 21 d of enrollment (50 vs. 50%), and treatment failure risk (presence of infection

  9. Comparison of Short Term with Long Term Catheterization after Anterior Colporrhaphy Surgery

    Directory of Open Access Journals (Sweden)

    F. Movahed

    2010-07-01

    Full Text Available Introduction & Objective: This belief that overfilling the bladder after anterior colporrhaphy might have a negative influence on surgical outcome, causes routine catheterization after operation. This study was done to compare short term (24h with long term (72h catheterization after anterior colporrhaphy.Materials & Methods: This randomized clinical trial was carried out at Kosar Hospital , Qazvin (Iran in 2005-2006. One hundred cases candidating for anterior colporrhaphy , were divided in two equal groups . In the first group foley catheter was removed 24 hours and in the second group 72 hours after the operation. Before removing catheter, urine sample was obtained for culture . After removal and urination, residual volume was determinded. If the volume exceeded 200 ml or retention occured, the catheter would be fixed for more 72 hours. Need for recatheterization, urinary retention, positive urine culture,and hospital stay were surveyed. The data was analyzed using T and Fisher tests.Results: Residual volume exceeding 200 ml and the need for recatheterization occurred in one case (2% in the short term group but in the long term group none of the subjects needed recatheterization (P=1. Retention was not seen. In the both groups, one case (2% had positive urine culture with no statistically significant difference (P=1. Mean hospital stay was short in the first group (P=0.00.Conclusion: Short term catheterization after anterior colporrhaphy does not cause urinary retention and decreases hospital stay.

  10. Social media in clinical trials.

    Science.gov (United States)

    Thompson, Michael A

    2014-01-01

    Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating, and engaging multiple groups involved in cancer clinical research. Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from a passive "push" of information to patients to a "pull" of patients requesting information. Patients and advocates are often driving an otherwise reluctant health care system into communication. Online patient communities are creating new information repositories. Potential clinical trial participants are using the Twittersphere and other sources to learn about potential clinical trial options. We are seeing more organized patient-centric and patient-engaged forums with the potential to crowd source to improve clinical trial accrual and design. This is an evolving process that will meet many individual, institutional, and regulatory obstacles as we move forward in a changed research landscape.

  11. Visual Short-Term Memory Complexity

    DEFF Research Database (Denmark)

    Sørensen, Thomas Alrik

    Several recent studies have explored the nature and limits of visual short-term memory (VSTM) (e.g. Luck & Vogel, 1997). A general VSTM capacity limit of about 3 to 4 letters has been found, thus confirming results from earlier studies (e.g. Cattell, 1885; Sperling, 1960). However, Alvarez...

  12. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Katz, J N; Losina, E; Lohmander, L S

    2015-01-01

    To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For eac...

  13. Quality Assurance for Clinical Trials

    Science.gov (United States)

    Ibbott, Geoffrey S.; Haworth, Annette; Followill, David S.

    2013-01-01

    Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution’s procedures for planning and delivering advanced external beam techniques (1–3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. The RPC is supported by grants CA 10953 and CA 81647 from the National Cancer Institute, NIH, DHHS. PMID:24392352

  14. Development of a clinical prediction rule for identifying women with tension-type headache who are likely to achieve short-term success with joint mobilization and muscle trigger point therapy.

    Science.gov (United States)

    Fernández-de-las-Peñas, César; Cleland, Joshua A; Palomeque-del-Cerro, Luis; Caminero, Ana Belén; Guillem-Mesado, Amparo; Jiménez-García, Rodrigo

    2011-02-01

    successful outcome (48%). Eight prognostic variables were retained in the regression model: mean age 69°, total tenderness score 42.23. The current clinical prediction rule may allow clinicians to make an a priori identification of women with TTH who are likely to experience short-term self-report improvement with a multimodal session including joint mobilizations and TrP therapies. Future studies are necessary to validate these findings. © 2010 American Headache Society.

  15. Randomised clinical trial

    DEFF Research Database (Denmark)

    Reimer, C; Lødrup, A; Smith, G

    2016-01-01

    of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. MethodsThis was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using...

  16. Hydroxychloroquine retinopathy after short-term therapy.

    Science.gov (United States)

    Phillips, Brandon N; Chun, Dal W

    2014-01-01

    To report an unusual case of hydroxychloroquine toxicity after short-term therapy. Observational case report. A 56-year-old woman presented to the Ophthalmology Clinic at Walter Reed Army Medical Center (WRAMC) with a 6-month history of gradually decreasing vision in both eyes. The patient had been taking hydroxychloroquine for the preceding 48 months for the treatment of rheumatoid arthritis. Examination of the posterior segment revealed bilateral "bull's eye" macular lesions. Fundus autofluorescence revealed hyperfluorescence of well-defined bull's eye lesions in both eyes. Optical coherence tomography revealed corresponding parafoveal atrophy with a loss of the retinal inner segment/outer segment junction. Humphrey visual field 10-2 white showed significant central and paracentral defects with a generalized depression. The patient was on a standard dose of 400 mg daily, which was above her ideal dose. The patient had no history of kidney or liver dysfunction. There were no known risk factors but there were several possible confounding factors. The patient was started on high-dose nabumetone, a nonsteroidal antiinflammatory drug, at the same time she was started on hydroxychloroquine. She also reported taking occasional ibuprofen. Retinal toxicity from chloroquine has been recognized for decades with later reports showing retinopathy from long-term hydroxychloroquine (Plaquenil) use for the treatment of antiinflammatory diseases. Hydroxychloroquine is now widely used and retinal toxicity is relatively uncommon. However, it can cause serious vision loss and is usually irreversible. The risk of hydroxychloroquine toxicity rises to nearly 1% with a total cumulative dose of 1,000 g, which is ∼5 years to 7 years of normal use. Toxicity is rare under this dose. For this reason, the American Academy of Ophthalmology has revised its recommendations such that annual screenings begin 5 years after therapy with hydroxychloroquine has begun unless there are known risk

  17. Short-term Memory of Deep RNN

    OpenAIRE

    Gallicchio, Claudio

    2018-01-01

    The extension of deep learning towards temporal data processing is gaining an increasing research interest. In this paper we investigate the properties of state dynamics developed in successive levels of deep recurrent neural networks (RNNs) in terms of short-term memory abilities. Our results reveal interesting insights that shed light on the nature of layering as a factor of RNN design. Noticeably, higher layers in a hierarchically organized RNN architecture results to be inherently biased ...

