Comparison of clinical efficacy and safety of thermotherapy versus cryotherapy in treatment of skin warts: A randomized controlled trial.

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Izadi Firouzabadi, Leila; Khamesipour, Ali; Ghandi, Narges; Hosseini, Hamed; Teymourpour, Amir; Firooz, Alireza

2018-01-01

The effect of thermotherapy in the treatment of skin warts in comparison to cryotherapy, as the standard conventional method, has remained uncertain. This study aimed to assess the clinical efficacy and safety of thermotherapy and cryotherapy in removing skin warts. This randomized controlled trial was conducted on 52 patients aged 18 years and over with ≤ 10 skin warts. The participants were randomly assigned into two groups to receive cryotherapy (every 2 to 3 weeks up to six sessions if required) or thermotherapy (one session). The patients in both groups were followed every 2 to 3 weeks for the first three months, and then three months after the last treatment session. The clearance rate was 79.2% in the thermotherapy group and 58.3% in the cryotherapy group with no significant difference (p = 0.212). The rate of scarring in the thermotherapy group was 20% (p = .018). A higher clearance rate was achieved in the thermotherapy group. However, this result was not statistically significant. There were some minimal post-treatment complications. Patients needed only one session of thermotherapy. Due to the risk of scarring, we suggest thermotherapy only as a suitable treatment method for palmoplantar warts. © 2017 Wiley Periodicals, Inc.

Mathematical modeling of efficacy and safety for anticancer drugs clinical development.

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Lavezzi, Silvia Maria; Borella, Elisa; Carrara, Letizia; De Nicolao, Giuseppe; Magni, Paolo; Poggesi, Italo

2018-01-01

Drug attrition in oncology clinical development is higher than in other therapeutic areas. In this context, pharmacometric modeling represents a useful tool to explore drug efficacy in earlier phases of clinical development, anticipating overall survival using quantitative model-based metrics. Furthermore, modeling approaches can be used to characterize earlier the safety and tolerability profile of drug candidates, and, thus, the risk-benefit ratio and the therapeutic index, supporting the design of optimal treatment regimens and accelerating the whole process of clinical drug development. Areas covered: Herein, the most relevant mathematical models used in clinical anticancer drug development during the last decade are described. Less recent models were considered in the review if they represent a standard for the analysis of certain types of efficacy or safety measures. Expert opinion: Several mathematical models have been proposed to predict overall survival from earlier endpoints and validate their surrogacy in demonstrating drug efficacy in place of overall survival. An increasing number of mathematical models have also been developed to describe the safety findings. Modeling has been extensively used in anticancer drug development to individualize dosing strategies based on patient characteristics, and design optimal dosing regimens balancing efficacy and safety.

Efficacy of cryotherapy for the treatment of cutaneous leishmaniasis: meta-analyses of clinical trials.

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López-Carvajal, Liliana; Cardona-Arias, Jaiberth Antonio; Zapata-Cardona, María Isabel; Sánchez-Giraldo, Vanesa; Vélez, Iván Darío

2016-07-26

Cryotherapy is a local treatment for cutaneous leishmaniasis with variable efficacy and greater safety than conventional treatment. The objective of this study is to evaluate the efficacy and safety of cryotherapy for the treatment of cutaneous leishmaniasis and to compare it with pentavalent antimonials. A meta-analysis based on a search of nine databases with eight strategies was conducted. Inclusion and exclusion criteria were applied, the methodological quality of each article was evaluated, and the reproducibility of the study selection and information extraction from each clinical trial was assured. The per lesion and per patient efficacy was calculated, and a meta-analysis of relative risks with the random effects model and the Dersimonian and Laird's, Begg, and Egger tests, along with a sensitivity analysis, were performed. A meta-regression based on the methodological quality of the trials included was also performed. Eight studies were included in which respective per lesion efficacies of 67.3 % and 67.7 % were reported for cryotherapy and pentavalent antimonials. In 271 patients treated with cryotherapy and in 199 with pentavalent antimonials, respective per protocol and intent to treat efficacies of 63.6 % and 54.2 % were found in the first group, and per protocol and intent to treat efficacies of 74.7 % and 68.3 % were found in the second group. The relative risk for the comparison of efficacy in the two groups was 0.73 (0.42-1.29). The results of the sensitivity analysis and the meta-regression analysis of relative risks were statistically equal to the overall results. This investigation provides evidence in favor of the use of cryotherapy given that its efficacy is similar to that of pentavalent antimonials.

Clinical efficacy and safety of polyethylene glycol 3350 versus liquid paraffin in the treatment of pediatric functional constipation.

Science.gov (United States)

Rafati, Mr; Karami, H; Salehifar, E; Karimzadeh, A

2011-01-01

Functional constipation is prevalent in children. Recently polyethylene glycol has been introduced as an effective and safe drug to treat chronic constipation. There are only a few clinical trials on comparison of PEG and liquid paraffin in childhood constipation. The purpose of this study was to evaluate clinical efficacy and safety of PEG 3350 solution and liquid paraffin in the treatment of children with functional constipation in Sari Toba clinic during the period of 2008-2009. Children with a history of functional constipation were subjects of this study. One hundred and sixty children of 2-12 years old with functional constipation were randomized in two PEG and paraffin treatment groups. Patients received either 1.0-1.5 g/kg/day PEG 3350 or 1.0-1.5 ml/kg/day liquid paraffin for 4 months. Clinical efficacy was evaluated by stool and encopresis frequency/week and overall treatment success rate was compared in two groups. Compared with the baseline, defecation frequency/ week increased significantly and encopresis frequency meaningfully decreased in two groups during the period of the study. Patients using PEG 3350 had more success rate (mean: 95.3%±3.7) compared with the patients in paraffin group (mean: 87.2%±7.1) (p=0.087). Administration of PEG 3350 were associated with less adverse events than liquid paraffin. In conclusion in treatment of pediatric functional constipation, regarding clinical efficacy and safety, PEG 3350 were at least as effective as liquid paraffin and but less adverse drug events.

Comparing student clinical self-efficacy and team process outcomes for a DEU, blended, and traditional clinical setting: A quasi-experimental research study.

Science.gov (United States)

Plemmons, Christina; Clark, Michele; Feng, Du

2018-03-01

Clinical education is vital to both the development of clinical self-efficacy and the integration of future nurses into health care teams. The dedicated education unit clinical teaching model is an innovative clinical partnership, which promotes skill development, professional growth, clinical self-efficacy, and integration as a team member. Blended clinical teaching models are combining features of the dedicated education unit and traditional clinical model. The aims of this study are to explore how each of three clinical teaching models (dedicated education unit, blended, traditional) affects clinical self-efficacy and attitude toward team process, and to compare the dedicated education unit model and blended model to traditional clinical. A nonequivalent control-group quasi-experimental design was utilized. The convenience sample of 272 entry-level baccalaureate nursing students included 84 students participating in a dedicated education unit model treatment group, 66 students participating in a blended model treatment group, and 122 students participating in a traditional model control group. Perceived clinical self-efficacy was evaluated by the pretest/posttest scores obtained on the General Self-Efficacy scale. Attitude toward team process was evaluated by the pretest/posttest scores obtained on the TeamSTEPPS® Teamwork Attitude Questionnaire. All three clinical teaching models resulted in significant increases in both clinical self-efficacy (p=0.04) and attitude toward team process (p=0.003). Students participating in the dedicated education unit model (p=0.016) and students participating in the blended model (pteam process among entry-level baccalaureate nursing students. Copyright © 2017 Elsevier Ltd. All rights reserved.

Efficacy of thermotherapy to treat cutaneous leishmaniasis: a meta-analysis of controlled clinical trials.

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Jaiberth Antonio Cardona-Arias

Full Text Available The efficacy of thermotherapy for the treatment of cutaneous leishmaniasis presents diverse results with low statistical power.To evaluate the efficacy of thermotherapy to treat cutaneous leishmaniasis.A meta-analysis of controlled clinical trials in 12 databases based on the implementation of a research protocol with inclusion and exclusion criteria and an assessment of methodological quality. The reproducibility and completeness were guaranteed in the information search and extraction. Heterogeneity, sensitivity and publication bias were assessed by graphical methods (Galbraith, L'Abblé, funnel plot, Egger plot, and influence plot and analytical methods (DerSimonian-Laird, Begg and Egger. Random-effects forest plots were constructed, and a cumulative meta-analysis was performed.Eight studies were included with 622 patients who underwent thermotherapy, with an efficacy of 73.2% (95% confidence interval (CI = 69.6-76.7%, and with 667 patients who underwent systemic treatment, with an efficacy of 70.6% (95% CI=67.1-74.1%. Heterogeneity between studies, good sensitivity for the combined measure, and no publication bias were observed. The relative risk for comparison of the efficacy of treatment was 1.02 (95%CI=0.91, 1.15, showing that the effectiveness of thermotherapy is equal to that of pentavalent antimonial drugs.Due to its efficacy, greater safety and lower cost, thermotherapy should be the first treatment option for cutaneous leishmaniasis in areas where the prevalence of the mucocutaneous form is low and in patients with contraindications to systemic treatment, such as kidney, liver and heart diseases, as well as in pregnant women, infants, and patients with human immunodeficiency virus infection/acquired immune deficiency syndrome.

Clinical efficacy and safety of polyethylene glycol 3350 versus liquid paraffin in the treatment of pediatric functional constipation

Directory of Open Access Journals (Sweden)

E Salehifar

2011-05-01

Full Text Available "nBackground and the purpose of the study: Functional constipation is prevalent in children. Recently has been introduced as an effective and safe drug to treat chronic constipation. There are only a few clinical trials on comparison of PEG and liquid paraffin in childhood constipation. The purpose of this study was to evaluate clinical efficacy and safety of PEG 3350 solution and liquid paraffin in the treatment of children with functional constipation in Sari Toba clinic during the period of 2008-2009. "nMethods: Children with a history of functional constipation were subjects of this study. One hundred and sixty children of 2-12 years old with functional constipation were randomized in two PEG and paraffin treatment groups. Patients received either 1.0-1.5 g/kg/day PEG 3350 or 1.0-1.5 ml/kg/day liquid paraffin for 4 months. Clinical efficacy was evaluated by stool and encopresis frequency/week and overall treatment success rate was compared in two groups. "nResults and major conclusion: Compared with the baseline, defecation frequency/ week increased significantly and encopresis frequency meaningfully decreased in two groups during the period of the study. Patients using PEG 3350 had more success rate (mean: 95.3%±3.7 compared with the patients in paraffin group (mean: 87.2%±7.1 (p=0.087. Administration of PEG 3350 was associated with less adverse events than liquid paraffin. In conclusion in treatment of pediatric functional constipation , regarding clinical efficacy and safety, PEG 3350 were at least as effective as liquid paraffin and but less adverse drug events.

Clinical efficacy and safety of polyethylene glycol 3350 versus liquid paraffin in the treatment of pediatric functional constipation

Science.gov (United States)

Rafati, MR.; Karami, H.; Salehifar, E.; Karimzadeh, A.

2011-01-01

Background and the purpose of the study Functional constipation is prevalent in children. Recently polyethylene glycol has been introduced as an effective and safe drug to treat chronic constipation. There are only a few clinical trials on comparison of PEG and liquid paraffin in childhood constipation. The purpose of this study was to evaluate clinical efficacy and safety of PEG 3350 solution and liquid paraffin in the treatment of children with functional constipation in Sari Toba clinic during the period of 2008–2009. Methods Children with a history of functional constipation were subjects of this study. One hundred and sixty children of 2–12 years old with functional constipation were randomized in two PEG and paraffin treatment groups. Patients received either 1.0–1.5 g/kg/day PEG 3350 or 1.0–1.5 ml/kg/day liquid paraffin for 4 months. Clinical efficacy was evaluated by stool and encopresis frequency/week and overall treatment success rate was compared in two groups. Results and major conclusion Compared with the baseline, defecation frequency/ week increased significantly and encopresis frequency meaningfully decreased in two groups during the period of the study. Patients using PEG 3350 had more success rate (mean: 95.3%±3.7) compared with the patients in paraffin group (mean: 87.2%±7.1) (p=0.087). Administration of PEG 3350 were associated with less adverse events than liquid paraffin. In conclusion in treatment of pediatric functional constipation, regarding clinical efficacy and safety, PEG 3350 were at least as effective as liquid paraffin and but less adverse drug events. PMID:22615652

Clinical efficacy of ampicillin in treatment of acute odontogenic abscess

Directory of Open Access Journals (Sweden)

Matijević Stevo

2009-01-01

Full Text Available Background/Aim. Antibiotics choice and the duration of their application in the therapy of acute odontogenic abscess is considered to be controversial. The aim of this study was to investigate the clinical efficacy of ampicillin in treatment of acute odontogenic abscess and to assess the antimicrobial susceptibility of the isolated bacteria in early phase of abscess development. Methods. This study included 60 patients with acute odontogenic abscess who were surgically treated (extraction of teeth and/or abscess incision divided into two groups, ampicillin group and surgical group (without antibiotic treatment. Results. In the ampicillin group of patients treatment lasted on the average 4.67 days, while in the surgical group 6.17 days. A total of 78 bacterial strains were isolated from 60 patients. The most often bacteria were found to be Gram-positive facultative anaerobs (68/78. The most common bacteria isolated were Viridans streptococci (43/78. Susceptibility of isolated bacteria to ampicillin were 70.5%. Conclusion. Peroral use of ampicillin, after surgical treatment in an early phase of dentoalveolar abscess development, statistically significantly reduced the time of clinical symptoms of acute odontogenic abscess in comparison to surgical treatment only. The isolated bacterial strains in an early phase of dentoalveolar abscess development showed a high sensitivity to ampicillin.

Clinical efficacy of radiotherapy combined with sodium glycididazole ...

African Journals Online (AJOL)

Purpose: To assess the clinical efficacy and side effects of radiotherapy combined with sodium glycididazole in the treatment of recurrent esophageal carcinoma. Methods: Ninety patients with locally recurrent oesophageal carcinoma who were admitted to the Oncology Department at Taian City Central Hospital, Shandong, ...

The importance of exercise self-efficacy for clinical outcomes in pulmonary rehabilitation.

Science.gov (United States)

Selzler, Anne-Marie; Rodgers, Wendy M; Berry, Tanya R; Stickland, Michael K

2016-11-01

Pulmonary rehabilitation (PR) improves functional exercise capacity and health status in people with chronic obstructive pulmonary disease (COPD), although these outcomes are often not maintained following PR. Self-efficacy is a precursor to outcomes achievement, yet few studies have examined the importance of self-efficacy to outcome improvement during PR, or how it develops over time. Further, the contribution of exercise-specific self-efficacy to outcomes in PR is unknown. The aims of this study were to determine (a) whether baseline exercise self-efficacy predicts PR attendance and change in functional exercise capacity and health status over PR, and (b) if exercise self-efficacy changes with PR. Fifty-eight out of 64 patients with COPD completed PR and assessments of exercise self-efficacy (task, coping, scheduling), the 6-minute walk test (6MWT), and St. George's Respiratory Questionnaire (SGRQ) at the beginning and end of PR. Analyses were conducted to predict attendance, and change in 6MWT and SGRQ, while controlling for baseline demographic and clinical indicators. Change in 6MWT, SGRQ, and self-efficacy with PR was also examined. Clinically significant increases in the 6MWT and SGRQ were achieved with PR. Stronger task self-efficacy predicted better attendance, while stronger coping self-efficacy predicted greater 6MWT improvement. No variables predicted SGRQ change. Scheduling self-efficacy significantly improved with PR, whereas task and coping self-efficacy did not. Baseline exercise self-efficacy appears to be a determinant of rehabilitation attendance and functional exercise improvement with PR. Clinicians should evaluate and target exercise self-efficacy to maximize adherence and health outcome improvement with PR. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

[Clinical efficacy of flomoxef in the field of pediatrics].

Science.gov (United States)

Ogura, H; Kubota, H; Murakami, N; Tomoda, T; Hamada, F; Matsumoto, K; Araki, K; Ogura, Y; Kurashige, T; Kitamura, I

1987-08-01

A new oxacephem antibiotic, flomoxef sodium (FMOX, 6315-S), was studied for its clinical efficacy in the field of pediatrics. The treated patients were infants and children ranging from 6 months to 14 years old suffering from bacterial pneumonia in 3 cases, acute tonsillitis in 2 cases, acute enterocolitis in 2 cases, and cellulitis and urinary tract infection in 1 case each, a total of 9 cases. FMOX was administered at (levels of) 57-150 mg/kg in daily dose with durations of treatment ranging from 5 to 18 days. Clinical efficacies of good or excellent results were obtained in all cases (excellent in 4, good in 5). As an adverse reaction, eosinophilia was observed in 1 patient. This elevation is, however, normalized with the cessation of the treatment.

MR arthrography: pharmacology, efficacy and safety in clinical trials

International Nuclear Information System (INIS)

Schulte-Altedorneburg, G.; Gebhard, M.; Wohlgemuth, W.A.; Fischer, W.; Zentner, J.; Bohndorf, K.; Wegener, R.; Balzer, T.

2003-01-01

A meta-analysis was carried out of clinical trials published between 1987 and 2001 in respect of the clinical pharmacology and safety as well as the diagnostic efficacy of gadolinium-DTPA (Gd-DTPA) for direct intra-articular injection before MRI examination.Design. Scientific papers (clinical, postmortem and experimental studies) and information from the manufacturer regarding intra-articular injection of Gd-DTPA that addressed questions of mode of action, optimal concentration and dose, elimination and safety were reviewed. Clinical studies were classified according to their study design. The sensitivity, specificity and accuracy of MR arthrography (MRA) were compared with a ''gold standard'' (arthroscopy, arthrotomy) and other radiological evidence for different joints.Results. Fifty-two clinical studies of the overall 112 studies addressed aspects of diagnostic efficacy of MRA in patients or in healthy volunteers. The shoulder was the most assessed joint (29 of 52 studies). Good (>80%) or even excellent (90-100%) sensitivity, specificity and accuracy were found for MRA in most indications, especially for the shoulder and knee joints and induced extension of rotator cuff lesions, labrum abnormalities and postoperative meniscal tears. Two millimoles per liter has proven to be the best concentration for intra-articular administration of Gd-DTPA. After passive complete diffusion from the joint within 6-24 h, complete and rapid renal elimination takes place after intra-articular injection. Local safety proved to be excellent after intra-articular administration of Gd-DTPA. Regarding systemic tolerance almost no side effects have been reported, but the same safety considerations apply for intra-articular administration of Gd-DTPA as for intravenous injection.Conclusions. The diagnostic efficacy of intra-articular MRA in most clinical conditions affecting major joints is greater than that of plain MRI. In some diagnostic problems MRA achieves almost the same

A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

African Journals Online (AJOL)

A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

[Clinical efficacy of flomoxef in neonatal bacterial infection].

Science.gov (United States)

Sakata, H; Hirano, Y; Maruyama, S

1993-03-01

One hundred and seventy one neonates were treated with flomoxef (FMOX) and the clinical efficacy and safety were evaluated. The ages of the patients ranged from 0 to 28 days, and their body weights from 450 to 4300 g. Dose levels were 12.4 to 24.9 mg/kg every 8 or 12 hours for 1 to 10 days. Fifty two patients who responded to the FMOX treatment included 5 neonates with sepsis, 17 with suspected sepsis, 9 with urinary tract infections, 12 with pneumonia, 8 with intrauterine infections, and 1 with omphalitis. The other neonates could not be retrospectively diagnosed as bacterial infections. Of 52 patients, clinical results were excellent in 15, good in 34, fair in 1, and poor in 2. And the FMOX treatment was effective in 13 out of 14 patients in which causative bacteria were identified. The drug was well tolerated, but 6 neonates out of 33 over 5 days old had diarrhea. From these results, empiric treatment with FMOX against neonatal bacterial infection was as clinically useful as that of combination with ampicillin and gentamicin or cefotaxime and ampicillin in our neonatal intensive care unit. But, as this study did not include neonate with meningitis, efficacy to meningitis was not evaluated.

Clinical Efficacy of Psychoeducational Interventions with Family Caregivers

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Limiñana-Gras, Rosa M.; Colodro-Conde, Lucía; Cuéllar-Flores, Isabel; Sánchez-López, M. Pilar

2016-01-01

The goal of this study is to investigate the efficacy of psychoeducational interventions geared to reducing psychological distress for caregivers in a sample of 90 family caregivers of elderly dependent (78 women and 12 men). We conducted an analysis of the statistical and clinical significance of the changes observed in psychological health…

Comparison of the medical students' perceived self-efficacy and the evaluation of the observers and patients.

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Ammentorp, Jette; Thomsen, Janus Laust; Jarbøl, Dorte Ejg; Holst, René; Øvrehus, Anne Lindebo Holm; Kofoed, Poul-Erik

2013-04-08

The accuracy of self-assessment has been questioned in studies comparing physicians' self-assessments to observed assessments; however, none of these studies used self-efficacy as a method for self-assessment. The aim of the study was to investigate how medical students' perceived self-efficacy of specific communication skills corresponds to the evaluation of simulated patients and observers. All of the medical students who signed up for an Objective Structured Clinical Examination (OSCE) were included. As a part of the OSCE, the student performance in the "parent-physician interaction" was evaluated by a simulated patient and an observer at one of the stations. After the examination the students were asked to assess their self-efficacy according to the same specific communication skills. The Calgary Cambridge Observation Guide formed the basis for the outcome measures used in the questionnaires. A total of 12 items was rated on a Likert scale from 1-5 (strongly disagree to strongly agree). We used extended Rasch models for comparisons between the groups of responses of the questionnaires. Comparisons of groups were conducted on dichotomized responses. Eighty-four students participated in the examination, 87% (73/84) of whom responded to the questionnaire. The response rate for the simulated patients and the observers was 100%. Significantly more items were scored in the highest categories (4 and 5) by the observers and simulated patients compared to the students (observers versus students: -0.23; SE:0.112; p=0.002 and patients versus students:0.177; SE:0.109; p=0.037). When analysing the items individually, a statistically significant difference only existed for two items. This study showed that students scored their communication skills lower compared to observers or simulated patients. The differences were driven by only 2 of 12 items. The results in this study indicate that self-efficacy based on the Calgary Cambridge Observation guide seems to be a reliable

Spinal Cord Stimulation: Clinical Efficacy and Potential Mechanisms.

Science.gov (United States)

Sdrulla, Andrei D; Guan, Yun; Raja, Srinivasa N

2018-03-11

Spinal cord stimulation (SCS) is a minimally invasive therapy used for the treatment of chronic neuropathic pain. SCS is a safe and effective alternative to medications such as opioids, and multiple randomized controlled studies have demonstrated efficacy for difficult-to-treat neuropathic conditions such as failed back surgery syndrome. Conventional SCS is believed mediate pain relief via activation of dorsal column Aβ fibers, resulting in variable effects on sensory and pain thresholds, and measurable alterations in higher order cortical processing. Although potentiation of inhibition, as suggested by Wall and Melzack's gate control theory, continues to be the leading explanatory model, other segmental and supraspinal mechanisms have been described. Novel, non-standard, stimulation waveforms such as high-frequency and burst have been shown in some studies to be clinically superior to conventional SCS, however their mechanisms of action remain to be determined. Additional studies are needed, both mechanistic and clinical, to better understand optimal stimulation strategies for different neuropathic conditions, improve patient selection and optimize efficacy. © 2018 World Institute of Pain.

Comparison of BNCT and GdNCT efficacy in treatment of canine cancer

Energy Technology Data Exchange (ETDEWEB)

Mitin, V.N. [Russian Cancer Research Center of the RAMS, Kashirskoe shosse, 24, 115478 Moscow (Russian Federation); Kulakov, V.N.; Khokhlov, V.F.; Sheino, I.N. [State Research Center Institute of Biophysics, Zhivopisnaya ul., 46, 123182 Moscow (Russian Federation); Arnopolskaya, A.M. [Russian Cancer Research Center of the RAMS, Kashirskoe shosse, 24, 115478 Moscow (Russian Federation)], E-mail: ariana_777@inbox.ru; Kozlovskaya, N.G. [Russian Cancer Research Center of the RAMS, Kashirskoe shosse, 24, 115478 Moscow (Russian Federation); Zaitsev, K.N.; Portnov, A.A. [Moscow Engineering Physics Institute, Kashirskoe shosse, 31, 115409 Moscow (Russian Federation)

2009-07-15

In this study efficacy of antineoplastic action of gadolinium NCT and boron NCT in cases of canine melanoma and osteosarcoma was compared. Canine spontaneous tumors, such as melanoma and osteosarcoma, have clinical common features with human malignancies, so these tumors in dogs can be considered as clinical model of human melanoma and osteosarcoma. The study has been carried out on 33 dogs with oral cavity melanoma and 9 dogs with osteosarcoma. Dogs with spontaneous melanoma of oral cavity and osteosarcoma of extremities were selected by the results of clinical examination. Irradiation was carried out at the NCT facility of the IRT MEPhI reactor. Neutron irradiation without boron or gadolinium was chosen as a control method to evaluate the efficacy of NCT.

Comparison of BNCT and GdNCT efficacy in treatment of canine cancer

International Nuclear Information System (INIS)

Mitin, V.N.; Kulakov, V.N.; Khokhlov, V.F.; Sheino, I.N.; Arnopolskaya, A.M.; Kozlovskaya, N.G.; Zaitsev, K.N.; Portnov, A.A.

2009-01-01

In this study efficacy of antineoplastic action of gadolinium NCT and boron NCT in cases of canine melanoma and osteosarcoma was compared. Canine spontaneous tumors, such as melanoma and osteosarcoma, have clinical common features with human malignancies, so these tumors in dogs can be considered as clinical model of human melanoma and osteosarcoma. The study has been carried out on 33 dogs with oral cavity melanoma and 9 dogs with osteosarcoma. Dogs with spontaneous melanoma of oral cavity and osteosarcoma of extremities were selected by the results of clinical examination. Irradiation was carried out at the NCT facility of the IRT MEPhI reactor. Neutron irradiation without boron or gadolinium was chosen as a control method to evaluate the efficacy of NCT.

Clinical efficacy of bromocriptine and the influence of serum ...

African Journals Online (AJOL)

Nouran Abdelaziz AbouKhedr

2013-05-18

May 18, 2013 ... Clinical efficacy of bromocriptine and the influence of serum prolactin levels on disease severity in patients with chronic plaque-type psoriasis. Nouran Abdelaziz AbouKhedr, Amira Abulfotooh Eid *. Department of Dermatology, Venereology and Andrology, Faculty of Medicine, University of Alexandria, ...

Alflutop clinical efficacy in vertebral osteochondrosis (12-mohth study

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V N Hodyrev

2005-01-01

Full Text Available Objective. To study clinical efficacy of aiflutop (A in lumbar osteochondrosis (LO with chronic back pain syndrome. Material and Methods. 32 pts with LO were included. 14 from them (group 1 during a year received 2 courses of A intramuscular injections (I ml/day, 30 ml total and nonsteroidal anti-inflammatory drugs (NSAIDs if necessary. 18 pts (group 2 received NSAIDs only. Clinical examination of pts was performed at the stert of the study, before and after each A course and in 3 months after the last course. Results. Pain in the spine at rest and forward bending significantly decreased in group 1 pts (p<0,05 after each A course. Full pain disappearance after the first A course was achieved in 7,1% and after the second course - in 35,7% of group I pts and was not shown in control group. Significant stepped decrease of Thomayer's test value (p<0,00l was also shown in group 1: 3,6 times decrease in comparison with baseline was achieved in 3 months after completion of treatment with A. During treatment period these pts showed 2-2,5 times increase of static and dynamic spine load (according to Vxdel chronic inability index. 42,9% of group I pts stopped NSAIDs after A treatment completion. Only 5,6% of control group pts stopped NSAIDs during follow up. A tolerability was good. It can be combined with any other medications the pts received due to comorbid diseases.

The efficacy of maggot debridement therapy - a review of comparative clinical trials

DEFF Research Database (Denmark)

Zarchi, K.; Jemec, G.B.

2012-01-01

in a variety of ulcers. However, comparative clinical trials and in particular randomized controlled trials investigating the efficacy of MDT are sparse. A systematic search in the literature showed three randomized clinical trials and five non randomized studies evaluating the efficacy of sterile Lucilia......, including hydrocolloid, hydrogel and saline moistened gauze. However, the design of the studies was suboptimal, with important differences in the use of other therapies, such as compression, that may influence both debridement and healing between the compared groups, as well as inappropriately short follow...

Clinical efficacy of bromocriptine and the influence of serum ...

African Journals Online (AJOL)

Background: Psoriasis is a T-cell mediated hyperproliferative cutaneous disease of multifactorial etiology. Prolactin (PRL) has been implicated in the pathogenesis of psoriasis and several studies have pointed to a potential therapeutic role of bromocriptine in psoriasis. Aim: To assess the clinical efficacy of bromocriptine ...

Clinical Efficacy Comparison of Saccharomyces Boulardii and Lactic Acid as Probiotics in Acute Pediatric Diarrhea.

Science.gov (United States)

Asmat, Shakila; Shaukat, Fouzia; Asmat, Raheela; Bakhat, Hafiz Faiq Siddique Gul; Asmat, Tauseef M

2018-03-01

To compare the efficacy of Saccharomyces boulardii and lactic acid producing probiotics in addition to usual treatment regimen to cure diarrhea among children (6 months to 5 years of age). Randomized controlled trial. Department of Pediatrics, Sheikh Zayed Hospital, Lahore, from February to July 2015. Children suffering from acute diarrhea were orally administered Saccharomyces boulardii and lactic acid producing probiotics for 5 days. The efficacy of administered probiotics was monitored. Patients were given Saccharomyces boulardii and lactic acid producing probiotics randomly to remove the bias. Two hundred patients randomly selected for trials; out of which, 100 were treated with Saccharomyces boulardii while the other 100 were supplemented with lactic acid concomitantly along with conventional diarrhea treatment. Results indicated that Saccharomyces boulardii treatment group has significantly higher efficacy rate (45%) compared to lactic acid producing probiotics (26%). This study concluded that Saccharomyces boulardii has a better efficacy compared to lactic acid and may be adopted as a probiotic of choice.

Clinical efficacy of a tea-bag formulation of Cryptolepis ...

African Journals Online (AJOL)

Objective: To evaluate the clinical efficacy and safety of a tea bag formulation of the root of C. sanguinolenta. Design: This is a prospective descriptive open trial. Setting: Patients were recruited from Korle-Bu, Mamprobi and Dansoman Polyclinics. Subjects: Forty-four subjects with uncomplicated malaria were recruited for ...

A clinical comparison of safety and efficacy in phacoemulsification with versus without ophthalmic viscoelastic device.

Science.gov (United States)

Kugu, Suleyman; Erdogan, Gurkan; Sahin Sevim, M; Ozerturk, Yusuf

2015-03-01

To evaluate in a comparative manner the safety and efficacy of 1.0% sodium-Hyaluronate used during capsulorhexis and intraocular lens (IOL) implantation in phacoemulsification surgery. 1.0% sodium-Hyaluronate, which is commonly used as one of the ophthalmic viscoelastic devices, was compared to intraocular irrigating solution, which can bring up these effects. In addition, the effect of both methods on occurring corneal endothelial cell (CEC) loss was investigated. Each group comprised 19 eyes. The mean preoperative CEC density was 2525.68 ± 181.85 in Group H and 2514.16 ± 174.59 in Group V; no statistically significant difference was found between the groups (p > 0.05). Preoperative and postoperative first and twelfth week CEC densities were 2438.21 ± 198.12 (p  0.05). Although it was found that there was no statistically difference in terms of preventing CEC loss between 1.0% sodium-Hyaluronate and the irrigation method during phacoemulsification, it was observed clinically that 1.0% sodium-hyaluronate can make the procedure easy, safer, very helpful, especially for understanding phacoemulsification.

A Comparison of the Anesthesia Efficacy of Articaine and Articaine plus

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Tahere Aliabadi

2014-07-01

Full Text Available Background: Successful local anesthesia is the bedrock of pain control in endodontics. Pain control is essential to reduce fear and anxiety associated with endodontic procedure. The aim of study was, identifying and comparison of the anesthesia efficacy of articaine and articaine plus morphine for buccal infiltration in mandibular posterior teeth with irriversible pulpitis. Materials and Methods: This randomized double-blind clinical trial included 75 patients with symtomatically irreversible pulpitis in mandibular teeth. Patient divided 3 groups randomly received either a buccal infiltration of 4% articaine with 1:100000 epinephrine or articaine morphine with 1:100000 epinephrine or IAN block of 2% lidocaine with 1:800000 epinephrine. Self-reported pain response was recorded on VAS scale before and after local anesthetic injection during access preparation. For statistical analysis were used χ2, t-test, one way ANOVA and Mann Whitney. Results: Statistical analysis result show success rate of articaine (68%, articaine morphine (52% and lidocaine (64%. There was no statistically difference in the success rate between groups. Conclusion: Addition of the morphine to articaine does not increase success rate of buccal infiltration.

Time-dependent efficacy of longitudinal biomarker for clinical endpoint.

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Kolamunnage-Dona, Ruwanthi; Williamson, Paula R

2018-06-01

Joint modelling of longitudinal biomarker and event-time processes has gained its popularity in recent years as they yield more accurate and precise estimates. Considering this modelling framework, a new methodology for evaluating the time-dependent efficacy of a longitudinal biomarker for clinical endpoint is proposed in this article. In particular, the proposed model assesses how well longitudinally repeated measurements of a biomarker over various time periods (0,t) distinguish between individuals who developed the disease by time t and individuals who remain disease-free beyond time t. The receiver operating characteristic curve is used to provide the corresponding efficacy summaries at various t based on the association between longitudinal biomarker trajectory and risk of clinical endpoint prior to each time point. The model also allows detecting the time period over which a biomarker should be monitored for its best discriminatory value. The proposed approach is evaluated through simulation and illustrated on the motivating dataset from a prospective observational study of biomarkers to diagnose the onset of sepsis.

Comparative Evaluation of the Antimicrobial Efficacy of Three Immersion Chemical Disinfectants on Clinically Derived Poly(Vinyl Siloxane) Impressions.

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Jeyapalan, Vidhya; Krishnan, Chitra Shankar; Ramasubramanian, Hariharan; Sampathkumar, Jayakrishnakumar; Azhagarasan, N S; Krishnan, Madhusudan

2016-07-06

To comparatively evaluate the antimicrobial efficacy of freshly prepared electrolyzed oxidizing water (EOW) with that of 2.4% glutaraldehyde (GA) and 1% sodium hypochlorite (SH) on clinically derived poly vinyl siloxane (PVS) impressions. Four clinically derived PVS impressions each were obtained from 10 subjects. One impression from each subject was randomly kept as control (group I), without disinfection. The remaining three impressions were randomly disinfected by immersion in either 2.4% GA (group II), 1% SH (group III), or freshly prepared EOW (group IV). The samples were subjected to microbial culture individually on brain heart infusion (BHI) agar medium. The organisms isolated were confirmed by visual examination and gram staining. Mean colony forming units (CFU) were counted, log 10 reduction obtained and compared. Data were statistically analyzed using one-way ANOVA, followed by multiple comparisons using Tukey-HSD post hoc tests (p < 0.05). Streptococci, Staphylococci, Pseudomonas, Candida, Proteus, Klebsiella, and E. coli were isolated from all impressions including the controls, except those disinfected by EOW. All three disinfectants showed significant reduction in CFU and log 10 reduction values as compared to the controls. EOW showed significantly higher reduction in log 10 values compared to GA and SH, whereas GA and SH showed similar reductions. EOW, GA, and SH showed kill rates of 100%, 99.60%, and 99.82%, respectively. EOW showed significant antimicrobial efficacy as evidenced by reduction in log 10 values when used as an immersion disinfectant for PVS impressions when compared with the results obtained using GA and SH. These results need further investigation. EOW shows high antimicrobial efficacy when used as an immersion disinfectant as compared to GA and SH for clinically derived PVS impressions. © 2016 by the American College of Prosthodontists.

Efficacy of local drug delivery of Achyranthes aspera gel in the management of chronic periodontitis: A clinical study

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Ramanarayana Boyapati

2017-01-01

Full Text Available Context: Periodontitis is an inflammatory disease of microbial origin. Locally delivered antimicrobials reduce subgingival flora. Achyranthes aspera gel has antimicrobial, antioxidant, anti-inflammatory, and immunostimulant effects. Aims: To evaluate the efficacy of local drug delivery of A. aspera gel in the management of chronic periodontitis. Materials and Methods: Thirty patients with chronic periodontitis were considered in the study and categorized into two equal groups (Group A: scaling and root planing (SRP with A. aspera gel, Group B: SRP with placebo gel. Patients were enlisted from the Department of Periodontics, Mamata Dental College and Hospital. The clinical parameters (gingival index, bleeding on probing, probing pocket depth, and clinical attachment level were recorded at baseline and 3 months. Statistical Analysis Used: All the obtained data were sent for statistical analyses using SPSS version 18. Results: The periodontitis and the Achyranthes were statistically analyzed. A comparison of clinical parameters for test group and control group from baseline to 3 months was done using paired t-test. Intergroup comparison for both the groups was done using independent sample t-test. Conclusions: A. aspera gel when delivered locally along with SRP showed a beneficial effect. A. aspera gel as a non-surgical local drug delivery system proved to be without any side effects in the management of periodontitis. A. aspera gel has strong anti-inflammatory effects in addition to its antioxidant activity.

Efficacy of local drug delivery of Achyranthes aspera gel in the management of chronic periodontitis: A clinical study.

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Boyapati, Ramanarayana; Gojja, Prathibha; Chintalapani, Srikanth; Nagubandi, Kirankumar; Ramisetti, Arpita; Salavadhi, Shyam Sunder

2017-01-01

Periodontitis is an inflammatory disease of microbial origin. Locally delivered antimicrobials reduce subgingival flora. Achyranthes aspera gel has antimicrobial, antioxidant, anti-inflammatory, and immunostimulant effects. To evaluate the efficacy of local drug delivery of A. aspera gel in the management of chronic periodontitis. Thirty patients with chronic periodontitis were considered in the study and categorized into two equal groups (Group A: scaling and root planing (SRP) with A. aspera gel, Group B: SRP with placebo gel). Patients were enlisted from the Department of Periodontics, Mamata Dental College and Hospital. The clinical parameters (gingival index, bleeding on probing, probing pocket depth, and clinical attachment level) were recorded at baseline and 3 months. All the obtained data were sent for statistical analyses using SPSS version 18. The periodontitis and the Achyranthes were statistically analyzed. A comparison of clinical parameters for test group and control group from baseline to 3 months was done using paired t -test. Intergroup comparison for both the groups was done using independent sample t -test. A. aspera gel when delivered locally along with SRP showed a beneficial effect. A. aspera gel as a non-surgical local drug delivery system proved to be without any side effects in the management of periodontitis. A. aspera gel has strong anti-inflammatory effects in addition to its antioxidant activity.

A comparative, randomized, controlled study on clinical efficacy and dental staining reduction of a mouthwash containing Chlorhexidine 0.20% and Anti Discoloration System (ADS).

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Marrelli, Massimo; Amantea, Massimiliano; Tatullo, Marco

2015-01-01

A good control of bacterial plaque is an essential factor for the success of periodontal therapy, therefore it is the main objective that the clinician together with the patient must get to have a healthy periodontium. The plaque control with mouthwashes is the most important home therapy as it helps to reduce the formation of plaque between the mechanical removal with a toothbrush. Authors analyzed the clinical data from a trial carried out with 3 different mouthwashes containing 0.2% Chlorhexidine (CHX). In addition, the ADS (Anti Discoloration System - Curaden Healthcare) was tested in comparison with the other mouthwashes without this system. We tested antiplaque activity showed by 3 of the most commercialized mouthwashes, moreover, we tested the ability in reducing the dental staining related to the oral assumption of Chlorhexidine. Our results demonstrated the clinical efficacy of the 3 mouthwashes with CHX. Particularly performing was the anti discoloration system (Curaden Healthcare), with a clinical detection of dental stainings significantly less than the others tested. This study demonstrated the clinical efficacy of ADS system in the reduction of tooth staining, without a loss of antiplaque activity with respect to the competing mouthwashes containing CHX.

Clinical efficacy and safety of edaravone therapy in acute cerebral ...

African Journals Online (AJOL)

Purpose: To evaluate the clinical efficacy and safety of edaravone in the treatment of acute cerebral haemorrhage (ACH). Methods: This study recruited 120 patients who developed ACH. The patients were divided into control and treatment groups with 60 patients per group. The control group underwent conventional ...

Comparison of efficacy of three commercially available antibiotic discs

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Joshi A

2008-01-01

Full Text Available A study was undertaken to evaluate the efficacy of commercially available antimicrobial discs manufactured by Oxoid, UK, HiMedia Laboratories, Mumbai and Span Diagnostics, Surat. The discs were evaluated for their performance on the basis of percentage of coefficient of variation (%CV which is a measure of reproducibility, mean zone diameters which is a measure of accuracy and range of zone diameter using both standard ATCC strains and clinical isolates. The data showed variation for all three manufacturers and therefore routine and regular quality control of discs as well as meticulous following of good laboratory practices is strongly advocated in clinical laboratories

Efficacy of Pharmacist Based Diabetes Educational Interventions on Clinical Outcomes of Adults With Type 2 Diabetes Mellitus: A Network Meta-Analysis

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Allah Bukhsh

2018-04-01

Full Text Available Background: Comparative efficacy of different pharmacist based interventions on glycemic control of type 2 diabetes patients is unclear. This review aimed to evaluate and compare the efficacy of different pharmacist based interventions on clinical outcomes of type 2 diabetes patients.Methods: A systematic search was conducted across five databases from date of database inception to September 2017. All randomized clinical trials evaluating the efficacy of pharmacist based interventions on type 2 diabetes patients were included for network meta-analysis (NMA. The protocol is available with PROSPERO (CRD42017078854.Results: A total of 43 studies, involving 6259 type 2 diabetes patients, were included. NMA demonstrated that all interventions significantly lowered glycosylated hemoglobin (HbA1c levels compared to usual care, but there was no statistical evidence from this study that one intervention was significantly better than the other for reducing HbA1c levels. Pharmacist based diabetes education plus pharmaceutical care showed maximum efficacy for reducing HbA1c levels [−0.86, 95% CI −0.983, −0.727; p < 0.001]. Pharmacist based diabetes education plus pharmaceutical care was observed to be statistically significant in lowering levels of systolic blood pressure [−4.94; 95%CI −8.65, −1.23] and triglycerides levels [−0.26, 95%CI −0.51, −0.01], as compared to the interventions which involved diabetes education by pharmacist, and for body mass index (BMI [−0.57; 95%CI −1.25, −0.12] in comparison to diabetes education by health care team involving pharmacist as member.Conclusion: The findings of this review demonstrate that all interventions had a significantly positive effect on HbA1c, but there was no statistical evidence from this study that one intervention was significantly better than the other for achieving glycemic control.Pharmacist based diabetes education plus pharmaceutical care showed maximum efficacy on HbA1c and

Rufinamide from clinical trials to clinical practice in the United States and Europe.

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Resnick, Trevor; Arzimanoglou, Alexis; Brown, Lawrence W; Flamini, Robert; Kerr, Michael; Kluger, Gerhard; Kothare, Sanjeev; Philip, Sunny; Harrison, Miranda; Narurkar, Milind

2011-05-01

Rufinamide is a triazole derivative structurally unrelated to other antiepileptic drugs that is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients aged ≥4 years. Originally granted orphan drug status, marketing authorisation was obtained on the basis of a randomised, double-blind, placebo-controlled trial conducted in 138 LGS patients. An open-label extension study subsequently demonstrated that rufinamide's efficacy and tolerability were maintained over the longer term (median duration of treatment, 432 days). Recently published reports from Europe and the United States have described the use of adjunctive rufinamide to treat LGS in clinical practice. These data complement the clinical trial results, by providing information on the efficacy and tolerability of rufinamide when used on an individualised basis in real-world practice, under less tightly restricted conditions in terms of patient population and dosing strategies. A comparison of the data reveals that a "lower and slower" dosing strategy tends to be adopted in clinical practice, in comparison with the clinical trial, which does not appear to compromise efficacy, but may provide improvements in tolerability. Individual case reports provide additional valuable information on how rufinamide is being used to treat different seizure types associated with LGS. Since clinical experience with rufinamide is currently at an early stage, there are still unanswered questions relating to its use, and it is likely that its place in the adjunctive treatment of LGS will evolve as further data emerge.

Comparison between Unilateral and Bilateral Ovarian Drilling in Clomiphene Citrate Resistance Polycystic Ovary Syndrome Patients: A Randomized Clinical Trial of Efficacy

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Zahiri Sorouri, Ziba; Sharami, Seyede Hajar; Tahersima, Zinab; Salamat, Fatemeh

2015-01-01

Background Laparoscopic ovarian drilling (LOD) is an alternative method to induce ovulation in polycystic ovary syndrome (PCOS) patients with clomiphene citrate (CC) resistant instead of gonadotropins. This study aimed to compare the efficacy of unilateral LOD (ULOD) versus bilateral LOD (BLOD) in CC resistance PCOS patients in terms of ovulation and pregnancy rates. Materials and Methods In a prospective randomized clinical trial study, we included 100 PCOS patients with CC resistance attending to Al-Zahra Hospital in Rasht, Guilan Province, Iran, from June 2011 to July 2012. Patients were randomly divided into two ULOD and BLOD groups with equal numbers. The clinical and biochemical responses on ovulation and pregnancy rates were assessed over a 6-month follow-up period. Results Differences in baseline characteristics of patients between two groups prior to laparoscopy were not significant (p>0.05). There were no significant differences between the two groups in terms of clinical and biochemical responses, spontaneous menstruation (66.1 vs. 71.1%), spontaneous ovulation rate (60 vs. 64.4%), and pregnancy rate (33.1 vs. 40%) (p>0.05). Following drilling, there was a significant decrease in mean serum concentrations of luteinizing hormone (LH) (p=0.001) and testosterone (p=0.001) in both the groups. Mean decrease in serum LH (p=0.322) and testosterone concentrations (p=0.079) were not statistically significant between two groups. Mean serum level of follicle stimulating hormone (FSH) did not change significantly in two groups after LOD (p>0.05). Conclusion Based on results of this study, ULOD seems to be equally efficacious as BLOD in terms of ovulation and pregnancy rates (Registration Number: IRCT138903291306N2). PMID:25918587

Comparison of the clinical efficacy between tigecycline plus extended-infusion imipenem and sulbactam plus imipenem against ventilator-associated pneumonia with pneumonic extensively drug-resistant Acinetobacter baumannii bacteremia, and correlation of clinical efficacy with in vitro synergy tests.

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Jean, Shio-Shin; Hsieh, Tai-Chin; Hsu, Chin-Wan; Lee, Wen-Sen; Bai, Kuan-Jen; Lam, Carlos

2016-12-01

To compare the clinical efficacy between salvage antimicrobial regimen consisting of tigecycline plus extended-infusion imipenem/cilastatin (TIC) and regimen of sulbactam plus imipenem/cilastatin (SIC) for patients with ventilator-associated pneumonia and pneumonic bacteremia due to extensively drug-resistant (XDR) Acinetobacter baumannii (Ab) isolates, and determine the correlation of results of in vitro tigecycline-imipenem synergy test with clinical efficacy. The comparative survey was conducted at a medical center in Taiwan in 2013. Patients comprising the TIC group (n = 28) received tigecycline plus extended-infusion imipenem/cilastatin following unresponsiveness to 3-day sulbactam-imipenem/cilastatin therapy, and those in the SIC group (n = 56) received sulbactam-imipenem/cilastatin throughout the course. Univariate and multivariate analyses were applied to explore 30-day case-fatality independent predictors. Additionally, the checkerboard test and time-kill analysis were performed for the bloodstream XDR-Ab isolates from patients in the TIC group, and molecular characterization was done for the bloodstream XDR-Ab strains of all patients. We found that the TIC scheme has a significant benefit on improving patients' survival status (the mortality rate of TIC and SIC group patients was 14.3% and 64.3%, respectively), corresponding well with in vitro synergy or additivity results by the checkerboard test. Twenty TIC group cases had monomicrobial XDR-Ab cultured from tracheal aspirates after 10 days of tigecycline-imipenem/cilastatin therapy, but none developed subsequent pneumonia. However, breakthrough primary Burkholderia cepacia (n = 3) and Pseudomonas aeruginosa (n = 1) bacteremias were attributed to four TIC case fatalities. Shock, SIC regimen usage, and development of breakthrough bacteremia were independent predictors of 30-day in-hospital mortality. Although the TIC regimen showed good efficacy, its value regarding managing XDR-Ab ventilator

Multiple comparisons in drug efficacy studies: scientific or marketing principles?

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Leo, Jonathan

2004-01-01

When researchers design an experiment to compare a given medication to another medication, a behavioral therapy, or a placebo, the experiment often involves numerous comparisons. For instance, there may be several different evaluation methods, raters, and time points. Although scientifically justified, such comparisons can be abused in the interests of drug marketing. This article provides two recent examples of such questionable practices. The first involves the case of the arthritis drug celecoxib (Celebrex), where the study lasted 12 months but the authors only presented 6 months of data. The second case involves the NIMH Multimodal Treatment Study (MTA) study evaluating the efficacy of stimulant medication for attention-deficit hyperactivity disorder where ratings made by several groups are reported in contradictory fashion. The MTA authors have not clarified the confusion, at least in print, suggesting that the actual findings of the study may have played little role in the authors' reported conclusions.

Clinical efficacy of composite versus ceramic inlays and onlays: a systematic review.

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Fron Chabouis, Hélène; Smail Faugeron, Violaine; Attal, Jean-Pierre

2013-12-01

Large tooth substance losses are frequent in posterior teeth because of primary caries or aging restorations. Inlays and onlays are often the minimal invasive solution in such cases, but the efficacy of the composite and ceramic materials used is unknown. We performed a systematic review of randomized controlled trials comparing the efficacy of composite and ceramic inlays or onlays. MEDLINE, Embase and the Cochrane Central Register of Controlled Trials were searched without any restriction on date or language, as were references of eligible studies and ClinicalTrials.gov. Eligible studies were randomized trials comparing the clinical efficacy of composite to ceramic inlays or onlays in adults with any clinical outcome for at least 6 months. From 172 records identified, we examined reports of 2 randomized controlled trials involving 138 inlays (no onlays evaluated) in 80 patients and exhibiting a high-risk of bias. Outcomes were clinical scores and major failures. The 3-year overall failure risk ratio was 2 [0.38-10.55] in favor of ceramic inlays although not statistically significant. The reported clinical scores (United States Public Health Services and Californian Dental Association) showed considerable heterogeneity between trials and could not be combined. We have very limited evidence that ceramics perform better than composite material for inlays in the short term. However, this result may not be valid in the long term, and other trials are needed. Trials should follow Fédération dentaire internationale recommendations and enhance their methodology. Trials comparing composite and ceramic onlays are needed. Copyright © 2013 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Clinical efficacy of gene-modified stem cells in adenosine deaminase-deficient immunodeficiency.

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Shaw, Kit L; Garabedian, Elizabeth; Mishra, Suparna; Barman, Provaboti; Davila, Alejandra; Carbonaro, Denise; Shupien, Sally; Silvin, Christopher; Geiger, Sabine; Nowicki, Barbara; Smogorzewska, E Monika; Brown, Berkley; Wang, Xiaoyan; de Oliveira, Satiro; Choi, Yeong; Ikeda, Alan; Terrazas, Dayna; Fu, Pei-Yu; Yu, Allen; Fernandez, Beatriz Campo; Cooper, Aaron R; Engel, Barbara; Podsakoff, Greg; Balamurugan, Arumugam; Anderson, Stacie; Muul, Linda; Jagadeesh, G Jayashree; Kapoor, Neena; Tse, John; Moore, Theodore B; Purdy, Ken; Rishi, Radha; Mohan, Kathey; Skoda-Smith, Suzanne; Buchbinder, David; Abraham, Roshini S; Scharenberg, Andrew; Yang, Otto O; Cornetta, Kenneth; Gjertson, David; Hershfield, Michael; Sokolic, Rob; Candotti, Fabio; Kohn, Donald B

2017-05-01

Autologous hematopoietic stem cell transplantation (HSCT) of gene-modified cells is an alternative to enzyme replacement therapy (ERT) and allogeneic HSCT that has shown clinical benefit for adenosine deaminase-deficient (ADA-deficient) SCID when combined with reduced intensity conditioning (RIC) and ERT cessation. Clinical safety and therapeutic efficacy were evaluated in a phase II study. Ten subjects with confirmed ADA-deficient SCID and no available matched sibling or family donor were enrolled between 2009 and 2012 and received transplantation with autologous hematopoietic CD34+ cells that were modified with the human ADA cDNA (MND-ADA) γ-retroviral vector after conditioning with busulfan (90 mg/m2) and ERT cessation. Subjects were followed from 33 to 84 months at the time of data analysis. Safety of the procedure was assessed by recording the number of adverse events. Efficacy was assessed by measuring engraftment of gene-modified hematopoietic stem/progenitor cells, ADA gene expression, and immune reconstitution. With the exception of the oldest subject (15 years old at enrollment), all subjects remained off ERT with normalized peripheral blood mononuclear cell (PBMC) ADA activity, improved lymphocyte numbers, and normal proliferative responses to mitogens. Three of nine subjects were able to discontinue intravenous immunoglobulin replacement therapy. The MND-ADA vector was persistently detected in PBMCs (vector copy number [VCN] = 0.1-2.6) and granulocytes (VCN = 0.01-0.3) through the most recent visits at the time of this writing. No patient has developed a leukoproliferative disorder or other vector-related clinical complication since transplant. These results demonstrate clinical therapeutic efficacy from gene therapy for ADA-deficient SCID, with an excellent clinical safety profile. ClinicalTrials.gov NCT00794508. Food and Drug Administration Office of Orphan Product Development award, RO1 FD003005; NHLBI awards, PO1 HL73104 and Z01 HG000122; UCLA

Clinical efficacy of gene-modified stem cells in adenosine deaminase–deficient immunodeficiency

Science.gov (United States)

Shaw, Kit L.; Garabedian, Elizabeth; Mishra, Suparna; Barman, Provaboti; Davila, Alejandra; Carbonaro, Denise; Shupien, Sally; Silvin, Christopher; Geiger, Sabine; Nowicki, Barbara; Smogorzewska, E. Monika; Brown, Berkley; Wang, Xiaoyan; de Oliveira, Satiro; Choi, Yeong; Ikeda, Alan; Terrazas, Dayna; Fu, Pei-Yu; Yu, Allen; Fernandez, Beatriz Campo; Cooper, Aaron R.; Engel, Barbara; Podsakoff, Greg; Balamurugan, Arumugam; Anderson, Stacie; Muul, Linda; Jagadeesh, G. Jayashree; Kapoor, Neena; Tse, John; Moore, Theodore B.; Purdy, Ken; Rishi, Radha; Mohan, Kathey; Skoda-Smith, Suzanne; Buchbinder, David; Abraham, Roshini S.; Scharenberg, Andrew; Yang, Otto O.; Cornetta, Kenneth; Gjertson, David; Hershfield, Michael; Sokolic, Rob; Candotti, Fabio

2017-01-01

BACKGROUND. Autologous hematopoietic stem cell transplantation (HSCT) of gene-modified cells is an alternative to enzyme replacement therapy (ERT) and allogeneic HSCT that has shown clinical benefit for adenosine deaminase–deficient (ADA-deficient) SCID when combined with reduced intensity conditioning (RIC) and ERT cessation. Clinical safety and therapeutic efficacy were evaluated in a phase II study. METHODS. Ten subjects with confirmed ADA-deficient SCID and no available matched sibling or family donor were enrolled between 2009 and 2012 and received transplantation with autologous hematopoietic CD34+ cells that were modified with the human ADA cDNA (MND-ADA) γ-retroviral vector after conditioning with busulfan (90 mg/m2) and ERT cessation. Subjects were followed from 33 to 84 months at the time of data analysis. Safety of the procedure was assessed by recording the number of adverse events. Efficacy was assessed by measuring engraftment of gene-modified hematopoietic stem/progenitor cells, ADA gene expression, and immune reconstitution. RESULTS. With the exception of the oldest subject (15 years old at enrollment), all subjects remained off ERT with normalized peripheral blood mononuclear cell (PBMC) ADA activity, improved lymphocyte numbers, and normal proliferative responses to mitogens. Three of nine subjects were able to discontinue intravenous immunoglobulin replacement therapy. The MND-ADA vector was persistently detected in PBMCs (vector copy number [VCN] = 0.1–2.6) and granulocytes (VCN = 0.01–0.3) through the most recent visits at the time of this writing. No patient has developed a leukoproliferative disorder or other vector-related clinical complication since transplant. CONCLUSION. These results demonstrate clinical therapeutic efficacy from gene therapy for ADA-deficient SCID, with an excellent clinical safety profile. TRIAL REGISTRATION. ClinicalTrials.gov NCT00794508. FUNDING. Food and Drug Administration Office of Orphan Product

Efficacy and safety of retinol palmitate ophthalmic solution in the treatment of dry eye: a Japanese Phase II clinical trial.

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Toshida, Hiroshi; Funaki, Toshinari; Ono, Koichi; Tabuchi, Nobuhito; Watanabe, Sota; Seki, Tamotsu; Otake, Hiroshi; Kato, Takuji; Ebihara, Nobuyuki; Murakami, Akira

2017-01-01

The purpose of this study was to investigate the efficacy and safety of the administration of retinol palmitate (VApal) ophthalmic solution (500 IU/mL) for the treatment of patients with dry eye. This study included 66 patients with dry eye. After a 2-week washout period, patients were randomized (1:1) into either a VApal ophthalmic solution or a placebo group, and a single drop of either solution was administered six times daily for 4 weeks. Efficacy measures were 12 subjective symptoms, rose bengal (RB) and fluorescein staining scores, tear film breakup time, and tear secretion. Safety measures included clinical blood and urine analyses and adverse event recordings. In comparisons of the two groups, the mean change in RB staining score from baseline was significantly lower in the VApal group at 2 and 4 weeks ( P ophthalmic solution (500 IU/mL) is safe and effective for the treatment of patients with dry eye.

An Exploration of the Needling Depth in Acupuncture: The Safe Needling Depth and the Needling Depth of Clinical Efficacy

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Jaung-Geng Lin

2013-01-01

Full Text Available Objective. To explore the existing scientific information regarding safe needling depth of acupuncture points and the needling depth of clinical efficacy. Methods. We searched the PubMed, EMBASE, Cochrane, Allied and Complementary Medicine (AMED, The National Center for Complementary and Alternative Medicine (NCCAM, and China National Knowledge Infrastructure (CNKI databases to identify relevant monographs and related references from 1991 to 2013. Chinese journals and theses/dissertations were hand searched. Results. 47 studies were recruited and divided into 6 groups by measuring tools, that is, MRI, in vivo evaluation, CT, ultrasound, dissected specimen of cadavers, and another group with clinical efficacy. Each research was analyzed for study design, definition of safe depth, and factors that would affect the measured depths. Depths of clinical efficacy were discussed from the perspective of de-qi and other clinical observations. Conclusions. Great inconsistency in depth of each point measured from different subject groups and tools exists. The definition of safe depth should be established through standardization. There is also lack of researches to compare the clinical efficacy. A well-designed clinical trial selecting proper measuring tools to decide the actual and advisable needling depth for each point, to avoid adverse effects or complications and promote optimal clinical efficacy, is a top priority.

Efficacy Coefficients Determined Using Nail Permeability and Antifungal Activity in Keratin-Containing Media Are Useful for Predicting Clinical Efficacies of Topical Drugs for Onychomycosis.

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Yoshiki Matsuda

Full Text Available Onychomycosis is difficult to treat topically due to the deep location of the infection under the densely keratinized nail plate. In order to obtain an in vitro index that is relevant to the clinical efficacy of topical anti-onychomycosis drugs, we profiled five topical drugs: amorolfine, ciclopirox, efinaconazole, luliconazole, and terbinafine, for their nail permeabilities, keratin affinities, and anti-dermatophytic activities in the presence of keratin. Efinaconazole and ciclopirox permeated full-thickness human nails more deeply than luliconazole. Amorolfine and terbinafine did not show any detectable permeation. The free-drug concentration of efinaconazole in a 5% human nail keratin suspension was 24.9%, which was significantly higher than those of the other drugs (1.1-3.9%. Additionally, efinaconazole was released from human nail keratin at a greater proportion than the other drugs. The MICs of the five drugs for Trichophyton rubrum were determined at various concentrations of keratin (0-20% in RPMI 1640 medium. The MICs of ciclopirox were not affected by keratin, whereas those of efinaconazole were slightly increased and those of luliconazole and terbinafine were markedly increased in the presence of 20% keratin. Efficacy coefficients were calculated using the nail permeation flux and MIC in media without or with keratin. Efinaconazole showed the highest efficacy coefficient, which was determined using MIC in media with keratin. The order of efficacy coefficients determined using MIC in keratin-containing media rather than keratin-free media was consistent with that of complete cure rates in previously reported clinical trials. The present study revealed that efficacy coefficients determined using MIC in keratin-containing media are useful for predicting the clinical efficacies of topical drugs. In order to be more effective, topical drugs have to possess higher efficacy coefficients.

Learning in clinical practice: Stimulating and discouraging response to social comparison.

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Raat, Janet; Kuks, Jan; Cohen-Schotanus, Janke

2010-01-01

Social comparison theory is relevant for learning in general. In a clinical context, we examined four hypotheses concerning: preferred other to compare with, preferred direction of comparison, response to social comparison and influence of personal social comparison orientation (SCO). To investigate the relevance of social comparison for clinical workplace learning. Students (n = 437) from nine different hospitals completed two questionnaires measuring their SCO and the direction of and response to their comparisons. t-tests were used to analyse the data. Students substantially did compare. They preferred to compare with peer students more than with residents or staff, and with peers doing better more than with peers doing worse. Their response to social comparison was more often stimulating for learning than discouraging. Students high in SCO reported a stronger stimulating and discouraging response to their comparisons than students low in SCO. Social comparison does play a role in clinical workplace learning. The mainly stimulating response to social comparison indicates a positive learning influence. The preferred comparison with peers emphasizes the role of peers in the learning process. Further research should focus on student comparison behaviour and on situations that strengthen the positive effects of social comparison and reduce the negative or obstructing ones.

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

African Journals Online (AJOL)

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

Acamprosate for treatment of alcohol dependence: mechanisms, efficacy, and clinical utility

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Witkiewitz K

2012-02-01

Full Text Available Katie Witkiewitz, Kimber Saville, Kacie HamreusDepartment of Psychology, Washington State University Vancouver, Vancouver, WA, USAAbstract: Acamprosate, or N-acetyl homotaurine, is an N-methyl-D-aspartate receptor modulator approved by the Food and Drug Administration (FDA as a pharmacological treatment for alcohol dependence. The exact mechanism of action of acamprosate is still under investigation, but the drug appears to work by promoting a balance between the excitatory and inhibitory neurotransmitters, glutamate and gamma-aminobutyric acid, respectively, and it may help individuals with alcohol dependence by reducing withdrawal-associated distress. Acamprosate has low bioavailability, but also has an excellent tolerability and safety profile. In comparison with naltrexone and disulfiram, which are the other FDA-approved treatments for alcohol dependence, acamprosate is unique in that it is not metabolized by the liver and is also not impacted by alcohol use, so can be administered to patients with hepatitis or liver disease (a common comorbid condition among individuals with alcohol dependence and to patients who continue drinking alcohol. Acamprosate has demonstrated its efficacy in more than 25 placebo-controlled, double-blind trials for individuals with alcohol dependence, and has generally been found to be more efficacious than placebo in significantly reducing the risk of returning to any drinking and increasing the cumulative duration of abstinence. However, acamprosate appears to be no more efficacious than placebo in reducing heavy drinking days. Numerous trials have found that acamprosate is not significantly more efficacious than naltrexone or disulfiram, and the efficacy of acamprosate does not appear to be improved by combining acamprosate with other active medications (eg, naltrexone or with psychosocial treatment (eg, cognitive-behavioral therapy. In this review, we present the data on acamprosate, including its pharmacology

Genetic Counseling Supervisors' Self-Efficacy for Select Clinical Supervision Competencies.

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Finley, Sabra Ledare; Veach, Pat McCarthy; MacFarlane, Ian M; LeRoy, Bonnie S; Callanan, Nancy

2016-04-01

Supervision is a primary instructional vehicle for genetic counseling student clinical training. Approximately two-thirds of genetic counselors report teaching and education roles, which include supervisory roles. Recently, Eubanks Higgins and colleagues published the first comprehensive list of empirically-derived genetic counseling supervisor competencies. Studies have yet to evaluate whether supervisors possess these competencies and whether their competencies differ as a function of experience. This study investigated three research questions: (1) What are genetic counselor supervisors' perceptions of their capabilities (self-efficacy) for a select group of supervisor competencies?, (2) Are there differences in self-efficacy as a function of their supervision experience or their genetic counseling experience, and 3) What training methods do they use and prefer to develop supervision skills? One-hundred thirty-one genetic counselor supervisors completed an anonymous online survey assessing demographics, self-efficacy (self-perceived capability) for 12 goal setting and 16 feedback competencies (Scale: 0-100), competencies that are personally challenging, and supervision training experiences and preferences (open-ended). A MANOVA revealed significant positive effects of supervision experience but not genetic counseling experience on participants' self-efficacy. Although mean self-efficacy ratings were high (>83.7), participant comments revealed several challenging competencies (e.g., incorporating student's report of feedback from previous supervisors into goal setting, and providing feedback about student behavior rather than personal traits). Commonly preferred supervision training methods included consultation with colleagues, peer discussion, and workshops/seminars.

CLINICAL AND IMMUNOPATHOLOGIC CHARACTERISTICS OF EARLY NEONATAL SEPSIS IN INFANTS OF DIFFERENT GESTATIONAL AGE AND CLINICAL AND ECONOMICAL EVALUATION OF IMMUNOSUPPORTIVE THERAPY EFFICACY

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I.G. Soldatova

2011-01-01

Full Text Available Study objective — to study clinical and immunopathologic characteristics of early neonatal sepsis in infants of different gestational age and to perform clinical and economical evaluation of immunosupportive therapy with Pentaglobin efficacy in complex treatment of this disease. 79 infants diagnosed with neonatal sepsis were included into prospective study. These patients were divided into 3 subgroups in order to evaluate clinical and economical efficacy of immunosupportive therapy: subgroup A (n = 38 — patients receiving. Pentaglobin as part of basic complex treatment from 3–6 days of life; subgroup B (n = 27 — from 7–10 days of life; subgroup C  (n = 27 — patients treated without Pentaglobin. Proven high clinical and economical efficacy of immunoglobulin preparations as a part of complex treatment of neonatal sepsis allows to recommend this type of therapy for a wide application in neonatology as a part of neonatal sepsis treatment.Key words: early neonatal sepsis, prematurity, extremely low body mass, immunosupportive therapy, intravenous immunoglobines, clinical and economical analysis, neonatal sepsis. (Voprosy sovremennoi pediatrii — Current Pediatrics. — 2011; 10 (6: 52–61

THE POSSIBILITIES AND RESULTS OF INDIRECT COMPARISON OF BIOLOGICAL AGENTS IN ANKYLOSING SPONDYLITIS

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Sh. F. Erdes

2016-01-01

Full Text Available The paper analyzes two matching-adjusted indirect comparison-based investigations of the efficacy of adalimumab (ADA and secukinumab (SCM in active ankylosing spondylitis, which have been recently reported at the EULAR Congress (London, 2016. One study sponsored by AbbVie was conducted to determine the short-term (16-week comparative clinical and economic efficacy of the test drugs and the other was supported by Novartis to reveal long-term (52-week, only clinical efficacy. Both studies have shown that the short-term efficacy ofADAand SCM is practically similar; however, the latter has a better long-term clinical efficacy. A pharmacoeconomic analysis of both drugs used during the first 12 weeks has demonstrated some advantage ofADA. 

Enhanced chemoprophylactic and clinical efficacy of albendazole formulated as solid dispersions in experimental cystic echinococcosis.

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Pensel, Patricia E; Castro, Silvina; Allemandi, Daniel; Bruni, Sergio Sánchez; Palma, Santiago D; Elissondo, María Celina

2014-06-16

Cystic echinococcosis is a chronic, complex, and still neglected disease. Although albendazole has demonstrated efficacy, only about one-third of patients experience complete remission or cure and 30-50% of treated patients develop some evidence of a therapeutic response. Different strategies have been developed in order to improve the albendazole water solubility and dissolution rate. The aim of the current work was to investigate the chemoprophylactic and clinical efficacy of an albendazole:poloxamer 188 solid dispersion formulation on mice infected with Echinococcus granulosus metacestodes. Albendazole formulated as solid dispersion had greater chemoprophylactic and clinical efficacy than albendazole alone. The improved in therapeutic efficacy could be a consequence of the increase in the systemic availability of albendazole sulfoxide. The work reported here demonstrates that in vivo treatment with albendazole:poloxamer 188 impairs the development of the hydatid cysts. This new pharmacotechnically based strategy could be a suitable alternative for treating cystic echinococcosis in humans. Copyright © 2014 Elsevier B.V. All rights reserved.

Clinical efficacy of Ranibizumab in the treatment of wet age-related macular degeneration

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Ling-Jun Wei

2017-12-01

Full Text Available AIM:To analyze the clinical efficacy of Ranibizumab in the treatment of wet age-related macular degeneration(ARMD.METHODS: Clinical data of patients with wet age-related macular degeneration received treatment of ranibizumab at our hospital from 2015 to 2017 were analyzed. At 1mo after treatment, the clinical efficacy, ocular hemodynamics and ocular inflammation were evaluated. RESULTS: A total of 41 patients were analyzed. After treatment, patients got significantly increased in LogMAR(0.651±0.067 vs 0.321±0.049; t=25.460, Pvs 452.9±69.8μm; t=15.740, Pvs 16.1±3.5ng/L; t=3.563, Pvs 13.8±2.5ng/L; t=3.467, PP>0.05. CONCLUSION: In the treatment of wet age-related macular degeneration, the ranibizumab shows a good therapeutic effect without serious adverse drug reactions.

Should academic medical centers conduct clinical trials of the efficacy of intercessory prayer?

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Halperin, E C

2001-08-01

Intercessory prayers for health or healing are requests to an object of worship for the preservation or restoration of health. There has been a recent proliferation of clinical trials that compare the health outcome of a group of prayed-for patients with that of controls, to test the efficacy of intercessory prayer. In this essay, the author defines the concept of intercessory prayer, contrasts it with other forms of prayer, and reviews the literature concerning clinical trials of its efficacy. The arguments put forward in favor of conducting such trials and those against are described and the reader is invited to consider their relative merits. The author concludes by discussing the potential power of faith in healing, reviewing the philosophical basis and pitfalls of clinical trials of intercessory prayer, and urging readers to weigh the arguments for and against such trials in academic medicine.

Comparison of clinical and biochemical markers of dehydration with the clinical dehydration scale in children: a case comparison trial.

