Office Visits to Monitor Stimulant Medication Safety and Efficacy: Recommended Care.

PubMed

Zima, Bonnie T; Norquist, Grayson S; Altchuler, Steven I; Behrens, Jacob; Iles-Shih, Matthew D; Ng, Yiu Kee Warren; Schaepper, Mary Ann

2018-06-01

The clinical guidance based on the research article, "Specific Components of Pediatricians' Medication-Related Care Predict Attention-Deficit/Hyperactivity Disorder Improvement," published in the June 2017 issue, 1 might be premature. The authors, Epstein et al., suggest that "Physicians do not need to necessarily rely on office visits to monitor medication response and side effects in the week(s) after initially prescribing medication, but instead could use phone calls or email correspondence to check in with the family" (p. 489). However, this advice has the potential to be misinterpreted that phone or email contact is acceptable clinical practice to monitor stimulant medication safety and efficacy, especially during the maintenance phase. It also could be erroneously interpreted that phone or email contact is sufficient for follow-up care for children receiving medication treatment for attention-deficit/hyperactivity disorder (ADHD) for national quality measures. Copyright © 2018 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Monitoring the efficacy of drugs for neglected tropical diseases controlled by preventive chemotherapy

PubMed Central

Albonico, M.; Levecke, B.; LoVerde, P.T.; Montresor, A.; Prichard, R.; Vercruysse, J.; Webster, J.P.

2017-01-01

In the last decade, pharmaceutical companies, governments and global health organisations under the leadership of the World Health Organization (WHO) have pledged large-scale donations of anthelmintic drugs, including ivermectin (IVM), praziquantel (PZQ), albendazole (ALB) and mebendazole (MEB). This worldwide scale-up in drug donations calls for strong monitoring systems to detect any changes in anthelmintic drug efficacy. This review reports on the outcome of the WHO Global Working Group on Monitoring of Neglected Tropical Diseases Drug Efficacy, which consists of three subgroups: (i) soil-transmitted helminthiases (ALB and MEB); (ii) onchocerciasis and lymphatic filariasis (IVM); and (iii) schistosomiasis (PZQ). Progress of ongoing work, challenges and research needs for each of the four main drugs used in helminthic preventive chemotherapy (PC) are reported, laying the ground for appropriate implementation of drug efficacy monitoring programmes under the co-ordination and guidelines of the WHO. Best practices for monitoring drug efficacy should be made available and capacity built as an integral part of neglected tropical disease (NTD) programme monitoring. Development of a disease-specific model to predict the impact of PC programmes, to detect outliers and to solicit responses is essential. Research studies on genetic polymorphisms in relation to low-efficacy phenotypes should be carried out to identify markers of putative resistance against all NTD drugs and ultimately to develop diagnostic assays. Development of combination and co-administration of NTD drugs as well as of new drug entities to boost the armamentarium of the few drugs available for NTD control and elimination should be pursued in parallel. PMID:27842865

Novel Insights in the Fecal Egg Count Reduction Test for Monitoring Drug Efficacy against Soil-Transmitted Helminths in Large-Scale Treatment Programs

PubMed Central

Levecke, Bruno; Speybroeck, Niko; Dobson, Robert J.; Vercruysse, Jozef; Charlier, Johannes

2011-01-01

Background The fecal egg count reduction test (FECRT) is recommended to monitor drug efficacy against soil-transmitted helminths (STHs) in public health. However, the impact of factors inherent to study design (sample size and detection limit of the fecal egg count (FEC) method) and host-parasite interactions (mean baseline FEC and aggregation of FEC across host population) on the reliability of FECRT is poorly understood. Methodology/Principal Findings A simulation study was performed in which FECRT was assessed under varying conditions of the aforementioned factors. Classification trees were built to explore critical values for these factors required to obtain conclusive FECRT results. The outcome of this analysis was subsequently validated on five efficacy trials across Africa, Asia, and Latin America. Unsatisfactory (<85.0%) sensitivity and specificity results to detect reduced efficacy were found if sample sizes were small (<10) or if sample sizes were moderate (10–49) combined with highly aggregated FEC (k<0.25). FECRT remained inconclusive under any evaluated condition for drug efficacies ranging from 87.5% to 92.5% for a reduced-efficacy-threshold of 90% and from 92.5% to 97.5% for a threshold of 95%. The most discriminatory study design required 200 subjects independent of STH status (including subjects who are not excreting eggs). For this sample size, the detection limit of the FEC method and the level of aggregation of the FEC did not affect the interpretation of the FECRT. Only for a threshold of 90%, mean baseline FEC <150 eggs per gram of stool led to a reduced discriminatory power. Conclusions/Significance This study confirms that the interpretation of FECRT is affected by a complex interplay of factors inherent to both study design and host-parasite interactions. The results also highlight that revision of the current World Health Organization guidelines to monitor drug efficacy is indicated. We, therefore, propose novel guidelines to support

Simultaneous sequential monitoring of efficacy and safety led to masking of effects.

PubMed

van Eekelen, Rik; de Hoop, Esther; van der Tweel, Ingeborg

2016-08-01

Usually, sequential designs for clinical trials are applied on the primary (=efficacy) outcome. In practice, other outcomes (e.g., safety) will also be monitored and influence the decision whether to stop a trial early. Implications of simultaneous monitoring on trial decision making are yet unclear. This study examines what happens to the type I error, power, and required sample sizes when one efficacy outcome and one correlated safety outcome are monitored simultaneously using sequential designs. We conducted a simulation study in the framework of a two-arm parallel clinical trial. Interim analyses on two outcomes were performed independently and simultaneously on the same data sets using four sequential monitoring designs, including O'Brien-Fleming and Triangular Test boundaries. Simulations differed in values for correlations and true effect sizes. When an effect was present in both outcomes, competition was introduced, which decreased power (e.g., from 80% to 60%). Futility boundaries for the efficacy outcome reduced overall type I errors as well as power for the safety outcome. Monitoring two correlated outcomes, given that both are essential for early trial termination, leads to masking of true effects. Careful consideration of scenarios must be taken into account when designing sequential trials. Simulation results can help guide trial design. Copyright © 2016 Elsevier Inc. All rights reserved.

Monitoring the efficacy of drugs for neglected tropical diseases controlled by preventive chemotherapy.

PubMed

Albonico, M; Levecke, B; LoVerde, P T; Montresor, A; Prichard, R; Vercruysse, J; Webster, J P

2015-12-01

In the last decade, pharmaceutical companies, governments and global health organisations under the leadership of the World Health Organization (WHO) have pledged large-scale donations of anthelmintic drugs, including ivermectin (IVM), praziquantel (PZQ), albendazole (ALB) and mebendazole (MEB). This worldwide scale-up in drug donations calls for strong monitoring systems to detect any changes in anthelmintic drug efficacy. This review reports on the outcome of the WHO Global Working Group on Monitoring of Neglected Tropical Diseases Drug Efficacy, which consists of three subgroups: (i) soil-transmitted helminthiases (ALB and MEB); (ii) onchocerciasis and lymphatic filariasis (IVM); and (iii) schistosomiasis (PZQ). Progress of ongoing work, challenges and research needs for each of the four main drugs used in helminthic preventive chemotherapy (PC) are reported, laying the ground for appropriate implementation of drug efficacy monitoring programmes under the co-ordination and guidelines of the WHO. Best practices for monitoring drug efficacy should be made available and capacity built as an integral part of neglected tropical disease (NTD) programme monitoring. Development of a disease-specific model to predict the impact of PC programmes, to detect outliers and to solicit responses is essential. Research studies on genetic polymorphisms in relation to low-efficacy phenotypes should be carried out to identify markers of putative resistance against all NTD drugs and ultimately to develop diagnostic assays. Development of combination and co-administration of NTD drugs as well as of new drug entities to boost the armamentarium of the few drugs available for NTD control and elimination should be pursued in parallel. Copyright © 2015 International Society for Chemotherapy of Infection and Cancer. Published by Elsevier Ltd. All rights reserved.

Efficacy of fenbendazole and levamisole treatments in captive Houston toads (Bufo [Anaxyrus] houstonensis).

PubMed

Bianchi, Catherine M; Johnson, Cassidy B; Howard, Lauren L; Crump, Paul

2014-09-01

Effective disease monitoring and prevention is critical to the success of captive amphibian care. Nematodes, including the genera Rhabdias and Strongyloides, are known to contribute to mortality in captive amphibians and have been identified in the Houston Zoo's endangered Houston toad (Bufo [Anaxyrus] houstonensis) captive assurance colony. Five years of fecal data for the toad colony were compiled and analyzed in order to investigate the efficacy of two anthelminthic medications, fenbendazole (FBZ) and levamisole (LMS), which were used to control nematode infections. Both FBZ (dusted onto food items) and topical LMS (6.5 to 13.5 mg/kg) significantly reduced the number of nematode eggs, larvae, and adults observed by fecal parasitologic examination. There were no significant differences between treatments, and egg reappearance periods were difficult to compare as a result of low sample size. No adverse effects from either anthelminthic treatment were observed. Both topical LMS and oral FBZ appear to be safe and efficacious treatments for the reduction of the internal nematode burden in captive Houston toads.

The Role of Self-Efficacy in HIV Treatment Adherence: Validation of the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES)

PubMed Central

Johnson, Mallory O.; Neilands, Torsten B.; Dilworth, Samantha; Morin, Stephen F.; Remien, Robert H.; Chesney, Margaret A.

2008-01-01

Adherence to HIV treatment, including adherence to antiretroviral (ART) medication regimens, is paramount in the management of HIV. Self-efficacy for treatment adherence has been identified as an important correlate of medication adherence in the treatment of HIV and other medical conditions. This paper describes the validation of the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES) with two samples of HIV+ adults on ART. Factor analyses support subscales measuring Adherence Integration (eigenvalue = 6.12) and Adherence Perseverance (eigenvalue = 1.16), accounting for 61% of the variance in scale items. The HIV-ASES demonstrates robust internal consistency (ρs > .90) and 3-month (rs > .70) and 15-month (rs > .40) test-retest reliability. Concurrent validity analyses revealed relationships with psychosocial measures, ART adherence, clinical status, and healthcare utilization. Findings support the use of the HIV-ASES and provide guidance for further investigation of adherence self-efficacy in the context of treatment for HIV and other diseases. PMID:17588200

Objective quantification of seizure frequency and treatment success via long-term outpatient video-EEG monitoring: a feasibility study.

PubMed

Stefan, H; Kreiselmeyer, G; Kasper, B; Graf, W; Pauli, E; Kurzbuch, K; Hopfengärtner, R

2011-03-01

A reliable method for the estimation of seizure frequency and severity is indispensable in assessing the efficacy of drug treatment in epilepsies. These quantities are usually deduced from subjective patient reports, which may cause considerable problems due to insufficient or false descriptions of seizures and their frequency. We present data from two difficult-to-treat patients with intractable epilepsy. Pat. 1 has had an unknown number of CP seizures. Here, a prolonged outpatient video-EEG monitoring over 160 h and 137 h (over an interval of three months) was performed with an automated seizure detection method. Pat. 2 suffered exclusively from nocturnal seizures originating from the frontal lobe. In this case, an objective quantification of the efficacy of drug treatment over a time period of 22 weeks was established. For the reliable quantification of seizures, a prolonged outpatient video/video-EEG monitoring was appended after a short-term inpatient monitoring period. Patient 1: The seizure detection algorithm was capable of detecting 10 out of 11 seizures. The number of false-positive events was <0.03/h. It was clearly demonstrated that the patient showed more seizures than originally reported. Patient 2: The add-on medication of lacosamide led to a significant reduction in seizure frequency and to a marked decrease in the mean duration of seizures. The severity of seizures was reduced from numerous hypermotoric seizures to few mild, head-turning seizures. Outpatient monitoring may be helpful to guide treatment for severe epilepsies and offers the possibility to more reliably quantify the efficacy of treatment in the long-term, even over several months. Copyright © 2010 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

MR Imaging in Monitoring and Predicting Treatment Response in Multiple Sclerosis.

PubMed

Río, Jordi; Auger, Cristina; Rovira, Àlex

2017-05-01

MR imaging is the most sensitive tool for identifying lesions in patients with multiple sclerosis (MS). MR imaging has also acquired an essential role in the detection of complications arising from these treatments and in the assessment and prediction of efficacy. In the future, other radiological measures that have shown prognostic value may be incorporated within the models for predicting treatment response. This article examines the role of MR imaging as a prognostic tool in patients with MS and the recommendations that have been proposed in recent years to monitor patients who are treated with disease-modifying drugs. Copyright © 2017 Elsevier Inc. All rights reserved.

Phonological Treatment Efficacy and Developmental Norms.

ERIC Educational Resources Information Center

Gierut, Judith A.; And Others

1996-01-01

Two studies, one within subjects and the other across subjects, evaluated the efficacy of teaching sounds in developmental sequence to nine young children (ages three to five). Treatment of later-acquired phonemes led to systemwide changes in untreated sound classes, whereas treatment of early-acquired phonemes did not. Findings suggest…

Efficacy of Artesunate/Amodiaquine in the Treatment of Uncomplicated Malaria among Children in Ghana.