  18. Short-term LNG-markets

    International Nuclear Information System (INIS)

    Eldegard, Tom; Lund, Arne-Christian; Miltersen, Kristian; Rud, Linda

    2005-01-01

    The global Liquefied Natural Gas (LNG) industry has experienced substantial growth in the past decades. In the traditional trade patterns of LNG the product has typically been handled within a dedicated chain of plants and vessels fully committed by long term contracts or common ownership, providing risk sharing of large investments in a non-liquid market. Increasing gas prices and substantial cost reductions in all parts of the LNG chain have made LNG projects viable even if only part of the capacity is secured by long-term contracts, opening for more flexible trade of the remainder. Increasing gas demand, especially in power generation, combined with cost reductions in the cost of LNG terminals, open new markets for LNG. For the LNG supplier, the flexibility of shifting volumes between regions represents an additional value. International trade in LNG has been increasing, now accounting for more than one fifth of the world's cross-border gas trade. Despite traditional vertical chain bonds, increased flexibility has contributed in fact to an increasing LNG spot trade, representing 8% of global trade in 2002. The focus of this paper is on the development of global short-term LNG markets, and their role with respect to efficiency and security of supply in European gas markets. Arbitrage opportunities arising from price differences between regional markets (such as North America versus Europe) are important impetuses for flexible short-term trade. However, the short-term LNG trade may suffer from problems related to market access, e.g. limited access to terminals and regulatory issues, as well as rigidities connected to vertical binding within the LNG chain. Important issues related to the role of short-term LNG-trade in the European gas market are: Competition, flexibility in meeting peak demand, security of supply and consequences of differences in pricing policies (oil-linked prices in Europe and spot market prices in North America). (Author)

  19. A short-term neural network memory

    Energy Technology Data Exchange (ETDEWEB)

    Morris, R.J.T.; Wong, W.S.

    1988-12-01

    Neural network memories with storage prescriptions based on Hebb's rule are known to collapse as more words are stored. By requiring that the most recently stored word be remembered precisely, a new simple short-term neutral network memory is obtained and its steady state capacity analyzed and simulated. Comparisons are drawn with Hopfield's method, the delta method of Widrow and Hoff, and the revised marginalist model of Mezard, Nadal, and Toulouse.

  20. Pivmecillinam versus sulfamethizole for short-term treatment of uncomplicated acute cystitis in general practice

    DEFF Research Database (Denmark)

    Bjerrum, Lars; Gahrn-Hansen, Bente; Grinsted, Per

    2009-01-01

    Objective. To investigate whether short-term treatment with pivmecillinam was more effective than sulfamethizole in patients with acute uncomplicated urinary tract infection (UTI). Design. Randomized controlled trial. Setting. General practice, Denmark. Subjects. Patients (n =167) with uncomplica......Objective. To investigate whether short-term treatment with pivmecillinam was more effective than sulfamethizole in patients with acute uncomplicated urinary tract infection (UTI). Design. Randomized controlled trial. Setting. General practice, Denmark. Subjects. Patients (n =167......) with uncomplicated UTI confirmed by positive urine phase-contrast microscopy. Main outcome measures. Drug efficacy based on clinical and bacteriological cure. Results. Urinary symptoms disappeared first in patients treated with pivmecillinam, but after five days there was no significant difference in clinical cure...... in 68.8% of patients randomized to pivmecillinam and in 77.9% randomized to sulfamethizole (difference -9.2%, CI -24.7%; 6.3%). Some 26.8% of patients randomized to pivmecillinam experienced a new UTI within 6 months after treatment compared with 18.4% of patients randomized to sulfamethizole...

  1. Randomized Clinical Trial of Indirect Resin Composite and Ceramic Veneers : Up to 3-year Follow-up

    NARCIS (Netherlands)

    Gresnigt, Marco M. M.; Kalk, Warner; Ozcan, Mutlu

    2013-01-01

    Purpose: This randomized controlled split-mouth clinical trial evaluated the short-term survival rate of indirect resin composite and ceramic laminate veneers. Materials and Methods: A total of 10 patients (mean age: 48.6 years) received 46 indirect resin composite (Estenia; n = 23) and ceramic

  2. Clinical relevance of the gap between pre-marketing trials and medical practice : the case of the cardiovascular drugs

    NARCIS (Netherlands)

    Wieringa, N F; Denig, P; de Graeff, P A; Vos, R

    OBJECTIVES/BACKGROUND: The external validity of trial results of new cardiovascular drugs is limited, because the short-term studies are performed with relatively small, highly selected populations. Using qualitative methods, we examined the clinical relevance of under-representation of subgroups of

  3. The epidemiology of long- and short-term cancer survivors

    DEFF Research Database (Denmark)

    Jarlbæk, Lene; Christensen, Linda; Bruera, Eduardo

    2014-01-01

    Introduction. In this study, we present data from a population-based cohort of incident cancer patients separated in long- and short-term survivors. Our aim was to procure denominators for use in the planning of rehabilitation and palliative care programs. Material and methods. A registry......-linkage cohort study. All cancer patients, diagnosed from 1993 to 2003 from a 470 000 large population, were followed individually from diagnosis to death or until 31 December 2008. Long-term survivors lived five years or more after the time of the cancer diagnosis (TOCD). Short-term survivors died less than...... and sex. Two-year crude cancer survival seems as a clinically relevant cut point for characterizing potential "denominators" for rehabilitation or palliative care programs. From this cohort of incident cancer patients, and using two-year survival as a cut point, it could be estimated that 54% would...

  4. Stem cells in clinical trials for treatment of retinal degeneration.

    Science.gov (United States)

    Klassen, Henry

    2016-01-01

    After decades of basic science research involving the testing of regenerative strategies in animal models of retinal degenerative diseases, a number of clinical trials are now underway, with additional trials set to begin shortly. These efforts will evaluate the safety and preliminary efficacy of cell-based products in the eyes of patients with a number of retinal conditions, notably including age-related macular degeneration, retinitis pigmentosa and Stargardt's disease. This review considers the scientific work and early trials with fetal cells and tissues that set the stage for the current clinical investigatory work, as well the trials themselves, specifically those either now completed, underway or close to initiation. The cells of interest include retinal pigment epithelial cells derived from embryonic stem or induced pluripotent stem cells, undifferentiated neural or retinal progenitors or cells from the vascular/bone marrow compartment or umbilical cord tissue. Degenerative diseases of the retina represent a popular target for emerging cell-based therapeutics and initial data from early stage clinical trials suggest that short-term safety objectives can be met in at least some cases. The question of efficacy will require additional time and testing to be adequately resolved.

  5. Clinical trials. A pending subject.

    Science.gov (United States)

    Gil-Extremera, B; Jiménez-López, P; Mediavilla-García, J D

    2018-04-01

    Clinical trials are essential tools for the progress of clinical medicine in its diagnostic and therapeutic aspects. Since the first trial in 1948, which related tobacco use with lung cancer, there have been more than 150,000 clinical trials to date in various areas (paediatrics, cardiology, oncology, endocrinology, etc.). This article highlights the importance for all physicians to participate, over the course of their professional career, in a clinical trial, due to the inherent benefits for patients, the progress of medicine and for curricular prestige. The authors have created a synthesis of their experience with clinical trials on hypertension, diabetes, dyslipidaemia and ischaemic heart disease over the course of almost 3 decades. Furthermore, a brief reference has been made to the characteristics of a phase I unit, as well as to a number of research studies currently underway. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  6. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.