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Tam, Ron K; Wong, Hubert; Plint, Amy; Lepage, Nathalie; Filler, Guido

2014-06-16

The clinical dehydration scale (CDS) is a quick, easy-to-use tool with 4 clinical items and a score of 1-8 that serves to classify dehydration in children with gastroenteritis as no, some or moderate/severe dehydration. Studies validating the CDS (Friedman JN) with a comparison group remain elusive. We hypothesized that the CDS correlates with a wide spectrum of established markers of dehydration, making it an appropriate and easy-to-use clinical tool. This study was designed as a prospective double-cohort trial in a single tertiary care center. Children with diarrhea and vomiting, who clinically required intravenous fluids for rehydration, were compared with minor trauma patients who required intravenous needling for conscious sedation. We compared the CDS with clinical and urinary markers (urinary electrolytes, proteins, ratios and fractional excretions) for dehydration in both groups using receiver operating characteristic (ROC) curves to determine the area under the curve (AUC). We enrolled 73 children (male = 36) in the dehydration group and 143 (male = 105) in the comparison group. Median age was 32 months (range 3-214) in the dehydration and 96 months (range 2.6-214 months, p dehydration group and 0 in the comparison group (p dehydrated group: difference in heart rate, diastolic blood pressure, urine sodium/potassium ratio, urine sodium, fractional sodium excretion, serum bicarbonate, and creatinine measurements. The best markers for dehydration were urine Na and serum bicarbonate (ROC AUC = 0.798 and 0.821, respectively). CDS was most closely correlated with serum bicarbonate (Pearson r = -0.3696, p = 0.002). Although serum bicarbonate is not the gold standard for dehydration, this study provides further evidence for the usefulness of the CDS as a dehydration marker in children. Registered at ClinicalTrials.gov (NCT00462527) on April 18, 2007.

The efficacy of trimetazidine on stable angina pectoris: a meta-analysis of randomized clinical trials.

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Peng, Song; Zhao, Min; Wan, Jing; Fang, Qi; Fang, Dong; Li, Kaiyong

2014-12-20

This meta-analysis aimed to evaluate the efficacy of trimetazidine in combination with other anti-anginal drugs versus other anti-anginal drugs in the treatment of stable angina pectoris (SAP). Randomized controlled trials (RCTs) published in English and Chinese were retrieved from computerized databases: Embase, PubMed, and CNKI. Primary outcomes consist of clinical parameters (numbers of weekly angina attacks and nitroglycerin use) and ergometric parameters (time to 1mm ST-segment depression, and total work (in Mets) and exercise duration (in seconds) at peak exercise) in stable angina pectoris treated by trimetazidine or not. The quality of studies was evaluated using Jadad score. Data analysis of 13 studies was performed using Stata 12.0 software. Results showed that treatment of trimetazidine and other anti-anginal drugs was associated with a smaller weekly mean number of angina attacks (WMD=-0.95, 95%CI: -1.30 to -0.61, Z=5.39, Pangina pectoris. Sensitivity analysis was performed. Sub-group analysis showed that treatment duration was not a significant moderator and patients treated within 8 weeks and above 12 weeks had no difference in the outcomes addressed in this meta-analysis. No publish bias was detected. This meta-analysis confirms the efficacy of trimetazidine in the treatment of stable angina pectoris, in comparison with conventional antianginal agents, regardless of treatment duration. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Randomized Clinical Trial of the Innovative Bilayered Wound Dressing Made of Silk and Gelatin: Safety and Efficacy Tests Using a Split-Thickness Skin Graft Model

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Hasatsri, Sukhontha; Angspatt, Apichai

2015-01-01

We developed the novel silk fibroin-based bilayered wound dressing for the treatment of partial thickness wounds. And it showed relevant characteristics and accelerated the healing of full-thickness wounds in a rat model. This study is the clinical evaluation of the bilayered wound dressing to confirm its safety and efficacy for the treatment of split-thickness skin donor sites. The safety test was performed using a patch model and no evidence of marked and severe cutaneous reactions was found. The efficacy test of the bilayered wound dressing was conducted on 23 patients with 30 split-thickness skin graft donor sites to evaluate healing time, pain score, skin barrier function, and systemic reaction in comparison to Bactigras. We found that the healing time of donor site wounds treated with the bilayered wound dressing (11 ± 6 days) was significantly faster than those treated with Bactigras (14 ± 6 days) (p = 10−6). The wound sites treated with the bilayered wound dressing showed significantly less pain and more rapid skin functional barrier recovery than those treated with Bactigras (p = 10−5). Therefore, these results confirmed the clinical safety and efficacy of the bilayered wound dressing for the treatment of split-thickness skin graft donor sites. PMID:26221170

Clinical Efficacy of Various Diagnostic Tests for Small Bowel Tumors and Clinical Features of Tumors Missed by Capsule Endoscopy

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Jung Wan Han

2015-01-01

Full Text Available Background. We aimed to evaluate the efficacy of various diagnostic tools such as computerized tomography (CT, small bowel follow-through (SBFT, and capsule endoscopy (CE in diagnosing small bowel tumors (SBTs. Additionally, we aimed to evaluate the clinical features of SBTs missed by CE. Methods. We retrospectively studied 79 patients with histologically proven SBT. Clinical data were analyzed with particular attention to the efficacy of CT, SBFT, and CE in detecting SBT preoperatively. We also analyzed the clinical features of SBTs missed by CE. Results. The most common symptoms of SBT were bleeding (43% and abdominal pain (13.9%. Diagnostic yields were as follows: CT detected 55.8% of proven SBTs; SBFT, 46.1%; and CE, 83.3%. The sensitivity for detecting SBTs was 40.4% for CT, 43.9% for SBFT, and 79.6% for CE. Two patients with nondiagnostic but suspicious findings on CE and seven patients with negative findings on CE were eventually found to have SBT. These nine patients were eventually diagnosed with gastrointestinal stromal tumor (4, small polyps (3, inflammatory fibroid polyp (1, and adenocarcinoma (1. These tumors were located in the proximal jejunum (5, middle jejunum (1, distal jejunum (1, and proximal ileum (1. Conclusion. CE is more efficacious than CT or SBFT for detecting SBTs. However, significant tumors may go undetected with CE, particularly when located in the proximal jejunum.

Comparison of the therapeutic efficacy of intravenous dimenhydrinate and intravenous piracetam in patients with vertigo: a randomised clinical trial.

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Doğan, Nurettin Özgür; Avcu, Nazire; Yaka, Elif; Yılmaz, Serkan; Pekdemir, Murat

2015-07-01

The present study aimed to compare the therapeutic efficacy of dimenhydrinate and piracetam in patients with vertigo. A blinded, parallel group, superiority, randomised clinical trial was carried out on patients who presented to the emergency department (ED) with vertigo. Healthy adult patients presenting to the ED with undifferentiated vertigo were included in the study. The efficacy of intravenous dimenhydrinate (100 mg) and intravenous piracetam (2000 mg) for reducing the intensity of vertigo was compared in two randomised treatment groups using a 10-point numeric rating scale (NRS). The determination of NRS scores was performed at presentation and at the 30th minute of presentation, after the study drug was implemented, both in immobile and ambulatory positions. The primary outcome variable was reduction in vertigo intensity documented on the NRS at the 30th minute after medication administration, analysed by intention to treat. A total of 94 patients were included in the randomisation (n=47 in both groups). The baseline NRS scores were 7.55±2.00 in the dimenhydrinate group and 8.19±1.79 in the piracetam group. The changes from baseline for dimenhydrinate and piracetam were 2.92±3.11 and 3.75±3.40 (difference -0.83 (95% CI -2.23 to 0.57)) in the immobile position and were 2.04±3.07 and 2.72±2.91 (difference -0.68 (95% CI -2.03 to 0.67)) in the ambulatory position. Rescue medication need was similar in both treatment groups (p=0.330), and only one adverse reaction was reported. We found no evidence of a difference between dimenhydrinate and piracetam in relieving the symptoms of vertigo. Clinical Trials Registration ID: NCT01890538. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Efficacy and predictive value of clinical stage in non-surgical patients with esophageal cancer

International Nuclear Information System (INIS)

Liu Xiao; Wang Guiqi; He Shun

2014-01-01

Objective: To investigate the efficacy and predictive value of clinical stage in non-surgical patients with esophageal cancer (EC). Methods: A retrospective study was conducted in 358 EC patients who underwent radical surgery in our hospital from April 2003 to October 2010 and who had preoperative work-up including endoscopic esophageal ultrasound (EUS), esophagoscopy, thoracic CT scans,and contrast esophagography and had detailed information on postoperative pathological stages. The predictive value of preoperative clinical T/N stage based on EUS + CT for postoperative pathological stage was analyzed. The disease free survival (DFS) and overall survival (OS) were analyzed according to the UICC TNM classification (2002/ 2009) and the clinical stage based on imaging findings. Results: The median follow-up was 47 months.A total of 305 (85.2%) of all patients were analyzed by clinical stage based on EUS + CT.Among them, the predictive value of clinical T stage for pathological T stage was 0-88.6%, highest (88.6%) for T1 stage and lowest for T4 stage. The predictive value of clinical N stage (N 0 /N1) was 62.5-100%. The significant differences in OS and DFS rates based on both 2002 and 2009 UICC TNM classifications were noted (P=0.000 and 0.000). There were significant differences in OS between stage groups, except the comparison between two stage Ⅳ patients and other groups, according to 2002 UICC TNM classification. There were usually insignificant differences in OS between stage groups, according to 2009 UICC TNM classification. For the 305 patients staged clinically based on EUS and CT according to 2002 UICC TNM classification, significant differences in OS and DFS rates were noted (P=0.000 and 0.000). Conclusions: Imaging modalities show good predictive value for N stage (N0/N1),even though they cannot accurately provide the number of metastatic lymph nodes. The clinical stage based on EUS + CT can effectively predict the prognosis of non-surgical EC patients

Clinical efficacy and safety of limited internal fixation combined with external fixation for Pilon fracture: A systematic review and meta-analysis

OpenAIRE

Zhang, Shaobo; Zhang, Yibao; Wang, Shenghong; Zhang, Hua; Liu, Peng; Zhang, Wei; Ma, Jing-Lin; Wang, Jing

2017-01-01

Purpose: To compare the clinical efficacy and complications of limited internal fixation combined with external fixation (LIFEF) and open reduction and internal fixation (ORIF) in the treatment of Pilon fracture. Methods: We searched databases including Pubmed, Embase, Web of science, Cochrane Library and China Biology Medicine disc for the studies comparing clinical efficacy and complications of LIFEF and ORIF in the treatment of Pilon fracture. The clinical efficacy was evaluated by the ...

Bridging the Gap Between Science and Clinical Efficacy: Physiology, Imaging, and Modeling of Aerosols in the Lung.

Science.gov (United States)

Darquenne, Chantal; Fleming, John S; Katz, Ira; Martin, Andrew R; Schroeter, Jeffry; Usmani, Omar S; Venegas, Jose; Schmid, Otmar

2016-04-01

Development of a new drug for the treatment of lung disease is a complex and time consuming process involving numerous disciplines of basic and applied sciences. During the 2015 Congress of the International Society for Aerosols in Medicine, a group of experts including aerosol scientists, physiologists, modelers, imagers, and clinicians participated in a workshop aiming at bridging the gap between basic research and clinical efficacy of inhaled drugs. This publication summarizes the current consensus on the topic. It begins with a short description of basic concepts of aerosol transport and a discussion on targeting strategies of inhaled aerosols to the lungs. It is followed by a description of both computational and biological lung models, and the use of imaging techniques to determine aerosol deposition distribution (ADD) in the lung. Finally, the importance of ADD to clinical efficacy is discussed. Several gaps were identified between basic science and clinical efficacy. One gap between scientific research aimed at predicting, controlling, and measuring ADD and the clinical use of inhaled aerosols is the considerable challenge of obtaining, in a single study, accurate information describing the optimal lung regions to be targeted, the effectiveness of targeting determined from ADD, and some measure of the drug's effectiveness. Other identified gaps were the language and methodology barriers that exist among disciplines, along with the significant regulatory hurdles that need to be overcome for novel drugs and/or therapies to reach the marketplace and benefit the patient. Despite these gaps, much progress has been made in recent years to improve clinical efficacy of inhaled drugs. Also, the recent efforts by many funding agencies and industry to support multidisciplinary networks including basic science researchers, R&D scientists, and clinicians will go a long way to further reduce the gap between science and clinical efficacy.

Safety and clinical efficacy of golimumab in the treatment of arthritides

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Ismail Simsek

2010-09-01

Full Text Available Ismail Simsek, Yusuf YaziciNew York University School of Medicine, NYU Hospital for Joint Diseases, New York, USAAbstract: Golimumab is a human anti-tumor necrosis factor (TNF-alpha monoclonal antibody that was recently approved for the treatment of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. This review covers the published clinical trial data on the use of golimumab for the approved indications mentioned above with respect to efficacy and safety. The various ongoing trials for golimumab have yielded promising results in terms of efficacy and safety in methotrexate-naive and -resistant patients with rheumatoid arthritis, as well as in patients who were previously treated with other anti-TNF agents. In addition, the efficacy of golimumab in psoriatic arthritis and ankylosing spondylitis has also been demonstrated. The real safety information will be available only once the drug has been used in many more patients, who frequently have comorbid conditions.Keywords: arthritis, rheumatoid, psoriatic arthritis, ankylosing spondylitis

Pharmacokinetics, pharmacodynamics and clinical efficacy of omalizumab for the treatment of asthma.

Science.gov (United States)

Luu, Maxime; Bardou, Marc; Bonniaud, Philippe; Goirand, Françoise

2016-12-01

Omalizumab is a subcutaneously administrated monoclonal anti-IgE antibody indicated in adults, adolescents and children 6 years of age and older with moderate to severe allergic asthma uncontrolled by conventional pharmacological treatments and sensitization to at least one perennial allergen. Area covered: This drug evaluation summarizes published data on pharmacokinetic and pharmacodynamic properties of omalizumab, on clinical efficacy and safety, including real-world evidence, and provides a medico-economic evaluation of the drug. Expert opinion: Omalizumab represents an efficient therapeutic option for the management of patients with uncontrolled moderate/severe allergic asthma. It provides a significant reduction in the asthma exacerbation rate with a steroid-sparing effect, an improvement in quality of life in adults and adolescents, despite a lack of evidence about its efficacy specifically in severe allergic asthma. Clinical trials have demonstrated its efficacy in the pediatric population but further real-life evidence is expected to better characterize long-term effects in this population. There is still some debate about the optimal treatment duration but, to date, it is recommended not to stop the treatment as cessation has resulted in symptom recurrence. Omalizumab is an expensive treatment, but a key therapeutic option when used for uncontrolled severe allergic asthma.

Comparison Of Clinical, Parasitological And Serological Diagnostic ...

African Journals Online (AJOL)

Comparison Of Clinical, Parasitological And Serological Diagnostic Methods For The Definitive ... Consideringthe relative significance of these methods in the diagnosis of onchocerciasis, we ... http://dx.doi.org/10.4314/ari.v1i3.40835.

Clinical, endoscopical and morphological efficacy of mesalazine in patients with irritable bowel syndrome

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Dorofeyev AE

2011-06-01

Full Text Available Andrey E Dorofeyev1, Elena A Kiriyan2, Inna V Vasilenko1, Olga A Rassokhina1, Andrey F Elin11National Medical University, Donetsk, Ukraine; 2Gastroenterological Center of Poltava Hospital Clinic, Poltava, UkraineObjectives: The aim of this study was to analyze the clinical efficacy and cytomorphologic changes of colon mucosa following the treatment of patients suffering from irritable bowel syndrome (IBS with mesalazine (5-aminosalicylic acid [5-ASA].Methods: In this controlled, randomized, blind clinical trial, a total of 360 patients with varying subtypes of IBS were randomly treated with 500 mg of mesalazine qid or by standard therapy without mesalazine for a period of 28 days. Pre- and post-treatment pain intensity, pain duration, meteorism, stool abnormalities and endoscopic parameters were monitored, and biopsies or brush biopsies were examined histologically.Results: Treatment of IBS patients with mesalazine significantly reduced intensity and duration of pain in all subtypes of IBS, except for duration of pain in the subtype “undifferentiated”, where the difference was not significant. In addition, in patients with diarrhea type and undifferentiated type of IBS, mesalazine also significantly reduced the abnormal stool pattern. In comparison to the control group, administration of mesalazine reduced the incidence of endoscopic and cytomorphologic changes of the bowel mucosa, including changes in colon mucus, mucus production, cytologic or histologic parameters, epithelial cell degeneration, appearance of leukocytes and macrophages and cell infiltrations.Conclusion: Mesalazine was effective in reducing several symptoms characteristic of IBS. It significantly reduced pain intensity and duration and improved cytohistologic parameters of the bowel mucosa.Keywords: 5-amino salicylic acid, 5-ASA, abdominal pain, irritable bowel syndrome, IBS, meteorism, stool abnormalities

Indirect comparison of the antiviral efficacy of peginterferon alpha 2a plus ribavirin used with or without simeprevir in genotype 4 hepatitis C virus infection, where common comparator study arms are lacking: a special application of the matching adjusted indirect comparison methodology.

Science.gov (United States)

Van Sanden, Suzy; Pisini, Marta; Duchesne, Inge; Mehnert, Angelika; Belsey, Jonathan

2016-01-01

The need to assess relative efficacy in the absence of comparative clinical trials is a problem that is often encountered in economic modeling. The use of matching adjusted indirect comparison (MAIC) in this situation has been suggested. We present the results of a MAIC used to evaluate the incremental benefit offered by adding simeprevir (SMV) to standard therapy in the treatment of patients infected with genotype 4 hepatitis C virus (HCV). Individual patient data for a single arm study evaluating the use of SMV with peginterferon alfa 2a + ribavirin (PR) in genotype 4 HCV were available (RESTORE study). A systematic literature review was used to identify studies of PR alone used in the same patient group. By applying the inclusion criteria for each study in turn to the RESTORE dataset and then applying the published MAIC covariate matching algorithm, a series of pseudosamples from RESTORE were generated. After assessment of the matching outcomes, the best matched comparisons were used to derive estimates of efficacy for SMV + PR in patients equivalent to those participating in the PR trial. Five potential comparator studies were identified. After applying the matching process, two emerged as offering the greatest equivalence with the generated RESTORE pseudosamples and were used to estimate SMV + PR efficacy, expressed as the percentage of patients achieving sustained viral response (SVR). In one comparison, SVR in the SMV + PR group was 85% versus 63% for PR alone. In the second comparison, the corresponding SVRs were 77% and 44% respectively. After matching for varying baseline characteristics, both comparisons of RESTORE versus studies of PR alone yielded a benefit for SMV + PR vs PR alone in genotype 4 HCV-infected patients. The incremental gain in SVR associated with use of SMV ranged from 22% to 33%. In the absence of direct comparative studies, the MAIC gives a better perspective than simple comparison of absolute SVR from individual

Efficacy of anti-leishmania therapy in visceral leishmaniasis among HIV infected patients: a systematic review with indirect comparison.

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Gláucia F Cota

Full Text Available We conducted a systematic literature review with indirect comparison of studies evaluating therapeutic efficacy and toxicity associated to visceral leishmaniasis (VL therapy among HIV infected individuals.The outcomes of interest were clinical and parasitological cure, mortality, and adverse events.PRISMA guidelines for systematic reviews and Cochrane manual were followed. Sources were MEDLINE, LILACS, EMBASE, Web of Knowledge databases and manual search of references from evaluated studies. We included all studies reporting outcomes after VL treatment, regardless of their design. Study quality was evaluated systematically by using the Newcastle-Ottawa Scale (NOS for assessing the quality of nonrandomized studies in meta-analyses. Comprehensive Meta-Analysis software v.2.2.048 was used to perform one-group meta-analysis of study arms with the same drug to estimate global rates of success and adverse events with each drug. These estimates were used, when possible, to indirectly compare treatment options, adjusted for CD4 count. Direct comparison was pooled when available.Seventeen studies reporting five treatment regimens and outcome of 920 VL episodes occurring in HIV infected individuals were included. The main outstanding difference in outcome among the treatment regimens was observed in mortality rate: it was around 3 times higher with high-dose antimony use (18.4%, CI 95% 13.3-25%, indirectly compared to lipid formulations of amphotericin B treatment (6.1%, CI 95% 3.9-9.4%. It was observed, also by indirect comparison, higher rates of clinical improvement in study arms using amphotericin B than in study arms using pentavalent antimonial therapy (Sb(v. The parasitological cure, an outcome that presented some degree of risk of selection and verification bias, had rates that varied widely within the same treatment arm, with high heterogeneity, hampering any formal comparison among drugs. One direct comparison of amphotericin and antimoniate was

One-to-one comparison of sunscreen efficacy, aesthetics and potential nanotoxicity

Science.gov (United States)

Barnard, Amanda S.

2010-04-01

Numerous reports have described the superior properties of nanoparticles and their diverse range of applications. Issues of toxicity, workplace safety and environmental impact have also been a concern. Here we show a theoretical comparison of how the size of titanium dioxide nanoparticles and their concentration in sunscreens can affect efficacy, aesthetics and potential toxicity from free radical production. The simulation results reveal that, unless very small nanoparticles can be shown to be safe, there is no combination of particle size and concentration that will deliver optimal performance in terms of sun protection and aesthetics. Such a theoretical method complements well the experimental approach for identifying these characteristics.

Child versus family cognitive-behavioral therapy in clinically anxious youth : An efficacy and partial effectiveness study

NARCIS (Netherlands)

Bodden, Denise H. M.; Bogels, Susan M.; Nauta, Maaike H.; De Haan, Else; Ringrose, Jaap; Appelboom, Carla; Brinkman, Andries G.; Appelboom-Geerts, Karen C. M. M. J.

2008-01-01

Objective: The efficacy and partial effectiveness of child-focused versus family-focused cognitive-behavioral therapy (CBT) for clinically anxious youths was evaluated, in particular in relation to parental anxiety disorders and child's age. Method: Clinically referred children with anxiety

Child Versus Family Cognitive-Behavioral Therapy in Clinically Anxious Youth: An Efficacy and Partial Effectiveness Study

NARCIS (Netherlands)

Bodden, D.H.M.; Bögels, S.M.; Nauta, M.H.; Haan, E. de; Ringrose, J.; Appelboom, C.; Brinkman, A.G.; Appelboom-Geerts, K.C.M.M.J.

2008-01-01

Objective: The efficacy and partial effectiveness of child-focused versus family-focused cognitive-behavioral therapy (CBT) for clinically anxious youths was evaluated, in particular in relation to parental anxiety disorders and child's age. Method: Clinically referred children with anxiety

Clinical Efficacy of Proton Pump Inhibitor versus Prompt Endoscopy for Management of People with Dyspepsia

DEFF Research Database (Denmark)

Kjeldsen, Hans Christian; Lauritzen, Torsten; Christensen, Bo

  Title:   Clinical Efficacy of Proton Pump Inhibitor versus Prompt Endoscopy for Management of People with Dyspepsia: A Randomized Clinical Trial in General Practice.     Purpose: To compare the clinical efficacy of two strategies for management of dyspepsia in general practice in a RCT design.......   Setting: June 2000 to August 2002, 41 GPs, Aarhus County, Denmark   Methods: 368 people with dyspepsia (epigastric pain/discomfort, no alarm symptoms) were randomly assigned to treatment with omeprazol 40 mg/day for two weeks (PPI group, n:185) or endoscopy (endoscopy group, n:183). Due to migration......, dyspeptic contacts to GP or patients' satisfaction. Conclusions: Prompt endoscopy was superior to proton pump inhibitor concerning symptom improvement in management of dyspepsia in general practice when pain/discomfort was the primary symptom. There were no differences between the two strategies in respect...

Clinical efficacy of melittin in the treatment of cats infected with the feline immunodeficiency virus.

Science.gov (United States)

Hartmann, Anja D; Wilhelm, Natalie; Erfle, Volker; Hartmann, Katrin

2016-12-05

The bee venom melittin shows an antiviral efficacy against the human immunodeficiency virus in cell culture. It was shown to be non-toxic for cats. Aim of this pilot study was to investigate the clinical efficacy and side-effects of melittin in cats naturally infected with feline immunodeficiency virus (FIV). The study was performed as a prospective, placebo-controlled double-blinded trial. Twenty cats were included, of which 10 cats each were treated with either melittin (500 µg/kg body weight) or phosphate-buffered saline (placebo) subcutaneously twice per week. During the treatment period of 6 weeks, the cats' general health status, determined by the Karnofsky's score, and the severity of clinical signs (conjunctivitis and stomatitis) using a clinical scoring system were evaluated. Haematology, biochemistry profiles, lymphocyte subpopulations, CD4/CD8 ratio, and pterines (biopterine, 7-xanthopterine) as surrogate parameters were also compared. The general health status and the clinical scores for conjunctivitis and stomatitis improved in cats treated with melittin. A statistically significant improvement however could only be detected for conjunctivitis in cats treated with melittin compared to cats treated with placebo which was likely due to different scores between both groups at the beginning. No influence on the lymphocyte subpopulations, CD4/CD8 ratio, and pterine concentrations was observed. No side effects occurred in this study. In the protocol used in the present study, no significant efficacy of melittin could be detected. However, efficacy of melittin, especially if applied in a higher dosage as in the present study or for a longer period, could be evaluated in further studies. Synergistic effects if used in combination with classic antiretroviral drugs could be an interesting future approach.

Efficacy of clinical diagnostic procedures utilized in nuclear medicine. Nine month progress report

Energy Technology Data Exchange (ETDEWEB)

None

1978-01-01

This study is designed to determine the efficacy of nuclear medicine procedures in clinical practice. Several methods of determining efficacy will be evaluated to determine those most suitable. Nuclear medicine methods will be confined to the study of lung diseases by pulmonary perfusion and ventilation. In addition to evaluating the above methods data will be obtained to determine the sensitivity, specificity, predictive value and efficiency of the test under consideration. These values, corrected for prevalence of the disease processes under consideration will then be compared to the values obtained by the MACRO and MICRO methods and will help to bound the clinical reliability of the diagnostic method depending on the degree to which the several methods trend together. Depending on the practicality of these two methods, in addition to the determination of efficacy, cost effectiveness factors and benefit-risk estimates which are used to apply to radiation effects will be determined for nuclear medicine studies of the brain, bone, heart, liver and thyroid subsequently. The measurement techniques will then be utilized to establish guidelines for the most useful applications of the given procedure so that clinicians will be able to obtain a pretest estimate of the utility of the nuclear medicine test.

Efficacy and safety of retinol palmitate ophthalmic solution in the treatment of dry eye: a Japanese Phase II clinical trial

Directory of Open Access Journals (Sweden)

Toshida H

2017-06-01

Full Text Available Hiroshi Toshida,1 Toshinari Funaki,2 Koichi Ono,3 Nobuhito Tabuchi,4 Sota Watanabe,4 Tamotsu Seki,5 Hiroshi Otake,6 Takuji Kato,7 Nobuyuki Ebihara,8 Akira Murakami2 1Department of Ophthalmology, Juntendo University Shizuoka Hospital, Shizuoka, 2Department of Ophthalmology, Juntendo University Graduate School of Medicine, 3Department of Ophthalmology, Juntendo Tokyo Koto Geriatric Medical Center, Tokyo, 4Pharmaceutical Research Laboratories, Lion Corporation, Kanagawa, 5Tamagawa Eye Clinic, Tokyo, 6Otake Eye Clinic, Kanagawa, 7Kato Eye Clinic, Tokyo, 8Department of Ophthalmology, Juntendo University Urayasu Hospital, Chiba, Japan Purpose: The purpose of this study was to investigate the efficacy and safety of the administration of retinol palmitate (VApal ophthalmic solution (500 IU/mL for the treatment of patients with dry eye. Patients and methods: This study included 66 patients with dry eye. After a 2-week washout period, patients were randomized (1:1 into either a VApal ophthalmic solution or a placebo group, and a single drop of either solution was administered six times daily for 4 weeks. Efficacy measures were 12 subjective symptoms, rose bengal (RB and fluorescein staining scores, tear film breakup time, and tear secretion. Safety measures included clinical blood and urine analyses and adverse event recordings. Results: In comparisons of the two groups, the mean change in RB staining score from baseline was significantly lower in the VApal group at 2 and 4 weeks (P<0.05 and P<0.01, respectively. Furthermore, the fluorescein clearance rate (fluorescein staining score was significantly higher in the VApal group at 4 weeks (P<0.05. The VApal group showed a significant improvement in blurred vision at 1 and 2 weeks (P<0.01 and P<0.05, respectively, and the mean change in the total score for subjective symptoms from baseline was significantly lower in the VApal group at 1 week (P<0.05. In before- and after-intervention comparisons, the

Clinical efficacy of valsartan combined with hydrochlorothiazide in treatment of elderly hypertension

Directory of Open Access Journals (Sweden)

Ya-Ting Shao

2016-06-01

Full Text Available Objective: To explore the clinical efficacy of valsartan combined with hydrochlorothiazide in the treatment of elderly hypertension. Methods: A total of 150 elderly patients with primary hypertension who were admitted in our hospital from January, 2015 to January, 2016 were included in the study and randomized into the observation group and the control group. The patients in the control group were given valsartan, 80 mg/time, 1 time/d. On this basis, the patients in the observation group were given additional hydrochlorothiazide 12.5 mg/time, 1 time/d. The patients in the two groups were administered with drugs in the morning. Six-month treatment was regarded as one course. The change of 24 h ambulatory blood pressure before and after treatment was detected, and the efficacy was evaluated. The heart color ultrasound was used to detect LVM and LVMI before and after treatment in the two groups. Results: The total effective rate in the observation group (90.7% was significantly superior to that in the control group (70.7% (P<0.05. The mean SBP and DBP 24h after treatment in the two groups were significantly reduced when compared with before treatment (P<0.05, and those in the observation group were significantly superior to those in the control group (P<0.05. LVM and LVMI after treatment in the two groups were significantly reduced when compared with before treatment (P<0.05, and those in the observation group were significantly superior to those in the control group (P<0.05. Conclusions: The combination of valsartan and hydrochlorothiazide in the treatment of elderly hypertension can effectively enhance the clinical efficacy, and effectively control the blood pressure. It is superior to that by a single drug; therefore, and deserves to be widely recommended in the clinic.

Safety and clinical efficacy of some radiation-sterilized medical products and pharmaceuticals

International Nuclear Information System (INIS)

Kulkarni, R.D.; Gopal, N.G.S.

1975-01-01

Medical products and pharmaceuticals must conform to certain minimum physico-chemical microbiological and biological requirements. The biological requirements comprise principally testing for toxicity, safety, and pyrogens. Besides the above-mentioned criteria, there are two other important characteristics, viz. clinical efficacy and tolerance in animal and/or human beings. These latter requirements, expected from the final product released for general human use, are not carried out routinely. In the present-day pharmaceutical and medical technology, numerous mew products are appearing, many of them requiring radiation sterilization as they are not stable towards the other conventional methods of sterilization. While the post-irradiation physicochemical changes in a product may not be significant, the bio-availability or biological activity of the product may be affected to a more significant extent. Some evidence of this has recently been reported. Hence, it is desirable to carry out studies on safety as well as clinical efficacy on irradiated products. This paper describes some studies on plastic-based medical products, a pharmaceutical raw material, a typical infusion fluid such as normal saline, antibiotics and their ointments. (author)

Closing the antidepressant efficacy gap between clinical trials and real patient populations.

Science.gov (United States)

Wade, Alan G

2006-01-01

Overall, patient outcomes in the primary care of depression are seldom as good as those achieved in clinical trials - the "efficacy gap". Many factors contribute to this, including poor patient compliance, poor family and social support and negative media reporting of antidepressants. Indeed, negative media reporting has had far more impact on physicians' prescribing of antidepressants than have regulatory agencies, partly as a result of changing public attitudes. Negative media reports linking SSRIs to increased child suicide rates have also resulted in a decline in the prescribing of SSRIs to this age group, but with no concomitant increase in the prescribing of fluoxetine, the only antidepressant recommended for the treatment of children. There are also inadequacies in the guidelines available to primary care givers that might contribute to the efficacy gap. Guidelines can be too specific for clinical practice - especially where depression coexists with anxiety disorders - and too passive, resulting in delayed or inadequate intervention. Evidence suggests that many physicians prefer to be more proactive. In the recent AHEAD survey, physicians identified faster resolution of symptoms as the property most desirable for improving antidepressant therapy. There is recent evidence that structured long-term therapy and easily-implemented measurement-based care procedures can improve remission rates and help bridge the efficacy gap. If these can be allied with greater public/media understanding of depression and its treatment, along with improved guidelines, then significant progress can be anticipated in the management of mood disorders.

Problem-based learning versus a traditional educational methodology: a comparison of preclinical and clinical periodontics performance.

Science.gov (United States)

Rich, Sandra K; Keim, Robert G; Shuler, Charles F

2005-06-01

To evaluate efficacy of a problem-based learning (PBL) pedagogy in preclinical and clinical teaching, test scores of 234 undergraduate dental students from the conventionally taught classes of 2003 and 2004 were compared with scores of 274 dental students from the PBL classes of 2005 and 2006. Although the groups' means were close together, t-test analysis of scores revealed that PBL students performed significantly better than traditional (TRAD) students on midterm (p=.0001) and final (p=.015) examinations taken on student partner/mock patients. ANOVA comparing the classes with each other showed significant differences for the midterm and final, but not for the clinical examination. Further multiple comparison tests (Tukey HSD) for the midterm and final revealed that differences specifically reflected superior performance of PBL classes against one of the TRAD classes (2004). There was no difference in performance between PBL (n=134) and TRAD (n=233) students on examinations taken with actual clinical patients who were undergoing nonsurgical periodontal treatment. Over a two-year period, PBL students rated their program instructors at a mean of 4.41 on a Likert-type scale of 1 (not helpful) to 5 (outstanding). The program provides a PBL model for teaching preclinical and clinical skills supported by a four-year evaluation of manual skills outcomes.

Efficacy of clinical supervision: influence on job satisfaction, burnout and quality of care.

Science.gov (United States)

Hyrkäs, Kristiina; Appelqvist-Schmidlechner, Kaija; Haataja, Riina

2006-08-01

This paper reports a study to determine how supervisees' backgrounds and surrounding infrastructure predict the efficacy of clinical supervision among Finnish nursing staff, their job satisfaction, levels of burnout and perceptions of the quality of care. Several studies have described the effects of clinical supervision, but few have focused on evaluating it. Until recently, no studies have examined how clinical supervision evaluations are related to supervisees' backgrounds, surrounding infrastructure or respondents' levels of burnout, job satisfaction and perceptions of the quality of care. The survey involved supervisees completing a range of standardized and validated evaluation measures. The respondents were identified from 12 regional, central and university hospitals across Finland (n = 799). The data collection took place from October 2000 to February 2001. The evaluations varied statistically significantly and were associated with statistically significant variations in the respondents' backgrounds. Clinical supervision infrastructure was also strongly related to evaluation scores. Supervisees' age, education, gender, employment status, area of specialty, working hours, work experience and experience as a supervisor were statistically significant predictors for evaluations of the efficacy of clinical supervision. These evaluations of clinical supervision were also found to predict the respondents' job satisfaction, levels of burnout and assessments of good nursing. Nursing staff, especially those who have over 10 years' work experience, work in general care, have a nursing diploma, are non-tenured, work part-time and work 24-hour rotating shifts can benefit from clinical supervision. However, resources need to be invested in supervisor education and nursing staff need to be encouraged to start working in both supervisor and supervisee roles because of the positive effects on job satisfaction and quality of care.

The role of religiosity, coping strategies, self-efficacy and personality dimensions in the prediction of Iranian undergraduate rehabilitation interns' satisfaction with their clinical experience.

Science.gov (United States)

Mirsaleh, Y R; Rezai, H; Kivi, S R; Ghorbani, R

2010-12-01

to investigate the relationship between religiosity, coping styles, self-efficacy and personality dimensions as predictors of satisfaction with clinical experience in rehabilitation interns during transition from academic study to clinical internship. a cross-sectional survey design. five rehabilitation faculties. three hundred and eighteen undergraduate rehabilitation interns, including physical therapy, occupational therapy and speech and language pathology students. Islamic Religiosity Scale, Ways of Coping Questionnaire, General Self-efficacy Scale, NEO Five Factor Inventory, and Satisfaction with Clinical Experiences Questionnaire. religiosity, problem-focused coping and general self-efficacy had significant positive correlation with satisfaction with clinical internship in rehabilitation students. Among personality dimensions, openness, agreement and consciousness had significant positive correlation with satisfaction with clinical experience and neuroticism had significant negative correlation with satisfaction with clinical experience. The results of regression analysis demonstrated that religiosity and self-efficacy had important roles in the prediction of satisfaction with clinical experience in all the rehabilitation intern students of three disciplines (physical therapy, occupational therapy, and speech and language pathology). religiosity, problem-focused coping and general self-efficacy seem to be good predictors of satisfaction with clinical internship in rehabilitation students.

Adverse events and therapeutic efficacy associated with TACE for hepatocellular carcinoma with a miriplatin-lipiodol suspension in comparison with a cisplatin-lipiodol suspension

International Nuclear Information System (INIS)

Araki, Takuji; Okada, Taiki; Kimura, Kazufumi; Sawada, Eiichi; Sano, Katushiro; Araki, Tsutomu

2012-01-01

The aim of this study was to evaluate the short-term adverse events and therapeutic efficacy of transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) with a miriplatin-lipiodol suspension in comparison with a cisplatin-lipiodol suspension. Of patients who underwent TACE for unresectable HCCs in 2009 and 2010, twenty-nine and twenty-seven patients underwent TACE using cisplatin-lipiodol suspension (C-LS) and miriplatin-lipiodol suspension (M-LS), respectively. Adverse events of fever, pain, nausea, anorexia, elevation of aspartate aminotransferase (AST), total bilirubin, creatinine and a decrease in platelet count were evaluated by the National Cancer Institute Common Toxicity Criteria Ver.4. to compare the C-LS and M-LS groups. The short-term therapeutic efficacy of both groups was evaluated by the treatment effect (TE) on the CT images three months after TACE according to the General Rules for the Clinical and Pathological Study of Primary Liver Cancer (the 5th edition, Revised Version). With regard to the adverse events, the M-LS group had significantly less fever and anorexia than the C-LS group. No critical adverse events were observed in either group. The therapeutic efficacy was not significantly different between the groups. TACE with M-LS had fewer adverse events than TACE with C-LS, but neither TACE led to any critical adverse events. The short-term therapeutic efficacy of TACE with M-LS was equivalent to that of TACE with C-LS. (author)

[Development of an Excel spreadsheet for meta-analysis of indirect and mixed treatment comparisons].

Science.gov (United States)

Tobías, Aurelio; Catalá-López, Ferrán; Roqué, Marta

2014-01-01

Meta-analyses in clinical research usually aimed to evaluate treatment efficacy and safety in direct comparison with a unique comparator. Indirect comparisons, using the Bucher's method, can summarize primary data when information from direct comparisons is limited or nonexistent. Mixed comparisons allow combining estimates from direct and indirect comparisons, increasing statistical power. There is a need for simple applications for meta-analysis of indirect and mixed comparisons. These can easily be conducted using a Microsoft Office Excel spreadsheet. We developed a spreadsheet for indirect and mixed effects comparisons of friendly use for clinical researchers interested in systematic reviews, but non-familiarized with the use of more advanced statistical packages. The use of the proposed Excel spreadsheet for indirect and mixed comparisons can be of great use in clinical epidemiology to extend the knowledge provided by traditional meta-analysis when evidence from direct comparisons is limited or nonexistent.

[Comparison of efficacy and safety of treatment with drugs of clopidogrel in patients after coronary artery stenting].

Science.gov (United States)

Avdeeva, L V; Shtegman, O A; Mosina, V A

2011-01-01

Proof of clinical equivalence of generic and original dugs - the way to lessen cost of therapy of patients while providing comparable clinical effects. We present in this paper results of 1 year follow-up of 115 patients receiving Egithromb or Plavics after coronary artery stenting. Comparable clinical efficacy and safety of Egithromb and Plavics has been established.

Bullying Behaviors and Self Efficacy among Nursing Students at Clinical Settings: Comparative Study

Science.gov (United States)

Kassem, Awatef Hassan

2015-01-01

Background: Nursing students who experienced bullying behaviors feel anger and missing their concentration, their capability to achieve a desired outcome. Also self-efficacy, often referred to as self-confidence, is essential to nursing students' ability and performance in the clinical setting. Aim: Study aimed to examine relation between bullying…

Efficacy and safety at 24 weeks of daily clinical use of tofacitinib in patients with rheumatoid arthritis.

Science.gov (United States)

Iwamoto, Naoki; Tsuji, Sosuke; Takatani, Ayuko; Shimizu, Toshimasa; Fukui, Shoichi; Umeda, Masataka; Nishino, Ayako; Horai, Yoshiro; Koga, Tomohiro; Kawashiri, Shin-Ya; Aramaki, Toshiyuki; Ichinose, Kunihiro; Hirai, Yasuko; Tamai, Mami; Nakamura, Hideki; Terada, Kaoru; Origuchi, Tomoki; Eguchi, Katsumi; Ueki, Yukitaka; Kawakami, Atsushi

2017-01-01

We evaluated the efficacy and safety of tofacitinib in patients with rheumatoid arthritis (RA) in a real-world setting. Seventy consecutive patients, for whom tofacitinib was initiated between November 2013 and May 2016, were enrolled. All patients fulfilled the 2010 ACR/EULAR classification criteria for RA. All patients received 5 mg of tofacitinib twice daily and were followed for 24 weeks. Clinical disease activity indicated by disease activity score (DAS)28-ESR, the simplified disease activity index, and the clinical disease activity index as well as adverse events (AEs) were evaluated. Statistical analysis was performed to determine which baseline variables influenced the efficacy of tofacitinib at 24 weeks. Fifty-eight patients (82.9%) continued tofacitinib at 24 weeks. Clinical disease activity rapidly and significantly decreased, and this efficacy continued throughout the 24 weeks: i.e., DAS28-ESR decreased from 5.04 ± 1.33 at baseline to 3.83 ± 1.11 at 4 weeks and 3.53 ± 1.17 at 24 weeks (Ptofacitinib treatment. The efficacy of tofacitinib was not changed in patients without concomitant use of methotrexate (MTX) or patients whose treatment with tocilizumab (TCZ) failed. Multivariable logistic analysis showed that the number of biologic DMARDs (bDMARDs) previously used was independently associated with achievement of DAS-low disease activity. Our present study suggests that tofacitinib is effective in real-world settings even without concomitant MTX use or after switching from TCZ. Our results also suggest that its efficacy diminishes if started after use of multiple bDMARDs.

Student distress in clinical workplace learning: differences in social comparison behaviours.

Science.gov (United States)

Janet Raat, A N; Schönrock-Adema, Johanna; van Hell, E Ally; Kuks, Jan B M; Cohen-Schotanus, Janke

2015-03-01

In medical education, student distress is known to hamper learning and professional development. To address this problem, recent studies aimed at helping students cope with stressful situations. Undergraduate students in clinical practice frequently use experiences of surrounding peers to estimate their abilities to master such challenging situations. This use of the experiences of others, known as social comparison, may affect student distress both positively and negatively. To find characteristics of a beneficial use of social comparison, we examined differences in comparison behaviours between students expressing low and high levels of distress. The participants in our study, response rate 93% (N = 301/321), were all medical students in their first year in clinical practice. They completed the General Health Questionnaire (GHQ-12) to measure distress, and three separate questionnaires to measure: (1) orientation to comparison, (2) motive for comparison, and (3) interpretation of comparison. Differences were analysed using multivariate analysis of variance. Although all students were oriented towards social comparison, the analyses showed that this orientation was less apparent among low-distress students. Besides, the low-distress students were less inclined to use motives indicative for comparisons with peers perceived as performing worse and were less negative in the interpretations of their comparisons. As social comparison is frequently used among all students, we recommend to make them aware of their comparison behaviours and inform them about the pros and cons of the distinguished aspects of the comparison process.

Comparison of the medical students? perceived self-efficacy and the evaluation of the observers and patients

OpenAIRE

Ammentorp, Jette; Thomsen, Janus Laust; Jarb?l, Dorte Ejg; Holst, Ren?; ?vrehus, Anne Lindebo Holm; Kofoed, Poul-Erik

2013-01-01

Background The accuracy of self-assessment has been questioned in studies comparing physicians? self-assessments to observed assessments; however, none of these studies used self-efficacy as a method for self-assessment. The aim of the study was to investigate how medical students? perceived self-efficacy of specific communication skills corresponds to the evaluation of simulated patients and observers. Methods All of the medical students who signed up for an Objective Structured Clinical Exa...

Suppression of TIM-1 predicates clinical efficacy of sublingual immunotherapy for allergic rhinitis in children.

Science.gov (United States)

Lin, Zhibin; Zhou, Lifeng; Luo, Xi; Xia, Wentong; Chen, Dehua; Xu, Rui; Wang, Jie; Luo, Renzhong; Xu, Geng; Li, Huabin

2013-08-01

To evaluate the clinical efficacy of sublingual immunotherapy (SLIT) with house-dust mite (HDM) extract and to examine the change of biomarkers (TIM-1, IL-5 and IL-10) after 6-month SLIT in children with allergic rhinitis (AR). One hundred and sixteen HDM-sensitized children with persistent AR were enrolled to assess the clinical efficacy of SLIT by determining the individual nasal symptom score (INSS) and total nasal symptom scores (TNSS) after 6-month SLIT. Moreover, the mRNA expression of TIM-1, IL-5 and IL-10 in peripheral blood mononuclear cells (PBMCs) was examined in 16 well-controlled and 12 uncontrolled AR patients using quantitative reverse transcription polymerase chain reaction (qRT-PCR). After 6-month SLIT, both TNSS and INSS scores were significantly decreased compared with the baseline value (p < 0.01). The rates for well-controlled, partly controlled and uncontrolled children were 43.1%, 32.8% and 24.1%, respectively. Accordingly, the mRNA levels of TIM-1 and IL-5 decreased significantly and IL-10 mRNA level increased significantly compared with the baseline value in well-controlled children (p < 0.05). Our findings suggest SLIT with HDM extract is effective and safe for AR children and TIM-1 may be considered as an indicator for evaluating the clinical efficacy of SLIT. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Comparison of the fibronectin-binding ability and antitumor efficacy of various mycobacteria.

Science.gov (United States)

Hudson, M A; Ritchey, J K; Catalona, W J; Brown, E J; Ratliff, T L

1990-07-01

Although the mechanism by which Bacillus Calmette-Guerin (BCG) exerts an antitumor effect on superficial bladder tumors is not fully understood, recent evidence has implicated binding of BCG organisms to fibronectin (FN) as requisite for this antitumor efficacy. Various substrains of BCG and other mycobacteria were tested in vitro for their relative capacities to bind both matrix and soluble FN. A substrain of Mycobacterium kansasii, designated the "high-binding strain," was found to bind FN more readily (P less than 0.05) in in vitro studies, when compared to commercially available substrains of BCG (Tice, Connaught, and Armand Frappier). The binding by the three commercial strains of BCG to FN in vitro appeared to be equivalent. The high-binding strain was further demonstrated to attach more readily in vivo to the acutely injured murine bladder (P less than 0.005) than the Armand Frappier substrain. Finally, using the MB49 murine bladder tumor model, an enhanced antitumor effect (P less than 0.05) was noted in mice treated with intravesical high-binding strain, in comparison to the Armand Frappier substrain, during five weekly treatments. It appears not only that the commercial substrains of BCG bind FN in an equivalent manner but also that the relative binding capacities of the substrains correlate directly with antitumor activity. A substrain of M. kansasii appears to have been identified which may prove more clinically effective than the currently available strains of BCG.

The first clinical experience on efficacy of topical flutamide on melasma compared with topical hydroquinone: a randomized clinical trial

Directory of Open Access Journals (Sweden)

Adalatkhah H

2015-08-01

Full Text Available Hassan Adalatkhah,1 Homayoun Sadeghi-Bazargani2,3 1Department of Dermatology, Ardabil University of Medical Sciences, Ardabil, Iran; 2Road Traffic Injury Research Center, Department of Statistics and Epidemiology, Tabriz University of Medical Sciences, Tabriz, Iran; 3Department of Public Health Sciences, Karolinska Institute, Stockholm, Sweden Background: Treatment of melasma is unsatisfactory most of the times. Hormonal role is shown to exist in pathogenesis of the melasma, and sex-hormone related drugs may have an effect on melasma.Aim: To investigate efficacy of 1% flutamide cream versus 4% hydroquinone cream on melasma.Methods: In a parallel randomized clinical trial, 74 women with melasma were allocated to receive a sunscreen along with 4% hydroquinone cream or 1% flutamide cream. Melasma Area and Severity Index (MASI, mexameter melanin assay, and patient satisfaction were investigated.Results: Mean age of the participants was 33.8 years. Mean length of time suffering from Melasma was 96.3 months. The subjects reported in average 1.1 hours per day of exposure to sunlight. Mean standardized total patient satisfaction score was 28.8 (standard deviation [SD] 17.2 in flutamide group patients versus 18 (SD 15.5 in control group (P<0.01. Regardless of treatment group, the skin darkness assessed upon MASI scales was reduced over the treatment course (P<0.001. Using mixed effects, longitudinal modeling showed better treatment efficacy based on MASI scale for flutamide group compared to the hydroquinone group (P<0.05. However, longitudinal analysis of mexameter scores did not reveal any significant difference in melanin measurements between flutamide and hydroquinone.Conclusion: Topical flutamide appeared as effective as topical hydroquinone in treating melasma using mexameter assessment but with a better MASI improvement trend and higher patient satisfaction in flutamide treatment versus topical hydroquinone. As the present study is possibly the

Comparison between the efficacies of Risperidone with Haloperidol in the treatment of attention-deficit hyperactivity disorder (ADHD) among preschoolers: a randomized double-blind clinical trial.

Science.gov (United States)

Riahi, Forough; Tashakori, Ashraf; Abdi, Leila

2016-09-01

Attention-deficit hyperactivity disorder (ADHD) is a common psychiatric disease with a worldwide pooled prevalence of 5.29%. To compare the efficacy of Risperidone with Haloperidol in the treatment of attention-deficit hyperactivity disorder (ADHD) among 3- to 6-year-old children. In a 6-week double-blind clinical trial, the efficacy of Risperidone 0.5-2 mg with a dose of maximum Haloperidol 0.075 mg/kg was assessed in 39 children aged 3-6 years. This study was conducted at the Golestan Psychiatric Clinic (Ahvaz, Iran). Measurement tools included the Conners' Parent Rating Scale (CPRS-48), Children's Global Assessment Scale (CGAS), and the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS). Data were analyzed using the Wilcoxon, Mann-Whitney, and Fisher's exact tests in the SPSS 19. During the 6 weeks, the decline in points was seen in Conner's rating scale and in ADHD-RS score in Risperidone and Haloperidol groups (pscale, an increase of performance in both groups for six weeks was statistically significant (pscales of ADHD-RS and CPRS-48, no statistically significant difference was observed between the two treatment groups; i.e., in terms of reducing the rate during weeks of two, four, and six (p>0.05). Haloperidol and Risperidone possibly can be an acceptable treatment choice in the ADHD treatment of 3- to 6-year-old children. The trial was registered at the Iranian Registry of Clinical Trials (http://www.irct.ir) with the Irct ID: IRCT2015082623766N1. This work was financially supported by grant (ref. no.: U-93130) from the vice chancellor for Research Affairs of Ahvaz Jundishapur University of Medical Sciences.

Methodology and lessons-learned from the efficacy clinical trial of the pentavalent rotavirus vaccine in Bangladesh.

Science.gov (United States)

Zaman, K; Yunus, M; El Arifeen, Shams; Azim, Tasnim; Faruque, A S G; Huq, Ehsanul; Hossain, Ilias; Luby, Stephen P; Victor, John C; Dallas, Michael J; Lewis, Kristen D C; Rivers, Stephen B; Steele, A Duncan; Neuzil, Kathleen M; Ciarlet, Max; Sack, David A

2012-04-27

An efficacy clinical trial with pentavalent rotavirus vaccine (PRV), RotaTeq(®), was conducted at Matlab field site of ICDDR,B, Bangladesh from March 2007 to March 2009. The methodology, including operation logistics, and lessons-learned are described in this report. Vaccination was organized at 41 fixed-site clinics twice/month. A total of 1136 infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6-, 10-, and 14-weeks of age with routine vaccines of the Expanded Programme on Immunization (EPI) schedule. Twelve field-workers routinely visited study participants for safety and efficacy follow-up. The study was conducted following good clinical practices and maintaining cold-chain requirements. There were no temperature deviations of clinical vaccine supplies. Data entry was done using the source documents to a central database developed by the sponsor which was linked to web. Among enrolled infants, 1128 (99.3%) received 3 doses of PRV/placebo and efficacy follow-up was conducted for a median of 554 days. For the evaluation of immunogenicity, blood samples were collected from 150 participants predose 1 and from 147 (98%) of the same participants post dose 3. Stool samples were collected from 778 (99.9%) acute gastroenteritis episodes among children who reported to diarrhoea treatment centres. Thirty-nine serious adverse events, including 6 deaths, occurred among study participants. The efficacy of PRV against severe rotavirus gastroenteritis was 42.7% through the entire follow-up period; serum anti-rotavirus IgA response was 78.1%. Inclement weather, difficult transportation, and movement of study participants were some of the challenges identified. This is the first vaccine trial in rural Bangladesh with online data entry. The study was well accepted in the community and was completed successfully. Copyright © 2011 Elsevier Ltd. All rights reserved.

Comparison of the analgesic efficacy of preoperative/postoperative oral dexketoprofen trometamol in third molar surgery: A randomized clinical trial.

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Esparza-Villalpando, Vicente; Chavarria-Bolaños, Daniel; Gordillo-Moscoso, Antonio; Masuoka-Ito, David; Martinez-Rider, Ricardo; Isiordia-Espinoza, Mario; Pozos-Guillen, Amaury

2016-09-01

The aim of this study was to compare the efficacy of preoperative and postoperative dexketoprofen trometamol for pain control after third molar surgery. Sixty subjects indicated for impacted mandibular third molar surgery were randomly assigned to two groups: preoperative (group 1, n = 30) and postoperative (group 2, n = 30) administration. Group 1 received 25 mg of dexketoprofen trometamol 30 min before surgery and 1 placebo capsule (same color and size with active drug) immediately after surgery. Group 2 received the placebo capsule 30 min before surgery and 25 mg of dexketoprofen trometamol immediately after surgery. Pain intensity was assessed using a numeric rating scale (NRS) during the first 8 h. The time of the need for a second dose of dexketoprofen trometamol, after the first administration, was recorded. The data were analyzed using mixed-model repeated-measures (MMRM), Wilcoxon rank-sum, and Kaplan-Meier analysis. After the 8 h period, no statistically significant difference was observed in the intensity of pain (MMRM, p = 0.41); and no significant difference in the time for a second dose (p = 0.956). In conclusion, preoperative administration of dexketoprofen trometamol is a reasonable clinical approach that is as effective as conventional postoperative pharmacological treatment, with the advantage of allowing early analgesia before pain develops. (ClinicalTrials.gov: NCT02380001). Copyright © 2016 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Observation of clinical efficacy of pattern scan laser photocoagulation on diabetic retinopathy

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Zhi-Hua Peng

2013-08-01

Full Text Available AIM: To evaluate the clinical efficacy of pattern scan laser photocoagulation(Pascalon proliferative diabetic retinopathy(PDR.METHODS: A total of 93 patients with retinopathy(186 eyeswere randomly divided into treatment group(96 eyes of 48 patientswho treated with panretinal photocoagulation(PRPusing Pascal at one time and control group(90 eyes of 45 patientswho treated with PRP using multi-wavelength krypton laser in 4-5 times. The visual acuity, FFA, OCT, visual field will be evaluated of each patient before and after the treatment.RESULTS: The visual acuity findings were stated as below: the overall effective rate of visual acuity in treatment group is 85.4% while it is 82.2% in control group. The overall effective rate in two groups has no significant difference. The retinal sensitivity has no significant decrease in the treatment group while which decreased significantly in the control group.CONCLUSION: The clinical efficacy of Pascal on treating the PDR is better than which of the regular argon laser. The field of vision has no significant narrowed after the Pascal treatment which can efficiently shorten the length of treatment and reduce the pain sensation.

Effects of an educational technology on self-efficacy for breastfeeding and practice of exclusive breastfeeding.

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Javorski, Marly; Rodrigues, Andreyna Javorski; Dodt, Regina Cláudia Melo; Almeida, Paulo César de; Leal, Luciana Pedrosa; Ximenes, Lorena Barbosa

2018-06-11

To evaluate the effects of using a flipchart (serial album) on maternal self-efficacy in breastfeeding and its effects on exclusive breastfeeding (EBF) in children's first two months of life. Clinical trial in Recife, Northeastern Brazil, with 112 women in the third trimester of gestation, randomly distributed in intervention group (IG) and control group (CG). The intervention was the use of the flipchart in IG. Data collection was performed through interviews in the prenatal period, and telephone contact at second, fourth and eighth weeks postpartum. The Breastfeeding Self-Efficacy Scale-Short-Form (BSES-SF) was used to measure self-efficacy scores. In the analysis, was used descriptive, bivariate statistics through tests of comparisons of proportions and means, and relative risk assessment. There was a statistically significant difference in mean values of self-efficacy scores between women in the IG and CG (peducational tool had positive effects on self-efficacy scores for breastfeeding and in maintenance of EBF in the IG. Brazilian Registry of Clinical Trials: RBR-5N7K99.

Clinical Efficacy of Acupuncture on Rheumatoid Arthritis and Associated Mechanisms: A Systemic Review

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Pei-Chi Chou

2018-01-01

Full Text Available Objective. The objective of this review is to investigate the detailed existing scientific information about the clinical efficacy of acupuncture on rheumatoid arthritis (RA conditions and to reveal the proposed mechanisms. Methods. We searched the PubMed, EMBASE, Cochrane, AMED (Allied and Complementary Medicine, NCCAM (The National Center for Complementary and Alternative Medicine, and CNKI (China National Knowledge Infrastructure databases to identify relevant monographs and related references from 1974 to 2018. Chinese journals and theses/dissertations were hand searched. Results. 43 studies were recruited. Each research was analyzed for study design, subject characteristics, intervention, selected acupoints, assessment parameters, proposed mechanisms, and results/conclusions. Conclusions. In our review, we concluded that acupuncture alone or combined with other treatment modalities is beneficial to the clinical conditions of RA without adverse effects reported and can improve function and quality of life and is worth trying. Several important possible mechanisms were summarized including anti-inflammatory effect, antioxidative effect, and regulation of immune system function. However, there is still inconsistency regarding the clinical efficacy and lack of well-designed human/animal double-blinded RCTs. Future discussion for further agreement on taking traditional Chinese medicine (TCM theory into consideration as much as possible is a top priority.

Clinical Efficacy Comparison of Saccharomyces boulardii and Yogurt Fluid in Acute Non-Bloody Diarrhea in Children: A Randomized, Controlled, Open Label Study

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Eren, Makbule; Dinleyici, Ener C.; Vandenplas, Yvan

2010-01-01

The purpose of this trial is to evaluate the clinical efficacy and cost/effectiveness of Saccharomyces boulardii compared with yogurt fluid (YF) in acute non-bloody diarrhea in children. This randomized, prospective open-label clinical trial includes 55 children (36 boys, 19 girls; mean age 21.2 ± 28.2 months). Group A (N = 28) received lyophilized S. boulardii and group B (N = 27) received YF. The duration of diarrhea was shorter with S. boulardii but the hospital stay was reduced with YF, although these differences were not significant. However, diarrhea had resolved in significantly more children on day 3 in the S. boulardii group (48.5% versus 25.5%; P < 0.05). In outpatient cases, yogurt treatment was cheaper than S. boulardii whereas in hospitalized patients, treatment cost was similar. In conclusion, the effect of daily freshly prepared YF was comparable to S. boulardii in the treatment of acute non-bloody diarrhea in children. The duration of diarrhea was shorter in the S. boulardii group, expressed as a significantly higher number of patients with normal stools on day 3. PMID:20207879

Clinical efficacy comparison of Saccharomyces boulardii and yogurt fluid in acute non-bloody diarrhea in children: a randomized, controlled, open label study.

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Eren, Makbule; Dinleyici, Ener C; Vandenplas, Yvan

2010-03-01

The purpose of this trial is to evaluate the clinical efficacy and cost/effectiveness of Saccharomyces boulardii compared with yogurt fluid (YF) in acute non-bloody diarrhea in children. This randomized, prospective open-label clinical trial includes 55 children (36 boys, 19 girls; mean age 21.2 +/- 28.2 months). Group A (N = 28) received lyophilized S. boulardii and group B (N = 27) received YF. The duration of diarrhea was shorter with S. boulardii but the hospital stay was reduced with YF, although these differences were not significant. However, diarrhea had resolved in significantly more children on day 3 in the S. boulardii group (48.5% versus 25.5%; P boulardii whereas in hospitalized patients, treatment cost was similar. In conclusion, the effect of daily freshly prepared YF was comparable to S. boulardii in the treatment of acute non-bloody diarrhea in children. The duration of diarrhea was shorter in the S. boulardii group, expressed as a significantly higher number of patients with normal stools on day 3.

Efficacy of α-blocker in improving ureteral stent-related symptoms: a meta-analysis of both direct and indirect comparison

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He F

2016-05-01

Full Text Available Feng He, Li-bo Man, Gui-zhong Li, Ning Liu Department of Urinary Surgery, Beijing Jishuitan Hospital, Beijing, People’s Republic of China Objective: To critically evaluate the efficacy of an α-blocker in improving ureteral-stent-related symptoms and preliminarily investigate the difference between different types of α-blockers. Methods: Relevant randomized controlled trials were identified through searching PubMed, the Cochrane Library, Embase, and other sources. After quality assessment and data abstraction, direct comparison based on the Ureteral Stent-related Symptom Questionnaire (USSQ between α-blockers and control was performed by RevMan 5.3. Indirect comparison between different types of α-blockers was performed by ITC 1.0. Sensitive and subgroup analyses were used to handle important clinical factors. Results: Sixteen randomized controlled trials containing 1,489 cases were included. Compared with control, α-blockers significantly reduced the overall urinary symptom, pain index, general health index, and scores related to sexual matters, while no significant difference was found in work performance and additional problem scores. Subgroup analysis showed that the duration of stent insertion, patient’s age, stent size, and the type of α-blocker had the potential to influence the outcomes. Through indirect comparison, we found alfuzosin and terazosin to be better than tamsulosin in pain relief and general health improvement. Conclusion: α-Blocker was effective in treating ureteral stent-related symptoms, as it improved the major indexes of USSQ post-insertion or post-removal. Alfuzosin and terazosin seemed to be better than tamsulosin, which needs further verification because of the lack of direct comparison currently. Keywords: α-blocker, tamsulosin, alfuzosin, terazosin, ureteral stent-related discomfort

Social support and moment-to-moment changes in treatment self-efficacy in men living with HIV: Psychosocial moderators and clinical outcomes

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Turan, Bulent; Fazeli, Pariya; Raper, James L.; Mugavero, Michael J.; Johnson, Mallory O.

2016-01-01

Objective For people living with HIV, treatment adherence self-efficacy is an important predictor of treatment adherence and therefore of clinical outcomes. Using experience sampling method (ESM), this study aimed to examine: (1) the within-person association between moment-to-moment changes in social support and HIV treatment self-efficacy; (2) the moderators of this within-person association, (3) the concordance between questionnaire and ESM measurement of treatment self-efficacy; and (4) the utility of each approach (ESM and questionnaire) in predicting adherence to medication, adherence to clinic visits, CD4 counts, and viral load. Methods 109 men living with HIV responded to the same set of ESM questions 3 times a day for 7 days via a smart phone given to them for the study. They also completed cross-sectional questionnaires and their clinic data was extracted from medical records in order to examine predictors and consequences of state and trait treatment self-efficacy. Results In within-person hierarchical linear modeling (HLM) analyses, receipt of recent social support predicted higher current ESM treatment self-efficacy. This association was stronger for individuals reporting higher avoidance coping with HIV. The correlation between ESM and questionnaire measures of treatment self-efficacy was r = .37. ESM measure of average treatment self-efficacy predicted medication adherence, visit adherence, CD4 counts, and viral load, while questionnaire-based self-efficacy did not predict these outcomes. Conclusion Interventions aimed at improving treatment adherence may target social support processes, which may improve treatment self-efficacy and adherence. PMID:27089459

Clinical evaluation of the efficacy of removing microorganisms to disinfect patient-derived dental impressions.

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Egusa, Hiroshi; Watamoto, Takao; Matsumoto, Takuya; Abe, Keiko; Kobayashi, Munemasa; Akashi, Yoshihiro; Yatani, Hirofumi

2008-01-01

Disinfection of dental impressions is an indispensable procedure for the control of cross-contamination; however, there is limited information on the efficacy of disinfection under clinical conditions. The objective of this study was to clinically evaluate the disinfection efficacy of commercially available agents in removing oral pathogens from patient-derived impressions. Impressions from 54 patients were divided into groups and either left undisinfected or underwent 1 of 5 disinfection treatments: (1) 2% glutaraldehyde (GA), (2) 1% sodium hypochlorite (SH), (3) 0.25% benzalkonium chloride (BC), (4) 1 ppm ozonated water (OW), or (5) the Hygojet/MD520 system (HJ). An impression culture technique using a brain heart infusion agar medium was used to visualize the microbial contamination on the surface of the impression cultures. The persistent presence of oral pathogens on the impression cultures was examined using selective isolation agar plates. The isolation frequencies of streptococci, staphylococci, Candida, methicillin-resistant Staphylococcus aureus, and Pseudomonas aeruginosa species from undisinfected impressions were 100%, 55.6%, 25.9%, 25.9% and 5.6%, respectively. Disinfection with HJ and BC removed the microorganisms with the greatest efficacy, followed by GA, SH, and OW. Potential bacterial contamination could be detected even after disinfection had been performed. Combined use of BC plus GA or SH removed oral pathogens almost completely from dental impressions. This investigation showed that potential contaminants are still present, even after general disinfection procedures. Therefore, either HJ or the combined use of BC with GA or SH is recommended for clinical and laboratory use.

Modeling clinical efficacy of the S1P receptor modulator ponesimod in psoriasis.

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Krause, Andreas; D'Ambrosio, Daniele; Dingemanse, Jasper

2018-02-01

Ponesimod is currently the only S1P receptor modulator studied in psoriasis. In a dose-finding study, the active doses showed similar efficacy. Prediction of efficacy at lower doses to aid clinical phase 3 planning with respect to dose selection, duration of treatment, and patient inclusion criteria based on pharma-co-kinetic/pharmacodynamic (PK/PD) modeling and simulation. The dose-finding study treated 326 patients (67 on placebo, 126 on 20mg, and 133 on 40mg) over 16 weeks. PK/PD modeling of steady-state trough concentrations and longitudinal PASI scores was employed to characterize data and simulate scenarios. PASI score continually decreased with time on ponesimod treatment, reaching a plateau at 16 weeks. Absolute and relative (percent) PASI score change was larger in patients with higher PASI score at baseline. Doses below 10mg were predicted to show lower efficacy than doses of 10mg and higher. Concentration-response modeling was able to predict the efficacy of doses that were not studied. In psoriasis patients, a dose of 10mg (not administered in the study) was predicted to show efficacy similar to 20mg. Disease status (PASI score at baseline) as study inclusion criterion has pronounced influence on study outcome. Copyright © 2017 Japanese Society for Investigative Dermatology. Published by Elsevier B.V. All rights reserved.

Clinical efficacy and safety of fluoxetine in generalized anxiety disorder in Chinese patients

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Zou C

2013-11-01

Full Text Available Chuan Zou,1 Xiang Ding,1 Joseph H Flaherty,2 Birong Dong1 1The Center of Gerontology and Geriatrics, West China Hospital, Sichuan University, Chengdu, People's Republic of China; 2St Louis University, St Louis, MO, USA Background: Generalized anxiety disorder (GAD is a prevalent, disabling disease and is highly comorbid with other psychiatric disorders both in Western countries and the People's Republic of China. Fluoxetine, a selective inhibitor of serotonin reuptake (SSRI, is widely utilized in the management of GAD in clinical practice despite the lack of strong evidence. This article reviews fluoxetine trials to investigate fluoxetine's efficacy and tolerability in Chinese patients with GAD. Methods: A literature review was conducted using the following databases up to and including April 2013: Chinese BioMedical Literature, China National Knowledge Infrastructure, EMBASE, MEDLINE, and PsycINFO. We selected clinical studies that utilized fluoxetine for GAD in which all participants were Chinese. Results: Fifteen open-label, non-placebo trials were identified and analyzed; eleven anxiolytics were compared with fluoxetine separately. Short-term efficacy of fluoxetine had been established in these open-label, head-to-head controlled trials. Fluoxetine had rapid onset of action (approximately 1–2 weeks and seemed to be effective in maintenance treatment. Fluoxetine was generally well-tolerated with the most common side effect of dry month and nausea. Compared to other anxiolytic agents, fluoxetine was equivalent with all of the comparative anxiolytics in terms of efficacy except mirtazapine which showed conflicting results with fluoxetine in two studies. In terms of side effects, fluoxetine was better tolerated than diazepam, doxepine, and amitriptyline, less tolerated than escitalopram, and had similar tolerability with duloxetine as well as alprazolam. Conclusion: Given the high risk of bias of the included studies, the overall small sample

Reliability of diagnosis and clinical efficacy of visceral osteopathy: a systematic review.

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Guillaud, Albin; Darbois, Nelly; Monvoisin, Richard; Pinsault, Nicolas

2018-02-17

In 2010, the World Health Organization published benchmarks for training in osteopathy in which osteopathic visceral techniques are included. The purpose of this study was to identify and critically appraise the scientific literature concerning the reliability of diagnosis and the clinical efficacy of techniques used in visceral osteopathy. Databases MEDLINE, OSTMED.DR, the Cochrane Library, Osteopathic Research Web, Google Scholar, Journal of American Osteopathic Association (JAOA) website, International Journal of Osteopathic Medicine (IJOM) website, and the catalog of Académie d'ostéopathie de France website were searched through December 2017. Only inter-rater reliability studies including at least two raters or the intra-rater reliability studies including at least two assessments by the same rater were included. For efficacy studies, only randomized-controlled-trials (RCT) or crossover studies on unhealthy subjects (any condition, duration and outcome) were included. Risk of bias was determined using a modified version of the quality appraisal tool for studies of diagnostic reliability (QAREL) in reliability studies. For the efficacy studies, the Cochrane risk of bias tool was used to assess their methodological design. Two authors performed data extraction and analysis. Eight reliability studies and six efficacy studies were included. The analysis of reliability studies shows that the diagnostic techniques used in visceral osteopathy are unreliable. Regarding efficacy studies, the least biased study shows no significant difference for the main outcome. The main risks of bias found in the included studies were due to the absence of blinding of the examiners, an unsuitable statistical method or an absence of primary study outcome. The results of the systematic review lead us to conclude that well-conducted and sound evidence on the reliability and the efficacy of techniques in visceral osteopathy is absent. The review is registered PROSPERO 12th of December

Efficacy and Safety of Rituximab in Children with Refractory Nephrotic Syndrome; A Multicenter Clinical Trial

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Yo Han Ahn

2014-06-01

Conclusions: In this interim analysis of clinical trial to evaluate the efficacy and safety of RTX in children with refractory NS, RTX treatment for refractory NS was safe and effective, especially in patients with DNS.

Efficacy and safety at 24 weeks of daily clinical use of tofacitinib in patients with rheumatoid arthritis.