PubMed

Abuaku, Benjamin K; Mensah, Benedicta A; Ofori, Michael F; Myers-Hansen, James; Derkyi-Kwarteng, Abigail N; Essilfie, Felicia; Dokurugu, Moses; Amoakoh, Emmanuel; Koram, Kwadwo A; Ghansah, Anita

2017-09-01

The declining efficacy of chloroquine in the early 2000s in Ghana led to its replacement with artesunate/amodiaquine (AS/AQ) combination as first-line drug for treating uncomplicated malaria in 2005. Since then efficacy studies have been ongoing in the country to provide continuous data on the efficacy of AS/AQ and other alternative antimalarials (artemether/lumefantrine and dihyroartemisinin/piperaquine combinations) introduced in 2008. In vivo AS/AQ efficacy studies were conducted between June and October 2014 among children aged 6 months to 14 years, in two sentinel sites representing the forest and coastal zones of the country. The 2009 World Health Organization protocol for monitoring antimalarial drug efficacy was used in these studies. The studies showed an overall cumulative polymerase chain reaction-corrected day 28 cure rate of 97.2% (95% confidence interval [CI]: 93.6-99.1): 97.7% (95% CI: 92.0-99.7) within the forest zone and 96.7% (95% CI: 90.7-99.3) within the coastal zone ( P = 0.686). Prevalence of fever declined from 100% to < 4% after first day of treatment in both ecological zones. All children in the coastal zone had cleared parasites by day 2. Three children (3.2%) in the forest zone were parasitemic on day 2, whereas one child was parasitemic on day 3. Gametocytemia was absent in both zones after day 14, and mean hemoglobin concentration significantly increased from 10.3 g/dL (95% CI: 10.1-10.5) on day 0 to 11.8 g/dL (95% CI: 11.6-12.0) on day 28. We conclude that AS/AQ combination remains efficacious in the treatment of uncomplicated malaria in Ghana.

Comparing Safety and Efficacy of "Third-Generation" Antiepileptic Drugs: Long-Term Extension and Post-marketing Treatment.

PubMed

Kwok, Charlotte S; Johnson, Emily L; Krauss, Gregory L

2017-11-01

Four "third-generation" antiepileptic drugs (AEDs) were approved for adjunctive treatment of refractory focal onset seizures during the past 10 years. Long-term efficacy and safety of the drugs were demonstrated in large extension studies and in reports of subgroups of patients not studied in pivotal trials. Reviewing extension study and post-marketing outcome series for the four newer AEDs-lacosamide, perampanel, eslicarbazepine acetate and brivaracetam-can guide clinicians in treating and monitoring patients. AED extension studies evaluate treatment retention, drug tolerability, and drug safety during individualized treatment with flexible dosing and thus provide information not available in rigid pivotal trials. Patient retention in the studies ranged from 75 to 80% at 1 year and from 36 to 68% at 2-year treatment intervals. Safety findings were generally similar to those of pivotal trials, with no major safety risks identified and with several specific adverse drug effects, such as hyponatremia, reported. The third-generation AEDs, some through new mechanisms and others with improved tolerability compared to related AEDs, provide new options in efficacy and tolerability.

The within-host population dynamics of Mycobacterium tuberculosis vary with treatment efficacy.

PubMed

Trauner, Andrej; Liu, Qingyun; Via, Laura E; Liu, Xin; Ruan, Xianglin; Liang, Lili; Shi, Huimin; Chen, Ying; Wang, Ziling; Liang, Ruixia; Zhang, Wei; Wei, Wang; Gao, Jingcai; Sun, Gang; Brites, Daniela; England, Kathleen; Zhang, Guolong; Gagneux, Sebastien; Barry, Clifton E; Gao, Qian

2017-04-19

Combination therapy is one of the most effective tools for limiting the emergence of drug resistance in pathogens. Despite the widespread adoption of combination therapy across diseases, drug resistance rates continue to rise, leading to failing treatment regimens. The mechanisms underlying treatment failure are well studied, but the processes governing successful combination therapy are poorly understood. We address this question by studying the population dynamics of Mycobacterium tuberculosis within tuberculosis patients undergoing treatment with different combinations of antibiotics. By combining very deep whole genome sequencing (~1000-fold genome-wide coverage) with sequential sputum sampling, we were able to detect transient genetic diversity driven by the apparently continuous turnover of minor alleles, which could serve as the source of drug-resistant bacteria. However, we report that treatment efficacy has a clear impact on the population dynamics: sufficient drug pressure bears a clear signature of purifying selection leading to apparent genetic stability. In contrast, M. tuberculosis populations subject to less drug pressure show markedly different dynamics, including cases of acquisition of additional drug resistance. Our findings show that for a pathogen like M. tuberculosis, which is well adapted to the human host, purifying selection constrains the evolutionary trajectory to resistance in effectively treated individuals. Nonetheless, we also report a continuous turnover of minor variants, which could give rise to the emergence of drug resistance in cases of drug pressure weakening. Monitoring bacterial population dynamics could therefore provide an informative metric for assessing the efficacy of novel drug combinations.

From traditional medicine to witchcraft: why medical treatments are not always efficacious.

PubMed

Tanaka, Mark M; Kendal, Jeremy R; Laland, Kevin N

2009-01-01

Complementary medicines, traditional remedies and home cures for medical ailments are used extensively world-wide, representing more than US$60 billion sales in the global market. With serious doubts about the efficacy and safety of many treatments, the industry remains steeped in controversy. Little is known about factors affecting the prevalence of efficacious and non-efficacious self-medicative treatments. Here we develop mathematical models which reveal that the most efficacious treatments are not necessarily those most likely to spread. Indeed, purely superstitious remedies, or even maladaptive practices, spread more readily than efficacious treatments under specified circumstances. Low-efficacy practices sometimes spread because their very ineffectiveness results in longer, more salient demonstration and a larger number of converts, which more than compensates for greater rates of abandonment. These models also illuminate a broader range of phenomena, including the spread of innovations, medical treatment of animals, foraging behaviour, and self-medication in non-human primates.

Predictors of weight loss success. Exercise vs. dietary self-efficacy and treatment attendance.

PubMed

Byrne, Shannon; Barry, Danielle; Petry, Nancy M

2012-04-01

Pre-treatment diet and exercise self-efficacies can predict weight loss success. Changes in diet self-efficacy across treatment appear to be even stronger predictors than baseline levels, but research on changes in exercise self-efficacy is lacking. Using data from a pilot study evaluating tangible reinforcement for weight loss (N=30), we examined the impact of changes in diet and exercise self-efficacy on outcomes. Multiple regression analyses indicated that treatment attendance and changes in exercise self-efficacy during treatment were the strongest predictors of weight loss. Developing weight loss programs that foster the development of exercise self-efficacy may enhance participants' success. Published by Elsevier Ltd.

Neuromodulatory treatments for chronic pain: efficacy and mechanisms

PubMed Central

Jensen, Mark P.; Day, Melissa A.; Miró, Jordi

2017-01-01

Chronic pain is common, and the available treatments do not provide adequate relief for most patients. Neuromodulatory interventions that modify brain processes underlying the experience of pain have the potential to provide substantial relief for some of these patients. The purpose of this Review is to summarize the state of knowledge regarding the efficacy and mechanisms of noninvasive neuromodulatory treatments for chronic pain. The findings provide support for the efficacy and positive side-effect profile of hypnosis, and limited evidence for the potential efficacy of meditation training, noninvasive electrical stimulation procedures, and neurofeedback procedures. Mechanisms research indicates that hypnosis influences multiple neurophysiological processes involved in the experience of pain. Evidence also indicates that mindfulness meditation has both immediate and long-term effects on cortical structures and activity involved in attention, emotional responding and pain. Less is known about the mechanisms of other neuromodulatory treatments. On the basis of the data discussed in this Review, training in the use of self-hypnosis might be considered a viable ‘first-line’ approach to treat chronic pain. More-definitive research regarding the benefits and costs of meditation training, noninvasive brain stimulation and neurofeedback is needed before these treatments can be recommended for the treatment of chronic pain. PMID:24535464

Neuromodulatory treatments for chronic pain: efficacy and mechanisms.

PubMed

Jensen, Mark P; Day, Melissa A; Miró, Jordi

2014-03-01

Chronic pain is common, and the available treatments do not provide adequate relief for most patients. Neuromodulatory interventions that modify brain processes underlying the experience of pain have the potential to provide substantial relief for some of these patients. The purpose of this Review is to summarize the state of knowledge regarding the efficacy and mechanisms of noninvasive neuromodulatory treatments for chronic pain. The findings provide support for the efficacy and positive side-effect profile of hypnosis, and limited evidence for the potential efficacy of meditation training, noninvasive electrical stimulation procedures, and neurofeedback procedures. Mechanisms research indicates that hypnosis influences multiple neurophysiological processes involved in the experience of pain. Evidence also indicates that mindfulness meditation has both immediate and long-term effects on cortical structures and activity involved in attention, emotional responding and pain. Less is known about the mechanisms of other neuromodulatory treatments. On the basis of the data discussed in this Review, training in the use of self-hypnosis might be considered a viable 'first-line' approach to treat chronic pain. More-definitive research regarding the benefits and costs of meditation training, noninvasive brain stimulation and neurofeedback is needed before these treatments can be recommended for the treatment of chronic pain.

Role of Therapeutic Drug Monitoring of Voriconazole in the Treatment of Invasive Fungal Infections

PubMed Central

Kuo, I fan; Ensom, Mary H H

2009-01-01

Background: Voriconazole is a broad-spectrum, second-generation triazole antifungal agent with demonstrated efficacy in the treatment of invasive fungal infections caused by Aspergillus spp. and Candida spp. Given the characteristically poor prognosis of patients with invasive fungal infections and the protracted duration of treatment required, therapeutic monitoring of voriconazole is, in theory, an attractive method to optimize antifungal therapy. Objective: To determine the utility of therapeutic drug monitoring for voriconazole. Methods: A previously published decision-making algorithm was used to assess the currently available literature on therapeutic drug monitoring of voriconazole. Results: Several analytical methods can be used to quantify plasma or serum concentrations of voriconazole. Reasons for therapeutic monitoring of this drug include wide variability both within and between individuals secondary to drug properties, drug–drug interactions, and disease states. Furthermore, voriconazole follows nonlinear pharmacokinetics with saturable hepatic clearance. Another potential factor in favour of therapeutic drug monitoring for voriconazole is genetic polymorphism of CYP2C19, whereby patients who are homozygous for poor metabolism (about 19% of non-Indian Asians) can have 4-fold greater exposure to voriconazole. The concentrations of this drug are also greater in patients with hepatic impairment. Drug–drug interactions with other substrates of CYP2C9, CYP2C19, and CYP3A4 can also alter voriconazole concentrations. However, the correlations between plasma concentrations of voriconazole and its efficacy and toxicity are not well defined. Although lower and upper target thresholds of 0.25–2 mg/L and 4–6 mg/L, respectively, have been suggested, studies to date have not been appropriately designed or powered to reveal any definitive association. Conclusions: Routine therapeutic drug monitoring of voriconazole is not recommended except in certain

The Role of Self-Efficacy in the Treatment of Substance Use Disorders

PubMed Central

Kadden, Ronald M.; Litt, Mark D.

2011-01-01

Self-efficacy is the belief that one has the ability to implement the behaviors needed to produce a desired effect. There has been growing interest in the role of self-efficacy as a predictor and/or mediator of treatment outcome in a number of domains. The present paper reviews the recent literature on self-efficacy in the substance abuse field. In numerous studies of substance abuse treatment, self-efficacy has emerged as an important predictor of outcome, or as a mediator of treatment effects. Despite these repeated positive findings, the self-efficacy concept has had little impact on the design of treatments. Since the concept was first introduced, there have been numerous suggestions regarding the means by which self-efficacy may be enhanced in clinical settings, but very little by way of empirical tests of those suggestions. This review concludes with a number of recommendations for further research to improve understanding of this potentially valuable concept and its interactions with other variables, and to develop effective strategies for enhancing self-efficacy. PMID:21849232

Self-Efficacy and the Self-Monitoring of Selected Exercise and Eating Behaviors of College Students.

ERIC Educational Resources Information Center

Kingery, Paul M.

1990-01-01

Results from a study of 85 college students indicate that self-efficacy is a moderately strong predictor of self-monitored performance of dietary and exercise behaviors when measured following a self-monitored performance attempt. (IAH)

Parent Caregiver Self-Efficacy and Child Reactions to Pediatric Cancer Treatment Procedures

PubMed Central

Peterson, Amy M.; Harper, Felicity W. K.; Albrecht, Terrance L.; Taub, Jeffrey W.; Orom, Heather; Phipps, Sean; Penner, Louis A.

2014-01-01

This study examined how parents’ sense of self-efficacy specific to caregiving for their child during cancer treatment procedures affected children’s distress and cooperation during procedures. Potential correlates of caregiver self-efficacy (ie, demographics, child clinical characteristics, parent dispositional attributes, and social support) were also examined. Participants were 119 children undergoing cancer treatment procedures and their parents. Parents’ self-efficacy about 6 procedure-specific caregiver tasks was measured. Parents, children, nurses, and observers rated child distress and parents, nurses and observers rated child cooperation during procedures. Higher parent self-efficacy about keeping children calm during procedures predicted lower child distress and higher child cooperation during procedures. Parent dispositional attributes (eg, enduring positive mood, empathy) and social support predicted self-efficacy. Parent caregiver self-efficacy influences child distress and cooperation during procedures and is associated with certain parent attributes. Findings suggest the utility of identifying parents who would benefit from targeted interventions to increase self-efficacy about caregiving during treatment procedures. PMID:24378818

Efficacy and Safety of Gonadotropin-Releasing Hormone Agonist Treatment to Suppress Puberty in Gender Dysphoric Adolescents.