    2015-01-01

    The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform...... the design, conduct and analytical approaches to RCTs evaluating the preventative effect of joint injury prevention strategies. Recommendations regarding the design, conduct, and reporting of RCTs evaluating injury prevention interventions were established based on the consensus of nine researchers...... internationally with expertise in epidemiology, injury prevention and/or osteoarthritis (OA). Input and resultant consensus was established through teleconference, face to face and email correspondence over a 1 year period. Recommendations for injury prevention RCTs include context specific considerations...

  7. Short-term memory stores organized by information domain.

    Science.gov (United States)

    Noyce, Abigail L; Cestero, Nishmar; Shinn-Cunningham, Barbara G; Somers, David C

    2016-04-01

    Vision and audition have complementary affinities, with vision excelling in spatial resolution and audition excelling in temporal resolution. Here, we investigated the relationships among the visual and auditory modalities and spatial and temporal short-term memory (STM) using change detection tasks. We created short sequences of visual or auditory items, such that each item within a sequence arose at a unique spatial location at a unique time. On each trial, two successive sequences were presented; subjects attended to either space (the sequence of locations) or time (the sequence of inter item intervals) and reported whether the patterns of locations or intervals were identical. Each subject completed blocks of unimodal trials (both sequences presented in the same modality) and crossmodal trials (Sequence 1 visual, Sequence 2 auditory, or vice versa) for both spatial and temporal tasks. We found a strong interaction between modality and task: Spatial performance was best on unimodal visual trials, whereas temporal performance was best on unimodal auditory trials. The order of modalities on crossmodal trials also mattered, suggesting that perceptual fidelity at encoding is critical to STM. Critically, no cost was attributable to crossmodal comparison: In both tasks, performance on crossmodal trials was as good as or better than on the weaker unimodal trials. STM representations of space and time can guide change detection in either the visual or the auditory modality, suggesting that the temporal or spatial organization of STM may supersede sensory-specific organization.

  8. Short-term memory stores organized by information domain

    Science.gov (United States)

    Noyce, Abigail L.; Cestero, Nishmar; Shinn-Cunningham, Barbara G.; Somers, David C.

    2016-01-01

    Vision and audition have complementary affinities, with vision excelling in spatial resolution and audition excelling in temporal resolution. Here, we investigate the relationships among visual and auditory modalities and spatial and temporal short-term memory (STM) using change detection tasks. We created short sequences of visual or auditory items, such that each item within a sequence arose at a unique spatial location at a unique time. On each trial, two successive sequences were presented; subjects attended to either space (the sequence of locations), or time (the sequence of inter-item intervals), and reported whether the patterns of locations or intervals were identical. Each subject completed blocks of unimodal trials (both sequences presented in the same modality) and crossmodal trials (sequence 1 visual and sequence 2 auditory, or vice versa) for both spatial and temporal tasks. We found a strong interaction between modality and task: spatial performance was best on unimodal visual trials, while temporal performance was best on unimodal auditory trials. The order of modalities on crossmodal trials also mattered, suggesting that perceptual fidelity at encoding is critical to STM. Critically, there was no cost attributable to crossmodal comparison: in both tasks, performance on crossmodal trials was as good or better than on the weaker unimodal trials. STM representations of space and time can guide change detection in either the visual or the auditory modality, suggesting that temporal or spatial organization of STM may supersede sensory-specific organization. PMID:26791231

  9. Implementation of short-term prediction

    Energy Technology Data Exchange (ETDEWEB)

    Landberg, L; Joensen, A; Giebel, G [and others

    1999-03-01

    This paper will giver a general overview of the results from a EU JOULE funded project (`Implementing short-term prediction at utilities`, JOR3-CT95-0008). Reference will be given to specialised papers where applicable. The goal of the project was to implement wind farm power output prediction systems in operational environments at a number of utilities in Europe. Two models were developed, one by Risoe and one by the Technical University of Denmark (DTU). Both prediction models used HIRLAM predictions from the Danish Meteorological Institute (DMI). (au) EFP-94; EU-JOULE. 11 refs.

  10. Is visual short-term memory depthful?

    Science.gov (United States)

    Reeves, Adam; Lei, Quan

    2014-03-01

    Does visual short-term memory (VSTM) depend on depth, as it might be if information was stored in more than one depth layer? Depth is critical in natural viewing and might be expected to affect retention, but whether this is so is currently unknown. Cued partial reports of letter arrays (Sperling, 1960) were measured up to 700 ms after display termination. Adding stereoscopic depth hardly affected VSTM capacity or decay inferred from total errors. The pattern of transposition errors (letters reported from an uncued row) was almost independent of depth and cue delay. We conclude that VSTM is effectively two-dimensional. Copyright © 2014 Elsevier Ltd. All rights reserved.

  11. Frequency-specific insight into short-term memory capacity.

    Science.gov (United States)

    Feurra, Matteo; Galli, Giulia; Pavone, Enea Francesco; Rossi, Alessandro; Rossi, Simone

    2016-07-01

    The digit span is one of the most widely used memory tests in clinical and experimental neuropsychology for reliably measuring short-term memory capacity. In the forward version, sequences of digits of increasing length have to be reproduced in the order in which they are presented, whereas in the backward version items must be reproduced in the reversed order. Here, we assessed whether transcranial alternating current stimulation (tACS) increases the memory span for digits of young and midlife adults. Imperceptibly weak electrical currents in the alpha (10 Hz), beta (20 Hz), theta (5 Hz), and gamma (40 Hz) range, as well as a sham stimulation, were delivered over the left posterior parietal cortex, a cortical region thought to sustain maintenance processes in short-term memory through oscillatory brain activity in the beta range. We showed a frequency-specific effect of beta-tACS that robustly increased the forward memory span of young, but not middle-aged, healthy individuals. The effect correlated with age: the younger the subjects, the greater the benefit arising from parietal beta stimulation. Our results provide evidence of a short-term memory capacity improvement in young adults by online frequency-specific tACS application. Copyright © 2016 the American Physiological Society.