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Naoki Iwamoto

Full Text Available We evaluated the efficacy and safety of tofacitinib in patients with rheumatoid arthritis (RA in a real-world setting.Seventy consecutive patients, for whom tofacitinib was initiated between November 2013 and May 2016, were enrolled. All patients fulfilled the 2010 ACR/EULAR classification criteria for RA. All patients received 5 mg of tofacitinib twice daily and were followed for 24 weeks. Clinical disease activity indicated by disease activity score (DAS28-ESR, the simplified disease activity index, and the clinical disease activity index as well as adverse events (AEs were evaluated. Statistical analysis was performed to determine which baseline variables influenced the efficacy of tofacitinib at 24 weeks.Fifty-eight patients (82.9% continued tofacitinib at 24 weeks. Clinical disease activity rapidly and significantly decreased, and this efficacy continued throughout the 24 weeks: i.e., DAS28-ESR decreased from 5.04 ± 1.33 at baseline to 3.83 ± 1.11 at 4 weeks and 3.53 ± 1.17 at 24 weeks (P<0.0001, vs. baseline. 15 AEs including 5 herpes zoster infection occurred during tofacitinib treatment. The efficacy of tofacitinib was not changed in patients without concomitant use of methotrexate (MTX or patients whose treatment with tocilizumab (TCZ failed. Multivariable logistic analysis showed that the number of biologic DMARDs (bDMARDs previously used was independently associated with achievement of DAS-low disease activity.Our present study suggests that tofacitinib is effective in real-world settings even without concomitant MTX use or after switching from TCZ. Our results also suggest that its efficacy diminishes if started after use of multiple bDMARDs.

Experimental data of global and diffuse luminous efficacy on vertical surfaces at Arcavacata di Rende and comparisons with calculation models

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Cucumo, M.; De Rosa, A.; Ferraro, V.; Kaliakatsos, D.; Marinelli, V.

2009-01-01

Measurements of natural global and diffuse illuminance on four vertical surfaces exposed to north, east, south and west have been carried out at Arcavacata di Rende (Italy). In the work the mean hourly values of the global and diffuse luminous efficacy measured in the period of a year are presented. The hourly data have been compared with the predictions of many calculation models. The comparisons show that, for global efficacy, the differences among the various models are not significant, and the use of a model with a constant value of efficacy gives good predictions of global illuminance. For the prediction of diffuse illuminance the different models behave in a similar way if their coefficients are recalculated and, again, the use of a constant diffuse efficacy provides a good estimate of diffuse illuminance on vertical surfaces

Anti-EGFR Therapy: Mechanism and Advances in Clinical Efficacy in Breast Cancer

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John F. Flynn

2009-01-01

Full Text Available This review will focus on recent advances in the application of antiepidermal growth factor receptor (anti-EGFR for the treatment of breast cancer. The choice of EGFR, a member of the ErbB tyrosine kinase receptor family, stems from evidence pinpointing its role in various anti-EGFR therapies. Therefore, an increase in our understanding of EGFR mechanism and signaling might reveal novel targets amenable to intervention in the clinic. This knowledge base might also improve existing medical treatment options and identify research gaps in the design of new therapeutic agents. While the approved use of drugs like the dual kinase inhibitor Lapatinib represents significant advances in the clinical management of breast cancer, confirmatory studies must be considered to foster the use of anti-EGFR therapies including safety, pharmacokinetics, and clinical efficacy.

Quantifying the Impact of Natural Immunity on Rotavirus Vaccine Efficacy Estimates: A Clinical Trial in Dhaka, Bangladesh (PROVIDE) and a Simulation Study.

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Rogawski, Elizabeth T; Platts-Mills, James A; Colgate, E Ross; Haque, Rashidul; Zaman, K; Petri, William A; Kirkpatrick, Beth D

2018-03-05

The low efficacy of rotavirus vaccines in clinical trials performed in low-resource settings may be partially explained by acquired immunity from natural exposure, especially in settings with high disease incidence. In a clinical trial of monovalent rotavirus vaccine in Bangladesh, we compared the original per-protocol efficacy estimate to efficacy derived from a recurrent events survival model in which children were considered naturally exposed and potentially immune after their first rotavirus diarrhea (RVD) episode. We then simulated trial cohorts to estimate the expected impact of prior exposure on efficacy estimates for varying rotavirus incidence rates and vaccine efficacies. Accounting for natural immunity increased the per-protocol vaccine efficacy estimate against severe RVD from 63.1% (95% confidence interval [CI], 33.0%-79.7%) to 70.2% (95% CI, 44.5%-84.0%) in the postvaccination period, and original year 2 efficacy was underestimated by 14%. The simulations demonstrated that this expected impact increases linearly with RVD incidence, will be greatest for vaccine efficacies near 50%, and can reach 20% in settings with high incidence and low efficacy. High rotavirus incidence leads to predictably lower vaccine efficacy estimates due to the acquisition of natural immunity in unvaccinated children, and this phenomenon should be considered when comparing efficacy estimates across settings. NCT01375647.

Promoting Assessment Efficacy through an Integrated System for Online Clinical Assessment of Practical Skills

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Hay, Peter J.; Engstrom, Craig; Green, Anita; Friis, Peter; Dickens, Sue; Macdonald, Doune

2013-01-01

This paper presents evaluation outcomes from an externally funded research project involving the online clinical assessment of practical skills (eCAPS) using web-based video technologies within a university medical programme. eCAPS was implemented to trial this web-based approach for promoting the efficacy of "practical" skills…

Illness severity and self-efficacy as course predictors of DSM-IV alcohol dependence in a multisite clinical sample.

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Langenbucher, J; Sulesund, D; Chung, T; Morgenstern, J

1996-01-01

Illness severity and self-efficacy are two constructs of growing interest as predictors of clinical response in alcoholism. Using alternative measures of illness severity (DSM-IV symptom count, Alcohol Dependence Scale, and Addiction Severity Index) and self-efficacy (brief version of the Situational Confidence Questionnaire) rigorously controlled for theoretically important background variables, we studied their unique contribution to multiple indices of relapse, relapse latency, and use of alternative coping behaviors in a large, heterogeneous clinical sample. The Alcohol Dependence Scale contributed to the prediction of 4 of 5 relapse indicators. The SCQ failed to predict relapse behavior or its precursor, coping response. The findings emphasize the predictive validity of severity of dependence as a course specifier and underline the need for more sensitive and externally valid measures of cognitive processes such as self-efficacy for application in future studies of posttreatment behavior.

Clinical efficacy and effectiveness of 3D printing: a systematic review.

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Diment, Laura E; Thompson, Mark S; Bergmann, Jeroen H M

2017-12-21

To evaluate the clinical efficacy and effectiveness of using 3D printing to develop medical devices across all medical fields. Systematic review compliant with Preferred Reporting Items for Systematic Reviews and Meta-Analyses. PubMed, Web of Science, OVID, IEEE Xplore and Google Scholar. A double-blinded review method was used to select all abstracts up to January 2017 that reported on clinical trials of a three-dimensional (3D)-printed medical device. The studies were ranked according to their level of evidence, divided into medical fields based on the International Classification of Diseases chapter divisions and categorised into whether they were used for preoperative planning, aiding surgery or therapy. The Downs and Black Quality Index critical appraisal tool was used to assess the quality of reporting, external validity, risk of bias, risk of confounding and power of each study. Of the 3084 abstracts screened, 350 studies met the inclusion criteria. Oral and maxillofacial surgery contained 58.3% of studies, and 23.7% covered the musculoskeletal system. Only 21 studies were randomised controlled trials (RCTs), and all fitted within these two fields. The majority of RCTs were 3D-printed anatomical models for preoperative planning and guides for aiding surgery. The main benefits of these devices were decreased surgical operation times and increased surgical accuracy. All medical fields that assessed 3D-printed devices concluded that they were clinically effective. The fields that most rigorously assessed 3D-printed devices were oral and maxillofacial surgery and the musculoskeletal system, both of which concluded that the 3D-printed devices outperformed their conventional comparators. However, the efficacy and effectiveness of 3D-printed devices remain undetermined for the majority of medical fields. 3D-printed devices can play an important role in healthcare, but more rigorous and long-term assessments are needed to determine if 3D-printed devices are

Methylphenidate dose optimization for ADHD treatment: review of safety, efficacy, and clinical necessity

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Huss M

2017-07-01

Full Text Available Michael Huss,1 Praveen Duhan,2 Preetam Gandhi,3 Chien-Wei Chen,4 Carsten Spannhuth,3 Vinod Kumar5 1Child and Adolescent Psychiatry, University Medicine, Mainz, Germany; 2Global Medical Affairs, Novartis Healthcare Pvt. Ltd., Hyderabad, India; 3Development Franchise, Established Medicine Neuroscience, Novartis Pharma AG, Basel, Switzerland; 4Biostatistics Cardio-Metabolic & Established Medicine, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 5Established Medicines, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA Abstract: Attention-deficit/hyperactivity disorder (ADHD is a chronic psychiatric disorder characterized by hyperactivity and/or inattention and is often associated with a substantial impact on psychosocial functioning. Methylphenidate (MPH, a central nervous system stimulant, is commonly used for pharmacological treatment of adults and children with ADHD. Current practice guidelines recommend optimizing MPH dosage to individual patient needs; however, the clinical benefits of individual dose optimization compared with fixed-dose regimens remain unclear. Here we review the available literature on MPH dose optimization from clinical trials and real-world experience on ADHD management. In addition, we report safety and efficacy data from the largest MPH modified-release long-acting Phase III clinical trial conducted to examine benefits of dose optimization in adults with ADHD. Overall, MPH is an effective ADHD treatment with a good safety profile; data suggest that dose optimization may enhance the safety and efficacy of treatment. Further research is required to establish the extent to which short-term clinical benefits of MPH dose optimization translate into improved long-term outcomes for patients with ADHD. Keywords: methylphenidate, dose optimization, attention-deficit/hyperactivity disorder, ADHD

Does Self-Efficacy Affect Cognitive Performance in Persons with Clinically Isolated Syndrome and Early Relapsing Remitting Multiple Sclerosis?

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Peter Joseph Jongen

2015-01-01

Full Text Available In persons with multiple sclerosis (MS a lowered self-efficacy negatively affects physical activities. Against this background we studied the relationship between self-efficacy and cognitive performance in the early stages of MS. Thirty-three patients with Clinically Isolated Syndrome (CIS and early Relapsing Remitting MS (eRRMS were assessed for self-efficacy (MSSES-18, cognition (CDR System, fatigue (MFIS-5, depressive symptoms (BDI, disease impact (MSIS-29, and disability (EDSS. Correlative analyses were performed between self-efficacy and cognitive scores, and stepwise regression analyses identified predictors of cognition and self-efficacy. Good correlations existed between total self-efficacy and Power of Attention (r= 0.65; P< 0.001, Reaction Time Variability (r= 0.57; P< 0.001, and Speed of Memory (r= 0.53; P< 0.01, and between control self-efficacy and Reaction Time Variability (r= 0.55; P< 0.01. Total self-efficacy predicted 40% of Power of Attention, 34% of Reaction Time Variability, and 40% of Speed of Memory variabilities. Disease impact predicted 65% of total self-efficacy and 58% of control self-efficacy variabilities. The findings may suggest that in persons with CIS and eRRMS self-efficacy may positively affect cognitive performance and that prevention of disease activity may preserve self-efficacy.

Efficacy of platelet-rich fibrin vs. enamel matrix derivative in the treatment of periodontal intrabony defects: a clinical and cone beam computed tomography study.

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Gupta, Swyeta Jain; Jhingran, Rajesh; Gupta, Vivek; Bains, Vivek Kumar; Madan, Rohit; Rizvi, Iram

2014-07-01

To evaluate and compare the efficacy of platelet-rich fibrin (PRF) with enamel matrix derivative (EMD; Emdogain) in the treatment of periodontal intrabony defects in patients with chronic periodontitis, six months after surgery. Forty-four (44) intrabony defects in 30 patients (15 males) were randomly allocated into two treatment groups: EMD (n = 22) and PRF (n = 22). Measurement of the defects was done using clinical and cone beam computed tomography at baseline and 6 months. Clinical and radiographic parameters such as probing depth, clinical attachment level, intrabony defect depth and defect angle, were recorded at baseline and 6 months post-operatively. Within group change was evaluated using the Wilcoxon signed rank test. Intergroup comparisons were made using the Mann-Whitney U test. Postsurgical measurements revealed that there was an equal reduction in probing depth and a greater but statistically non-significant attachment gain for the Emdogain group when compared to the platelet-rich fibrin group. The Emdogain group presented with significantly greater percentage defect resolution (43.07% ± 12.21) than did the platelet-rich fibrin group (32.41% ± 14.61). Post-operatively the changes in defect width and defect angle were significant in both groups, but upon intergroup comparison they were found to be statistically non-significantly different. Both Emdogain and platelet-rich fibrin were effective in the regeneration of intrabony defects. Emdogain was significantly superior in terms of percentage defect resolution.

The clinical efficacy of dietary fat restriction in treatment of dogs with intestinal lymphangiectasia.

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Okanishi, H; Yoshioka, R; Kagawa, Y; Watari, T

2014-01-01

Intestinal lymphangiectasia (IL), a type of protein-losing enteropathy (PLE), is a dilatation of lymphatic vessels within the gastrointestinal tract. Dietary fat restriction previously has been proposed as an effective treatment for dogs with PLE, but limited objective clinical data are available on the efficacy of this treatment. To investigate the clinical efficacy of dietary fat restriction in dogs with IL that were unresponsive to prednisolone treatment or showed relapse of clinical signs and hypoalbuminemia when the prednisolone dosage was decreased. Twenty-four dogs with IL. Retrospective study. Body weight, clinical activity score, and hematologic and biochemical variables were compared before and 1 and 2 months after treatment. Furthermore, the data were compared between the group fed only an ultra low-fat (ULF) diet and the group fed ULF and a low-fat (LF) diet. Nineteen of 24 (79%) dogs responded satisfactorily to dietary fat restriction, and the prednisolone dosage could be decreased. Clinical activity score was significantly decreased after dietary treatment compared with before treatment. In addition, albumin (ALB), total protein (TP), and blood urea nitrogen (BUN) concentration were significantly increased after dietary fat restriction. At 2 months posttreatment, the ALB concentrations in the ULF group were significantly higher than that of the ULF + LF group. Dietary fat restriction appears to be an effective treatment in dogs with IL that are unresponsive to prednisolone treatment or that have recurrent clinical signs and hypoalbuminemia when the dosage of prednisolone is decreased. © 2014 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of American College of Veterinary Internal Medicine.

MRI assessment program. Consensus statement on clinical efficacy of MRI

International Nuclear Information System (INIS)

1998-05-01

This consensus statement is largely based on the experience gained at the MRI units at the four hospitals which have operated scanners in the MRI program. It reflects the considered opinion of the radiologists responsible for the MRI services at those hospitals. Account has also been taken of relevant overseas data. This collection of opinion relates particularly to comparison with other imaging modalities. The specific comments will require further consideration as technical developments with MRI become available, additional experience is gained with gadolinium contrast material and additional data are obtained on the influence of MRI on patient management. MRI, at present, is used either to improve diagnostic accuracy when other tests are negative or equivocal, when there is strong clinical suspicion of disease, or to improve surgical or other management planning when the diagnosis known. In some situations (eg syringomyelia, congenital spinal disease, posterior fossa/cerebello-pontine angle tumours) it may entirely replace other tests (eg myelography, air contrast, CT) which are substantially less accurate and/or more invasive. In other situations (eg hemispheric brain tumours, lumbar disc protrusions) when other tests, such as CT, can be as accurate, MRI is not usually or initially indicated because it is currently more expensive and of limited availability. However, balanced against this is the fact that it does not expose the patient to potentially harmful ionising radiation. It is also stressed that MRI images depend on complex, widely variable and, as yet, incompletely understood parameters. There is concern that this may result in false positive diagnoses, especially where MRI is used alone as a screening test, or used as the initial test. For several reasons (availability, cost, medical and diagnostic efficacy), the specific comments on indications for MRI presented are based upon the assumption that MRI is a tertiary and complementary imaging examination

A comprehensive comparison of the efficacy and tolerability of racecadotril with other treatments of acute diarrhea in adults

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Wolfgang Fischbach

2016-10-01

Full Text Available Racecadotril is a guideline-recommended treatment to alleviate symptoms of acute diarrhea. A systematic review of randomized studies was performed comparing efficacy and safety of treatment with racecadotril to that with placebo or active treatments in adults. In five double-blind studies, racecadotril and placebo had comparable tolerability but racecadotril was more effective. This was consistent across multiple efficacy parameters including duration of diarrhea, number of diarrheic stools, abdominal pain and meteorism; it was also consistent across countries in Africa, Asia and Europe. In six randomized studies in outpatients comparing racecadotril to loperamide, resolution of symptoms occurred with similar speed and efficacy; however, racecadotril treatment was associated with less rebound constipation and less abdominal discomfort. A seventh comparative study performed in geriatric nursing home residents reported a superior efficacy of racecadotril. In direct comparison with Saccharomyces boulardii treatment, racecadotril exhibited similar tolerability but was more efficacious. One study compared racecadotril to octreotide in patients with acute diarrhea requiring hospitalization, rehydration and antibiotic treatment; in this cohort, octreotide was more efficacious than racecadotril. In conclusion, in adults with acute diarrhea racecadotril is more efficacious than placebo or Saccharomyces boulardii, similarly efficacious as loperamide and, in patients with moderate to severe disease as add-on to antibiotics, less than octreotide. The tolerability of racecadotril is similar to that of placebo or Saccharomyces boulardii and better than that of loperamide, particularly with regard to risk of rebound constipation. Taken together these data demonstrate that racecadotril is a suitable treatment to alleviate symptoms of acute diarrhea in adults.

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

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Buechner, Stanislaw A

2014-06-01

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

The efficacy of chiropractic manipulation for back pain : Blinded review of relevant randomized clinical trials

NARCIS (Netherlands)

Assendelft, W. J J; Koes, B. W.; Van der Heijden, G. J M G; Bouter, L. M.

1992-01-01

Objective: To assess the efficacy of chiropractic for patients with back pain. Data Sources: Randomized clinical trials (RCTs) on spinal manipulation were identified with a Medline search (1966-1990), by citation tracking, and by manual examination of the relevant chiropractic reference systems

Interventional treatment of renal artery stenosis: a mid-term evaluation of clinical efficacy

International Nuclear Information System (INIS)

Liu Jing; Zhang Xitong

2009-01-01

Objective: To assess the clinical efficacy of interventional management for the treatment of renal artery stenosis. Methods: Percutaneous transluminal balloon renal angioplasty and / or percutaneous transluminal renal artery stenting were performed in 47 patients with renal artery stenosis (55 stenosed arteries in total). A follow-up study on the blood pressure and renal function was conducted and the results were statistically analyzed. Results: Fifty-four stenosed renal arteries were successfully reopened, of which only percutaneous transluminal balloon angioplasty was adopted in 17 and percutaneous transluminal renal artery stenting in 37. One patient died during the procedure. A follow-up for a mean period of (2.5 ± 0.6) years was carried out. The blood pressure determined at one (n = 46), 6 (n = 46), 12 (n = 33) and 24 (n = 29) months after the treatment was significantly decreased when compared to that determined before the treatment (P < 0.01). The clinical effective rate was 89.13% (41 / 46), 72.73% (24 / 33) and 62.07% (18 / 29), respectively. After the therapy,the renal function was improved in 5, remained unchanged in 33 and became worse in 3 patients. The comparison of the post-operative renograms (obtained within 2 months) with the pre-operative ones showed that in eight patients there was an increase in renal blood flow with an improvement in renal function impairment, which took a turn from severe degree to mild or moderate degree. Nevertheless, severe impairment in renal blood flow remained in 3 patients. Conclusion: Percutaneous transluminal balloon renal angioplasty and percutaneous transluminal renal artery stenting are safe and effective treatments for the renal artery stenosis, which also has a beneficial effect on the related renal hypertension and renal insufficiency. (authors)

Cervical interlaminar epidural steroid injection for unilateral cervical radiculopathy: Comparison of midline and paramedian approaches for efficacy

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Yoon, Ji Young; Kwon, Jong Won; Yoon, Young Cheol [Dept. of Radiology and Center for Imaging Science, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul (Korea, Republic of); Lee, Jong Seok [School of Business Administration, Hallym University, Chuncheon (Korea, Republic of)

2015-06-15

The objective of this study was to compare the clinical outcomes of the cervical interlaminar epidural steroid injection (CIESI) for unilateral radiculopathy by the midline or paramedian approaches and to determine the prognostic factors of CIESI. We retrospectively analyzed 182 patients who underwent CIESI from January 2009 to December 2012. Inclusion criteria were no previous spinal steroid injection, presence of a cross-sectional image, and presence of follow-up records. Exclusion criteria were patients with bilateral cervical radiculopathy and/or dominant cervical axial pain, combined peripheral neuropathy, and previous cervical spine surgery. Short-term clinical outcomes were evaluated at the first follow-up after CIESI. We compared the clinical outcomes between the midline and paramedian approaches. Possible prognostic factors for the outcome, such as age, gender, duration of radiculopathy, and cause of radiculopathy were also analyzed. Cervical interlaminar epidural steroid injections were effective in 124 of 182 patients (68.1%) at the first follow-up. There was no significant difference in the clinical outcomes of CIESI, between midline (69.6%) and paramedian (63.7%) approaches (p = 0.723). Cause of radiculopathy was the only significant factor affecting the efficacy of CIESI. Patients with disc herniation had significantly better results than patients with neural foraminal stenosis (82.9% vs. 56.0%) (p < 0.001). There is no significant difference in treatment efficacy between the midline and paramedian approaches in CIESI, for unilateral radiculopathy. The cause of the radiculopathy is significantly associated with the treatment efficacy; patients with disc herniation experience better pain relief than those with neural foraminal stenosis.

Cervical interlaminar epidural steroid injection for unilateral cervical radiculopathy: Comparison of midline and paramedian approaches for efficacy

International Nuclear Information System (INIS)

Yoon, Ji Young; Kwon, Jong Won; Yoon, Young Cheol; Lee, Jong Seok

2015-01-01

The objective of this study was to compare the clinical outcomes of the cervical interlaminar epidural steroid injection (CIESI) for unilateral radiculopathy by the midline or paramedian approaches and to determine the prognostic factors of CIESI. We retrospectively analyzed 182 patients who underwent CIESI from January 2009 to December 2012. Inclusion criteria were no previous spinal steroid injection, presence of a cross-sectional image, and presence of follow-up records. Exclusion criteria were patients with bilateral cervical radiculopathy and/or dominant cervical axial pain, combined peripheral neuropathy, and previous cervical spine surgery. Short-term clinical outcomes were evaluated at the first follow-up after CIESI. We compared the clinical outcomes between the midline and paramedian approaches. Possible prognostic factors for the outcome, such as age, gender, duration of radiculopathy, and cause of radiculopathy were also analyzed. Cervical interlaminar epidural steroid injections were effective in 124 of 182 patients (68.1%) at the first follow-up. There was no significant difference in the clinical outcomes of CIESI, between midline (69.6%) and paramedian (63.7%) approaches (p = 0.723). Cause of radiculopathy was the only significant factor affecting the efficacy of CIESI. Patients with disc herniation had significantly better results than patients with neural foraminal stenosis (82.9% vs. 56.0%) (p < 0.001). There is no significant difference in treatment efficacy between the midline and paramedian approaches in CIESI, for unilateral radiculopathy. The cause of the radiculopathy is significantly associated with the treatment efficacy; patients with disc herniation experience better pain relief than those with neural foraminal stenosis.

[Self-stigma, self-esteem and self-efficacy of mentally ill].

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Pasmatzi, E; Koulierakis, G; Giaglis, G

2016-01-01

The way that the social stigma of mental illness is related with the self-stigma, which in turn affects self-esteem and self-efficacy of mental patients was investigated. A sample of 66 patients in the Adult Psychiatric Clinic of the Thessaloniki General Hospital "G. Papanikolaou" was participated in this descriptive association study, with cross-sectional comparisons. The sample comprised of patients who were hospitalized or visited the Clinic as out-patients during the period that the study was undertaken. A tool for measuring the basic demographic, social and clinical characteristics of the participants was designed and used. Additionally, the Self-Stigma of Mental Illness Scale, SSMIS, Rosenberg's Self-Esteem Scale, RSE and the General Self-Efficacy Sherer Scale, GSESH were used for measuring self-stigma, self-esteem and self-efficacy respectively. Results showed that self-esteem and self-efficacy were highly associated with each another. Self-esteem and self-efficacy co varied. Greater self-stigma was associated with lower self-esteem and selfefficacy confirming the power of this relationship which is connected with patients' psychological empowerment and acts as mediator between patients' self-categorization as "mentally ill" and their self-esteem and self-efficacy. Additionally, a mild negative association between self-esteem, self-efficacy and age was found while higher educational level was associated with greater selfefficacy. Greater self-stigma along with lower educational level were the most significant predictors of both self-esteem and self-efficacy of mental patients, as shown by regression analysis. Some of our results, such as the percentage of low self-esteem (30.3%), were different from previous relevant data (9.1-24%), probably due to differences in sample's cultural characteristics and composition, research tools used, and the degree of mentally ill patients' reaction to social stigma perception. Despite its methodological limitations, the

Comparison of the Efficacy of Different Drugs on Non-Motor Symptoms of Parkinson's Disease: a Network Meta-Analysis.

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Li, Bao-Dong; Cui, Jing-Jun; Song, Jia; Qi, Ce; Ma, Pei-Feng; Wang, Ya-Rong; Bai, Jing

2018-01-01

A network meta-analysis is used to compare the efficacy of ropinirole, rasagiline, rotigotine, entacapone, apomorphine, pramipexole, sumanirole, bromocriptine, piribedil and levodopa, with placebo as a control, for non-motor symptoms in Parkinson's disease (PD). PubMed, Embase and the Cochrane Library were searched from their establishment dates up to January 2017 for randomized controlled trials (RCTs) investigating the efficacy of the above ten drugs on the non-motor symptoms of PD. A network meta-analysis combined the evidence from direct comparisons and indirect comparisons and evaluated the pooled weighted mean difference (WMD) values and surfaces under the cumulative ranking curves (SUCRA). The network meta-analysis included 21 RCTs. The analysis results indicated that, using the United Parkinson's Disease Rating Scale (UPDRS) III, the efficacies of placebo, ropinirole, rasagiline, rotigotine, entacapone, pramipexole, sumanirole and levodopa in treating PD were lower than that of apomorphine (WMD = -10.90, 95% CI = -16.12∼-5.48; WMD = -11.85, 95% CI = -17.31∼-6.16; WMD = -11.15, 95% CI = -16.64∼-5.04; WMD = -11.70, 95% CI = -16.98∼-5.60; WMD = -11.04, 95% CI = -16.97∼-5.34; WMD = -13.27, 95% CI = -19.22∼-7.40; WMD = -10.25, 95% CI = -15.66∼-4.32; and WMD = -11.60, 95% CI = -17.89∼-5.57, respectively). Treatment with ropinirole, rasagiline, rotigotine, entacapone, pramipexole, sumanirole, bromocriptine, piribedil or levodopa, with placebo as a control, on PD exhibited no significant differences on PD symptoms when the UPDRS II was used for evaluation. Moreover, using the UPDRS III, the SUCRA values indicated that a pomorphine had the best efficacy on the non-motor symptoms of PD (99.0%). Using the UPDRS II, the SUCRA values for ropinirole, rasagiline, rotigotine, entacapone, pramipexole, sumanirole, bromocriptine, piribedil and levodopa treatments, with placebo as a control, indicated that bromocriptine showed the best efficacy on the non

Efficacy and acceptability of 0.074% diclofenac-containing mouthwash after periodontal surgery: A clinical study

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Agarwal Sangita

2010-01-01

Full Text Available Background: The systemic use of non-steroidal anti-inflammatory drugs are associated with various side-effects like hepatotoxicity, blood dyscrasias, nephrotoxicity and gastric irritability. Among these, gastric irritability is the most common and the most important one, which should be taken care of. Therefore, it may be preferable to use a local formulation such as a mouthwash to treat the inflammatory conditions of the oral cavity. Aim: To determine the efficacy and acceptability of 0.074% diclofenac mouthwash in relieving pain and inflammation of post-periodontal surgery patients. Materials and Methods: The study was designed as a double-blind, placebo-controlled clinical trial. Twenty chronic periodontitis patients who were scheduled for full-mouth periodontal flap surgery were randomized to receive either diclofenac mouthwash or placebo to rinse with 15 ml of solution daily for a period of 7 days. Modified gingival index (Lobene 1986 was used to verify gingival inflammation and visual analog scale was used to assess pain. After the baseline measurements for all the parameters were recorded, spontaneous pain and burning were evaluated daily while redness and edema were recorded on the 3 rd and 7 th day from the day of treatment. Results: Data obtained were analyzed statistically using paired " t" test for intragroup comparison and unpaired " t"-test for intergroup comparison. Spontaneous pain was significantly reduced by diclofenac mouthwash. Other parameters, i.e. gingival inflammation and swelling, had not shown significant reduction in scores in either group, although the reduction was higher in the test group. Conclusion: The new 0.074% diclofenac mouthwash is an effective and tolerable medicinal product for post-surgical symptomatic relief.

Examiner Reliability of Fluorosis Scoring: A Comparison of Photographic and Clinical Examination Findings

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Cruz-Orcutt, Noemi; Warren, John J.; Broffitt, Barbara; Levy, Steven M.; Weber-Gasparoni, Karin

2012-01-01

Objective To assess and compare examiner reliability of clinical and photographic fluorosis examinations using the Fluorosis Risk Index (FRI) among children in the Iowa Fluoride Study (IFS). Methods The IFS examined 538 children for fluorosis and dental caries at age 13 and obtained intra-oral photographs from nearly all of them. To assess examiner reliability, duplicate clinical examinations were conducted for 40 of the subjects. In addition, 200 of the photographs were scored independently for fluorosis by two examiners in a standardized manner. Fluorosis data were compared between examiners for the clinical exams and separately for the photographic exams, and a comparison was made between clinical and photographic exams. For all 3 comparisons, examiner reliability was assessed using kappa statistics at the tooth level. Results Inter-examiner reliability for the duplicate clinical exams on the sample of 40 subjects as measured by kappa was 0.59, while the repeat exams of the 200 photographs yielded a kappa of 0.64. For the comparison of photographic and clinical exams, inter-examiner reliability, as measured by weighted kappa, was 0.46. FRI scores obtained using the photographs were higher on average than those obtained from the clinical exams. Fluorosis prevalence was higher for photographs (33%) than found for clinical exam (18%). Conclusion Results suggest inter-examiner reliability is greater and fluorosis scores higher when using photographic compared to clinical examinations. PMID:22316120

Biomarkers for Monitoring Clinical Efficacy of Allergen Immunotherapy for Allergic Rhinoconjunctivitis and Allergic Asthma

DEFF Research Database (Denmark)

Shamji, M H; Kappen, J H; Akdis, M

2017-01-01

be administered either subcutaneously (SCIT) or sublingually (SLIT) (3-12). Although AIT is effective, the degree of remission strongly varies depending on the complex interaction between patient, allergy, symptomatology and vaccines used for AIT (3-9). Clinical management of patients receiving AIT and efficacy...... medicine (18). This article is protected by copyright. All rights reserved....

Safety and clinical efficacy of tenvermectin, a novel antiparasitic 16-membered macrocyclic lactone antibiotics.

Science.gov (United States)

Fei, Chenzhong; She, Rufeng; Li, Guiyu; Zhang, Lifang; Fan, Wushun; Xia, Suhan; Xue, Feiqun

2018-05-30

Tenvermectin (TVM) is a novel 16-membered macrocyclic lactone antibiotics, which contains component TVM A and TVM B. However there is not any report on safety and clinical efficacy of TVM for developing as a potential drug. In order to understand the part of safety and clinical efficacy of TVM, we conducted the acute toxicity test, the standard bacterial reverse mutation (Ames) test and the clinical deworming test. In the acute toxicity studies, TVM, TVM A and ivermectin (IVM) were administrated once by oral gavage to mice and rats. Results showed that the oral LD 50 values of TVM, TVM A and IVM in mice were 74.41, 106.95 and 53.06 mg/kg respectively. The oral LD 50 values of TVM and TVM A in rats were determined to be 164.22 and 749.34 mg/kg respectively. TVM and IVM are moderately toxic substances, meanwhile the TVM A belongs to low toxic compounds, implying that the acute toxicity is highly related to the length of side chain of TVM at position C25. In the Ames test, results showed that TVM did not induce mutagenicity in Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 with and without metabolic activation system, speculating that the mutagenicity is probably not related to the side chain at position C25 of 16-membered macrocyclic lactone antibiotics. In the efficacy trail of TVM against swine nematodes, growing pigs natural infection of Ascaris suum and Trichuris suis were treated with a single subcutaneous injection 0.3 mg/kg b.w.. Results showed that TVM and IVM had excellent effect in expelling Ascaris suum, and TVM had potential efficacy against Trichuris suis, however IVM had no effect on Trichuris suis. This study suggests that the side chain of TVM at position C25 may have important biological functions, which is one of the key sites of the studies on structure-activity relationship of 16-membered macrocyclic lactone compounds. TVM is a new compound exhibited some advantages worthy of developing. Copyright © 2018 Elsevier B.V. All

Traditional and new composite endpoints in heart failure clinical trials : facilitating comprehensive efficacy assessments and improving trial efficiency

NARCIS (Netherlands)

Anker, Stefan D. t; Schroeder, Stefan; Atar, Dan; Bax, Jeroen J.; Ceconi, Claudio; Cowie, Martin R.; AdamCrisp,; Dominjon, Fabienne; Ford, Ian; Ghofrani, Hossein-Ardeschir; Gropper, Savion; Hindricks, Gerhard; Hlatky, Mark A.; Holcomb, Richard; Honarpour, Narimon; Jukema, J. Wouter; Kim, Albert M.; Kunz, Michael; Lefkowitz, Martin; Le Floch, Chantal; Landmesser, Ulf; McDonagh, Theresa A.; McMurray, John J.; Merkely, Bela; Packer, Milton; Prasad, Krishna; Revkin, James; Rosano, Giuseppe M. C.; Somaratne, Ransi; Stough, Wendy Gattis; Voors, Adriaan A.; Ruschitzka, Frank

Composite endpoints are commonly used as the primary measure of efficacy in heart failure clinical trials to assess the overall treatment effect and to increase the efficiency of trials. Clinical trials still must enrol large numbers of patients to accrue a sufficient number of outcome events and

Review on the efficacy, safety and clinical applications of polihexanide, a modern wound antiseptic.

Science.gov (United States)

Hübner, N-O; Kramer, A

2010-01-01

Infected wounds are still one of the great challenges in medicine. In the last decade, it has become increasingly clear that antimicrobial chemotherapy is limited by the spread of antimicrobial resistance. Fortunately, new, highly effective antiseptic substances with a broad antimicrobial spectrum are available, so local treatment is expected to get increasingly more important in wound therapy. This paper reviews the antiseptic agent polihexanide (polyhexamethylene biguanide, PHMB), one of the most promising substances available today, from a clinical point of view, focusing on efficacy, safety and clinical applications. Copyright © 2010 S. Karger AG, Basel.

Efficacy comparison of duloxetine and SSRIs at doses approved in Japan

Directory of Open Access Journals (Sweden)

Harada E

2015-01-01

Full Text Available Eiji Harada,1 Alexander Schacht,2 Tsukasa Koyama,3 Lauren Marangell,4,5 Toshinaga Tsuji,6 Rodrigo Escobar41Medical Science, Eli Lilly Japan K.K, Kobe, Japan; 2Global Statistical Sciences, Eli Lilly and Company, Bad Homburg, Germany; 3Clinical Research Center, Ohyachi Hospital, Sapporo, Japan; 4Eli Lilly and Company, Indianapolis, IN, 5The University of Texas Health Science Center, Houston, TX, USA; 6Medical Affairs, Shionogi & Co Ltd, Osaka, JapanBackground: Approved doses of antidepressants in Japan are usually lower than those in the USA and European Union, but to date meta-analyses comparing antidepressants have all used the higher doses approved in the USA and European Union and often have used indirect comparisons. The purpose of this study was to conduct an integrated database analysis of patient level data to compare the effects of duloxetine with those of selective serotonin reuptake inhibitors (SSRIs at the doses approved in Japan.Methods: Pooled data were analyzed from four randomized, double-blind, placebo-controlled studies that compared duloxetine at the dose range approved in Japan (40–60 mg/day with other SSRIs (paroxetine 20 mg/day or escitalopram 10 mg/day and placebo in patients with major depressive disorder. In total, 1,694 patients were included in the analysis (duloxetine, n=688; selective serotonin reuptake inhibitors, n=690; placebo, n=316. The primary outcome measure was the mean change from baseline at week 8 in 17-item Hamilton Rating Scale for Depression (HAMD17 total and subscale scores.Results: Duloxetine and both selective serotonin reuptake inhibitors were superior to placebo in HAMD17 total score at week 8 in both the all-randomized group and the more severe subgroup (HAMD17 total scores ≥19. Duloxetine was superior to SSRIs in improving the HAMD17 Retardation subscale score (least squares mean difference [95% confidence interval]: all-randomized group, −0.33 [−0.60, −0.07], P=0.015; severe subgroup, �

Clinical and bacteriological efficacy of twice daily topical retapamulin ointment 1% in the management of impetigo and other uncomplicated superficial skin infections.

Science.gov (United States)

Bohaty, Benjamin R; Choi, Sangbum; Cai, Chunyan; Hebert, Adelaide A

2015-02-01

Cutaneous bacterial infections are common in children and adults and frequently are caused by Staphylococcus aureus ( S. aureus ). Treatment failures with topical agents are not uncommon and have been shown to be secondary to bacterial resistance. To determine clinical and bacteriological efficacy of retapamulin ointment 1% in treatment of patients with cutaneous bacterial infections caused by methicillin-resistant S. aureus (MRSA) and other bacteria. Prospective, nonrandomized, uncontrolled, open label, single center trial conducted between April 2008 and November 2012 that evaluated efficacy of retapamulin ointment 1% in the treatment of impetigo, folliculitis, and other minor soft tissue infections in children and adults. Fifty patients, who presented to a dermatology outpatient clinic and were clinically diagnosed with impetigo, folliculitis, or minor soft tissue infection suitable for treatment with a topical antibiotic, were screened. Thirty-eight patients were enrolled and received treatment: topical retapamulin ointment 1% twice daily for 5 days. Seven patients were MRSA positive and qualified for the primary efficacy population. One patient withdrew due to an adverse event. Clinical and microbiological exams were performed at baseline and follow-up 5 to 7 days later to assess clinical, microbiological, and therapeutic responses. Primary outcome was clinical response at follow-up in primary efficacy population with MRSA isolated as the baseline pathogen. Secondary outcomes included clinical, microbiologic, and therapeutic responses in patients who were culture positive for any species of bacteria. Clinical response at follow-up in the primary efficacy population (MRSA-positive patients) was not sufficiently powered to demonstrate significance; however, outcomes were excellent, with 7 of 7 patients demonstrating clinical success (5 of 7) or clinical improvement (2 of 7) at follow-up. Barring lack of significance due to small total sample size for patients

Clinical efficacy and safety of imepitoin in comparison with phenobarbital for the control of idiopathic epilepsy in dogs.

Science.gov (United States)

Tipold, A; Keefe, T J; Löscher, W; Rundfeldt, C; de Vries, F

2015-04-01

The anticonvulsant activity and safety of imepitoin, a novel antiepileptic drug licensed in the European Union, were evaluated in a multicentre field efficacy study as well as in a safety study under laboratory conditions. Efficacy of imepitoin was compared with phenobarbital in 226 client-owned dogs in a blinded parallel group design. The administration of imepitoin twice daily in incremental doses of 10, 20 or 30 mg/kg demonstrated comparable efficacy to phenobarbital in controlling seizures in dogs. The frequency of adverse events including somnolence/sedation, polydipsia and increased appetite was significantly higher in the phenobarbital group. In phenobarbital-treated dogs, significantly increased levels of alkaline phosphatase, gamma-glutamyl-transferase and other liver enzymes occurred, while no such effect was observed in the imepitoin group. In a safety study under laboratory conditions, healthy beagle dogs were administered 0, 30, 90 or 150 mg/kg imepitoin twice daily for 26 weeks. A complete safety evaluation including histopathology was included in the study. A no-observed-adverse-event level of 90 mg/kg twice daily was determined. These results indicate that imepitoin is a potent and safe antiepileptic drug for dogs. © 2014 The Authors. Journal of Veterinary Pharmacology and Therapeutics Published by John Wiley & Sons Ltd.

Incorporating Experiential Learning Techniques to Improve Self-Efficacy in Clinical Special Care Dentistry Education.

Science.gov (United States)

Watters, Amber L; Stabulas-Savage, Jeanine; Toppin, James D; Janal, Malvin N; Robbins, Miriam R

2015-09-01

The New York University College of Dentistry has introduced a clinical rotation for fourth-year dental students that focuses on treating people with special health care needs (PSN). The aim of this study was to investigate the hypothesis that clinical experience in treating patients with special health care needs during predoctoral education is associated with increased self-assessed student ability and comfort and therefore self-efficacy. The study also investigated whether other characteristics, such as prior personal or volunteer experience with this population, service-mindedness, and/or the inclination to treat underserved populations, were associated with comfort in treating PSN. A survey was used to assess changes in students' perceived knowledge, beliefs, and attitudes regarding treating PSN before and after the clinical experience for July 2012-June 2013. The survey included questions about students' service-mindedness, comfort, perceptions of abilities of PSN and educational importance of learning to treat PSN, desire for clinical experience, and future intent or interest in treating PSN. Out of 364 students invited to participate, 127 surveys were returned, for a response rate of 34.9%. The results showed statistically significant increases on six items following training: impressions about the importance of oral health among PSN, comfort in treating people with cognitive disabilities and with medical complexities, intent to treat PSN in future practice, interest in including PSN in postgraduate training, and belief that PSN could be treated in the private practice setting. These students reported preferring to learn in the clinical setting over didactic instruction. This clinical experience was associated with improved self-efficacy in treating PSN and increased intentions to treat this population in future practice. Improvements were particularly evident among those with the least prior experience with PSN and were independent of other aspects of the

Comparison of oral robenacoxib and carprofen for the treatment of osteoarthritis in dogs: a randomized clinical trial.

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Edamura, Kazuya; King, Jonathan N; Seewald, Wolfgang; Sakakibara, Nobuhiro; Okumura, Masahiro

2012-09-01

The efficacy and tolerability of robenacoxib for the treatment of osteoarthritis in dogs were evaluated in a prospective, multicenter, randomized, noninferiority design clinical trial. A total of 32 dogs presenting with osteoarthritis were allocated randomly to receive, orally once daily for 28 days, either 1-2 mg/kg robenacoxib (n=21) or 3.5-5 mg/kg carprofen (n=11). Dogs were assessed by clinicians and owners using numerical rating scale scores at baseline and days 14 and 28. The primary efficacy endpoint was the global functional disability score, which was the sum of clinician scores for standing posture, lameness at walk, lameness at trot, willingness to raise the contralateral limb and pain at palpation. There was a good to excellent level of efficacy in both treatment groups. Differences between days 14 and 28 compared to day 0 were significant for all 11 clinician and owner scores for robenacoxib, and for 6 of 11 scores for carprofen. The efficacy of robenacoxib was numerically superior to carprofen for all 13 endpoints, but differences were not statistically significant. For the global functional disability score, the estimated efficacy of robenacoxib was 1.244 (95% confidence interval 0.555-2.493) relative to carprofen. The tolerability of both treatments was good as assessed from adverse events, clinical signs, and hematology and serum biochemistry variables. In conclusion, once daily administration of robenacoxib tablets had noninferior efficacy and tolerability compared to carprofen for the treatment of the clinical signs of osteoarthritis in dogs.

Efficacy of clinical diagnostic procedures utilized in nuclear medicine. Technical progress report, 1 December 1981-30 November 1982

International Nuclear Information System (INIS)

Saenger, E.L.

1982-07-01

The efficacy of nuclear medicine diagnostic procedures was measured. Three levels of efficacy were defined. However, two different methods of evaluating efficacy itself were first compared. Using two methods, logistic regression and entropy-minimax pattern detection, substantial agreement was found between them in several clinical observations. (1) There are no attributes that indicate that any grouping of symptoms, signs, and laboratory findings is capable of suggesting that a patient does or does not have a pulmonary embolus. (2) The lung scan test is the only reliable method which indicates that a patient may have a pulmonary embolus or does not have a pulmonary embolus. (3) The validity of these conclusions and the ability to apply them widely to ongoing clinical practice is based on the prospective design of the Study which included an appropriate distribution of institutions by type, size, and geographic location. Also, the only judgement samples was that of the referring physician

[Efficacy and Safety Evaluation of Bushen Shuji Granule in Treating Ankylosing Spondylitis Patients: a Clinical Study].

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Kong, Wei-ping; Tao, Qing-wen; Zhang, Ying-ze; Yang, Shu; Xu, Yuan; Zhu, Xiao-xia; Jin, Yue; Yang, Wen-xue; Yan, Xiao-ping

2015-06-01

To evaluate the short-term efficacy and safety of Bushen Shuji Granule (BSG) in treating ankylosing spondylitis (AS) patients. A prospective randomized controlled clinical trial was carried out in 62 active stage AS patients with Shen deficiency Du-channel cold syndrome (SDDCS), who were randomly assigned to the BSG group (treated with BSG) and the control group (treated with Celecoxib Capsule). Twelve weeks consisted of one therapeutic course. Therapeutic effects were evaluated by ASAS20 and ASAS40 (set by Assessments in Ankylosing Spondylitis working group) , BASDA150, Chinese medical (CM) syndrome efficacy evaluation standards. BASDAI, the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath AS Metrology Index (BASMI), scores for spine pain, scores for pain at night, patient global assessment (PGA) , erythrocyte sedimentation rate (ESR) , and C reactive protein (CRP) were observed before and after treatment. After three-month treatment by BSG, ASAS20 standard rate was 63. 33% (19/30 cases) in the BSG group and 66.67% (20/30 cases) in the control group with no significant difference between the two groups (χ2 = 0.073, P > 0.05). The efficacy for CM syndromes was 70.00% (21/30 cases) in the BSG group, higher than that in the control group [40.00% (12/30 cases), χ2 = 5.455, P channel strengthening, blood activating, and channels dredging method had good short-term clinical efficacy and safety in treating AS.

[Efficacy comparison between electroacupuncture and dyne-35 in treatment of polycystic ovary syndrome].

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Jin, Chun-Lan; Wei, Li-Xin; Zhao, Ji-Ping; Wu, Zhong-Chao

2014-12-01

To compare the difference in clinical efficacy on polycystic ovary syndrome (PCOS) between electroacupuncture (EA) and dyne-35 and to explore the effect mechanism. Sixty-five patients were randomized into an EA group (33 cases) and a western medication group (32 cases). In the EA group, the selected acupoints were Danzhong (CV 17), Qimen (LR 14), Zhongwan (CV 12), Tianshu (ST 25), Guanyuan (CV 4), Zigong (EX-CA 1), Sanyinjiao (SP 6), Zusanli (ST 36) and Taichong (LR 3), etc. After the arrival of qi, electric stimulation was attached to the acupoints for 30 min. The treatment was given 3 times a week. In the western medication group, dyne-35 was prescribed on the 5th day of natural menstruation or withdrawal bleeding, one tablet a day, continuously for 21 days. The treatment cycle was 3 months in the two groups. The menstrual condition, body mass, body mass index (BMI), serum testosterone (T), luteinizing hormone (LH), follicle-stimulating hormone (FSH) and LH/FSH were compared before and after treatment in the two groups. The clinical efficacy was assessed in the two groups. The total effective rate was 90.6% (29/32) in the EA group and was 93.3% (28/30) in the western medication group. The efficacy was similar in the two groups (P > 0.05). After treatment, the levels of LH and LH/FSH were all reduced significantly in the two groups (all P medication group (P medication group (P < 0.01, P < 0.05). EA is the effective method for PCOS, similar to that of dyne-35. The effect of it for weight loss is superior to dyne-35 and no apparent adverse reactions happen. The effect mechanism of EA is related to the regulation of serum sexual hormone levels and their ratio, as well as to the regulation of body lipid metabolism.

Efficacy and safety of Ginkgo biloba standardized extract in the treatment of vascular cognitive impairment: a randomized, double-blind, placebo-controlled clinical trial

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Demarin V

2017-02-01

Full Text Available Vida Demarin,1,2 Vanja Bašić Kes,1 Zlatko Trkanjec,1 Mislav Budišić,1 Marija Bošnjak Pašić,3,4 Petra Črnac,5 Hrvoje Budinčević4,5 1Department of Neurology, University Hospital Center “Sestre Milosrdnice”, 2International Institute for Brain Health, 3Department of Neurology, University Hospital Center Zagreb, Zagreb, 4Department of Neurology, School of Medicine, University Josip Juraj Strossmayer, Osijek, 5Department of Neurology, Stroke and Intensive Care Unit, University Hospital “Sveti Duh”, Zagreb, Croatia Objectives: The aim of this randomized, double-blind, placebo-controlled trial was to determine the efficacy and safety of Ginkgo biloba extract in patients diagnosed with vascular cognitive impairment (VCI. Methods: A total of 90 patients (aged 67.1±8.0 years; 59 women were randomly allocated (1:1:1 to receive G. biloba 120 mg, G. biloba 60 mg, or placebo during a 6-month period. Assessment was made for efficacy indicators, including neuropsychological tests scores (Sandoz Clinical Assessment Geriatric Scale, Folstein Mini-Mental State Examination, Mattis Dementia Rating Scale, and Clinical Global Impression and transcranial Doppler ultrasound findings. Safety indicators included laboratory findings, reported adverse reactions, and clinical examination. Results: At the end of 6-month study period, G. biloba 120 and 60 mg showed a statistically significant positive effect in comparison with placebo only on the Clinical Global Impression score (2.6±0.8 vs 3.1±0.7 vs 2.8±0.7, respectively; P=0.038. The Clinical Global Impression score showed a significant deterioration from the baseline values in the placebo group (-0.3±0.5; P=0.021 as opposed to G. biloba groups. No significant differences were found in the transcranial Doppler ultrasound findings. Adverse reactions were significantly more common and serious in the placebo group (16 subjects than in either of the two G. biloba extract groups (eight and nine subjects

Comparison of Antidepressant Efficacy-related SNPs Among Taiwanese and Four Populations in the HapMap Database

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Mei-Hung Chi

2011-07-01

Full Text Available The genetic influence of single nucleotide polymorphisms (SNPs on antidepressant efficacy has been previously demonstrated. To evaluate whether there are ethnic differences, we compared the allele frequencies of antidepressant efficacy-related SNPs between the Taiwanese population and four other populations in the HapMap database. We recruited 198 Taiwanese major depression patients and 106 Taiwanese controls. A panel of possible relevant SNPs (in brain-derived neurotrophic factor, 5-hydroxytryptamine receptor 2A, interleukin 1 beta, and G-protein beta 3 subunit genes was selected for comparisons of allele frequencies using the χ2 test. Our results suggested no difference between Taiwanese patients and controls, but there were significant differences among Taiwanese controls and the other four ethnic groups in brain-derived neurotrophic factor, 5-hydroxytryptamine receptor 2A, interleukin 1 beta and G-protein beta 3 subunit genes. We conclude that there are ethnic differences in the allele frequencies of antidepressant efficacy-related SNPs, and that the degree of variations is consistent with geographic distances. Further investigation is required to verify the attribution of genetic differences to ethnic-specific antidepressant responses.

Efficacy and safety of oral antidiabetic drugs in comparison to insulin in treating gestational diabetes mellitus: a meta-analysis.

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Nalinee Poolsup

Full Text Available OBJECTIVE: To assess the efficacy and safety of oral antidiabetic drugs (OADs in gestational diabetes mellitus (GDM in comparison to insulin. METHODS: A meta-analysis of randomized controlled trials was conducted. The efficacy and safety of OADs in comparison to insulin in GDM patients were explored. Studies were identified by conducting a literature search using the electronic databases of Medline, CENTRAL, CINAHL, LILACS, Scopus and Web of Science in addition to conducting hand search of relevant journals from inception until October 2013. RESULTS: Thirteen studies involving 2,151 patients met the inclusion criteria. These studies were randomized controlled trials of metformin and glyburide in comparison to insulin therapy. Our results indicated a significant increase in the risk for preterm births (RR, 1.51; 95% CI, 1.04-2.19, p = 0.03 with metformin compared to insulin. However, a significant decrease in the risk for gestational hypertension (RR, 0.54; 95% CI, 0.31-0.91, p = 0.02 was found. Postprandial glucose levels also decreased significantly in patients receiving metformin (MD, -2.47 mg/dL; 95% CI, -4.00, -0.94, p = 0.002. There was no significant difference between the two groups for the remaining outcomes. There were significant increases in the risks of macrosomia (RR, 2.34; 95% CI, 1.18-4.63, p = 0.03 and neonatal hypoglycemia (RR, 2.06; 95% CI, 1.27-3.34, p = 0.005 in the glyburide group compared to insulin whereas results for the other analyzed outcomes remained non-significant. CONCLUSION: The available evidence suggests favorable effects of metformin in treating GDM patients. Metformin seems to be an efficacious alternative to insulin and a better choice than glyburide especially those with mild form of disease.

Florfenicol - pharmacodynamic, pharmacokinetics and clinical efficacy of oral formulations in domestic animals: A systematic review

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Ščuka Leon

2005-01-01

Full Text Available Porcine respiratory disease complex (PRDC is a major economic problem for swine producers world-wide. Pharmacodynamic, pharmacokinetics and clinical efficacy of florfenicol oral formulations in domestic animals were evaluated. For this purpose the systematic review and meta-analysis were done. In vitro efficacy of florfenicol showed that this drug is highly effective against most important respiratory pathogens. All these facts are shown in our survey. Three studies in pigs were relevant to include in the meta-analysis, which showed that results in the florfenicol group were better than in comparative control groups in all observed parameters: clinical signs, lung lesions and resolution of Actinobacillus pleuropneumoniae (P<0,001. A second meta-analysis with 7 studies showed that the usage of florfenicol reduces mortality in pig herds with PRDC (P<0.05. Other field trials in pigs using florfenicol oral forms where reviewed. After treatment with florfenicol oral solution there was a significant drop of mortality in both groups of pigs (P<0.01; eg. one using florfenicol oral solution in treating PRDC (n=85 and another mixed pneumoenteric infection (n=54. Analysis of data when using premix in pigs (n=118 also suggests that a medicated premix has a favorable anti-infectious effect on pigs, irrespective of the group of animals or the evolution stage of the disease. Finally, favorable effect of florfenicol in treating swine ileitis was also presented. Regarding their pharmacokinetics, in vitro and clinical efficacy of florfenicol oral forms, they should be considered as a powerful tool for combating complex infections that are frequently met in intensive animal production.

Efficacy of chemomechanical caries removal in reducing cariogenic microbiota: a randomized clinical trial

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Michelle Mikhael AMMARI

2014-08-01

Full Text Available The aim of this study was to compare the efficacy of chemochemical methods (Carisolv™ and Papacárie® versus the manual method (excavators in reducing the cariogenic microbiota in dentine caries of primary teeth. Forty-six healthy children (5 to 9 years old having at least one primary tooth with a cavitated dentine carious lesion were included in the study. The teeth presented no clinical or radiographic signs of pulpal involvement. The sample of 74 teeth was randomly divided into three different groups: Papacárie® (n = 25, Carisolv™ (n = 27 and Manual (n = 22. Samples of carious and sound dentine were collected with sterile excavators before and after caries removal in the three groups. The dentine samples were transferred to glass tubes containing a 1mL thioglycollate medium used as a carrier and enriched for microbiological detection of mutans streptococci and Lactobacillus spp, after incubation for 6h at room temperature. The minimum detection value for colony forming units (CFU was 3.3 x 102 CFU/ml, and the results were converted into scores from 0 to 4. A significant difference was observed in relation to the microbiological scores before and after caries removal for all methods (Wilcoxon test; p < 0.001. The use of chemomechanical methods for caries removal did not improve the reduction of cariogenic microorganisms in dentine caries lesions, in comparison with manual excavation.

Imaging drugs with and without clinical analgesic efficacy.

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Upadhyay, Jaymin; Anderson, Julie; Schwarz, Adam J; Coimbra, Alexandre; Baumgartner, Richard; Pendse, G; George, Edward; Nutile, Lauren; Wallin, Diana; Bishop, James; Neni, Saujanya; Maier, Gary; Iyengar, Smriti; Evelhoch, Jeffery L; Bleakman, David; Hargreaves, Richard; Becerra, Lino; Borsook, David

2011-12-01

The behavioral response to pain is driven by sensory and affective components, each of which is mediated by the CNS. Subjective pain ratings are used as readouts when appraising potential analgesics; however, pain ratings alone cannot enable a characterization of CNS pain circuitry during pain processing or how this circuitry is modulated pharmacologically. Having a more objective readout of potential analgesic effects may allow improved understanding and detection of pharmacological efficacy for pain. The pharmacological/functional magnetic resonance imaging (phMRI/fMRI) methodology can be used to objectively evaluate drug action on the CNS. In this context, we aimed to evaluate two drugs that had been developed as analgesics: one that is efficacious for pain (buprenorphine (BUP)) and one that failed as an analgesic in clinical trials aprepitant (APREP). Using phMRI, we observed that activation induced solely by BUP was present in regions with μ-opioid receptors, whereas APREP-induced activation was seen in regions expressing NK(1) receptors. However, significant pharmacological modulation of functional connectivity in pain-processing pathways was only observed following BUP administration. By implementing an evoked pain fMRI paradigm, these drugs could also be differentiated by comparing the respective fMRI signals in CNS circuits mediating sensory and affective components of pain. We report a correlation of functional connectivity and evoked pain fMRI measures with pain ratings as well as peak drug concentration. This investigation demonstrates how CNS-acting drugs can be compared, and how the phMRI/fMRI methodology may be used with conventional measures to better evaluate candidate analgesics in small subject cohorts.

Academic procrastination, emotional intelligence, academic self-efficacy, and GPA: a comparison between students with and without learning disabilities.

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Hen, Meirav; Goroshit, Marina

2014-01-01

Academic procrastination has been seen as an impediment to students' academic success. Research findings suggest that it is related to lower levels of self-regulated learning and academic self-efficacy and associated with higher levels of anxiety, stress, and illness. Emotional intelligence (EI) is the ability to assess, regulate, and utilize emotions and has been found to be associated with academic self-efficacy and a variety of better outcomes, including academic performance. Students with learning disabilities (LD) are well acquainted with academic difficulty and maladaptive academic behavior. In comparison to students without LD, they exhibit high levels of learned helplessness, including diminished persistence, lower academic expectations, and negative affect. This study examined the relationships among academic procrastination, EI, and academic performance as mediated by academic self-efficacy in 287 LD and non-LD students. Results indicated that the indirect effect of EI on academic procrastination and GPA was stronger in LD students than in non-LD students. In addition, results indicated that LD students scored lower than non-LD students on both EI and academic self-efficacy and higher on academic procrastination. No difference was found in GPA.

Comparison of clinical efficacy among remifentanil, nicardipine, and remifentanil plus nicardipine continuous infusion for hypotensive anesthesia during arthroscopic shoulder surgery.

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Kim, Joon Yub; Song, Seong Hun; Cho, Jae Ho; Cho, Hyung Rae

2017-01-01

Hypotensive anesthesia is crucial during arthroscopic shoulder surgery to reduce bleeding and allow for clear visibility. The aim of this study was to compare the clinical efficacy of continuous infusion of remifentanil, nicardipine, and remifentanil plus nicardipine to control hypotensive anesthesia in arthroscopic shoulder surgery. For this study, we enrolled 45 consecutive patients who were scheduled to have arthroscopic rotator cuff repair surgery and randomly allocated them into remifentanil (group R, n = 15), nicardipine (group N, n = 15), and remifentanil plus nicardipine (group RN, n = 15) groups. During the surgeries, these drugs were administered with continuous infusion. We analyzed the mean arterial pressure (MAP) and heart rate during surgery, stay time in the recovery room, visual analogue scale (VAS) scores, use of antiemetics in the recovery room, and postoperative blood urea nitrogen and creatinine changes. The VAS score in the recovery room was higher for group R (mean 5.6, SD 1.4) than for groups N (mean 3.9, SD 0.9) and RN (mean 4.0, SD 1.1; p = 0.000). There were no statistical differences regarding other clinical variables among the three groups (all p > 0.05) except for MAP at 120 min of surgery between groups N and RN (N: 84.67 (SD 10.7) mmHg, RN: 65.4 (SD 9.2) mmHg, p = 0.027). The continuous infusion of remifentanil plus nicardipine appeared to be advantageous for maintaining hypotensive anesthesia until 120 min of arthroscopic shoulder surgery without rebound pain in a postanesthesia care unit.

The Infatuation With Biotin Supplementation: Is There Truth Behind Its Rising Popularity? A Comparative Analysis of Clinical Efficacy versus Social Popularity.

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Soleymani, Teo; Lo Sicco, Kristen; Shapiro, Jerry

2017-05-01

Biotin, also known as Vitamin B7 or vitamin H, is a water-soluble B vitamin that acts as an essential cofactor for several carboxylases involved in the cellular metabolism of fatty acids, amino acids, and gluconeogenesis. Although there exists an incredible amount of social media hype and market advertising touting its efficacy for the improvement of hair quantity and quality, biotin's efficacy for hair remains largely unsubstantiated in scientific literature. We reviewed all pertinent scientific literature regarding the efficacy of biotin supplementation for hair growth and quality improvement, and we also investigated its popularity in society defined as a function of market analytics. To date, there have been no clinical trials conducted to investigate the efficacy of biotin supplementation for the treatment of alopecia of any kind, nor has there been any randomized controlled trial to study its effect on hair quality and quantity in human subjects. Because of the lack of clinical evidence, its use to improve hair quantity or quality is not routinely recommended. However, societal infatuation with biotin supplementation is not only propagated by its glamorization in popular media, its popularity is vastly disproportionate to the insufficient clinical evidence supporting it's efficacy in hair improvement. In other words, biotin supplements are quite "in vogue", without there being any real reason to be so. J Drugs Dermatol. 2017;16(5):496-500..

Clinical efficacy of turmeric use in gingivitis: A comprehensive review.

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Stoyell, Karissa A; Mappus, Jennifer L; Gandhi, Mona A

2016-11-01

Gingivitis affects an estimated 80% of the population, and is characterized as the world's most predominant inflammatory periodontal disease. Without intervention, gingivitis can advance to alveolar bone loss. Therefore, the primary goal in patients suffering with gingivitis is to control plaque buildup and soft tissue inflammation. Current guidelines consider chlorhexidine as the gold standard in the prevention and treatment of gingivitis. However, negative side effects of chlorhexidine, including oral mucosal erosion, discoloration of teeth, and bitter taste, provide an opportunity for alternative medications. Turmeric, a commonly used herb, possesses anti-inflammatory, antioxidant, antibacterial, antiviral, and antifungal properties. By virtue of these properties, multiple controlled trials have been performed to investigate the efficacy of turmeric in gingivitis. The aim of this comprehensive review is to summarize and evaluate the evidence on the efficacy of turmeric as compared to chlorhexidine in the prevention and treatment of gingivitis. PubMed, MedLine (Web of Science), and EBSCO (academic search complete) were utilized as primary literature search tools. The following search strategy was used: ((turmeric OR curcumin OR curcuma) AND (gingivitis OR "gum inflammation")). Five reviewed studies show that both turmeric and chlorhexidine significantly decrease plaque index (PI) and gingival index (GI), and can therefore be used in the prevention and treatment of gingivitis. Both chlorhexidine and turmeric can be used as an adjunct to mechanical means in preventing and treating gingivitis. However, trials longer than 21 days with a greater number of patients are necessary to further evaluate the comparison between turmeric and chlorhexidine. Copyright © 2016 Elsevier Ltd. All rights reserved.

Comparison of efficacy between sodium morrhuate and lauromacrogol as sclerosing agents in treatment of hepatic cyst

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QIN Zuyun

2015-07-01

Full Text Available Objective To compare the efficacy of sodium morrhuate versus lauromacrogol in the treatment of hepatic cyst. Methods Seventy-four patients with hepatic cyst who were admitted to our hospital from January 2009 to May 2013 were enrolled as subjects and divided into two groups. After the cystic fluid was drained by percutaneous liver biopsy, sodium morrhuate solution was injected into the cystic cavity for adhesion and sclerosis in 46 patients in group A, and lauromacrogol solution was injected in 28 patients in group B. The incidence rates of pain in patients during and after surgery were compared between the two groups. The follow-up comparison of hepatic cyst recurrence rates within one year after surgery was performed between the two groups. Between-group comparison was performed by χ2 test. Results Five patients (10.87% in group A and two patients (7.14% in group B had recurrence within one year after treatment. There was no significant difference in recurrence rate between the two groups (χ2=0.283, P＞0.05. The incidence of pain in group A was significantly higher than that in group B (χ2=5.258, P＜0.05. Conclusion With the same efficacy as sodium morrhuate in the treatment of hepatic cyst, lauromacrogol can be routinely used as a sclerosing agent due to its mild side effects.

Short-term glucocorticoid administration in patients with protracted and chronic gout arthritis. Part 2 — comparison of different medication forms efficacy

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A A Fedorova

2008-01-01

Full Text Available Objective. To compare efficacy of different glucocorticoid (GC medication forms in protracted and chronic gout arthritis. Material and methods. 59 pts with tophaceous gout (crystal-verified diagnosis and arthritis of three and more joints lasting more than a months in spite of treatment with sufficient doses of nonsteroidal anti-inflammatory drugs were included. Median age of pts was 56 [48;63], median disease duration — 15,2 years [7,4;20], median swollen joint count at the examination — 8 [5; 11]. The patients were randomized into 2 groups. Methylprednisolone (MP 500 mg/day iv during 2 days and placebo im once was administered in one of them, betamethasone (BM 7 mg im once and placebo iv twice — in the other. Results. Number of pts with full resolution of arthritis, recurrent exacerbation, insufficient arthritis resolution or clinically insignificant response was comparable in both groups. More rapid decrease of pain at moving was achieved during the first 2-3 days after GC administration in pts with full resolution of arthritis (p=0,03 in group receiving MP in comparison with BM. At day 14 joint damage measures did not differ between groups. Conclusion. Efficacy of short-term glucocorticoid administration does not depend on mode of administration and GC medication form (methylprednisolone 500 mg/day iv during 2 days or betamethasone 7 mg im once.

Peer influence in clinical workplace learning : A study of medical students’ use of social comparison in clinical practice

NARCIS (Netherlands)

Raat, Adriana

2015-01-01

Undergraduate students in clinical workplace frequently compare their own experiences with those of peers. The research reported in this thesis shows that these so called social comparisons are vital to the process of learning in clinical practice. The first study confirms students’ tendency to

Therapeutic efficacy of rose oil: A comprehensive review of clinical evidence

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Safieh Mohebitabar

2017-04-01

Full Text Available Objective: Rose oil is obtained from the petals of difference Rosa species especially Rosa centifolia L. and Rosa damascena Mill. Various pharmacological properties have been attributed to rose oil. The aim of the present study was to review the rose oil therapeutic effects which had been clinically evaluated in trial studies. Materials and Methods: Google scholar, PubMed, Cochrane Library, and Scopus were searched for human studies which have evaluated the therapeutic effects of rose oil and published in English language until August 2015. Results: Thirteen clinical trials (772 participants were included in this review. Rose oil was administered via inhalation or used topically. Most of the studies (five trials evaluated the analgesic effect of rose oil. Five studies evaluated the physiological relaxation effect of rose oil. Anti-depressant, psychological relaxation, improving sexual dysfunction, and anti-anxiety effects were the other clinical properties reported for rose oil. Conclusion: Numerous studies on the pharmacological properties of rose oil have been done in animals, but studies in humans are few.  In this study, it was observed that rose oil had physiological and psychological relaxation, analgesic and anti-anxiety effects. To obtain conclusive results on the efficacy and safety of rose oil, further clinical trials with larger sample size and better designation are required.

Systematic review and meta-analysis of the clinical efficacy and adverse effects of Chinese herbal decoction for the treatment of gout.

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Liang Zhou

Full Text Available BACKGROUND: In East Asia, numerous reports describe the utilization of traditional Chinese herbal decoctions to treat gout. However, the reported clinical effects vary. OBJECTIVES: In this study, we reviewed and analyzed a large number of randomized controlled clinical trials to systematically assess the clinical efficacy and adverse reactions of Chinese herbal decoctions for treating gout. METHODS: We performed a comprehensive search of databases, such as PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, Chinese biomedical literature database, et al. In addition, we manually searched the relevant meeting information in the library of the Third Military Medical University. RESULTS: Finally, 17 randomized controlled trials with a sample size of 1,402 cases met the criteria and were included in the study. The results of the meta-analysis showed that when gout had progressed to the stage of acute arthritis, there was no significant difference in clinical efficacy between Chinese herbal decoctions and traditional Western medicine, as indicated based on the following parameters: serum uric acid (standardized mean difference (SMD:0.35, 95% confidence interval (CI: 0.03 to 0.67, C reactive protein (SMD: 0.25, 95% CI: -0.18 to 0.69, erythrocyte sedimentation rate (SMD: 0.21, 95% CI: -0.02 to 0.45 and overall clinical response (relative risk (RR: 1.05, 95% CI: 1.01 to 1.10. However, the Chinese herbal decoction was significantly better than traditional Western medicine in controlling adverse drug reactions (RR: 0.06, 95% CI: 0.03 to 0.13. CONCLUSIONS: Through a systematic review of the clinical efficacy and safety of Chinese herbal decoctions and traditional Western medicine for the treatment of gout, we found that Chinese herbal decoction and traditional Western medicine led to similar clinical efficacy, but the Chinese herbal decoctions were superior to Western medicine in terms of controlling adverse drug reactions.

Comparison of the Efficacy of Different Drugs on Non-Motor Symptoms of Parkinson’s Disease: a Network Meta-Analysis

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Bao-Dong Li

2018-01-01

Full Text Available Background/Aims: A network meta-analysis is used to compare the efficacy of ropinirole, rasagiline, rotigotine, entacapone, apomorphine, pramipexole, sumanirole, bromocriptine, piribedil and levodopa, with placebo as a control, for non-motor symptoms in Parkinson’s disease (PD. Methods: PubMed, Embase and the Cochrane Library were searched from their establishment dates up to January 2017 for randomized controlled trials (RCTs investigating the efficacy of the above ten drugs on the non-motor symptoms of PD. A network meta-analysis combined the evidence from direct comparisons and indirect comparisons and evaluated the pooled weighted mean difference (WMD values and surfaces under the cumulative ranking curves (SUCRA. The network meta-analysis included 21 RCTs. Results: The analysis results indicated that, using the United Parkinson’s Disease Rating Scale (UPDRS III, the efficacies of placebo, ropinirole, rasagiline, rotigotine, entacapone, pramipexole, sumanirole and levodopa in treating PD were lower than that of apomorphine (WMD = -10.90, 95% CI = -16.12∼-5.48; WMD = -11.85, 95% CI = -17.31∼-6.16; WMD = -11.15, 95% CI = -16.64∼-5.04; WMD = -11.70, 95% CI = -16.98∼-5.60; WMD = -11.04, 95% CI = -16.97∼-5.34; WMD = -13.27, 95% CI = -19.22∼-7.40; WMD = -10.25, 95% CI = -15.66∼-4.32; and WMD = -11.60, 95% CI = -17.89∼-5.57, respectively. Treatment with ropinirole, rasagiline, rotigotine, entacapone, pramipexole, sumanirole, bromocriptine, piribedil or levodopa, with placebo as a control, on PD exhibited no significant differences on PD symptoms when the UPDRS II was used for evaluation. Moreover, using the UPDRS III, the SUCRA values indicated that a pomorphine had the best efficacy on the non-motor symptoms of PD (99.0%. Using the UPDRS II, the SUCRA values for ropinirole, rasagiline, rotigotine, entacapone, pramipexole, sumanirole, bromocriptine, piribedil and levodopa treatments, with placebo as a control, indicated that

Evaluation of clinical efficacy of a combined analgetic drug "Fanigan" for symptomatic treatment of patients with pain syndrome of various genesis

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Mamchur V.Y.