PubMed

Schagen, Sebastian E E; Cohen-Kettenis, Peggy T; Delemarre-van de Waal, Henriette A; Hannema, Sabine E

2016-07-01

Puberty suppression using gonadotropin-releasing hormone agonists (GnRHas) is recommended by current guidelines as the treatment of choice for gender dysphoric adolescents. Although GnRHas have long been used to treat precocious puberty, there are few data on the efficacy and safety in gender dysphoric adolescents. Therefore, the Endocrine Society guideline recommends frequent monitoring of gonadotropins, sex steroids, and renal and liver function. To evaluate the efficacy and safety of GnRHa treatment to suppress puberty in gender dysphoric adolescents. Forty-nine male-to-female and 67 female-to-male gender dysphoric adolescents treated with triptorelin were included in the analysis. Physical examination, including assessment of Tanner stage, took place every 3 months and blood samples were drawn at 0, 3, and 6 months and then every 6 months. Body composition was evaluated using dual energy x-ray absorptiometry. GnRHa treatment caused a decrease in testicular volume in 43 of 49 male-to-female subjects. In one of four female-to-male subjects who presented at Tanner breast stage 2, breast development completely regressed. Gonadotropins and sex steroid levels were suppressed within 3 months. Treatment did not have to be adjusted because of insufficient suppression in any subject. No sustained abnormalities of liver enzymes or creatinine were encountered. Alkaline phosphatase decreased, probably related to a slower growth velocity, because height SD score decreased in boys and girls. Lean body mass percentage significantly decreased during the first year of treatment in girls and boys, whereas fat percentage significantly increased. Triptorelin effectively suppresses puberty in gender dysphoric adolescents. These data suggest routine monitoring of gonadotropins, sex steroids, creatinine, and liver function is not necessary during treatment with triptorelin. Further studies should evaluate the extent to which changes in height SD score and body composition that occur

Abstinence Self-Efficacy and Abstinence 1 Year After Substance Use Disorder Treatment

ERIC Educational Resources Information Center

Ilgen, Mark; McKellar, John; Tiet, Quyen

2005-01-01

To better understand the relationship between abstinence self-efficacy and treatment outcomes in substance use disorder patients, experts in the field need more information about the levels of abstinence self-efficacy most predictive of treatment outcomes. Participants (N = 2,967) from 15 residential substance use disorder treatment programs were…

Neurodevelopmental Treatment (NDT): Therapeutic Intervention and Its Efficacy.

ERIC Educational Resources Information Center

Stern, Francine Martin; Gorga, Delia

1988-01-01

Use of neurodevelopmental treatment, also known as the Bobath method, is discussed, including its history, philosophy, goals, and treatment emphasis with infants and children with movement disorders. Examples of children before and after therapeutic intervention illustrate use of the technique, and controversies in measuring therapy efficacy are…

Efficacy of Albendazole-Chitosan Microsphere-based Treatment for Alveolar Echinococcosis in Mice.

PubMed

Abulaihaiti, Maitiseyiti; Wu, Xiang-Wei; Qiao, Lei; Lv, Hai-Long; Zhang, Hong-Wei; Aduwayi, Nasrul; Wang, Yan-Jie; Wang, Xin-Chun; Peng, Xin-Yu

2015-01-01

This study aimed to investigate the pharmacology and anti-parasitic efficacy of albendazole-chitosan microspheres (ABZ-CS-MPs) for established intraperitoneal infections of Echinococcus multilocularis metacestodes in an experimental murine model. Male outbred Kunming mice infected with E. multilocularis Metacestodes were administered with three ABZ formulations, namely, ABZ-CS-MPs, Liposome-Albendazole (L-ABZ), and albendazole tablet (ABZ-T). Each of the ABZ formulations was given orally at three different doses of 37.5, 75, and 150 mg/kg, three times a week for 12 weeks postinfection. After administering the drugs, we monitored the pharmacological performance and anti-parasitic efficacy of ABZ-CS-MPs compared with L-ABZ, and ABZ-T treated mice. ABZ-CS-MPs reduced the weight of tissues containing E. multilocularis metacestodes most effectively compared with the ABZ-T group and untreated controls. Metacestode grown was Highly suppressed during treatment with ABZ-CS-MPs. Significantly higher plasma levels of ABZ metabolites were measured in mice treated with ABZ-CS-MPs or L-ABZ compared with ABZ-T. In particular, enhanced ABZ-sulfoxide concentration profiles were observed in the mice given 150 mg/kg of ABZ-CS-MPs, but not in the mice treated with L-ABZ. Histological examination showed that damages caused disorganization of both the germinal and laminated layers of liver hyatid cysts, demolishing their characteristic structures after treatment with ABZ-CS-MPs or L-ABZ. Over time, ABZ-CS-MPs treatment induced a shift from Th2-dominant to Th1-dominant immune response. CS-MPs As a new carrier exhibited improved absorption and increased bioavailability of ABZ in the treatment of E. multilocularis infections in mice.

In vivo Confocal Laser Microscopy for monitoring of actinic keratosis treatment: a comparison with histopathologic assessment after treatment with topical 5% 5-fluorouracil.

PubMed

Ishioka, P; Maia, M; Rodrigues, S B; Lellis, R F; Hirata, S H

2017-11-24

Histological examination is the gold standard for actinic keratosis diagnosis; however, it is not always a feasible approach. Reflectance confocal microscopy (RCM) is a non-invasive technique that may be an alternative for monitoring actinic keratoses treatment response. Topical 5-fluorouracil is indicated for actinic keratosis multiple lesions and for field cancerization treatment. To assess the RCM accuracy, sensibility and specificity for actinic keratosis, considering as a gold standard the histopathological examination; as well as to evaluate the efficacy of 5% 5-fluorouracil treatment. This is a prospective study in actinic keratosis patients between August 2014 and November 2015. RCM analyses were performed in one randomly selected actinic keratosis lesion of the upper limbs by two independent observers before and after 5% 5-fluorouracil treatment. At the end of treatment and with clinical bleaching of treated lesions, histological examination was performed by two pathologists. A total of 50 lesions were enroled, and 40 lesions presented complete clinical bleaching after treatment and were included in the final analysis. Accuracy, sensibility and specificity means among observers were 83.8%, 84.6% and 83.3%, respectively. After 5-fluorouracil treatment, actinic keratosis was diagnosed in 45.0% (observer 1) and 32.5% (observer 2) of subjects according to RCM and in 32.5% of subjects according to histological examination. Considering RCM observers diagnosis, the concordance was substantial (k 0.637, P < 0.001). 5-fluorouracil led to a reduction in 55.0%-67.5% of actinic keratoses according to RCM analysis. This study allows to validate RCM as a non-invasive method capable of monitoring actinic keratosis therapeutic response to 5-fluorouracil, presenting efficacy comparable to histological examination. Additionally, the results suggest that 5-fluorouracil may be a satisfactory option for therapeutic control of this condition. © 2017 European Academy of

Self-Efficacy and Illicit Opioid Use in a 180-Day Methadone Detoxification Treatment.

ERIC Educational Resources Information Center

Reilly, Patrick M.; And Others

1995-01-01

Studied self-efficacy and treatment outcomes in a sample of opioid addicts. Results show self-efficacy influenced subsequent drug use in parallel with previous behavior. Suggests that psychological constructs like self-efficacy may hold promise for understanding and decreasing illicit opioid use during long-term methadone detoxification treatment.…

Efficacy of mechanical fuel treatments for reducing wildfire hazard

Treesearch

Robert J. Jr. Huggett; Karen L. Abt; Wayne Shepperd

2008-01-01

Mechanical fuel treatments are increasingly being used for wildfire hazard reduction in the western U.S. However, the efficacy of these treatments for reducing wildfire hazard at a landscape scale is difficult to quantify, especially when including growth following treatment. A set of uneven- and even-aged treatments designed to reduce fire hazard were simulated on 0.8...

[Clinical assessment of infrasonic phonophoresis efficacy in the treatment of bacterial keratitis].

PubMed

Sidorenko, E I; Filatov, V V; Alimova, Iu M

1999-01-01

Therapeutic efficacy of infrasonic phonophoresis is studied in 30 patients with bacterial keratitis. Control group consisted of 87 patients with the same diagnosis. Clinical studies included comparative evaluation of the therapeutic efficacy of infrasonic phonophoresis and traditional local instillations of the same drugs. Before treatment, visual acuity was the same in both groups, while after regression of inflammation after treatment it was 0.13 higher in the phonophoresis group. Results of clinical studies indicate a higher efficacy of infrasonic therapy of patients with keratitis. The duration of therapy was decreased, number of bed-days decreased, and visual acuity after treatment improved.

Auditory verbal hallucinations as atypical inner speech monitoring, and the potential of neurostimulation as a treatment option☆

PubMed Central

Moseley, Peter; Fernyhough, Charles; Ellison, Amanda

2013-01-01

Auditory verbal hallucinations (AVHs) are the experience of hearing voices in the absence of any speaker, often associated with a schizophrenia diagnosis. Prominent cognitive models of AVHs suggest they may be the result of inner speech being misattributed to an external or non-self source, due to atypical self- or reality monitoring. These arguments are supported by studies showing that people experiencing AVHs often show an externalising bias during monitoring tasks, and neuroimaging evidence which implicates superior temporal brain regions, both during AVHs and during tasks that measure verbal self-monitoring performance. Recently, efficacy of noninvasive neurostimulation techniques as a treatment option for AVHs has been tested. Meta-analyses show a moderate effect size in reduction of AVH frequency, but there has been little attempt to explain the therapeutic effect of neurostimulation in relation to existing cognitive models. This article reviews inner speech models of AVHs, and argues that a possible explanation for reduction in frequency following treatment may be modulation of activity in the brain regions involving the monitoring of inner speech. PMID:24125858

Novel diode-based laser system for combined transcutaneous monitoring and computer-controlled intermittent treatment of jaundiced neonates

NASA Astrophysics Data System (ADS)

Hamza, Mostafa; El-Ahl, Mohammad H. S.; Hamza, Ahmad M.

2001-06-01

The high efficacy of laser phototherapy combined with transcutaneous monitoring of serum bilirubin provides optimum safety for jaundiced infants from the risk of bilirubin encephalopathy. In this paper the authors introduce the design and operating principles of a new laser system that can provide simultaneous monitoring and treatment of several jaundiced babies at one time. The new system incorporates diode-based laser sources oscillating at selected wavelengths to achieve both transcutaneous differential absorption measurements of bilirubin concentration in addition to the computer controlled intermittent laser therapy through a network of optical fibers. The detailed description and operating characteristics of this system are presented.

Efficacy and safety of a lindane 1% treatment regimen for scabies, confirmed by dermoscopy-guided skin scraping with microscopic examination.

PubMed

Park, S E; Her, Y; Kim, S S; Kim, C W

2015-08-01

This is the first study investigating scabies treatment since 1992 to involve examination of patients with microscopically confirmed scabies. To assess the efficacy of 1% lindane cream in treating microscopically confirmed scabies, and to determine the utility of dermoscopy-guided skin scraping with microscopic examination (DSGSS-ME) in evaluating the efficacy of scabies treatment. This retrospective study analysed patients treated for scabies between January 2012 and December 2013. From the hospital database, 287 cases of scabies were identified and 50 were enrolled in the study. Patients were treated with 1% lindane cream twice weekly (days 0 and 1) and were evaluated with DSGSS-ME on day 7. Treatment and evaluations were repeated once weekly until a negative DSGSS-ME result was obtained. The cumulative efficacy of lindane 1% cream was 40% (20/50) after 1 week, 88% (44/50) after 2 weeks and 98% (49/50) after 3 weeks of treatment. There was a statistically significant difference between the 1- and 2-week (P = 0.03), and 1- and 3-week (P = 0.02) treatments. A total of 90 post-treatment DSGSS-MEs were performed, with a sensitivity of 97.3% (95% CI 85.8-99.9) and a negative predictive value of 98.2% (95% CI 90.1-100). Specificity and positive predictive value were 100%, as this procedure cannot yield false-positive results, because it relies on finding mites, eggs or faeces. We suggest that a twice-weekly schedule (on consecutive days) of 1% lindane treatment lasting at least 2 weeks is required to clear scabies. DSGSS-ME appears to be a good method to evaluate the efficacy of scabies treatment. This study introduces a safe and effective method to treat scabies, and to accurately monitor infestation status in patients. © 2015 British Association of Dermatologists.

Knowledge Monitoring, Goal Orientations, Self-Efficacy, and Academic Performance: A Path Analysis

ERIC Educational Resources Information Center

Al-Harthy, Ibrahim S.; Was, Christopher A.

2013-01-01

The purpose of this study was to examine the relationship between knowledge monitoring and motivation as defined by self-efficacy and goal orientations. A path model was proposed to hypothesize the causal relations among predictors of the students' total score in the Educational Psychology course. The sample consisted of undergraduate students…

Cancer survivors' self-efficacy to self-manage in the year following primary treatment.

PubMed

Foster, C; Breckons, M; Cotterell, P; Barbosa, D; Calman, L; Corner, J; Fenlon, D; Foster, R; Grimmett, C; Richardson, A; Smith, P W

2015-03-01

Cancer survivors are increasingly expected to manage the consequences of cancer and its treatment for themselves. There is evidence that self-efficacy is important for successful self-management and that this can be enhanced with support. The purpose of this study was to assess self-efficacy to manage problems in the year following primary treatment. This cross-sectional online survey included cancer survivors who had completed their treatment within the past 12 months. Self-efficacy was assessed and variables expected to be associated with self-efficacy were measured using validated scales including quality of life, well-being, illness perceptions, depression and social support. One hundred eighty-two respondents (mean age 50; 81% female) completed the survey. They had been treated for a range of cancers; most commonly breast (45%). Self-efficacy scores varied between individuals and according to the illness-related task to be managed. Respondents were least confident in managing fatigue and most confident in accessing information about their cancer. Individuals most likely to report low self-efficacy were women, those experiencing higher levels of pain and/or depression, lower well-being scores, lower socio-economic status, low levels of social support, or a more negative perception of cancer. Self-efficacy to self-manage problems faced as a consequence of cancer and its treatment can vary widely in the year following treatment. Fatigue may be particularly difficult to manage. Variations in self-efficacy highlight the importance of assessing specific problems faced and people's confidence to manage them in order to tailor appropriate self-management support.