  12. Effect of Short-Term Supplementation with Ready-to-Use Therapeutic Food or Micronutrients for Children after Illness for Prevention of Malnutrition: A Randomised Controlled Trial in Uganda

    Science.gov (United States)

    van der Kam, Saskia; Roll, Stephanie; Swarthout, Todd; Edyegu-Otelu, Grace; Matsumoto, Akiko; Kasujja, Francis Xavier; Casademont, Cristian; Shanks, Leslie; Salse-Ubach, Nuria

    2016-01-01

    Background Globally, Médecins Sans Frontières (MSF) treats more than 300,000 severely malnourished children annually. Malnutrition is not only caused by lack of food but also by illnesses and by poor infant and child feeding practices. Breaking the vicious cycle of illness and malnutrition by providing ill children with nutritional supplementation is a potentially powerful strategy for preventing malnutrition that has not been adequately investigated. Therefore, MSF investigated whether incidence of malnutrition among ill children malnutrition rate between 8.4% and 11.5% of which 2% to 3% severe malnutrition, more than half (58%) of the population in the district of Kaabong is considered food insecure. Methods and Findings We investigated the effect of two types of nutritional supplementation on the incidence of malnutrition in ill children presenting at outpatient clinics during March 2011 to April 2012 in Kaabong, Karamoja region, Uganda, a resource-poor region where malnutrition is a chronic problem for its seminomadic population. A three-armed, partially-blinded, randomised controlled trial was conducted in children diagnosed with malaria, diarrhoea, or lower respiratory tract infection. Non-malnourished children aged 6 to 59 mo were randomised to one of three arms: one sachet/d of ready-to-use therapeutic food (RUTF), two sachets/d of micronutrient powder (MNP), or no supplement (control) for 14 d for each illness over 6 mo. The primary outcome was the incidence of first negative nutritional outcome (NNO) during the 6 mo follow-up. NNO was a study-specific measure used to indicate progression to moderate or severe acute malnutrition; it was defined as weight-for-height z-score malnutrition in eastern Uganda. The low incidence of malnutrition in this population may warrant a more targeted intervention to improve cost effectiveness. Trial Registration clinicaltrials.gov NCT01497236 PMID:26859481

  13. Short term depression unmasks the ghost frequency.

    Directory of Open Access Journals (Sweden)

    Tjeerd V Olde Scheper

    Full Text Available Short Term Plasticity (STP has been shown to exist extensively in synapses throughout the brain. Its function is more or less clear in the sense that it alters the probability of synaptic transmission at short time scales. However, it is still unclear what effect STP has on the dynamics of neural networks. We show, using a novel dynamic STP model, that Short Term Depression (STD can affect the phase of frequency coded input such that small networks can perform temporal signal summation and determination with high accuracy. We show that this property of STD can readily solve the problem of the ghost frequency, the perceived pitch of a harmonic complex in absence of the base frequency. Additionally, we demonstrate that this property can explain dynamics in larger networks. By means of two models, one of chopper neurons in the Ventral Cochlear Nucleus and one of a cortical microcircuit with inhibitory Martinotti neurons, it is shown that the dynamics in these microcircuits can reliably be reproduced using STP. Our model of STP gives important insights into the potential roles of STP in self-regulation of cortical activity and long-range afferent input in neuronal microcircuits.

  14. Short-term energy outlook, July 1998

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-07-01

    The Energy Information Administration (EIA) prepares The Short-Term Energy Outlook (energy supply, demand, and price projections) monthly for distribution on the internet at: www.eia.doe.gov/emeu/steo/pub/contents.html. In addition, printed versions of the report are available to subscribers in January, April, July and October. The forecast period for this issue of the Outlook extends from July 1998 through December 1999. Values for second quarter of 1998 data, however, are preliminary EIA estimates (for example, some monthly values for petroleum supply and disposition are derived in part from weekly data reported in EIA`s Weekly Petroleum Status Report) or are calculated from model simulations that use the latest exogenous information available (for example, electricity sales and generation are simulated by using actual weather data). The historical energy data, compiled in the July 1998 version of the Short-Term Integrated Forecasting System (STIFS) database, are mostly EIA data regularly published in the Monthly Energy Review, Petroleum Supply Monthly, and other EIA publications. Minor discrepancies between the data in these publications and the historical data in this Outlook are due to independent rounding. 28 figs., 19 tabs.

  15. Short-term energy outlook, January 1999

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1999-01-01

    The Energy Information Administration (EIA) prepares the Short-Term Energy Outlook (energy supply, demand, and price projections) monthly. The forecast period for this issue of the Outlook extends from January 1999 through December 2000. Data values for the fourth quarter 1998, however, are preliminary EIA estimates (for example, some monthly values for petroleum supply and disposition are derived in part from weekly data reported in EIA`s Weekly Petroleum Status Report) or are calculated from model simulations that use the latest exogenous information available (for example, electricity sales and generation are simulated by using actual weather data). The historical energy data, compiled in the January 1999 version of the Short-Term Integrated Forecasting System (STIFS) database, are mostly EIA data regularly published in the Monthly Energy Review, Petroleum Supply Monthly, and other EIA publications. Minor discrepancies between the data in these publications and the historical data in this Outlook are due to independent rounding. The STIFS model is driven principally by three sets of assumptions or inputs: estimates of key macroeconomic variables, world oil price assumptions, and assumptions about the severity of weather. Macroeconomic estimates are produced by DRI/McGraw-Hill but are adjusted by EIA to reflect EIA assumptions about the world price of crude oil, energy product prices, and other assumptions which may affect the macroeconomic outlook. By varying the assumptions, alternative cases are produced by using the STIFS model. 28 figs., 19 tabs.

  16. Measuring Short-term Energy Security

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-07-01

    Ensuring energy security has been at the centre of the IEA mission since its inception, following the oil crises of the early 1970s. While the security of oil supplies remains important, contemporary energy security policies must address all energy sources and cover a comprehensive range of natural, economic and political risks that affect energy sources, infrastructures and services. In response to this challenge, the IEA is currently developing a Model Of Short-term Energy Security (MOSES) to evaluate the energy security risks and resilience capacities of its member countries. The current version of MOSES covers short-term security of supply for primary energy sources and secondary fuels among IEA countries. It also lays the foundation for analysis of vulnerabilities of electricity and end-use energy sectors. MOSES contains a novel approach to analysing energy security, which can be used to identify energy security priorities, as a starting point for national energy security assessments and to track the evolution of a country's energy security profile. By grouping together countries with similar 'energy security profiles', MOSES depicts the energy security landscape of IEA countries. By extending the MOSES methodology to electricity security and energy services in the future, the IEA aims to develop a comprehensive policy-relevant perspective on global energy security. This Brochure provides and overview of the analysis and results. Readers interested in an in-depth discussion of methodology are referred to the MOSES Working Paper.

  17. Adaptive designs in clinical trials

    Directory of Open Access Journals (Sweden)

    Suresh Bowalekar

    2011-01-01

    Full Text Available In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.

  18. Adaptive designs in clinical trials.

    Science.gov (United States)

    Bowalekar, Suresh

    2011-01-01

    In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA)/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.