2017-04-01

Full Text Available The authors studied the efficacy of combined drug Fanigan (paracetamol 500 mg and diclofenac sodium 50 mg (production of "Kusum Pharm" (Ukraine or "Kusum Heltker PVT. LTD" (India in tablets for symptomatic treatment of patients with pain syndrome. A pronounced clinical efficiency of its application in patients with pain syndrome of various genesis in a daily dose from 2 to 3 tablets for 3 to 7 days was established. The obtained data on the clinical efficacy of the drug. Fanigan in the treatment of patients with pain syndrome of various genesis allow to recommend it for application in wide clinical practice.

Intranasal ketamine for acute traumatic pain in the Emergency Department: a prospective, randomized clinical trial of efficacy and safety.

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Shimonovich, Shachar; Gigi, Roy; Shapira, Amir; Sarig-Meth, Tal; Nadav, Danielle; Rozenek, Mattan; West, Debra; Halpern, Pinchas

2016-11-09

Ketamine has been well studied for its efficacy as an analgesic agent. However, intranasal (IN) administration of ketamine has only recently been studied in the emergency setting. The objective of this study was to elucidate the efficacy and adverse effects of a sub-dissociative dose of IN Ketamine compared to IV and IM morphine. A single-center, randomized, prospective, parallel clinical trial of efficacy and safety of IN ketamine compared to IV and IM morphine for analgesia in the emergency department (ED). A convenience sample of 90 patients aged 18-70 experiencing moderate-severe acute traumatic pain (≥80 mm on 100 mm Visual Analog Scale [VAS]) were randomized to receive either 1.0 mg/kg IN ketamine, 0.1 mg/kg IV MO or 0.15 mg/kg IM MO. Pain relief and adverse effects were recorded for 1 h post-administration. The primary outcome was efficacy of IN ketamine compared to IV and IM MO, measured by "time-to-onset" (defined as a ≥15 mm pain decrease on VAS), as well as time to and degree of maximal pain reduction. The 3 study groups showed a highly significant, similar maximal pain reduction of 56 ± 26 mm for IN Ketamine, and 59 ± 22 and 48 ± 30 for IV MO and IM MO, respectively. IN Ketamine provided clinically-comparable results to those of IV MO with regards to time to onset (14.3 ± 11.2 v. 8.9 ± 5.6 min, respectively) as well as in time to maximal pain reduction (40.4 ± 16.3) versus (33.4 ± 18), respectively. IN ketamine shows efficacy and safety comparable to IV and IM MO. Given the benefits of this mode of analgesia in emergencies, it should be further studied for potential clinical applications. Retrospectively registered on 27 June 2016. ClinicalTrials.gov ID: NCT02817477.

Myocardial Contrast Agents – Safety Considerations and Clinical Efficacy in Stress Echocardiography

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Maier Anca

2016-11-01

Full Text Available Transthoracic echocardiographic examination is known to be a safe, non-invasive and reproducible method, used in every day clinical practice to obtain important information about cardiac structure and function. Unfortunately, a significant proportion of studies have highlighted the considerable technically difficultly in producing diagnostic images due to a poor acoustic window and more than 33% of patients undergoing stress echocardiography have suboptimal echocardiographic images. All these limitations have led to the use of contrast agents to improve the quality of standard ultrasound examination to provide a better delineation of left ventricle endocardial borders or to obtain information that cannot be achieved by using standard echocardiography, such as assessing myocardial microcirculation and therefore perfusion. This paper sought to review the clinical efficacy and safety of ultrasound contrast agents focusing on stress echocardiography.

The Role of Irrational Beliefs, Self Efficacy and Social Support in Relapse of Abuse Disorder

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Toraj Hashemi

2010-05-01

Full Text Available Aim: This study aimed to determine the role of irrational beliefs system, self efficacy and social support network in predicting of relapse/non-relapse of drug misusing, and comparison of mentioned variables between these two groups. Method: For this purpose 100 persons who had repeated relapse and 100 persons who did not have relapse were selected by available sampling of Rehabilitation Organization of Tabriz city. Albert Alic’s irrational beliefs, Sherer’s self efficacy and Wax’s social support questionnaires administered among selected samples. Results: The results showed that, there were significant differences between two relapse and non-relapse groups on irrational beliefs, self-efficacy and social support. Conclusion: The results have applied implications in addiction treatment clinics.

Development of a rotavirus vaccine: clinical safety, immunogenicity, and efficacy of the pentavalent rotavirus vaccine, RotaTeq.

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Ciarlet, Max; Schödel, Florian

2009-12-30

Initial approaches for rotavirus vaccines were based on the classical "Jennerian" approach and utilized simian and bovine rotavirus strains, which provided cross-protection against human rotavirus strains but did not cause illness in infants and young children because of their species-specific tropism. The demonstrated efficacy of these vaccines was not consistent across studies. Thus, human-animal reassortants containing an animal rotavirus backbone with human rotavirus surface G and/or P proteins were developed, which demonstrated more consistent efficacy than that observed with the non-reassortant rotavirus strains. The pentavalent rotavirus vaccine, RotaTeq, contains 5 human-bovine reassortant rotaviruses consisting of a bovine (WC3) backbone with human rotavirus surface proteins representative of the most common G (G1, G2, G3, G4) or P (P1A[8]) types worldwide. The present review focuses on the development of the pentavalent rotavirus vaccine RotaTeq. Results of a large-scale Phase III clinical study showed that three doses of RotaTeq were immunogenic, efficacious, and well tolerated with no increased clinical risk of intussusception. RotaTeq was efficacious against rotavirus gastroenteritis of any severity (74%) and severe disease (98-100%), using a validated clinical scoring system. Reductions in rotavirus-associated hospitalizations and emergency department (ED) visits, for up to 2 years post-vaccination, were 95% in Europe, 97% in the United States, and 90% in the Latin American/Caribbean regions. RotaTeq was recently shown to be up to 100% effective in routine use in the US in reducing hospitalizations and ED visits and 96% effective in reducing physician visits. Additional studies in 8 different locations in the US have shown 85-95% reduction in rotavirus-associated hospitalizations and/or ED visits in the first 2-2.5 years of routine use.

Moving from Efficacy to Effectiveness in Cognitive Behavioral Therapy for Psychosis: A Randomized Clinical Practice Trial

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Lincoln, Tania M.; Ziegler, Michael; Mehl, Stephanie; Kesting, Marie-Luise; Lullmann, Eva; Westermann, Stefan; Rief, Winfried

2012-01-01

Objective: Randomized controlled trials have attested the efficacy of cognitive behavioral therapy (CBT) in reducing psychotic symptoms. Now, studies are needed to investigate its effectiveness in routine clinical practice settings. Method: Eighty patients with schizophrenia spectrum disorders who were seeking outpatient treatment were randomized…

Clinical utility, safety, and efficacy of pregabalin in the treatment of fibromyalgia

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Bhusal S

2016-02-01

Full Text Available Santosh Bhusal,1 Sherilyn Diomampo,1 Marina N Magrey2 1Division of Rheumatology, Metrohealth Medical Center, 2Case Western Reserve University School of Medicine at Metrohealth Medical Center, Cleveland OH, USA Abstract: Fibromyalgia is a chronic debilitating medical syndrome with limited therapeutic options. Pregabalin, an anticonvulsant and α-2-Δ subunit receptor ligand, is one of the anchor drugs approved by the US Food and Drug Administration for the treatment of fibromyalgia. The drug has shown clinically meaningful benefits across multiple symptom domains of fibromyalgia. Efficacy of pregabalin in fibromyalgia pain has been evaluated in at least five high-quality randomized trials, two long-term extension studies, a meta-analysis, a Cochrane database systematic review, and several post hoc analyses. These studies also hint towards a meaningful benefit on sleep, functioning, quality of life, and work productivity. Side effects of pregabalin, although common, are mild to moderate in intensity. They are noted early during therapy, improve or disappear with dose reduction, and are not usually life- or organ threatening. In most patients, tolerance develops to the most common side effects, dizziness, and somnolence, with time. With close clinical monitoring at initiation or dose titration, pregabalin can be effectively used in primary care setting. Pregabalin is cost saving with long-term use and its cost-effectiveness profile is comparable, if not better, to that of other drugs used in fibromyalgia. In the present era of limited therapeutic options, pregabalin undoubtedly retains its role as one of cardinal drugs used in the treatment of fibromyalgia. This review intends to discuss the clinical utility of pregabalin in the management of fibromyalgia with a focus on efficacy, safety, and cost-effectiveness. Keywords: fibrositis, myofascial pain, diffuse pain syndrome, lyrica

A contribution to the comparison of the efficacy of radiotherapeutic procedures in cervival carcinoma

International Nuclear Information System (INIS)

Tacev, T.; Michalek, J.; Polach, J.

1992-01-01

This paper presents a new method in which the regression velocity of cervical carcinoma is measured by computer tomography and the results evaluated by two statistical methods: non-linear regression analysis and survival analysis. By means of this approach it was possible to compare the early effect of therapy in patients treated with intracavitary application of 226 Ra plus external radiotherapy with those treated with 252 Cf, 226 Ra and extended radiotherapy. In the latter group a higher efficacy of the therapy was demonstrated by both statistical methods. As the timing between external and intracavitary radiotherapy was different in the two groups and as 252 Cf contributed to a rather small part of the total radiation dose it could not be concluded that the difference in efficacy really was due to 252 Cf. Of essential interest was, however, that an obvious difference in efficacy could be found between two slightly different treatment techniques. The statistical procedure called survival analysis, used hereparallely with weighed regression analysis seemed to give better results than a classical regression analysis and can thus be recommended for processing of clinical data of the type which is discussed in this paper. (orig.)

A social comparison theory analysis of group composition and efficacy of cancer support group programs.

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Carmack Taylor, Cindy L; Kulik, James; Badr, Hoda; Smith, Murray; Basen-Engquist, Karen; Penedo, Frank; Gritz, Ellen R

2007-07-01

Group-based psychosocial programs provide an effective forum for improving mood and social support for cancer patients. Because some studies show more benefit for patients with initially high psychosocial distress, and little or no benefit for patients with initially low distress, support programs may better address patient needs by only including distressed patients. However, distressed patients may benefit particularly from the presence of nondistressed patients who model effective coping, an idea many researchers and extensions of social comparison theory support. We present a theoretical analysis, based on a social comparison perspective, of how group composition (heterogeneous group of distressed and nondistressed patients versus homogeneous group of distressed patients) may affect the efficacy of cancer support programs. We propose that a heterogeneous group allows distressed patients maximal opportunity for the various social comparison activities they are likely to prefer; a homogeneous group does not. Though the presence of nondistressed patients in a heterogeneous group potentially benefits distressed patients, the benefits for nondistressed patients are unclear. For nondistressed patients, heterogeneous groups may provide limited opportunities for preferred social comparison activity and may create the possibility for no benefit or even negative effects on quality of life. We also discuss ethical issues with enrolling nondistressed patients whose presence may help others, but whose likelihood of personal benefit is questionable.

Peer influence on students' estimates of performance : social comparison in clinical rotations

NARCIS (Netherlands)

Raat, A. N. (Janet); Kuks, Jan B. M.; van Hell, E. Ally; Cohen-Schotanus, Janke

Context During clinical rotations, students move from one clinical situation to another. Questions exist about students strategies for coping with these transitions. These strategies may include a process of social comparison because in this context it offers the student an opportunity to estimate

Management of advanced pancreatic cancer with gemcitabine plus erlotinib: efficacy and safety results in clinical practice.

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Diaz Beveridge, Robert; Alcolea, Vicent; Aparicio, Jorge; Segura, Ángel; García, Jose; Corbellas, Miguel; Fonfría, María; Giménez, Alejandra; Montalar, Joaquin

2014-01-10

The combination of gemcitabine and erlotinib is a standard first-line treatment for unresectable, locally advanced or metastatic pancreatic cancer. We reviewed our single centre experience to assess its efficacy and toxicity in clinical practice. Clinical records of patients with unresectable, locally advanced or metastatic pancreatic cancer who were treated with the combination of gemcitabine and erlotinib were reviewed. Univariate survival analysis and multivariate analysis were carried out to indentify independent predictors factors of overall survival. Our series included 55 patients. Overall disease control rate was 47%: 5% of patients presented complete response, 20% partial response and 22% stable disease. Median overall survival was 8.3 months). Cox regression analysis indicated that performance status and locally advanced versus metastatic disease were independent factors of overall survival. Patients who developed acne-like rash toxicity, related to erlotinib administration, presented a higher survival than those patients who did not develop this toxicity. Gemcitabine plus erlotinib doublet is active in our series of patients with advanced pancreatic cancer. This study provides efficacy and safety results similar to those of the pivotal phase III clinical trial that tested the same combination.

Two-year efficacy of tocilizumab in patients with active rheumatoid arthritis in clinical practice.

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Notario Ferreira, Irene; Ferrer González, Miguel Angel; Morales Garrido, Pilar; González Utrilla, Alfonso; García Sanchez, Antonio; Soto Pino, María José; Suero Rosario, Evelyn; Caro Hernández, Cristina; Añón Oñate, Isabel; Pérez Albaladejo, Lorena; Cáliz Cáliz, Rafael

To evaluate the efficacy of tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) in clinical practice, retention rates of the drug and predictors of response. We performed a descriptive, prospective, longitudinal, open-label study in patients receiving TCZ (8mg/kg/4 weeks) in a clinical practice setting. The clinical responses were evaluated using the European League Against Rheumatism (EULAR) response criteria, and the low activity and remission rates according to the Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) and the Clinical Disease Activity Index (CDAI). The EULAR response rate was 86.63% and the DAS28 remission rate was 53.7% after 6 months of treatment; rates of low disease activity were 52.9% on CDAI and 47.1% on DAS28 at month 24. There were no statistically significant differences in EULAR response, rates of low activity and remission on DAS28 between patients receiving TCZ alone and those receiving TCZ in combination therapy, or between patients positive or negative for rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP) antibodies. The naïve biological therapy patients showed better remission and low activity rates after 6 months of treatment. The retention rate was 61% at month 24. Adverse events were among the most frequent causes of discontinuation. Tocilizumab is effective in RA, has a similar efficacy when used alone or in combination with synthetic disease-modifying antirheumatic drugs (DMARDs) and shows high retention rates. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

High-Level Disinfection of Otorhinolaryngology Clinical Instruments: An Evaluation of the Efficacy and Cost-effectiveness of Instrument Storage.

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Yalamanchi, Pratyusha; Yu, Jason; Chandler, Laura; Mirza, Natasha

2018-01-01

Objectives Despite increasing interest in individual instrument storage, risk of bacterial cross-contamination of otorhinolaryngology clinic instruments has not been assessed. This study is the first to determine the clinical efficacy and cost-effectiveness of standard high-level disinfection and clinic instrument storage. Methods To assess for cross-contamination, surveillance cultures of otorhinolaryngology clinic instruments subject to standard high-level disinfection and storage were obtained at the start and end of the outpatient clinical workday. Rate of microorganism recovery was compared with cultures of instruments stored in individual peel packs and control cultures of contaminated instruments. Based on historical clinic data, the direct allocation method of cost accounting was used to determine aggregate raw material cost and additional labor hours required to process and restock peel-packed instruments. Results Among 150 cultures of standard high-level disinfected and co-located clinic instruments, 3 positive bacterial cultures occurred; 100% of control cultures were positive for bacterial species ( P cost of individual semicritical instrument storage at $97,852.50 per year. Discussion With in vitro inoculation of >200 otorhinolaryngology clinic instruments, this study demonstrates that standard high-level disinfection and storage are equally efficacious to more time-consuming and expensive individual instrument storage protocols, such as peel packing, with regard to bacterial contamination. Implications for Practice Standard high-level disinfection and storage are equally effective to labor-intensive and costly individual instrument storage protocols.

Hyperbaric oxygen therapy for wound healing in diabetic rats: Varying efficacy after a clinically-based protocol

NARCIS (Netherlands)

J.W. van Neck (Han); B. Tuk (Bastiaan); E.M.G. Fijneman (Esther ); Redeker, J.J. (Jonathan J.); Talahatu, E.M. (Edwin M.); M. Tong (Miao)

2017-01-01

textabstractHyperbaric oxygen therapy (HBOT) is a clinical treatment in which a patient breathes pure oxygen for a limited period of time at an increased pressure. Although this therapy has been used for decades to assist wound healing, its efficacy for many conditions is unproven and its mechanism

The effect of relational continuity of care in maternity and child health clinics on parenting self-efficacy of mothers and fathers with loneliness and depressive symptoms.

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Tuominen, Miia; Junttila, Niina; Ahonen, Pia; Rautava, Päivi

2016-06-01

This study explored the parenting self-efficacy of the parents of 18-month-old children in the context of Finnish maternity and child health clinics. This parenting self-efficacy was observed in relation with the relational continuity of care and parents' experienced loneliness and depressive symptoms. The relational continuity of care was provided by a public health nurse in maternity and child health clinics. The participating parents were drawn from the STEPS study that is being carried out by the Institute for Child and Youth Research at the University of Turku. The results showed that relational continuity of care provided by the same public health nurse in the maternity and child health clinics was associated with mothers' higher emotional loneliness and with lower scores on three dimensions of parents' parenting self-efficacy. Loneliness and depressive symptoms negatively influenced parents' parenting self-efficacy - however, in the case where the family had experienced relational continuity of care, the parents' higher levels of depressive symptoms had not weakened their parenting self-efficacy beliefs. These results are discussed in terms of organizing maternity and child health clinic services. © 2016 Scandinavian Psychological Associations and John Wiley & Sons Ltd.

cp-R, an interface the R programming language for clinical laboratory method comparisons.

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Holmes, Daniel T

2015-02-01

Clinical scientists frequently need to compare two different bioanalytical methods as part of assay validation/monitoring. As a matter necessity, regression methods for quantitative comparison in clinical chemistry, hematology and other clinical laboratory disciplines must allow for error in both the x and y variables. Traditionally the methods popularized by 1) Deming and 2) Passing and Bablok have been recommended. While commercial tools exist, no simple open source tool is available. The purpose of this work was to develop and entirely open-source GUI-driven program for bioanalytical method comparisons capable of performing these regression methods and able to produce highly customized graphical output. The GUI is written in python and PyQt4 with R scripts performing regression and graphical functions. The program can be run from source code or as a pre-compiled binary executable. The software performs three forms of regression and offers weighting where applicable. Confidence bands of the regression are calculated using bootstrapping for Deming and Passing Bablok methods. Users can customize regression plots according to the tools available in R and can produced output in any of: jpg, png, tiff, bmp at any desired resolution or ps and pdf vector formats. Bland Altman plots and some regression diagnostic plots are also generated. Correctness of regression parameter estimates was confirmed against existing R packages. The program allows for rapid and highly customizable graphical output capable of conforming to the publication requirements of any clinical chemistry journal. Quick method comparisons can also be performed and cut and paste into spreadsheet or word processing applications. We present a simple and intuitive open source tool for quantitative method comparison in a clinical laboratory environment. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

A controlled study to determine the efficacy of Loxostylis alata (Anacardiaceae in the treatment of aspergillus in a chicken (Gallus domesticus model in comparison to ketoconazole

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Suleiman Mohammed M

2012-10-01

Full Text Available Abstract Background The poultry industry due to intensive methods of farming is burdened with losses from numerous infectious agents, of which one is the fungus Aspergillus fumigatus. In a preliminary study, the extracts of Loxostylis alata A. Spreng, ex Rchb. showed good activity in vitro against A. fumigatus with a minimum inhibitory concentration of 0.07 mg/ml. For this study crude, a crude acetone extract of L. alata leaves was evaluated for its acute toxicity in a healthy chicken model and for efficacy in an infectious model of aspergillosis (A. fumigatus. Results At a dose of 300 mg/kg, the extract induced some toxicity characterised by decreased feed intake and weight loss. Consequently, 100 and 200 mg/kg were used to ascertain efficacy in the infectious model. The plant extract significantly reduced clinical disease in comparison to the control in a dose dependant manner. The extract was as effective as the positive control ketoconazole dosed at 60 mg/kg. Conclusions The results indicate that a crude extract of L. alata leaves has potential as an antifungal agent to protect poultry against avian aspergillosis.

Efficacy of enrofloxacin for the treatment of acute clinical mastitis caused by Escherichia coli in dairy cows.

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Persson, Y; Katholm, J; Landin, H; Mörk, M J

2015-06-27

Evidence for the efficacy of antimicrobial treatments in Escherichia coli mastitis is limited. The aim of this double-blinded field trial was to investigate the efficacy of enrofloxacin compared with placebo, with a special focus on survival, in dairy cows with acute clinical mastitis caused by E. coli. Dairy cows (n=116) with acute clinical mastitis were included in the study. A clinical examination was performed and a milk sample from the affected udder quarter was collected for investigation of somatic cell count (SCC) and bacteriology on the first day of treatment (day 0) and at day 3 (clinical examination only), day 22 and day 28. Data regarding culled cows, SCC and daily milk yield were retrieved from monthly milk recording each month until 180 days after treatment. All cows were treated with either enrofloxacin or placebo once a day for three days, starting at day 0. After culturing, 56 cows with confirmed E. coli mastitis remained in the study. Nine (16 per cent) of them died within the first week. Enrofloxacin-treated cows had lower SCC compared with placebo-treated cows at first monthly milk recordings after being treated for mastitis. Treatment with enrofloxacin did not result in a higher probability of survival compared with placebo. British Veterinary Association.

Efficacy of chemomechanical caries removal in reducing cariogenic microbiota: a randomized clinical trial

OpenAIRE

AMMARI, Michelle Mikhael; MOLITERNO, Luiz Flávio Martins; HIRATA JÚNIOR, Raphael; SÉLLOS, Mariana Canano; SOVIERO, Vera Mendes; COUTINHO FILHO, Wagner Pereira

2014-01-01

The aim of this study was to compare the efficacy of chemochemical methods (Carisolv™ and Papacárie®) versus the manual method (excavators) in reducing the cariogenic microbiota in dentine caries of primary teeth. Forty-six healthy children (5 to 9 years old) having at least one primary tooth with a cavitated dentine carious lesion were included in the study. The teeth presented no clinical or radiographic signs of pulpal involvement. The sample of 74 teeth was randomly divided into thr...

[Clinical efficacy of Viagra with behavior therapy against premature ejaculation].

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Tang, Wenhao; Ma, Lulin; Zhao, Lianming; Liu, Yuqing; Chen, Zhenwen

2004-05-01

To study the efficacy of Viagra combined with behavior therapy against premature ejaculation (PE). Sixty PE patients were divided into two groups randomly: control group (behavior therapy alone) and the group of Viagra combined with behavior therapy. Intra-vaginal ejaculation latency time (IELT) and the coitus satisfaction of the patient and the partner were recorded before and after treatment. The IELTs of the two groups were 0.80 +/- 0.20 and 0.73 +/- 0.24 minutes respectively before treatment, and 1.82 +/- 0.54 and 3.63 +/- 0.55 minutes respectively after treatment. As for IELT and satisfaction degree, Viagra produced better result than behavior therapy. During this clinical trial, Viagra combined with behavior therapy prolonged IELT, which suggests that Viagra may be helpful for the treatment of premature ejaculation.

Clinical Efficacy and Safety of Benjakul Remedy Extract for Treating Primary Osteoarthritis of Knee Compared with Diclofenac: Double Blind, Randomized Controlled Trial

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Patamaporn Rachawat

2017-01-01

Full Text Available Background. The purpose of this study was to investigate the clinical efficacy and safety of Benjakul (BJK extract for treating primary osteoarthritis (OA of the knee compared with diclofenac. Methods. A phase 2, double blind, randomized, and controlled study was conducted. The BJK group received 300 mg of BJK extract per day, while another group received 75 mg of diclofenac per day. All patients were followed up at 14 and 28 days. The changing of visual analogue scale (VAS for pain, 100-meter walking times, the modified Thai WOMAC index scores, and the global assessment were evaluated for efficacy. For safety issue, clinical signs and symptoms, complete physical examination, and renal and liver function were evaluated. Results. 39 and 38 patients for BJK extract group and diclofenac group were evaluated. For efficacy, all patients from both groups reported a decrease in the VAS pain score and 100-meter walking times but only the diclofenac group showed significant reduction of both measurements when compared with day 0. The modified Thai WOMAC scores of both groups were significantly reduced from baseline. However, all efficacy outcomes were not significantly different for both groups. For safety outcomes, the patients from both groups had no severe adverse events reported and only BJK had no toxicity in renal and liver functions. Conclusions. The BJK remedy extract showed equal clinical efficacy in relieving symptoms of OA knee when compared with diclofenac.

Topical 0.25% desoximetasone spray efficacy for moderate to severe plaque psoriasis: a randomized clinical trial.

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Saleem, Mohammed D; Negus, Deborah; Feldman, Steven R

2018-02-01

Traditionally, ointments were the vehicle of choice for psoriasis. Poor adherence of traditional vehicles limits the use of topical corticosteroids. Alternative formulations have gained popularity due to their ease of application, improved adherence and efficacy. To evaluate the efficacy of topical desoximetasone 0.25% spray formulation in extensive psoriasis. This multicenter, double-blinded, randomized trial compared twice daily topical 0.25% desoximetasone spray to placebo in subjects ≥18 with moderate to severe plaque psoriasis. Primary outcome of the study was the proportion of subjects in each group that achieved clinical success (Physician Global Assessment [PGA] of 0 or 1) and/or treatment success at (target lesion score of 0 or 1) day 28. One-hundred-and-twenty subjects were enrolled. At baseline, 75.0% and 73.3% of the treatment and placebo group had at least moderate PGA, respectively. Clinical success in the intended-to treat and placebo group was 30% and 5% (p = .0003), respectively; treatment success was 39% and 7% (p psoriasis treatments limits the ability to compare the results to other treatments. Topical desoximetasone spray provides rapid control of moderate to severe psoriasis lesions and may be considered for patients awaiting approval of biologicals. Clinical Trial was registered at clinicaltrial.gov: NCT01206387.

Is Deqi an Indicator of Clinical Efficacy of Acupuncture? A Systematic Review

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Shuo Zhang

2013-01-01

Full Text Available Objective. Despite the systematic literature review of the current evidence, we aim to answer the question “ is Deqi an indicator of clinical effects in acupuncture treatment?” Methods. We systematically searched CNKI, VIP, Wanfang Data, PubMed, Embase, and the CENTRAL for three types of study: (1 empirical research probing into the role of Deqi in acupuncture; (2 mechanism studies examining the effect of Deqi on physiological parameters in animal models and human subjects; (3 clinical studies that compared the outcome of acupuncture with Deqi with that of acupuncture without Deqi. Two reviewers independently extracted data, undertook qualitative or quantitative analysis, and summarized findings. Results. The ancient Chinese acupuncturists valued the role of Deqi as a diagnostic tool, a prognosis predictor, and a necessary part of the therapeutic procedure. Findings from modern experimental research provided preliminary evidence for the physiological mechanism that produced Deqi. Few clinical studies generated conflicting evidence of the comparative effectiveness of acupuncture with Deqi versus acupuncture without Deqi for a variety of conditions. Conclusion. The current evidence base is not solid enough to draw any conclusion regarding the predicative value of natural Deqi for clinical efficacy or the therapeutic value of manipulation-facilitated Deqi.

Randomized, controlled clinical trial evaluating the efficacy of pulsed signal therapy in dogs with osteoarthritis.

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Sullivan, Meghan O; Gordon-Evans, Wanda J; Knap, Kim E; Evans, Richard B

2013-04-01

To evaluate the efficacy of pulsed signal therapy (PST) in reducing pain and increasing function in dogs with osteoarthritis (OA) using a randomized, blinded, controlled clinical trial. Randomized, controlled, blinded clinical trial. Adult dogs (n = 60) with moderate-to-severe clinical signs of OA. Dogs were randomized by age into 2 groups: dogs ≥ 9 years and dogs Goniometry and gait analysis were performed, and the Canine Brief Pain Inventory (CBPI) questionnaire was given to the owners to fill out without supervision. Outcome measures were repeated at the end of treatment (Day 11) and 6 weeks after beginning treatment (Day 42). The PST group performed significantly better than the control group as measured by the CBPI Severity and Interference scores (P Veterinary Surgeons.

Efficacy of curcumin in the treatment for oral submucous fibrosis - A randomized clinical trial

OpenAIRE

Hazarey, Vinay K; Sakrikar, Aditee R; Ganvir, Sindhu M

2015-01-01

Introduction: Oral submucous fibrosis (OSF) is a chronic, insidious disease that is associated with significant functional morbidity and an increased risk for malignancy. Turmeric and its active ingredient "curcumin′′ are being studied upon as chemopreventive agents in various diseases. The present study aims to determine the efficacy of curcumin in the treatment of OSF. Materials and Methods: Thirty clinically diagnosed OSF patients were divided into two groups, 15 patients in each group fro...

A review of the pharmacology and clinical efficacy of brivaracetam

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Klein P

2018-01-01

Full Text Available Pavel Klein,1 Anyzeila Diaz,2 Teresa Gasalla,3 John Whitesides4 1Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA; 2Neurology Patient Value Unit, UCB Pharma, Smyrna, GA, USA; 3Neurology Patient Value Unit, UCB Pharma, Monheim am Rhein, Germany; 4Asset Development, UCB Pharma, Raleigh, NC, USA Abstract: Brivaracetam (BRV; Briviact is a new antiepileptic drug (AED approved for adjunctive treatment of focal (partial-onset seizures in adults. BRV is a selective, high-affinity ligand for synaptic vesicle 2A (SV2A with 15- to 30-fold higher affinity than levetiracetam, the first AED acting on SV2A. It has high lipid solubility and rapid brain penetration, with engagement of the target molecule, SV2A, within minutes of administration. BRV has potent broad-spectrum antiepileptic activity in animal models. Phase I studies indicated BRV was well tolerated and showed a favorable pharmacokinetic profile over a wide dose range following single (10–1,000 mg and multiple (200–800 mg/day oral dosing. Three pivotal Phase III studies have demonstrated promising efficacy and a good safety and tolerability profile across doses of 50–200 mg/day in the adjunctive treatment of refractory focal seizures. Long-term data indicate that the response to BRV is sustained, with good tolerability and retention rate. BRV is highly effective in patients experiencing secondarily generalized tonic–clonic seizures. Safety data to date suggest a favorable psychiatric adverse effect profile in controlled studies, although limited postmarketing data are available. BRV is easy to use, with no titration and little drug–drug interaction. It can be initiated at target dose with no titration. Efficacy is seen on day 1 of oral use in a significant percentage of patients. Intravenous administration in a 2-minute bolus and 15-minute infusion is well tolerated. Here, we review the pharmacology, pharmacokinetics, and clinical data of BRV. Keywords: brivaracetam, efficacy

Child versus Family Cognitive-Behavioral Therapy in Clinically Anxious Youth: An Efficacy and Partial Effectiveness Study

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Bodden, Denise H. M.; Bogels, Susan M.; Nauta, Maaike H.; De Hann, Else; Ringrose, Jaap; Appelboom, Carla; Brinkman, Andries G.; Appelboom-Geerts, Karen C. M. M. J.

2008-01-01

Child-focused and family-focused cognitive-behavioral therapy (CBT) for 128 children with clinical anxiety disorders and their parents were compared in terms of efficacy and partial effectiveness. Results indicate that 53% of the children under the child CBT became free of anxiety disorders at posttreamtent compared to only 28% under family CBT.…

Clinical efficacy, onset time and safety of bright light therapy in acute bipolar depression as an adjunctive therapy: A randomized controlled trial.

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Zhou, Tian-Hang; Dang, Wei-Min; Ma, Yan-Tao; Hu, Chang-Qing; Wang, Ning; Zhang, Guo-Yi; Wang, Gang; Shi, Chuan; Zhang, Hua; Guo, Bin; Zhou, Shu-Zhe; Feng, Lei; Geng, Shu-Xia; Tong, Yu-Zhen; Tang, Guan-Wen; He, Zhong-Kai; Zhen, Long; Yu, Xin

2018-02-01

Bright light therapy (BLT) is an effective treatment for seasonal affective disorder and non- seasonal depression. The efficacy of BLT in treating patients with bipolar disorder is still unknown. The aim of this study is to examine the efficacy, onset time and clinical safety of BLT in treating patients with acute bipolar depression as an adjunctive therapy (trial registration at ClinicalTrials.gov: NCT02009371). This was a multi-center, single blind, randomized clinical trial. Seventy-four participants were randomized in one of two treatment conditions: BLT and control (dim red light therapy, dRLT). Sixty-three participants completed the study (33 BLT, 30 dRLT). Light therapy lasted for two weeks, one hour every morning. All participants were required to complete several scales assessments at baseline, and at the end of weeks 1 and 2. The primary outcome measures were the clinical efficacy of BLT which was assessed by the reduction rate of HAMD-17 scores, and the onset time of BLT which was assessed by the reduction rate of QIDS-SR16 scores. The secondary outcome measures were rates of switch into hypomania or mania and adverse events. 1) Clinical efficacy: BLT showed a greater ameliorative effect on bipolar depression than the control, with response rates of 78.19% vs. 43.33% respectively (p < 0.01). 2) Onset day: Median onset day was 4.33 days in BLT group. 3) BLT-emergent hypomania: No participants experienced symptoms of hypomania. 4) Side effects: No serious adverse events were reported. BLT can be considered as an effective and safe adjunctive treatment for patients with acute bipolar depression. Copyright © 2017 Elsevier B.V. All rights reserved.

Clinical Efficacy and Residue Depletion of 10% Enrofloxacin Enteric-Coated Granules in Pigs.

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Lei, Zhixin; Liu, Qianying; Yang, Bing; Xiong, Jincheng; Li, Kun; Ahmed, Saeed; Hong, Liping; Chen, Pin; He, Qigai; Cao, Jiyue

2017-01-01

A new, more palatable formulation of 10% enrofloxacin enteric-coated granules was investigated to evaluate the pharmacokinetic effect in plasma, the residue elimination in tissues and the clinical efficacy against Actinobacillus pleuropneumonia (APP) and Mycoplasam suis (MS) in pigs. In this study, the enrofloxacin concentrations in plasma and tissues were detected using high-performance liquid chromatography with phosphate buffer (pH = 3) and acetonitrile. The pharmacokinetics and elimination of enrofloxacin enteric-coated granules were performed after oral administration at a single dose of 10 mg/kg body weight (bw) and 5 mg/kg twice per day for 5 consecutive days, respectively. The in vivo antibacterial efficacy and clinical effectiveness of enrofloxacin enteric-coated granules against APP and MS were assayed at 2.5, 5, 10 mg/kg, compared with tiamulin (8 mg/kg) based on establishment of APP and MS infection models. 56 APP strains were selected and tested for in vitro antibacterial activity of enrofloxacin enteric-coated granules. The main parameters of elimination half-life (t 1/2β ), T max , and area under the curve (AUC) were 14.99 ± 4.19, 3.99 ± 0.10, and 38.93 ± 1.52 μg h/ml, respectively, revealing that the enrofloxacin concentration remained high and with a sustainable distribution in plasma. Moreover, the analysis on the evaluation of enrofloxacin and ciprofloxacin in muscle, fat, liver and kidney showed that the recovery were more than 84% recovery in accordance with the veterinary drug residue guidelines of United States pharmacopeia, and the withdrawal periods were 4.28, 3.81, 4.84, and 3.51 days, respectively, suggesting that the withdrawal period was 5 d after oral administration of 5 mg/kg twice per day. The optimal dosage of enrofloxacin enteric-coated granules against APP and MS was 5 mg/kg, with over 90% efficacy, which was significantly different ( p enrofloxacin enteric-coated granules had significant potential for treating APP and MS

Influence of motivation, self-efficacy and situational factors on the teaching quality of clinical educators.

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Dybowski, Christoph; Sehner, Susanne; Harendza, Sigrid

2017-05-08

Being exposed to good teachers has been shown to enhance students' knowledge and their clinical performance, but little is known about the underlying psychological mechanisms that provide the basis for being an excellent medical teacher. Self-Determination Theory (SDT) postulates that more self-regulated types of motivation are associated with higher performance. Social Cognitive Theory (SCT) focuses on self-efficacy that has been shown to be positively associated with performance. To investigate the influences of different types of teaching motivation, teaching self-efficacy, and teachers' perceptions of students' skills, competencies and motivation on teaching quality. Before the winter semester 2014, physicians involved in bedside teaching in internal medicine at the University Medical Center Hamburg-Eppendorf completed a questionnaire with sociodemographic items and instruments measuring different dimensions of teaching motivation as well as teaching self-efficacy. During the semester, physicians rated their perceptions of the participating students who rated the teaching quality after each lesson. We performed a random intercept mixed-effects linear regression with students' ratings of teaching quality as the dependent variable and students' general interest in a subject as covariate. We explored potential associations between teachers' dispositions and their perceptions of students' competencies in a mixed-effects random intercept logistic regression. 94 lessons given by 55 teachers with 500 student ratings were analyzed. Neither teaching motivation nor teaching self-efficacy were directly associated with students' rating of teaching quality. Teachers' perceptions of students' competencies and students' general interest in the lesson's subject were positively associated with students' rating of teaching quality. Physicians' perceptions of their students' competencies were significantly positively predicted by their teaching self-efficacy. Teaching quality

Randomized clinical trial to comparing efficacy of daily, weekly and monthly administration of vitamin D3.

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Takács, István; Tóth, Béla E; Szekeres, László; Szabó, Boglárka; Bakos, Bence; Lakatos, Péter

2017-01-01

The comparative efficacy and safety profiles of selected daily 1000 IU, weekly 7000 IU and monthly 30,000 IU vitamin D 3 -not previously investigated-will be evaluated. Here, a prospective, randomized clinical trial, comparing efficacy and safety of a daily single dose of 1000 IU (group A) to a once-weekly 7000 IU dose (group B), or monthly 30,000 IU dose (group C) of vitamin D 3 . The present study is a controlled, randomized, open-label, multicenter clinical trial, 3  months in duration. Sixty-four adult subjects with vitamin D deficiency (25OHD<20 ng/ml), were included according to the inclusion and exclusion criteria. Dose-responses for increases in serum vitamin 25OHD were statistically equivalent for each of the three groups: A, B and C. Outcomes were 13.0 ± 1.5; 12.6 ± 1.1 and 12.9 ± 0.9 ng/ml increases in serum 25OHD per 1000 IU, daily, weekly and monthly, respectively. The treatment of subjects with selected doses restored 25OHD values to levels above 20 ng/ml in all groups. Treatment with distinct administration frequency of vitamin D 3 did not exhibit any differences in safety parameters. The daily, weekly and monthly administrations of daily equivalent of 1000 IU of vitamin D 3 provide equal efficacy and safety profiles.

Efficacy of iontophoresis-assisted epithelium-on corneal cross-linking for keratoconus

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Hong-Zhen Jia

2018-04-01

Full Text Available Corneal cross-linking (CXL is a noninvasive therapeutic procedure for keratoconus that is aimed at improving corneal biomechanical properties by induction of covalent cross-links between stromal proteins. It is accomplished by ultraviolet A (UVA radiation of the cornea, which is first saturated with photosensitizing riboflavin. It has been shown that standard epithelium-off CXL (S-CXL is efficacious, and it has been recommended as the standard of care procedure for keratoconus. However, epithelial removal leads to pain, transient vision loss, and a higher risk of corneal infection. To avoid these disadvantages, transepithelial CXL was developed. Recently, iontophoresis has been adopted to increase riboflavin penetration through the epithelium. Several clinical observations have demonstrated the safety and efficacy of iontophoresis-assisted epithelium-on CXL (I-CXL for keratoconus. This review aimed to provide a comprehensive summary of the published studies regarding I-CXL and a comparison between I-CXL and S-CXL. All articles used in this review were mainly retrieved from the PubMed database. Original articles and reviews were selected if they were related to the I-CXL technique or related to the comparison between I-CXL and S-CXL.

A direct comparison of efficacy between desloratadine and rupatadine in seasonal allergic rhinoconjunctivitis: a randomized, double-blind, placebo-controlled study.

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Lukat, Kf; Rivas, P; Roger, A; Kowalski, Ml; Botzen, U; Wessel, F; Sanquer, F; Agache, I; Izquierdo, I

2013-01-01

H1-antihistamines are recommended as the first-line symptomatic treatment of allergic rhinitis. The objective of this study was to evaluate the effects of rupatadine (RUP) versus desloratadine (DES) in subjects with seasonal allergic rhinitis (SAR). To assess the efficacy and safety of RUP in SAR in comparison with placebo (PL) and DES. A randomized, double-blind, multicenter, international, and PL-controlled study was carried out. The main selection criteria included SAR patients over 12 years old with a positive prick test to a relevant seasonal allergen for the geographic area. Symptomatic patients at screening with a nasal symptom sum score of ≥6 points (nasal discharge, nasal obstruction, sneezing, and nasal pruritus), a non-nasal score of ≥3 points (ocular pruritus, ocular redness, and tearing eyes), and a rhinorrhea score of ≥2 points with laboratory test results and electrocardiography within acceptable limits were included in the study. Change from baseline in the total symptom-score (T7SS) over the 4-week treatment period (reflective evaluation) was considered the primary efficacy variable. Secondary efficacy measures included total nasal symptom score (T4NSS) and conjunctival symptom score (T3NNSS), both of which are reflective and instantaneous evaluations. Furthermore questions related to quality of life (eg, sleep disturbances or impairment of daily activities) have also been evaluated. Safety was assessed according to adverse events reported, as well as laboratory and electrocardiography controls. A total of 379 patients were randomized, of which 356 were included and allocated to PL (n = 122), RUP (n = 117), or DES (n = 117). Mean change of T7SS over the 4-week treatment period was significantly reduced in the RUP (-46.1%, P = 0.03) and DES (-48.9%, P = 0.01) groups, compared with PL. Similarly, RUP and DES were comparable and significantly superior to PL for all secondary endpoints, including nasal and conjunctival symptoms and patients' and

Endovascular Treatment of Malignant Superior Vena Cava Syndrome: Results and Predictive Factors of Clinical Efficacy

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Fagedet, Dorothee, E-mail: DFagedet@chu-grenoble.fr [CHU de Grenoble, Clinique universitaire de medecine interne, Pole Pluridisciplinaire de Medecine (France); Thony, Frederic, E-mail: FThony@chu-grenoble.fr [CHU de Grenoble, Clinique universitaire de radiologie et imagerie medicale, Pole d' Imagerie (France); Timsit, Jean-Francois, E-mail: JFTimsit@chu-grenoble.fr [CHU de Grenoble, Clinique universitaire de reanimation, Pole Medecine Aiguee Communautaire (France); Rodiere, Mathieu, E-mail: MRodiere@chu-grenoble.fr [CHU de Grenoble, Clinique universitaire de radiologie et imagerie medicale, Pole d' Imagerie (France); Monnin-Bares, Valerie, E-mail: v-monnin@chu-montpellier.fr [CHRU Arnaud de Villeneuve, Imagerie Medicale Thoracique Cardiovasculaire (France); Ferretti, Gilbert R., E-mail: GFerretti@chu-grenoble.fr [CHU de Grenoble, Clinique universitaire de radiologie et imagerie medicale, Pole d' Imagerie (France); Vesin, Aurelien; Moro-Sibilot, Denis, E-mail: DMoro.pneumo@chu-grenoble.fr [University Grenoble 1 e Albert Bonniot Institute, Inserm U823 (France)

2013-02-15

To demonstrate the effectiveness of endovascular treatment (EVT) with self-expandable bare stents for malignant superior vena cava syndrome (SVCS) and to analyze predictive factors of EVT efficacy. Retrospective review of the 164 patients with malignant SVCS treated with EVT in our hospital from August 1992 to December 2007 and followed until February 2009. Endovascular treatment includes angioplasty before and after stent placement. We used self-expandable bare stents. We studied results of this treatment and looked for predictive factors of clinical efficacy, recurrence, and complications by statistical analysis. Endovascular treatment was clinically successful in 95% of cases, with an acceptable rate of early mortality (2.4%). Thrombosis of the superior vena cava was the only independent factor for EVT failure. The use of stents over 16 mm in diameter was a predictive factor for complications (P = 0.008). Twenty-one complications (12.8%) occurred during the follow-up period. Relapse occurred in 36 patients (21.9%), with effective restenting in 75% of cases. Recurrence of SVCS was significantly increased in cases of occlusion (P = 0.01), initial associated thrombosis (P = 0.006), or use of steel stents (P = 0.004). Long-term anticoagulant therapy did not influence the risk of recurrence or complications. In malignancy, EVT with self-expandable bare stents is an effective SVCS therapy. These results prompt us to propose treatment with stents earlier in the clinical course of patients with SVCS and to avoid dilatation greater than 16 mm.

Endovascular Treatment of Malignant Superior Vena Cava Syndrome: Results and Predictive Factors of Clinical Efficacy

International Nuclear Information System (INIS)

Fagedet, Dorothée; Thony, Frederic; Timsit, Jean-François; Rodiere, Mathieu; Monnin-Bares, Valérie; Ferretti, Gilbert R.; Vesin, Aurélien; Moro-Sibilot, Denis

2013-01-01

To demonstrate the effectiveness of endovascular treatment (EVT) with self-expandable bare stents for malignant superior vena cava syndrome (SVCS) and to analyze predictive factors of EVT efficacy. Retrospective review of the 164 patients with malignant SVCS treated with EVT in our hospital from August 1992 to December 2007 and followed until February 2009. Endovascular treatment includes angioplasty before and after stent placement. We used self-expandable bare stents. We studied results of this treatment and looked for predictive factors of clinical efficacy, recurrence, and complications by statistical analysis. Endovascular treatment was clinically successful in 95% of cases, with an acceptable rate of early mortality (2.4%). Thrombosis of the superior vena cava was the only independent factor for EVT failure. The use of stents over 16 mm in diameter was a predictive factor for complications (P = 0.008). Twenty-one complications (12.8%) occurred during the follow-up period. Relapse occurred in 36 patients (21.9%), with effective restenting in 75% of cases. Recurrence of SVCS was significantly increased in cases of occlusion (P = 0.01), initial associated thrombosis (P = 0.006), or use of steel stents (P = 0.004). Long-term anticoagulant therapy did not influence the risk of recurrence or complications. In malignancy, EVT with self-expandable bare stents is an effective SVCS therapy. These results prompt us to propose treatment with stents earlier in the clinical course of patients with SVCS and to avoid dilatation greater than 16 mm.

Effects of Depression Alleviation on ART Adherence and HIV Clinic Attendance in Uganda, and the Mediating Roles of Self-Efficacy and Motivation.

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Wagner, Glenn J; Ghosh-Dastidar, Bonnie; Robinson, Eric; Ngo, Victoria K; Glick, Peter; Mukasa, Barbara; Musisi, Seggane; Akena, Dickens

2017-06-01

With depression known to impede HIV care adherence and retention, we examined whether depression alleviation improves these disease management behaviors. A sample of 1028 depressed HIV clients in Uganda enrolled in a cluster randomized controlled trial of two depression care models, and were surveyed over 12 months. Serial regression analyses examined whether depression alleviation was associated with self-reported antiretroviral therapy (ART) adherence and clinic attendance at month 12, and whether these relationships were mediated by self-efficacy and motivation. Among those with major depression, depression alleviation was associated with better ART adherence and clinic attendance at month 12; these relationships were fully mediated by self-efficacy at month 12, while adherence motivation partially mediated the relationship between depression alleviation and ART adherence. When both mediators were entered simultaneously, only self-efficacy was a significant predictor and still fully mediated the relationship between depression alleviation and adherence. These findings suggest that depression alleviation benefits both ART adherence and clinic attendance, in large part through improved confidence and motivation to engage in these disease management behaviors.

A Cross-Cultural Comparison of Singaporean and Taiwanese Eighth Graders' Science Learning Self-Efficacy from a Multi-Dimensional Perspective

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Lin, Tzung-Jin; Tan, Aik Ling; Tsai, Chin-Chung

2013-05-01

Due to the scarcity of cross-cultural comparative studies in exploring students' self-efficacy in science learning, this study attempted to develop a multi-dimensional science learning self-efficacy (SLSE) instrument to measure 316 Singaporean and 303 Taiwanese eighth graders' SLSE and further to examine the differences between the two student groups. Moreover, within-culture comparisons were made in terms of gender. The results showed that, first, the SLSE instrument was valid and reliable for measuring the Singaporean and Taiwanese students' SLSE. Second, through a two-way multivariate analysis of variance analysis (nationality by gender), the main result indicated that the SLSE held by the Singaporean eighth graders was significantly higher than that of their Taiwanese counterparts in all dimensions, including 'conceptual understanding and higher-order cognitive skills', 'practical work (PW)', 'everyday application', and 'science communication'. In addition, the within-culture gender comparisons indicated that the male Singaporean students tended to possess higher SLSE than the female students did in all SLSE dimensions except for the 'PW' dimension. However, no gender differences were found in the Taiwanese sample. The findings unraveled in this study were interpreted from a socio-cultural perspective in terms of the curriculum differences, societal expectations of science education, and educational policies in Singapore and Taiwan.

The relation between quality of clinical trials and acupuncture efficacy

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David Gonçalves Nordon

2013-06-01

Full Text Available Introduction: Clinical trials of acupuncture not always have concordant results, mostly due to their great heterogeneity. Two indexes have been developed to analyze the quality of acupuncture trials. This study hypothesizes that, the more adequate the intervention and the control techniques, the more efficacious the acupuncture. Methods: Both indexes were applied to 27 randomized clinical trials comparing acupuncture to placebo. Results were compared by using the Mann-Whitney test. Results: Studies favorable to acupuncture had a intervention score’s median of 11.5; for the unfavorable ones, it was 7, p: 0.0017. Articles with and without statistically significant differences, though, had the same median for their scores in the control index: 6. Discussion: There is a positive relation between a better score for acupuncture technique and a statistically significant difference between acupuncture and interventional control. However, due to the little heterogeneity in the degree of physiological effect from each article, the control index had no statistical significance. Conclusion: This study established that, among acupuncture RCT controlled by placebo or sham of moderate physiological effect, the adequacy of the technique is more important than the adequacy of control in establishing a statistically significant difference between acupuncture and interventional control.

Efficacy of 8- and 4-Session Mindfulness-Based Interventions in a Non-clinical Population: A Controlled Study.

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Demarzo, Marcelo; Montero-Marin, Jesus; Puebla-Guedea, Marta; Navarro-Gil, Mayte; Herrera-Mercadal, Paola; Moreno-González, Sergio; Calvo-Carrión, Sandra; Bafaluy-Franch, Laura; Garcia-Campayo, Javier

2017-01-01

Background: Many attempts have been made to abbreviate mindfulness programmes in order to make them more accessible for general and clinical populations while maintaining their therapeutic components and efficacy. The aim of this study was to assess the efficacy of an 8-week mindfulness-based intervention (MBI) programme and a 4-week abbreviated version for the improvement of well-being in a non-clinical population. Method: A quasi-experimental, controlled, pilot study was conducted with pre-post and 6-month follow-up measurements and three study conditions (8- and 4-session MBI programmes and a matched no-treatment control group, with a sample of 48, 46, and 47 participants in each condition, respectively). Undergraduate students were recruited, and mindfulness, positive and negative affect, self-compassion, resilience, anxiety, and depression were assessed. Mixed-effects multi-level analyses for repeated measures were performed. Results: The intervention groups showed significant improvements compared to controls in mindfulness and positive affect at the 2- and 6-month follow-ups, with no differences between 8- vs. 4-session programmes. The only difference between the abbreviated MBI vs. the standard MBI was found in self-kindness at 6 months, favoring the standard MBI. There were marginal differences in anxiety between the controls vs. the abbreviated MBI, but there were differences between the controls vs. the standard MBI at 2- and 6-months, with higher levels in the controls. There were no differences in depression between the controls vs. the abbreviated MBI, but differences were found between the controls vs. the standard MBI at 2- and 6-months, favoring the standard MBI. There were no differences with regard to negative affect and resilience. Conclusion: To our knowledge, this is the first study to directly investigate the efficacy of a standard 8-week MBI and a 4-week abbreviated protocol in the same population. Based on our findings, both programmes

Efficacy of 8- and 4-Session Mindfulness-Based Interventions in a Non-clinical Population: A Controlled Study

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Marcelo Demarzo

2017-08-01

Full Text Available Background: Many attempts have been made to abbreviate mindfulness programmes in order to make them more accessible for general and clinical populations while maintaining their therapeutic components and efficacy. The aim of this study was to assess the efficacy of an 8-week mindfulness-based intervention (MBI programme and a 4-week abbreviated version for the improvement of well-being in a non-clinical population.Method: A quasi-experimental, controlled, pilot study was conducted with pre-post and 6-month follow-up measurements and three study conditions (8- and 4-session MBI programmes and a matched no-treatment control group, with a sample of 48, 46, and 47 participants in each condition, respectively. Undergraduate students were recruited, and mindfulness, positive and negative affect, self-compassion, resilience, anxiety, and depression were assessed. Mixed-effects multi-level analyses for repeated measures were performed.Results: The intervention groups showed significant improvements compared to controls in mindfulness and positive affect at the 2- and 6-month follow-ups, with no differences between 8- vs. 4-session programmes. The only difference between the abbreviated MBI vs. the standard MBI was found in self-kindness at 6 months, favoring the standard MBI. There were marginal differences in anxiety between the controls vs. the abbreviated MBI, but there were differences between the controls vs. the standard MBI at 2- and 6-months, with higher levels in the controls. There were no differences in depression between the controls vs. the abbreviated MBI, but differences were found between the controls vs. the standard MBI at 2- and 6-months, favoring the standard MBI. There were no differences with regard to negative affect and resilience.Conclusion: To our knowledge, this is the first study to directly investigate the efficacy of a standard 8-week MBI and a 4-week abbreviated protocol in the same population. Based on our findings, both

[Research and development on efficacy of Chinese herbal compound].

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Liu, Jian-Xun; Ren, Jian-Xun; Lin, Cheng-Ren

2016-03-01

The efficacy not only is summarized by clinical effect of Chinese herbal compound on theory of traditional Chinese medicine, but also is manifested to clinical effect by interaction of many intricate chemical substances. The efficacy of Chinese herbal compound is current research focus in field of traditional Chinese medicine. By currently knowing in different aspects which included the progression in efficacy of Chinese herbal compound, symptomatic efficacy of Chinese herbal compound, the relationship between the efficacy and pharmacologic effect of Chinese herbal compound, the efficacy related pharmacodynamic substance and the evaluation of efficacy, it had been summarized mainly problems and methods in research and development process of the efficacy of Chinese herbal compound in this paper. Paper also elucidated problems that need to pay attention in research of efficacy in order to provide references for clinical and experimental studies of efficacy in Chinese herbal compound, boost research and development level of new traditional Chinese drug and facilitate modernization of traditional Chinese medicines. Copyright© by the Chinese Pharmaceutical Association.

Extracellular gadolinium-based contrast media: Differences in diagnostic efficacy

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Molen, Aart J. van der [Department of Radiology C-2S, Leiden University Medical Centre, Albinusdreef 2, NL-2333 ZA Leiden (Netherlands)], E-mail: molen@lumc.nl; Bellin, Marie-France [Universite Paris-Sud XI, AP-HP, Service de Radiologie, Hopital Paul Brousse, 12-14 Avenue Paul Vaillant Couturier, F-94804 Villejuif Cedex (France)

2008-05-15

Since the introduction of the first gadolinium-based contrast agent (Gd-CA) in 1988 it has become clear that these agents significantly improve the diagnostic efficacy of MRI. Studies on single agents have shown that, in comparison to unenhanced sequences, all agents help to improve the detection and delineation of lesions which can alter diagnosis in up to 40% of patients. Doubling or tripling the standard dose of 0.1 mmol/kg body weight may be beneficial for selected indications (e.g. brain perfusion, equivocal single dose study in MRI for brain metastasis, small vessel MR angiography). A more limited number of studies have compared the various agents. These studies do not show clinically significant differences in diagnostic efficacy between the various extracellular Gd-CA. Agents with higher concentration or protein binding may be relatively better suitable for selected applications (e.g. perfusion MRI). The higher relaxivity agents may be used in somewhat lower doses than the extracellular agents.

Extracellular gadolinium-based contrast media: Differences in diagnostic efficacy

International Nuclear Information System (INIS)

Molen, Aart J. van der; Bellin, Marie-France

2008-01-01

Since the introduction of the first gadolinium-based contrast agent (Gd-CA) in 1988 it has become clear that these agents significantly improve the diagnostic efficacy of MRI. Studies on single agents have shown that, in comparison to unenhanced sequences, all agents help to improve the detection and delineation of lesions which can alter diagnosis in up to 40% of patients. Doubling or tripling the standard dose of 0.1 mmol/kg body weight may be beneficial for selected indications (e.g. brain perfusion, equivocal single dose study in MRI for brain metastasis, small vessel MR angiography). A more limited number of studies have compared the various agents. These studies do not show clinically significant differences in diagnostic efficacy between the various extracellular Gd-CA. Agents with higher concentration or protein binding may be relatively better suitable for selected applications (e.g. perfusion MRI). The higher relaxivity agents may be used in somewhat lower doses than the extracellular agents

Clinical efficacy of raltegravir against B and non-B subtype HIV-1 in phase III clinical studies.

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Rockstroh, Jürgen K; Teppler, Hedy; Zhao, Jing; Sklar, Peter; Miller, Michael D; Harvey, Charlotte M; Strohmaier, Kim M; Leavitt, Randi Y; Nguyen, Bach-Yen T

2011-07-17

We evaluated the long-term efficacy of raltegravir according to HIV-1 subtype (B and non-B) using data from three phase III studies in treatment-experienced (BENCHMRK-1 and 2) and treatment-naive (STARTMRK) HIV-infected patients. HIV-1 subtypes were identified from baseline plasma specimens using genotypic data of the PhenoSense GT test (Monogram Biosciences, South San Francisco, California, USA). Non-B subtypes were combined for the current analyses due to small numbers of each specific subtype. An observed failure approach was used (only discontinuations due to lack of efficacy were treated as failures). Resistance evaluation was performed in patients with documented virologic failure. Seven hundred and forty-three patients received raltegravir and 519 received comparator (efavirenz in STARTMRK; optimized background therapy in BENCHMRK). Non-B subtype virus (A, A/C, A/D, A/G, A1, AE, AG, B/G, BF, C, D, D/F, F, F1, G, and complex) was isolated at baseline in 98 (13%) raltegravir recipients and 62 (12%) comparator recipients. Subtypes AE and C were most common, isolated in 41 and 43 patients, respectively. The proportion of raltegravir recipients achieving HIV RNA less than 50 copies/ml was similar between non-B and B subtypes (STARTMRK: 94.5 vs. 88.7%; BENCHMRK-1 and 2: 66.7 vs. 60.7%); change in CD4 cell count also was similar between non-B and B subtypes (STARTMRK: 243 vs. 221 cells/μl; BENCHMRK-1 and 2: 121 vs. 144 cells/μl). Phenotypic resistance to raltegravir in non-B virus was associated with integrase mutations observed previously in subtype B virus. In phase III studies in treatment-naive and treatment-experienced patients, raltegravir showed comparable and potent clinical efficacy against B and non-B HIV-1 subtypes.

Comparative investigation on the efficacy of tulathromycin and florfenicol in the treatment of bronchopneumonia in feedlot calves

Directory of Open Access Journals (Sweden)

Jezdimirović Milanka

2011-01-01

Full Text Available The clinical efficacy of tulathromycin (TU and florfenicol (FL in the treatment of bronchopneumonia (BP caused by Pasteurella multocida which was isolated from nose swabs of diseased calves has been examined. The symptoms of bronchopneumonia (BP were quantified by means of the clinical score (CS with a maximum of 47 points. In the current investigation the average CS in diseased calves was 23.5± 0.15. The clinical efficacy of TU and FL was assessed every day in the first week after the administration of the drugs and was based on the decrease in CS and on microbiological findings on days 7, 28 and 35 after the completion of therapy. Tulathromycin was administered s.c., in the prescribed therapeutic dose (2.5 mg/kg BW, and florfenicol s.c., twice at a 48 h interval, in its respective therapeutic dose (40 mg/kg BW. In spite of the repeated administration of FL, TU was significantly more rapid to decrease the major clinical symptoms in the first four days following the application, in comparison with FL (P<0.05. On the fourth day after the administration, the clinical efficacy of TU in the therapy of BP in calves was 43.4±1.5 %, and of florfenicol 27.2±1.6 %. However, five days after the application of TU and two days after the repeated application of FL the assessed clinical efficacy of the two antibiotics was roughly the same. The average efficacy of TU was 57.1±0.0%, and of florfenicol 58.5±0.0%, both the individual and mean CS in the treated calves was 10 points, due to hyperthermia, which remained the only symptom. Six days after the administration of TU and three days after the repeated application of FL both antibiotics had equal maximum efficacy (100% in the treatment of BP. The clinical efficacy remained unchanged on day seven. The recovery was confirmed by the absence of P. multocida in nose swabs sampled on the seventh day after the initial treatment. However, in 4 calves (21.05 % of the 19 treated Streptococcus alpha haemolyticus

Improved Clinical Efficacy with Wound Support Network Between Hospital and Home Care Service.

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Bergersen, Tone Kristin; Storheim, Elisabeth; Gundersen, Stina; Kleven, Linn; Johnson, Maria; Sandvik, Leiv; Kvaerner, Kari Jorunn; Ørjasæter, Nils-Otto

2016-11-01

The aim of this study was to test the efficacy of a wound support network model between the primary home care service and the hospital. The impact on wound healing rate, cost benefit, and transfer of knowledge was investigated. The intervention group was exposed to a wound support network (n = 32), and the control group continued standard organization of treatment (n = 21). Nonrandomized controlled study; observations were made before (baseline) and after the implementation of the intervention (12 weeks). Patients with chronic wounds (lasting >6 weeks and with wound area >1 cm) in Oslo, Norway. Closure of the observation wound; wound size; total number of wounds; presence of eczema, edema, and pain; number of dressings per week; time spent per dressing; and number of control appointments at the hospital. The economic impact is calculated for the hospital and for the community of Oslo, Norway. The number of control appointments (t = 3.80, P home care service and the hospital is cost-effective, improves clinical efficacy of the home care services' work, and reduces the need for consultations at the hospital.

Effect of clinical response to active drugs and placebo on antipsychotics and mood stabilizers relative efficacy for bipolar depression and mania: A meta-regression analysis.

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Bartoli, Francesco; Clerici, Massimo; Di Brita, Carmen; Riboldi, Ilaria; Crocamo, Cristina; Carrà, Giuseppe

2018-04-01

Randomised placebo-controlled trials investigating treatments for bipolar disorder have been hampered by wide variations of active drugs and placebo clinical response rates. It is important to estimate whether the active drug or placebo response has a greater influence in determining the relative efficacy of drugs for psychosis (antipsychotics) and relapse prevention (mood stabilisers) for bipolar depression and mania. We identified 53 randomised, placebo-controlled trials assessing antipsychotic or mood stabiliser monotherapy ('active drugs') for bipolar depression or mania. We carried out random-effects meta-regressions, estimating the influence of active drugs and placebo response rates on treatment relative efficacy. Meta-regressions showed that treatment relative efficacy for bipolar mania was influenced by the magnitude of clinical response to active drugs ( p=0.002), but not to placebo ( p=0.60). On the other hand, treatment relative efficacy for bipolar depression was influenced by response to placebo ( p=0.047), but not to active drugs ( p=0.98). Despite several limitations, our unexpected findings showed that antipsychotics / mood stabilisers relative efficacy for bipolar depression seems unrelated to active drugs response rates, depending only on clinical response to placebo. Future research should explore strategies to reduce placebo-related issues in randomised, placebo-controlled trials for bipolar depression.

Antibiotic therapy versus appendicectomy in uncomplicated acute appendicitis in terms of efficacy

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Zaidi, M.A.; Nazeer, T.B.; Aziz, O.B.A.; Asad, T.; Dar, Z.S.

2017-01-01

Objective: To compare antibiotic therapy and appendectomy in uncomplicated acute appendicitis in terms of efficacy. Study Design: Randomized controlled trial. Place and Duration of Study: Surgical Ward Forward Treatment Centre (FTC), 5 Mountain Medical Battalion Forward Kahuta Azad Jammu Kashmir (AJK), from Oct 2011 to Mar 2013. Material and Methods: A total of 103 patients with clinical diagnosis of acute appendicitis (AA) were admitted during the duration of study and divided into two groups by consecutive sampling. The antibiotic group consisted of 51 patients who received intravenous antibiotics for 48 hours and oral antibiotics for another 8 days. The appendectomy group comprised of 52 patients who all underwent standard appendectomy. All the patients were followed up at 1 month and 1 year for assessing efficacy and post treatment complications. Results: The efficacy of antibiotic treatment is 90.625 percent as compared to appendectomy which was 88.46 percent (p=0.759) at 1 month follow up after treatment. At one year post treatment, the comparison between the efficacy of antibiotic therapy (71.87 percent) and appendectomy (87.14 percent) remains statistically insignificant (p=0.055). Conclusion: Antibiotic therapy is comparable to appendectomy in AA in terms of efficacy at 1 month and 1 year post treatment. (author)

A Pilot Clinical Trial to Objectively Assess the Efficacy of Electroacupuncture on Gait in Patients with Parkinson's Disease Using Body Worn Sensors.

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Hong Lei

Full Text Available Gait disorder, a key contributor to fall and poor quality of life, represents a major therapeutic challenge in Parkinson's disease (PD. The efficacy of acupuncture for PD remains unclear, largely due to methodological flaws and lack of studies using objective outcome measures.To objectively assess the efficacy of electroacupuncture (EA for gait disorders using body-worn sensor technology in patients with PD.In this randomized pilot study, both the patients and assessors were masked. Fifteen PD patients were randomly assigned to an experimental group (n = 10 or to a control group (n = 5. Outcomes were assessed at baseline and after completion of three weekly EA treatments. Measurements included gait analysis during single-task habitual walking (STHW, dual-task habitual walking (DTHW, single-task fast walking (STFW, dual-task fast walking (DTFW. In addition, Unified Parkinson's Disease Rating Scale (UPDRS, SF-12 health survey, short Falls Efficacy Scale-International (FES-I, and visual analog scale (VAS for pain were utilized.All gait parameters were improved in the experimental group in response to EA treatment. After adjustment by age and BMI, the improvement achieved statistical significant level for gait speed under STHW, STFW, and DTFW (9%-19%, p0.110. The highest correlation between gait parameters and UPRDS scores at baseline was observed between gait speed during STFW and UPDRS II (r = -0.888, p = 0.004. The change in this gait parameter in response to active intervention was positively correlated with baseline UPDRS (r = 0.595, p = 0.057. Finally, comparison of responses to treatment between groups showed significant improvement, prominently in gait speed (effect size 0.32-1.16, p = 0.001.This study provides the objective proof of concept for potential benefits of non-pharmaceutical based EA therapy on enhancing gait in patients with PD.ClinicalTrials.gov NCT02556164.

Vaginal Use of Ibuprofen Isobutanolammonium (Ginenorm): Efficacy, Tolerability, and Pharmacokinetic Data: A Review of Available Data

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Milani, Massimo; Iacobelli, Piero

2012-01-01

Vaginal infection and inflammation with or without vulvar involvement are very common gynecologicaly clinical conditions associated with morbidity and reduced quality of life. Vaginal infections are commonly treated with causal antimicrobial treatments. In addition to specific antimicrobial treatment, anti-inflammatory therapy, both systemic or topical (vaginal douche), could be useful in the integrated treatment approach of these conditions reducing symptoms and speeding up the recovery in vulvovaginitis. Ibuprofen is a well-known effective and well-tolerated anti-COX (anti-COX1 and COX2) compound. In addition, several in vitro studies suggest that Ibuprofen shares antimicrobial and antifungal activities. Ibuprofen isobutanolammonium (Ib-isb) (Ginenorm) is a soluble salt from formulation suitable for external and intravaginal use. This salt completely dissociates in aqueous solution. Ib-isob is available in sachet and vaginal douche pharmaceutical formulations. Clinical efficacy of Ib-isob has been documented in 10 clinical studies (6 controlled and 4 open trials) which have enrolled in total 399 women with vulvovaginitis. The six controlled clinical trials were performed both versus placebo (2 studies) or versus active comparators such as benzydamine. In these studied, Ib-Isb has been used in general for 7 consecutive days with a twice application daily regimen at the dose of 1 g per application. Topical application of Ib-isob induced a marked and rapid reduction in signs (erythema, oedema) and symptoms (itching and burning sensation) of vulvovaginitis. In head-to-head studies carried out in comparison with other topical products, Ib-isob induced a more rapid reduction in both subjective and objective symptoms. In particular a remarkable significant improvement of all the symptoms has been observed in the group of patients treated with Ib-isob in comparison with women receiving benzydamine. The clinical data available for Ib-isob confirm that this salt

Efficacy of botulinum toxins on bruxism: an evidence-based review.

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Long, Hu; Liao, Zhengyu; Wang, Yan; Liao, Lina; Lai, Wenli

2012-02-01

The objective of this study was to assess the efficacy of botulinum toxins on bruxism. Electronic databases (PubMed, Embase and Science Citation Index), websites (Cochrane Central Register of Controlled Trials and ClinicalTrials.gov) and the literature database of SIGLE (System for Information on Grey Literature in Europe) were searched from January 1990 to April 2011 for randomised controlled trials or nonrandomised studies assessing the efficacy of botulinum toxins on bruxism. There was no language restriction. Through a predefined search strategy, we retrieved 28 studies from PubMed, 94 from Embase, 60 from the Science Citation Index, two ongoing clinical trials and two from the Cochrane Central Register of Controlled Trials. Of these, only four studies met our inclusion criteria and were finally included. Of the four included studies, two were randomised controlled trials and two were controlled before-and-after studies. These studies showed that botulinum toxin injections can reduce the frequency of bruxism events, decrease bruxism-induced pain levels and satisfy patients' self-assessment with regard to the effectiveness of botulinum toxins on bruxism. In comparison with oral splint, botulinum toxins are equally effective on bruxism. Furthermore, botulinum toxin injections at a dosage of bruxism and are safe to use. Therefore, they can be used clinically for otherwise healthy patients with bruxism. © 2012 FDI World Dental Federation.

The Recombinant Bacille Calmette–Guérin Vaccine VPM1002: Ready for Clinical Efficacy Testing

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Natalie E. Nieuwenhuizen

2017-09-01

Full Text Available The only licensed vaccine against tuberculosis (TB, bacille Calmette–Guérin (BCG, protects against severe extrapulmonary forms of TB but is virtually ineffective against the most prevalent form of the disease, pulmonary TB. BCG was genetically modified at the Max Planck Institute for Infection Biology to improve its immunogenicity by replacing the urease C encoding gene with the listeriolysin encoding gene from Listeria monocytogenes. Listeriolysin perturbates the phagosomal membrane at acidic pH. Urease C is involved in neutralization of the phagosome harboring BCG. Its depletion allows for rapid phagosome acidification and promotes phagolysosome fusion. As a result, BCGΔureC::hly (VPM1002 promotes apoptosis and autophagy and facilitates release of mycobacterial antigens into the cytosol. In preclinical studies, VPM1002 has been far more efficacious and safer than BCG. The vaccine was licensed to Vakzine Projekt Management and later sublicensed to the Serum Institute of India Pvt. Ltd., the largest vaccine producer in the world. The vaccine has passed phase I clinical trials in Germany and South Africa, demonstrating its safety and immunogenicity in young adults. It was also successfully tested in a phase IIa randomized clinical trial in healthy South African newborns and is currently undergoing a phase IIb study in HIV exposed and unexposed newborns. A phase II/III clinical trial will commence in India in 2017 to assess efficacy against recurrence of TB. The target indications for VPM1002 are newborn immunization to prevent TB as well as post-exposure immunization in adults to prevent TB recurrence. In addition, a Phase I trial in non-muscle invasive bladder cancer patients has been completed, and phase II trials are ongoing. This review describes the development of VPM1002 from the drawing board to its clinical assessment.