Treatment of chronic myeloid leukemia: assessing risk, monitoring response, and optimizing outcome.

PubMed

Shanmuganathan, Naranie; Hiwase, Devendra Keshaorao; Ross, David Morrall

2017-12-01

Over the past two decades, tyrosine kinase inhibitors have become the foundation of chronic myeloid leukemia (CML) treatment. The choice between imatinib and newer tyrosine kinase inhibitors (TKIs) needs to be balanced against the known toxicity and efficacy data for each drug, the therapeutic goal being to maximize molecular response assessed by BCR-ABL RQ-PCR assay. There is accumulating evidence that the early achievement of molecular targets is a strong predictor of superior long-term outcomes. Early response assessment provides the opportunity to intervene early with the aim of ensuring an optimal response. Failure to achieve milestones or loss of response can have diverse causes. We describe how clinical and laboratory monitoring can be used to ensure that each patient is achieving an optimal response and, in patients who do not reach optimal response milestones, how the monitoring results can be used to detect resistance and understand its origins.

Hydroxyurea for the Treatment of Sickle Cell Disease: Efficacy, Barriers, Toxicity, and Management in Children

PubMed Central

Strouse, John J.; Heeney, Matthew M.

2012-01-01

Hydroxyurea is the only approved medication in the United States for the treatment of sickle cell anemia (HbSS) and is widely used in children despite an indication limited to adults. We review the evidence of efficacy and safety in children with reference to pivotal adult studies. This evidence and expert opinion form the basis for recommended guidelines for the use of hydroxyurea in children including indications, dosing, therapeutic and safety monitoring, and interventions to improve adherence. However, there are substantial gaps in our knowledge to be addressed by on-going and planned studies in children. PMID:22517797

Treatment with phenobarbital and monitoring of epileptic patients in rural Mali.

PubMed Central

Nimaga, K.; Desplats, D.; Doumbo, O.; Farnarier, G.

2002-01-01

OBJECTIVE: To assess the efficacy of phenobarbital treatment for epileptic patients in rural Mali. METHODS: Epileptic patients were treated at home with phenobarbital at daily dosages ranging from 50 mg for children to 200 mg for adults and their condition was monitored. Advice was given to patients, their families, and the village authorities in order to achieve compliance. An uninterrupted supply of generic phenobarbital was provided and a rural physician made two follow-up visits to each village to ensure that the drug was taken in the correct doses. The physician gave information to the population, distributed the phenobarbital in sufficient quantities to cover the periods between visits, and monitored the patients' responses to treatment. During the first year the physician visited the patients every two months. The frequency of visits was subsequently reduced to once every four months. FINDINGS: In the six months preceding treatment the average rate of seizures among patients exceeded four per month. After a year of treatment, 80.2% of the patients experienced no seizures for at least five months. A total of 15.7% of patients experienced a reduction in seizures. In many cases no further seizures occurred and there were improvements in physical health, mental health and social status. There were very few side-effects and no cases of poisoning were reported. The cost of treatment per patient per year was 7 US dollars for generic phenobarbital and 8.4 US dollars for logistics. CONCLUSION: Low doses of phenobarbital were very effective against epilepsy. However, there is an urgent need for programmes involving increased numbers of physicians in rural areas and, at the national level, for the inclusion of epilepsy treatment in the activities of health care facilities. Internationally, an epilepsy control programme providing free treatment should be developed. PMID:12163916

The efficacy of attentional distraction and sensory monitoring in chronic pain patients: A meta-analysis.

PubMed

Van Ryckeghem, Dimitri Ml; Van Damme, Stefaan; Eccleston, Christopher; Crombez, Geert

2018-02-01

Attentional strategies, such as distraction and sensory monitoring, are often offered to reduce pain and pain-related distress. However, evidence for their efficacy in chronic pain patients is equivocal. We report a meta-analysis on the efficacy of distraction and sensory monitoring in chronic pain patients, and explore possible methodological and theoretical moderators. The scientific literature was searched for relevant articles, which were coded for methodological quality and several theoretical and methodological moderator variables. Only 10 articles fulfilled the search criteria. Eight studies allowed us to compare distraction with a control condition, two studies to compare sensory monitoring with a control condition, and four studies to compare the effect of distraction with the effect of sensory monitoring. Overall, results indicate that distraction did not differ from control in altering pain experience (k=8; Hedges' g=0.10, ns) and distress (k=2; Hedges' g=0.549). Sensory monitoring did also not alter pain experience (k=2; Hedges' g=-0.21, ns) and distress (k=1; Hedges' g=-0.191, ns). We found no evidence to support the superiority of distraction or sensory monitoring in altering pain compared to control conditions. We offer guidance for future theory-driven research to investigate distraction and sensory monitoring in this largely unexplored field, albeit one replete with methodological difficulties. Copyright © 2017 Elsevier Ltd. All rights reserved.

Monitoring breast cancer treatment using a Fourier transform infrared spectroscopy-based computational model.

PubMed

Depciuch, J; Kaznowska, E; Golowski, S; Koziorowska, A; Zawlik, I; Cholewa, M; Szmuc, K; Cebulski, J

2017-09-05

Breast cancer affects one in four women, therefore, the search for new diagnostic technologies and therapeutic approaches is of critical importance. This involves the development of diagnostic tools to facilitate the detection of cancer cells, which is useful for assessing the efficacy of cancer therapies. One of the major challenges for chemotherapy is the lack of tools to monitor efficacy during the course of treatment. Vibrational spectroscopy appears to be a promising tool for such a purpose, as it yields Fourier transformation infrared (FTIR) spectra which can be used to provide information on the chemical composition of the tissue. Previous research by our group has demonstrated significant differences between the infrared spectra of healthy, cancerous and post-chemotherapy breast tissue. Furthermore, the results obtained for three extreme patient cases revealed that the infrared spectra of post-chemotherapy breast tissue closely resembles that of healthy breast tissue when chemotherapy is effective (i.e., a good therapeutic response is achieved), or that of cancerous breast tissue when chemotherapy is ineffective. In the current study, we compared the infrared spectra of healthy, cancerous and post-chemotherapy breast tissue. Characteristic parameters were designated for the obtained spectra, spreading the function of absorbance using the Kramers-Kronig transformation and the best fit procedure to obtain Lorentz functions, which represent components of the bands. The Lorentz function parameters were used to develop a physics-based computational model to verify the efficacy of a given chemotherapy protocol in a given case. The results obtained using this model reflected the actual patient data retrieved from medical records (health improvement or no improvement). Therefore, we propose this model as a useful tool for monitoring the efficacy of chemotherapy in patients with breast cancer. Copyright © 2017 Elsevier B.V. All rights reserved.

Efficacy of Single and Combined Antibiotic Treatments of Anthrax in Rabbits.

PubMed

Weiss, Shay; Altboum, Zeev; Glinert, Itai; Schlomovitz, Josef; Sittner, Assa; Bar-David, Elad; Kobiler, David; Levy, Haim

2015-12-01

Respiratory anthrax is a fatal disease in the absence of early treatment with antibiotics. Rabbits are highly susceptible to infection with Bacillus anthracis spores by intranasal instillation, succumbing within 2 to 4 days postinfection. This study aims to test the efficiency of antibiotic therapy to treat systemic anthrax in this relevant animal model. Delaying the initiation of antibiotic administration to more than 24 h postinfection resulted in animals with systemic anthrax in various degrees of bacteremia and toxemia. As the onset of symptoms in humans was reported to start on days 1 to 7 postexposure, delaying the initiation of treatment by 24 to 48 h (time frame for mass distribution of antibiotics) may result in sick populations. We evaluated the efficacy of antibiotic administration as a function of bacteremia levels at the time of treatment initiation. Here we compare the efficacy of treatment with clarithromycin, amoxicillin-clavulanic acid (Augmentin), imipenem, vancomycin, rifampin, and linezolid to the previously reported efficacy of doxycycline and ciprofloxacin. We demonstrate that treatment with amoxicillin-clavulanic acid, imipenem, vancomycin, and linezolid were as effective as doxycycline and ciprofloxacin, curing rabbits exhibiting bacteremia levels of up to 10(5) CFU/ml. Clarithromycin and rifampin were shown to be effective only as a postexposure prophylactic treatment but failed to treat the systemic (bacteremic) phase of anthrax. Furthermore, we evaluate the contribution of combined treatment of clindamycin and ciprofloxacin, which demonstrated improvement in efficacy compared to ciprofloxacin alone. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

Assessment of a Neck-Based Treatment and Monitoring Device for Positional Obstructive Sleep Apnea

PubMed Central

Levendowski, Daniel J.; Seagraves, Sean; Popovic, Djordje; Westbrook, Philip R.

2014-01-01

Study Objectives: A majority of patients diagnosed with obstructive sleep apnea are position dependent whereby they are at least twice as severe when sleeping supine (POSA). This study evaluated the accuracy and efficacy of a neck-worn device designed to limit supine sleep. The study included nightly measurements of snoring, sleep/wake, time supine, and the frequency and duration of feedback to monitor compliance. Methods: Thirty patients between ages 18 and 75 years, BMI ≤ 35 with an overall apnea-hypopnea index (AHI) ≥ 5 and an overall AHI ≥ 1.5 times the non-supine AHI, and an Epworth score ≥ 5 were prospectively studied. Subjective reports and polysomnography were used to assess efficacy resulting from 4 weeks of in-home supine-avoidance therapy and to measure device accuracy. From 363 polysomnography reports, 209 provided sufficient positional data to estimate one site's prevalence of positional OSA. Results: In 83% of participants exhibiting > 50% reduction in overall AHI, the mean and median reductions were 69% and 79%. Significant reductions in the overall and supine AHI, apnea index, percent time SpO2 < 90%, and snoring contributed to significant improvements in stage N1 and N2 sleep, reductions in cortical arousals and awakenings, and improved depression scores. Supine position was under-detected by > 5% in 3% of cases. Sleep efficiency by neck actigraphy was within 10% of polysomnography in 87% of the studies when position feedback was delivered. The prevalence of POSA was consistently > 70% when the overall AHI was < 60. Conclusions: The neck position therapy device is accurate and effective in restricting supine sleep, improving AHI, sleep architecture and continuity, and monitoring treatment outcomes. Citation: Levendowski DJ, Seagraves S, Popovic D, Westbrook PR. Assessment of a neck-based treatment and monitoring device for positional obstructive sleep apnea. J Clin Sleep Med 2014;10(8):863-871. PMID:25126032

Excimer laser for the treatment of psoriasis: safety, efficacy, and patient acceptability

PubMed Central

Abrouk, Michael; Levin, Ethan; Brodsky, Merrick; Gandy, Jessica R; Nakamura, Mio; Zhu, Tian Hao; Farahnik, Benjamin; Koo, John; Bhutani, Tina

2016-01-01

Introduction The 308 nm excimer laser is a widely used device throughout the field of dermatology for many diseases including psoriasis. Although the laser has demonstrated clinical efficacy, there is a lack of literature outlining the safety, efficacy, and patient acceptability of the excimer laser. Methods A literature search on PubMed was used with combinations of the terms “excimer”, “excimer laser”, “308 nm”, “psoriasis”, “protocol”, “safety”, “efficacy”, acceptability”, “side effects”, and “dose”. The search results were included if they contained information pertaining to excimer laser and psoriasis treatment and description of the safety, efficacy, and patient acceptability of the treatment. Results The 308 nm excimer laser is generally safe and well tolerated with minimal side effects including erythema, blistering, and pigmentary changes. It has a range of efficacies depending on the protocol used with several different treatment protocols, including the induration protocol, the minimal erythema dose protocol, and the newer minimal blistering dose protocol. Conclusion Although the excimer laser is not a first-line treatment, it remains an excellent treatment option for psoriasis patients and has been demonstrated to be an effective treatment with little to no side effects. PMID:29387603

Efficacy of florfenicol for treatment of clinical and subclinical bovine mastitis.

PubMed

Wilson, D J; Sears, P M; Gonzalez, R N; Smith, B S; Schulte, H F; Bennett, G J; Das, H H; Johnson, C K

1996-04-01

To evaluate efficacy of florfenicol treatment for bovine mastitis caused by Streptococcus agalactiae, Staphylococcus aureus nonagalactiae streptococci, coagulase-negative staphylococci, Escherichia coli, Klebsiella sp, and others. Double blind study with cases randomly assigned to 1 of 2 treatment groups. 861 cows/10 commercial dairy farms. Experimental (750 mg of florfenicol) or control (200 mg of cloxacillin) treatment was administered by intramammary infusion every 12 hours for 3 treatment to all cases. Treatments were randomly assigned identified only by numerical labels. To retain blinding, the longer withdrawal time was adhered to for all cases. Cases remained in the study only if there was no other treatment. Quarter samples were recultured 14, 21, and 28 days later. If all samples after day 1 were culture negative, the case was defined as cured. If only 1 of the follow-up results was positive, the case was considered cured if the day-28 somatic cell count was < 300,000/ ml. Failure of treatment was defined as 2 or more culture positive follow-up samples. Florfenicol and cloxacillin did not differ significantly in efficacy versus clinical (n = 85) or subclinical (n = 71) bovine mastitis, or for any etiologic agent (X2). Overall cure rates for mastitis were: Str agalactiae, 5 of 8 (63%); Sta aureus, 5 of 54 (9%); Streptococcus sp, 16 of 35 (46%); Staphylococcus sp, 7 of 33 (21%); E coli, 5 of 11 (46%); Klebsiella sp, 3 of 6 (50%); others, 1 of 9 (11%); and all cases, 42 of 156 (27%). Florfenicol did not offer any advantage over cloxacillin in efficacy against bovine mastitis. Overall cure rates were low. As with most mastitis treatment regimens poor efficacy may be partly attributable to the short duration of treatment.