  19. Short-term memory for emotional faces in dysphoria.

    Science.gov (United States)

    Noreen, Saima; Ridout, Nathan

    2010-07-01

    The study aimed to determine if the memory bias for negative faces previously demonstrated in depression and dysphoria generalises from long- to short-term memory. A total of 29 dysphoric (DP) and 22 non-dysphoric (ND) participants were presented with a series of faces and asked to identify the emotion portrayed (happiness, sadness, anger, or neutral affect). Following a delay, four faces were presented (the original plus three distractors) and participants were asked to identify the target face. Half of the trials assessed memory for facial emotion, and the remaining trials examined memory for facial identity. At encoding, no group differences were apparent. At memory testing, relative to ND participants, DP participants exhibited impaired memory for all types of facial emotion and for facial identity when the faces featured happiness, anger, or neutral affect, but not sadness. DP participants exhibited impaired identity memory for happy faces relative to angry, sad, and neutral, whereas ND participants exhibited enhanced facial identity memory when faces were angry. In general, memory for faces was not related to performance at encoding. However, in DP participants only, memory for sad faces was related to sadness recognition at encoding. The results suggest that the negative memory bias for faces in dysphoria does not generalise from long- to short-term memory.

  20. Pitavastatin 4 mg Provides Significantly Greater Reduction in Remnant Lipoprotein Cholesterol Compared With Pravastatin 40 mg: Results from the Short-term Phase IV PREVAIL US Trial in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia.

    Science.gov (United States)

    Miller, P Elliott; Martin, Seth S; Joshi, Parag H; Jones, Steven R; Massaro, Joseph M; D'Agostino, Ralph B; Sponseller, Craig A; Toth, Peter P

    2016-03-01

    Remnants are partially hydrolyzed, triglyceride-rich lipoproteins that are implicated in atherosclerosis. We assessed the adequacy of pitavastatin 4 mg and pravastatin 40 mg in reducing atherogenic lipid parameters beyond LDL-C, in particular remnant lipoprotein cholesterol (RLP-C). From the Phase IV, multicenter, randomized, double-blind PREVAIL US (A Study of Pitavastatin 4 mg Vs. Pravastatin 40 mg in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia) trial, we examined lipoprotein cholesterol subfractions using Vertical Auto Profile testing and apolipoproteins B and A-I at baseline and 12 weeks. Participants with primary hyperlipidemia or mixed dyslipidemia had LDL-C levels of 130 to 220 mg/dL and triglyceride levels ≤ 400 mg/dL. In this post hoc analysis, changes in lipid parameters were compared by using ANCOVA. Lipoprotein subfraction data were available in 312 patients (pitavastatin, n = 157; pravastatin, n = 155). Pitavastatin promoted a greater reduction in RLP-C than pravastatin (-13.6 [8.7] vs -9.3 [9.5] mg/dL). Furthermore, the pitavastatin group reported greater reductions in both components of RLP-C (both, P < 0.001): intermediate-density lipoprotein cholesterol (-9.5 [6.3] vs -6.4 [6.6] mg/dL) and very low-density lipoprotein cholesterol subfraction 3 (-4.1 [3.5] vs -2.9 [3.8] mg/dL). There were also greater reductions in the major ratios of risk (apolipoprotein B/apolipoprotein A-I and total cholesterol/HDL-C) (both, P < 0.001). There were no significant changes in HDL-C, its subfractions, or natural log lipoprotein(a)-cholesterol. The mean age was 58.8 ± 8.9 years in the pitavastatin group and 57.0 ± 10.2 years in the pravastatin group. Compared with pravastatin 40 mg daily, pitavastatin 4 mg provided superior reductions in atherogenic lipid parameters beyond LDL-C, including RLP-C. Future studies are needed investigate the clinical implications of lowering directly measured RLP-C as the principal target. ClinicalTrials.gov identifier

  1. Distribution of Short-Term and Lifetime Predicted Risks of Cardiovascular Diseases in Peruvian Adults.

    Science.gov (United States)

    Quispe, Renato; Bazo-Alvarez, Juan Carlos; Burroughs Peña, Melissa S; Poterico, Julio A; Gilman, Robert H; Checkley, William; Bernabé-Ortiz, Antonio; Huffman, Mark D; Miranda, J Jaime

    2015-08-07

    Short-term risk assessment tools for prediction of cardiovascular disease events are widely recommended in clinical practice and are used largely for single time-point estimations; however, persons with low predicted short-term risk may have higher risks across longer time horizons. We estimated short-term and lifetime cardiovascular disease risk in a pooled population from 2 studies of Peruvian populations. Short-term risk was estimated using the atherosclerotic cardiovascular disease Pooled Cohort Risk Equations. Lifetime risk was evaluated using the algorithm derived from the Framingham Heart Study cohort. Using previously published thresholds, participants were classified into 3 categories: low short-term and low lifetime risk, low short-term and high lifetime risk, and high short-term predicted risk. We also compared the distribution of these risk profiles across educational level, wealth index, and place of residence. We included 2844 participants (50% men, mean age 55.9 years [SD 10.2 years]) in the analysis. Approximately 1 of every 3 participants (34% [95% CI 33 to 36]) had a high short-term estimated cardiovascular disease risk. Among those with a low short-term predicted risk, more than half (54% [95% CI 52 to 56]) had a high lifetime predicted risk. Short-term and lifetime predicted risks were higher for participants with lower versus higher wealth indexes and educational levels and for those living in urban versus rural areas (PPeruvian adults were classified as low short-term risk but high lifetime risk. Vulnerable adults, such as those from low socioeconomic status and those living in urban areas, may need greater attention regarding cardiovascular preventive strategies. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  2. Distribution of Short-Term and Lifetime Predicted Risks of Cardiovascular Diseases in Peruvian Adults

    Science.gov (United States)

    Quispe, Renato; Bazo-Alvarez, Juan Carlos; Burroughs Peña, Melissa S; Poterico, Julio A; Gilman, Robert H; Checkley, William; Bernabé-Ortiz, Antonio; Huffman, Mark D; Miranda, J Jaime

    2015-01-01

    Background Short-term risk assessment tools for prediction of cardiovascular disease events are widely recommended in clinical practice and are used largely for single time-point estimations; however, persons with low predicted short-term risk may have higher risks across longer time horizons. Methods and Results We estimated short-term and lifetime cardiovascular disease risk in a pooled population from 2 studies of Peruvian populations. Short-term risk was estimated using the atherosclerotic cardiovascular disease Pooled Cohort Risk Equations. Lifetime risk was evaluated using the algorithm derived from the Framingham Heart Study cohort. Using previously published thresholds, participants were classified into 3 categories: low short-term and low lifetime risk, low short-term and high lifetime risk, and high short-term predicted risk. We also compared the distribution of these risk profiles across educational level, wealth index, and place of residence. We included 2844 participants (50% men, mean age 55.9 years [SD 10.2 years]) in the analysis. Approximately 1 of every 3 participants (34% [95% CI 33 to 36]) had a high short-term estimated cardiovascular disease risk. Among those with a low short-term predicted risk, more than half (54% [95% CI 52 to 56]) had a high lifetime predicted risk. Short-term and lifetime predicted risks were higher for participants with lower versus higher wealth indexes and educational levels and for those living in urban versus rural areas (PPeruvian adults were classified as low short-term risk but high lifetime risk. Vulnerable adults, such as those from low socioeconomic status and those living in urban areas, may need greater attention regarding cardiovascular preventive strategies. PMID:26254303