The efficacy of Isotretinoin-loaded solid lipid nanoparticles in comparison to Isotrex® on acne treatment

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Shiva Golmohammadzadeh

2013-01-01

Full Text Available Abstract: Topical retinoids are considered as the first line therapy in the treatment of acne vulgaris, but they are associated with cutaneous irritation. In this study, isotretinoin-loaded solid lipid nanoparticles(IT-SLN were prepared to treat the mild to moderate acne. Also using IT-SLN would minimize IT adverse effects in comparison to commercial product, Isotrex®. This study was conducted to prepare and characterize IT-SLN and assessing the efficiency of IT-SLN comparing to Isotrex® acne. IT-SLN was prepared using hot high pressure homogenization method.  IT-SLN contained 0.05% IT in 5% of lipid phase (Glyceryl monostearate- GMS and tween 80 (2.5 % w/v was used as surfactant in the aqueous phase. IT-SLN was characterized by particle size analyzing, differential scanning calorimetry and transmission electron microscopy. Encapsulation efficacy was also obtained using spectrophotometry. The efficacy of IT-SLN was evaluated in a randomized, single-blind, parallel-group study and compared with Isotrex®. Forty patients encountered in the study and divided in two groups. Treatment regimen was once-nightly topical administration accompanied with topical administration of clindamycin 2% solution twice a day for 8 weeks. The particle size of IT-SLN was around 60 nm with PDI of 0.4 and zeta potential was about -40 mV. Encapsulation efficacy of IT in SLN in crystalline form was 84±0.21%. IT-SLN produced significantly better treatment than Isotrex® in both non-inflammatory and inflammatory lesions according to its recovery percent after 8 weeks. Also IT-SLN gained better global assessment scores. Our results showed that IT-SLN had higher efficacy than Isotrex® to clear non-inflammatory and inflammatory lesions.

Clinical efficacy of levofloxacin 500 mg once daily for 7 days for patients with non-gonococcal urethritis.

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Takahashi, Satoshi; Ichihara, Kohji; Hashimoto, Jiro; Kurimura, Yuichiro; Iwasawa, Akihiko; Hayashi, Kenji; Sunaoshi, Kenichi; Takeda, Koichi; Suzuki, Nobukazu; Satoh, Takashi; Tsukamoto, Taiji

2011-06-01

To confirm the efficacy of the treatment regimen with oral levofloxacin (LVFX) 500 mg once daily for 7 days for patients with non-gonococcal urethritis (NGU), we evaluated the microbiological and clinical outcomes of the regimen in those patients. We finally evaluated 53 patients with symptomatic NGU and 5 patients with asymptomatic NGU. As a result of microbiological examinations, 19 of the symptomatic patients were diagnosed as having non-gonococcal chlamydial urethritis (NGCU); 13 had non-gonococcal non-chlamydial urethritis (NGNCU), and 21 had urethritis without any microbial detection. Five of the asymptomatic patients were diagnosed as having NGCU. Microbiological cure was achieved in 91% of the 32 patients with symptomatic NGU and in 80% of the 5 patients with asymptomatic NGCU. Clinical cure was obtained in 92% of the 53 patients with symptomatic NGU. The microbiological eradication rate for Chlamydia trachomatis was 92% in 24 patients. As for other organisms, the microbiological eradication rate for Mycoplasma genitalium was 60% in 5 patients and that for Ureaplasma urealyticum was 100% in 10. The microbiological and clinical efficacy of oral LVFX 500 mg once daily for 7 days for the patients with NGU was the same for the azithromycin (AZM) 1,000 mg single dose that we previously reported. The eradication rates of C. trachomatis and U. urealyticum in the treatment regimen with LVFX 500 mg were high enough in the clinical setting; however, for M. genitalium, the rate was relatively inferior to that with AZM.

[Clinical efficacy of preferred use of high-frequency oscillatory ventilation in treatment of neonatal pulmonary hemorrhage].

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Wang, Hua; Du, Li-Zhong; Tang, Jun; Wu, Jin-Lin; Mu, De-Zhi

2015-03-01

To investigate the clinical efficacy and safety of preferred use of high-frequency oscillatory ventilation (HFOV) in the treatment of neonatal pulmonary hemorrhage. The clinical efficacy of preferred use of HFOV (preferred use group) and rescue use of HFOV after conventional mechanical ventilation proved ineffective (rescue use group) in the treatment of 26 cases of neonatal pulmonary hemorrhage was retrospectively analyzed. The oxygenation index (OI), pulmonary hemorrhage time, hospitalization time, ventilation time, oxygen therapy time, complications, and outcome of the two groups were compared. Compared with the rescue use group, the preferred use group had significantly lower IO values at 1, 6, 12, 24, 48, and 72 hours after treatment (Phemorrhage, and digestive tract hemorrhage between the two groups (P>0.05). Compared with those in the rescue use group, children who survived in the preferred use group had significantly shorter pulmonary hemorrhage time, hospitalization time, ventilation time, and oxygen therapy time (P<0.05). Compared with the rescue use of HFOV, preferred use of HFOV can better improve oxygenation function, reduce the incidence of VAP, shorten the course of disease, and increase cure rate while not increasing the incidence of adverse effects.

Treg depletion inhibits efficacy of cancer immunotherapy: implications for clinical trials.

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James F Curtin

2008-04-01

Full Text Available Regulatory T lymphocytes (Treg infiltrate human glioblastoma (GBM; are involved in tumor progression and correlate with tumor grade. Transient elimination of Tregs using CD25 depleting antibodies (PC61 has been found to mediate GBM regression in preclinical models of brain tumors. Clinical trials that combine Treg depletion with tumor vaccination are underway to determine whether transient Treg depletion can enhance anti-tumor immune responses and improve long term survival in cancer patients.Using a syngeneic intracrabial glioblastoma (GBM mouse model we show that systemic depletion of Tregs 15 days after tumor implantation using PC61 resulted in a decrease in Tregs present in tumors, draining lymph nodes and spleen and improved long-term survival (50% of mice survived >150 days. No improvement in survival was observed when Tregs were depleted 24 days after tumor implantation, suggesting that tumor burden is an important factor for determining efficacy of Treg depletion in clinical trials. In a T cell dependent model of brain tumor regression elicited by intratumoral delivery of adenoviral vectors (Ad expressing Fms-like Tyrosine Kinase 3 ligand (Flt3L and Herpes Simplex Type 1-Thymidine Kinase (TK with ganciclovir (GCV, we demonstrate that administration of PC61 24 days after tumor implantation (7 days after treatment inhibited T cell dependent tumor regression and long term survival. Further, depletion with PC61 completely inhibited clonal expansion of tumor antigen-specific T lymphocytes in response to the treatment.Our data demonstrate for the first time, that although Treg depletion inhibits the progression/eliminates GBM tumors, its efficacy is dependent on tumor burden. We conclude that this approach will be useful in a setting of minimal residual disease. Further, we also demonstrate that Treg depletion, using PC61 in combination with immunotherapy, inhibits clonal expansion of tumor antigen-specific T cells, suggesting that new, more

The Cynomolgus Macaque Natural History Model of Pneumonic Tularemia for Predicting Clinical Efficacy Under the Animal Rule

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Guina, Tina; Lanning, Lynda L.; Omland, Kristian S.; Williams, Mark S.; Wolfraim, Larry A.; Heyse, Stephen P.; Houchens, Christopher R.; Sanz, Patrick; Hewitt, Judith A.

2018-01-01

Francisella tularensis is a highly infectious Gram-negative bacterium that is the etiologic agent of tularemia in animals and humans and a Tier 1 select agent. The natural incidence of pneumonic tularemia worldwide is very low; therefore, it is not feasible to conduct clinical efficacy testing of tularemia medical countermeasures (MCM) in human populations. Development and licensure of tularemia therapeutics and vaccines need to occur under the Food and Drug Administration's (FDA's) Animal Rule under which efficacy studies are conducted in well-characterized animal models that reflect the pathophysiology of human disease. The Tularemia Animal Model Qualification (AMQ) Working Group is seeking qualification of the cynomolgus macaque (Macaca fascicularis) model of pneumonic tularemia under Drug Development Tools Qualification Programs with the FDA based upon the results of studies described in this manuscript. Analysis of data on survival, average time to death, average time to fever onset, average interval between fever and death, and bacteremia; together with summaries of clinical signs, necropsy findings, and histopathology from the animals exposed to aerosolized F. tularensis Schu S4 in five natural history studies and one antibiotic efficacy study form the basis for the proposed cynomolgus macaque model. Results support the conclusion that signs of pneumonic tularemia in cynomolgus macaques exposed to 300–3,000 colony forming units (cfu) aerosolized F. tularensis Schu S4, under the conditions described herein, and human pneumonic tularemia cases are highly similar. Animal age, weight, and sex of animals challenged with 300–3,000 cfu Schu S4 did not impact fever onset in studies described herein. This study summarizes critical parameters and endpoints of a well-characterized cynomolgus macaque model of pneumonic tularemia and demonstrates this model is appropriate for qualification, and for testing efficacy of tularemia therapeutics under Animal Rule. PMID

Day treatment versus enhanced standard methadone services for opioid-dependent patients: a comparison of clinical efficacy and cost.

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Avants, S K; Margolin, A; Sindelar, J L; Rounsaville, B J; Schottenfeld, R; Stine, S; Cooney, N L; Rosenheck, R A; Li, S H; Kosten, T R

1999-01-01

This study examined the differential efficacy and relative costs of two intensities of adjunctive psychosocial services--a day treatment program and enhanced standard care--for the treatment of opioid-dependent patients maintained on methadone hydrochloride. A 12-week randomized clinical trial with 6-month follow-up was conducted in a community-based methadone maintenance program. Of the 308 patients who met inclusion criteria, 291 began treatment (day treatment program: N=145; enhanced standard care: N=146), and 237 completed treatment (82% of those assigned to the day treatment program and 81% of those receiving enhanced standard care). Two hundred twenty of the patients participated in the 6-month follow-up (75% of those in the day treatment program and 73% of those in enhanced standard care provided a follow-up urine sample for screening). Both interventions were 12 weeks in duration, manual-guided, and provided by master's-level clinicians. The day treatment was an intensive, 25-hour-per-week program. The enhanced standard care was standard methadone maintenance plus a weekly skills training group and referral to on- and off-site services. Outcome measures included twice weekly urine toxicology screens, severity of addiction-related problems, prevalence of HIV risk behaviors, and program costs. Although the cost of the day treatment program was significantly higher, there was no significant difference in the two groups' use of either opiates or cocaine. Over the course of treatment, drug use, drug-related problems, and HIV risk behaviors decreased significantly for patients assigned to both treatment intensities. Improvements were maintained at follow-up. Providing an intensive day treatment program to unemployed, inner-city methadone patients was not cost-effective relative to a program of enhanced methadone maintenance services, which produced comparable outcomes at less than half the cost.

A report on the clinical efficacy of a new Bougie-internal urethrectomy.

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Hyn, Choe Sung; Jong, Kim Han; Chol, Choe Un

2015-01-01

We compare the clinical efficacy of the new bougie-internal urethrectomy (BIU) with internal urethrotomy and urethroplasty to treat urethral stricture disease. We prospectively studied 186 people with urethral stricture disease. Of these, 84 were identified for urethroplasty and 102 for internal urethrotomy (endoscopic urethrotomy). Among the 84 identified for urethroplasty, 52 received BIU (Group 1) and the remaining 32 received urethroplasty. Among the 102 identified for internal urethrotomy, 58 received BIU (Group 2) and the remaining 44 received the internal urethrotomy. After surgery, we evaluated the clinical efficacy of the BIU (operative invasions, voiding flow rates, complications, sequelae) compared with the endoscopic treatment and urethroplasty. Patient age ranged from 20 to 70 years. The follow-up period was 2 years. In the BIU Group 1, the BIU Group 2, and the internal urethrotomy (endoscopic treatment), the length of strictures were 2.9 ± 1.5, 2.8 ± 1.3, 1.6 ± 0.7, and 1.5 ± 0.6, respectively. In the BIU Group 1, the urethroplasty, the BIU Group 2, and the internal urethrotomy (endoscopic treatment), the amount of bleeding was 34.1 ± 17.1, 172.2 ± 29.8, 28.5 ± 9.8, and 49.7 ± 13.6 mL, respectively. In the BIU Group 1, the urethroplasty, the BIU Group 2, and the internal urethrotomy, the recurrence rates were 5.8%, 86%, 6.8% and 25%, and the average flow rates were 18.1 ± 4.8, 13.1 ± 3.9, 18.2 ± 3.6, 10.1 ± 3.1 mL/s, respectively. There was no sequealae (sexual dysfunction, penile change) in both BIU groups. The new BIU could be considered first-line treatment in all patients with indications for visual internal urethrotomy and urethroplasty.

Efficacy of an Ice Popsicle on Thirst Management in the Immediate Postoperative Period: A Randomized Clinical Trial.

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Conchon, Marilia Ferrari; Fonseca, Ligia Fahl

2018-04-01

Perioperative thirst is an intense discomfort with high incidence in the immediate postoperative period, but nonetheless, it is highly neglected in clinical practice. The purpose of this study was to evaluate the efficacy of an ice popsicle compared with water at room temperature for thirst relief in the immediate postoperative period in terms of variation in the intensity of the initial compared with the final thirst and the satiety reached after an hour of evaluation and intervention. A parallel randomized clinical trial was used. A total of 208 patients in the immediate postoperative period were assessed for 1 hour, every 15 minutes. Thirst intensity was assessed initially and subsequently; interventions were performed according to the group: (1) control group, 10 mL of water at room temperature; and (2) experimental group, 10-mL ice popsicle. The ice popsicle was 37.8% (P popsicle has greater efficacy than water at room temperature for thirst management in the immediate postoperative period. Copyright © 2016 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.

The Efficacy of Iopamidol (Pamiray 370) in Aortic and Extremity CT Angiography

International Nuclear Information System (INIS)

Lee, Yoo Jin; Lee, Jong Min; Lee, Hui Joong; Park, Ji Won

2010-01-01

To evaluate the clinical safety and radiological feasibility of a domestic iopamidol-based contrast media (Pamiray 370) during an aortic and extremity CT angiography. Between August and December of 2008, 100 patients (M:F=51:49; mean age, 59 years) underwent an aortic and extremity CT angiography using Pamiray 370 based with informed consent. All changes in vital signs, clinical symptoms, and adverse reactions to the contrast media were monitored. Two radiologists assessed the image quality of the CT angiography. A statistical comparison was conducted using an independent t-test and a Mann-Whitney test based on the 100-patient group studied using Optiray 350. The contrast enhancement of the descending aorta in the arterial phase showed a statistically greater efficacy (p<0.001) of Pamiray 370 compared to Optiray 350, which was the routine contrast media for CT angiography for our institute. Adverse reaction signs were evident in 3%(3/100) of the subjects. All of them showed mild and transient reactions such as vomiting (n=2) and coughing (n=1), with no medical treatment required. Contrast media related symptoms including dizziness (n=7), nausea (n=3), headaches (n=2), and injection site pain (n=1), were noted in 12%(12/100). The clinical efficacy of Pamiray 370 was acceptable for the aortic and extremity CT angiography, in terms of clinical safety, tolerance, and image quality

Sensitivity Analysis of Per-Protocol Time-to-Event Treatment Efficacy in Randomized Clinical Trials

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Gilbert, Peter B.; Shepherd, Bryan E.; Hudgens, Michael G.

2013-01-01

Summary Assessing per-protocol treatment effcacy on a time-to-event endpoint is a common objective of randomized clinical trials. The typical analysis uses the same method employed for the intention-to-treat analysis (e.g., standard survival analysis) applied to the subgroup meeting protocol adherence criteria. However, due to potential post-randomization selection bias, this analysis may mislead about treatment efficacy. Moreover, while there is extensive literature on methods for assessing causal treatment effects in compliers, these methods do not apply to a common class of trials where a) the primary objective compares survival curves, b) it is inconceivable to assign participants to be adherent and event-free before adherence is measured, and c) the exclusion restriction assumption fails to hold. HIV vaccine efficacy trials including the recent RV144 trial exemplify this class, because many primary endpoints (e.g., HIV infections) occur before adherence is measured, and nonadherent subjects who receive some of the planned immunizations may be partially protected. Therefore, we develop methods for assessing per-protocol treatment efficacy for this problem class, considering three causal estimands of interest. Because these estimands are not identifiable from the observable data, we develop nonparametric bounds and semiparametric sensitivity analysis methods that yield estimated ignorance and uncertainty intervals. The methods are applied to RV144. PMID:24187408

Using translational medicine to understand clinical differences between botulinum toxin formulations.

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Aoki, K R; Ranoux, D; Wissel, J

2006-12-01

When using botulinum toxin-based products, the physician must decide the optimal location and dose required to alleviate symptoms and improve the patient's quality of life. To deliver effective treatment, the physician needs to understand the importance of accurate target muscle selection and localization and the implications of each product's migration properties when diluted in different volumes. Pre-clinical mouse models of efficacy and safety have been utilized to compare local and distal muscle relaxation effects following defined intramuscular administration. Data from the model allow the products to be ranked based on their propensity for local efficacy versus their distal migration properties. Using standardized dilutions, the non-parallel dose-response curves for the various formulations demonstrate that they have different efficacy profiles. Distal effects were also noted at different treatment doses, which are reflected in the different safety and/or therapeutic margins. Based on these pre-clinical data, the safety and therapeutic margin rankings are ordered, largest to smallest, as BOTOX, Dysport and Myobloc. The results of subsequent clinical trials are variable and dose comparisons are inconclusive, thus supporting the regulatory position that the dose units of the individual preparations are unique and cannot be simply converted between products.

Using simulation pedagogy to teach clinical education skills: A randomized trial.

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Holdsworth, Clare; Skinner, Elizabeth H; Delany, Clare M

2016-05-01

Supervision of students is a key role of senior physiotherapy clinicians in teaching hospitals. The objective of this study was to test the effect of simulated learning environments (SLE) on educators' self-efficacy in student supervision skills. A pilot prospective randomized controlled trial with concealed allocation was conducted. Clinical educators were randomized to intervention (SLE) or control groups. SLE participants completed two 3-hour workshops, which included simulated clinical teaching scenarios, and facilitated debrief. Standard Education (StEd) participants completed two online learning modules. Change in educator clinical supervision self-efficacy (SE) and student perceptions of supervisor skill were calculated. Between-group comparisons of SE change scores were analyzed with independent t-tests to account for potential baseline differences in education experience. Eighteen educators (n = 18) were recruited (SLE [n = 10], StEd [n = 8]). Significant improvements in SE change scores were seen in SLE participants compared to control participants in three domains of self-efficacy: (1) talking to students about supervision and learning styles (p = 0.01); (2) adapting teaching styles for students' individual needs (p = 0.02); and (3) identifying strategies for future practice while supervising students (p = 0.02). This is the first study investigating SLE for teaching skills of clinical education. SLE improved educators' self-efficacy in three domains of clinical education. Sample size limited the interpretation of student ratings of educator supervision skills. Future studies using SLE would benefit from future large multicenter trials evaluating its effect on educators' teaching skills, student learning outcomes, and subsequent effects on patient care and health outcomes.

A Comparison of two measures of quality of life of Nigerian clinic ...

African Journals Online (AJOL)

A Comparison of two measures of quality of life of Nigerian clinic patients with ... well-being questionnaire and the WHOQOL-BREF, a generic instrument. ... not influenced by characteristics such as age, gender, marital or educational status.

Clinical Efficacy and Residue Depletion of 10% Enrofloxacin Enteric-Coated Granules in Pigs

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Zhixin Lei

2017-05-01

Full Text Available A new, more palatable formulation of 10% enrofloxacin enteric-coated granules was investigated to evaluate the pharmacokinetic effect in plasma, the residue elimination in tissues and the clinical efficacy against Actinobacillus pleuropneumonia (APP and Mycoplasam suis (MS in pigs. In this study, the enrofloxacin concentrations in plasma and tissues were detected using high-performance liquid chromatography with phosphate buffer (pH = 3 and acetonitrile. The pharmacokinetics and elimination of enrofloxacin enteric-coated granules were performed after oral administration at a single dose of 10 mg/kg body weight (bw and 5 mg/kg twice per day for 5 consecutive days, respectively. The in vivo antibacterial efficacy and clinical effectiveness of enrofloxacin enteric-coated granules against APP and MS were assayed at 2.5, 5, 10 mg/kg, compared with tiamulin (8 mg/kg based on establishment of APP and MS infection models. 56 APP strains were selected and tested for in vitro antibacterial activity of enrofloxacin enteric-coated granules. The main parameters of elimination half-life (t1/2β, Tmax, and area under the curve (AUC were 14.99 ± 4.19, 3.99 ± 0.10, and 38.93 ± 1.52 μg h/ml, respectively, revealing that the enrofloxacin concentration remained high and with a sustainable distribution in plasma. Moreover, the analysis on the evaluation of enrofloxacin and ciprofloxacin in muscle, fat, liver and kidney showed that the recovery were more than 84% recovery in accordance with the veterinary drug residue guidelines of United States pharmacopeia, and the withdrawal periods were 4.28, 3.81, 4.84, and 3.51 days, respectively, suggesting that the withdrawal period was 5 d after oral administration of 5 mg/kg twice per day. The optimal dosage of enrofloxacin enteric-coated granules against APP and MS was 5 mg/kg, with over 90% efficacy, which was significantly different (p < 0.05 to the 2.5 mg/kg group, but not to the 10 mg/kg group or the positive

Clinical efficacy of pranoprofen and sodium hyaluronate for dry eye

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Hong-Chao Hou

2016-01-01

Full Text Available AIM:To observe the clinical efficacy of pranoprofen and sodium hyaluronate for dry eye, and to provide the reference for clinical treatment of dry eye. METHODS: From January 2012 to January 2015 inour hospital, 106 patients with dry eye were tested and observed. In accordance with the number table, patients were divided into observation group and control group, 53 patients in the control group using conventional treatment plus single sodium hyaluronate eye drops, observation group using pranoprofen combined sodium hyaluronate eye drops, besides conventional treatment. Clinical outcomes between the two groups before and after treatments, dry eye score, fluorescein staining score, Schirmer I test and tear film break up time(BUTwere observed and analyzed. RESULTS:The effective rates of the two groups were 94.3%(50/53and 84.9%(45/53. Dry eye score of observation group before and after treatment were 3.24±0.52 and 0.32±0.06points, those of the control group were 3.26±0.48 and 0.75±0.24points. BUT of the experimental group before and after treatments were 5.67±3.052 and 12.95±2.865s, those of the control group were 6.23±2.985 and 9.85±2.714s.The differences between the two groups on the indicators above were statistically significant(PCONCLUSION: The combination of pranoprofen and sodium hyaluronate for the treatment of dry eye is effective, with high security and water holding capacity, which can improve the symptoms of dry eye and the patients' life quality.

Overview: clinical and physiological comparison of meditation with other self-control strategies.

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Shapiro, D H

1982-03-01

In 1977 the American Psychiatric Association called for a critical examination of the clinical effectiveness of meditation. The author provides a review of the literature bearing on clinical and physiological comparisons of meditation with other self-control strategies. He begins by providing a definition of mediation and then cites the literature comparing mediation with such self-regulation strategies as biofeedback, hypnosis, and progressive relaxation. He pays particular attention to the "uniqueness" of mediation as a clinical intervention strategy a well as the adverse effects of meditation. Finally, he offers suggestions and guidelines for future research.

Pharmacokinetics and clinical efficacy of long-term epidural ropivacaine infusion in children

DEFF Research Database (Denmark)

Hansen, Tom Giedsing; Ilett, K F; Lim, S I

2000-01-01

The clinical efficacy and pharmacokinetics of long-term epidural ropivacaine infusion were investigated in 18 postoperative children aged between 0.3 and 7.3 yr. A lumbar or thoracic epidural catheter was inserted after the anaesthetic induction. Sixty minutes following a bolus dose of ropivacaine...... 1 mg kg-1, 0.2% ropivacaine was infused at a fixed rate of 0.4 mg kg-1 h-1 for a mean of 61.3 h (range 36-96 h). Clinical evaluation comprised hourly recording of pain, sedation, motor block, nausea/vomiting, pruritus-scores, SpO2, pulse and respiratory rates, and recording of non-invasive arterial......) and free (10-56 micrograms litre-1) ropivacaine concentrations were within the range reported to be 'safe' in previous studies in adults. Mean (95% CI) volume of distribution was 3.1 litre kg-1 (2.1-4.2 litre kg-1), total clearance was 8.5 ml kg-1 min-1 (5.8-11.1 ml kg-1 min-1), free clearance was 220 ml...

A Reanalysis of Engineering Majors' Self-Efficacy Beliefs

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Concannon, James P.; Barrow, Lloyd H.

2012-01-01

This study examines differences in women's engineering self-efficacy beliefs across grade levels in comparison to men's engineering self-efficacy (ESE) beliefs across grade levels. Data for this study was collected from 746 (635 men, 111 women) engineering students enrolled in a large research extensive university. Four major conclusions resulted…

Efficacy of pentavalent antimoniate intralesional infiltration therapy for cutaneous leishmaniasis: A systematic review.

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Nayara Castelano Brito

Full Text Available The mainstays of cutaneous leishmaniasis (CL treatment, in several world regions, are pentavalent antimony (Sbv compounds administered parenterally, despite their recognized toxicity, which requires frequent laboratory monitoring and complicates their use in areas with scarce infrastructure. As result of these drawbacks, the WHO Expert Committee on leishmaniasis has expanded the recommendations for the use of local therapies, including Sbv intralesional infiltration (IL-Sbv, as CL therapy alternatives even in the New World. However, the efficacy of these approaches has never been compiled. The aim of this study was to critically and systematically assess the efficacy of IL-Sbv for CL treatment.The PRISMA guidelines for systematic reviews and the Cochrane manual were followed. The sources used were the MEDLINE and LILACS databases and the International Clinical Trials Registry Platform of the World Health Organization. The outcome of interest was a clinical cure, defined as complete re-epithelialization of all lesions. The IL-Sbv pooled cure rate was estimated for several subgroups and direct comparisons were performed when possible.Thirty nine articles (40 studies involving 5679 patients treated with IL-Sbv infiltration were included. In direct comparison, only three studies involving 229 patients compared IL-Sbv infiltration versus placebo and no difference was observed (OR: 1,9; 95%IC 0,93 to 3,82 based on cure rate 69.6% (95%CI 17.6-96.1% and 83,2% (95%CI 66-92.7% for placebo and IL-Sbv, respectively. In an alternative and non-comparative analysis, gathering all study arms using the intervention, the pooled IL-Sbv efficacy rate was 75% (95%CI 68-81%. In the Old World, the observed overall IL-Sbv efficacy rate was 75% (95%CI 66-82%, and the cure rates were significantly higher with sodium stibogluconate (SSG than with meglumine antimoniate (MA: 83% (95%CI 75-90% versus 68% (95%CI 54-79%, p = 0.03. Studies directly comparing IL-Sbv with topical

Uterine arterial embolization for uterine leiomyoma: efficacy and clinical outcome

International Nuclear Information System (INIS)

Park, Jeong Seon; Lee, Do Yon; Kim, Yong Tae; Park, Ki Hyun; Park, Yong Won; Cho, Jae Sung; Kim, Myung Jun; Won, Je Hwan; Kang, Byung Chul

1999-01-01

To determine the efficacy and clinical outcome of uterine arterial embolization as a new approach to the management of uterine leiomyomas. Uterine arterial embolization was performed in 21 patients aged 26-62(mean, 42) years. Twenty of these had menorrhagia, dysmenorrhea, and mass-related symptoms (low abdominal discomfort, backache, urinary frequency, etc.) and one was diagnosed incidentally. Bilateral uterine arteries were selected individually and polyvinyl alcohol and/or gelfoam was used as an embolic material. Nineteen patients were followed up after embolization. Seventeen (89.5 %)reported satisfactory improvement of symptoms and follow-up sonography three months later showed a 58.5 % reduction in mean myoma volume. In 17 patients (89.5 %), the menstrual cycle returned to normal. All patients experienced pain after the procedure and other complications were vaginal bleeding (26.3 %) and fever (23.8 %). Uterine arterial embolization represents a new approach to the management of uterine leiomyoma-related symptoms. Further investigations and long-term follow-up are, however, enquired

Uterine arterial embolization for uterine leiomyoma: efficacy and clinical outcome

Energy Technology Data Exchange (ETDEWEB)

Park, Jeong Seon; Lee, Do Yon; Kim, Yong Tae; Park, Ki Hyun; Park, Yong Won; Cho, Jae Sung; Kim, Myung Jun [Yonsei Univ. College of Medicine, Seoul (Korea, Republic of); Won, Je Hwan [Ajou Univ. College of Medicine, Suwon (Korea, Republic of); Kang, Byung Chul [Ewha Womans Univ. College of Medicine, Seoul (Korea, Republic of)

1999-09-01

To determine the efficacy and clinical outcome of uterine arterial embolization as a new approach to the management of uterine leiomyomas. Uterine arterial embolization was performed in 21 patients aged 26-62(mean, 42) years. Twenty of these had menorrhagia, dysmenorrhea, and mass-related symptoms (low abdominal discomfort, backache, urinary frequency, etc.) and one was diagnosed incidentally. Bilateral uterine arteries were selected individually and polyvinyl alcohol and/or gelfoam was used as an embolic material. Nineteen patients were followed up after embolization. Seventeen (89.5 %)reported satisfactory improvement of symptoms and follow-up sonography three months later showed a 58.5 % reduction in mean myoma volume. In 17 patients (89.5 %), the menstrual cycle returned to normal. All patients experienced pain after the procedure and other complications were vaginal bleeding (26.3 %) and fever (23.8 %). Uterine arterial embolization represents a new approach to the management of uterine leiomyoma-related symptoms. Further investigations and long-term follow-up are, however, enquired.

Estimating the efficacy of medical abortion.

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Trussell, J; Ellertson, C

1999-09-01

Comparisons of the efficacy of different regimens of medical abortion are difficult because of the widely varying protocols (even for testing identical regimens), divergent definitions of success and failure, and lack of a standard method of analysis. In this article we review the current efficacy literature on medical abortion, highlighting some of the most important differences in the way that efficacy has been analyzed. We then propose a standard conceptual approach and the accompanying statistical methods for analyzing clinical trials of medical abortion and to explain how clinical investigators can implement this approach. Our review reveals that research on the efficacy of medical abortion has closely followed the conceptual model used for analysis of surgical abortion. The problem, however, is that, whereas surgical abortion is a discrete event occurring in the space of a few minutes or less, medical abortion is a process typically lasting from several days to several weeks. In this process, two events may occur that are not possible with surgical abortion. First, the woman can opt out of the process before a fair determination of efficacy can be made. Second, the process of medical abortion allows time for surgical interventions that may be convenient for the clinician but not strictly necessary from a medical perspective. Another difference from surgical abortions is that, for medical abortions, different medical abortion protocols specify different waiting periods, giving the drugs less time to work in some studies than in others before a determination of efficacy is made. We argue that, when analyzing efficacy of medical abortion, researchers should abandon their close reliance on the analogy to surgical abortion. In fact, medical abortion is more appropriately analyzed by life table procedures developed for the study of another fertility regulation technology; contraception. As with medical abortion, a woman initiating use of a contraceptive method can

Investigations of efficacy of intramammary applied antimicrobials and glucocorticosteroides in the treatment of subclinical and clinical mastitis in cows

OpenAIRE

Vakanjac, Slobodanka; Pavlović, Vojislav; Magaš, Vladimir; Pavlović, Miloš; Đurić, Miloje; Maletić, Milan; Nedić, Svetlana; Sočo, Ivan

2013-01-01

Inflammation of the mammary gland, mastitis in cows, presents one of the most acute problems in intensive dairy production, inflicting huge economic losses. In the course of one year, 80 samples were taken at investigated farms from udder quarters of cows with clinical mastitis and 160 samples from udder quarters of cows with subclinical mastitis. The efficacy of three preparations, A, B, and C, was examined in the treatment of clinical and subclinical mast...

Efficacy of Turmeric Extracts and Curcumin for Alleviating the Symptoms of Joint Arthritis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

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Daily, James W; Yang, Mini; Park, Sunmin

2016-08-01

Although turmeric and its curcumin-enriched extracts have been used for treating arthritis, no systematic review and meta-analysis of randomized clinical trials (RCTs) have been conducted to evaluate the strength of the research. We systemically evaluated all RCTs of turmeric extracts and curcumin for treating arthritis symptoms to elucidate the efficacy of curcuma for alleviating the symptoms of arthritis. Literature searches were conducted using 12 electronic databases, including PubMed, Embase, Cochrane Library, Korean databases, Chinese medical databases, and Indian scientific database. Search terms used were "turmeric," "curcuma," "curcumin," "arthritis," and "osteoarthritis." A pain visual analogue score (PVAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) were used for the major outcomes of arthritis. Initial searches yielded 29 articles, of which 8 met specific selection criteria. Three among the included RCTs reported reduction of PVAS (mean difference: -2.04 [-2.85, -1.24]) with turmeric/curcumin in comparison with placebo (P curcumin treatment (mean difference: -15.36 [-26.9, -3.77]; P = .009). Furthermore, there was no significant mean difference in PVAS between turmeric/curcumin and pain medicine in meta-analysis of five studies. Eight RCTs included in the review exhibited low to moderate risk of bias. There was no publication bias in the meta-analysis. In conclusion, these RCTs provide scientific evidence that supports the efficacy of turmeric extract (about 1000 mg/day of curcumin) in the treatment of arthritis. However, the total number of RCTs included in the analysis, the total sample size, and the methodological quality of the primary studies were not sufficient to draw definitive conclusions. Thus, more rigorous and larger studies are needed to confirm the therapeutic efficacy of turmeric for arthritis.

An Enzymatic Clinical Chemistry Laboratory Experiment Incorporating an Introduction to Mathematical Method Comparison Techniques

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Duxbury, Mark

2004-01-01

An enzymatic laboratory experiment based on the analysis of serum is described that is suitable for students of clinical chemistry. The experiment incorporates an introduction to mathematical method-comparison techniques in which three different clinical glucose analysis methods are compared using linear regression and Bland-Altman difference…

Platelet-Rich Plasma in Bone Regeneration: Engineering the Delivery for Improved Clinical Efficacy

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Isaac A. Rodriguez

2014-01-01

Full Text Available Human bone is a tissue with a fairly remarkable inherent capacity for regeneration; however, this regenerative capacity has its limitations, and defects larger than a critical size lack the ability to spontaneously heal. As such, the development and clinical translation of effective bone regeneration modalities are paramount. One regenerative medicine approach that is beginning to gain momentum in the clinical setting is the use of platelet-rich plasma (PRP. PRP therapy is essentially a method for concentrating platelets and their intrinsic growth factors to stimulate and accelerate a healing response. While PRP has shown some efficacy in both in vitro and in vivo scenarios, to date its use and delivery have not been optimized for bone regeneration. Issues remain with the effective delivery of the platelet-derived growth factors to a localized site of injury, the activation and temporal release of the growth factors, and the rate of growth factor clearance. This review will briefly describe the physiological principles behind PRP use and then discuss how engineering its method of delivery may ultimately impact its ability to successfully translate to widespread clinical use.

Efficacy and Tolerability of Intravenous Ferric Carboxymaltose in Patients with Iron Deficiency at a Hospital Outpatient Clinic: A Retrospective Cohort Study of Real-World Clinical Practice

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António Robalo Nunes

2017-01-01

Full Text Available Ferric carboxymaltose (FCM is an intravenous iron formulation to correct iron deficiency. Although its use has been extensively studied in clinical trials, real-world evidence regarding FCM treatment is scarce. Our aim was to evaluate the efficacy and tolerability of FCM treatment in patients with iron deficiency, with or without anemia, at a hospital outpatient clinic. Data was collected retrospectively from medical records. During this 2-year study, 459 patients were included. Mean age was 58.6 ± 17.5 years and most patients received cumulative FCM doses of 501–1000 mg (63.2%. Six weeks after administration of FCM, efficacy endpoints hemoglobin increase ≥2 g/dL, hemoglobin increase ≥3 g/dL, and transferrin saturation > 20% were attained by 41%, 20%, and 63% of patients, respectively. Patients who received higher FCM doses showed significant reduced odds of not achieving hemoglobin increase ≥2 g/dL (501–1000 mg, adjusted odds ratio [OR]: 0.34, 95% confidence interval [CI] 0.18–0.62; 1001–3000 mg, OR: 0.19, 95% CI 0.07–0.49, compared to 500 mg doses. Treatment-emergent adverse events were documented in <4% of patients. In conclusion, FCM treatment was effective and well-tolerated by outpatients with iron deficiency at a hospital clinic, and its dosage should be adjusted to improve iron deficiency management in clinical practice.

Clinical impact of concomitant immunomodulators on biologic therapy: Pharmacokinetics, immunogenicity, efficacy and safety.

Science.gov (United States)

Xu, Zhenhua; Davis, Hugh M; Zhou, Honghui

2015-03-01

Immune-mediated inflammatory diseases encompass a variety of different clinical syndromes, manifesting as either common diseases such as rheumatoid arthritis (RA), inflammatory bowel disease (IBD) and psoriasis, or rare diseases such as cryopyrin-associated periodic syndromes. The therapy for these diseases often involves the use of a wide range of drugs including nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, immunomodulators, and biologic therapies. Due to the abundance of relevant clinical data, this article provides a general overview on the clinical impact of the concomitant use of immunomodulators and biologic therapies, with a focus on anti-tumor necrosis factor-α agents (anti-TNFα), for the treatment of RA and Crohn's disease (CD). Compared to biologic monotherapy, concomitant use of immunomodulators (methotrexate, azathioprine, and 6-mercaptopurine) often increases the systemic exposure of the anti-TNFα agent and decreases the formation of antibodies to the anti-TNFα agent, consequently enhancing clinical efficacy. Nevertheless, long-term combination therapy with immunomodulators and anti-TNFα agents may be associated with increased risks of serious infections and malignancies. Therefore, the determination whether combination therapy is suitable for a patient should always be based on an individualized benefit-risk evaluation. More research should be undertaken to identify and validate prognostic markers for predicting patients who would benefit the most and those who are at greater risk from combination therapy with immunomodulators and anti-TNFα agents. © 2015, The American College of Clinical Pharmacology.

Clinical efficacy, safety, and tolerability of fingolimod for the treatment of relapsing-remitting multiple sclerosis

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Gajofatto A

2015-12-01

Full Text Available Alberto Gajofatto,1,2 Marco Turatti,2 Salvatore Monaco,1,2 Maria Donata Benedetti2 1Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, Italy; 2Division of Neurology B, Verona University Hospital, Verona, Italy Abstract: Fingolimod is a selective immunosuppressive agent approved worldwide for the treatment of relapsing-remitting multiple sclerosis (MS, a chronic and potentially disabling neurological condition. Randomized double-blind clinical trials have shown that fingolimod significantly reduces relapse rate and ameliorates a number of brain MRI measures, including cerebral atrophy, compared to both placebo and intramuscular interferon-1a. The effect on disability progression remains controversial, since one Phase III trial showed a significant benefit of treatment while two others did not. Although fingolimod has a very convenient daily oral dosing, the possibility of serious cardiac, ocular, infectious, and other rare adverse events justified the decision of the European Medicines Agency to approve the drug as a second-line treatment for MS patients not responsive to first-line therapy, or those with rapidly evolving course. In the United States, fingolimod is instead authorized as a first-line treatment. The aim of this review is to describe and discuss the characteristics of fingolimod concerning its efficacy, safety, and tolerability in the clinical context of multiple sclerosis management. Keywords: multiple sclerosis, fingolimod, safety, tolerability, efficacy

Cross-cultural comparisons of university students' science learning self-efficacy: structural relationships among factors within science learning self-efficacy

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Wang, Ya-Ling; Liang, Jyh-Chong; Tsai, Chin-Chung

2018-04-01

Science learning self-efficacy could be regarded as a multi-factor belief which comprises different aspects such as cognitive skills, practical work, and everyday application. However, few studies have investigated the relationships among these factors that compose science learning self-efficacy. Also, culture may play an important role in explaining the relationships among these factors. Accordingly, this study aimed to investigate cultural differences in science learning self-efficacy and examine the relationships within factors constituting science learning self-efficacy by adopting a survey instrument for administration to students in the U.S. and Taiwan. A total of 218 university students (62.40% females) were surveyed in the U.S.A, and 224 university students (49.10% females) in Taiwan were also invited to take part in the study. The results of the structural equation modelling revealed cultural differences in the relationships among the factors of science learning self-efficacy. It was found that U.S. students' confidence in their ability to employ higher-order cognitive skills tended to promote their confidence in their ability to accomplish practical work, strengthening their academic self-efficacy. However, the aforementioned mediation was not found for the Taiwanese participants.

Comparative Efficacy of Daratumumab Monotherapy and Pomalidomide Plus Low-Dose Dexamethasone in the Treatment of Multiple Myeloma: A Matching Adjusted Indirect Comparison.

Science.gov (United States)

Van Sanden, Suzy; Ito, Tetsuro; Diels, Joris; Vogel, Martin; Belch, Andrew; Oriol, Albert

2018-03-01

Daratumumab (a human CD38-directed monoclonal antibody) and pomalidomide (an immunomodulatory drug) plus dexamethasone are both relatively new treatment options for patients with heavily pretreated multiple myeloma. A matching adjusted indirect comparison (MAIC) was used to compare absolute treatment effects of daratumumab versus pomalidomide + low-dose dexamethasone (LoDex; 40 mg) on overall survival (OS), while adjusting for differences between the trial populations. The MAIC method reduces the risk of bias associated with naïve indirect comparisons. Data from 148 patients receiving daratumumab (16 mg/kg), pooled from the GEN501 and SIRIUS studies, were compared separately with data from patients receiving pomalidomide + LoDex in the MM-003 and STRATUS studies. The MAIC-adjusted hazard ratio (HR) for OS of daratumumab versus pomalidomide + LoDex was 0.56 (95% confidence interval [CI], 0.38-0.83; p  = .0041) for MM-003 and 0.51 (95% CI, 0.37-0.69; p  < .0001) for STRATUS. The treatment benefit was even more pronounced when the daratumumab population was restricted to pomalidomide-naïve patients (MM-003: HR, 0.33; 95% CI, 0.17-0.66; p  = .0017; STRATUS: HR, 0.41; 95% CI, 0.21-0.79; p  = .0082). An additional analysis indicated a consistent trend of the OS benefit across subgroups based on M-protein level reduction (≥50%, ≥25%, and <25%). The MAIC results suggest that daratumumab improves OS compared with pomalidomide + LoDex in patients with heavily pretreated multiple myeloma. This matching adjusted indirect comparison of clinical trial data from four studies analyzes the survival outcomes of patients with heavily pretreated, relapsed/refractory multiple myeloma who received either daratumumab monotherapy or pomalidomide plus low-dose dexamethasone. Using this method, daratumumab conferred a significant overall survival benefit compared with pomalidomide plus low-dose dexamethasone. In the absence of head-to-head trials, these

How does the efficacy and safety of Oralair® compare to other products on the market?

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Larenas-Linnemann D

2016-05-01

Full Text Available Désirée Larenas-Linnemann Pediatric Allergy and Asthma Clinic, Department of Investigation, Hospital Médica Sur, México City, México Abstract: Due to differences between allergen immunotherapy (AIT trials in patient populations, trial design (including primary efficacy variables, the definition of a pollen season, data analysis, and comparisons between AIT products with existing data, is not possible nor valid. The efficacy of two grass pollen AIT tablets, Oralair® and Grazax®/Grastek®, should not be compared by looking at the percentage of score improvement in their respective trials. However, the evidence available concerning the efficacy and safety in trials can be compared by paying close attention to the scientific quality of the trials, details in the administration schedules, and safety issues. It can be concluded due to the high level of evidence available, that Oralair® is effective in a pre (2-months-coseasonal schedule to reduce symptoms and medication use, and improve a patients’ quality of life during the treatment season. For the long-term, where the quality of efficacy evidence is moderate at 2-year posttreatment due to a high dropout rate, the pre (4-months-coseasonal schedule should be used. No clinical efficacy data exists for starting treatment in-season, but the clinical onset of action of Oralair® is detectable after only 1 month of treatment. In the pivotal trials in Europe and the USA, no tablet-related epinephrine was needed, though some rare severe local reactions have been reported. Research for Grazax®/Grastek® showed that the long-term efficacy needs a continuous 3-year administration (moderate-low quality evidence available, and in two patients, tablet-related epinephrine was given. Further details on the comparative efficacy of both tablets would only be possible if both were evaluated in the same, adequately powered trial. Keywords: sublingual allergen immunotherapy, grass pollen, allergic rhinitis

Diagnostic efficacy and therapeutic impact of computed tomography in the evaluation of clinically suspected otosclerosis

International Nuclear Information System (INIS)

Dudau, Cristina; Salim, Fakhruddin; Jiang, Dan; Connor, Steve E.J.

2017-01-01

To assess the diagnostic efficacy and therapeutic impact of CT in evaluating patients with clinically suspected otosclerosis. CT scans performed over a 5-year period for clinically suspected otosclerosis were retrospectively reviewed. CT diagnoses were correlated with subsequent surgical management. For otosclerosis positive cases, clinically significant extensions of otosclerosis were correlated with audiometry and the diagnosis was correlated with surgical findings. Of 259 CT studies, 46 % of patients were positive, 49 % negative and 5 % equivocal for otosclerosis. A relevant alternative CT diagnosis was evident in 33 % of the negative studies. One targeted surgery was performed for every four CT studies. CT outcome influenced the decision to perform stapedectomy in 41 % CT-positive versus 4 % CT-negative patients. CT-positive ears for otosclerosis could not be predicted from baseline clinical or audiometric criteria. Those with endosteal extension demonstrated lower bone conduction thresholds presurgically. The positive predictive value of CT diagnosis of otosclerosis was 100 %. CT demonstrated a high rate of clinically relevant diagnoses in both CT-positive and -negative for otosclerosis patients, and this frequently influenced surgical management. CT also added value by demonstrating relevant extensions of the otosclerotic foci, some of which were predictive of audiometric parameters. (orig.)

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.

Diagnostic efficacy and therapeutic impact of computed tomography in the evaluation of clinically suspected otosclerosis

Energy Technology Data Exchange (ETDEWEB)

Dudau, Cristina [King' s College Hospital NHS Foundation Trust, Department of Neuroradiology, London (United Kingdom); Salim, Fakhruddin; Jiang, Dan [Department of Otolaryngology, Head and Neck Surgery, Auditory Implantation Centre, London (United Kingdom); Connor, Steve E.J. [Department of Radiology, Guy' s and St Thomas' NHS Foundation Trust, London (United Kingdom)

2017-03-15

To assess the diagnostic efficacy and therapeutic impact of CT in evaluating patients with clinically suspected otosclerosis. CT scans performed over a 5-year period for clinically suspected otosclerosis were retrospectively reviewed. CT diagnoses were correlated with subsequent surgical management. For otosclerosis positive cases, clinically significant extensions of otosclerosis were correlated with audiometry and the diagnosis was correlated with surgical findings. Of 259 CT studies, 46 % of patients were positive, 49 % negative and 5 % equivocal for otosclerosis. A relevant alternative CT diagnosis was evident in 33 % of the negative studies. One targeted surgery was performed for every four CT studies. CT outcome influenced the decision to perform stapedectomy in 41 % CT-positive versus 4 % CT-negative patients. CT-positive ears for otosclerosis could not be predicted from baseline clinical or audiometric criteria. Those with endosteal extension demonstrated lower bone conduction thresholds presurgically. The positive predictive value of CT diagnosis of otosclerosis was 100 %. CT demonstrated a high rate of clinically relevant diagnoses in both CT-positive and -negative for otosclerosis patients, and this frequently influenced surgical management. CT also added value by demonstrating relevant extensions of the otosclerotic foci, some of which were predictive of audiometric parameters. (orig.)

Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial

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Hengwei Jin

2017-09-01

Full Text Available Introduction: Brain arteriovenous malformations (BAVMs are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed. Methods: This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety, and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy. Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula, volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS. Discussion: The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs. Keywords: Brain arteriovenous malformation, Clinical trial, Endovascular therapy, Gamma knife, Safety, Efficacy

Efficacy of the clinical agent VT-1161 against fluconazole-sensitive and -resistant Candida albicans in a murine model of vaginal candidiasis.

Science.gov (United States)

Garvey, E P; Hoekstra, W J; Schotzinger, R J; Sobel, J D; Lilly, E A; Fidel, P L

2015-09-01

Vulvovaginal candidiasis (VVC) and recurrent VVC (RVVC) remain major health problems for women. VT-1161, a novel fungal CYP51 inhibitor which has potent antifungal activity against fluconazole-sensitive Candida albicans, retained its in vitro potency (MIC50 of ≤0.015 and MIC90 of 0.12 μg/ml) against 10 clinical isolates from VVC or RVVC patients resistant to fluconazole (MIC50 of 8 and MIC90 of 64 μg/ml). VT-1161 pharmacokinetics in mice displayed a high volume of distribution (1.4 liters/kg), high oral absorption (73%), and a long half-life (>48 h) and showed rapid penetration into vaginal tissue. In a murine model of vaginal candidiasis using fluconazole-sensitive yeast, oral doses as low as 4 mg/kg VT-1161 significantly reduced the fungal burden 1 and 4 days posttreatment (P < 0.0001). Similar VT-1161 efficacy was measured when an isolate highly resistant to fluconazole (MIC of 64 μg/ml) but fully sensitive in vitro to VT-1161 was used. When an isolate partially sensitive to VT-1161 (MIC of 0.12 μg/ml) and moderately resistant to fluconazole (MIC of 8 μg/ml) was used, VT-1161 remained efficacious, whereas fluconazole was efficacious on day 1 but did not sustain efficacy 4 days posttreatment. Both agents were inactive in treating an infection with an isolate that demonstrated weaker potency (MICs of 2 and 64 μg/ml for VT-1161 and fluconazole, respectively). Finally, the plasma concentrations of free VT-1161 were predictive of efficacy when in excess of the in vitro MIC values. These data support the clinical development of VT-1161 as a potentially more efficacious treatment for VVC and RVVC. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

National comparison of {sup 131}I measurement among nuclear medicine clinics of eight countries

Energy Technology Data Exchange (ETDEWEB)

Olsovcova, Veronika, E-mail: volsovcova@cmi.c [Czech Metrology Institute, Radiova 1, Praha 10, 102 00 (Czech Republic); Iwahara, Akira [Laboratorio Nacional de Metrologia das Radiacoes Ionizantes, Instituto de Radioprotecao e Dosimetria, Av. Salvador Allende, s/no. Recreio, Rio de Janeiro, CEP 22780-160 Brazil (Brazil); Oropesa, Pilar [Centro de Isotopos, Ave. Monumental y Carretera La Rada, Km 31/2, Guanabacoa, Ciudad Habana (Cuba); Joseph, Leena; Ravindra, Anuradha [Bhabha Atomic Research Centre, Radiation Safety Systems Division, Trombay, Mumbai-400 085 (India); Ghafoori, Mostafa [SSDL, Agricultural, Medical and Industrial Research School (AMIRS). Nuclear Science and Technology Research Institute, AEOI, Karaj (Iran, Islamic Republic of); Son, Hye-Kyung [Radiation Safety Division, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration, 194 Tongilro, Eunpyung-Gu, Seoul, 122-704 (Korea, Republic of); Sahagia, Maria [Horia Hulubei National Institute of R and D for Physics and Engineering, POB MG-6, 077125 Bucharest (Romania); Tastan, Selma [Ankara University Medical Faculty, Department of Nuclear Medicine, Cebeci 06100, Ankara (Turkey); Zimmerman, Brian [Dosimetry and Medical Radiation Physics Section, International Atomic Energy Agency, P.O. Box 100, A-1400 Vienna (Austria); Ionizing Radiation Division, National Institute of Standards and Technology, Gaithersburg, MD 20899-8462 (United States)

2010-07-15

A generally applicable protocol for organizing comparisons among nuclear medicine clinics created within the IAEA project CRP E2.10.05 was tested in Brazil, Cuba, Czech Republic, India, Iran, Republic of Korea, Romania and Turkey in 2007. Comparisons of measurement of {sup 131}I were organized by local pilot laboratories with different backgrounds and levels of experience in this field. The results and experiences gained were compared and analyzed. A majority of results in each national comparison were within 10% of the reference value.

Prematurity and parental self-efficacy: the Preterm Parenting & Self-Efficacy Checklist.

Science.gov (United States)

Pennell, Claire; Whittingham, Koa; Boyd, Roslyn; Sanders, Matthew; Colditz, Paul

2012-12-01

There is a lack of research investigating parental self-efficacy in parents of infants born preterm as well as a paucity of parental self-efficacy measures that are domain-specific and theoretically grounded. This study aimed to compare parental self-efficacy in parents of infants born term, preterm and very preterm as well as to test whether parental self-efficacy mediates the relationship between psychological symptoms and parental competence. In order to achieve this, a new measure of parental self-efficacy and parental competence relevant for the preterm population and consistent with Bandura's (1977, 1986, 1989) conceptualisation of self-efficacy was developed. Participants included 155 parents, 83 of whom were parents of very preterm (GAparents of preterm (GAparents of term born infants. Parents completed the Preterm Parenting & Self-Efficacy Checklist (the new measure), Family Demographic Questionnaire, Depression Anxiety Stress Scale and Self-Efficacy Questionnaire. This initial study indicates that the Preterm Parenting & Self-Efficacy Checklist has adequate content validity, construct validity, internal consistency and split half reliability. Contrary to expectations, parents of very preterm infants did not report significantly lower overall levels of parental self-efficacy or significantly higher levels of psychological symptoms compared to parents of preterm and term infants. Parental self-efficacy about parenting tasks mediated the relationship between psychological symptoms and self perceived parental competence as predicted. Clinical implications of the results and suggestions for future research are discussed. Crown Copyright © 2012. Published by Elsevier Inc. All rights reserved.

The efficacy of laser therapy for musculoskeletal and skin disorders : A criteria-based meta-analysis of randomized clinical trials

NARCIS (Netherlands)

Beckerman, H.; De Bie, R. A.; Bouter, L. M.; De Cuyper, H. J.; Oostendorp, R. A.B.

1992-01-01

The efficacy of laser therapy for musculoskeletal and skin disorders has been assessed on the basis of the results of 36 randomized clinical trials (RCTs) involving 1,704 patients. For this purpose, a criteria-based meta- analysis that took into account the methodological quality of the individual

Therapeutic Efficacy Comparison of 5 Major EGFR-TKIs in Advanced EGFR-positive Non-Small-cell Lung Cancer: A Network Meta-analysis Based on Head-to-Head Trials.

Science.gov (United States)

Zhang, Yaxiong; Zhang, Zhonghan; Huang, Xiaodan; Kang, Shiyang; Chen, Gang; Wu, Manli; Miao, Siyu; Huang, Yan; Zhao, Hongyun; Zhang, Li

2017-09-01

Five major first- and second-generation epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs), including erlotinib, gefitinib, icotinib, afatinib, and dacomitinib, are currently optional for patients with advanced non-small-cell lung cancer (NSCLC) who harbor EGFR mutations. However, there was no head-to-head-based network meta-analysis among all the TKIs in EGFR-mutated populations. Eligible literature was searched from an electronic database. Data of objective response rate, disease control rate, progression-free survival, and overall survival were extracted from enrolled studies. Multiple treatment comparisons based on Bayesian network integrated the efficacy of all included treatments. Six phase III randomized trials involving 1055 EGFR-mutated patients with advanced NSCLC were enrolled. Multiple treatment comparisons showed that 5 different EGFR-TKIs shared equivalent therapeutic efficacy in terms of all outcome measures. Rank probabilities indicated that dacomitinib and afatinib had potentially better efficacy compared with erlotinib, gefitinib, and icotinib in the EGFR-mutated patients. When compared with other agents, potential survival benefits (progression-free and overall survival) were observed in dacomitinib, whereas afatinib showed a better rank probability in overall response rate and disease control rate. Our study indicated a preferable therapeutic efficacy in the second-generation TKIs (dacomitinib and afatinib) when compared with the first-generation TKIs (erlotinib, gefitinib, and icotinib). Copyright © 2016 Elsevier Inc. All rights reserved.

The relationship between maternal self-efficacy and parenting practices: implications for parent training.

Science.gov (United States)

Sanders, M R; Woolley, M L

2005-01-01

The present study examined the relationship between maternal self-efficacy, dysfunctional discipline practices and child conduct problems. Specifically, three levels of self-efficacy, global, domain and task-specific self-efficacy, were assessed in mothers of 2- to 8-year-old children with conduct problems (clinic group, n=45) and non-clinic mothers from the community (non-clinic group, n=79). Measures of global, domain and task-specific self-efficacy were completed by mothers. Clinic mothers reported significantly lower self-efficacy than non-clinic mothers for all but one of the parenting tasks assessed. Both groups of mothers reported lowest self-efficacy for similar parenting tasks. In the sample as a whole self-efficacy measures were significant predictors of maternal discipline style after controlling for other parent, child and risk factors. Of the self-efficacy variables behavioural self-efficacy was the best predictor of mothers discipline style. The findings support the importance of developing parenting strategies that enable parents to generalize their parenting skills to a diverse range of diverse parenting contexts both in the home and in the community.

A randomized, multi-center, clinical trial to assess the efficacy and safety of alginate carboxymethylcellulose hyaluronic acid compared to carboxymethylcellulose hyaluronic acid to prevent postoperative intrauterine adhesion.

Science.gov (United States)

Kim, Tak; Ahn, Ki Hoon; Choi, Doo Seok; Hwang, Kyung Joo; Lee, Byoung Ick; Jung, Min Hyung; Kim, Jae Weon; Kim, Jong Hyuk; Cha, Sun Hee; Lee, Ki Hwan; Lee, Kyu Sup; Oh, Sung Tack; Cho, Chi Heum; Rhee, Jeong Ho

2012-01-01

To estimate the efficacy of alginate carboxymethylcellulose hyaluronic acid (ACH) gel to prevent intrauterine adhesions after hysteroscopic surgery in comparison with carboxymethylcellulose hyaluronic acid (CH) gel, which is known as an effective adhesion inhibitor. Randomized, multicenter, single-blind, clinical trial (Canadian Task Force classification I). Tertiary university hospital. One hundred eighty-seven patients with a surgically treatable intrauterine lesion (myomas, polyps, septa, intrauterine adhesion, dysfunctional uterine bleeding). Patients were randomized to 2 groups: hysteroscopic surgery plus intrauterine application of ACH or CH. The rate of adhesion formation and the adhesion severity score with type and extent were calculated 4 weeks after surgery. The ACH group had results that were comparable to the CH group in terms of the development of intrauterine adhesions at 4 weeks follow-up. The adhesion severities were not different between the 2 groups. In a subgroup without baseline intrauterine adhesion, the ACH group showed a lower intrauterine adhesion rate than the CH group (p = .016). ACH had a comparable efficacy to CH in terms of the adhesion rate and severity. In the case of no baseline intrauterine adhesion, intrauterine application of ACH after hysteroscopic surgery had a lower rate of intrauterine adhesion than application of CH. Copyright © 2012 AAGL. Published by Elsevier Inc. All rights reserved.

A comparison of the analgesic efficacy of transforaminal methylprednisolone alone and with low doses of clonidine in lumbo-sacral radiculopathy.

Science.gov (United States)

Tauheed, Nazia; Usmani, Hammad; Siddiqui, Anwar Hasan

2014-01-01

Although transforaminal epidural steroid injections under fluoroscopic guidance have become a common mode of treatment of lumbosacral radiculopathy due to herniated disc, the efficacy of steroid with low doses of clonidine has not been compared yet. Comparison of the analgesic efficacy of methylprednisolone alone and with low doses of clonidine for transforaminal injection in lumbosacral radiculopathy. A randomized, double-blind trial. This study was performed at the Pain Clinic under the Department of Anaesthesiology, Jawaharlal Nehru Medical College Hospital, Aligarh Muslim University, Aligarh, India. One hundred and eighty ASA grade I and II patients aged between 18 and 55 years were allocated into groups I, II and III to receive methylprednisolone 60 mg alone or methylprednisolone 60 mg with or without low doses of clonidine (0.5 mcg/kg or 1 mcg/kg) as transforaminal epidural injection. Pain relief and patient's satisfaction were evaluated with the global pain scale. Follow-up visits were advised at 1, 2, 4, 6 and 12 weeks and then at 6 months after injection. Associated complications were recorded. Maximum pain relief was observed at 2 weeks after injection in all the three groups, with no difference in complication rate among the three groups. The most common complication observed was paresthesia in the nerve distribution. Greater than 60% improvement in pain scores was seen in 40% of the patients in group I, 50% of the patients in group II and 75% of the patients in group III. This study is limited by the lack of a placebo group. Adding 1 mcg/kg clonidine to 60 mg methylprednisolone in transforaminal epidural injections provided better pain relief than 60 mg methylprednisolone with 0.5 mcg/kg clonidine or 60 mg methylprednisolone alone in patients suffering from lumbosacral radiculopathy, with practically no significant side-effects.

An audit on virological efficacy of anti-retroviral therapy in a specialist infectious disease clinic.

LENUS (Irish Health Repository)

Reyad, A

2009-06-01

We have assessed the efficacy of anti retroviral therapy (ART) using undetectable viral load (VL) (<50 RNA copies\\/ml) as a marker of virological success, in patients who have Human Immunodeficiency Virus (HIV) attending the Department of Infectious Disease. A cross-sectional review of patients\\' case notes was used to obtain their demographics and treatment details. 79% (253) of the hospital case notes of clinic population was available for analysis, which represents 90% of those receiving ART in the clinic. 166\\/253 of the cohort were receiving treatment at the time of this study and 95% (157\\/166) of these were on treatment for greater than 6 months. The total virological success rate is 93%, which is comparable to other centres and are as good as those from published clinical trials. 56% of those on therapy who have virological failure were Intravenous Drug Users (IVDUs). Case by case investigation for those with treatment failure is warranted.

Protective efficacy of standard Edmonston-Zagreb measles vaccination in infants aged 4.5 months: interim analysis of a randomised clinical trial.

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Martins, Cesário L; Garly, May-Lill; Balé, Carlito; Rodrigues, Amabelia; Ravn, Henrik; Whittle, Hilton C; Lisse, Ida M; Aaby, Peter

2008-07-24

To examine the protective efficacy of measles vaccination in infants in a low income country before 9 months of age. Randomised clinical trial. 1333 infants aged 4.5 months: 441 in treatment group and 892 in control group. Urban area in Guinea-Bissau. Measles vaccination using standard titre Edmonston-Zagreb vaccine at 4.5 months of age. Vaccine efficacy against measles infection, admission to hospital for measles, and measles mortality before standard vaccination at 9 months of age. 28% of the children tested at 4.5 months of age had protective levels of maternal antibodies against measles at enrolment. After early vaccination against measles 92% had measles antibodies at 9 months of age. A measles outbreak offered a unique situation for testing the efficacy of early measles vaccination. During the outbreak, 96 children developed measles; 19% of unvaccinated children had measles before 9 months of age. The monthly incidence of measles among the 441 children enrolled in the treatment arm was 0.7% and among the 892 enrolled in the control arm was 3.1%. Early vaccination with the Edmonston-Zagreb measles vaccine prevented infection; vaccine efficacy for children with serologically confirmed measles and definite clinical measles was 94% (95% confidence interval 77% to 99%), for admissions to hospital for measles was 100% (46% to 100%), and for measles mortality was 100% (-42% to 100%). The number needed to treat to prevent one case of measles between ages 4.5 months and 9 months during the epidemic was 7.2 (6.8 to 9.2). The treatment group tended to have lower overall mortality (mortality rate ratio 0.18, 0.02 to 1.36) although this was not significant. In low income countries, maternal antibody levels against measles may be low and severe outbreaks of measles can occur in infants before the recommended age of vaccination at 9 months. Outbreaks of measles may be curtailed by measles vaccination using the Edmonston-Zagreb vaccine as early as 4.5 months of age. TRIAL

Randomized controlled clinical trial on the efficacy of fosfomycin trometamol for uncomplicated gonococcal urethritis in men.

Science.gov (United States)

Yuan, Z; He, C; Yan, S; Ke, Y; Tang, W

2016-06-01

We assessed the efficacy of fosfomycin trometamol in treating uncomplicated gonococcal urethritis in men. We conducted an open randomized controlled trial in 152 consecutive men with any main complaints suggestive of uncomplicated gonococcal urethritis in Dujiangyan Medical Center between 1 September 2013 and 31 August 2015. In total, 126 patients completed all aspects of this study. Sixty were provided therapy with fosfomycin trometamol 3 g orally on days 1, 3 and 5 in the intervention group; the other 61 were provided ceftriaxone 250 mg intramuscularly plus azithromycin 1 g orally simultaneously as a single dose in the control group. The primary outcomes involved clinical and microbiologic cure on days 7 and 14 after receipt of all the study medications. At the day 7 follow-up visit, all the 121 participants had complete resolution of clinical symptoms and signs. In addition, five patients (two in the intervention group and three in the control group) discontinued intervention because of unsuccessful treatment. After receipt of all the study medications, these five patients still had urethral purulent discharge and were switched to other unknown treatment regimens by other doctors. The bacterial smears and cultures of urethral or urine specimens in the 121 patients who completed all aspects of the study were negative on a test-of-cure visit. In the per-protocol analysis, both clinical and microbiologic cure were experienced by 96.8% (60/62 patients) in the intervention group and 95.3% (61/64 patients) in the control group. There were no recurrences at the day 14 test-of-cure visit. This trial indicates that fosfomycin trometamol exhibits excellent efficacy for treatment of uncomplicated gonococcal urethritis in men. Serious adverse effects are rare. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Comparison of analgesic efficacy of paracetamol and tramadol for pain relief in active labor.

Science.gov (United States)

Kaur Makkar, Jeetinder; Jain, Kajal; Bhatia, Nidhi; Jain, Vanita; Mal Mithrawal, Sanwar

2015-03-01

To evaluate the efficacy and safety profile of paracetamol in comparison with tramadol for pain relief during active labor. Prospective, randomized, double-blind study. Maternity Wing of the Postgraduate Institute of Medical Education and Research, Chandigarh. Sixty laboring, primiparous, full-term parturients with uncomplicated, singleton pregnancy in spontaneous labor and cervical dilatation of 3-5 cm. Parturients were randomized into 2 groups to receive either 1 mg/kg of tramadol intramuscularly (group T; n = 29) or 1 g of paracetamol intravenously (group P; n = 30). Same doses of the drugs were repeated after 4 hours of initial dose. Primary outcome of the study was to assess the analgesic efficacy of the 2 drugs as measured by visual analog scale (VAS) score. Secondary outcome recorded was duration of labor, presence of any maternal, or fetal adverse events during the study. Both the groups showed comparable VAS scores at all times of observation. Lower mean VAS scores were reported in both the groups till 120 minutes only. The duration of first stage of labor was shorter in group P (248.00 ± 98.171 vs 340.63 ± 111.592 minutes; P = .003). The duration of second stage of labor was comparable between the 2 groups. Higher incidence of maternal side effects such as nausea/vomiting and sedation was associated with the use of tramadol. Neonatal outcome was comparable. Intravenous paracetamol provides comparable analgesia as intramuscular tramadol during active labor. Copyright © 2014 Elsevier Inc. All rights reserved.

Clinical efficacy of entecavir in treatment of hepatogenous diabetes

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GOU Wei

2013-06-01

Full Text Available ObjectiveTo observe the clinical efficacy of entecavir in the treatment of hepatogenous diabetes (HD. MethodsA retrospective analysis was performed on the clinical data of 72 HD patients, who were divided into treatment group (n=36 and control group (n=36. Both groups were given diabetic diet and received liver-protecting treatment, symptomatic treatment, and supportive treatment. In addition, the treatment group received oral entecavir (0.5 mg once daily. The therapeutic effect was assessed after 52 weeks of treatment; the serum hepatitis B virus (HBV DNA level, liver function (alanine aminotransferase, aspartate aminotransferase, total bilirubin, and albumin, blood glucose, and glycosylated hemoglobin were measured before and after treatment. The two groups were compared by t test (for measurement data and chi-square test (for numeration data. ResultsAfter 52 weeks of treatment, 29 (80.56% of the patients in treatment group had virological response, versus 7 (19.44% of those in control group (χ2 = 18.00, P＜0.01; 26 (72.22% of the patients in treatment group had liver function recovery and controlled diabetes, versus 16 (44.44% of those in control group (χ2=5.774, P＜0.05. The treatment group showed significant improvements in liver function and blood glucose after treatment (P＜0.05; the treatment group had significantly lower glycosylated hemoglobin and fasting blood glucose than the control group (P＜0.01. ConclusionIn the treatment of HBV DNA-positive hepatitis B cirrhosis with HD, entecavir not only can effectively inhibit the replication of viral DNA and promote the recovery of liver function, but also can effectively control HD.

Clinical efficacy of sitafloxacin 100 mg twice daily for 7 days for patients with non-gonococcal urethritis.

Science.gov (United States)

Takahashi, Satoshi; Hamasuna, Ryoichi; Yasuda, Mitsuru; Ito, Shin; Ito, Kenji; Kawai, Shuichi; Yamaguchi, Takamasa; Satoh, Takashi; Sunaoshi, Kenichi; Takeda, Koichi; Suzuki, Nobukazu; Maeda, Shinichi; Nishimura, Hirofumi; Fukuda, Souichirou; Matsumoto, Tetsuro

2013-10-01

To clarify the clinical efficacy of STFX for patients with non-gonococcal urethritis (NGU), including chlamydial urethritis and Mycoplasma genitalium-positive urethritis, this study included male patients with NGU who were 20 years old or older. The pathogens, including Chlamydia trachomatis, M. genitalium and Ureaplasma urealyticum, were detected by nucleic acid amplification tests and the patients were treated with sitafloxacin 100 mg twice daily for 7 days. Microbiological and clinical efficacies were assessed for the patients with NGU posttreatment. Among the 208 patients enrolled in this study, data for a total of 118 patients could be analyzed. The median age was 32 (20-61) years. The median duration from the completion of treatment to the second visit was 21 (14-42) days. There were 68 pathogen-positive NGU cases and 50 with NGU without any microbial detection. Microbiological cure was achieved in 95.6% of the pathogen-positive NGU patients. Total clinical cure was achieved in 91.3% (105/115). In this study, STFX was able to eradicate 95.7% of C. trachomatis, 93.8% of M. genitalium and 100% of U. urealyticum. The results of our clinical research indicate that the STFX treatment regimen should become a standard regimen recommended for patients with NGU. In addition, this regimen is recommended for patients with M. genitalium-positive NGU.