SSRI adverse events: how to monitor and manage.

PubMed

Murphy, Tanya K; Segarra, Ana; Storch, Eric A; Goodman, Wayne K

2008-04-01

Antidepressants are efficacious for pediatric major depressive disorder, obsessive compulsive disorder (OCD), and non-OCD anxiety disorders. Antidepressants should be used in an evidence-based fashion, with frequent monitoring for side effects, especially when initiating treatment and adjusting dosage. With diligence to appropriate prescribing and monitoring, the benefits of therapy outweigh the potential of treatment related risk.

Prototype CoolCup cryolipolysis applicator with over 40% reduced treatment time demonstrates equivalent safety and efficacy with greater patient preference.

PubMed

Kilmer, Suzanne L

2017-01-01

Cryolipolysis is a safe, effective non-surgical procedure to reduce fat. For most cryolipolysis treatments, tissue is pulled between parallel cooling plates with a treatment duration of 60 minutes. A novel contoured cup, medium-sized applicator was developed to increase tissue contact with reduced skin tension and reduced treatment time. This prototype contoured cup was investigated with a standard cryolipolysis applicator to evaluate safety, efficacy, and patient preference. A prototype CoolCup medium-sized vacuum applicator (CoolSculpting System, ZELTIQ Aesthetics) was used to treat n = 19 subjects in the flanks. Randomly assigned, one flank received standard treatment with the CoolCore applicator (-10°C for 60 minutes). The contralateral flank received treatment from the CoolCup (-11°C for 35 minutes). The clinical study primary efficacy endpoint was 70% correct identification of baseline photographs by independent physician review. Incidence of adverse device effects was monitored. Fat layer reduction was measured by ultrasound and subject surveys were administered 12 weeks post-treatment. Equivalent efficacy was demonstrated between the CoolCore standard treatment and the prototype CoolCup. Independent review from three blinded physicians found 81% correct identification of baseline photographs for the standard treatment and 79% for the CoolCup. Ultrasound measurements indicated mean fat layer reduction of 4.38 mm for the standard treatment and 4.40 mm for the CoolCup; no statistically significant difference was found when comparing treatment efficacy of the two applicators (P = 0.96). Patient questionnaires revealed 85% preferred CoolCup because of shorter treatment duration and greater comfort. Procedural assessments revealed 45% lower pain scores for CoolCup. Immediate post-treatment clinical assessments revealed 82% less bruising. Typical side effects, such as numbness and erythema, were similar. There were no adverse events. This clinical

DynAMo: A Modular Platform for Monitoring Process, Outcome, and Algorithm-Based Treatment Planning in Psychotherapy.

PubMed

Kaiser, Tim; Laireiter, Anton Rupert

2017-07-20

In recent years, the assessment of mental disorders has become more and more personalized. Modern advancements such as Internet-enabled mobile phones and increased computing capacity make it possible to tap sources of information that have long been unavailable to mental health practitioners. Software packages that combine algorithm-based treatment planning, process monitoring, and outcome monitoring are scarce. The objective of this study was to assess whether the DynAMo Web application can fill this gap by providing a software solution that can be used by both researchers to conduct state-of-the-art psychotherapy process research and clinicians to plan treatments and monitor psychotherapeutic processes. In this paper, we report on the current state of a Web application that can be used for assessing the temporal structure of mental disorders using information on their temporal and synchronous associations. A treatment planning algorithm automatically interprets the data and delivers priority scores of symptoms to practitioners. The application is also capable of monitoring psychotherapeutic processes during therapy and of monitoring treatment outcomes. This application was developed using the R programming language (R Core Team, Vienna) and the Shiny Web application framework (RStudio, Inc, Boston). It is made entirely from open-source software packages and thus is easily extensible. The capabilities of the proposed application are demonstrated. Case illustrations are provided to exemplify its usefulness in clinical practice. With the broad availability of Internet-enabled mobile phones and similar devices, collecting data on psychopathology and psychotherapeutic processes has become easier than ever. The proposed application is a valuable tool for capturing, processing, and visualizing these data. The combination of dynamic assessment and process- and outcome monitoring has the potential to improve the efficacy and effectiveness of psychotherapy. ©Tim Kaiser

DynAMo: A Modular Platform for Monitoring Process, Outcome, and Algorithm-Based Treatment Planning in Psychotherapy

PubMed Central

Laireiter, Anton Rupert

2017-01-01

Background In recent years, the assessment of mental disorders has become more and more personalized. Modern advancements such as Internet-enabled mobile phones and increased computing capacity make it possible to tap sources of information that have long been unavailable to mental health practitioners. Objective Software packages that combine algorithm-based treatment planning, process monitoring, and outcome monitoring are scarce. The objective of this study was to assess whether the DynAMo Web application can fill this gap by providing a software solution that can be used by both researchers to conduct state-of-the-art psychotherapy process research and clinicians to plan treatments and monitor psychotherapeutic processes. Methods In this paper, we report on the current state of a Web application that can be used for assessing the temporal structure of mental disorders using information on their temporal and synchronous associations. A treatment planning algorithm automatically interprets the data and delivers priority scores of symptoms to practitioners. The application is also capable of monitoring psychotherapeutic processes during therapy and of monitoring treatment outcomes. This application was developed using the R programming language (R Core Team, Vienna) and the Shiny Web application framework (RStudio, Inc, Boston). It is made entirely from open-source software packages and thus is easily extensible. Results The capabilities of the proposed application are demonstrated. Case illustrations are provided to exemplify its usefulness in clinical practice. Conclusions With the broad availability of Internet-enabled mobile phones and similar devices, collecting data on psychopathology and psychotherapeutic processes has become easier than ever. The proposed application is a valuable tool for capturing, processing, and visualizing these data. The combination of dynamic assessment and process- and outcome monitoring has the potential to improve the efficacy

Therapeutic efficacy of artesunate-amodiaquine and artemether-lumefantrine combinations in the treatment of uncomplicated malaria in two ecological zones in Ghana.

PubMed

Abuaku, Benjamin; Duah, Nancy; Quaye, Lydia; Quashie, Neils; Malm, Keziah; Bart-Plange, Constance; Koram, Kwadwo

2016-01-05

Case management based on prompt diagnosis and adequate treatment using artemisinin-based combination therapy (ACT) remains the main focus of malaria control in Ghana. As part of routine surveillance on the therapeutic efficacy of ACT in Ghana, the efficacy of amodiaquine-artesunate (AS-AQ) and artemether-lumefantrine (AL) were studied in six sentinel sites representing the forest and savannah zones of the country. Three sites representing the two ecological zones studied AS-AQ whilst the other three sites studied AL. In each site, the study was a one-arm prospective evaluation of the clinical, parasitological, and haematological responses to directly observed therapy for uncomplicated malaria with either AS-AQ or AL among children aged 6 months and 9 years. The WHO 2009 protocol for monitoring anti-malarial drug efficacy was used for the study between July 2013 and March 2014. Per-protocol analyses on day 28 showed an overall PCR-corrected cure rate of 100% for AS-AQ and 97.6% (95% CI 93.1, 99.5) for AL: 97.2% (95% CI 92.0, 99.4) in the forest zone and 100% in the savannah zone. Kaplan-Meier survival analysis showed similar outcomes. Prevalence of fever decreased by about 75% after the first day of treatment with each ACT in the two ecological zones. No child studied was parasitaemic on day 3, and gametocytaemia was generally maintained at low levels (<5%). Post-treatment mean haemoglobin concentrations significantly increased in the two ecological zones. Therapeutic efficacy of AS-AQ and AL remains over 90% in the forest and savannah zones of Ghana. Additionally, post-treatment parasitaemia on day 3 is rare suggesting that artemisinin is still efficacious in Ghana.

Indigenous traditional knowledge and substance abuse treatment outcomes: the problem of efficacy evaluation.

PubMed

Gone, Joseph P

2012-09-01

In the field of substance abuse treatment, American Indian and Alaska Native (AI/AN) communities have routinely incorporated ceremonial practices as one important component in the promotion of recovery and healing. The beneficial effects of such practices are frequently described as plainly apparent by community-based advocates, providers, and professionals alike. In the present era of evidence-based substance abuse intervention, however, indigenous integration of such practices raises questions pertaining to the systematic evaluation of treatment efficacy. The focus of this article is outcome evaluation. Although intervention outcome researchers recognize the randomized controlled trial as the "gold standard" against which claims of treatment efficacy are measured, AI/AN efficacy assertions grounded in indigenous traditional knowledge (ITK) reflect different concerns that have emerged in non-Western historical contexts. The interface between scientific and indigenous "ways of knowing" is explored here relative to efficacy claims about substance abuse treatment. Distinguishing features of both scientific knowing and ITK are summarized and compared. ITK has been described as personal and experiential, reflecting the primacy of autonomous individual knowing. In contrast, intervention scientists are skeptical of personal inference as a basis for efficacy evaluation. The evident divergence between these epistemic paradigms can result in potentially contradictory claims. Proper appraisal of the status and relevance of ITK for determining treatment efficacy requires further exploration of these marginalized approaches to knowledge. Intervention scientists who work in AI/AN communities should remain open to the legitimacy and role of ITKs in investigations of substance abuse treatment.

Efficacy of delayed treatment of China-made Peramivir with repeated intravenous injections in a mouse influenza model: from clinical experience to basal experiment.

PubMed

Li, Zhengtu; Li, Runfeng; Li, Jing; Xie, Hui; Hao, Yanbing; Du, Qiuling; Chen, Tingting; Li, Yimin; Chen, Rongchang; Yang, Zifeng; Zhong, Nanshan

2016-07-08

China-made Peramivir, an anti-influenza neuraminidase inhibitor drug, is manufactured and widely used in China. Although effective if initiated within 48 h of the onset of symptoms, yet we observed that this drug shows an inconclusive efficacy if treatment is delayed in clinical. Thus we evaluated the efficacy of delayed treatment of China-made Peramivir in a mouse model. The mouse model of influenza infection was made and Peramivir was administered intravenously for 5 days following infection, and weight loss, lung index, viral shedding and survival rates were monitored. Peramivir (60 mg/kg · d, repeated intravenous injections, quaque die (QD) × 5 days) enhanced survival rate and suppressed weight loss when treatment was initiated 24, 36, 48, or even 60 h post-infection (p.i.) (p < 0.01), compared with the virus-untreated group, and efficacy was abolished at 72 h p.i.. However the efficacy of delayed treatment was dose dependent, with the highest dose (90 mg/kg · d) even showing efficacy at 72 h p.i.. Furthermore, Peramivir (60 mg/kg · d, repeated intravenous injections, QD × 5 days) also reduced the lung virus titer 24 and 36 h p.i. on day 5, and even at 48 and 60 h p.i. on day 7 after infection, and the lung index was also improved. What is interesting that the concentration of the drug was maintained in blood after infected. Delayed treatment with China-made Peramivir can reduce the severity of influenza disease, accelerate viral clearance and enhance the survival rate. This drug therefore shows good efficacy and is a promising candidate to control the influenza epidemic in China.

Safety and efficacy of aneurysm treatment with WEB: results of the WEBCAST study.

PubMed

Pierot, Laurent; Costalat, Vincent; Moret, Jacques; Szikora, Istvan; Klisch, Joachim; Herbreteau, Denis; Holtmannspötter, Markus; Weber, Werner; Januel, Anne-Christine; Liebig, Thomas; Sychra, Vojtech; Strasilla, Christoph; Cognard, Christophe; Bonafé, Alain; Molyneux, Andrew; Byrne, James V; Spelle, Laurent

2016-05-01

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 monitor. Six-month follow-up digital subtraction angiography was also performed and independently analyzed by a core laboratory. Success was defined at 6 months as complete occlusion or stable neck remnant, no worsening in angiographic appearance from postprocedure, and no retreatment performed or planned. 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 in a permanent deficit (modified Rankin Scale [mRS] Score 1) in 1 patient (2.0%). Intraoperative rupture was not observed. Morbidity (mRS score > 2) and mortality were 2.0% (1 of 51 patients, related to rupture status on entry to study) and 0.0% at 1 month, respectively. Success was achieved at 6 months in 85.4% of patients treated with WEB: 23 of 41 patients (56.1%) had complete occlusion, 12 of 41 (29.3%) had a neck remnant, and 6 of 41 (14.6%) had an aneurysm remnant. CONCLUSIONS The WEBCAST study showed good procedural and short-term safety of aneurysm treatment with WEB and good 6-month anatomical results.

Efficacy, Safety, and Pharmacokinetics of Coadministered Diethylcarbamazine, Albendazole, and Ivermectin for Treatment of Bancroftian Filariasis.