  3. Effect of Short-Term Supplementation with Ready-to-Use Therapeutic Food or Micronutrients for Children after Illness for Prevention of Malnutrition: A Randomised Controlled Trial in Nigeria

    Science.gov (United States)

    van der Kam, Saskia; Salse-Ubach, Nuria; Roll, Stephanie; Swarthout, Todd; Gayton-Toyoshima, Sayaka; Jiya, Nma Mohammed; Matsumoto, Akiko; Shanks, Leslie

    2016-01-01

    Background Globally, Médecins Sans Frontières (MSF) treats more than 300,000 severely malnourished children annually. Malnutrition is not only caused by lack of food and poor infant and child feeding practices but also by illnesses. Breaking the vicious cycle of illness and malnutrition by providing ill children with nutritional supplementation is a potentially powerful strategy for preventing malnutrition that has not been adequately investigated. Therefore, MSF investigated whether incidence of malnutrition among ill children malnutrition rates. Methods and Findings We investigated the effect of supplementation with ready-to-use therapeutic food (RUTF) and a micronutrient powder (MNP) on the incidence of malnutrition in ill children presenting at an outpatient clinic in Goronyo during February to September 2012. A three-armed, partially-blinded, randomised controlled trial was conducted in children diagnosed as having malaria, diarrhoea, or lower respiratory tract infection. Children aged 6 to 59 mo were randomised to one of three arms: one sachet/d of RUTF; two sachets/d of micronutrients or no supplement (control) for 14 d for each illness over 6 mo. The primary outcome was the incidence of first negative nutritional outcome (NNO) during the 6 mo follow-up. NNO was a study-specific measure used to indicate occurrence of malnutrition; it was defined as low weight-for-height z-score (malnutrition. The lack of effect in Goronyo may be due to a high frequency of morbidity, which probably further affects a child’s nutritional status and children’s ability to escape from the illness–malnutrition cycle. The duration of the supplementation may have been too short or the doses of the supplements may have been too low to mitigate the effects of high morbidity and pre-existing malnutrition. An integrated approach combining prevention and treatment of diseases and treatment of moderate malnutrition, rather than prevention of malnutrition by nutritional

  4. Short-term effects of a hypocaloric diet with low glycemic index and low glycemic load on body adiposity, metabolic variables, ghrelin, leptin, and pregnancy rate in overweight and obese infertile women: a randomized controlled trial.

    Science.gov (United States)

    Becker, Geórgia F; Passos, Eduardo P; Moulin, Cileide C

    2015-12-01

    Obesity is related to hormonal disorders that affect the reproductive system. Low-glycemic index (LGI) diets seem to exert a positive effect on weight loss and on metabolic changes that result from obesity. We investigated the effects of a hypocaloric diet with an LGI and low glycemic load on anthropometric and metabolic variables, ghrelin and leptin concentrations, and the pregnancy rate in overweight and obese infertile women who were undergoing in vitro fertilization (IVF). The study was a randomized block-design controlled trial in which we analyzed 26 overweight or obese infertile women. Patients were assigned to a hypocaloric LGI-diet group or a control group and followed the protocol for 12 wk. Body weight, body mass index (BMI), percentage of body fat, glucose, insulin, homeostasis model assessment of insulin resistance, serum lipids, reproductive hormones, leptin, acylated ghrelin, number of oocytes retrieved in the IVF cycle, and pregnancy rate were determined. There were greater reductions in body mass, BMI, percentage of body fat, waist:hip ratio, and leptin in the LGI-diet group than in the control group (P diet group had 85.4% more oocytes retrieved than did the control group (7.75 ± 1.44 and 4.18 ± 0.87, respectively; P = 0.039) in the IVF cycle. Three patients (21.4%) in the LGI group experienced a spontaneous pregnancy during the follow-up, which generated 3 live births. The hypocaloric LGI diet promoted a decrease in BMI, percentage of body fat, and leptin concentrations, which improved oocyte development and pregnancy rate. These results support the clinical recommendation to advise overweight and obese women to lose weight through a balanced diet before being submitted for treatment with assisted reproduction technologies. A hypocaloric diet combined with LGI foods seems to be beneficial for these patients, but additional studies are required before this treatment is recommended. This trial was registered at clinicaltrials.gov as NCT02416960

  5. Short Term Airing by Natural Ventilation

    DEFF Research Database (Denmark)

    Heiselberg, Per; Perino, M.

    2010-01-01

    The need to improve the energy efficiency of buildings requires new and more efficient ventilation systems. It has been demonstrated that innovative operating concepts that make use of natural ventilation seem to be more appreciated by occupants. Among the available ventilation strategies...... that are currently available, buoyancy driven, single-sided natural ventilation has proved to be very effective and can provide high air change rates for temperature and Indoor Air Quality (IAQ) control. However, to promote a wider distribution of these systems an improvement in the knowledge of their working...... airflow rate, ventilation efficiency, thermal comfort and dynamic temperature conditions. A suitable laboratory test rig was developed to perform extensive experimental analyses of the phenomenon under controlled and repeatable conditions. The results showed that short-term window airing is very effective...

  6. Short-term forecasting of internal migration.

    Science.gov (United States)

    Frees, E W

    1993-11-01

    A new methodological approach to the forecasting of short-term trends in internal migration in the United States is introduced. "Panel-data (or longitudinal-data) models are used to represent the relationship between destination-specific out-migration and several explanatory variables. The introduction of this methodology into the migration literature is possible because of some new and improved databases developed by the U.S. Bureau of the Census.... Data from the Bureau of Economic Analysis are used to investigate the incorporation of exogenous factors as variables in the model." The exogenous factors considered include employment and unemployment, income, population size of state, and distance between states. The author concludes that "when one...includes additional parameters that are estimable in longitudinal-data models, it turns out that there is little additional information in the exogenous factors that is useful for forecasting." excerpt

  7. Economics of solar energy: Short term costing

    Science.gov (United States)

    Klee, H.

    The solar economics based on life cycle costs are refuted as both imaginary and irrelevant. It is argued that predicting rates of inflation and fuel escalation, expected life, maintenance costs, and legislation over the next ten to twenty years is pure guesswork. Furthermore, given the high mobility level of the U.S. population, the average consumer is skeptical of long run arguments which will pay returns only to the next owners. In the short term cost analysis, the house is sold prior to the end of the expected life of the system. The cash flow of the seller and buyer are considered. All the relevant factors, including the federal tax credit and the added value of the house because of the solar system are included.