New synthetic peptide with efficacy for heparin reversal and low toxicity and immunogenicity in comparison to protamine sulfate

Energy Technology Data Exchange (ETDEWEB)

Li, Tong; Meng, Zhiyun; Zhu, Xiaoxia; Gan, Hui; Gu, Ruolan; Wu, Zhuona; Li, Jian; Zheng, Ying; Liu, Taoyun; Han, Peng; Han, Su; Dou, Guifang, E-mail: douguifang@vip.sina.com

2015-11-20

Protamine sulfate (PS), the only clinically approved antidote to unfractionated heparin (UFH), is widely used for cardiopulmonary surgery or other extracorporeal circulation situations. However, the applications of PS have accompanied various severe side-effects. In this study, we presented a novel synthesized peptide compound (RRRRR-RRRRR-RRRRR-sulfate, R15S) served as a safer UFH antidote. Comparison studies were conducted between PS and R15S on efficacy and safety, aided by heparin neutralization studies, drug toxicity studies and anaphylactic analysis. Our research demonstrated that R15S contained comparable UFH neutralization activity in vitro and in rats in vivo as to active partial thromboplastin time (APTT) and anti-FXa assays. There was no cytotoxicity for R15S at 60 μg mg{sup −1} or below and the median lethal dose (LD{sub 50}) of R15S in mice was 35.4 mg kg{sup −1}, both of which were similar to that of PS. Furthermore, R15S exhibited no immunogenicity while it was obvious in guinea pigs immunized with PS. The level of cross-reactivity to anti-PS antibodies of R15S was about 30%. Both of which indicated much safer properties of R15S than PS. In conclusion, we presented a promising candidate R15S for UFH reversal, which is effective in neutralizing UFH and potentially safer in use. - Highlights: • R15 sulfate has a comparable unfractionated heparin neutralization activity to PS. • R15 sulfate avoided severe anaphylactic responses which happened to PS in clinical use. • R15 sulfate could provide a stricter quality control compared to PS which may vary with different batches.

A comparison of clinical efficacy between covered stent-grafts and bare stents in transjuglar in-trahepatic portosystemic shunt

International Nuclear Information System (INIS)

Jiang Yongbin; Zhang Xitong; Zhang Wei; Xia Yonghui; Liang Songnian; Xu Ke

2010-01-01

Objective: To compare the clinical efficacy between covered stent and uncovered stent in transjuglar in-trahepatic portosystemic shunt (TIPS). Methods: Thirty patients with liver cirrhosis (portal hypertension), who received TIPS, were retrospectively studied. All patients were divided into two groups covered-stent group (n=20) and uncovered-stent group (n=10). For each patient, portal pressure was measured before and after operation, and the patency of shunt was evaluated by color Doppler ultrasound after operation. The mortality, recurrent bleeding rate and incidence of hepatic encephalopathy were analyzed by Fisher exact probability test. Results: The TIPS treatment was successful in all patients, the portal pressure in the covered-stent group reduced from (3.78 ± 0.50)kPa to (2.13 ± 0.44) kPa and that of the uncovered-stent group reduced from (3.67 ± 0.48)kPA TO (2.13 ± 0.35)kPa. Twenty-six cases were postoperatively followed-up (17 cases in covered-stent group, 9 cases in uncovered-stent group). the follow-up period varied from 7 days to 62 months (median follow-up period was 23 months). Thirteen patients died of upper gastrointestinal bleeding and hepatic failure. The difference of mortality between covered-stent group (8/17) and uncovered-stent group (5/17) and the uncovered-stent group (3/9) was not different too (P>0.05). The incidence of hepatic encephalopathy in the covered-stent group (4/17) was not different from that of the uncovered-stent group (2/9) (P>0.05). The patency rates of 6 months and 12 months reached 100% in the covered-stent group, which were higher than those in the uncovered-stent group 77.8% (7/9) and 55.6%(5/9) (P<0.05). Conclusions: The patency rate of shunt at 12 months after TIPS was higher in the covered-stent group than the uncovered-stent group, while the mortality, recurrent bleeding rate and incidence of hepatic encephalopathy were not significantly different between the two groups. (authors)

Comparison of Hemodynamic Responses in the Prefrontal Cortex According to Differences in Self-Efficacy.

Science.gov (United States)

Hirao, Kazuki

2017-07-01

Although self-efficacy has been used extensively in the field of nursing (e.g., as an outcome measure of nursing interventions), its underlying nature is poorly understood. Investigation of the relationship between self-efficacy and brain activation will help explain the fundamental nature of self-efficacy. In this study, we compared prefrontal activation measured with near-infrared spectroscopy (NIRS) across 89 undergraduate students categorized into three groups based on their General Self-Efficacy Scale scores: low self-efficacy ( n = 59), moderate self-efficacy ( n = 17), and high self-efficacy ( n = 13). Changes in the hemoglobin levels of the prefrontal cortex (PFC) during a verbal fluency task were assessed using two-channel NIRS. Significant differences in the oxygenated hemoglobin (oxy-Hb) level of the left PFC (LPFC) were observed via analysis of variance. Post hoc Tukey's test showed a significant difference only between low self-efficacy and moderate self-efficacy groups. We found a medium between-group effect size in the moderate self-efficacy group versus the low self-efficacy group for the changes in oxy-Hb levels of the LPFC ( d = .78; 95% confidence interval for effect size [0.22, 1.33]). No significant between-group differences were observed with respect to changes in the oxy-Hb in the right PFC. The results indicate less left prefrontal activation in the low self-efficacy group than in the moderate self-efficacy group. These findings provide evidence to support the fundamental nature of self-efficacy.

Clinical efficacy and safety of T-DM1 for patients with HER2-positive breast cancer

Directory of Open Access Journals (Sweden)

Ma B

2016-02-01

Full Text Available Bo Ma,1 Qianqian Ma,2 Hongqiang Wang,3 Guolei Zhang,1 Huiying Zhang,1 Xiaohong Wang1 1Affiliated Central Hospital of Huzhou Teachers College, Huzhou, Zhejiang, People’s Republic of China; 2University Hospital of Tuebingen, Tuebingen, Germany; 3Department of Oncology, Hospital of Zhoushan, Zhoushan, Zhejiang, People’s Republic of China Purpose: The aim of this study was to evaluate the therapeutic efficacy and safety of trastuzumab emtansine (T-DM1 for the treatment of patients with human epidermal growth factor receptor 2-positive breast cancer.  Methods: We performed a systemic review and meta-analysis of the relevant published clinical studies. A computerized search was performed for controlled clinical trials of T-DM1 in targeted treatment. Overall survival, progression-free survival, objective response rate, symptom progression free, and adverse events (AEs were evaluated.  Results: Eight eligible trials with a total of 2,016 patients with breast cancer were included in the present meta-analysis. The treatment of patients with breast cancer with T-DM1 was associated with significantly increased overall and progression-free survival when compared with controls (P<0.0001. An analysis of the objective response rate and symptom progression free also demonstrated favorable results for T-DM1 treatment (P≤0.0001. There was no significant difference between the T-DM1 and control groups with respect to nonhematologic or hematologic AEs (P=0.99 and P=0.30, respectively.  Conclusion: Overall, T-DM1 is efficacious in the treatment of patients with human epidermal growth factor receptor 2-positive breast cancer and low rates of AEs compared with controls. Keywords: breast cancer, meta-analysis, HER2, T-DM1, efficacy

Comparison of autogeneic and allogeneic natural killer cells immunotherapy on the clinical outcome of recurrent breast cancer

Directory of Open Access Journals (Sweden)

Liang S

2017-08-01

Full Text Available Shuzhen Liang,1,2 Kecheng Xu,1,2 Lizhi Niu,1,2 Xiaohua Wang,1 Yingqing Liang,1 Mingjie Zhang,3 Jibing Chen,1,2 Mao Lin1,2 1Department of Central Laboratory, Fuda Cancer Hospital, Jinan University School of Medicine, Guangzhou, Guangdong, China; 2Fuda Cancer Institute, Guangzhou, Guangdong, China; 3Hank Bioengineering Co., Ltd, Shenzhen, China Abstract: In the present study, we aimed to compare the clinical outcome of autogeneic and allogeneic natural killer (NK cells immunotherapy for the treatment of recurrent breast cancer. Between July 2016 and February 2017, 36 patients who met the enrollment criteria were randomly assigned to two groups: autogeneic NK cells immunotherapy group (group I, n=18 and allogeneic NK cells immunotherapy group (group II, n=18. The clinical efficacy, quality of life, immune function, circulating tumor cell (CTC level, and other related indicators were evaluated. We found that allogeneic NK cells immunotherapy has better clinical efficacy than autogeneic therapy. Moreover, allogeneic NK cells therapy improves the quality of life, reduces the number of CTCs, reduces carcinoembryonic antigen and cancer antigen 15-3 (CA15-3 expression, and significantly enhances immune function. To our knowledge, this is the first clinical trial to compare the clinical outcome of autogeneic and allogeneic NK cells immunotherapy for recurrent breast cancer. Keywords: clinical outcome, autogeneic, allogeneic, natural killer cells, recurrent breast cancer

The forgotten role of alcohol: a systematic review and meta-analysis of the clinical efficacy and perceived role of chlorhexidine in skin antisepsis.

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Maiwald, Matthias; Chan, Edwin S Y

2012-01-01

Skin antisepsis is a simple and effective measure to prevent infections. The efficacy of chlorhexidine is actively discussed in the literature on skin antisepsis. However, study outcomes due to chlorhexidine-alcohol combinations are often attributed to chlorhexidine alone. Thus, we sought to review the efficacy of chlorhexidine for skin antisepsis and the extent of a possible misinterpretation of evidence. We performed a systematic literature review of clinical trials and systematic reviews investigating chlorhexidine compounds for blood culture collection, vascular catheter insertion and surgical skin preparation. We searched PubMed, CINAHL, the Cochrane Library, the Agency for Healthcare Research and Quality website, several clinical trials registries and a manufacturer website. We extracted data on study design, antiseptic composition, and the following outcomes: blood culture contamination, catheter colonisation, catheter-related bloodstream infection and surgical site infection. We conducted meta-analyses of the clinical efficacy of chlorhexidine compounds and reviewed the appropriateness of the authors' attribution. In all three application areas and for all outcomes, we found good evidence favouring chlorhexidine-alcohol over aqueous competitors, but not over competitors combined with alcohols. For blood cultures and surgery, we found no evidence supporting chlorhexidine alone. For catheters, we found evidence in support of chlorhexidine alone for preventing catheter colonisation, but not for preventing bloodstream infection. A range of 29 to 43% of articles attributed outcomes solely to chlorhexidine when the combination with alcohol was in fact used. Articles with ambiguous attribution were common (8-35%). Unsubstantiated recommendations for chlorhexidine alone instead of chlorhexidine-alcohol were identified in several practice recommendations and evidence-based guidelines. Perceived efficacy of chlorhexidine is often in fact based on evidence for the

Early-Onset Psychoses: Comparison of Clinical Features and Adult Outcome in 3 Diagnostic Groups

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Ledda, Maria Giuseppina; Fratta, Anna Lisa; Pintor, Manuela; Zuddas, Alessandro; Cianchetti, Carlo

2009-01-01

A comparison of clinical features and adult outcome in adolescents with three types of psychotic disorders: schizophrenic (SPh), schizoaffective (SA) and bipolar with psychotic features (BPP). Subjects (n = 41) were finally diagnosed (DSM-IV criteria) with SPh (n = 17), SA (n = 11) or BPP (n = 13). Clinical evaluation took place at onset and at a…

Building Surgical Research Capacity Globally: Efficacy of a Clinical Research Course for Surgeons in Low-Resource Settings

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Theodore A. Miclau

2017-11-01

Full Text Available Musculoskeletal injury confers an enormous burden of preventable disability and mortality in low- and moderate-income countries (LMICs. Appropriate orthopedic and trauma care services are lacking. Leading international health agencies emphasize the critical need to create and sustain research capacity in the developing world as a strategic factor in the establishment of functional, independent health systems. One aspect of building research capacity is partnership between developing and developed countries, and knowledge sharing via these collaborations. This study evaluated the efficacy of a short, intensive course designed to educate surgeons on fundamental aspects of clinical research using evidence-based medicine (EBM principles. Orthopedic surgeons from the United States and Canada presented a one-day course on the fundamentals of clinical research in Havana, Cuba. Knowledge acquisition was assessed on the part of course participants and surveyed current involvement with and attitudes toward clinical research. Questionnaires were presented to participants immediately preceding and following the course. The mean pre-test score was 43.9% (95% CI: 41.1–46.6%. The mean post-test score was 59.3% (95% CI: 56.5–62.1%. There were relative score increases in each subgroup based on professional level, subjective level of familiarity with EBM concepts, and subjective level of experience in research. This study establishes the short-term efficacy of an intensive course designed to impart knowledge in EBM and clinical research. Further study is necessary to determine the long-term benefits of this type of course. This may be a useful part of an overall strategy to build health research capacity in LMICs, ultimately contributing to improved access to high-quality surgical care.

Efficacy, safety and tolerability of ongoing statin plus ezetimibe versus doubling the ongoing statin dose in hypercholesterolemic Taiwanese patients: an open-label, randomized clinical trial

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Yu Chih-Chieh

2012-05-01

Full Text Available Abstract Background Reducing low-density lipoprotein cholesterol (LDL-C is associated with reduced risk for major coronary events. Despite statin efficacy, a considerable proportion of statin-treated hypercholesterolemic patients fail to reach therapeutic LDL-C targets as defined by guidelines. This study compared the efficacy of ezetimibe added to ongoing statins with doubling the dose of ongoing statin in a population of Taiwanese patients with hypercholesterolemia. Methods This was a randomized, open-label, parallel-group comparison study of ezetimibe 10 mg added to ongoing statin compared with doubling the dose of ongoing statin. Adult Taiwanese hypercholesterolemic patients not at optimal LDL-C levels with previous statin treatment were randomized (N = 83 to ongoing statin + ezetimibe (simvastatin, atorvastatin or pravastatin + ezetimibe at doses of 20/10, 10/10 or 20/10 mg or doubling the dose of ongoing statin (simvastatin 40 mg, atorvastatin 20 mg or pravastatin 40 mg for 8 weeks. Percent change in total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C and triglycerides, and specified safety parameters were assessed at 4 and 8 weeks. Results At 8 weeks, patients treated with statin + ezetimibe experienced significantly greater reductions compared with doubling the statin dose in LDL-C (26.2% vs 17.9%, p = 0.0026 and total cholesterol (20.8% vs 12.2%, p = 0.0003. Percentage of patients achieving treatment goal was greater for statin + ezetimibe (58.6% vs doubling statin (41.2%, but the difference was not statistically significant (p = 0.1675. The safety and tolerability profiles were similar between treatments. Conclusion Ezetimibe added to ongoing statin therapy resulted in significantly greater lipid-lowering compared with doubling the dose of statin in Taiwanese patients with hypercholesterolemia. Studies to assess clinical outcome benefit are ongoing. Trial registration Registered at ClinicalTrials.gov: NCT00652327

A novel and well tolerated mite allergoid subcutaneous immunotherapy: evidence of clinical and immunologic efficacy

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Roger, Albert; Depreux, Nathalie; Jurgens, Yani; Heath, Matthew D; Garcia, Gloria; Skinner, Murray A

2014-01-01

Allergy to house dust mite is one of the most common causes of allergic rhinitis. A novel tyrosine-adsorbed, modified allergen product, Acarovac Plus, developed for the treatment of perennial mite allergy seeks to address the underlying cause of allergic rhinitis in this instance. One of two dosing regimens may be used, either the Conventional Regimen or the Cluster Regimen. We sought to compare the efficacy and safety of a specific immunotherapy, developed for the treatment of perennial mite allergy, administered under a Conventional and Clustered dosing schedule in patients with persistent allergic rhinitis. Thirty adult patients, between 18 and 65 years old, with allergic rhinitis and/or asthma secondary to hypersensitivity to Dermatophagoides pteronyssinus were administered with either conventional or cluster initial regime, with a final visit one week after the last dose administration. The efficacy to the Conventional and Cluster regimens was measured using a Nasal Challenge Test monitoring clinical symptoms and peak nasal inspiratory flow. Total IgE, serum-specific inmunoglobulins (IgE and IgG4) to Dermatophagoides pteronyssinus and relevant cytokines (IFN-γ, IL-4, IL-5, IL-10 and IL-13) were assessed. A Satisfaction Questionnaire (TSQM) was completed after each patient's final visit. The tolerability of the vaccine was assessed monitoring adverse reactions. No adverse events were recorded in either conventional or cluster regime. The specific Nasal Challenge Test led to a decrease in symptom scores and a significant decrease in mean nasal peak inspiratory flow drop was recorded in both dosing regimen groups. A significant increase in IgG4-specific antibody titres was assessed. No significant changes were observed in concentrations of total IgE, specific IgE or cytokines (IFN-γ, IL-4, IL-5, IL-10 and IL-13). Patients declared themselves most satisfied in relation to “Secondary effects”, with high overall satisfaction in both groups. Cluster and

The pharmacokinetics and clinical efficacy of AVP-825: a potential advancement for acute treatment of migraine.

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Cady, Roger

2015-01-01

Oral triptans have dominated the prescription market for acute treatment of migraine for nearly 25 years. Today, patients often express dissatisfaction with prescribed acute treatment in part because they do not have confidence that the therapy will provide consistent efficacy over time. Major limitations to sustained successful use of oral triptans are their relatively slow onset of meaningful clinical benefit and variable absorption/efficacy due to impaired gastrointestinal function during migraine. AVP-825, a new intranasal delivery system for sumatriptan , may be an effective alternative to oral triptans. This article reviews AVP-825, which deposits low-dose sumatriptan powder deep into the vascular mucosa of the posterior nose, allowing rapid absorption of drug into the systemic circulation. Studies suggest that AVP-825 is a highly effective, well-tolerated acute treatment for episodic migraine. Oral triptans are limited in providing effective patient-centered outcomes to migraine patients. Failed or suboptimal abortive treatment of migraine is a major driver of migraine chronification and increases in healthcare costs. AVP-825 is an easy to use, novel, breath-powered intranasal delivery system that provides early onset of efficacy with low systemic drug exposure and few triptan-associated adverse events. AVP-825 will be a welcomed therapeutic tool for the acute treatment of migraine.

Efficacy and Safety of Remifentanil as an Alternative Labor Analgesic

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Sandeep Devabhakthuni

2013-01-01

Full Text Available The objective of this review was to evaluate the clinical efficacy and safety of remifentanil in the management of labor pain. Although neuraxial analgesia is the best option during labor, alternative analgesic options are needed for patients with contraindications. Using a systematic literature search, clinical outcomes of remifentanil for labor pain have been summarized. Also, comparisons of remifentanil to other options including meperidine, epidural analgesia, fentanyl, and nitrous oxide are provided. Based on the literature review, remifentanil is associated with high overall maternal satisfaction and favorable side-effect profile. However, due to the low reporting of adverse events, large, randomized controlled trials are needed to evaluate maternal and neonatal safety adequately and determine the optimal dosing needed to provide effective analgesia. While remifentanil is a feasible alternative for patients who cannot or do not want to receive epidural analgesia, administration should be monitored closely for potential adverse effects.

Clinical efficacy of CT-guided 125I seed implantation therapy for advanced pancreatic cancer

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Wang Zhongmin; Lu Jian; Gong Ju; Zheng Yunfeng; Zhang Liyun; Huang Gang; Chen Kemin

2009-01-01

Objective: To discuss the clinical efficacy of CT-guided radioactive 125 I seed implantation treatment for unresectable pancreatic cancer. Methods: Forty patients with inoperable pancreatic cancer were enrolled in this study, including 25 males and 15 females with an median age of 69 years (38-89 years). Treatment planning system (TPS) was used to reconstruct 3-dimensional images of pancreatic tumor and to define the quantity and distribution of 125 I seeds. The radioactivity of 125 I seeds was 0.5 - 0.8 mCi / seed. The seeds were implanted into pancreatic tumor under CT guidance at intervals of 1 cm and were kept away from vessels, pancreatic duct and other adjacent important organs. The tumor matched peripheral dose (MPD) was 60-140 Gy. The median amount of implanted 125 I seeds was 36 (18-68) in number. CT scan was performed immediately after the procedure to check the quality of the seeds. In addition, 10 patients received concurrent chemotherapy with arterial infusion of gemcitabin and 5-fluororacil (5-Fu) for 3 to 4 therapeutic courses. Results: The median diameter of the tumors was 4.9 cm. The follow-up period was 2 to 28 months. After the treatment the refractory pain was significantly relieved (P 125 I seed implantation is a safe, effective and minimally-invasive brachytherapy for unresectable pancreatic cancer with reliable short-term efficacy. It has an excellent anti-pain effect. The curative results can be further improved when chemotherapy is employed together. However, its long-term efficacy needs to be observed. (authors)

Clinical efficacy and safety of ICS/LABA in patients with combined idiopathic pulmonary fibrosis and emphysema.

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Dong, Fushi; Zhang, Yimei; Chi, Fangzhou; Song, Qi; Zhang, Lijuan; Wang, Yupeng; Che, Chunli

2015-01-01

The study aim was to explore the clinical efficacy and safety of inhaled corticosteroids (ICS)/long-acting beta2-agonists (LABA) in combined with idiopathic pulmonary fibrosis and emphysema. 45 patients with combined idiopathic pulmonary fibrosis and emphysema (CPFE) who were treated with ICS/LABA (Group A), 24 patients with CPFE who were treated without ICS/LABA (Group B) and 35 patients with idiopathic pulmonary fibrosis (IPF) (Group C) were enrolled into this study. Then, clinical efficacy and safety of ICS/LABA was analyzed through lung function scores and lung high-resolution computed tomography (HRCT) scans. Compared with baseline levels, the FEV1%, FVC% and DLCO% levels were increased 11.2%, 13.53% and 12.8% respectively in group A, but declined 14.21%, 16.8% and 21.25% respectively in group B, meanwhile, lung HRCT score was declined 9.31 in group A but increased 14.87 in group B, and there was significant difference between group A and group B (P0.05). The incidence of adverse reaction was higher in group A than that in group B during this study, but there was no significant difference (P>0.05). ICS/LABA therapy could improve lung function condition in patients with CPFE and declined acute out-break frequency and severity of diseases during acute episode period.

Surveillance on The Safety and Efficacy of Ambrisentan (Volibris Tablet 2.5 mg) in Patients with Pulmonary Arterial Hypertension in Real Clinical Practice: Post-marketing Surveillance (Interim Analysis Report).

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Takahashi, Tomohiko; Hayata, Satoru; Kobayashi, Akihiro; Onaka, Yuna; Ebihara, Takeshi; Hara, Terufumi

2018-03-01

Pulmonary arterial hypertension (PAH) is an intractable and rare disease and the accumulation of clinical evidence under real-world setting is needed. A post-marketing surveillance for the endothelin receptor antagonist ambrisentan (Volibris tablet) has been conducted by all-case investigation since September 2010. This paper is an interim report on the safety and efficacy of ambrisentan in 702 patients with PAH. PAH patients aged 15 years or older were subjected to the analysis. The safety analysis by overall cases or stratification of patient backgrounds and the efficacy analysis were investigated. Regarding patient characteristics, the 702 patients subjected to safety analysis included 543 (77.4%) women and 546 (77.8%) patients at WHO functional class II/III. The mean observational time was 392.7 days. A total of 324 adverse drug reaction (ADR) occurred in 204 (29.1%) patients. Common ADRs (≥ 2%) included anemia (4.6%), peripheral edema (4.1%), headache (3.6%), edema and face edema (2.6% each), abnormal hepatic function (2.3%), and epistaxis (2.1%). There were 82 serious ADRs occurring in 44 (6.3%) patients (385 serious adverse events in 184 (26.2%) patients). Although 11 (1.6%) interstitial lung disease (ILD) cases were reported, all were observed in patients with disease that may contribute to ILD and therefore it is difficult to assess if ambrisentan was associated with these events. There was no difference in safety in relation to the presence/absence of connective tissue disease-related PAH (CTD-PAH) or combination therapy. Among 677 patients subjected to efficacy analysis, those in whom hemodynamic status was determined before and after treatment showed improvement in the mean pulmonary arterial pressure and pulmonary vascular resistance after treatment. The interim results showed safety consistent with the known profile of ambrisentan in terms of the types and frequencies of ADRs in patients with PAH in real clinical practice, in comparison with

Clinical efficacy of dexmedetomidine in the diminution of fentanyl dosage in pediatric cardiac surgery.

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Sun, Yingying; Ye, Hongwu; Xia, Yin; Li, Yuanhai; Yuan, Xianren; Wang, Xing

2017-06-01

This study aims to explore the clinical efficacy of dexmedetomidine (DEX) in the diminution of fentanyl dosage in pediatric cardiac surgery based on some clinical and biochemical parameters. Fifty pediatric patients (American Society of Anesthesiologists II), 1-6 years old, were randomly allocated into two groups: group F (control group), in which patients received normal saline and high dosage of fentanyl (30 μg/kg), and group D, in which patients were given DEX and low dosage of fentanyl (15 μg/kg). Some hemodynamic and clinical parameters of the two groups were recorded. Furthermore, stress hormone (serum cortisol, norepinephrine, blood glucose) levels and cytokine (interleukin 6, tumor necrosis factor alpha) levels in the two groups were compared with each other. Stress hormone levels, cytokine levels, hemodynamic parameters and the consumption of sevoflurane did not differ between the two groups. Meanwhile, the extubation time was significantly shorter in Group D than F (Pfentanyl supplemented with DEX almost had the same anesthesia effects and inflammation extent compared with high dose of fentanyl, which suggested that infusion DEX might decrease fentanyl consumption in pediatric cardiac surgery.

Isavuconazole for the treatment of invasive aspergillosis and mucormycosis: current evidence, safety, efficacy, and clinical recommendations

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Natesan SK

2016-12-01

Full Text Available Suganthini Krishnan Natesan,1,2 Pranatharthi H Chandrasekar1 1Division of Infectious Diseases, Department of Internal Medicine, Wayne State University, 2John D Dingell VA Medical Center, Detroit, MI, USA Abstract: The majority of invasive mold infections diagnosed in immunocompromised cancer patients include invasive aspergillosis (IA and mucormycosis. Despite timely and effective therapy, mortality remains considerable. Antifungal agents currently available for the management of these serious infections include triazoles, polyenes, and echinocandins. Until recently, posaconazole has been the only triazole with a broad spectrum of anti-mold activity against both Aspergillus sp. and mucorales. Other clinically available triazoles voriconazole and itraconazole, with poor activity against mucorales, have significant drug interactions in addition to a side effect profile inherent for all triazoles. Polyenes including lipid formulations pose a problem with infusion-related side effects, electrolyte imbalance, and nephrotoxicity. Echinocandins are ineffective against mucorales and are approved as salvage therapy for refractory IA. Given that all available antifungal agents have limitations, there has been an unmet need for a broad-spectrum anti-mold agent with a favorable profile. Following phase III clinical trials that started in 2006, isavuconazole (ISZ seems to fit this profile. It is the first novel triazole agent recently approved by the United States Food and Drug Administration (FDA for the treatment of both IA and mucormycosis. This review provides a brief overview of the salient features of ISZ, its favorable profile with regard to spectrum of antifungal activity, pharmacokinetic and pharmacodynamic parameters, drug interactions and tolerability, clinical efficacy, and side effects. Keywords: isavuconazole, aspergillosis, mucormycosis, efficacy, antifungal therapy, novel azole, tolerability, drug interactions

Comparisons of hypertension-related costs from multinational clinical studies.

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Mullins, C Daniel; Sikirica, Mirko; Seneviratne, Viran; Ahn, Jeonghoon; Akhras, Kasem S

2004-01-01

This study identifies and compares the individual cost components of hospital and ambulatory services that manage the care of hypertensive patients in eight countries: the US, the UK, France, Spain, Germany, Italy, Canada and Australia. Hypertension-related costs are classified according to four major cardiovascular events: (i) acute myocardial infarction; (ii) congestive heart failure; (iii) stroke; and (iv) renal failure, which was subdivided into renal failure treated by dialysis and renal failure treated by kidney transplantation. To make cross-country costs comparisons, we used the DRG codes used in the US and DRG-like codes from each country. US cost information was obtained from hypertension data available from the literature and health economics researchers. For costs in other countries, we consulted with national health economics experts in each country, used analyses by the Research Triangle Institute, and performed Medline and international literature searches. When available, we obtained information from the countries' public and private nationally representative data sources. For cross-country currency adjustments, all currencies were converted using the Purchasing Power Parities from the Organisation for Economic Cooperation and Development, and then converted into inflation-adjusted year 2000 US dollars. There exists considerable variation in hypertension-related costs from multinational clinical studies. This study documents that costs are generally higher in the US than in other countries; however, this is not always true. In particular, costs of treating heart failure in France and the costs of renal failure without transplantation in Germany and the UK are relatively high. While analysing multinational hypertensive cost data, this study also addresses the impact of cross-country cost variations on cost analyses. During the last decade, drug-development researchers have drawn extensively upon multinational trials to resolve enrollment problems and

Clinical efficacy of basic fibroblast growth factor (bFGF) for diabetic ulcer.

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UCHI, Hiroshi; IGARASHI, Atsuyuki; URABE, Kazunori; KOGA, Tetsuya; NAKAYAMA, Juichiro; KAWAMORI, Ryuzo; TAMAKI, Kunihiko; HIRAKATA, Hideki; OHURA, Takehiko; FURUE, Masutaka

2009-01-01

Basic fibroblast growth factor (bFGF) has been shown to promote wound healing. The present trial evaluated the clinical efficacy of bFGF for diabetic ulcer, a type of refractory skin ulcer, and the dose-response relationship. This was designed as a randomized, double-blind, dose-ranging, placebo-controlled trial. A total of 150 patients with non-ischaemic diabetic ulcers measuring 900 mm2 or less were randomized into a placebo group (n = 51), a 0.001% bFGF group (n = 49) and a 0.01% bFGF group (n = 50), and 148 of these patients received treatment for 8 weeks or less. The efficacy evaluation was carried out on 139 patients who met the protocol in this trial. The primary outcome was the percentage of patients showing 75% or greater reductions in the area of ulcer. The area of ulcer decreased by 75% or more in 57.5% (27/47), 72.3% (34/47), and 82.2% (37/45) in the placebo, 0.001% bFGF and 0.01% bFGF groups, respectively, and differences were significant between the 0.01% bFGF and placebo groups (p = 0.025). The cure rate was 46.8% (22/47), 57.4% (27/47), and 66.7% (30/45) in the placebo, 0.001% bFGF and 0.01% bFGF groups, respectively. The findings obtained in this trial showed wound healing accelerating effects of bFGF on diabetic ulcers.

Entrepreneurial Self-Efficacy of University Students: A Cross-Cultural Study

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Oguz Basol

2017-03-01

Full Text Available The present study investigated the entrepreneurial self-efficacy perceptions among university students across two countries, i.e., Poland and Turkey. Data were obtained through questionnaires designed to assess the perceptions of entrepreneurial self-efficacy. In all, 365 Polish and 278 Turkish students completed the questionnaires. Results indicated that Polish and Turkish students did not differ significantly in regard to the overall measure of entrepreneurial self-efficacy. Our study contributed to the entrepreneurship literature by performing a cross-cultural comparison of the perceptions of entrepreneurial self-efficacy. Thus, it provided recommendations for fostering entrepreneurial self efficacy among university students.

Gabapentin enacarbil – clinical efficacy in restless legs syndrome

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Pinky Agarwal

2010-04-01

Full Text Available Pinky Agarwal1, Alida Griffith1, Henry R Costantino2, Narendra Vaish31Booth Gardner Parkinson’s Center, Kirkland, WA, USA; 2Costantino Consulting, Woodinville, WA, USA; 3Kirkland, WA, USAAbstract: Restless legs syndrome (RLS is a sleep-related movement disorder commonly involving an unpleasant urge to move the limbs, typically the legs. Dopaminergic agents represent the first-line therapy for RLS; however, long-term use of such drugs results in worsening symptoms due to “augmentation” or other adverse events. Gabapentin, an analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA, is an anticonvulsant/analgesic agent. Gabapentin is only mildly effective in relieving RLS symptoms, perhaps a result of its poor absorption from the gastrointestinal (GI tract. Gabapentin enacarbil is a prodrug of gabapentin specifically designed to enhance absorption via the GI tract, and hence provide improved circulating levels of gabapentin on metabolism. Clinical trials to date have demonstrated favorable safety and (compared to traditional gabapentin improved pharmacokinetics and efficacy in treating RLS symptoms. Thus, gabapentin enacarbil may prove to be a useful drug in treating RLS. An application of gabapentin enacarbil for treatment of RLS is currently pending with FDA for approval.Keywords: restless legs syndrome, gabapentin enacarbil, movement disorder

Efficacy of deferoxamine in animal models of intracerebral hemorrhage: a systematic review and stratified meta-analysis.

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Han-Jin Cui

Full Text Available Intracerebral hemorrhage (ICH is a subtype of stroke associated with high morbidity and mortality rates. No proven treatments are available for this condition. Iron-mediated free radical injury is associated with secondary damage following ICH. Deferoxamine (DFX, a ferric-iron chelator, is a candidate drug for the treatment of ICH. We performed a systematic review of studies involving the administration of DFX following ICH. In total, 20 studies were identified that described the efficacy of DFX in animal models of ICH and assessed changes in the brain water content, neurobehavioral score, or both. DFX reduced the brain water content by 85.7% in animal models of ICH (-0.86, 95% CI: -.48- -0.23; P < 0.01; 23 comparisons, and improved the neurobehavioral score by -1.08 (95% CI: -1.23- -0.92; P < 0.01; 62 comparisons. DFX was most efficacious when administered 2-4 h after ICH at a dose of 10-50 mg/kg depending on species, and this beneficial effect remained for up to 24 h postinjury. The efficacy was higher with phenobarbital anesthesia, intramuscular injection, and lysed erythrocyte infusion, and in Fischer 344 rats or aged animals. Overall, although DFX was found to be effective in experimental ICH, additional confirmation is needed due to possible publication bias, poor study quality, and the limited number of studies conducting clinical trials.

Efficacy of magneto-laser therapy in the treatment of ureaplasma infection

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N N Aliev

2018-04-01

Full Text Available Aim. To study clinical and epidemiological data in males and females with ureaplasma infection and to evaluate efficacy of magneto-laser therapy used as additional treatment of ureaplasma infection. Methods. 104 patients (94 men and 10 women with urogenital ureaplasma infection were observed. Patients were divided into two groups: a study group (n=55 that received standard and magneto-laser therapy, and a comparison group (n=49 that received only standard treatment. Polymerase chain reaction was used to investigate samples for Mycoplasma hominis, Ureaplasma parvum and urealyticum, and bacteriological study for Mycoplasma hominis and Ureaplasma spp. was additionally performed with determining their antibiotic susceptibility. Magnetic therapy was conducted with the use of Michelangelo device (Italy for 10 minutes to small pelvis area for 10 days. Results. As a result, 78 (82.9% males were diagnosed with uretritis, 52 (55.3% with prostatitis, 37 (39.3% with cystitis. In females monoinfection was more prevalent than in males (50.0% vs 40.4%. Ureaplasmosis predominantly affected subjects aged 20-29 (97.8% and 30-39 (86.0% years. In female group, patients aged 20-29 years prevailed, while in a male group - patients aged 30-39 years. In males, the association of Ureaplasma with Mycoplasma hominis (36.1% prevailed. Conclusion. Complex treatment of ureaplasma infection of urogenital tract including magneto-laser therapy demonstrated high clinical efficacy and allowed achieving clinical and laboratory cure of ureaplasma infection in 85.4% of cases.

The comparative study of clinical efficacy and safety of baclofen vs tolperisone in spasticity caused by spinal cord injury

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Dejun Luo

2017-05-01

Full Text Available In the present study we compared the clinical efficacy and safety of baclofen vs tolperisone in spasticity caused by spinal cord injury. A total of 150 patients were enrolled in the present study and were divided into two groups with 75 patients in each group, receiving baclofen or tolperisone, respectively. We used Modified Ashworth Scale, Medical research council scale, Barthel Index, and Coefficient of efficacy to measure clinical efficacy. After 6-week treatment, both groups demonstrated significant improvement in muscle tone, muscle strength and functional outcome (Group I, 1.55 ± 0.053, 2.79 ± 0.032, 59.31 ± 1.32; Group II, 1.57 ± 0.053, 3.04 ± 0.032, 73 ± 1.32 respectively. There was no significant difference regarding improvement in muscle tone and muscle strength between the two groups (Group I, 1.055 ± 0.053 vs Group II, 1.57 ± 0.053; Group I, 2.79 ± 0.032 vs Group II, 3.04 ± 0.032, p > 0.05. However, the improvement in functional outcomes was greater in group II as compared to that in group I (Group I, 59.31 ± 1.32 vs Group II, 73 ± 1.32, p < 0.05. In addition, overall efficacy coefficient was greater for group II as compared to group I (Group I, 3.6 vs Group II, 2.3, p < 0.05. Group I had more side effects compared to Group II. Compared to baclofen, tolperisone offers greater improvement in activities of daily living compared to baclofen.

Comparison of the efficacy of dihydropyridine calcium channel blockers in African American patients with hypertension. ISHIB Investigators Group. International Society on Hypertension in Blacks.

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Hall, W D; Reed, J W; Flack, J M; Yunis, C; Preisser, J

1998-10-12

Hypertension is a prevalent disease among African Americans, and successful treatment rates are low. Since calcium channel blockers are well-tolerated and efficacious in African Americans, we undertook this study to compare the efficacy, safety, and tolerability of 3 commonly prescribed calcium channel blockers: amlodipine besylate (Norvasc), nifedipine coat core (CC) (Adalat CC), and nifedipine gastrointestinal therapeutic system (GITS) (Procardia XL). One hundred ninety-two hypertensive patients across 10 study centers were randomly assigned to double-blind monotherapy with amlodipine besylate (5 mg/d), nifedipine CC (30 mg/d), or nifedipine GITS (30 mg/d) for 8 weeks. Patients not achieving therapeutic response after 4 weeks had their dose doubled for the next 4 weeks. The primary end point was a comparison of the average reduction (week 8 minus baseline) in 24-hour ambulatory diastolic blood pressure (DBP). Secondary end points included a comparison of average 24-hour ambulatory systolic blood pressure (SBP), office SBP or DBP reduction, responder rates, safety, and tolerability. One hundred sixty-three patients were evaluable for efficacy after 8 weeks. There was no significant difference in the average 24-hour ambulatory DBP (-8.5, -9.0, and -6.1 mm Hg, respectively) or SBP (-14.3, -15.7, and -11.8 mm Hg, respectively) reduction. Average office SBP and DBP were reduced to a comparable degree (19-22 mm Hg [P =.50] and 12-14 mm Hg [P =.51], respectively). Responder rates (DBP or = 10 mm Hg) were similar (P = .38). Discontinuation rates and adverse event frequency were distributed similarly across the 3 treatment groups. The efficacy, safety, and tolerability of the 3 dihydropyridine calcium channel blockers are equivalent in African Americans with stages 1 and 2 hypertension.

Safety, efficacy and pharmacokinetics of rVIII-SingleChain in children with severe hemophilia A: results of a multicenter clinical trial.

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Stasyshyn, O; Djambas Khayat, C; Iosava, G; Ong, J; Abdul Karim, F; Fischer, K; Veldman, A; Blackman, N; St Ledger, K; Pabinger, I

2017-04-01

Essentials rVIII-SingleChain is a novel recombinant factor VIII with covalently bonded heavy and light chains. Efficacy, safety and pharmacokinetics were studied in pediatric patients with severe hemophilia A. Across all prophylaxis regimens, the median annualized spontaneous bleeding rate was 0.00. rVIII-SingleChain showed excellent hemostatic efficacy and a favorable safety profile. Background rVIII-SingleChain is a novel B-domain truncated recombinant factor VIII (rFVIII) comprised of covalently bonded FVIII heavy and light chains, demonstrating a high binding affinity to von Willebrand factor. Objectives This phase III study investigated the safety, efficacy and pharmacokinetics of rVIII-SingleChain in previously treated pediatric patients hemophilia A. Patients/Methods Patients could be assigned to prophylaxis or on-demand therapy by the investigator. For patients assigned to prophylaxis, the treatment regimen and dose were based on the bleeding phenotype. For patients receiving on-demand therapy, dosing was guided by World Federation of Hemophilia recommendations. The primary endpoint was treatment success, defined as a rating of 'excellent' or 'good' on the investigator's clinical assessment of hemostatic efficacy for all treated bleeding events. Results The study enrolled 84 patients (0 to 50 EDs. In the 347 bleeds treated and evaluated by the investigator, hemostatic efficacy was rated as excellent or good in 96.3%. The median annualized spontaneous bleeding rate was 0.00 (Q1, Q3: 0.00, 2.20), and the median annualized bleeding rate was 3.69 (Q1, Q3: 0.00, 7.20) across all prophylaxis regimens. No participant developed an inhibitor. Conclusions rVIII-SingleChain is a novel rFVIII molecule showing excellent hemostatic efficacy and a favorable safety profile in a clinical study in children hemophilia A. © 2017 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals, Inc. on behalf of International Society on Thrombosis and

Efficacy, safety and tolerability of rasagiline as adjunctive therapy in elderly patients with Parkinson's disease.

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Tolosa, E; Stern, M B

2012-02-01

Rasagiline, an MAO-B inhibitor, is indicated for the treatment of Parkinson's disease (PD). In this post hoc analysis, the efficacy, safety and tolerability of rasagiline as an adjunct to levodopa were compared with placebo in elderly (≥70 years) and younger (Rasagiline: Efficacy and Safety on the Treatment of 'OFF' and Lasting effect in Adjunct therapy with Rasagiline Given Once daily randomized, double-blind, placebo-controlled trials with the primary efficacy end-point being the reduction from baseline in daily OFF time. Secondary efficacy end-points included scores for Clinical Global Improvement (CGI)-Examiner during ON time, Unified Parkinson's Disease Rating Scale (UPDRS)-ADL during OFF time, UPDRS-Motor during ON time and total daily ON time with and without troublesome dyskinesia. Tolerability was evaluated from adverse events (AEs) in the two age groups. Rasagiline decreased daily OFF time versus placebo (Prasagiline but were not significant. Between-group comparisons (≥70 vs. efficacy was unaffected by age for all end-points (P>0.1), and rasagiline was well tolerated amongst both groups of patients with a comparable incidence of total and dopaminergic AEs (P>0.1). Adjunct rasagiline is efficacious and well tolerated in elderly non-demented patients (≥70 years) with moderate to advanced PD. Confirmation of the efficacy and safety of rasagiline in the elderly patient subgroup is especially relevant because of the increasing number of elderly patients with PD. © 2011 The Author(s). European Journal of Neurology © 2011 EFNS.

Exposure-response relationships in patients with metastatic renal cell carcinoma receiving sunitinib: maintaining optimum efficacy in clinical practice.

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Ravaud, Alain; Bello, Carlo L

2011-06-01

Targeted agents such as sunitinib, an oral, multitargeted receptor tyrosine kinase inhibitor, have greatly improved the prognosis for patients with metastatic renal cell carcinoma (mRCC). In this review we analyse data from sunitinib preclinical and clinical studies in detail and consider the key implications for the effective use of sunitinib in clinical practice. Sunitinib has shown efficacy and acceptable tolerability in patients with mRCC in phase II and III clinical studies. In a pivotal phase III study in treatment-naïve patients with mRCC, median progression-free survival for sunitinib-treated patients was double of that with interferon-α (P relationship between clinical end points and sunitinib exposure showed that increased sunitinib exposure was associated with a greater probability of objective response, longer time to tumour progression and overall survival, as well as some increased risk of specific adverse events. It is important to consider the relationship between exposure and response to maximize clinical benefit from sunitinib treatment.

Efficacy of praziquantel against Schistosoma mekongi and Opisthorchis viverrini: a randomized, single-blinded dose-comparison trial.

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Leonore Lovis

Full Text Available BACKGROUND: Schistosomiasis and opisthorchiasis are of public health importance in Southeast Asia. Praziquantel (PZQ is the drug of choice for morbidity control but few dose comparisons have been made. METHODOLOGY: Ninety-three schoolchildren were enrolled in an area of Lao PDR where Schistosoma mekongi and Opisthorchis viverrini coexist for a PZQ dose-comparison trial. Prevalence and intensity of infections were determined by a rigorous diagnostic effort (3 stool specimens, each examined with triplicate Kato-Katz before and 28-30 days after treatment. Ninety children with full baseline data were randomized to receive PZQ: the 40 mg/kg standard single dose (n = 45 or a 75 mg/kg total dose (50 mg/kg+25 mg/kg, 4 hours apart; n = 45. Adverse events were assessed at 3 and 24 hours posttreatment. PRINCIPAL FINDINGS: Baseline infection prevalence of S. mekongi and O. viverrini were 87.8% and 98.9%, respectively. S. mekongi cure rates were 75.0% (95% confidence interval (CI: 56.6-88.5% and 80.8% (95% CI: 60.6-93.4% for 40 mg/kg and 75 mg/kg PZQ, respectively (P = 0.60. O. viverrini cure rates were significantly different at 71.4% (95% CI: 53.4-84.4% and 96.6% (95% CI: not defined, respectively (P = 0.009. Egg reduction rates (ERRs against O. viverrini were very high for both doses (>99%, but slightly lower for S. mekongi at 40 mg/kg (96.4% vs. 98.1% and not influenced by increasing diagnostic effort. O. viverrini cure rates would have been overestimated and no statistical difference between doses found if efficacy was based on a minimum sampling effort (single Kato-Katz before and after treatment. Adverse events were common (96%, mainly mild with no significant differences between the two treatment groups. CONCLUSIONS/SIGNIFICANCE: Cure rate from the 75 mg/kg PZQ dose was more efficacious than 40 mg/kg against O. viverrini but not against S. mekongi infections, while ERRs were similar for both doses. TRIAL REGISTRATION: Controlled

Desonide: a review of formulations, efficacy and safety.

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Kahanek, Nr; Gelbard, Cg; Hebert, Aa

2008-07-01

Desonide is a low-potency topical corticosteroid that has been used for decades in the treatment of steroid-responsive dermatoses. The favorable safety profile of this topical agent makes it ideal for patients of all ages. This article provides a review of desonide's history, pharmacodynamic properties, vehicle technology, efficacy and safety. Randomized controlled trials, as well as open-label and non-comparative studies, case series and reports, experimental models, and data from the Galderma pharmacovigiliance program were reviewed in order to address the clinical efficacy and safety of desonide. Clinical efficacy and safety have been proven in multiple clinical trials. In addition to cream, lotion and ointment formulations, the recently developed hydrogel and foam preparations have increased desonide's versatility and patient tolerability.

[Note on the epistemology of clinical pharmacology: comparison with the approach of Karl Popper].

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Boissel, J P

1999-01-01

Is clinical pharmacology a science or only an application of science? Karl Popper suggested a method to identify science and to sort it out from other logical activities such as metaphysics, whereby the falsification criterion he proposed can apply to the theory in such a way that the theory could be refuted. The clinical pharmacologist's approach requires the build-up of a therapeutic model on the basis of two other models: the physiopathologic and the pharmacological. The three-model construct is a theory. Is it scientific in the Popperian sense? From the therapeutic model, one can predict the efficacy of a drug, and the corresponding statement is tested by a clinical trial. Whatever the original statement, it is modified into a refutable one because of the use of the statistical approach in clinical trials. Furthermore, the predicate represents a hypothesis of the model validity, which will then be confronted with 'reality' through clinical experiment. As the therapeutic model is refutable, clinical pharmacology is a science in the Popperian sense.

Efficacy and safety of topical diquafosol ophthalmic solution for treatment of dry eye: a systematic review of randomized clinical trials.

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Wu, Di; Chen, Wang Qi; Li, Ryan; Wang, Yan

2015-06-01

To evaluate the efficacy and safety of topical diquafosol ophthalmic solution for treatment of dry eye. Randomized clinical trials (RCTs) from MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were identified to evaluate the efficacy and safety of topical administration of diquafosol to patients with dry eyes. Data evaluation was based on endpoints including Schirmer test, tear film break-up time, ocular surface staining score, subjective symptom score, and adverse events. A total of 8 RCTs involving 1516 patients were selected based on the prespecified criteria. Significant improvement of Schirmer test values and tear film break-up time were reported in 40% (2 of 5) and 80% (4 of 5) studies, respectively. Ocular surface staining scores significantly decreased in 100% (fluorescein corneal staining, 6 of 6; Rose Bengal corneal and conjunctival staining, 4 of 4) RCTs. Symptoms significantly improved in 75% (6 of 8) RCTs in patients with dry eyes. No severe adverse events were reported with the concentration of diquafosol from 0.5% to 5%. Heterogeneity in study design prevented meta-analysis from statistical integration and summarization. Topical diquafosol seems to be a safe therapeutic option for the treatment of dry eye. The high variability of the selected RCTs compromised the strength of evidence and limits the determination of efficacy. However, the topical administration of diquafosol seems to be beneficial in improving the integrity of the epithelial cell layer of the ocular surface and mucin secretion in patients with dry eyes. This review indicates a need for standardized criteria and methods for evaluation to assess the efficacy of diquafosol in the future clinical trials.

Comparative efficacy of escitalopram in the treatment of major depressive disorder

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Mazen K Ali

2011-02-01

inhibitors but the number of trials in these comparisons is limited. Efficacy differences are modest but clinically relevant, especially in more severely depressed patients.Keywords: escitalopram, depressive disorders, meta-analysis, pooled analysis, efficacy, antidepressants

Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache: An Open-Label, Single-Arm, Clinical Trial

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Cherubino Di Lorenzo

2018-02-01

Full Text Available IntroductionDrug-resistant cluster headache (CH is still an open clinical challenge. Recently, our group observed the clinical efficacy of a ketogenic diet (KD, usually adopted to treat drug-resistant epilepsies, on migraine.AimHere, we aim to detect the effect of KD in a group of drug-resistant chronic CH (CCH patients.Materials and methodsEighteen drug-resistant CCH patients underwent a 12-week KD (Modified Atkins Diet, MAD, and the clinical response was evaluated in terms of response (≥50% attack reduction.ResultsOf the 18 CCH patients, 15 were considered responders to the diet (11 experienced a full resolution of headache, and 4 had a headache reduction of at least 50% in terms of mean monthly number of attacks during the diet. The mean monthly number of attacks for each patient at the baseline was 108.71 (SD = 81.71; at the end of the third month of diet, it was reduced to 31.44 (SD = 84.61.ConclusionWe observed for the first time that a 3-month ketogenesis ameliorates clinical features of CCH.Clinical Trial Registrationwww.ClinicalTrials.gov, identifier NCT03244735.

Clinical efficacy of sunitinib combined with autologous DC and CIK for patients with metastatic renal cell carcinoma

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Liang ZHANG

2014-01-01

Full Text Available Objective　To analyze the clinical efficacy and safety of sunitinib combined with autologous dentritic cell (DC and cytokine induced killer cell (CIK for patients suffering from metastatic renal cell carcinoma (mRCC. Methods　Clinical data of 27 mRCC patients treated with sunitinib combined with autologous DC and CIK were reviewed retrospectively. Efficacy, quality of life, immunology and safety of this treatment were evaluated. Results　Follow-up time ranged from 4 to 25 months. Out of all the patients, sunitinib was reduced in 1 and discontinued in 2 due to side effects; 1 patient quit for personal reasons; 14 patients developed progressive disease. The progression-free survival (PFS was 4 to 19.5 months. Ten patients died from tumor, the overall survival time (OS was 6 to 21 months. The median PFS was 16 months (95%CI 12.5-19.5. The OS was not achieved. The efficacy was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST. All the patients received treatment over 1 cycle. After one course of treatment, among 27 patients, 0 had complete remission (CR, 4 had partial remission (PR, 17 had stable disease (SD, and 6 had progressive disease (PD. The overall objective remission rate (ORR and disease control rate (DCR were 14.8% (4/27 and 77.8% (21/27, respectively. Sunitinib and autologous transfusion of DC and CIK improved the immune function and quality of life. The major adverse events were fatigue, hand-foot syndrome, hypertension, hypothyroidism, thrombocytopenia, neutropenia and fever. Most of the adverse events were ameliorated by supportive treatment or dose reduction. Conclusions　 Sunitinib combined with autologous DC and CIK may be beneficial in the treatment of mRCC with acceptable toxic reactions, and it may be considered as a new approach for the comprehensive treatment of RCC. DOI: 10.11855/j.issn.0577-7402.2013.12.06

Radiosensitizing efficacy of iso-metronidazole after intravesical application in bladder cancer. A clinical phase II study

International Nuclear Information System (INIS)

Kob, D.; Lilienthal, A.; Bauhardt, H.; Merkle, K.; Schroeder, E.; Schroeder, E.; Hentschel, M.

1991-01-01

The radiosensitizing efficacy of iso-Metronidazole, a 4-Nitroimidazole derivative, was evaluated in a prospective clinical phase II study. The results of combined radiotherapy of 25 patients with bladder cancer were compared with those of a control group of 25 patients treated with radiotherapy only. Tumor regression six months after radiotherapy was used as an endpoint. The surgical procedure was performed as double TUR. Evaluating the local tumor control after additional application of iso-Metronidazole a gain factor of 1.2 is obtained. (orig.) [de

Efficacy of Turmeric Extracts and Curcumin for Alleviating the Symptoms of Joint Arthritis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

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Daily, James W.; Yang, Mini

2016-01-01

Abstract Although turmeric and its curcumin-enriched extracts have been used for treating arthritis, no systematic review and meta-analysis of randomized clinical trials (RCTs) have been conducted to evaluate the strength of the research. We systemically evaluated all RCTs of turmeric extracts and curcumin for treating arthritis symptoms to elucidate the efficacy of curcuma for alleviating the symptoms of arthritis. Literature searches were conducted using 12 electronic databases, including PubMed, Embase, Cochrane Library, Korean databases, Chinese medical databases, and Indian scientific database. Search terms used were “turmeric,” “curcuma,” “curcumin,” “arthritis,” and “osteoarthritis.” A pain visual analogue score (PVAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) were used for the major outcomes of arthritis. Initial searches yielded 29 articles, of which 8 met specific selection criteria. Three among the included RCTs reported reduction of PVAS (mean difference: −2.04 [−2.85, −1.24]) with turmeric/curcumin in comparison with placebo (P < .00001), whereas meta-analysis of four studies showed a decrease of WOMAC with turmeric/curcumin treatment (mean difference: −15.36 [−26.9, −3.77]; P = .009). Furthermore, there was no significant mean difference in PVAS between turmeric/curcumin and pain medicine in meta-analysis of five studies. Eight RCTs included in the review exhibited low to moderate risk of bias. There was no publication bias in the meta-analysis. In conclusion, these RCTs provide scientific evidence that supports the efficacy of turmeric extract (about 1000 mg/day of curcumin) in the treatment of arthritis. However, the total number of RCTs included in the analysis, the total sample size, and the methodological quality of the primary studies were not sufficient to draw definitive conclusions. Thus, more rigorous and larger studies are needed to confirm the therapeutic efficacy

Comparison of Efficacy of Long?term Oral Treatment with Telmisartan and Benazepril in Cats with Chronic Kidney Disease

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Sent, U.; G?ssl, R.; Elliott, J.; Syme, H. M.; Zimmering, T.

2015-01-01

Background The efficacy and benefits of telmisartan in cats with chronic kidney disease (CKD) have not previously been reported. Hypothesis Long?term treatment of cats with CKD using telmisartan decreases urine protein?to?creatinine ratio (UP/C) similar to benazepril. Animals Two?hundred and twenty?four client?owned adult cats with CKD. Methods Prospective, multicenter, controlled, randomized, parallel group, blinded clinical trial with noninferiority design. Cats were allocated in a 1 : 1 ra...

Comparison of Self-Efficacy and Loneliness Between Community-Dwelling & Institutionalized Older People

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Mohammad Heidari

2016-04-01

Conclusion: With regard to the low mean score of self-efficacy of older adults residing in nursing homes, the authorities of nursing homes should pay attention to the needs of older adults and provide general education about promoting the tradition of caring older people by their families. Furthermore, all institutions and organizations that have important goals such as healthy older adults should advance toward their goals by planning, education, and consultation with families that care about their older adults. Finally, with regard to the results about the association of self-efficacy with loneliness, self-efficacy assessment should be considered one of the effective factors in psychological dimensions of the people and a way to support the self-care of older adults because promoting self-efficacy will result in managing stress and improving the mental health. 

Clinical Efficacy of Andrographolide Sulfonate in the Treatment of Severe Hand, Foot, and Mouth Disease (HFMD) is Dependent upon Inhibition of Neutrophil Activation.

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Wen, Tao; Xu, Wenjun; Liang, Lianchun; Li, Junhong; Ding, Xiaorong; Chen, Xiao; Hu, Jianhua; Lv, Aiping; Li, Xiuhui

2015-08-01

Andrographolide sulfonate treatment has been shown to improve clinical severe hand, foot, and mouth disease (HFMD) efficacies when combined with conventional therapy. However, the mechanisms for its therapeutic effects remain elusive. In this study, we aimed to investigate whether andrographolide sulfonate exerts its efficacy by acting on neutrophil activation. We obtained serial plasma samples at two time points (before and after 5 days of therapy) from 28 HFMD patients who received conventional therapy and 18 patients who received combination therapy (andrographolide sulfonate plus conventional therapy). Then, we measured plasma myeloperoxidase (MPO), S100A8/A9, histone, and inflammatory cytokine levels. Furthermore, we examined if andrographolide sulfonate had direct effects on neutrophil activation in vitro. We observed that MPO and S100A8/A9 levels were markedly elevated in the HFMD patients before clinical treatment. At 5 days post-medication, the MPO, S100A8/A9, histone, and interleukin-6 levels were markedly lower in the combination therapy group compared with the conventional therapy group. In vitro studies showed that andrographolide sulfonate inhibited lipopolysaccharide-stimulated neutrophil activation, demonstrated by the decreased production of reactive oxygen species and cytokines. These data indicate that neutrophil activation modulation by andrographolide sulfonate may be a critical determinant for its clinical HFMD treatment efficacy. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

The forgotten role of alcohol: a systematic review and meta-analysis of the clinical efficacy and perceived role of chlorhexidine in skin antisepsis.

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Matthias Maiwald

Full Text Available BACKGROUND: Skin antisepsis is a simple and effective measure to prevent infections. The efficacy of chlorhexidine is actively discussed in the literature on skin antisepsis. However, study outcomes due to chlorhexidine-alcohol combinations are often attributed to chlorhexidine alone. Thus, we sought to review the efficacy of chlorhexidine for skin antisepsis and the extent of a possible misinterpretation of evidence. METHODS: We performed a systematic literature review of clinical trials and systematic reviews investigating chlorhexidine compounds for blood culture collection, vascular catheter insertion and surgical skin preparation. We searched PubMed, CINAHL, the Cochrane Library, the Agency for Healthcare Research and Quality website, several clinical trials registries and a manufacturer website. We extracted data on study design, antiseptic composition, and the following outcomes: blood culture contamination, catheter colonisation, catheter-related bloodstream infection and surgical site infection. We conducted meta-analyses of the clinical efficacy of chlorhexidine compounds and reviewed the appropriateness of the authors' attribution. RESULTS: In all three application areas and for all outcomes, we found good evidence favouring chlorhexidine-alcohol over aqueous competitors, but not over competitors combined with alcohols. For blood cultures and surgery, we found no evidence supporting chlorhexidine alone. For catheters, we found evidence in support of chlorhexidine alone for preventing catheter colonisation, but not for preventing bloodstream infection. A range of 29 to 43% of articles attributed outcomes solely to chlorhexidine when the combination with alcohol was in fact used. Articles with ambiguous attribution were common (8-35%. Unsubstantiated recommendations for chlorhexidine alone instead of chlorhexidine-alcohol were identified in several practice recommendations and evidence-based guidelines. CONCLUSIONS: Perceived efficacy

The use of educational video to promote maternal self-efficacy in preventing early childhood diarrhoea.

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Joventino, Emanuella Silva; Ximenes, Lorena Barbosa; da Penha, Jardeliny Corrêa; Andrade, Lucilande Cordeiro de Oliveira; de Almeida, Paulo César

2017-06-01

Diarrhoea is responsible for high rates of infant morbidity and mortality. It is multifactorial, manifested by socioeconomic, hygienic, and maternal factors. The aim of this study is to evaluate the effects of an educational video on maternal self-efficacy for the prevention of childhood diarrhoea. This was a randomized trial conducted in the state of Ceará, Brazil. Participants were 2 groups (comparison and intervention), composed of mothers of children under 5 years of age. Group membership was allocated by cluster randomization. Outcomes were maternal self-efficacy measured using the Maternal Self-efficacy Scale for Prevention of Early Childhood Diarrhoea; outcome data collectors were blinded to group allocation. Ninety participants were randomized to each group; 83 intervention group and 80 comparison group members were contained in the final analysis. Maternal self-efficacy in preventing childhood diarrhoea increased in both groups, but average scores of the intervention group were higher at all time than those of the comparison group. The educational video had a significant effect on maternal self-efficacy. © 2017 John Wiley & Sons Australia, Ltd.

Nanodiamonds enhance therapeutic efficacy of doxorubicin in treating metastatic hormone-refractory prostate cancer.

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Salaam, Amanee D; Hwang, Patrick T J; Poonawalla, Aliza; Green, Hadiyah N; Jun, Ho-wook; Dean, Derrick

2014-10-24

Enhancing therapeutic efficacy is essential for successful treatment of chemoresistant cancers such as metastatic hormone-refractory prostate cancer (HRPC). To improve the efficacy of doxorubicin (DOX) for treating chemoresistant disease, the feasibility of using nanodiamond (ND) particles was investigated. Utilizing the pH responsive properties of ND, a novel protocol for complexing NDs and DOX was developed using a pH 8.5 coupling buffer. The DOX loading efficiency, loading on the NDs, and pH responsive release characteristics were determined utilizing UV-Visible spectroscopy. The effects of the ND-DOX on HRPC cell line PC3 were evaluated with MTS and live/dead cell viability assays. ND-DOX displayed exceptional loading efficiency (95.7%) and drug loading on NDs (23.9 wt%) with optimal release at pH 4 (80%). In comparison to treatment with DOX alone, cell death significantly increased when cells were treated with ND-DOX complexes demonstrating a 50% improvement in DOX efficacy. Of the tested treatments, ND-DOX with 2.4 μg mL(-1) DOX exhibited superior efficacy (60% cell death). ND-DOX with 1.2 μg mL(-1) DOX achieved 42% cell death, which was comparable to cell death in response to 2.4 μg mL(-1) of free DOX, suggesting that NDs aid in decreasing the DOX dose necessary to achieve a chemotherapeutic efficacy. Due to its enhanced efficacy, ND-DOX can be used to successfully treat HRPC and potentially decrease the clinical side effects of DOX.

Two-year clinical comparison of a flowable-type nano-hybrid composite and a paste-type composite in posterior restoration.

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Hirata-Tsuchiya, Shizu; Yoshii, Shinji; Ichimaru-Suematsu, Miki; Washio, Ayako; Saito, Noriko; Urata, Mariko; Hanada, Kaori; Morotomi, Takahiko; Kitamura, Chiaki

2017-08-01

The purpose of the present study was to compare the clinical efficacy between a flowable-type nano-hybrid composite and a paste-type composite for posterior restoration. Of 62 posterior teeth in 33 patients (mean age: 34.1 years), 31 were filled with a paste-type composite (Heliomolar [HM] group), and another 31 with a flowable nano-hybrid composite (MI FIL [MI] group). Clinical efficacy was evaluated at 2 years after the restoration. There were no differences for retention, surface texture deterioration, anatomical form change, deterioration of marginal adaptation, and secondary caries, while a statistical difference was found for marginal discoloration, which was significantly greater in the HM group (P < 0.05). Furthermore, color matching in the MI group was superior to that in the HM group immediately after the restoration throughout the study period. The present 2-year clinical evaluation of different composites showed that the flowable nano-hybrid composite could be an effective esthetic material for posterior restoration. © 2016 John Wiley & Sons Australia, Ltd.

Pharmacotherapy of Insomnia with Ramelteon: Safety, Efficacy and Clinical Applications

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Seithikurippu R. Pandi-Perumal

2011-01-01

Full Text Available Ramelteon is a tricyclic synthetic analog of melatonin that acts specifically on MT 1 and MT 2 melatonin receptors. Ramelteon is the first melatonin receptor agonist approved by the Food and Drug Administration (FDA for the treatment of insomnia characterized by sleep onset difficulties. Ramelteon is both a chronobiotic and a hypnotic that has been shown to promote sleep initiation and maintenance in various preclinical and in clinical trials. The efficacy and safety of ramelteon in patients with chronic insomnia was initially confirmed in short-term placebo-controlled trials. These showed little evidence of next-day residual effects, withdrawal symptoms or rebound insomnia. Other studies indicated that ramelteon lacked abuse potential and had a minimal risk of producing dependence or adverse effects on cognitive or psychomotor performance. A 6-month placebo-controlled international study and a 1-year open-label study in the USA demonstrated that ramelteon was effective and well tolerated. Other potential off-label uses of ramelteon include circadian rhythm sleep disorders such as shift-work and jet lag. At the present time the drug should be cautiously prescribed for short-term treatment only.

Antihypertensive efficacy and tolerability of lercanidipine in daily clinical practice. The ELYPSE Study. Eficacia de Lercanidipino y su Perfil de Seguridad.

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Barrios, Vivencio; Navarro, Angel; Esteras, Antonio; Luque, Manuel; Romero, Joaquima; Tamargo, Juan; Prieto, Luis; Carrasco, Jose Luis; Herranz, Inmaculada; Navarro-Cid, Josefa; Ruilope, Luis M

2002-01-01

Lercanidipine, a long-acting dihydropyridine with a good antihypertensive efficacy and tolerability in clinical use. With the aim to determine the efficacy and tolerability of this drug in usual clinical practice we performed the ELYPSE trial. Grade 1 or 2 essential hypertensive patients in whom their physicians considered to prescribe a dihydropyridine were conferred to Lercanidipine 10 mg once daily with a 3-month follow-up; 9059 patients were included (age: 63 +/- 11 years; 58% women, 60% over 60 years, 56% grade 2 hypertensives and 69% previously treated with other antihypertensive drugs). A subgroup of 1267 patients (14%) who were included in the study had experienced adverse reactions with other drugs. Electronic case-report forms and a central database (Internet) were used in this trial. At baseline, blood pressure (BP) was 160.1 +/- 10.2/95.6 +/- 6.6 mmHg; and heart rate (HR) 77.3 +/- 9.3 beats/min. Significant reductions in both systolic and diastolic BP were attained at 1 month with slight additional decreases 2 months later. At 3 months, BP was 141.4 +/- 11.3/ 83.1 +/- 6.9 mmHg, and HR 75.2 +/- 8.2 beats/min (p < 0.001 versus baseline). At the study end. 64% of the patients achieved a diastolic BP < 90 mmHg, BP control (< 140/90 mmHg) was attained in 32%. In the subgroup of diabetics (n = 1269) an adequate BP control (< 130/85) was attained in only 16.4%. The overall incidence of adverse events was 6.5%, of which the most frequent were headache (2.9%), ankle oedema (1.2%), flushing (1.1%) and palpitations (0.6%). Withdrawal rate was < 1%. The efficacy and tolerability in the subgroup of patients included in the study due to adverse events with other drugs were similar to the whole study group. In this study Lercanidipine has shown a good efficacy and tolerability in daily clinical practice. These findings are concordant with those reported in randomized controlled trials.

The clinical efficacy evaluation of transcatheter hardening treatment for varicose veins of lower extremity

International Nuclear Information System (INIS)

Chen Junhui; Ren Yi; He Ping; Xiong Hongli; Wang Li; Zhou Xianbo

2007-01-01

Objective: To explore the clinical efficacy and safety of transcatheter absolute ethanol injection treatment on varicose veins of lower extremity. Methods: twenty-there patients with 25 varicose veins of lower extremity were treated by puncture of great saphenous vein above 1-2 cm of complicated inner ankle, perforating catheter to the point below the 3-4 cm of the conjunction of great saphenous vein and Femoral vein and pressing the conjunction of these two veins. Under the monitor of DSA, inject the absolute ethanol slowly while retrieve the catheter little by little (one limb with varicose veins injected total volume 15-20 mi), in the mean time, using contrast agent to monitor the level of embolism until the formation of total embolism in the all great saphenous veins. Results: All the cases were retrospectively followed up with CDFI examination after 3-12 months of the surgery, No blood flow were seen in the 25 embolismic great saphenous vein. Clinical symptom were alleviated obviously after 2-3 weeks of treatment; varicose veins were collapse after 3 to 7 days. Two cases of leg ulceration were healed after 4 to 6 weeks of operation. 20 limbs were found mild swelling in the 2 day after the surgery. However, all the cases were disappeared after 1 to 2 weeks; 4 treated limbs developed delayed paresthesia in the 3 day after the surgery, and recovered totally in the 2 weeks. No complications of deep vein thrombosis, lung thrombosis etc al, were found after operation. Conclusions: Using transcatheter injection of absolute ethanol to treat varicose veins of lower extremity has the advantage of less invasion, more safety and low appearance of complications. The short term efficacy is solid while the long term effect needs further evaluation. (authors)

Efficacy and tolerability of rasagiline in daily clinical use--a post-marketing observational study in patients with Parkinson's disease.

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Reichmann, H; Jost, W H

2010-09-01

The MAO-B inhibitor rasagiline is indicated for the treatment of idiopathic Parkinson's disease (PD), and its use is supported by evidence from large-scale, controlled clinical studies. The post-marketing observational study presented here investigated the efficacy and tolerability of rasagiline treatment (monotherapy or combination therapy) in daily clinical practice. The study included patients with idiopathic PD who received rasagiline (recommended dose 1 mg, once daily) as monotherapy or combination therapy. The treatment and observation period was approximately 4 months. Outcome measures included the change from baseline in the Columbia University Rating Scale (CURS), the Unified PD Rating Scale fluctuation subscale, daily OFF time (patient home diaries) and the PD Questionnaire-39. Adverse drug reactions/adverse events (ADRs/AEs) and the physician's global judgement of tolerability and efficacy were also examined. Overall, 754 patients received rasagiline during the study. Patients treated with rasagiline (monotherapy or combination therapy) showed significant improvements from baseline in symptom severity (including classical motor and non-classical motor/non-motor symptoms) and quality of life (QoL). Patients receiving combination therapy also experienced significant reductions in daily OFF time. Tolerability was rated as good/very good in over 90% of patients. In daily clinical practice, monotherapy or combination therapy with rasagiline is able to improve PD symptoms, reduce OFF time, and improve QoL, whilst demonstrating favourable tolerability. In addition, rasagiline has a simple dosing schedule of one tablet, once daily, with no titration. These results are consistent with the pivotal rasagiline clinical studies (TEMPO, LARGO and PRESTO).

The effect of nurse-led problem-solving therapy on coping, self-efficacy and depressive symptoms for patients with chronic obstructive pulmonary disease: a randomised controlled trial.