PubMed

Thomsen, Edward K; Sanuku, Nelly; Baea, Manasseh; Satofan, Samson; Maki, Elit; Lombore, Bart; Schmidt, Mark S; Siba, Peter M; Weil, Gary J; Kazura, James W; Fleckenstein, Lawrence L; King, Christopher L

2016-02-01

Available treatments for lymphatic filariasis (LF) are limited in their longterm clearance of microfilaria from the blood. The safety and efficacy of a single-dose triple-drug therapy of the antifilarial drugs diethylcarbamazine (DEC), ivermectin (IVM), and albendazole (ALB) for LF are unknown. We performed a pilot study to test the efficacy, safety, and pharmacokinetics of single-dose DEC, IVM, and ALB in Wuchereria bancrofti-infected Papua New Guineans. Adults were randomized into 2 treatment arms, DEC 6 mg/kg + ALB 400 mg (N = 12) or DEC 6 mg/kg + ALB 400 mg + IVM 200 μg/kg (N = 12), and monitored for microfilaria, parasite antigenemia, adverse events (AEs), and serum drug levels. Triple-drug therapy induced >2-log reductions in microfilaria levels at 36 and 168 hours after treatment compared with approximately 1-log reduction with 2 drugs. All 12 individuals who received 3 drugs were microfilaria negative 1 year after treatment, whereas 11 of 12 individuals in the 2-drug regimen were microfilaria positive. In 6 participants followed 2 years after treatment, those who received 3 drugs remained microfilaria negative. AEs, particularly fever, myalgias, pruritus, and proteinuria/hematuria, occurred in 83% vs 50% of those receiving triple-drug compared to 2-drug treatment respectively (P = .021); all resolved within 7 days after treatment. No serious AEs were observed in either group. There was no significant effect of IVM on DEC or ALB drug levels. Triple-drug therapy is safe and more effective than DEC + ALB for Bancroftian filariasis and has the potential to accelerate elimination of lymphatic filariasis. NCT01975441. © The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Family-based treatment for transition age youth: parental self-efficacy and caregiver accommodation.

PubMed

Dimitropoulos, Gina; Landers, Ashley L; Freeman, Victoria E; Novick, Jason; Cullen, Olivia; Engelberg, Marla; Steinegger, Cathleen; Le Grange, Daniel

2018-01-01

Family-Based Treatment (FBT) is the first line of care in paediatric treatment while adult programs focus on individualized models of care. Transition age youth (TAY) with Anorexia Nervosa (AN) are in a unique life stage and between systems of care. As such, they and their caregivers may benefit from specialized, developmentally tailored models of treatment. The primary purpose of this study was to assess if parental self-efficacy and caregiver accommodation changed in caregivers during the course of FBT-TAY for AN. The secondary aim was to determine if changes in parental self-efficacy and caregiver accommodation contributed to improvements in eating disorder behaviour and weight restoration in the transition age youth with AN. Twenty-six participants (ages 16-22) and 39 caregivers were recruited. Caregivers completed the Parents versus Anorexia Scale and Accommodation and Enabling Scale for Eating Disorders at baseline, end-of-treatment (EOT), and 3 months follow-up. Unbalanced repeated measures designs for parental self-efficacy and caregiver accommodation towards illness behaviours were conducted using generalized estimation equations. Parental self-efficacy increased from baseline to EOT, although not significantly ( p =  .398). Parental self-efficacy significantly increased from baseline to 3 months post-treatment ( p  = .002). Caregiver accommodation towards the illness significantly decreased from baseline to EOT ( p  = 0.0001), but not from baseline to 3 months post-treatment ( p  = 1.000). Stepwise ordinary least squares regression estimates of eating disorder behaviour and weight restoration did not show that changes in parental-self efficacy and caregiver accommodation predict eating disorder behaviour or weight restoration at EOT or 3 months post-treatment. Our findings demonstrate, albeit preliminary at this stage, that FBT-TAY promotes positive increases in parental self-efficacy and assists caregivers in decreasing their accommodation

The application of Bandura's self-efficacy theory to abstinence-oriented alcoholism treatment.

PubMed

Rollnick, S; Heather, N

1982-01-01

This paper explores the relevance of self-efficacy theory (Bandura, 1977b) to the process of abstinence treatment and the phenomenon of relapse. By distinguishing between the particular efficacy and outcome expectations created in treatment it is possible to clarify some of the problems encountered between clinicians and alcoholics. Bandura's theory also explains why some treatment methods might be more effective than others. Analysis of relapse suggests that while some of the expectations created in treatment might serve to promote abstinence, others might unwittingly precipitate relapse. The understanding of abstinence treatment could be enhanced by the testing of hypotheses which emerge from this analysis.

A Meta-Analysis of D-Cycloserine in Exposure-Based Treatment: Moderators of Treatment Efficacy, Response, and Diagnostic Remission

PubMed Central

McGuire, Joseph F.; Wu, Monica S.; Piacentini, John; McCracken, James T.; Storch, Eric A.

2018-01-01

Objective This meta-analysis examined treatment efficacy, treatment response, and diagnostic remission effect sizes (ES) and moderators of d-cycloserine (DCS) augmented exposure treatment in randomized controlled trials (RCTs) of individuals with anxiety disorders, obsessive-compulsive disorder (OCD), and posttraumatic stress disorder (PTSD). Data Sources and Study Selection Using search terms d-cycloserine AND randomized controlled trial, PubMED (1965-May 2015), PsycInfo, and Scopus were searched for randomized placebo-controlled trials of DCS-augmented exposure therapy for anxiety disorders, OCD, and PTSD. Data Extraction Clinical variables and ES were extracted from 20 RCTs (957 participants). A random effects model calculated the ES for treatment efficacy, treatment response, and diagnostic remission using standardized rating scales. Subgroup analyses and meta-regression examined potential moderators. Results A small non-significant benefit of DCS augmentation compared to placebo augmentation was identified across treatment efficacy (g=0.15), response (RR=1.08), and remission (RR=1.109), with a moderately significant effect for anxiety disorders specifically (g=0.33, p=.03). At initial follow-up assessments, a small non-significant ES of DCS augmentation compared to placebo was found for treatment efficacy (g=0.21), response (RR=1.06), and remission (RR=1.12). Specific treatment moderators (e.g., comorbidity, medication status, gender, publication year) were found across conditions for both acute treatment and initial follow-up assessments. Conclusions DCS does not universally enhance treatment outcomes, but demonstrates promise for anxiety disorders. Distinct treatment moderators may account for discrepant findings across RCTs and disorders. Future trials may be strengthened by accounting for identified moderators in their design, with ongoing research needed on the mechanisms of DCS to tailor treatment protocols and maximize its benefit. PMID:27314661

A review of the efficacy of transcranial magnetic stimulation (TMS) treatment for depression, and current and future strategies to optimize efficacy.

PubMed

Loo, Colleen K; Mitchell, Philip B

2005-11-01

There is a growing interest in extending the use of repetitive transcranial magnetic stimulation (rTMS) beyond research centres to the widespread clinical treatment of depression. Thus it is timely to critically review the evidence for the efficacy of rTMS as an antidepressant treatment. Factors relevant to the efficacy of rTMS are discussed along with the implications of these for the further optimization of rTMS. Clinical trials of the efficacy of rTMS in depressed subjects are summarized and reviewed, focusing mainly on sham-controlled studies and meta-analyses published to date. There is a fairly consistent statistical evidence for the superiority of rTMS over a sham control, though the degree of clinical improvement is not large. However, this data is derived mainly from two-week comparisons of rTMS versus sham, and evidence suggests greater efficacy with longer treatment courses. Studies so far have also varied greatly in approaches to rTMS stimulation (with respect to stimulation site, stimulus parameters etc) with little empirical evidence to inform on the relative merits of these approaches. Only studies published in English were reviewed. Many of the studies in the literature had small sample sizes and different methodologies, making comparisons between studies difficult. Current published studies and meta-analyses have evaluated the efficacy of rTMS as given in treatment paradigms that are almost certainly suboptimal (e.g of two weeks' duration). While the data nevertheless supports positive outcomes for rTMS, there is much scope for the further refinement and development of rTMS as an antidepressant treatment. Ongoing research is critical for optimizing the efficacy of rTMS.

Depression and Cancer Survivorship: Importance of Coping Self-Efficacy in Post-Treatment Survivors

PubMed Central

Philip, Errol J.; Merluzzi, Thomas V.; Zhang, Zhiyong; Heitzmann, Carolyn A.

2012-01-01

Purpose An estimated 30% of cancer patients are expected to experience clinically significant psychological distress during the treatment phase of their disease. Despite significant attention being directed to the mental health needs of individuals undergoing and completing treatment, there is less known about the mental health needs of survivors and the role of potential protective factors in survivorship, such as coping self-efficacy and social support. Method One hundred and twenty-four post-treatment cancer survivors (mean age = 62.23 years, female = 70%, average 9.3 years post-treatment) were asked to complete measures of physical symptoms, coping self-efficacy, social support, and depression as part of a national convenience sample of cancer patients and survivors. Results About 20% of participants possessed scores on the CES-D indicative of clinically-relevant depression. Coping self-efficacy was not only a significant predictor of depression (43% VAC); it also partially mediated the relationship between symptoms and depression. Social support accounted for limited variance and was not a significant predictor of depression in a model containing both social support and coping self-efficacy as predictors. Conclusion A substantial minority of post-treatment survivors reported depression symptomatology. Coping self-efficacy may be an important component of patients’ adjustment and possible target for intervention. These results highlight the ongoing mental health and support needs of cancer survivors. PMID:22573371

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

PubMed

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

2012-09-01

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

Failed efficacy of ziprasidone in the treatment of post-traumatic stress disorder.

PubMed

Ramaswamy, Sriram; Driscoll, David; Smith, Lynette M; Bhatia, Subhash C; Petty, Frederick

2016-04-15

Post-traumatic stress disorder (PTSD) is a chronic anxiety disorder that is often difficult to treat. Patients suffering from PTSD often fail to respond to antidepressants and may have a high incidence of positive symptoms of psychosis, though antipsychotic medications have been minimally studied in this population. The aim of this study was to assess the impact of the atypical antipsychotic ziprasidone (Geodon) on PTSD symptom clusters, as well as comorbid major depressive disorder. To our knowledge, this is the first completed randomized controlled trial investigating the potential efficacy and tolerability of ziprasidone in patients with chronic PTSD. We conducted a 9-week prospective, randomized, double-blind, placebo-controlled trial of ziprasidone in 30 patients diagnosed with PTSD and comorbid depression. After screening and randomization, patients completed nine weekly study visits at which treatment safety and efficacy were evaluated. Primary measures of efficacy included total and subscale scores from the Clinician-Administered PTSD Scale (CAPS), while the Hamilton Rating Scale for Depression (HAM-D), Hamilton Anxiety Scale (HAM-A), Clinical Global Impression (CGI), and Treatment Outcome PTSD Scale (TOP-8) were implemented as secondary efficacy measures. We observed no significant effect of treatment on reduction of PTSD or depression symptoms from pre- to post-treatment. Our findings suggest that ziprasidone treatment may not significantly improve symptoms of PTSD or comorbid depression, though further study is needed.

Efficacy and Safety of Gabapentin in Comparison to Solifenacin Succinate in Adult Overactive Bladder Treatment.

PubMed

Chua, Michael E; See, Manuel C; Esmeňa, Ednalyn B; Balingit, Jaime C; Morales, Marcelino L

2018-05-01

To evaluate the efficacy and safety of gabapentin in comparison to solifenacin succinate and placebo for the treatment of adult patients with overactive bladder (OAB). A 12-week, randomized, double-blind, double dummy placebo-controlled, clinical trial was conducted between October 2010 and August 2014 at a tertiary medical center. Eligible and consenting patients included were randomized into three treatment groups (placebo, gabapentin and solifenacin). After a 12-week treatment period, an intention to treat analysis was applied to assess between group differences on the micturitions and urgency episodes per 24 h; which were evaluated by 3-day micturition diary mean change from baseline to post treatment. Health related quality of life (HRQOL) domains were likewise assessed by OAB questionnaire (OAB-q). Adverse event were monitored and summarized. Study results were analyzed at statistical significance of 0.05. (ClinicalTrials.gov ID NCT01486706) RESULT: A total of 94 participants were included for end-study efficacy and safety analysis. Compared to placebo, gabapentin and solifenacin have statistically significant improvement in mean number of micturitions per 24 h (adjusted mean difference [AMD] -1.179, 95%CI -1.98, -0.38; P < 0.001; -1.706, 95%CI -2.52, -0.09; P < 0.001; respectively), and in mean number of urgency episodes per 24 h (AMD -0.903, 95%CI -1.44, -0.37; P < 0.001; -0.896, 95%CI -1.44, -0.35; P < 0.001). Gabapentin also demonstrated significant improvement over the solifenacin in the mean number of nocturia episodes/24 h (AMD -0.607, 95%CI -1.04, -0.18; P < 0.001). Adverse event related to gabapentin treatment was lesser than solifenacin, and comparable to placebo. Gabapentin treatment with acceptable safety profile, improves OAB symptoms and HRQOL domains. © 2017 John Wiley & Sons Australia, Ltd.

Increasing nerve agent treatment efficacy by P-glycoprotein inhibition.