  8. Short-term plasticity in auditory cognition.

    Science.gov (United States)

    Jääskeläinen, Iiro P; Ahveninen, Jyrki; Belliveau, John W; Raij, Tommi; Sams, Mikko

    2007-12-01

    Converging lines of evidence suggest that auditory system short-term plasticity can enable several perceptual and cognitive functions that have been previously considered as relatively distinct phenomena. Here we review recent findings suggesting that auditory stimulation, auditory selective attention and cross-modal effects of visual stimulation each cause transient excitatory and (surround) inhibitory modulations in the auditory cortex. These modulations might adaptively tune hierarchically organized sound feature maps of the auditory cortex (e.g. tonotopy), thus filtering relevant sounds during rapidly changing environmental and task demands. This could support auditory sensory memory, pre-attentive detection of sound novelty, enhanced perception during selective attention, influence of visual processing on auditory perception and longer-term plastic changes associated with perceptual learning.

  9. Pediatric Obstructive Uropathy: Clinical Trials

    International Nuclear Information System (INIS)

    Chan, C. M. C.; Scheinman, J. I.; Roth, K. S.

    2005-01-01

    As the powerful tools of molecular biology continue to delineate new concepts of pathogenesis of diseases, new molecular-level therapeutic modalities are certain to emerge. In order to design and execute clinical trials to evaluate outcomes of these new treatment modalities, we will soon need a new supply of investigators with training and experience in clinical research. The slowly-progressive nature of chronic pediatric kidney disease often results in diagnosis being made at a time remote from initial result, and the inherently slow rate of progression makes changes difficult to measure. Thus, development of molecular markers for both diagnosis and rate of progression will be critical to studies of new therapeutic modalities. We will review general aspects of clinical trials and will use current and past studies as examples to illustrate specific points, especially as these apply to chronic kidney disease associated with obstructive uropathy in children. (author)

  10. Oral health promotion reduces plaque and gingival bleeding in the short term.

    Science.gov (United States)

    Hausen, Hannu

    2005-01-01

    Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Health Technology Assessment Database, UK National Health Service Economic Evaluation Database, Cochrane Central Register of Controlled Trials and Medline. There were no date limits or language restriction. Systematic reviews and controlled trials (randomised or quasi-randomised) assessing reductions in dental plaque levels and/or gingival bleeding (gingivitis) and comparing health education/health promotion interventions that did not involve clinical professional input or the use of pharmacological interventions, such as antiplaque agents were included. Studies involving only special groups, such as orthodontic or medically compromised patients or assessing only denture plaque, were excluded. A range of data were extracted from systematic reviews and trials, quality assessment was undertaken, and a qualitative overview of the findings was provided. Twenty-six potentially relevant studies were identified. Six reports of five systematic reviews and 13 trials were discussed: four studies were not assessed as one was published in Polish and three could not be located.A wide range of educational and behavioural interventions were considered. These did not generally include clinical interventions and social or environmental approaches. The reviews have a number of limitations so their conclusions should be viewed with a degree of caution. However, the majority of studies achieved short-term reductions in plaque and gingival bleeding. Precise estimates of the improvement are difficult to assess because of the range and diversity of outcome measures used. The results of two meta-analyses indicate a reduction in plaque levels of 32-37%. Of 13 recently published trials evaluating educational interventions, five were set in schools, four focused on adults either in a clinical or workplace setting, three targeted older people, and one, infants. The design quality of the trials was variable

  11. Clinical Trials in Noninfectious Uveitis

    Science.gov (United States)

    Kim, Jane S.; Knickelbein, Jared E.; Nussenblatt, Robert B.; Sen, H. Nida

    2015-01-01

    The treatment of noninfectious uveitis continues to remain a challenge for many ophthalmologists. Historically, clinical trials in uveitis have been sparse, and thus, most treatment decisions have largely been based on clinical experience and consensus guidelines. The current treatment paradigm favors initiation then tapering of corticosteroids with addition of steroid-sparing immunosuppressive agents for persistence or recurrence of disease. Unfortunately, in spite of a multitude of highly unfavorable systemic effects, corticosteroids are still regarded as the mainstay of treatment for many patients with chronic and refractory noninfectious uveitis. However, with the success of other conventional and biologic immunomodulatory agents in treating systemic inflammatory and autoimmune conditions, interest in targeted treatment strategies for uveitis has been renewed. Multiple clinical trials on steroid-sparing immunosuppressive agents, biologic agents, intraocular corticosteroid implants, and topical ophthalmic solutions have already been completed, and many more are ongoing. This review discusses the results and implications of these clinical trials investigating both alternative and novel treatment options for noninfectious uveitis. PMID:26035763

  12. Presentation Modality and Proactive Interference in Children's Short-Term Memory.

    Science.gov (United States)

    Douglas, Joan Delahanty

    This study examined the role of visual and auditory presentation in memory encoding processes of 80 second-grade children, using the release-from-proactive-interference short-term memory (STM) paradigm. Words were presented over three trials within one of the presentation modes and one taxonomic category, followed by a fourth trial in which the…

  13. Short-term effects of a low glycemic index carob-containing snack on energy intake, satiety, and glycemic response in normal-weight, healthy adults: Results from two randomized trials.

    Science.gov (United States)

    Papakonstantinou, Emilia; Orfanakos, Nickolaos; Farajian, Paul; Kapetanakou, Anastasia E; Makariti, Ifigenia P; Grivokostopoulos, Nikolaos; Ha, Marie-Ann; Skandamis, Panagiotis N

    2017-10-01

    The potential positive health effects of carob-containing snacks are largely unknown. Therefore, the aims of these studies were to determine the glycemic index (GI) of a carob snack compared with chocolate cookie containing equal amounts of available carbohydrates and to compare the effects of a carob versus chocolate cookie preload consumed as snack before a meal on (a) short-term satiety response measured by subsequent ad libitum meal intake, (b) subjective satiety as assessed by visual analog scales and (c) postprandial glycemic response. Ten healthy, normal-weight volunteers participated in GI investigation. Then, 50 healthy, normal-weight individuals consumed, crossover, in random order, the preloads as snack, with 1-wk washout period. Ad libitum meal (lunch and dessert) was offered. Capillary blood glucose samples were collected at baseline, 2 h after breakfast, just before preload consumption, 2 h after preload, 3 h after preload, just before meal (lunch and dessert), 1 h after meal, and 2 h after meal consumption. The carob snack was a low GI food, whereas the chocolate cookie was a high GI food (40 versus 78, respectively, on glucose scale). Consumption of the carob preload decreased the glycemic response to a following meal and to the individual's feelings of hunger, desire to eat, preoccupation with food, and thirst between snack and meal, as assessed with the use of visual analog scales. Subsequently, participants consumed less amounts of food (g) and had lower total energy intake at mealtimes. The carob snack led to increased satiety, lower energy intake at meal, and decreased postmeal glycemic response possibly due to its low GI value. Identifying foods that promote satiety and decrease glycemic response without increasing the overall energy intake may offer advantages to body weight and glycemic control. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Evaluation of Short Term Memory Span Function In Children

    OpenAIRE

    Barış ERGÜL; Arzu ALTIN YAVUZ; Ebru GÜNDOĞAN AŞIK

    2016-01-01

    Although details of the information encoded in the short-term memory where it is stored temporarily be recorded in the working memory in the next stage. Repeating the information mentally makes it remain in memory for a long time. Studies investigating the relationship between short-term memory and reading skills that are carried out to examine the relationship between short-term memory processes and reading comprehension. In this study information coming to short-term memory and the factors ...