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Lee, Haejung; Yoon, Ju Young; Lim, Yeonjung; Jung, HeeYoung; Kim, Sungmin; Yoo, Younja; Kim, Yunseong; Ahn, Jong-Joon; Park, Hye-Kyung

2015-05-01

to examine the effects of nurse-led, problem-solving therapy (PST) on coping, self-efficacy and depressive symptoms for patients with chronic obstructive pulmonary disease (COPD) using a randomised controlled trial. a total of 254 patients with COPD were recruited, screened and randomly allocated into the intervention group with nurse-led PST or the comparison group with usual care. A total of 151 patients (intervention = 78 and comparison = 73) completed the study for 6 months. the nurse-led PST was an individualised and patient-centred intervention to improve patients' problem-solving skills related to symptom management and lifestyle modification. Twelve telephone-based PST sessions were provided to the intervention group, while the control group received usual care from their primary care providers. there were no group differences of post-test scores in problem-oriented coping, self-efficacy and depressive symptoms between the two groups. However, despite the lack of group differences, the nurse-led PST was effective for clinically depressed patients with COPD, who experienced decreased depressive symptoms (mean difference = 6.8, P = 0.009) and increased self-efficacy (mean difference = -0.6, P = 0.041) in the intervention group (n = 12). the nurse-led PST offered to patients with COPD did not demonstrate any different effects compared with usual care over 6 months; however, a subgroup analysis with clinically depressed subjects showed improved self-efficacy and decreased depressive symptoms in the intervention group. © The Author 2014. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Clinical efficacy of Rifampicin and Streptomycin in combination ...

African Journals Online (AJOL)

Buruli ulcer (BU) is a cutaneous neglected tropical disease caused by Mycobacterium ulcerans. Synthesizing the evidence on their efficacy of antibiotic in the management of BU can help to better define their roles, identify weaknesses and inform clinicians on relevant measures than can be used to control BU.

Clinical spectrum of seizures and efficacy of anticonvulsive treatment in children

International Nuclear Information System (INIS)

Mahmud, S.; Zman, S.Q.

2017-01-01

Objective: To study the clinical spectrum of seizures and efficacy of anticonvulsive treatment in children. Study Design: A descriptive study. Place and Duration of Study: Military Hospital (MH) Rawalpindi from October 2011 to March 2012. Material and Methods: One hundred children of either gender aged 1 month to 12 years presenting with seizures at Military Hospital Rawalpindi were evaluated and consented to participate in the study. All children with a febrile seizures were evaluated. The seizures were classified according to international league against epilepsy guidelines. Antiepileptic treatment regimen was evaluated in terms of number of drugs, correct dosage and efficacy in control of seizures. Results: It was observed that generalized seizures were (58 percent) followed by focal seizures (32 percent) in children. Valproic acid was prescribed in (51 percent) cases. Epilepsy was diagnosed in (56 percent) followed by cerebral palsy (20 percent), post meningoencephalitis sequalae (11 percent), intracranial hemorrhage (7 percent) and leukodystrophies (3 percnet) as underlying cause of seizures. Statistically significant association was seen between age groups and diagnosis (p value=0.001); age groups and types of seizures (p value=0.046); correct dosage of antiepileptics and control of seizures (p value=0.007); compliance to treatment and control of seizures (p value=0.007). Conclusion: Generalized seizures are the commonest form followed by focal seizures. Epilepsy was the common etiology of seizures in all age groups in children. Cerebral palsy was the second leading cause of seizures in children followed by post meningoencephalitis, stroke and leukodystrophies. Valproic acid was the most commonly prescribed antiepileptic. Normal delivery with delayed cry was the major risk factor for cerebral palsy. Prescription of appropriate antiepileptics according to diagnosis in optimum dosage and compliance to treatment affect control of seizures in children. (author)

[Pharmacokinetics and clinical efficacy of flomoxef in neonates].

Science.gov (United States)

Azagami, S; Isohata, E; Takeda, S; Kin, Y; Oikawa, T; Osano, M; Shiro, H

1991-11-01

Clinical pharmacology and efficacy of flomoxef (FMOX) in neonates were investigated. And the following results were obtained. 1. Mean serum concentrations of FMOX at 30 minutes after administration were 24.3 micrograms/ml, 47.6 micrograms/ml, and 85.8 micrograms/ml at doses of 10 mg/kg, 20 mg/kg, and 40 mg/kg administered, respectively. 2. Mean serum half-lives of FMOX were 3.4 hours in 0-3 day-old neonates, and 2.6 hours in 4 day-old or older subjects. 3. A dose response was evident among different dose groups given 10 mg/kg, 20 mg/kg, and 40 mg/kg. 4. Urinary recovery rates of FMOX in the first 6 hours after administration ranged between 12.8 and 51.1%. 5. FMOX was effective in 7 out of 8 cases in which causative pathogens were identified. 6. Diarrhea was observed in 1 case as a side effect of the drug, but the symptom was relieved soon after the completion of the treatment. There was no case in which any abnormal laboratory results were observed. 7. FMOX has a broad spectrum of activities against Gram-positive and Gram-negative aerobes and anaerobes. It is stable against most of beta-lactamases. It was demonstrated to be highly effective in our study, and yet without any serious side effects. FMOX is therefore considered to be one of the useful agents of the first choice for the treatment of bacterial infections such as sepsis and urinary tract infections in neonates and infants.

Randomized clinical trial to evaluate the efficacy of a 5-day ceftiofur hydrochloride intramammary treatment on nonsevere gram-negative clinical mastitis.

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Schukken, Y H; Bennett, G J; Zurakowski, M J; Sharkey, H L; Rauch, B J; Thomas, M J; Ceglowski, B; Saltman, R L; Belomestnykh, N; Zadoks, R N

2011-12-01

The objective of this study was to evaluate the efficacy of intramammary treatment with ceftiofur hydrochloride of nonsevere, clinical coliform mastitis. One hundred four cases on 5 farms met the enrollment criteria for the study. Escherichia coli was the most common coliform species identified in milk samples from cows with mild to moderate clinical mastitis, followed by Klebsiella spp. and Enterobacter spp. At enrollment, a milk sample from the affected quarter was taken and used for on-farm culture or submitted to the laboratory. For cows in the treatment group, treatment was initiated with ceftiofur hydrochloride via intramammary infusion at 24-h intervals for 5 d according to label standards. Cows in the control group did not receive treatment. Culture results were available on the day after enrollment and only cows with coliform mastitis continued in the treatment and untreated control groups. Bacteriological cure was defined based on 2 posttreatment milk samples. Molecular typing was used for final definition of bacteriological cure. Treatment of nonsevere clinical gram-negative mastitis with ceftiofur hydrochloride resulted in a significant increase in bacteriological cure compared with nontreated controls in animals infected with E. coli or Klebsiella spp. Treated animals clinically improved significantly more compared with control cows. No significant differences were observed between treated and control animals in milk production or linear score before or after clinical mastitis. Treated animals left the study less frequently compared with control animals. Copyright © 2011 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Clinical efficacy of puerarin combined with compound ammonium glycyrrhetate S in treatment of alcoholic hepatitis

Directory of Open Access Journals (Sweden)

JI Huichun

2014-10-01

Full Text Available ObjectiveTo investigate the clinical efficacy of puerarin combined with compound ammonium glycyrrhetate S in the treatment of alcoholic hepatitis. MethodsA total of 92 patients with alcoholic hepatitis who were admitted to our hospital from February 2011 to February 2014 were recruited in this study and randomly divided into two groups. The control group (n=46 was treated with conventional therapy combined with compound ammonium glycyrrhetate S. The test group (n=46 was treated with puerarin in addition to the regimen used in the control group. After 20 days of treatment, the levels of total bilirubin (TBil, alanine aminotransferase (ALT, aspartate aminotransferase (AST, glutamyl transpeptidase (GGT, albumin (Alb, Glasgow alcoholic hepatitis score (GAHS, and abdominal ultrasound were measured and compared with the results before the treatment in both groups. The clinical efficacy and adverse reactions in the two groups were also compared. ResultsAfter the treatment, the GAHSs and levels of TBil, ALT, AST, and GGT in the two groups were all significantly lower than those before the treatment (all P＜0.05. In the test group after the treatment, the levels of TBil (20.96±6.85 μmol/L, ALT (33.72±14.18 U/L, and AST (38.69±6.38 U/L were all significantly lower than those in the control group (all P＜0.05. The marked response rate, overall response rate, and rate of improvement in abdominal ultrasound in the test group were 63.04%, 93.48%, and 44.44%, respectively, all significantly higher than those in the control group (all P＜0.05. There was no significant difference in adverse reactions between the two groups (P＞0.05. ConclusionFor patients with alcoholic hepatitis, the combined therapy with puerarin and compound ammonium glycyrrhetate S can improve the treatment outcome and protect the liver function, and it has high safety and holds promise for clinical application.

Preclinical antivenom-efficacy testing reveals potentially disturbing deficiencies of snakebite treatment capability in East Africa.

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Robert A Harrison

2017-10-01

Full Text Available Antivenom is the treatment of choice for snakebite, which annually kills an estimated 32,000 people in sub-Saharan Africa and leaves approximately 100,000 survivors with permanent physical disabilities that exert a considerable socioeconomic burden. Over the past two decades, the high costs of the most polyspecifically-effective antivenoms have sequentially reduced demand, commercial manufacturing incentives and production volumes that have combined to create a continent-wide vacuum of effective snakebite therapy. This was quickly filled with new, less expensive antivenoms, many of which are of untested efficacy. Some of these successfully marketed antivenoms for Africa are inappropriately manufactured with venoms from non-African snakes and are dangerously ineffective. The uncertain efficacy of available antivenoms exacerbates the complexity of designing intervention measures to reduce the burden of snakebite in sub-Saharan Africa. The objective of this study was to preclinically determine the ability of antivenoms available in Kenya to neutralise the lethal effects of venoms from the most medically important snakes in East Africa.We collected venom samples from the most medically important snakes in East Africa and determined their toxicity in a mouse model. Using a 'gold standard' comparison protocol, we preclinically tested the comparative venom-neutralising efficacy of four antivenoms available in Kenya with two antivenoms of clinically-proven efficacy. To explain the variant efficacies of these antivenoms we tested the IgG-venom binding characteristics of each antivenom using in vitro IgG titre, avidity and venom-protein specificity assays. We also measured the IgG concentration of each antivenom.None of the six antivenoms are preclinically effective, at the doses tested, against all of the most medically important snakes of the region. The very limited snake polyspecific efficacy of two locally available antivenoms is of concern. In vitro

Clinical and Demographic Factors Associated with the Cognitive and Emotional Efficacy of Regular Musical Activities in Dementia.

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Särkämö, Teppo; Laitinen, Sari; Numminen, Ava; Kurki, Merja; Johnson, Julene K; Rantanen, Pekka

2016-01-01

Recent evidence suggests that music-based interventions can be beneficial in maintaining cognitive, emotional, and social functioning in persons with dementia (PWDs). Our aim was to determine how clinical, demographic, and musical background factors influence the cognitive and emotional efficacy of caregiver-implemented musical activities in PWDs. In a randomized controlled trial, 89 PWD-caregiver dyads received a 10-week music coaching intervention involving either singing or music listening or standard care. Extensive neuropsychological testing and mood and quality of life (QoL) measures were performed before and after the intervention (n = 84) and six months later (n = 74). The potential effects of six key background variables (dementia etiology and severity, age, care situation, singing/instrument playing background) on the outcome of the intervention were assessed. Singing was beneficial especially in improving working memory in PWDs with mild dementia and in maintaining executive function and orientation in younger PWDs. Music listening was beneficial in supporting general cognition, working memory, and QoL especially in PWDs with moderate dementia not caused by Alzheimer's disease (AD) who were in institutional care. Both music interventions alleviated depression especially in PWDs with mild dementia and AD. The musical background of the PWD did not influence the efficacy of the music interventions. Our findings suggest that clinical and demographic factors can influence the cognitive and emotional efficacy of caregiver-implemented musical activities and are, therefore, recommended to take into account when applying and developing the intervention to achieve the greatest benefit.

Efficacy measures associated to a plantar pressure based classification system in diabetic foot medicine.

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Deschamps, Kevin; Matricali, Giovanni Arnoldo; Desmet, Dirk; Roosen, Philip; Keijsers, Noel; Nobels, Frank; Bruyninckx, Herman; Staes, Filip

2016-09-01

The concept of 'classification' has, similar to many other diseases, been found to be fundamental in the field of diabetic medicine. In the current study, we aimed at determining efficacy measures of a recently published plantar pressure based classification system. Technical efficacy of the classification system was investigated by applying a high resolution, pixel-level analysis on the normalized plantar pressure pedobarographic fields of the original experimental dataset consisting of 97 patients with diabetes and 33 persons without diabetes. Clinical efficacy was assessed by considering the occurence of foot ulcers at the plantar aspect of the forefoot in this dataset. Classification efficacy was assessed by determining the classification recognition rate as well as its sensitivity and specificity using cross-validation subsets of the experimental dataset together with a novel cohort of 12 patients with diabetes. Pixel-level comparison of the four groups associated to the classification system highlighted distinct regional differences. Retrospective analysis showed the occurence of eleven foot ulcers in the experimental dataset since their gait analysis. Eight out of the eleven ulcers developed in a region of the foot which had the highest forces. Overall classification recognition rate exceeded 90% for all cross-validation subsets. Sensitivity and specificity of the four groups associated to the classification system exceeded respectively the 0.7 and 0.8 level in all cross-validation subsets. The results of the current study support the use of the novel plantar pressure based classification system in diabetic foot medicine. It may particularly serve in communication, diagnosis and clinical decision making. Copyright © 2016 Elsevier B.V. All rights reserved.

Duloxetine compared with fluoxetine and venlafaxine: use of meta-regression analysis for indirect comparisons

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Lançon Christophe

2006-07-01

Full Text Available Abstract Background Data comparing duloxetine with existing antidepressant treatments is limited. A comparison of duloxetine with fluoxetine has been performed but no comparison with venlafaxine, the other antidepressant in the same therapeutic class with a significant market share, has been undertaken. In the absence of relevant data to assess the place that duloxetine should occupy in the therapeutic arsenal, indirect comparisons are the most rigorous way to go. We conducted a systematic review of the efficacy of duloxetine, fluoxetine and venlafaxine versus placebo in the treatment of Major Depressive Disorder (MDD, and performed indirect comparisons through meta-regressions. Methods The bibliography of the Agency for Health Care Policy and Research and the CENTRAL, Medline, and Embase databases were interrogated using advanced search strategies based on a combination of text and index terms. The search focused on randomized placebo-controlled clinical trials involving adult patients treated for acute phase Major Depressive Disorder. All outcomes were derived to take account for varying placebo responses throughout studies. Primary outcome was treatment efficacy as measured by Hedge's g effect size. Secondary outcomes were response and dropout rates as measured by log odds ratios. Meta-regressions were run to indirectly compare the drugs. Sensitivity analysis, assessing the influence of individual studies over the results, and the influence of patients' characteristics were run. Results 22 studies involving fluoxetine, 9 involving duloxetine and 8 involving venlafaxine were selected. Using indirect comparison methodology, estimated effect sizes for efficacy compared with duloxetine were 0.11 [-0.14;0.36] for fluoxetine and 0.22 [0.06;0.38] for venlafaxine. Response log odds ratios were -0.21 [-0.44;0.03], 0.70 [0.26;1.14]. Dropout log odds ratios were -0.02 [-0.33;0.29], 0.21 [-0.13;0.55]. Sensitivity analyses showed that results were

Real-life efficacy and reliability of training a hearing aid.

Science.gov (United States)

Keidser, Gitte; Alamudi, Karima

2013-09-01

Commercial trainable hearing aids (HA) (i.e., devices that for a period are adjusted by the user in different acoustic environments and that subsequently with changing environments automatically adapt to the user's preferred settings), are readily available; however, little information exists about the efficacy of training a HA. The purpose of this study was to investigate the efficacy and reliability of training a HA in everyday environments. The participants were 26 hearing-impaired volunteers with a median age of 79 years and an average pure-tone average of 53 dB HL. Test devices were commercial, multimemory, prototype devices that enabled training of the compression characteristics in four frequency bands and in six sound classes. Participants wore the National Acoustic Laboratories nonlinear fitting procedure version 2 prescription for 3 weeks and trained the devices from the prescribed response for 3 weeks, before comparing their trained response with the prescription for 2 weeks. The devices were reset to the prescription, and 19 participants repeated the training and comparison trials. During the comparison trial, participants made daily diary ratings of their satisfaction with the programs, and a structured interview was completed at the end of the comparison trial. The participants displayed different needs for changing the prescription, with more daily adjustments leading to training across more sound classes. Unreliable observations were obtained from 8 participants after each of the test and retest comparison trials. Of the 10 participants who made sufficient changes to the prescription during the first trial, 80% preferred their trained response. The 8 "low trainers" reported no preference, and also reported lower overall satisfaction with the device. Fewer adjustments were made during the repeat trial, resulting in less training. Significant correlations between trained variations were seen for 63% of 19 participants. Of the 10 participants who

Field comparison of solar water disinfection (SODIS) efficacy between glass and polyethylene terephalate (PET) plastic bottles under sub-Saharan weather conditions.

Science.gov (United States)

Asiimwe, J K; Quilty, B; Muyanja, C K; McGuigan, K G

2013-12-01

Concerns about photodegradation products leaching from plastic bottle material into water during solar water disinfection (SODIS) are a major psychological barrier to increased uptake of SODIS. In this study, a comparison of SODIS efficacy using glass and plastic polyethylene terephalate (PET) bottles was carried out under strong real sunlight and overcast weather conditions at Makerere University in central Uganda. Both clear and turbid natural water samples from shallow wells and open dug wells, respectively, were used. Efficacy was determined from the inactivation of a wild strain of Escherichia coli in solar-exposed contaminated water in both glass and PET bottles. The studies reveal no significant difference in SODIS inactivation between glass and PET bottles (95% CI, p > 0.05), for all water samples under the different weather conditions except for clear water under overcast conditions where there was a small but significant difference (95% CI, p = 0.047) with less viable bacterial counts in PET bottles at two intermediate time points but not at the end of the exposure. The results demonstrate that SODIS efficacy in glass under tropical field conditions is comparable to PET plastic. SODIS users in these regions can choose either of reactors depending on availability and preference of the user.

Selective serotonin reuptake inhibitors (SSRIs) for post-partum depression (PPD): a systematic review of randomized clinical trials.

Science.gov (United States)

De Crescenzo, Franco; Perelli, Federica; Armando, Marco; Vicari, Stefano

2014-01-01

The treatment of postpartum depression with selective serotonin reuptake inhibitors (SSRIs) has been claimed to be both efficacious and well tolerated, but no recent systematic reviews have been conducted. A qualitative systematic review of randomized clinical trials on women with postpartum depression comparing SSRIs to placebo and/or other treatments was performed. A comprehensive literature search of online databases, the bibliographies of published articles and grey literature were conducted. Data on efficacy, acceptability and tolerability were extracted and the quality of the trials was assessed. Six randomised clinical trials, comprising 595 patients, met quality criteria for inclusion in the analysis. Cognitive-behavioural intervention, psychosocial community-based intervention, psychodynamic therapy, cognitive behavioural therapy, a second-generation tricyclic antidepressant and placebo were used as comparisons. All studies demonstrated higher response and remission rates among those treated with SSRIs and greater mean changes on depression scales, although findings were not always statistically significant. Dropout rates were high in three of the trials but similar among treatment and comparison groups. In general, SSRIs were well tolerated and trial quality was good. There are few trials, patients included in the trials were not representative of all patients with postpartum depression, dropout rates in three trials were high, and long-term efficacy and tolerability were assessed in only two trials. SSRIs appear to be efficacious and well tolerated in the treatment of postpartum depression, but the available evidence fails to demonstrate a clear superiority over other treatments. © 2013 Elsevier B.V. All rights reserved.

Direct contra naïve-indirect comparison of clinical failure rates between high-viscosity GIC and conventional amalgam restorations: an empirical study.

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Mickenautsch, Steffen; Yengopal, Veerasamy

2013-01-01

Naïve-indirect comparisons are comparisons between competing clinical interventions' evidence from separate (uncontrolled) trials. Direct comparisons are comparisons within randomised control trials (RCTs). The objective of this empirical study is to test the null-hypothesis that trends and performance differences inferred from naïve-indirect comparisons and from direct comparisons/RCTs regarding the failure rates of amalgam and direct high-viscosity glass-ionomer cement (HVGIC) restorations in permanent posterior teeth have similar direction and magnitude. A total of 896 citations were identified through systematic literature search. From these, ten and two uncontrolled clinical longitudinal studies for HVGIC and amalgam, respectively, were included for naïve-indirect comparison and could be matched with three out twenty RCTs. Summary effects sizes were computed as Odds ratios (OR; 95% Confidence intervals) and compared with those from RCTs. Trend directions were inferred from 95% Confidence interval overlaps and direction of point estimates; magnitudes of performance differences were inferred from the median point estimates (OR) with 25% and 75% percentile range, for both types of comparison. Mann-Whitney U test was applied to test for statistically significant differences between point estimates of both comparison types. Trends and performance differences inferred from naïve-indirect comparison based on evidence from uncontrolled clinical longitudinal studies and from direct comparisons based on RCT evidence are not the same. The distributions of the point estimates differed significantly for both comparison types (Mann-Whitney U  =  25, n(indirect)  =  26; n(direct)  =  8; p  =  0.0013, two-tailed). The null-hypothesis was rejected. Trends and performance differences inferred from either comparison between HVGIC and amalgam restorations failure rates in permanent posterior teeth are not the same. It is recommended that clinical practice

Contraceptive efficacy and clinical performance of Nestorone implants in postpartum women.

Science.gov (United States)

Massai, M R; Díaz, S; Quinteros, E; Reyes, M V; Herreros, C; Zepeda, A; Croxatto, H B; Moo-Young, A J

2001-12-01

The objective of this study was to evaluate the contraceptive efficacy and clinical performance of a Nestorone subdermal implant (NES) in the postpartum period. NES (n = 100) and Copper T intrauterine device (T-Cu; n = 100) acceptors initiated contraception at 8 weeks postpartum and were followed at monthly intervals during the first year and at 3-month intervals thereafter. Pregnancy rates, breastfeeding performance, infant growth, bleeding pattern, and side effects were assessed. Blood and milk NES concentration were measured. No pregnancy occurred in 2195 and 2145 woman-months of NES implant and T-Cu use, respectively. No effect of NES on lactation and infant growth and no serious adverse events were observed. Lactational amenorrhea was significantly longer in NES users (353 +/- 20 days) than in T-Cu users (201 +/- 11 days). More NES users (55.8%) experienced prolonged bleedings than did T-Cu users (36.2%). Concentrations of NES in breast milk ranged between 54-135 pmol/liter. The Nestorone implant is a highly effective contraceptive, safe for breastfed infants because the steroid is inactive by the oral route.

Public Reporting of Primary Care Clinic Quality: Accounting for Sociodemographic Factors in Risk Adjustment and Performance Comparison.

Science.gov (United States)

Wholey, Douglas R; Finch, Michael; Kreiger, Rob; Reeves, David

2018-01-03

Performance measurement and public reporting are increasingly being used to compare clinic performance. Intended consequences include quality improvement, value-based payment, and consumer choice. Unintended consequences include reducing access for riskier patients and inappropriately labeling some clinics as poor performers, resulting in tampering with stable care processes. Two analytic steps are used to maximize intended and minimize unintended consequences. First, risk adjustment is used to reduce the impact of factors outside providers' control. Second, performance categorization is used to compare clinic performance using risk-adjusted measures. This paper examines the effects of methodological choices, such as risk adjusting for sociodemographic factors in risk adjustment and accounting for patients clustering by clinics in performance categorization, on clinic performance comparison for diabetes care, vascular care, asthma, and colorectal cancer screening. The population includes all patients with commercial and public insurance served by clinics in Minnesota. Although risk adjusting for sociodemographic factors has a significant effect on quality, it does not explain much of the variation in quality. In contrast, taking into account the nesting of patients within clinics in performance categorization has a substantial effect on performance comparison.

Education as prescription for patients with type 2 diabetes mellitus: compliance and efficacy in clinical practice.

Science.gov (United States)

Kim, Mi Yeon; Suh, Sunghwan; Jin, Sang-Man; Kim, Se Won; Bae, Ji Cheol; Hur, Kyu Yeon; Kim, Sung Hye; Rha, Mi Yong; Cho, Young Yun; Lee, Myung-Shik; Lee, Moon Kyu; Kim, Kwang-Won; Kim, Jae Hyeon

2012-12-01

Diabetes self-management education has an important role in diabetes management. The efficacy of education has been proven in several randomized trials. However, the status of diabetes education programs in real Korean clinical practice has not yet been evaluated in terms of patient compliance with the education prescription. We retrospectively analyzed clinical and laboratory data from all patients who were ordered to undergo diabetes education during 2009 at Samsung Medical Center, Seoul, Korea (n=2,291). After excluding ineligible subjects, 588 patients were included in the analysis. Among the 588 patients, 433 received education. The overall compliance rate was 73.6%, which was significantly higher in the subjects with a short duration or living in a rural area compared to those with a long duration (85.0% vs. 65.1%, respectively; Ppatients refuse to get education despite having a prescription from their physician. This refusal rate was higher in the patients with long-standing diabetes or in urban residence. Furthermore, education was more effective in patients with a short duration of diabetes in clinical practice.

Cross-Cultural Comparisons of University Students' Science Learning Self-Efficacy: Structural Relationships among Factors within Science Learning Self-Efficacy

Science.gov (United States)

Wang, Ya-Ling; Liang, Jyh-Chong; Tsai, Chin-Chung

2018-01-01

Science learning self-efficacy could be regarded as a multi-factor belief which comprises different aspects such as cognitive skills, practical work, and everyday application. However, few studies have investigated the relationships among these factors that compose science learning self-efficacy. Also, culture may play an important role in…

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

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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.

ISCOM-based equine influenza vaccine: Duration of immunity and randomised clinical trials to assess an accelerated schedule of immunisation and efficacy

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R. Paillot

2015-01-01

Study 3: efficacy against Florida clade 2 EIV strain (randomised trial. Efficacy against the representative Florida clade 2 strain A/eq/Richmond/1/07 was also evaluated at the peak of immunity, shortly after 2nd vaccination (V2. Six ponies were vaccinated with EquipFT according to label (6-week interval between first and second injection and 6 control ponies received saline injections. Sixteen days after V2 (day 58, all animals were experimentally infected with A/eq/Richmond/1/07. Clinical signs of disease and virus shedding were assessed for 14 days and found to be significantly reduced in vaccinated animals.

Clinical Trials

Medline Plus

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. ...

Comparison of the efficacy of three PubMed search filters in finding randomized controlled trials to answer clinical questions.

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Yousefi-Nooraie, Reza; Irani, Shirin; Mortaz-Hedjri, Soroush; Shakiba, Behnam

2013-10-01

The aim of this study was to compare the performance of three search methods in the retrieval of relevant clinical trials from PubMed to answer specific clinical questions. Included studies of a sample of 100 Cochrane reviews which recorded in PubMed were considered as the reference standard. The search queries were formulated based on the systematic review titles. Precision, recall and number of retrieved records for limiting the results to clinical trial publication type, and using sensitive and specific clinical queries filters were compared. The number of keywords, presence of specific names of intervention and syndrome in the search keywords were used in a model to predict the recalls and precisions. The Clinical queries-sensitive search strategy retrieved the largest number of records (33) and had the highest recall (41.6%) and lowest precision (4.8%). The presence of specific intervention name was the only significant predictor of all recalls and precisions (P = 0.016). The recall and precision of combination of simple clinical search queries and methodological search filters to find clinical trials in various subjects were considerably low. The limit field strategy yielded in higher precision and fewer retrieved records and approximately similar recall, compared with the clinical queries-sensitive strategy. Presence of specific intervention name in the search keywords increased both recall and precision. © 2010 John Wiley & Sons Ltd.

Effect of the dedicated education unit on nursing student self-efficacy: A quasi-experimental research study.

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George, Lynn E; Locasto, Lisa W; Pyo, Katrina A; W Cline, Thomas

2017-03-01

Although the Dedicated Education Unit (DEU) has shown initial promise related to satisfaction with the teaching/learning environment, few studies have examined student outcomes related to the use of the DEU as a clinical education model beyond student satisfaction. The purpose of this quantitative, quasi-experimental study was to compare student outcomes from the traditional clinical education (TCE) model with those from the DEU model. Participants were students enrolled in a four-year baccalaureate program in nursing (n = 193) who had clinical education activities in one of three clinical agencies. Participants were assigned to either the DEU or a TCE model. Pre-clinical and post-clinical self-efficacy scores were measured for each group using an adapted Generalized Self-Efficacy Scale (Schwarzer and Jerusalem, 1995). Both groups experienced a significant increase in self-efficacy scores post clinical education. The increase in self-efficacy for the DEU students was significantly greater than the increase in self-efficacy for the traditional students. Self-efficacy is considered an important outcome of nursing education because high self-efficacy has been linked to making an easier transition from student to nursing professional. This study supports the quality of the DEU as a clinical education model by examining student self-efficacy outcomes. Copyright © 2017 Elsevier Ltd. All rights reserved.

Indirect comparison for Anti-TNF drugs in moderate to severe ulcerative colitis

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M. Galván-Banqueri

2015-01-01

Full Text Available Objective: To compare the relative efficacy of infliximab, adalimumab and golimumab through adjusted indirect treatment comparisons (ITCs. Methods: An exhaustive search was performed until October 2013. Databases consulted were MEDLINE, EMBASE, the Cochrane Library, the Centre for Reviews and Dissemination and the Web of Science. Randomized control trials (RCTs comparing the efficacy of infliximab, adalimumab or golimumab versus placebo, in terms of clinical remission, clinical response and mucosal healing, were included. In the case that more than one RCT fulfilled the inclusion criteria for the same drug, a metanalysis was undertaken using a fixed effects model. ITCs were carried out using the method proposed by Bucher et al. Results: 6 RCTs published in 5 papers were included: 2 for infliximab (ACT 1 and ACT 2, 2 for adalimumab (ULTRA 1 y ULTRA 2 and 2 for golimumab (PURSUIT-SC y PURSUIT-M.In these RTCs, each biological agent was superior in efficacy to placebo. The results of the adjusted ITC are the following. In relation to the clinical remission, in the induction and maintenance period, there are no statistically significant differences between the three anti-TNF drugs. In relation to the clinical response and mucosal healing, in the induction period, there are statistically significant differences between infliximab and adalimumab. Conclusion: In view of the results obtained, infliximab, adalimumab and golimumab appear to be similarly effective therapeutic alternatives. Therefore, other considerations such as safety, tolerance and cost-effectiveness should be taken into account in order to select the most appropriate treatment

Alpha lipoic acid efficacy in burning mouth syndrome. A controlled clinical trial

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Palacios-Sánchez, Begoña; Cerero-Lapiedra, Rocío; Llamas-Martínez, Silvia; Esparza-Gómez, Germán

2015-01-01

Background A double-blind placebo-controlled trial was conducted in order to evaluate the efficacy of alpha lipoic acid (ALA) and determine the statistical significance of the outcome variables. Burning mouth syndrome (BMS) is defined as an oral burning sensation in the absence of clinical signs which could justify the syndrome. Recent studies suggest the existence of neurological factors as a possible cause of the disease. Material and Methods 60 patients with BMS, in two groups: case group with 600 mg/day and placebo as control group; with follow up of 2 months. Results 64% of ALA patients reported some level of improvement, with a level of maintenance of 68.75% one month after treatment. 27.6% of the placebo group also demonstrated some reduction in BMS symptoms. Conclusions Long-term evolution and the intensity of symptoms are variables that reduce the probability of improvement with ALA treatment. Key words: Burning mouth syndrome, neuropathy, alpha lipoic acid. PMID:26034927

Comparison of antibacterial efficacy of coconut oil and chlorhexidine on Streptococcus mutans: An in vivo study.

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Peedikayil, Faizal C; Remy, Vimal; John, Seena; Chandru, T P; Sreenivasan, Prathima; Bijapur, Gufran Ahmed

2016-01-01

Streptococcus mutans is the most common organism causing dental caries. Various chemotherapeutic agents are available that help in treating the bacteria, with each having their own merits and demerits. Recent research has shown that coconut oil has anti-inflammatory and antimicrobial action. Therefore, the present was conducted to determine the antibacterial efficacy of coconut oil and to compare it with chlorhexidine. A total of fifty female children aged 8-12 years were included in the study. Twenty five children were randomly distributed to each group, i.e., the study group (coconut oil) and the control group (chlorhexidine). The participants were asked to routinely perform oil swishing with coconut oil and chlorhexidine and rinse every day in the morning after brushing for 2-3 minutes. S. mutans in saliva and plaque were determined using a chairside method, i.e., the Dentocult SM Strip Mutans test. Patients were instructed to continue oil swishing for 30 days. S. mutans . counts in plaque and saliva on day 1, day 15, and day 30 were recorded and the results were compared using Wilcoxon matched pairs signed ranks test. The results showed that there is a statistically significant decrease in S. mutans . count from coconut oil as well as chlorhexidine group from baseline to 30 days. The study also showed that in comparison of coconut oil and chlorhexidine there is no statistically significant change regarding the antibacterial efficacy. Coconut oil is as effective as chlorhexidine in the reduction of S. mutans .

Efficacy of Cellular Therapy for Diabetic Foot Ulcer: A Meta-Analysis of Randomized Controlled Clinical Trials.

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Zhang, Ye; Deng, Hong; Tang, Zhouping

2017-12-01

Diabetes mellitus is a widely spread chronic disease with growing incidence worldwide, and diabetic foot ulcer is one of the most serious complications of diabetes. Cellular therapy has shown promise in the management of diabetic foot ulcer in many preclinical experiments and clinical researches. Here, we performed a meta-analysis to evaluate the efficacy and safety of cellular therapy in the management of diabetic foot ulcer. We systematically searched PubMed, MEDLINE, EMBASE, and Cochrane Library databases from inception to May 2017 for randomized controlled trials assessing the efficacy of cellular therapy in diabetic foot ulcer, and a meta-analysis was conducted. A total of 6 randomized controlled clinical trials involving 241 individuals were included in this meta-analysis. The results suggested that cellular therapy could help accelerating the healing of diabetic foot ulcer, presented as higher ankle-brachial index (mean difference = 0.17, 95% confidence interval [CI] = 0.11 to 0.23), higher transcutaneous oxygen pressure (standardized mean difference [SMD] = 1.43; 95% CI, 1.09- to 1.78), higher ulcer healing rate (relative risk [RR] = 1.78; 95% CI, 1.41 to 2.25), higher amputation-free survival (RR = 1.25; 95% CI, 1.11 to 1.40), and lower scale of pain (SMD = -1.69; 95% CI, -2.05 to -1.33). Furthermore, cellular therapy seemed to be safe, with no serious complications and low risk of short-term slight complications. Cellular therapy could accelerate the rate of diabetic foot ulcer healing and may be more efficient than standard therapy for diabetic foot treatment.

Clinical efficacy and economic evaluation of online cognitive behavioral therapy for major depressive disorder: a systematic review and meta-analysis.

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Ahern, Elayne; Kinsella, Stephen; Semkovska, Maria

2018-02-01

Leading cause of disability worldwide, depression is the most prevalent mental disorder with growing societal costs. As mental health services demand often outweighs provision, accessible treatment options are needed. Our systematic review and meta-analysis evaluated the clinical efficacy and economic evidence for the use of online cognitive behavioral therapy (oCBT) as an accessible treatment solution for depression. Areas covered: Electronic databases were searched for controlled trials published between 2006 and 2016. Of the reviewed 3,324 studies, 29 met the criteria for inclusion in the efficacy meta-analysis. The systematic review identified five oCBT economic evaluations. Therapist-supported oCBT was equivalent to face-to-face CBT at improving depressive symptoms and superior to treatment-as-usual, waitlist control, and attention control. Depression severity, number of sessions, or support did not affect efficacy. From a healthcare provider perspective, oCBT tended to show greater costs with greater benefits in the short term, relative to comparator treatments. Expert commentary: Although efficacious, further economic evidence is required to support the provision of oCBT as a cost-effective treatment for depression. Economic evaluations that incorporate a societal perspective will better account for direct and indirect treatment costs. Nevertheless, oCBT shows promise of effectively improving depressive symptoms, considering limited mental healthcare resources.

Clinical and radiographic comparison of indirect pulp treatment using light-cured calcium silicate and mineral trioxide aggregate in primary molars: A randomized clinical trial.

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Menon, Navya P; Varma, Balagopal R; Janardhanan, Sureshkumar; Kumaran, Parvathy; Xavier, Arun Mamachan; Govinda, Bhat Sangeetha

2016-01-01

To clinically and radiographically evaluate the reparative dentin formation in indirect pulp treatment (IPT) using mineral trioxide aggregate (MTA) and light cured calcium silicate (TheraCal) in primary molars over a period of 6 months. A clinical trial on IPT on 43 primary molars in 21 patients between the age of 4-7 years, divided into two groups: 22 teeth in MTA group and 21 in TheraCal group. Measurement of the variation in dentin thickness was done on the digitalized radiograph at baseline, 3 months and 6 months using CorelDRAW X3 software. Statistical analysis using an independent t -test for intragroup and intergroup comparison showed a significant increase in dentin thickness in both the MTA and TheraCal group (intragroup comparison [ P 0.05). Clinically and radiographically, both MTA and TheraCal are good IPT materials. The better handling characteristics and comparable reparative dentin-forming ability of TheraCal make this material an alternative to MTA in pediatric restorative procedures.

THE EFFICACY OF COMBINED PHARMACOLOGICAL BLOCKING OF RAAS IN CHILDREN WITH CHRONIC RENAL DISEASE

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E.S. Otroshchenko

2010-01-01

Full Text Available 14 children with various clinical forms of steroid-resistant nephrotic syndrome have been examined to assess the efficacy of pharmacological blocking of RAAS using inhibitors of angiotensin-converting enzyme and Angiotensin II receptor blockers. While assessing the efficacy of the nephroprotective therapy, the following was found in all the children: a reliably meaningful 1,5 times reduction ((р = 0,013 in the daily proteinuria level in 3 to 6 months, and by the end of the study — a 2,5 times reduction (р = 0,001 and improvement in the renal filtration function metrics in 3 to 6 months (р = 0,001, in 1 year (р = 0,013 and by the end of the study (p = 0,002 in comparison with the metrics prior to the launch of the nephroprotective therapy. Key words: chronic renal disease, proteinuria, RAAS, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers. (Pediatric Pharmacology. – 2010; 7(2:105-109

Clinical and immunological efficacy of combination therapy of children with measles

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V. N. Timchenko

2016-01-01

Full Text Available The aim of the study was to assess the clinical and immunological efficacy of recombinant interferon Alfa-2b. Examined 34 children aged from 1 year to 7 years carrying medium to heavy degree of measles. All patients were not vaccinated against measles. In the treatment of 18 people (Control group were used only basic therapy (pathogenic, symptomatic. At 16 people (Study group used a combination therapy (basic + Viferon. As an antiviral agent used and immunotropic preparation of human recombinant interferon alfa-2b in the form of rectal suppositories – Viferon (OOO «Feron», Russia. Immunological patient survey was conducted in the dynamics of the disease – during the height (in 1-6 days the rash and in convalescence period (10-16 days rash. Indicators of cellular immunity (leukocytes, lymphocytes, CD3 +, CD3 + CD (16 + 56 +, CD3 + CD4 +, CD3 + CD8 +, CD4 + CD8 +, CD3-CD8 +, CD3-CD (16 + 56, CD19 +, CD25 +, CD3 + HLA DR +, CD (16 + 56 + HLA DR +, HLA DR +, CD95 + were evaluated by flow cytometry. To assess the production of IFN-α and IFN-γ in the samples of peripheral blood were cultured in the CO2 incubator for 18 hours at 37 C and 4% CO2. The supernatants of cell culture were investigated with the purpose of studying spontaneous and induced production of interferon alpha and gamma. The concentrations of interferon α and γ (IFNα, IFNγ in the blood serum, as well as levels of spontaneous and induced cytokine production data of blood cells of sick children was determined by ELISA. All the children at the peak of the disease found a dramatic inhibition of cellular immunity and the production of cytokines, which is consistent with the concept of «measles anergy» accepted in the scientific literature. The period of convalescence oppression immunity indices remained, but it was less pronounced in the group of children treated with the drug of human recombinant interferon alfa-2b -Viferon. Clinical efficacy

Analysis of allergen immunotherapy studies shows increased clinical efficacy in highly symptomatic patients

DEFF Research Database (Denmark)

Howarth, P; Malling, Hans-Jørgen; Molimard, M

2011-01-01

them. Thus, clinical studies of AIT can neither establish baseline symptom levels nor limit the enrolment of patients to those with the most severe symptoms. Allergen immunotherapy treatment effects are therefore diluted by patients with low symptoms for a particular pollen season. The objective...... tertiles). The difference observed in the average score in each tertile in active vs placebo-treated patients was assessed. This allowed an estimation of the efficacy that could be achieved in patients from sites where symptoms were high during the pollen season. Results:  An increased treatment effect...... of this analysis was to assess the effect possible to achieve with AIT in the groups of patients presenting the most severe allergic symptoms. Methods:  Study centres were grouped into tertiles categorized according to symptom severity scores observed in the placebo patients in each centre (low, middle and high...

The efficacy of amino acid-based formulas in relieving the symptoms of cow's milk allergy: a systematic review.

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Hill, D J; Murch, S H; Rafferty, K; Wallis, P; Green, C J

2007-06-01

The aim of this systematic review was to evaluate the efficacy of amino acid-based formulas (AAF) in patients with cow's milk allergy (CMA). Studies were identified using electronic databases and bibliography searches. Subjects eligible for inclusion were patients of any age with CMA or symptoms suggestive of it. Comparisons of interest were AAF vs. extensively hydrolysed formula (eHF), AAF vs. soy-based formula (SF) and AAF vs. cow's milk or cow's milk-based formula. Outcomes of interest were gastrointestinal (GI), dermatological, respiratory and behavioural symptoms as well as growth. A total of 20 studies [three head-to-head randomized controlled trials (RCTs), three cross-over challenge RCTs, seven clinical trials (CTs) and seven case reports (CRs)] were included in the review. In infants with confirmed or suspected CMA, the use of an AAF was shown to be safe and efficacious. Findings from RCT comparisons of AAF with eHF showed that both formulas are equally efficacious at relieving the symptoms of CMA in confirmed or suspected cases. However, infants in specific subgroups (e.g. non-IgE mediated food-induced gastro-enterocolitis-proctitis syndromes with failure to thrive, severe atopic eczema, or with symptoms during exclusive breastfeeding) were more likely overall to benefit from AAF, as intolerance to eHF may occur. In such cases, symptoms persisting despite eHF feeding usually remit on AAF, and catch-up growth may be seen. Meta-analysis of the findings was not possible due to lack of homogenous reporting of outcomes in the original trials. This systematic review shows clinical benefit from use of AAF in both symptoms and growth in infants and children with CMA who fail to tolerate eHF. Further studies are required to determine the relative medical or economic value of initial treatment with AAF in infants at high risk of eHF intolerance.

Clinical Efficacy of Piracetam on Breath Holding Spells in Children

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F. Ashrafzadeh

2004-07-01

Full Text Available Breath holding spells (BHS is a type of syncope in children , most commonly encontered in the early years of life. Although these athacks don't damage the brain , if these are frequent or prolonged cause , parents frighten , so physician should intervent. In this study we evaluated clinical efficacy of piracetam on B.H.S of children in Mashhad Ghaem Hospital during 2001-2002.In this double blind placebo control study , piracetam or placebo on a randomized basis was administered to children with 40 mg/kg/day in 2 divided doses for 2 months. From the 41 children that were enrolled , 21 cases received piracetam and 20 cases received placebo. Parents denoted the numbers of spells two months before and two months after taking drug. Control of breath holding spells were observed in 90.5% of patients in the group taking piracetam as compared with 40% in the group taking placebo (P = 0.002. Of the all patients 10 cases had iron deficiency anemia so they had taken elemental Fe too. The side effects were the same in these two groups. The results of this study indicated that piracetam was efficient for the treatment of children with B.H.S without greater incidence adverse effects than placebo.

Enhanced antitumor efficacy and counterfeited cardiotoxicity of combinatorial oral therapy using Doxorubicin- and Coenzyme Q10-liquid crystalline nanoparticles in comparison with intravenous Adriamycin

DEFF Research Database (Denmark)

Swarnakar, Nitin K; Thanki, Kaushik; Jain, Sanyog

2014-01-01

and strong synergism for combination at 1:10 dose ratio owing to higher cellular uptake, nuclear colocalization, higher apoptotic index and 8-OHdG levels. The prophylactic antitumor efficacy of the CoQ10-LCNPs was also established using tumor induction and progression studies. Finally, therapeutic antitumor......, with Dox-induced-cardiotoxicity was completely counterfeited in combination. In nutshell, LCNPs pose great potential in improving the therapeutic efficacy of drugs by oral route of administration. FROM THE CLINICAL EDITOR: This study describes the use of liquid crystalline nanoparticles containing coenzyme...

Comparison of the Developmental Potential and Clinical Results of In Vivo Matured Oocytes Cryopreserved with Different Vitrification Media

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Mei Li

2015-01-01

Full Text Available Background: Oocyte vitrification is widely used throughout the world, but its clinical efficacy is inconsistent and depends on the vitrification media. This study compared the developmental potential and clinical results of in vivo matured oocytes cryopreserved with different vitrification media. Methods: This retrospective study involved vitrified-warmed oocytes at one in vitro fertilization laboratory. Vitrification media kits comprised the MC kit (ethylene glycol [EG] plus 1,2-propanediol [PROH], the KT kit (EG plus dimethyl sulphoxide [DMSO], and the Modified kit (EG plus DMSO and PROH kit. Rates of oocyte survival and subsequent developmental potential were recorded and analyzed. The t-test and the Chi-square test were used to evaluate each method′s efficacy. Results: Oocyte survival rate was significantly higher for the Modified kit (92.0% than for the MC kit (88.2% (P 0.05. The high-quality embryo rate per warmed oocyte was significantly higher (23.4% in the Modified kit group than in the other groups (P 0.05. Conclusions: Modified vitrification media are efficient for oocyte vitrification and, with further verification, may be able to replace commercially available media in future clinical applications.

In vitro efficacy of cold atmospheric pressure plasma on S. sanguinis biofilms in comparison of two test models

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Gorynia, Susanne

2013-04-01

Full Text Available [english] Dental plaque critically affects the etiology of caries, periodontitis and periimplantitis. The mechanical removal of plaque can only be performed partially due to limited accessibility. Therefore, plaque still represents one of the major therapeutic challenges. Even though antiseptic mouth rinses reduce the extent of biofilm temporarily, plaque removal remains incomplete and continuous usage can even result in side effects. Here we tested argon plasma produced by kinpen09 as one option to inactivate microorganisms and to eliminate plaque. biofilms cultivated in either the European Biofilm Reactor (EUREBI or in 24 well plates were treated with argon plasma. In both test systems a homogeneous, good analyzable and stable biofilm was produced on the surface of titan plates within 72 h (>6,9 log CFU/ml. Despite the significantly more powerful biofilm production in EUREBI, the difference of 0.4 log CFU/ml between EUREBI and the 24 well plates was practically not relevant. For that reason both test models were equally qualified for the analysis of efficacy of cold atmospheric pressure plasma. We demonstrate a significant reduction of the biofilm compared to the control in both test models. After plasma application of 180 s the biofilm produced in EUREBI or in 24 well plates was decreased by 0.6 log CFU/ml or 0.5 log CFU/ml, respectively. In comparison to recently published studies analyzing the efficacy of kinpen09, produces a hardly removable biofilm. Future investigations using reduced distances between plasma source and biofilm, various compositions of plasma and alternative plasma sources will contribute to further optimization of the efficacy against biofilms.

Predation Efficacy of Bdellovibrio bacteriovorus on Multidrug-Resistant Clinical Pathogens and Their Corresponding Biofilms.

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Sun, Yao; Ye, Jianzhong; Hou, Yuanbo; Chen, Huale; Cao, Jianming; Zhou, Tieli

2017-09-25

The aim of the present study was to evaluate the predation efficacy of Bdellovibrio bacteriovorus on multidrug-resistant (MDR) or extensive drug resistant (XDR) gram-negative pathogens and their corresponding biofilms. In this study, we examined the ability of B. bacteriovorus to prey on MDR and XDR gram-negative clinical bacteria, including Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Acinetobacter baumannii. Results showed that B. bacteriovorus was able to prey on all planktonic cultures, among which the most efficient predation was observed for drug-resistant E. coli, with a 3.11 log10 reduction in viability. Furthermore, B. bacteriovorus demonstrated promising efficacy in preventing biofilm formation and dispersing the established biofilm. Reductions in biofilm formation of E. coli, K. pneumoniae, P. aeruginosa, and A. baumannii co-cultured with B. bacteriovorus were 65.2%, 37.1%, 44.7%, and 36.8%, respectively. Meanwhile, the established biofilms of E. coli, K. pneumoniae, P. aeruginosa, and A. baumannii were significantly reduced by 83.4%, 81.8%, 83.1%, and 79.9%, respectively. A visual analysis supported by scanning electron microscopy demonstrated the role of B. bacteriovorus in removing the established biofilms. This study highlights the potential use of B. bacteriovorus as a biological control agent with the capability to prey on MDR/XDR gram-negative pathogens and eradicate biofilms.

Comparison of mania patients suitable for treatment trials versus clinical treatment.

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Talamo, Alessandra; Baldessarini, Ross J; Centorrino, Franca

2008-08-01

It remains uncertain whether bipolar disorder (BPD) patients in randomized-controlled trials (RCTs) are sufficiently representative of clinically encountered patients as to guide clinical-therapeutic practice. We complied inclusion/exclusion criteria by frequency from reports of 21 RCTs for mania, and applied them in a pilot study of patients hospitalized for DSM-IV BPD manic/mixed states to compare characteristics and clinical responses of patients who did versus did not meet exclusion criteria. From 27 initially identified inclusion/exclusion criteria ranked by citation frequency, we derived six inclusion, and 10 non-redundant-exclusion factors. Of 67 consecutive patients meeting inclusion criteria, 15 (22.4%) potential "research subjects" met all 10 exclusion criteria. The remaining 52 "clinical patients" differed markedly on exclusion criteria, including more psychiatric co-morbidity, substance abuse, involuntary hospitalization, and suicide attempts or violence, but were otherwise similar. In both groups responses to clinically determined inpatient treatments were similar, including improvement in mania ratings. Based on applying reported inclusion/exclusion criteria for RCTs to a pilot sample of hospitalized-manic patients, those likely to be included in modern RCTs were similar to patients who would be excluded, most notably in short-term antimanic-treatment responses. The findings encourage further comparisons of subjects included/excluded from RCTs to test potential clinical generalizability of research findings. The pilot study is limited in numbers and exposure times with which to test for the minor differences between "research subjects" and "clinical patients." (c) 2008 John Wiley & Sons, Ltd.

Efficacy of rasagiline and selegiline in Parkinson's disease: a head-to-head 3-year retrospective case-control study.

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Cereda, Emanuele; Cilia, Roberto; Canesi, Margherita; Tesei, Silvana; Mariani, Claudio Bruno; Zecchinelli, Anna Lena; Pezzoli, Gianni

2017-06-01

Monoamine oxidase type B (MAO-B) inhibitors, such as selegiline and rasagiline, can be used as monotherapy or adjuvant therapy to levodopa in Parkinson's disease (PD). Data on long-term efficacy of MAO-B inhibitors are limited with no head-to-head comparison available to date. The aim of this case-control retrospective study was to analyze data from patients with PD attending the Parkinson Institute (Milan, Italy) over a 6-year period (2009-2015) and compare the effects of selegiline and rasagiline on levodopa treatment outcomes. Patients with PD treated with either selegiline (n = 85) or rasagiline (n = 85) for 3 years as well as a control group of patients (N = 170) who have never received MAO-B inhibitors, were matched for gender, disease duration (±1 year) and age (±1 year) at baseline assessment (ratio 1:1:2). The Unified PD Rating Scale and the Hoehn-Yahr staging system were used for clinical comparisons. At baseline, mean PD duration was 6.5 years and clinical features were comparable across all three groups. After a mean follow-up of approximately 37 months, no differences in clinical progression of motor and non-motor symptoms were observed between the three groups. However, MAO-B inhibitor use was associated with ~2-fold lower change in daily dose of levodopa (p rasagiline. Long-term use of MAO-B inhibitors resulted in a significant reduction in levodopa requirements and a lower frequency of dyskinesias in patients with PD. Selegiline and rasagiline had equal efficacy in controlling motor symptoms in PD patients on optimized therapy.

Patient-prosthesis mismatch in patients treated with transcatheter aortic valve implantation – predictors, incidence and impact on clinical efficacy. A preliminary study

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Karol Zbroński

2017-11-01

Full Text Available Introduction : Patient-prosthesis mismatch (PPM is relatively frequent after surgical aortic valve replacement (SAVR and negatively impacts prognosis. Aim : We sought to determine the frequency and clinical effects of PPM after transcatheter aortic valve implantation (TAVI. Material and methods : Overall, 238 patients who underwent TAVI were screened. Moderate PPM was defined as indexed effective orifice area (EOAi between 0.65 and 0.85 cm2/m2, and severe PPM as < 0.65 cm2/m2. All-cause mortality and the Valve Academic Research Consortium 2 (VARC-2 defined composite of clinical efficacy at 1 year were the primary endpoints. Results : Finally, 201 patients were included (mean age: 79.6 ±7.4 years, 52% females. The femoral artery served as the delivery route in 79% and most of the prostheses were self-expanding (68%. Any PPM was present in 48 (24% subjects, and only 7 (3.5% had severe PPM. Body surface area (BSA independently predicted any PPM (OR = 16.9, p 20 mm Hg. Conclusions : Severe PPM after TAVI is rare, can be predicted by larger BSA and does not seem to affect mid-term mortality or composite clinical outcome. Larger studies are needed to find different independent predictors of PPM and elucidate its impact in terms of device durability and long-term clinical efficacy.

Clinical efficacy and safety of limited internal fixation combined with external fixation for Pilon fracture: A systematic review and meta-analysis.

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Zhang, Shao-Bo; Zhang, Yi-Bao; Wang, Sheng-Hong; Zhang, Hua; Liu, Peng; Zhang, Wei; Ma, Jing-Lin; Wang, Jing

2017-04-01

To compare the clinical efficacy and complications of limited internal fixation combined with external fixation (LIFEF) and open reduction and internal fixation (ORIF) in the treatment of Pilon fracture. We searched databases including Pubmed, Embase, Web of science, Cochrane Library and China Biology Medicine disc for the studies comparing clinical efficacy and complications of LIFEF and ORIF in the treatment of Pilon fracture. The clinical efficacy was evaluated by the rate of nonunion, malunion/delayed union and the excellent/good rate assessed by Mazur ankle score. The complications including infections and arthritis symptoms after surgery were also investigated. Nine trials including 498 pilon fractures of 494 patients were identified. The meta-analysis found no significant differences in nonunion rate (RR = 1.60, 95% CI: 0.66 to 3.86, p = 0.30), and the excellent/good rate (RR = 0.95, 95% CI: 0.86 to 1.04, p = 0.28) between LIFEF group and ORIF group. For assessment of infections, there were significant differences in the rate of deep infection (RR = 2.18, 95% CI: 1.34 to 3.55, p = 0.002), and the rate of arthritis (RR = 1.26, 95% CI: 1.03 to 1.53, p = 0.02) between LIFEF group and ORIF group. LIFEF has similar effect as ORIF in the treatment of pilon fractures, however, LIFEF group has significantly higher risk of complications than ORIF group does. So LIFEF is not recommended in the treatment of pilon fracture. 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.

Efficacy of Metformin Versus Insulin in the Management of Pregnancy with Diabetes

International Nuclear Information System (INIS)

Waheed, S.; Malik, F.P.

2013-01-01

Objective: To compare the efficacy of metformin with insulin in the management of pregnancy with diabetes. Study Design: Randomized clinical trial. Place and Duration of Study: Department of Obstetrics and Gynaecology, Maternal and Child Health Centre (MCH), Pakistan Institute of Medical Sciences, Islamabad, from May 2010 to January 2011. Methodology: A total of 68 pregnant patients with diabetes were included in this study. Patients were randomly divided in to two groups of each 34 patients based on table of random numbers. One was labelled as group-A and other was labelled as group-B. Group-A received insulin and group-B received metformin for the management of diabetes. Results: The mean age was 29.82 A+- 4.58 and 29.35 A+- 4.97 years in groups-A and B respectively. Fasting blood sugar level after 1 month was controlled in 22 (64.7%) patients in group-A and in 27 (79.4%) in group-B (p > 0.05). Fasting blood sugar level at term, remained controlled in 30 (88.2%) patients in group-A and 27 (79.4%) in group-B (p > 0.05). Comparison of random blood sugar levels within normal limits after 1 month in 25 (73.5%) in group-A and in 24 (70.6%) in group-B. At term, random blood sugar level was controlled in 28 (82.4%) and 27 (79.4%) patients in group-A and B, respectively. Comparison of post-treatment HBA1C level depicts that diabetes controlled in 27 (79.4%) patients in group-A while in 28 (82.3%) patients of group-B. The efficacy of metformin and insulin in controlling diabetes was equal in two groups. Conclusion: There was no marked difference in efficacy of metformin and insulin in controlling diabetes in pregnant patients in two groups. (author)

Efficacy of metformin versus insulin in the management of pregnancy with diabetes.

Science.gov (United States)

Waheed, Seema; Malik, Farhat Perveen; Mazhar, Syeda Batool

2013-12-01

To compare the efficacy of metformin with insulin in the management of pregnancy with diabetes. Randomized clinical trial. Department of Obstetrics and Gynaecology, Maternal and Child Health Centre (MCH), Pakistan Institute of Medical Sciences, Islamabad, from May 2010 to January 2011. A total of 68 pregnant patients with diabetes were included in this study. Patients were randomly divided in to two groups of each 34 patients based on table of random numbers. One was labelled as group-A and other was labelled as group-B. Group-A received insulin and group-B received metformin for the management of diabetes. The mean age was 29.82 ± 4.58 and 29.35 ± 4.97 years in groups-A and B respectively. Fasting blood sugar level after 1 month was controlled in 22 (64.7%) patients in group-A and in 27 (79.4%) in group-B (p > 0.05). Fasting blood sugar level at term, remained controlled in 30 (88.2%) patients in group-A and 27 (79.4%) in group-B (p > 0.05). Comparison of random blood sugar levels within normal limits after 1 month in 25 (73.5%) in group-A and in 24 (70.6%) in group-B. At term, random blood sugar level was controlled in 28 (82.4%) and 27 (79.4%) patients in group-A and B, respectively. Comparison of post-treatment HBA1C level depicts that diabetes controlled in 27 (79.4%) patients in group-A while in 28 (82.3%) patients of group-B. The efficacy of metformin and insulin in controlling diabetes was equal in two groups. There was no marked difference in efficacy of metformin and insulin in controlling diabetes in pregnant patients in two groups.

Systematic review of clinical trials assessing the therapeutic efficacy of visceral leishmaniasis treatments: A first step to assess the feasibility of establishing an individual patient data sharing platform.

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Jacob T Bush

2017-09-01

Full Text Available There are an estimated 200,000 to 400,000 cases of visceral leishmaniasis (VL annually. A variety of factors are taken into account when considering the best therapeutic options to cure a patient and reduce the risk of resistance, including geographical area, malnourishment and HIV coinfection. Pooled analyses combine data from many studies to answer specific scientific questions that cannot be answered with individual studies alone. However, the heterogeneity of study design, data collection, and analysis often makes direct comparison difficult. Individual Participant Data (IPD files can be standardised and analysed, allowing detailed analysis of this merged larger pool, but only a small fraction of systematic reviews and meta-analyses currently employ pooled analysis of IPD. We conducted a systematic literature review to identify published studies and studies reported in clinical trial registries to assess the feasibility of developing a VL data sharing platform to facilitate an IPD-based analysis of clinical trial data. Studies conducted between 1983 to 2015 that reported treatment outcome were eligible.From the 2,271 documents screened, 145 published VL clinical trials were identified, with data from 26,986 patients. Methodologies varied for diagnosis and treatment outcomes, but overall the volume of data potentially available on different drugs and dose regimens identified hundreds or possibly thousands of patients per arm suitable for IPD pooled meta-analyses.A VL data sharing platform would provide an opportunity to maximise scientific use of available data to enable assessment of treatment efficacy, contribute to evidence-based clinical management and guide optimal prospective data collection.

Clinical efficacy of Qinggan Huashi Huoxue decoction combined with liver-protecting and enzyme-lowering drugs in treatment of alcoholic liver disease

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YAO Zhishan

2016-07-01

Full Text Available ObjectiveTo investigate the clinical efficacy and safety of Qinggan Huashi Huoxue decoction combined with liver-protecting and enzyme-lowering drugs in the treatment of alcoholic liver disease (ALD. MethodsA total of 175 ALD patients who were admitted to The Second People′s Hospital of Tangshan from January 2012 to December 2015 were enrolled and randomly divided into treatment group (87 patients and control group (88 patients. The patients in the control group were asked to quit smoking and were given nutritional support and medications including polyene phosphatidylcholine, reduced glutathione, magnesium isoglycyrrhizinate, and ursodeoxycholic acid capsules, and those in the treatment group were given the self-made traditional Chinese medicine Qinggan Huashi Huoxue decoction in addition to the therapeutic regimen for the control group. During the three courses of treatment (12 weeks, the patients′ clinical symptoms and signs were observed, liver function ［alanine aminotransferase (ALT, aspartate aminotransferase (AST, gamma-glutamyl transpeptidase (GGT, albumin (Alb, and total bilirubin (TBil］ and blood lipids ［total cholesterol (TC, triglyceride (TG, high-density lipoprotein (HDL, and low-density lipoprotein (LDL］ were performed regularly, the results of routine blood tests and abdominal ultrasound findings were recorded regularly, and adverse events which occurred during treatment were recorded. The independent samples t-test was used for comparison of continuous data between groups, an analysis of variance with repeated measures was used to compare the differences at each time point between the two groups, and the chi-square test was used for comparison of categorical data between groups. ResultsAfter treatment, all patients achieved varying degrees of improvements in clinical symptoms and signs, which showed significant differences between the two groups at weeks 4, 8, and 12 of treatment (t=14.390, 10.487, and 13.547, all P�

Comparing clinical efficacy of Symbicort versus Pulmicort in reducing asthma symptom and improving its control

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Mohammad Emami

2014-01-01

Full Text Available Background: Recently, higher efficacy of the combination of long-acting beta2-adrenoceptor agonist and inhaled corticosteroids on controlling asthma symptoms has been hypothesized. This study aimed to examine the clinical effects of the combination of Budesonide with formoterol (Symbicort and Budesonide (Pulmicort alone in persistent asthma. Materials and Methods: In a randomized double-blinded clinical trial, 76 patients with definite diagnosis of moderate-to-severe asthma were randomized to receive Pulmicort 180 mcg/inhalation two puffs twice daily, or receive Symbicort 80/4.5 mg/inhalation two puffs twice daily, or receive Symbicort 160/4.5 mg/inhalation two puffs twice daily for 3 months. All participants were initially evaluated by spirometry for assessing respiratory parameters and also the level of asthma control was assessed by Asthma Control Test (ACT. Results: More significant improvement in spirometry parameters, including forced expiratory volume in 1 second (FEV1, forced vital capacity (FVC, FEV1/FVC ratio, as well as in peak expiratory flow (PEF in both groups of Symbicort with the regimens 80/4.5 mg/inhalation or 160/4.5 mg/inhalation 2 puffs twice daily compared with Pulmicort group, ACT score was significantly improved in Symbicort group with the regimens 160/4.5 mg/inhalation compared with both Symbicort groups with lower dosage and Pulmicort group . Response to treatment in PEF parameter and also in ACT level was significantly more in those who received Symbicort with the regimens 160/4.5 mg/inhalation compared with other two interventional groups adjusted for gender and age. Conclusion: Symbicort with the regimens 160/4.5 mg/inhalation has higher efficacy in reducing asthma symptom and improving its control compared with low doses of this drug and with Pulmicort.

Efficacy of cryotherapy associated with laser therapy for decreasing severity of melphalan-induced oral mucositis during hematological stem-cell transplantation: a prospective clinical study.

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de Paula Eduardo, Fernanda; Bezinelli, Leticia Mello; da Graça Lopes, Roberta Marques; Nascimento Sobrinho, Jairo Jose; Hamerschlak, Nelson; Correa, Luciana

2015-09-01

Melphalan followed by hematopoietic stem-cell transplantation (HSCT) is the standard treatment for multiple myeloma and other hematopoietic neoplasms. However, high doses of melphalan cause severe oral mucositis (OM). The objective was to verify the efficacy of cryotherapy plus laser therapy on reduction of OM severity. HSCT patients undergoing melphalan chemotherapy (n = 71) were randomly divided into two groups according to OM treatment: oral cryotherapy performed with ice chips for 1 h 35 min followed by low-level laser therapy (InGaAIP, 660 nm, 40 mW, 6 J/cm(2) ) (n = 54) and laser therapy alone with the same protocol (n = 17). A control group (n = 33) was composed of HSCT patients treated with melphalan who received no specific treatment for OM. OM scores and clinical information were collected from D0 to D + 11. The cryotherapy/laser therapy group showed the lowest OM scores (maximum Grade I) and the lowest mean number of days (8 days) with OM in comparison with the other groups (p cryotherapy with laser therapy was effective in reducing OM severity in HSCT patients who underwent melphalan conditioning. Copyright © 2014 John Wiley & Sons, Ltd.

Clinical Evaluation of Efficacy and Performance of All-Poly Tibial Freedom® Total Knee System for Treating Osteoarthritis Patients: Three-Year Follow Up Study.

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Singh, Avatar; Singh, Kanwar Kulwinder

2017-09-01

Advancement in technology in terms of design and building materials has made Total Knee Replacement (TKR) a highly effective, safe, and predictable orthopedic procedure. To review the clinical outcomes for efficacy and performance of Freedom Total Knee System for the management of Osteoarthritis (OA), at a minimum of three years follow up. For this retrospective, post-marketing study, clinical data of patients treated with Freedom Total Knee System was retrieved from the clinical records after approval from the Institutional Ethics Committee . All the patients above the age of 18 years who completed at least three years after TKR were observed for the study purpose. Patients treated for OA were included while the patients who received the implant for treatment of rheumatoid arthritis and traumatic injury were excluded. Factors such as aseptic loosening, implant failure, and need for revision surgery were observed to evaluate implant performance. Cases were recruited for clinical assessment of primary efficacy endpoint in terms of post-surgery maximun range of motion. Secondary efficacy endpoint was to determine the clinical and social quality of life as per the American Knee Society Score (AKSS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and stiffness scores. A total of 158 patients who had 191 TKR were observed for performance. The mean age of the patients was 67.67 years; mean BMI was 28.97±3.33, and the group comprised of 43% men and 57% women. Telephonic follow up at three years of 158 patients identified that none of them required revision surgery or had aseptic loosening suggesting excellent performance. Final clinical follow up at three years was available for only 35 patients (41 knee implants). The range of motion significantly improved from preoperative 104°±5.67° (range, 85°-119°) to 119.8°±11.05° (98°-123°) at follow-up (ppain, and improved functionality.

EFFICACY AND LONG-TERM CLINICAL OUTCOME OF COMORBID POSTTRAUMATIC STRESS DISORDER AND MAJOR DEPRESSIVE DISORDER AFTER ELECTROCONVULSIVE THERAPY.

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Ahmadi, Naser; Moss, Lori; Simon, Edwin; Nemeroff, Charles B; Atre-Vaidya, Nutan

2016-07-01

Many patients fulfill criteria for both posttraumatic stress disorder (PTSD) and major depressive disorder (MDD). Electroconvulsive therapy (ECT) is generally acknowledged to be the most-effective treatment for refractory MDD. This study investigated the efficacy of ECT on long-term clinical outcome of comorbid PTSD and MDD. This retrospective nested matched case-control study is inclusive of 22,164 subjects [3,485 with comorbid MDD and PTSD (92 with ECT and 3,393 without ECT) and 18,679 without MDD and PTSD]. Using the clinical global impression scale (CGI) to assess efficacy, more-robust improvement of PTSD and MDD symptoms was observed with ECT (90%), compared to antidepressant-treatment alone(50%) (P = 0.001). During the median of 8 years of follow-up, the death-rate was 8% in subjects without PTSD and MDD, 9.7% in PTSD and MDD treated with ECT and 18% in PTSD and MDD without ECT (P 0.05). The relative risk of suicidality, all-cause, and cardiovascular mortality was reduced 64, 65, and 46% in MDD and PTSD patients treated with ECT, compared to those without ECT (P < 0.05). ECT is associated with a significant reduction of symptoms of PTSD and MDD, as well as reduction in risk of suicidality, cardiovascular, and all-cause mortality in MDD and PTSD, an effect more robust than antidepressant-therapy alone. © 2015 Wiley Periodicals, Inc.

The efficacy and safety of palonosetron compared with granisetron in preventing highly emetogenic chemotherapy-induced vomiting in the Chinese cancer patients: a phase II, multicenter, randomized, double-blind, parallel, comparative clinical trial.

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Yu, Zhaocai; Liu, Wenchao; Wang, Ling; Liang, Houjie; Huang, Ying; Si, Xiaoming; Zhang, Helong; Liu, Duhu; Zhang, Hongmei

2009-01-01

This clinical trial was conducted to evaluate the efficacy and safety of Palonosetron in preventing chemotherapy-induced vomiting (CIV) among the Chinese cancer patients. Two hundred and forty patients were scheduled to be enrolled and randomized to receive a single intravenous dose of palonosetron 0.25 mg, or granisetron 3 mg, 30 min before receiving highly emetogenic chemotherapy. The primary efficacy endpoint was the complete response (CR) rate for acute CIV (during the 0-24-h interval after chemotherapy). Secondary endpoints included the CR rates for delayed CIV (more than 24 h after chemotherapy). Two hundred and eight patients were accrued and received study medication. CR rates for acute CIV were 82.69% for palonosetron and 72.12% for granisetron, which demonstrated that palonosetron was not inferior to granisetron in preventing acute CIV. Comparisons of CR rates for delayed CIV yielded no statistical difference between palonosetron and granisetron groups and did not reveal non-inferiority of palonosetron to granisetron. Adverse events were mostly mild to moderate, with quite low rates among the two groups. A single dose (0.25 mg) of palonosetron is not inferior to a single dose (3 mg) of granisetron in preventing CIV and possesses an acceptable safety profile in the Chinese population.

Overview of the anti-inflammatory effects, pharmacokinetic properties and clinical efficacies of arctigenin and arctiin from Arctium lappa L.

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Gao, Qiong; Yang, Mengbi; Zuo, Zhong

2018-05-01

Arctigenin (AR) and its glycoside, arctiin, are two major active ingredients of Arctium lappa L (A lappa), a popular medicinal herb and health supplement frequently used in Asia. In the past several decades, bioactive components from A lappa have attracted the attention of researchers due to their promising therapeutic effects. In the current article, we aimed to provide an overview of the pharmacology of AR and arctiin, focusing on their anti-inflammatory effects, pharmacokinetics properties and clinical efficacies. Compared to acrtiin, AR was reported as the most potent bioactive component of A lappa in the majority of studies. AR exhibits potent anti-inflammatory activities by inhibiting inducible nitric oxide synthase (iNOS) via modulation of several cytokines. Due to its potent anti-inflammatory effects, AR may serve as a potential therapeutic compound against both acute inflammation and various chronic diseases. However, pharmacokinetic studies demonstrated the extensive glucuronidation and hydrolysis of AR in liver, intestine and plasma, which might hinder its in vivo and clinical efficacy after oral administration. Based on the reviewed pharmacological and pharmacokinetic characteristics of AR, further pharmacokinetic and pharmacodynamic studies of AR via alternative administration routes are suggested to promote its ability to serve as a therapeutic agent as well as an ideal bioactive marker for A lappa.