PubMed

Joosen, Marloes J A; Vester, Stefanie M; Hamelink, Jouk; Klaassen, Steven D; van den Berg, Roland M

2016-11-25

One of the shortcomings of current treatment of nerve agent poisoning is that not all drugs effectively penetrate the blood-brain barrier (BBB), whereas most nerve agents easily do. P-glycoprotein (Pgp) efflux transporters at the BBB may contribute to this aspect. It was previously shown that Pgp inhibition by tariquidar enhanced the efficacy of nerve agent treatment when administered as a pretreatment. In the present study soman-induced seizures were also substantially prevented when the animals were intravenously treated with tariquidar post-poisoning, in addition to HI-6 and atropine. In these animals, approximately twice as much AChE activity was present in their brain as compared to control rats. The finding that tariquidar did not affect distribution of soman to the brain indicates that the potentiating effects were a result of interactions of Pgp inhibition with drug distribution. In line with this, atropine appeared to be a substrate for Pgp in in vitro studies in a MDR1/MDCK cell model. This indicates that tariquidar might induce brain region specific effects on atropine distribution, which could contribute to the therapeutic efficacy increase found. Furthermore, the therapeutic enhancement by tariquidar was compared to that of the less specific and less potent Pgp inhibitor cyclosporine A. This compound appeared to induce a protective effect similar to tariquidar. In conclusion, treatment with a Pgp inhibitor resulted in enhanced therapeutic efficacy of HI-6 and atropine in a soman-induced seizure model in the rat. The mechanism underlying these effects should be further investigated. To that end, the potentiating effect of nerve agent treatment should be addressed against a broader range of nerve agents, for oximes and atropine separately, and for those at lower doses. In particular when efficacy against more nerve agents is shown, a Pgp inhibitor such as tariquidar might be a valid addition to nerve agent antidotes. Copyright © 2016 Elsevier Ireland

Field Validity and Feasibility of Four Techniques for the Detection of Trichuris in Simians: A Model for Monitoring Drug Efficacy in Public Health?

PubMed Central

Levecke, Bruno; De Wilde, Nathalie; Vandenhoute, Els; Vercruysse, Jozef

2009-01-01

Background Soil-transmitted helminths, such as Trichuris trichiura, are of major concern in public health. Current efforts to control these helminth infections involve periodic mass treatment in endemic areas. Since these large-scale interventions are likely to intensify, monitoring the drug efficacy will become indispensible. However, studies comparing detection techniques based on sensitivity, fecal egg counts (FEC), feasibility for mass diagnosis and drug efficacy estimates are scarce. Methodology/Principal Findings In the present study, the ether-based concentration, the Parasep Solvent Free (SF), the McMaster and the FLOTAC techniques were compared based on both validity and feasibility for the detection of Trichuris eggs in 100 fecal samples of nonhuman primates. In addition, the drug efficacy estimates of quantitative techniques was examined using a statistical simulation. Trichuris eggs were found in 47% of the samples. FLOTAC was the most sensitive technique (100%), followed by the Parasep SF (83.0% [95% confidence interval (CI): 82.4–83.6%]) and the ether-based concentration technique (76.6% [95% CI: 75.8–77.3%]). McMaster was the least sensitive (61.7% [95% CI: 60.7–62.6%]) and failed to detect low FEC. The quantitative comparison revealed a positive correlation between the four techniques (Rs = 0.85–0.93; p<0.0001). However, the ether-based concentration technique and the Parasep SF detected significantly fewer eggs than both the McMaster and the FLOTAC (p<0.0083). Overall, the McMaster was the most feasible technique (3.9 min/sample for preparing, reading and cleaning of the apparatus), followed by the ether-based concentration technique (7.7 min/sample) and the FLOTAC (9.8 min/sample). Parasep SF was the least feasible (17.7 min/sample). The simulation revealed that the sensitivity is less important for monitoring drug efficacy and that both FLOTAC and McMaster were reliable estimators. Conclusions/Significance The results of this study

Use of a Battery of Chemical and Ecotoxicological Methods for the Assessment of the Efficacy of Wastewater Treatment Processes to Remove Estrogenic Potency

PubMed Central

Beresford, Nicola; Baynes, Alice; Kanda, Rakesh; Mills, Matthew R.; Arias-Salazar, Karla; Collins, Terrence J.; Jobling, Susan

2016-01-01

Endocrine Disrupting Compounds pose a substantial risk to the aquatic environment. Ethinylestradiol (EE2) and estrone (E1) have recently been included in a watch list of environmental pollutants under the European Water Framework Directive. Municipal wastewater treatment plants are major contributors to the estrogenic potency of surface waters. Much of the estrogenic potency of wastewater treatment plant (WWTP) effluents can be attributed to the discharge of steroid estrogens including estradiol (E2), EE2 and E1 due to incomplete removal of these substances at the treatment plant. An evaluation of the efficacy of wastewater treatment processes requires the quantitative determination of individual substances most often undertaken using chemical analysis methods. Most frequently used methods include Gas Chromatography-Mass Spectrometry (GCMS/MS) or Liquid Chromatography-Mass Spectrometry (LCMS/MS) using multiple reaction monitoring (MRM). Although very useful for regulatory purposes, targeted chemical analysis can only provide data on the compounds (and specific metabolites) monitored. Ecotoxicology methods additionally ensure that any by-products produced or unknown estrogenic compounds present are also assessed via measurement of their biological activity. A number of in vitro bioassays including the Yeast Estrogen Screen (YES) are available to measure the estrogenic activity of wastewater samples. Chemical analysis in conjunction with in vivo and in vitro bioassays provides a useful toolbox for assessment of the efficacy and suitability of wastewater treatment processes with respect to estrogenic endocrine disrupting compounds. This paper utilizes a battery of chemical and ecotoxicology tests to assess conventional, advanced and emerging wastewater treatment processes in laboratory and field studies. PMID:27684328

Retrospective analysis of factors affecting the efficacy of surgical treatment of the scar.

PubMed

Yang, Z; Shi, X; Zhang, Y; Wang, S; Lei, Z; Liu, X; Fan, D

2014-04-01

The scar is a major problem in the medical profession. Its timely treatment is very important for the better outcome of the scar treatment and for the improvement of the life quality of the patients. The aim of this study was retrospectively analyzed the epidemiological characteristics affecting the efficacy of the scar surgical treatment of the people in the western part of China. Total 414 scar cases were retrospectively analyzed to clarify the epidemiological characteristics and the factors affecting the scar surgical treatment efficacy. The factors included were sex, age, area distribution, treatment seasons, injury sites, injury causes, and the time from scarring to the surgical treatment. All scar cases were surgically treated with the repairing technology including skin graft, flap and soft tissue dilation. There were 206 males and 208 females with the average age 20.53±12.9 years (age range 1-68 years). The patient proportions in the age groups of 0-20, 21-40 and >40 years were 61.4% (254 cases), 29.2% (121 cases), and 9.4% (39 cases) respectively. The patient's attendance rate reached the highest during the summer and winter. Most patients were from the rural areas with an increasing tendency each year. The burn scars were the most abundant and the injury sites were mostly the head and face. Univariate analysis showed that the time from scarring to the surgical treatment and the injury sites were significantly influenced the scar surgical treatment efficacy. Logistic regression analysis demonstrated that the injured sites of the head and face significantly influenced the scar surgical treatment efficacy. With the development of economy in China, more scar patients especially younger and children visit doctors predominantely from the rural areas. Usually, they get their scars in the exposed area of their bodies (head and face) which seriously affect the patient's appearance and function. Factors influencing the scar surgical treatment efficacy has

Efficacy of Doxycycline in the Treatment of Syphilis.

PubMed

Dai, Ting; Qu, Rui; Liu, Jinfen; Zhou, Pingyu; Wang, Qianqiu

2017-01-01

Doxycycline is an alternative antibiotic drug for the treatment of syphilis, but data on its efficacy, especially data on its efficacy against late latent syphilis, are limited. A retrospective study was conducted to evaluate the effectiveness of doxycycline for the treatment of patients with different stages of syphilis. Patients who received doxycycline treatment between June 2011 and June 2014 were involved. The serological response to doxycycline was defined as either a negative toluidine red unheated serum test (TRUST) result or a ≥4-fold decrease in titer at 12 months following the treatment. Univariate and multivariate logistic regression analyses were performed to identify factors associated with the serological response. During the study period, a total of 163 syphilis patients were treated with doxycycline, and 118 patients completed doxycycline treatment and the 12-month follow-up. Among the 118 patients, the serological response rate at 12 months was 100.0% (7/7) in patients with primary syphilis, 96.9% (62/64) in patients with secondary syphilis, 91.3% (21/23) in patients with early latent syphilis, and 79.2% (19/24) in patients with late latent syphilis. The total serological response rates were 92.4% (109/118) for preprotocol (PP) patients and 66.9% (109/163) for all intention-to-treat (ITT) patients. In multivariate analysis, patients who serologically responded at 12 months following treatment were positively associated with a higher baseline TRUST titer and an earlier syphilis stage than nonresponders. Our study showed excellent treatment outcomes in patients with different stages of syphilis. Our data, along with those from other reports, support the usage of doxycycline as a good alternative therapeutic option in the treatment of syphilis. Copyright © 2016 American Society for Microbiology.

End-of-treatment abstinence self-efficacy, behavioral processes of change, and posttreatment drinking outcomes in Project MATCH.

PubMed

Crouch, Taylor Berens; DiClemente, Carlo C; Pitts, Steven C

2015-09-01

This study evaluated whether alcohol abstinence self-efficacy at the end of alcohol treatment was moderated by utilization of behavioral processes of change (coping activities used during a behavior change attempt). It was hypothesized that self-efficacy would be differentially important in predicting posttreatment drinking outcomes depending on the level of behavioral processes, such that the relation between self-efficacy and outcomes would be stronger for individuals who reported low process use. Analyses were also estimated with end-of-treatment abstinence included as a covariate. Data were analyzed from alcohol-dependent individuals in both treatment arms of Project MATCH (Matching Alcoholism Treatments to Client Heterogeneity; N = 1,328), a large alcohol treatment study. Self-efficacy was moderated by behavioral process use in predicting drinking frequency 6 and 12 months posttreatment and drinking quantity 6 months posttreatment such that self-efficacy was more strongly related to posttreatment drinking when low levels of processes were reported than high levels, but interactions were attenuated when end-of-treatment abstinence was controlled for. Significant quadratic relations between end-of-treatment self-efficacy and 6- and 12-month posttreatment drinking quantity and frequency were found (p < .001, ƒ² = 0.02-0.03), such that self-efficacy most robustly predicted outcomes when high. These effects remained significant when end-of-treatment abstinence was included as a covariate. Findings highlight the complex nature of self-efficacy's relation with drinking outcomes. Although the interaction between self-efficacy and behavioral processes was attenuated when end-of-treatment abstinence was controlled for, the quadratic effect of self-efficacy on outcomes remained significant. The pattern of these effects did not support the idea of "overconfidence" as a negative indicator. (c) 2015 APA, all rights reserved).

Is psychological treatment efficacious for attention deficit hyperactivity disorder (ADHD)? Review of non-pharmacological treatments in children and adolescents with ADHD.

PubMed

Serrano-Troncoso, Eduardo; Guidi, Monica; Alda-Díez, José Ángel

2013-01-01

Attention deficit hyperactivity disorder (ADHD) is the most prevalent psychiatric disorder in children and adolescents, and has a great impact on the psychological development of affected patients. Even though its efficacy is proven, the use of medication for ADHD has several limitations, and non-pharmacological interventions are considered a necessary component of treatment. This work is a review of evidence-based non-pharmacological treatments with demonstrated efficacy for ADHD in children and adolescents, analyzed by age groups. Non-pharmacological treatments that have shown scientific evidence of efficacy are psychological and psychoeducational interventions. Psychological interventions include behavioral therapy, parent training (PT) and social skills training. Psychoeducational interventions include a set of practices to improve learning and are carried out in the school setting. Scientific evidence of efficacy in preschool children is limited to PT, while different psychological and psychoeducational interventions have been shown to be beneficial in school-age children. The available evidence for non-pharmacological treatment in adolescence is so far insufficient. Though more randomized controlled trials are necessary for non-pharmacological interventions to become established practices, there are clear indications of their efficacy. For more severe cases of ADHD, a combination of non-pharmacological and pharmacological treatment is recommended.

Hydromorphone efficacy and treatment protocol impact on tolerance and mu-opioid receptor regulation.

PubMed

Kumar, Priyank; Sunkaraneni, Soujanya; Sirohi, Sunil; Dighe, Shveta V; Walker, Ellen A; Yoburn, Byron C

2008-11-12

This study examined the antinociceptive (analgesic) efficacy of hydromorphone and hydromorphone-induced tolerance and regulation of mu-opioid receptor density. Initially s.c. hydromorphone's time of peak analgesic (tail-flick) effect (45 min) and ED50 using standard and cumulative dosing protocols (0.22 mg/kg, 0.37 mg/kg, respectively) were determined. The apparent analgesic efficacy (tau) of hydromorphone was then estimated using the operational model of agonism and the irreversible mu-opioid receptor antagonist clocinnamox. Mice were injected with clocinnamox (0.32-25.6 mg/kg, i.p.) and 24 h later, the analgesic potency of hydromorphone was determined. The tau value for hydromorphone was 35, which suggested that hydromorphone is a lower analgesic efficacy opioid agonist. To examine hydromorphone-induced tolerance, mice were continuously infused s.c. with hydromorphone (2.1-31.5 mg/kg/day) for 7 days and then morphine cumulative dose response studies were performed. Other groups of mice were injected with hydromorphone (2.2-22 mg/kg/day) once, or intermittently every 24 h for 7 days. Twenty-four hours after the last injection, mice were tested using morphine cumulative dosing studies. There was more tolerance with infusion treatments compared to intermittent treatment. When compared to higher analgesic efficacy opioids, hydromorphone infusions induced substantially more tolerance. Finally, the effect of chronic infusion (31.5 mg/kg/day) and 7 day intermittent (22 mg/kg/day) hydromorphone treatment on spinal cord mu-opioid receptor density was determined. Hydromorphone did not produce any change in mu-opioid receptor density following either treatment. These results support suggestions that analgesic efficacy is correlated with tolerance magnitude and regulation of mu-opioid receptors when opioid agonists are continuously administered. Taken together, these studies indicate that analgesic efficacy and treatment protocol are important in determining tolerance and

Efficacy of Curcuma for Treatment of Osteoarthritis

PubMed Central

Perkins, Kimberly; Sahy, William; Beckett, Robert D.