  15. In Search of Decay in Verbal Short-Term Memory

    Science.gov (United States)

    Berman, Marc G.; Jonides, John; Lewis, Richard L.

    2009-01-01

    Is forgetting in the short term due to decay with the mere passage of time, interference from other memoranda, or both? Past research on short-term memory has revealed some evidence for decay and a plethora of evidence showing that short-term memory is worsened by interference. However, none of these studies has directly contrasted decay and…

  16. Dissociating Measures of Consciousness from Measures of Short-Term Memory

    DEFF Research Database (Denmark)

    Sørensen, Thomas Alrik; Ásgeirsson, Árni Gunnar; Staugaard, Camilla Funch

    Often, the contents of consciousness are equated with the contents of short-term memory (or working memory), sometimes to a point where they are treated as identical entities. In the present study we aimed to investigate whether they may be modulated independently and thus dissociated from each...... if conscious content simply can be reduced to a cognitive process like short-term memory. In two experiments, we combined two different measures of short-term memory capacity to investigate how manipulations of set-size affect performance in observers with the Perceptual Awareness Scale (PAS) to measure...... conscious experience of the stimulus in every trial (Ramsøy & Overgaard, 2004; Overgaard & Sørensen, 2004). We trained observers to report their experience of a visual target stimulus on the four-point PAS scale; ranging from “no experience” to “clear experience”. To measure short-term memory we used...

  17. Gatekeepers for pragmatic clinical trials.

    Science.gov (United States)

    Whicher, Danielle M; Miller, Jennifer E; Dunham, Kelly M; Joffe, Steven

    2015-10-01

    To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the US clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This article provides a framework to help guide gatekeepers' decision-making related to the use of resources for pragmatic clinical trials. Relevant ethical considerations for gatekeepers include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers' decisions, including protection from harm and maximization of benefits; (2) advancement of organizational mission and values; and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers' actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding

  18. Circulating adiponectin levels in type 2 diabetes mellitus patients with or without non-alcoholic fatty liver disease: Results of a small, open-label, randomized controlled intervention trial in a subgroup receiving short-term exenatide.

    Science.gov (United States)

    Savvidou, Savvoula; Karatzidou, Kyparissia; Tsakiri, Kalliopi; Gagalis, Asterios; Hytiroglou, Prodromos; Goulis, John

    2016-03-01

    Diabetes mellitus type 2 (DMT2) and non-alcoholic fatty liver disease (NAFLD) are both characterized by decreased circulating adiponectin. Recently, glucagon-like peptide-1 receptor agonists have been shown to induce adiponectin's expression. However, their interaction on clinical grounds needs to be further elucidated. DMT2 patients with abnormal aminotransferases were screened for NAFLD and subjected to liver biopsy (group A, n=17). A subgroup of patients (n=110), after assessed for eligibility criteria, was blindly randomized to receive either 6-month exenatide supplementation on glargine insulin (group B) or intense, self-regulated, insulin therapy alone (group C). Baseline patient characteristics: 49(38.6%) males, aged 63.1 ± 7.5 years-old, BMI 32.9 ± 4.9 kg/m(2), HbA1c 8.1 ± 1.2% (65 ± 14 mmol/mol), median ALT 23 U/L (range 5-126), AST 20 U/L (7-72). Group A had biopsy-proven NAFLD with a median Activity Score of 5 and fibrosis stage 3. Presence of NAFLD was accompanied by a significant decline in adiponectin (p<0.001), which was negatively correlated with the degree of ALT in all groups (Spearman's correlation, rs=-0.644, p<0.001). In the subgroup intervention trial, adiponectin was significantly raised in both groups B and C (t-Student for paired samples, p=0.001) by Δ=+24.2% (interquartile range 14.8-53.2%). This elevation was not associated with the type of intervention but with weight loss, glycemic control and reduction of C-reactive protein (one-way ANCOVA). Supplementation of exenatide to glargine insulin compared to standard insulin was: (i) effective in inducing weight loss, (ii) non-inferior in lowering HbA1c and (iii) non-inferior in increasing circulating adiponectin. Higher adiponectin was associated with lower ALT, suggesting a hepato-protective role for this cytokine. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  19. Effect of Short-Term Supplementation with Ready-to-Use Therapeutic Food or Micronutrients for Children after Illness for Prevention of Malnutrition: A Randomised Controlled Trial in Uganda.

    Science.gov (United States)

    van der Kam, Saskia; Roll, Stephanie; Swarthout, Todd; Edyegu-Otelu, Grace; Matsumoto, Akiko; Kasujja, Francis Xavier; Casademont, Cristian; Shanks, Leslie; Salse-Ubach, Nuria

    2016-02-01

    Globally, Médecins Sans Frontières (MSF) treats more than 300,000 severely malnourished children annually. Malnutrition is not only caused by lack of food but also by illnesses and by poor infant and child feeding practices. Breaking the vicious cycle of illness and malnutrition by providing ill children with nutritional supplementation is a potentially powerful strategy for preventing malnutrition that has not been adequately investigated. Therefore, MSF investigated whether incidence of malnutrition among ill children malnutrition rate between 8.4% and 11.5% of which 2% to 3% severe malnutrition, more than half (58%) of the population in the district of Kaabong is considered food insecure. We investigated the effect of two types of nutritional supplementation on the incidence of malnutrition in ill children presenting at outpatient clinics during March 2011 to April 2012 in Kaabong, Karamoja region, Uganda, a resource-poor region where malnutrition is a chronic problem for its seminomadic population. A three-armed, partially-blinded, randomised controlled trial was conducted in children diagnosed with malaria, diarrhoea, or lower respiratory tract infection. Non-malnourished children aged 6 to 59 mo were randomised to one of three arms: one sachet/d of ready-to-use therapeutic food (RUTF), two sachets/d of micronutrient powder (MNP), or no supplement (control) for 14 d for each illness over 6 mo. The primary outcome was the incidence of first negative nutritional outcome (NNO) during the 6 mo follow-up. NNO was a study-specific measure used to indicate progression to moderate or severe acute malnutrition; it was defined as weight-for-height z-score children who died in the RUTF, MNP, and control groups were 0%, 0.8%, and 0.4%. The findings apply to ill but not malnourished children and cannot be generalised to a general population including children who are not necessarily ill or who are already malnourished. A 2-wk nutrition supplementation programme with RUTF

  20. HIV/AIDS Clinical Trials Fact Sheet

    Science.gov (United States)

    ... AIDS Drugs Clinical Trials Apps skip to content HIV Overview Home Understanding HIV/AIDS Fact Sheets HIV/ ... 4 p.m. ET) Send us an email HIV/AIDS Clinical Trials Last Reviewed: August 25, 2017 ...