Cell-assisted lipotransfer for facial lipoatrophy: efficacy of clinical use of adipose-derived stem cells.

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Yoshimura, Kotaro; Sato, Katsujiro; Aoi, Noriyuki; Kurita, Masakazu; Inoue, Keita; Suga, Hirotaka; Eto, Hitomi; Kato, Harunosuke; Hirohi, Toshitsugu; Harii, Kiyonori

2008-09-01

Lipoinjection is a promising treatment, but its efficacy in recontouring facial lipoatrophy remains to be established. The objective was to evaluate the efficacy and adverse effects of lipoinjection and supplementation of adipose-derived stem/stromal cells (ASCs) to adipose grafts. To overcome drawbacks of autologous lipoinjection, we have developed a novel strategy called cell-assisted lipotransfer (CAL). In CAL, stromal vascular fraction containing ASCs was freshly isolated from half of an aspirated fat sample and attached to the other half of aspirated fat sample with the fat acting as a scaffold. This process converts relatively ASC-poor aspirated fat into ASC-rich fat. We performed conventional lipoinjection (non-CAL; n=3) or CAL (n=3) on six patients with facial lipoatrophy due to lupus profundus or Parry-Romberg syndrome. All patients obtained improvement in facial contour, but the CAL group had a better clinical improvement score than did the non-CAL patients, although the difference did not reach statistical significance (p=.11). Adipose necrosis was found in one non-CAL case who took perioperative oral corticosteroids. Our results suggest that CAL is both effective and safe and potentially superior to conventional lipoinjection for facial recontouring. The authors have indicated no significant interest with commercial supporters.

Telmisartan in daily clinical practice: Factors affecting efficacy in treatment of primary arterial hypertension

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Bergovac M

2009-01-01

Full Text Available Background: Telmisartan provides effective treatment of hypertension in a broad spectrum of patients. Aims: To evaluate factors affecting the efficacy of telmisartan in daily clinical practice. Setting and Design: Prospective practice-based 12-week uncontrolled cohort study. Materials and Methods: Consecutive incident/prevalent outpatients with mild to moderate essential hypertension were started on telmisartan 40 mg/day with optional up-titration to 80 mg/day in order to achieve seated systolic (SSBP and diastolic (SDBP blood pressure < 140/90 mm Hg. Intent-to-treat (ITT, N=282 and per protocol (PP, N=275 efficacy assessment was based on SSBP/SDBP reduction and delivered doses. Results: SSBP/SDBP decreased (165.2±13.1 / 98.3±6.7 mm Hg to 137.9±13.2 / 82.6±7.3 mm Hg, whilst telmisartan was up-titrated in 40.5% of patients during the study. Multivariate (practically identical ITT and PP analysis indicated poorer response in obese vs. non-obese patients: lesser SDBP reduction (by around 2.2-2.3 mm Hg, P < 0.05 with higher odds of dose up-titration (odds ratio, OR around 1.90, P < 0.05; and better response in: a patients started on telmisartan monotherapy than when added to a preexisting treatment: greater SSBP/SDBP reduction (by around 4.0 and 3.0 mm Hg, respectively, P < 0.05 with comparable odds of up-titration; b diabetics vs. non-diabetics: greater SDBP reduction (by around 3.6-3.7 mm Hg, P < 0.05 with comparable odds of up-titration; c men vs. women: slightly greater SDBP reduction (by around 1.2 mm Hg, 0.05 P < 0.1 with lower odds of up-titration (OR around 0.51, P < 0.05. Conclusion: Previous unsuccessful treatment, obesity, diabetes and gender should be considered in order to optimize the use of telmisartan for mild to moderate essential hypertension in daily clinical practice.

Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial.

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Jin, Hengwei; Huo, Xiaochuan; Jiang, Yuhua; Li, Xiaolong; Li, Youxiang

2017-09-01

Brain arteriovenous malformations (BAVMs) are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed. This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety), and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy). Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula), volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS). The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs.

Systematic review of efficacy of nutraceuticals to alleviate clinical signs of osteoarthritis.

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Vandeweerd, J-M; Coisnon, C; Clegg, P; Cambier, C; Pierson, A; Hontoir, F; Saegerman, C; Gustin, P; Buczinski, S

2012-01-01

Various treatments of osteoarthritis (OA) have been described, including use of nutraceuticals. To review systematically the literature about the effects of nutraceuticals on clinical signs of pain or abnormal locomotion in horses, dogs, and cats, and to discuss methodological aspects of trials and systematic reviews. A systematic search of controlled trials evaluating the impact of nutraceuticals on OA in horses, dogs, and cats was performed, using Medline, CAB Abstracts, and Google Scholar. Scientific evidence was evaluated by means of criteria proposed by the Food and Drug Administration (FDA), and a scoring system adapted from both the CONsolidated Standards of Reporting Trials (CONSORT) statement and recommendations for assessing trials by the Center of Evidence Based Medicine of Oxford. Twenty-two papers were selected and reviewed, with 5 studies performed in horses, 16 in dogs, and 1 in cats. The strength of evidence was low for all nutraceuticals except for omega-3 fatty acid in dogs. There were limited numbers of rigorous randomized controlled trials and of participants in clinical trials. The evidence of efficacy of nutraceuticals is poor, with the exception of diets supplemented with omega-3 fatty acids in dogs. Greater access to systematic reviews must be part of the objectives of the veterinary science in the future. Their reporting would be improved by internationally agreed-upon criteria for standards and guidelines. Copyright © 2012 by the American College of Veterinary Internal Medicine.

Clinical preference for factors in treatment of geriatric depression

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Riepe MW

2014-12-01

Full Text Available Matthias W Riepe Mental Health and Geriatric Psychiatry, Psychiatry II, Ulm University, Ulm, Germany Abstract: Little is known about symptom preferences of clinical psychiatrists in the treatment of geriatric depression and preferences for avoiding adverse drug effects. Participants (board-certified psychiatrists were recruited prior to a lecture on geriatric depression during a continuing education program. An analytic hierarchy process was performed and participants were asked for pairwise comparison of criteria guiding them in appraising therapeutic efficacy, and in avoiding toxicity and adverse events. Of the 61 participants from the continuing education program, 42 (69% returned their data sheet. Avoidance of cardiotoxicity was regarded as more important than avoidance of hepatotoxicity or hematotoxicity. Concerning adverse events, highest preference was given to avoidance of falls and drug interactions, followed by avoidance of sedation, weight change, and impairment of sexual function. The most important preferences for appraisal of therapeutic efficacy were suicidality over ability to concentrate and sleep. Clinical psychiatrists have a hierarchy of preferences for treatment goals and avoidance of adverse events and toxicity. This raises the question for future research whether these preferences cause differences in prescription patterns in clinical practice even though a multitude of antidepressants are similarly effective when judged with instruments used in clinical trials. Keywords: depressive disorder, symptoms, analytic hierarchy process, toxicity, adverse events, symptoms

A Comparison of Medical Birth Register Outcomes between Maternity Health Clinics and Integrated Maternity and Child Health Clinics in Southwest Finland.

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Tuominen, Miia; Kaljonen, Anne; Ahonen, Pia; Mäkinen, Juha; Rautava, Päivi

2016-07-08

Primary maternity care services are globally provided according to various organisational models. Two models are common in Finland: a maternity health clinic and an integrated maternity and child health clinic. The aim of this study was to clarify whether there is a relation between the organisational model of the maternity health clinics and the utilisation of maternity care services, and certain maternal and perinatal health outcomes. A comparative, register-based cross-sectional design was used. The data of women (N = 2741) who had given birth in the Turku University Hospital area between 1 January 2009 and 31 December 2009 were collected from the Finnish Medical Birth Register. Comparisons were made between the women who were clients of the maternity health clinics and integrated maternity and child health clinics. There were no clinically significant differences between the clients of maternity health clinics and integrated maternity and child health clinics regarding the utilisation of maternity care services or the explored health outcomes. The organisational model of the maternity health clinic does not impact the utilisation of maternity care services or maternal and perinatal health outcomes. Primary maternity care could be provided effectively when integrated with child health services.

Efficacy of a novel, biologically active food supplement in type 2 diabetes mellitus: a patient-blinded, prospective, clinical trial

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Podichetty, Vinod; Weshler,; Schlosser,

2011-01-01

Vinod K Podichetty1, Mishel Weshler2, John Schlosser31Research Practice Partners Inc., Miramar, Florida, USA; 2Weshler and Weshler Clinic, Nazareth Illit, Israel; 3Rockland Endocrine and Diabetic Services, Suffern, New York, USAAbstract: Despite significant achievements in the prevention and management of diabetes, its prevalence has risen exponentially, creating a paramount need for alternative therapies. The purpose of the study was to investigate the safety and efficacy of two novel, biolo...

VIBE: Evaluation of Ibandronate Efficacy - Original Investigation

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J-Y Reginster

2008-12-01

Full Text Available No prospective head-to-head trials comparing the fracture efficacy of the currently marketed weekly and monthly bisphosphonates have been conducted. Due to the large sample size such studies would require to reliably detect differences in fracture risk and the associated high costs, they are considered to be impractical. Whilst providing the highest level of evidence, clinical trials also have inherent limitations. Patients are selected by a number of criteria and therefore usually do not represent the normal patient population. Also due to a protocol, normal clinical practice is usually not reflected. In contrast, database studies allow the assessment of treatments in normal clinical practice. Whilst observational studies have limitations owing to more confounding variables, they do have an important place in evidence-based medicine (especially in the absence of prospective clinical trials, and if well-designed can give some indications regarding the comparative efficacy of osteoporosis therapies in real-world clinical practice. (From the World of Osteoporosis 2008;14: 62-5

Clinical efficacy of edaravone for the treatment of amyotrophic lateral sclerosis.

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Sawada, Hideyuki

2017-05-01

Amyotrophic lateral sclerosis (ALS) is a progressive, fatal, neurodegenerative disease. Although the pathogenesis remains unresolved, oxidative stress is known to play a pivotal role. Edaravone works in the central nervous system as a potent scavenger of oxygen radicals. In ALS mouse models, edaravone suppresses motor functional decline and nitration of tyrosine residues in the cerebrospinal fluid. Areas covered: Three clinical trials, one phase II open-label trial, and two phase III placebo-control randomized trials were reviewed. In all trials, the primary outcome measure was the changes in scores on the revised ALS functional rating scale (ALSFRS-R) to evaluate motor function of patients. Expert opinion: The phase II open label trial suggested that edaravone is safe and effective in ALS, markedly reducing 3-nitrotyrosine levels in the cerebrospinal fluid. One of the two randomized controlled trials showed beneficial effects in ALSFRS-R, although the differences were not significant. The last trial demonstrated that edaravone provided significant efficacy in ALSFRS-R scores over 24 weeks where concomitant use of riluzole was permitted. Eligibility was restricted to patients with a relatively short disease duration and preserved vital capacity. Therefore, combination therapy with edaravone and riluzole should be considered earlier.

Evaluation of clinical efficacy of transrectal sonography and computed tomography for prostatic diseases

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Watanabe, Hiroki; Ohe, Hiroshi; Tanahashi, Toshikatsu and others

1988-07-01

Receiver operating characteristics (ROC) analysis was performed to evaluate the clinical efficacy of transrectal sonography (US) and computed tomography (CT) for prostatic diseases. One hundred US and CT images of prostatic diseases collected from 10 medical institutions, including 33 cases of prostatic cancer, 29 of benign prostatic hypertrophy, 7 of prostatitis, 2 of prostatic stone and 29 of normal finding, were read by 21 urologists. As the results, US was found to be more useful than CT for both the detection of prostatic diseases and the differentiation between prostatic cancer and benign prostatic hypertrophy. The sensitivity of US for the diagnosis of prostatic cancer was 64.2 % on average of all the urologists. However, the sensitivity was 80.0 % on average of 5 urologists who have read more than 3,000 US images and 59.5 % on average of 16 doctors who have read within 3,000 US images.

Does Digital Game Interactivity Always Promote Self-Efficacy?

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Lee, Yu-Hao

2015-11-01

Interactive digital games can promote self-efficacy by engaging players in enactive and observational learning. However, interactivity does not always lead to greater self-efficacy. Important constructs in social cognitive theory, such as performance outcome and perceived similarity, are often not accounted for in studies that have tested the effect of digital game interactivity on self-efficacy. This study assessed the effects of interactive digital games compared with passive digital games based on video comparison, a common experimental design used to test the effect of digital game interactivity on self-efficacy. In addition, this study also evaluated player performance and measured perceived similarity to the observed player. Findings suggested that in general, digital game interactivity predicted higher self-efficacy compared with noninteractive passive games. However, in the noninteractive conditions, the effects of performance on self-efficacy were moderated by perceived similarity between the observer and the observed player. When the observed player was perceived to be similar to the observer, the effects of performance on self-efficacy were comparable to the interactive game, but when the observed player was perceived as dissimilar to the observer, observing the dissimilar player failed to increase observer self-efficacy. Implications for interactivity manipulations and game developers are discussed.

[Overdenture supported by natural teeth: analysis of clinical advantages].

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Scotti, R; Melilli, D; Pizzo, G

2003-05-01

Hybrid prosthesis supported by natural teeth (overdenture) is widely used in clinical practice and should be executed whenever the clinical conditions suggest it. Through a critical review of the literature, the anatomical, functional, psychological and clinical advantages are emphasized. Among the first ones, the prophylaxis of residual anatomical components, due to the limitation of bone resorption, and the preservation of sensorial proprioception are relevant. Important advantages are also represented by a better crown-root ratio of residual teeth supporting overdenture, with the consequent improvement of the longitudinal prognosis of such teeth. The greater retention and stability of overdenture in comparison with complete denture greatly improve the masticatory efficacy. The psychological advantages resulting from the dental anchorage, which allows the patient to be more confident in social life, are also relevant. Finally, when the dental support is lost, converting overdenture into complete denture is simple and quick, and makes easier the longitudinal clinical maintenance of the denture.

Clinical Course Score (CCS): a new clinical score to evaluate efficacy of neurotrauma treatment in traumatic brain injury and subarachnoid hemorrhage.

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Brandner, Sebastian; Kellermann, Isabel; Hore, Nirjhar; Bozhkov, Yavor; Buchfelder, Michael

2015-01-01

Neurotrauma continues to represent a challenging public health issue requiring continual improvement in therapeutic approaches. As no such current system exists, we present in this study the Clinical Course Score (CCS) as a new clinical score to evaluate the efficacy of neurotrauma treatment. The CCS was calculated in neurotrauma patients to be the difference between the grade of the Glasgow Outcome Scale 6 months after discharge from our department and the grade of a 1 to 5 point reduced Glasgow Coma Scale on admission. We assessed the CCS in a total of 248 patients (196 traumatic brain injury [TBI] patients and 52 subarachnoid hemorrhage [SAH] patients) who were treated in our Department of Neurosurgery between January 2011 and December 2012. We found negative CCS grades both in mild TBI and in mild SAH patients. In patients with severe TBI or SAH, we found positive CCS grades. In SAH patients, we found higher CCS scores in younger patients compared with elderly subjects in both mild and severe cases. The CCS can be useful in evaluating different therapeutic approaches during neurotrauma therapy. This new score might improve assessment of beneficial effects of therapeutic procedures.

[Epidemiologic and therapeutic study on gonococcal infections--clinical efficacy of cefetamet pivoxil].

Science.gov (United States)

Nishimura, M; Kumamoto, Y; Hirose, T; Hayashi, K; Tsukamoto, T; Gohro, T; Ikegaki, S; Kamito, H; Inoke, T; Henmi, I

1990-07-01

We studied the epidemiology of 109 cases of gonococcal infections (105 males with urethritis and 4 females with cervicitis), together with the basic and clinical effects of cefetamet pivoxil in the cases. The peak of age distribution of the male patients was in the younger half of their twenties, and all of the 4 female cases were between 20 and 39 years old. The major source of infections in the males younger than 25 years old was their girl friends or so-called pick-up friends, and that of the males older than 25 years old workers serving at an amusement center, for example, bars and so-called special massage parlor, which accounted for about three fourths of the male cases between 35 and 44 years old. The distribution of the MIC (inoculum size; 10(6) CFU/ml) of Cefetamet against beta-lactamase non penicillinase producing Neisseria gonorrhoeae (non-PPNG) ranged from 0.025 to 0.1 microgram/ml and that against beta-lactamase producing Neisseria gonorrhoeae ranged from 0.025 to 0.05 microgram/ml. The isolation rate of PPNG was 10.2% (9/88). In male patients with gonococcal urethritis, the efficacy rate was 100% on days 3 and 7 for 1,000 mg single dose and 7-day treatment and 500 mg single dose treatment. One of the cases treated with 250 mg single dose therapy was unchanged at 3, but the efficacy rate of the remaining cases was 100% at day 7. Complicated urethritis with C. trachomatis was noticed in 25.7% (5/105) of the male urethritis and in 25.0% (1/4) of the female cervicitis cases. The only side effect was diarrhea observed in 1 of the 124 case (0.8%).

[Clinical efficacy of mouse nerve growth factor in treatment of occupational hand-arm vibration disease].

Science.gov (United States)

Fan, Chunyue; Wang, Yanyan; Zhang, Ying; Lang, Li; Deng, Xiaofeng; Cheng, Ying

2014-12-01

To investigate the efficacy of mouse nerve growth factor (mNGF) in treating occupational hand-arm vibration disease (HAVD). Sixty-four patients with HAVD were equally and randomly divided into treatment group and control group. The control group was given Salvia miltiorrhiza Bunge and deproteinized extract of calf blood to improve circulation, and also given methylcobalamin tablets and vitamin B6 for neurotrophic treatment. In addition to the above treatments for the control group, the treatment group was also given 30 µg/d mNGF by intramuscular injection for two courses (4 weeks for each course) with a 15-day interval. Both the treatment group and the control group showed significant improvements in clinical symptoms and signs (hand numbness and pain, and reduced senses of touch, pain, and vibration), cold water loading test (CWLT), and electroneuromyography (ENMG) after treatments (P hand numbness and pain, reduced senses of touch, pain, and vibration, CWLT, and ENMG, so it has better clinical effect and safety in treating HAVD. Early diagnosis and treatment can improve the outcome of patients with HAVD.

Comparison of the efficacy and safety of thrombectomy devices in acute stroke : a network meta-analysis of randomized trials.

Science.gov (United States)

Saber, Hamidreza; Rajah, Gary B; Kherallah, Riyad Y; Jadhav, Ashutosh P; Narayanan, Sandra

2017-12-15

Mechanical thrombectomy (MT) is increasingly used for large-vessel occlusions (LVO), but randomized clinical trial (RCT) level data with regard to differences in clinical outcomes of MT devices are limited. We conducted a network meta-analysis (NMA) that enables comparison of modern MT devices (Trevo, Solitaire, Aspiration) and strategies (stent retriever vs aspiration) across trials. Relevant RCTs were identified by a systematic review. The efficacy outcome was 90-day functional independence (modified Rankin Scale (mRS) score 0-2). Safety outcomes were 90-day catastrophic outcome (mRS 5-6) and symptomatic intracranial hemorrhage (sICH). Fixed-effect Bayesian NMA was performed to calculate risk estimates and the rank probabilities. In a NMA of six relevant RCTs (SWIFT, TREVO2, EXTEND-IA, SWIFT-PRIME, REVASCAT, THERAPY; total of 871 patients, 472 Solitaire vs medical-only, 108 Aspiration vs medical-only, 178 Trevo vs Merci, and 113 Solitaire vs Merci) with medical-only arm as the reference, Trevo had the greatest functional independence (OR 4.14, 95% credible interval (CrI) 1.41-11.80; top rank probability 92%) followed by Solitaire (OR 2.55, 95% CrI 1.75-3.74; top rank probability 72%). Solitaire and Aspiration devices had the greatest top rank probability with respect to low sICH and catastrophic outcomes (76% and 91%, respectively), but without significant differences between each other. In a separate network of seven RCTs (MR-CLEAN, ESCAPE, EXTEND-IA, SWIFT-PRIME, REVASCAT, THERAPY, ASTER; 1737 patients), first-line stent retriever was associated with a higher top rank probability of functional independence than aspiration (95% vs 54%), with comparable safety outcomes. These findings suggest that Trevo and Solitaire devices are associated with a greater likelihood of functional independence whereas Solitaire and Aspiration devices appear to be safer. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights

ASSESSMENT OF RELATED ANAMNESTIC AND CLINICAL FACTORS ON EFFICACY AND SAFETY OF ANTI-HELICOBACTER PYLORI THERAPY

Directory of Open Access Journals (Sweden)

D. N. Andreev

2016-01-01

Full Text Available The article presents the results of a prospective clinical study in which 100 patients with H. pylori-associated peptic ulcer disease of stomach/duodenum were examined. The aim of the study was to assess the effect of concomitant anamnestic and clinical factors on the efficacy and safety of eradication therapy (ET. Type 2 diabetes mellitus is a factor that significantly reduces the efficiency of ET with OR 0.21 (95% CI 0,06-0,69, p = 0,0102. Using a macrolide antibiotics prior to ET during the previous 12 months is associated with a reduction in the effectiveness of H. pylori eradication with OR 0.27 (95% CI 0,08-0,90, p = 0,0342. Despite the lack of statistical significance observed negative effect on the efficiency of ET factors such as smoking and increased BMI. Smoking, female gender, age over 50 years and the presence of type 2 diabetes mellitus had no significant impact on the safety profile of ET. 

Comparison of the efficacy of ibuprofen and belladonna in the control of orthodontic separator pain

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Harshal Ashok Patil

2018-01-01

Full Text Available Background: The purpose of this study was to compare the efficacy of ibuprofen and Belladonna in the control of orthodontic pain and to ascertain the pain relief by Belladonna in comparison with ibuprofen during orthodontic separation. Materials and Methods: Patients, between 20 and 35 years of age, 51 females and 21 males, were included in this study. Patients were randomly divided into two groups; one group was assigned to ibuprofen 400 mg and second group was allocated to Belladonna 6C group. Patients were given two doses of medication of their respective groups, 1 h before placement of elastomeric separators (Ormco Separators, Ormco Corporation, CA, USA which was administered in the department and one dose 6 h after the placement. Pain scores recorded on visual analogue scale (VAS. VAS was a 10 cm scale with millimetre calibration to record their pain at the following intervals, 2 h after placement, 6 h after placement, bedtime, day 1 morning, day 2 morning, day 3 morning and day 5 morning. Results: Post hoc comparisons indicated that there was no difference between the two groups at 2 h (P = 0.77, 6 h (0.073, 1 day (P = 0.120, 2 days (P = 0.283, 3 days (P = 0.363, 5 days (P = 0.622 and 7 days. Conclusion: Ibuprofen and Belladonna 6C are effective and provide adequate analgesia with no statistically significant difference. Lack of adverse effects with Belladonna 6C makes it an effective and viable alternative.

Genetic Diversity and Protective Efficacy of the RTS,S/AS01 Malaria Vaccine

DEFF Research Database (Denmark)

Neafsey, Daniel E; Juraska, Michal; Bedford, Trevor

2015-01-01

Background The RTS,S/AS01 vaccine targets the circumsporozoite protein of Plasmodium falciparum and has partial protective efficacy against clinical and severe malaria disease in infants and children. We investigated whether the vaccine efficacy was specific to certain parasite genotypes at the c......Background The RTS,S/AS01 vaccine targets the circumsporozoite protein of Plasmodium falciparum and has partial protective efficacy against clinical and severe malaria disease in infants and children. We investigated whether the vaccine efficacy was specific to certain parasite genotypes...... protein had on vaccine efficacy against first episodes of clinical malaria within 1 year after vaccination. Results In the per-protocol group of 4577 RTS,S/AS01-vaccinated participants and 2335 control-vaccinated participants who were 5 to 17 months of age, the 1-year cumulative vaccine efficacy was 50.......3% (95% confidence interval [CI], 34.6 to 62.3) against clinical malaria in which parasites matched the vaccine in the entire circumsporozoite protein C-terminal (139 infections), as compared with 33.4% (95% CI, 29.3 to 37.2) against mismatched malaria (1951 infections) (P=0.04 for differential vaccine...

GASTROESOPHAGEAL REFLUX DISEASE IN PATIENTS WITH FUNCTIONAL DYSPEPSIA AND CONSTIPATION PREDOMINANT IRRITABLE BOWEL SYNDROME: CLINICAL FEATURES AND EFFICACY OF LACTULOSE AND ITOPRIDE HYDROCHLORIDE

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O. V. Krapivnaya

2014-01-01

Full Text Available Background: The frequent coexistence of gastroesophageal reflux disease (GERD with functional dyspepsia (FD and an irritable bowel syndrome (IBS has been described in the literature. Aim: To study the specific features of GERD clinical course and diagnosis in patients with GERD in combination with FD and constipation predominant IBS (IBS-C in comparison to patients with isolated GERD; to assess the efficacy of lactulose and itopride hydrochloride. Materials and methods: A total of 60 patients with GERD, FD (Rome criteria III, and IBS-C (Rome criteria III and 29 patients with isolated GERD were examined. GERD diagnosis was based on clinical, endoscopic, and pH-metric criteria. For 4 weeks 10 patients with combination of non-erosive reflux disease (NERD, FD and IBS-C received lactulose monotherapy and other 10 patients received combination of lactulose with itopride hydrochloride. Clinical symptoms and pH-metric parameters were assessed before and 4 weeks after treatment. Results: Combination of GERD, FD and IBS-C was noted more frequently in women under 40 with normal body mass index (р<0.05. Classic GERD symptoms were absent in 43.4% of patients with gastrointestinal comorbidity and in 10.3% of patients with isolated GERD (р=0.004. A higher prevalence of belching and nausea was found in patients, suffering from GERD, FD and IBS-C, than in those with isolated GERD (р<0.05. After 4-week lactulose and itopride hydrochloride treatment all the patients with GERD, FD and IBS-C showed a reduction of clinical symptoms (p<0.05 and normalization of pH-metric parameters (р<0.001. Conclusion: GERD course in patients with concomitant FD and IBS-C has the following peculiarities: predominance of women, absence of classic GERD-symptoms in almost half of these patients, and frequent combination with other functional symptoms. Combination therapy with lactulose and itopride hydrochloride enables successful control of GERD and FD symptoms as well as

Towards Clinical Application of Neurotrophic Factors to the Auditory Nerve; Assessment of Safety and Efficacy by a Systematic Review of Neurotrophic Treatments in Humans

NARCIS (Netherlands)

Bezdjian, Aren; Kraaijenga, Véronique J C; Ramekers, Dyan; Versnel, Huib; Thomeer, Hans G X M; Klis, Sjaak F L; Grolman, Wilko

2016-01-01

Animal studies have evidenced protection of the auditory nerve by exogenous neurotrophic factors. In order to assess clinical applicability of neurotrophic treatment of the auditory nerve, the safety and efficacy of neurotrophic therapies in various human disorders were systematically reviewed.

Clinical Efficacy and Its Prognostic Factor of Percutaneous Endoscopic Lumbar Annuloplasty and Nucleoplasty for the Treatment of Patients with Discogenic Low Back Pain.

Science.gov (United States)

Lee, Jung Hwan; Lee, Sang-Ho

2017-09-01

The choice of appropriate treatment of discogenic low back pain (DLBP) frequently is difficult. This study sought to identify the clinical efficacy of percutaneous endoscopic lumbar annuloplasty and nucleoplasty (PELAN) to treat patients with DLBP and to investigate prognostic clinical or radiologic variables. Eighty-nine patients with a diagnosis of DLBP who underwent PELAN were included. Numeric Rating Scale (NRS) for back pain, Oswestry Disability Index % (ODI%), and modified Macnab criteria were measured at short-term (3-4 weeks) and long-term follow-up period (at least 12 months) to investigate clinical efficacy of PELAN. The subjects were defined as successful group in case of 50% or more reduction of NRS, 40% or more reduction of ODI%, and good or excellent response of Macnab criteria. Clinical and radiologic variables were compared between successful and unsuccessful outcomes group to determine prognostic variables. NRS and ODI% were significantly reduced at short- and long-term follow-up after PELAN. Sixty-two (69.7%) and 68 (76.4%) obtained successful NRS reduction and 59 (66.3%) and 68 (76.4%) accomplished successful ODI% reduction at short-term and long-term follow-up, respectively. Successful Mcnab response was found in 61% at short term and 65.2% at long term. Pain during waist flexion among clinical variables was significantly related to good clinical outcomes and Modic change among radiologic variables was significantly related to poor clinical outcomes. PELAN provided favorable outcomes in patients with DLBP who were refractory to conservative treatments. Flexion pain was good prognostic, and Modic change was a poor prognostic variable. Copyright © 2017 Elsevier Inc. All rights reserved.

Comparison of Efficacy of Long-term Oral Treatment with Telmisartan and Benazepril in Cats with Chronic Kidney Disease.

Science.gov (United States)

Sent, U; Gössl, R; Elliott, J; Syme, H M; Zimmering, T

2015-01-01

The efficacy and benefits of telmisartan in cats with chronic kidney disease (CKD) have not previously been reported. Long-term treatment of cats with CKD using telmisartan decreases urine protein-to-creatinine ratio (UP/C) similar to benazepril. Two-hundred and twenty-four client-owned adult cats with CKD. Prospective, multicenter, controlled, randomized, parallel group, blinded clinical trial with noninferiority design. Cats were allocated in a 1:1 ratio to either telmisartan (1 mg/kg; n = 112) or benazepril (0.5-1.0 mg/kg; n = 112) PO q24 h. The primary endpoint was prospectively defined as the change in proteinuria (benazepril:telmisartan) based on a log transformed weighted average of UP/C change from baseline (AUC 0→t/t) as a percentage compared using a confidence interval (CI) approach. Changes of UP/C from baseline were assessed on all study days and corrected for multiple comparisons. Telmisartan proved noninferior to benazepril in controlling proteinuria (CI, -0.035 to 0.268). At Day 180, UP/C compared to baseline in the telmisartan group was significantly lower (-0.05 ± 0.31; P = .016), whereas in the benazepril group the change (-0.02 ± 0.48) was not statistically significant (P = .136). Similar results were obtained at all assessment points with significant decrease in UP/C occurring with telmisartan but not benazepril. Both telmisartan and benazepril were well tolerated and safe. Telmisartan proved to be noninferior to benazepril and significantly decreased proteinuria relative to baseline at all assessment points whereas benazepril did not. Copyright © 2015 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Clinical and radiographic comparison of indirect pulp treatment using light-cured calcium silicate and mineral trioxide aggregate in primary molars: A randomized clinical trial

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Navya P Menon

2016-01-01

Full Text Available Aim: To clinically and radiographically evaluate the reparative dentin formation in indirect pulp treatment (IPT using mineral trioxide aggregate (MTA and light cured calcium silicate (TheraCal in primary molars over a period of 6 months. Materials and Methods: A clinical trial on IPT on 43 primary molars in 21 patients between the age of 4–7 years, divided into two groups: 22 teeth in MTA group and 21 in TheraCal group. Measurement of the variation in dentin thickness was done on the digitalized radiograph at baseline, 3 months and 6 months using CorelDRAW X3 software. Results: Statistical analysis using an independent t-test for intragroup and intergroup comparison showed a significant increase in dentin thickness in both the MTA and TheraCal group (intragroup comparison [P 0.05. Conclusion: Clinically and radiographically, both MTA and TheraCal are good IPT materials. The better handling characteristics and comparable reparative dentin-forming ability of TheraCal make this material an alternative to MTA in pediatric restorative procedures.

The breastfeeding self-efficacy scale: psychometric assessment of the short form.

Science.gov (United States)

Dennis, Cindy-Lee

2003-01-01

The purpose of this study was to reduce the number of items on the original Breastfeeding Self-Efficacy Scale (BSES) and psychometrically assess the revised BSES-Short Form (BSES-SF). As part of a longitudinal study, participants completed mailed questionnaires at 1, 4, and 8 weeks postpartum. Health region in British Columbia. A population-based sample of 491 breastfeeding mothers. BSES, Edinburgh Postnatal Depression Scale, Rosenberg Self-Esteem Scale, and Perceived Stress Scale. Internal consistency statistics with the original BSES suggested item redundancy. As such, 18 items were deleted, using explicit reduction criteria. Based on the encouraging reliability analysis of the new 14-item BSES-SF, construct validity was assessed using principal components factor analysis, comparison of contrasted groups, and correlations with measures of similar constructs. Support for predictive validity was demonstrated through significant mean differences between breastfeeding and bottle feeding mothers at 4 (p self-efficacy and considered ready for clinical use to (a) identify breastfeeding mothers at high risk, (b) assess breastfeeding behaviors and cognitions to individualize confidence-building strategies, and (c) evaluate the effectiveness of various interventions and guide program development.

[Analyses of clinical features and efficacy of sudden deafness with vertigo and dizziness].

Science.gov (United States)

Liu, Bo; Han, Demin; Zhang, Yi; Li, Yongxin; Gong, Shusheng; Chen, Xiuwu; Meng, Xixi; Tang, Junxiang; Xiang, Jie; Jiang, Xuejun; Yang, Ning; Tian, Ying; Hui, Lian; Feng, Shuai

2015-06-01

To investigate the clinical characteristics and the effect of drug treatment for sudden hearing loss with vertigo or dizziness. In a prospective, randomized, single blinded randomized multicenter clinical study, patients with sudden deafness, ranging in age from 18 to 65 years old, with a duration less than 2 weeks, and with no any medical treatments were collected. In accordance with the hearing curve, those patients were divided into four types, i.e., low and intermediate frequency descent type; high frequency descent type; fall flat type; and total deafness type. Each type was treated by four different treatment options, according to the unified design of the random table, and randomly selected one of the options for treatment. The efficacy of the patients with sudden deafness with vertigo and dizziness was analyzed statistically after the follow-up for 4 weeks. SPSS 13.0 software was used to analyze the data. In August 2007 to October 2011, 33 hospitals in the country included 1 024 patients with sudden deafness in line with the inclusion criteria, of whom 296 (28.91%) were accompanied by vertigo/dizziness symptoms, 126 were males and 170 were females, with an average age of (41.2 ± 13.5) years old. types of the different audiometric curves of sudden deafness, the occurrence of complete deafness with vertigo/dizziness was the highest (44.93%), followed by flat down type (25.87%), high frequency descent type (21.28%) and low intermediate frequency descent type (18.54%). After the standard treatment, the vertigo and dizziness symptoms of the sudden deafness patients could disappear, and the hearing in each group was obviously improved. The hearing curative effect on patients accompanied by vertigo/dizziness of low frequency and intermediate frequency descent type was the best, and the total efficiency can reach up to 94.74%, with the cure rate of 68.42%; followed by flat type, in which the total effective rate was 80.76%, with the recovery rate of 22.12%; and

Efficacy and tolerability assessment of a topical formulation containing copper sulfate and hypericum perforatum on patients with herpes skin lesions: a comparative, randomized controlled trial.

Science.gov (United States)

Clewell, Amy; Barnes, Matt; Endres, John R; Ahmed, Mansoor; Ghambeer, Daljit K S

2012-02-01

Topical Acyclovir has moderate efficacy on recurrent HSV symptoms, requiring repeat applications for several days. Topical Dynamiclear, which requires only a single dose application, may provide a more effective and convenient treatment option for symptomatic management of HSV. The study assessed the comparative efficacy and tolerability of a single use, topical formulation containing copper sulfate pentahydrate and Hypericum perforatum that is marketed as Dynamiclear™ to a topical 5% Acyclovir cream standard preparation and use. A prospective, randomized, multi-centered, comparative, open-label clinical study was conducted. A total of 149 participants between 18 and 55 years of age with active HSV-1 and HSV-2 lesions were recruited for the 14-day clinical trial. Participants were randomized into two groups: A (n=61), those receiving the Dynamiclear formulation, and B (n=59), those receiving 5% Acyclovir. Efficacy parameters were assessed via physical examination at baseline (day 1), day 2, 3, 8, and 14. Laboratory safety tests were conducted at baseline and on day 14. Use of the Dynamiclear formulation was found to have no significant adverse effects and was well tolerated by participants. All hematological and biochemical markers were within normal range for the Dynamiclear group. Statistically, odds for being affected by burning and stinging sensation were 1.9 times greater in the Acyclovir group in comparison to the Dynamiclear group. Similarly, the odds of being affected by symptoms of acute pain, erythema and vesiculation were 1.8, 2.4, and 4.4 times higher in the Acyclovir group in comparison to the Dynamiclear group. The Dynamiclear formulation was well tolerated, and efficacy was demonstrated in a number of measured parameters, which are helpful in the symptomatic management of HSV-1 and HSV-2 lesions in adult patients. Remarkably, the effects seen from this product came from a single application.

Generic substitution comparing the clinical efficacy of a generic ...

African Journals Online (AJOL)

Long-acting neuroleptics have become the mainstay of the long-term treatment of schizophrenia, improving compliance and thus preventing relapse. Since schizophrenia is a common condition and ... Concerns about the quality and efficacy of these drugs should be investigated. In this study, no significant differences in the ...

Clinical efficacy and safety evaluation of tailoring iron chelation practice in thalassaemia patients from Asia-Pacific: a subanalysis of the EPIC study of deferasirox.

Science.gov (United States)

Viprakasit, Vip; Ibrahim, Hishamshah; Ha, Shau-Yin; Ho, Phoebe Joy; Li, Chi-Kong; Chan, Lee-Lee; Chiu, Chang-Fang; Sutcharitchan, Pranee; Habr, Dany; Domokos, Gabor; Roubert, Bernard; Xue, Hong-Ling; Bowden, Donald K; Lin, Kai-Hsin

2011-03-01

Although thalassaemia is highly prevalent in the Asia-Pacific region, clinical data on efficacy and safety profiles of deferasirox in patients from this region are rather limited. Recently, data from the multicentre Evaluation of Patients' Iron Chelation with Exjade (EPIC) study in 1744 patients with different anaemias has provided an opportunity to analyse 1115 thalassaemia patients, of whom 444 patients were from five countries in the Asia-Pacific region (AP) for whom thalassaemia management and choice of iron chelators were similar. Compared to the rest of the world (ROW), baseline clinical data showed that the AP group appeared to be more loaded with iron (3745.0 vs. 2822.0 ng/ml) and had a higher proportion on deferoxamine monotherapy prior to the study (82.9 vs. 58.9%). Using a starting deferasirox dose based on transfusional iron intake and tailoring it to individual patient response, clinical efficacy based on serum ferritin reduction in AP and ROW thalassaemia patients was similar. Interestingly, the AP group developed a higher incidence of drug-related skin rash compared to ROW (18.0 vs. 7.2%), which may indicate different pharmacogenetic backgrounds in the two populations. Our analysis confirms that, with appropriate adjustment of dose, deferasirox can be clinically effective across different regions, with manageable side effects.

Physical stability and clinical efficacy of Crocodylus niloticus oil lotion

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Telanie Venter

Full Text Available ABSTRACT The stability and the anti-ageing, skin hydrating and anti-erythema effects of a commercialized Crocodylus niloticus Laurenti, 1768, Crocodylidae, oil lotion was determined. The lotion was stored at controlled conditions over six months during which several stability tests were performed. For the clinical efficacy studies lotion was applied on volar forearm skin (female volunteers and compared to a liquid paraffin-containing reference product. Skin hydrating and anti-ageing effects were determined with a Corneometer®, Cutometer® and Visioscan®, following single (3 h and multiple applications (12 weeks. The Vapometer® and Mexameter® were utilized to determine this lotion's anti-erythema effects on sodium lauryl sulfate irritated skin. The lotion demonstrated good stability over 6 months. The reference product increased skin hydration and decreased skin wrinkles to a larger extent than the C. niloticus lotion after a single application, whereas the C. niloticus lotion decreased skin scaliness better than the reference product. During the long-term study, the reference product overall increased skin hydration more than the C. niloticus lotion, whereas C. niloticus lotion increased skin elasticity to a larger extent than the reference product. C. niloticus lotion increased skin wrinkles and decreased skin scaliness over 12 weeks. Compared to non-treated, irritated skin, C. niloticus lotion demonstrated some potential anti-inflammatory characteristics.

Core schemas across the continuum of psychosis: a comparison of clinical and non-clinical groups.

Science.gov (United States)

Taylor, Hannah E; Stewart, Suzanne L K; Dunn, Graham; Parker, Sophie; Fowler, David; Morrison, Anthony P

2014-11-01

Research suggests that core schemas are important in both the development and maintenance of psychosis. The aim of the study was to investigate and compare core schemas in four groups along the continuum of psychosis and examine the relationships between schemas and positive psychotic symptomatology. A measure of core schemas was distributed to 20 individuals experiencing first-episode psychosis (FEP), 113 individuals with "at risk mental states" (ARMS), 28 participants forming a help-seeking clinical group (HSC), and 30 non-help-seeking individuals who endorse some psychotic-like experiences (NH). The clinical groups scored significantly higher than the NH group for negative beliefs about self and about others. No significant effects of group on positive beliefs about others were found. For positive beliefs about the self, the NH group scored significantly higher than the clinical groups. Furthermore, negative beliefs about self and others were related to positive psychotic symptomatology and to distress related to those experiences. Negative evaluations of the self and others appear to be characteristic of the appraisals of people seeking help for psychosis and psychosis-like experiences. The results support the literature that suggests that self-esteem should be a target for intervention. Future research would benefit from including comparison groups of people experiencing chronic psychosis and people who do not have any psychotic-like experiences.

Efficacy of panoramic radiography as a screening procedure in dental examination compared with clinical evaluation

International Nuclear Information System (INIS)

An, Seo Young; An, Chang Hyeon; Choi, Karp Shik

2007-01-01

To evaluate the efficacy of panoramic radiography by comparing the results of clinical examination with radiographic findings. We studied 190 patients (20 men and 170 women; mean age, 40 years; range, 22 to 68 years) who visited the health promotion center of Korea Medical Science Institute and were examined both clinically and by panoramic radiography. We compared results from both examinations. Treatment options by clinical examination were described as 'no treatment indicated', 'treatment of dental caries', 'removal of calculus', 'treatment of periodontal disease'. 'prothodonic treatment' and 'extraction of the third molar'. Findings taken from the panoramic radiography were: dental caries, peroapical lesion, alveolar bone loss, calculus deposition, retained root, impaction of the third molar, disease of maxillary sinus, bony change of mandibular condyle, etc. The prevalence of panoramic findings were: 37.9% of dental caries, 17.4% of periapical lesions, 44.7% of alveolar bone losses, 62.6% of calculi deposition. 7.9% of retained roots, 26.8% of third molar impactions, 6.3% of disease of maxillary sinus, 2.1% of bony changes of mandibular condlye and 35.8% of miscellaneous lesions. Abnormal conditions revealed by panoramic radiography which had not been discovered on clinical examination were: 24.2% of the patients had dental caries, 17.4% had periapical lesions, 7.4% had calculi deposition, 5.3% had retained roots, 15.3% had third molar impactions. The opposite cases were: 5.2% had dental caries, 12.6% had calculi deposition, and 9.5% had third molar impactions. The use of panoramic radiography as a supplement to the clinical examination might be a valuable screening technique

Efficacy of panoramic radiography as a screening procedure in dental examination compared with clinical evaluation

Energy Technology Data Exchange (ETDEWEB)

An, Seo Young; An, Chang Hyeon; Choi, Karp Shik [Kyungpook National Univ. School of Dentistry, Daegu (Korea, Republic of)

2007-06-15

To evaluate the efficacy of panoramic radiography by comparing the results of clinical examination with radiographic findings. We studied 190 patients (20 men and 170 women; mean age, 40 years; range, 22 to 68 years) who visited the health promotion center of Korea Medical Science Institute and were examined both clinically and by panoramic radiography. We compared results from both examinations. Treatment options by clinical examination were described as 'no treatment indicated', 'treatment of dental caries', 'removal of calculus', 'treatment of periodontal disease'. 'prothodonic treatment' and 'extraction of the third molar'. Findings taken from the panoramic radiography were: dental caries, peroapical lesion, alveolar bone loss, calculus deposition, retained root, impaction of the third molar, disease of maxillary sinus, bony change of mandibular condyle, etc. The prevalence of panoramic findings were: 37.9% of dental caries, 17.4% of periapical lesions, 44.7% of alveolar bone losses, 62.6% of calculi deposition. 7.9% of retained roots, 26.8% of third molar impactions, 6.3% of disease of maxillary sinus, 2.1% of bony changes of mandibular condlye and 35.8% of miscellaneous lesions. Abnormal conditions revealed by panoramic radiography which had not been discovered on clinical examination were: 24.2% of the patients had dental caries, 17.4% had periapical lesions, 7.4% had calculi deposition, 5.3% had retained roots, 15.3% had third molar impactions. The opposite cases were: 5.2% had dental caries, 12.6% had calculi deposition, and 9.5% had third molar impactions. The use of panoramic radiography as a supplement to the clinical examination might be a valuable screening technique.

Comparison of efficacy of phenol and sodium hydroxide matricectomies for management of ingrown toenails

International Nuclear Information System (INIS)

Jabbar, A.; Majeed, S.; Arif, A.

2015-01-01

To compare the efficacy of Phenol and Sodium Hydroxide Matricectomies in terms of frequency of pain and wound healing in the management of Ingrown Toenails. Study Design: Randomized Clinical Trial Place of Duration of Study: Out Patient Department of Surgery Combined Military Hospital Kharian from Aug 2010 to Feb 2011. Patients and Methods: A total of 140 cases with Ingrown Toenails were selected and randomly divided into two groups of 70 each. Cases of Group A and B were subjected to Phenol Matricectomy (PMC) and Sodium Hydroxide Matricectomy (SHMC) respectively. Postoperative pain was comparatively and Southampton Wound Grade for wound healing were analyzed at 2nd and 10th postop day. Results: Mean age of Group A was 28.86 ± 6.423 whereas that of Group B was 28.80 ± 5.997. Group A had 58 (83%) males and 12 (17%) females. Group B had 48 (69%) males and 22 (31%) females. Postoperative pain was comparatively less in group A with statistical difference between two groups on 2nd day (p = 0.014), whereas it was less intense in group B with no statistical significant difference on 10th day (p=0.662). Wound healing was better in group B with statistical difference between two groups on 2nd (p = 0.022) and 10th day (p = 0.024). Group B (91.4%) had more statistically significant efficacy than Group A (71.4%) (p = 0.004). Conclusion: SHMC is superior to PMC in reducing pain and improving wound healing for managing Ingrown Toenails. (author)

Math and Science Pursuits: A Self-Efficacy Intervention Comparison Study

Science.gov (United States)

Cordero, Elizabeth D.; Porter, Sarah H.; Israel, Tania; Brown, Michael T.

2010-01-01

This study compared two interventions to increase math self-efficacy among undergraduate students. Ninety-nine first-year undergraduate students participated in an intervention involving performance accomplishment or an intervention combining performance accomplishment and belief-perseverance techniques in which participants constructed a…

Safety and efficacy of aneurysm treatment with WEB

DEFF Research Database (Denmark)

Pierot, Laurent; Costalat, Vincent; Moret, Jacques

2016-01-01

OBJECT WEB is an innovative intrasaccular treatment for intracranial aneurysms. Preliminary series have shown good safety and efficacy. The WEB Clinical Assessment of Intrasaccular Aneurysm Therapy (WEBCAST) trial is a prospective European trial evaluating the safety and efficacy of WEB in wide......-neck bifurcation aneurysms. METHODS Patients with wide-neck bifurcation aneurysms for which WEB treatment was indicated were included in this multicentergood clinical practices study. Clinical data including adverse events and clinical status at 1 and 6 months were collected and independently analyzed by a medical....... RESULTS Ten European neurointerventional centers enrolled 51 patients with 51 aneurysms. Treatment with WEB was achieved in 48 of 51 aneurysms (94.1%). Adjunctive implants (coils/stents) were used in 4 of 48 aneurysms (8.3%). Thromboembolic events were observed in 9 of 51 patients (17.6%), resulting...

A comparison of the efficacy and tolerability of oxcarbazepine oral suspension between infants and children with epilepsy: a retrospective chart review at a single medical center in Taiwan.

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Wei, Shu-Hao; Liu, Cheng-Chao; Fan, Pi-Chuan

2014-02-01

Few clinical studies have assessed the efficacy and safety of oxcarbazepine (OXC) oral suspension in Asian pediatric patients and particularly in infants. The aim of this study was to investigate and compare the efficacy, tolerability, and side effects of OXC oral suspension in Taiwanese infants and children with various types of epilepsy. A retrospective review of the efficacy, tolerability, and side effects of OXC oral suspension in a tertiary medical center in Taiwan was conducted and included children (1-9 years old) and infants (effects (30 vs. 21 %, p = 0.525) after OXC oral suspension treatment. The efficacy was significantly correlated with the epilepsy subtype (p effective and well tolerated in both infants and children with partial epilepsy in Taiwan. Treatment efficacy was related to epilepsy subtype and number of combined AEDs before OXC treatment. Monotherapy had an excellent therapeutic response in partial epilepsy but not in multifocal epilepsy.

Pioglitazone utilization, efficacy & safety in Indian type 2 diabetic patients: A systematic review & comparison with European Medicines Agency Assessment Report.

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Pai, Sarayu A; Kshirsagar, Nilima A

2016-11-01

With pioglitazone ban and subsequent revoking in India along with varying regulatory decisions in other countries, it was decided to carry out a systematic review on its safety, efficacy and drug utilization in patients with type 2 diabetes mellitus (T2DM) in India and compare with the data from the European Medicines Agency Assessment Report (EMA-AR). Systematic review was performed as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, searching Medline/PubMed, Google Scholar and Science Direct databases using 'pioglitazone AND India AND human' and 'pioglitazone AND India AND human AND patient' and compared with EMA-AR. Spontaneous reports in World Health Organization VigiBase from India were compared with VigiBase data from other countries. Sixty six publications, 26 (efficacy), 32 (drug utilization) and eight (safety), were retrieved. In India, pioglitazone was used at 15-30 mg/day mostly with metformin and sulphonylurea, being prescribed to 26.7 and 8.4 per cent patients in north and south, respectively. The efficacy in clinical trials (CTs) was similar to those in EMA-AR. Incidence of bladder cancer in pioglitazone exposed and non-exposed patients was not significantly different in an Indian retrospective cohort study. There were two cases and a series of eight cases of bladder cancer published but none reported in VigiBase. In India, probably due to lower dose, lower background incidence of bladder cancer and smaller sample size in epidemiological studies, association of bladder cancer with pioglitazone was not found to be significant. Reporting of CTs and adverse drug reactions to Clinical Trials Registry of India and Pharmacovigilance Programme of India, respectively, along with compliance studies with warning given in package insert and epidemiological studies with larger sample size are needed.

A comparison of ultrasound and clinical examination in the detection of flexor tenosynovitis in early arthritis

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Abouqal Redouane

2011-05-01

Full Text Available Abstract Background Tenosynovitis is widely accepted to be common in rheumatoid arthritis (RA and postulated to be the first manifestation of RA, but its true prevalence in early disease and in particular the hand has not been firmly established. The aims of this study were first to investigate the frequency and distribution of finger flexor tenosynovitis using ultrasound in early arthritis, second to compare clinical examination with ultrasound (US using the latter as the gold standard. Methods 33 consecutive patients who had who were initially diagnosed with polyarthritis and suspected of polyarthritis and clinical suspicion of inflammatory arthritis of the hands and wrists were assessed during consecutive, routine presentations to the rheumatology outpatient clinic. We scanned a total of 165 finger tendons and subsequent comparisons were made using clinical examination. Results Flexor tenosynovitis was found in 17 patients (51.5% on ultrasound compared with 16 (48.4% of all patients on clinical examination. Most commonly damaged joint involved on US was the second finger followed by the third, fifth, and fourth. Both modalities demonstrated more pathology on the second and third metacarpophalangeal (MCP compared with the fourth and fifth MCP. A joint-by-joint comparison of US and clinical examination demonstrated that although the sensitivity, specificities and positive predictive values of clinical examination were relatively high, negative predictive value of clinical examination was low (0.23. Conclusions Our study suggest that clinical examination can be a valuable tool for detecting flexor disease in view of its high specificity and positive predictive values, but a negative clinical examination does not exclude inflammation and an US should be considered. Further work is recommended to standardize definitions and image acquisition for peritendinous inflammation for ultrasound.

The clinical significance of 5% change in vital capacity in patients with idiopathic pulmonary fibrosis: extended analysis of the pirfenidone trial

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Nakata Koichiro

2011-07-01

Full Text Available Abstract Background Our phase III clinical trial of pirfenidone for patients with idiopathic pulmonary fibrosis (IPF revealed the efficacy in reducing the decline of vital capacity (VC and increasing the progression-free survival (PFS time by pirfenidone. Recently, marginal decline in forced VC (FVC has been reported to be associated with poor outcome in IPF. We sought to evaluate the efficacy of pirfenidone from the aspects of 5% change in VC. Methods Improvement ratings based on 5% change in absolute VC, i.e., "improved (VC ≥ 5% increase", "stable (VC Results In the comparison of the improvement ratings, the statistically significant differences were clearly revealed at months 3, 6, 9, and 12 between pirfenidone and placebo groups. Risk reductions by pirfenidone to placebo were approximately 35% over the study period. In the comparison of the PFS times, statistically significant difference was also observed between pirfenidone and placebo groups. The positive/negative predictive values in placebo and pirfenidone groups were 86.1%/50.8% and 87.1%/71.7%, respectively. Further, the baseline characteristics of patients worsened at month 3 had generally severe impairment, and their clinical outcomes including mortality were also significantly worsened after 1 year. Conclusions The efficacy of pirfenidone in Japanese phase III trial was supported by the rating of 5% decline in VC, and the VC changes at month 3 may be used as a prognostic factor of IPF. Trial Registration This clinical trial was registered with the Japan Pharmaceutical Information Center (JAPIC on September 13th, 2005 (Registration Number: JAPICCTI-050121.

Efficacy of bendamustine and rituximab as first salvage treatment in chronic lymphocytic leukemia and indirect comparison with ibrutinib: a GIMEMA, ERIC and UK CLL FORUM study.

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Cuneo, Antonio; Follows, George; Rigolin, Gian Matteo; Piciocchi, Alfonso; Tedeschi, Alessandra; Trentin, Livio; Medina Perez, Angeles; Coscia, Marta; Laurenti, Luca; Musuraca, Gerardo; Farina, Lucia; Rivas Delgado, Alfredo; Orlandi, Ester Maria; Galieni, Piero; Mauro, Francesca Romana; Visco, Carlo; Amendola, Angela; Billio, Atto; Marasca, Roberto; Chiarenza, Annalisa; Meneghini, Vittorio; Ilariucci, Fiorella; Marchetti, Monia; Molica, Stefano; Re, Francesca; Gaidano, Gianluca; Gonzalez, Marcos; Forconi, Francesco; Ciolli, Stefania; Cortelezzi, Agostino; Montillo, Marco; Smolej, Lukas; Schuh, Anna; Eyre, Toby A; Kennedy, Ben; Bowles, Kris M; Vignetti, Marco; de la Serna, Javier; Moreno, Carol; Foà, Robin; Ghia, Paolo

2018-04-19

We performed an observational study on the efficacy of bendamustine and rituximab as first salvage regimen in chronic lymphocytic leukemia. In an intention-to-treat analysis including 237 patients, the median progression free survival was 25 months. The presence of del(17p), unmutated IGHV and advanced stage were associated with a shorter progression free survival at multivariate analysis. The median time-to-next treatment was 31.3 months. Front-line treatment with a chemoimmunotherapy regimen was the only predictive factor for a shorter time to next treatment at multivariate analysis. The median overall survival was 74.5 months. Advanced Binet stage (i.e. III-IV or C) and resistant disease were the only parameters significantly associated with a shorter OS. Grade 3-5 infections were recorded in 6.3% of patients. A matched-adjusted indirect comparison with ibrutinib given second-line within named patient programs in the United Kingdom and in Italy was carried out with overall survival as objective endpoint. When restricting the analysis to patients with intact 17p who had received chemoimmunotherapy in first line, the overall survival did not differ between patients treated with ibrutinib (63% alive at 36 months) and patients treated with BR (74.4% alive at 36 months). BR is an efficacious first salvage regimen in chronic lymphocytic leukemia in a real-life population, including the elderly and unfit patients. BR and ibrutinib may be equally effective in terms of overall survival when used as first salvage treatment in patients without 17p deletion. ClinicalTrials.gov identifier: NCT02491398. Copyright © 2018, Ferrata Storti Foundation.

Comparison of the efficacy of preoperative X-ray and thermoradiotherapy used for the treatment of breast cancer

International Nuclear Information System (INIS)

Muravskaya, G.V.; Pantyushenko, T.A.; Fradkin, S.Z.; Zhavrid, Eh.A.; Moiseenko, V.V.

1984-01-01

An experience of the first randomatized clinical investigation on the usage of different variants of preoperative X-ray (with simultaneous local UHF hyperthepmia and without it) action in the case of combined treatment of patients with breast cancer has been summarized. It has been shown that conventional values of preoperative X-ray therapy (about 30-45 G.) are optimum ones. An increase of complex thermoradiotherapy efficacy in the case of considered cancer forms may be achieved at the expense of a stre gthening of preoperative X-ray action by means of dose increase up to the cancerogenic level or preoperative irradiation under the conditions of local UHF-hyperthermia

Clinical efficacy of gamma knife and surgery treatment of mesial temporal lobe epilepsy and their effects on EF-Tumt and EF-Tsmt expression.

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Wang, X-Q; Zhang, X-D; Han, Y-M; Shi, X-F; Lan, Z-B; Men, X-X; Pan, Y-W

2017-04-01

To study the clinical efficacy of gamma knife and surgery treatment of mesial temporal lobe epilepsy (MTLE) and their effects on EF-Tumt and EF-Tsmt expression. The data of 78 cases of MTLE patients treated in our hospital from April 2011 to March 2013 were retrospectively analyzed. The patients were divided into two groups according to the treatment methods: the surgery group (including 41 cases) and the gamma knife group (including 37 cases). The clinical efficacy, the occurrence and recurrence of complications were evaluated, respectively; meanwhile, the expression of the EF-Tumt protein and EF-Tsmt protein in brain tissue were analyzed. The difference between the efficacy rate of the two groups showed no statistical significance (χ2=0.960, p>0.05). The complication rate of the gamma knife group was significantly lower than that of the control group (χ2=6.430, pknife group was significantly lower than that of the patients in the surgery group (p>0.05). Within the two groups, the positive expression granum of EF-Tsmt protein and EF-Tumt protein of the two groups after treatment were significantly lower than that before treatment (pknife group was obviously more than that of the patients in the surgery group (p0.05). Before and after treatment within the group, the positive cell of EF-Tsmt protein and EF-Tumt protein of the two groups of patients after treatment were significantly lower than that before treatment (p0.05). Both surgery and gamma knife could treat MTLE effectively, and the efficacy may be related to the ability to reduce the expression of EF-Tsmt protein and EF-Tumt protein in brain tissue.

Differential clinical pharmacology of rolapitant in delayed chemotherapy-induced nausea and vomiting (CINV

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Rashad N

2017-03-01

Full Text Available Noha Rashad,1 Omar Abdel-Rahman2 1Medical Oncology Department, Maadi Armed Forces Hospital, 2Clinical Oncology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt Abstract: Rolapitant is a highly selective neurokinin-1 receptor antagonist, orally administered for a single dose of 180 mg before chemotherapy with granisetron D1, dexamethasone 8 mg BID on day 2–4. It has a unique pharmacological characteristic of a long plasma half-life (between 163 and 183 hours; this long half-life makes a single use sufficient to cover the delayed emesis risk period. No major drug–drug interactions between rolapitant and dexamethasone or other cytochrome P450 inducers or inhibitors were observed. The clinical efficacy of rolapitant was studied in two phase III trials in highly emetogenic chemotherapy and in one clinical trial in moderately emetogenic chemotherapy. The primary endpoint was the proportion of patients achieving a complete response (defined as no emesis or use of rescue medication in the delayed phase (>24–120 hours after chemotherapy. In comparison to granisetron (10 µg/kg intravenously and dexamethasone (20 mg orally on day 1, and dexamethasone (8 mg orally twice daily on days 2–4 and placebo, rolapitant showed superior efficacy in the control of delayed and overall emesis. This review aims at revising the pharmacological characteristics of rolapitant, offering an updated review of the available clinical efficacy and safety data of rolapitant in different clinical settings, highlighting the place of rolapitant in the management of chemotherapy-induced nausea and vomiting (CINV among currently available guidelines, and exploring the future directions of CINV management. Keywords: nausea, vomiting, chemotherapy, rolapitant, CINV

Clinical safety and efficacy of implantation of octacalcium phosphate collagen composites in tooth extraction sockets and cyst holes

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Tadashi Kawai

2016-09-01

Full Text Available It was demonstrated that octacalcium phosphate collagen composite achieved notable bone regeneration in bone defects in preclinical studies. On the basis of the research results, an investigator-initiated exploratory clinical trial was conducted after approval from a local Institutional Review Board. This clinical study was performed as a single-arm non-randomized intervention study. Octacalcium phosphate collagen composite was implanted into a total of 10 cases of alveolar bone defects after tooth extractions and cystectomy. Safety assessment was performed in terms of the clinical course and several consecutive laboratory examinations, and sequential radiographs were used for efficacy assessment. All participants uneventfully completed the clinical trial without major problems in their general condition. Postoperative wound swelling was observed, as also commonly seen in tooth extraction or cystectomy. Although no serious liver dysfunction, renal dysfunction, electrolyte imbalance, or abnormal urinalysis results were recognized, the number of white blood cells and C-reactive protein level temporarily increased after the operation. An increase in radiopacity in the octacalcium phosphate collagen composite–implanted site was observed in all cases. Finally, the border between the original bone and the octacalcium phosphate collagen composite–implanted site became indistinguishable. These results suggest that octacalcium phosphate collagen composite could be utilized safely in clinical situations in the future.

COMPARISONS OF SELF-EFFICACY AND HOPE AMONG STUDENTS WITH AND WITHOUT LEARNING DISABILITIES

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Mohammad HOJATI

2013-03-01

Full Text Available Learning disability is a life-long condition that can affect academic functioning, everyday life and social life. In multiple areas, academic and other, students with LD often underachieve, and often with pervasive negative consequences. This study compared self-efficacy and hope in 30 elementary school (sixth grade children with learning disabilities (LD and 30 their peers without LD. An ex post facto design was used. Statistical population comprised of all students in elementary schools (sixth grade in, Harsin, Iran, during the 2012-2013 academic year. Students with learning disabilities were randomly selected. The students with LD had been diagnosed by Colorado Learning Difficulties Questionnaire (CLDQ. The students completed the Wechsler Memory Scale, General Self-Efficacy Scale, and Children’s Hope Scale. Data were analyzed using analysis of variance. The Statistical Package for Social Sciences (SPSS 20 was used for computing descriptive statistics and analysis of variance. Differences were found between the groups on the self-efficacy and hope. The study demon­strated the important role of self-efficacy and hope for students with LD.

COMPARISON BETWEEN POST ISOMETRIC RELAXATION AND RECIPROCAL INHIBITION MANUEVERS ON HAMSTRING FLEXIBILITY IN YOUNG HEALTHY ADULTS: RANDOMIZED CLINICAL TRIAL

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Agrawal Sonal S

2016-01-01

Full Text Available Background & Purpose: Variations in the application of muscle energy technique (MET for increasing the extensibility of muscles have been advocated, but little evidence exists to support the relative merit of a particular approach. This study investigated two types of muscle energy techniques that have been advocated in the osteopathic literature that differ primarily in the muscle group targeted. Aim: To compare the efficacy of Post Isometric Relaxation (PIR and Reciprocal Inhibition (RI on hamstring length in young healthy adults Methodology: Randomized clinical trial 100 college students aged between 18-25 years were included. The subjects were randomly assigned to PIR and RI group. Each group consisted of 50 subjects (25 male, 25 female. Knee extension limitation was measured by using active knee extension test (AKET pre & post-intervention, i.e. after 3 weeks of stretching regimen, with the help of universal full circle goniometer. Results: There was significant improvement in hamstrings flexibility (p=0.000 in both PIR and RI groups. Statistical comparison of the results of both the technique showed that PIR group had greater improvement than the RI group (p=0.000 Conclusion: PIR and RI were both found to be effective in improving hamstring flexibility but, PIR is more effective therapeutic maneuver.

The efficacy of negative pressure wound therapy in the management of lower extremity trauma: review of clinical evidence.

Science.gov (United States)

Kanakaris, N K; Thanasas, C; Keramaris, N; Kontakis, G; Granick, Mark S; Giannoudis, P V

2007-12-01

A large number of aids have been conceived and introduced into clinical practice (nutritional supplements, local dressings, technical innovations) aimed at facilitating and optimising wound healing in both acute and chronic wound settings. Among these advances, negative pressure wound therapy (NPWT) has been introduced during the last 30 years, and has been analysed in over 400 manuscripts of the English, Russian and German literature. Until very recently, vacuum assisted closure (VAC) (KCI, TX, USA) has been the only readily available commercial device that provides localised negative pressure to the wound and is the predominant agent used to deliver NPWT featured in this review. We conducted a comprehensive review of the existing clinical evidence of the English literature on the applications of NPWT in the acute setting of trauma and burns of the lower extremity. Overall, 16 clinical studies have been evaluated and scrutinised as to the safety and the efficacy of this adjunct therapy in the specific environment of trauma. Effectiveness was comparable to the standard dressing and wound coverage methods. The existing clinical evidence justifies its application in lower limb injuries associated with soft tissue trauma.

Efficacy of a clinical stroke score in monitoring complications in ...

African Journals Online (AJOL)

Background: Presence of medical complications in stroke patients has been established. The efficacy of ... inpatient stroke rehabilitation have been reported .... Lancet. 1975;1:480-44. 12. Langfitt TW. Measuring outcomes from head injuries. J.

Clinical Efficacy, Safety, and Immunogenicity of a Live Attenuated Tetravalent Dengue Vaccine (CYD-TDV in Children: A Systematic Review with Meta-analysis

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Moffat Malisheni

2017-08-01

Full Text Available BackgroundDengue hemorrhagic fever is the leading cause of hospitalization and death in children living in Asia and Latin America. There is an urgent need for an effective and safe dengue vaccine to reduce morbidity and mortality in this high-risk population given the lack of dengue specific treatment at present. This review aims to determine the efficacy, safety, and immunogenicity of CYD-TDV vaccine in children.MethodsThis is a systematic review including meta-analysis of randomized controlled clinical trial data from Embase, Medline, the Cochrane Library, Web of Science, and ClinicalTrials.gov. Studies that assessed CYD-TDV vaccine efficacy [(1 − RR*100], safety (RR, and immunogenicity (weighted mean difference in children were included in this study. Random effects model was employed to analyze patient-level data extracted from primary studies.ResultsThe overall efficacy of CYD-TDV vaccine was 54% (40–64, while serotype-specific efficacy was 77% (66–85 for DENV4, 75% (65–82 for DENV3, 50% (36–61 for DENV1, and 34% (14–49 for DENV2. 15% (−174–74 vaccine efficacy was obtained for the unknown serotype. Meta-analysis of included studies with longer follow-up time (25 months revealed that CYD-TDV vaccine significantly increased the risk of injection site reactions (RR = 1.1: 1.04–1.17; p-value = 0.001. Immunogenicity (expressed as geometric mean titers in descending order was 439.7 (331.7–547.7, 323 (247 – 398.7, 144.1 (117.9–170.2, and 105 (88.7–122.8 for DENV3, DENV2, DENV1, and DENV4, respectively.ConclusionCYD-TDV vaccine is effective and immunogenic in children overall. Reduced efficacy of CYD-TDV vaccine against DENV2 notoriously known for causing severe dengue infection and dengue outbreaks cause for serious concern. Post hoc meta-analysis of long-term follow-up data (≥25 months from children previously vaccinated with CYD-TDV vaccine is needed to make a conclusion regarding CYD-TDV vaccine

Comparison of the clinical efficacy of methylprednisolone with ibuprofen and ibuprofen alone on the postoperative sequelae of surgical removal of impacted third molar

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Navneet Kaur

2014-01-01

Full Text Available Purpose: The aim of the study was to compare the clinical efficacy of methylprednisolone with ibuprofen to ibuprofen alone on the postoperative sequelae of surgical removal of impacted third molars. Materials and Methods: The present study was conducted on the 35 patients requiring surgical extraction of bilateral impacted third molars attending the Outpatient Department of Oral and Maxillofacial Surgery, Guru Nanak Dev Dental College and Research Institute. The impacted teeth were removed in two sessions at least 3 weeks apart. The selected patients were randomly put on regimen 1 or regimen II at either the first or second surgery in accordance with randomization plan. The measurements and recordings for pain, swelling, and interincisal distance (mouth opening, were made on 1 st , 3 rd , and 7 th day postoperatively on the scales designed for the purpose. The data recorded was compiled and put to statistical analysis. Results: It was observed from the present study that postoperative sequelae, that is, pain, swelling, and trismus was significantly less in the regimen I group than regimen II group on the 1 st and 3 rd postoperative day. Conclusion: The results of this study substantiate the fact that a single class of drugs (nonsteroidal anti-inflammatory drug (NSAID is less effective in controlling postoperative inflammatory sequelae than the combination of ibuprofen (NSAID and methylprednisolone (corticosteroid following the third molar surgery. Therefore, this pharmaceutical combination should be considered for attenuation of postoperative sequelae in healthy patients undergoing surgical removal of impacted mandibular third molar.

Paired-eye comparison of medical therapies for glaucoma

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Alfred M Solish

2010-09-01

Full Text Available Alfred M Solish1,2, Friedericke James1, John G Walt3, Tina H Chiang31Southern California Glaucoma Consultants, Pasadena CA, USA; 2Jules Stein Eye Institute, University of California Los Angeles, Los Angeles, 3Allergan Inc., Irvine, CA, USA Objective: To evaluate efficacy and patient preference retrospectively among intraocular pressure (IOP-lowering prostamide and prostaglandin medications in a real-world clinical setting.Methods: Chart review of patients with uncontrolled glaucoma or ocular hypertension seen at a private practice clinic (n = 55 who received bimatoprost 0.03% once daily in one eye and either travoprost 0.004% or latanoprost 0.005% once daily in the fellow eye. IOP was evaluated at the initial visit and at a follow-up visit scheduled 4–6 weeks later. At the follow-up visit, each patient discussed the clinical results with their physician, chose which medication they preferred to continue using, and were queried regarding the reason for their choice. This paired-eye comparison method is used routinely in clinical practice to assess clinical response and involve patients in decisions regarding treatment. Change in mean IOP from baseline and patient medication choice were the outcome measures.Results: Bimatoprost-treated eyes (n = 52 had a mean IOP reduction of 2.7 mmHg and travoprost-treated eyes (n = 47 had an average decrease of 1.7 mmHg (P = 0.230. Bimatoprost significantly reduced mean IOP (from 19.8 mmHg at baseline to 17.1 mmHg at follow-up, P < 0.0001, as did travoprost (from 19.4 mmHg at baseline to 17.7 mmHg at follow-up, P = 0.009. Latanoprost-treated eyes were excluded from the efficacy analysis due to small sample size (n = 5. For continued therapy, patients chose bimatoprost over travoprost by a factor of 2.4 to 1. Of the 15 patients who gave a reason for their choice, 80% said their decision was based primarily on IOP change.Conclusions: Bimatoprost and travoprost were efficacious in reducing IOP among patients with

Comparison of pharmacological and nonpharmacological treatment strategies in promotion of infertility self-efficacy scale in infertile women: A randomized controlled trial