2016-01-01

The objective of this review is to identify, summarize, and evaluate clinical trials to determine the efficacy of curcuma in the treatment of osteoarthritis. A literature search for interventional studies assessing efficacy of curcuma was performed, resulting in 8 clinical trials. Studies have investigated the effect of curcuma on pain, stiffness, and functionality in patients with knee osteoarthritis. Curcuma-containing products consistently demonstrated statistically significant improvement in osteoarthritis-related endpoints compared with placebo, with one exception. When compared with active control, curcuma-containing products were similar to nonsteroidal anti-inflammatory drugs, and potentially to glucosamine. While statistical significant differences in outcomes were reported in a majority of studies, the small magnitude of effect and presence of major study limitations hinder application of these results. Further rigorous studies are needed prior to recommending curcuma as an effective alternative therapy for knee osteoarthritis. PMID:26976085

Reviewing depot injection efficacy in the treatment of schizophrenia.

PubMed

Jones, Adrian; Jones, Martin

2016-04-13

Schizophrenia is a severe and enduring mental health disorder. Treatment includes antipsychotic medication and psychological interventions. Medication can be administered as a depot injection; these treatments reduce the risk of relapse in some people with schizophrenia who have difficulties adhering to oral medication regimens. This article outlines the types of depot and medications that are available for the treatment of schizophrenia, and discusses the evidence base supporting their efficacy. The role of antipsychotic medication as part of a treatment plan should be reinforced by enabling patients to make an informed choice about which medication best supports their health and wellbeing.

Effect of electrical energy on the efficacy of biofilm treatment using the bioelectric effect

PubMed Central

Kim, Young Wook; Subramanian, Sowmya; Gerasopoulos, Konstantinos; Ben-Yoav, Hadar; Wu, Hsuan-Chen; Quan, David; Carter, Karen; Meyer, Mariana T; Bentley, William E; Ghodssi, Reza

2015-01-01

Background/Objectives: The use of electric fields in combination with small doses of antibiotics for enhanced treatment of biofilms is termed the ‘bioelectric effect’ (BE). Different mechanisms of action for the AC and DC fields have been reported in the literature over the last two decades. In this work, we conduct the first study on the correlation between the electrical energy and the treatment efficacy of the bioelectric effect on Escherichia coli K-12 W3110 biofilms. Methods: A thorough study was performed through the application of alternating (AC), direct (DC) and superimposed (SP) potentials of different amplitudes on mature E. coli biofilms. The electric fields were applied in combination with the antibiotic gentamicin (10 μg/ml) over a course of 24 h, after the biofilms had matured for 24 h. The biofilms were analysed using the crystal violet assay, the colony-forming unit method and fluorescence microscopy. Results: Results show that there is no statistical difference in treatment efficacy between the DC-, AC- and SP-based BE treatment of equivalent energies (analysis of variance (ANOVA) P>0.05) for voltages <1 V. We also demonstrate that the efficacy of the BE treatment as measured by the crystal violet staining method and colony-forming unit assay is proportional to the electrical energy applied (ANOVA P<0.05). We further verify that the treatment efficacy varies linearly with the energy of the BE treatment (r2 =0.984). Our results thus suggest that the energy of the electrical signal is the primary factor in determining the efficacy of the BE treatment, at potentials less than the media electrolysis voltage. Conclusions: Our results demonstrate that the energy of the electrical signal, and not the type of electrical signal (AC or DC or SP), is the key to determine the efficacy of the BE treatment. We anticipate that this observation will pave the way for further understanding of the mechanism of action of the BE treatment method and may

Efficacy and safety of leflunomide for the treatment of BK virus-associated hemorrhagic cystitis in allogeneic hematopoietic stem cell transplantation recipients.

PubMed

Chen, Xin-Chuan; Liu, Ting; Li, Jian-Jun; He, Chuan; Meng, Weng-Tong; Huang, Rui

2013-01-01

BK virus-associated hemorrhagic cystitis (BKV-HC) is a severe complication after allogeneic hematopoietic stem cell transplantation. So far, no specific antiviral drug with proven efficacy has been approved for treating BKV-HC. Leflunomide is an immunosuppressive drug with antiviral activity and has been used in treating BKV-associated nephropathy after renal transplantation. This is the first report on the efficacy and safety of leflunomide in the treatment of BKV-HC. From January 2006 to January 2009, 89 patients received allogeneic hematopoietic stem cell transplantation, and among them, 18 patients were identified as having BKV-HC, with a 20% cumulative incidence. Fourteen patients were treated with oral leflunomide. Three days of 100 mg/day leflunomide was used as loading doses and followed by maintenance doses of 20 mg/day. The urinary BKV-DNA load was monitored weekly by real-time quantitative PCR. The efficacy was evaluated on day 20 after leflunomide treatment. Seven patients (50%) achieved complete remission, 5 patients (35.7%) achieved partial remission, and 2 patients (14.3%) had more than a 1-log reduction in urinary BKV-DNA loads after treatment. During the leflunomide treatment, the graft-versus-host disease of the patients did not progress, and the dosages of the immunosuppressant were reduced simultaneously. One patient discontinued treatment because of intolerable gastrointestinal symptoms. Neutropenia occurred in 2 cases. These preliminary data suggest that leflunomide may be a potentially effective medication for treating BKV-HC without significant toxicity, but evidence supporting its use requires randomized controlled trials. Copyright © 2013 S. Karger AG, Basel.

The Efficacy and Safety of Azelaic Acid 15% Foam in the Treatment of Truncal Acne Vulgaris.

PubMed

Hoffman, Lauren K; Del Rosso, James Q; Kircik, Leon H

2017-06-01

INTRODUCTION: Truncal acne is often associated with facial acne, but there are fewer options for an effective topical treatment on the trunk. Given the advent of foam formulations with enhanced percutaneous absorption and convenient application due to easy spreadability on skin, the previously held idea that effective treatment of truncal acne requires oral treatment is challenged. Azelaic acid cream has been previously approved for acne vulgaris, thus azelaic acid foam may be a viable treatment option for truncal acne.

STUDY DESIGN: A single-center, open label pilot study was conducted to investigate the efficacy and safety of azelaic acid 15% foam as a treatment modality for moderate truncal acne. Use for facial acne was also allowed and monitored during the study.

RESULTS: Twice-daily application of azelaic acid 15% foam to affected areas resulted in a 1-grade reduction in truncal investigator global assessment (IGA) scores in nearly all patients (16/18). Eight out of 18 patients (44%) were rated as Clear or Almost Clear in the trunk by the end of the study. There were also improvements in facial IGA scores; 9 of 18 patients (50%) exhibited a 1-grade improvement in IGA scores and 11 of 18 were Clear or Almost Clear by the end of the study. A significant reduction in lesion counts was found throughout the study and the medication was well tolerated.

CONCUSION: Azelaic acid 15% foam was effective in treating moderate truncal acne and facial acne in this pilot study. Given the efficacy and convenience of the foam vehicle, azelaic acid may be considered as a viable option for treatment of acne vulgaris, including on the trunk. Further studies are suggested in a larger population of patients, including adult females with acne.

J Drugs Dermatol. 2017;16(6):534-538.

Levofloxacin efficacy in the treatment of community-acquired legionellosis.

PubMed

Yu, Victor L; Greenberg, Richard N; Zadeikis, Neringa; Stout, Janet E; Khashab, Mohammed M; Olson, William H; Tennenberg, Alan M

2004-06-01

Although fluoroquinolones possess excellent in vitro activity against Legionella, few large-scale clinical trials have examined their efficacy in the treatment of Legionnaires disease. Even fewer studies have applied rigorous criteria for diagnosis of community-acquired Legionnaires disease, including culture of respiratory secretions on selective media. Data from six clinical trials encompassing 1,997 total patients have been analyzed to determine the efficacy of levofloxacin (500 mg qd or 750 mg qd) in treating patients with community-acquired pneumonia (CAP) due to Legionella. Of the 1,997 total patients with CAP from the clinical trials, 75 patients had infection with a Legionella species. Demographics showed a large portion of these patients were < 55 years of age and nonsmokers. More than 90% of mild-to-moderate and severe cases of Legionella infection resolved clinically at the posttherapy visit, 2 to 14 days after treatment termination. No deaths were reported for any patient with Legionnaires disease treated with levofloxacin during the studies. Levofloxacin was efficacious at both 500 mg for 7 to 14 days and 750 mg for 5 days. Legionnaires disease is not associated only with smokers, the elderly, and the immunosuppressed, but also has the potential to affect a broader demographic range of the general population than previously thought.

7 CFR 305.4 - Monitoring and certification of treatments.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 5 2012-01-01 2012-01-01 false Monitoring and certification of treatments. 305.4 Section 305.4 Agriculture Regulations of the Department of Agriculture (Continued) ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE PHYTOSANITARY TREATMENTS § 305.4 Monitoring and certification...

7 CFR 305.3 - Monitoring and certification of treatments.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 5 2010-01-01 2010-01-01 false Monitoring and certification of treatments. 305.3 Section 305.3 Agriculture Regulations of the Department of Agriculture (Continued) ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE PHYTOSANITARY TREATMENTS § 305.3 Monitoring and certification...

Safety and Efficacy of Liposomal Cytarabine in the Treatment of Neoplastic Meningitis.

PubMed

Jahn, Franziska; Jordan, Karin; Behlendorf, Timo; Globig, Cordula; Schmoll, Hans-Joachim; Müller-Tidow, Carsten; Jordan, Berit

2015-01-01

Although rare, neoplastic meningitis (NM) has been increasingly observed in patients with cancer due to the prolonged course of the disease. Intrathecal chemotherapy with methotrexate or cytarabine with repeating injection schedules of 2-3 times per week is currently the mainstay of treatment. An efficacious and comfortable treatment alternative might be represented by liposomal cytarabine. In this retrospective study, we reviewed all patients with NM due to solid tumors or hematological malignancies treated with liposomal cytarabine at our institution between March 2004 and September 2011. The primary endpoint was treatment response, which was defined as improvement in neurological symptoms and/or conversion of the initial cerebrospinal fluid cytology and/or response in the radiological findings. The main secondary endpoint was safety. Fifty-one adult patients were evaluable for safety and 44 patients for efficacy. In 36 patients (81.8%), a treatment response was achieved. The median overall survival after diagnosis of NM was 11 months (95% confidence interval 8.8-13.2). Adverse events grade 1-4 occurred in 31 patients (60.8%), whereas grade 3-4 occurred in 18 patients (35.3%). The encouraging efficacy and safety data obtained in our analysis and the convenient administration schedule make intrathecal liposomal cytarabine a favorable treatment option for NM patients.

Efficacy of Curcuma for Treatment of Osteoarthritis.

PubMed

Perkins, Kimberly; Sahy, William; Beckett, Robert D

2017-01-01

The objective of this review is to identify, summarize, and evaluate clinical trials to determine the efficacy of curcuma in the treatment of osteoarthritis. A literature search for interventional studies assessing efficacy of curcuma was performed, resulting in 8 clinical trials. Studies have investigated the effect of curcuma on pain, stiffness, and functionality in patients with knee osteoarthritis. Curcuma-containing products consistently demonstrated statistically significant improvement in osteoarthritis-related endpoints compared with placebo, with one exception. When compared with active control, curcuma-containing products were similar to nonsteroidal anti-inflammatory drugs, and potentially to glucosamine. While statistical significant differences in outcomes were reported in a majority of studies, the small magnitude of effect and presence of major study limitations hinder application of these results. Further rigorous studies are needed prior to recommending curcuma as an effective alternative therapy for knee osteoarthritis. © The Author(s) 2016.

Chronomodulation of topotecan or X-radiation treatment increases treatment efficacy without enhancing acute toxicity.

PubMed

Mullins, Dana; Proulx, Denise; Saoudi, A; Ng, Cheng E

2005-05-01

Topotecan (TPT), a camptothecin analog, is currently used to treat human ovarian and small-cell lung cancer and is in clinical trials for other tumor sites. However, it is unknown whether chronomodulation of TPT treatment is beneficial. We examined the effects of administering TPT or X-radiation (XR) alone at different times of the day or night. We treated mice bearing human colorectal tumor xenografts at four different times representing the early rest period (9 am or 3 HALO [hours after light onset]), late rest period (3 pm or 9 HALO), early active period (9 pm or 15 HALO), and late active period (3 am or 21 HALO) of the mice. We gave either TPT (12 mg/kg, injected i.p.) or XR (4 Gy, directed to the tumor) twice weekly on Days 0, 4, 7, 10 within 2 weeks. Treatment with either TPT or XR at 3 am demonstrated the greatest efficacy (measured by a tumor regrowth assay) without significantly increasing acute toxicity (assessed by a decrease in leukocyte counts or body weight). Conversely, treatment at 3 pm, in particular, showed increased toxicity without any enhanced efficacy. Our study provided the first evidence that chronomodulation of TPT treatments, consistent with the findings of other camptothecin analogs, is potentially clinically beneficial. Additionally, our findings suggest that chronomodulation of fractionated XR treatments is also potentially clinically beneficial.

[Mentalization-Based Treatment for Adolescents with Borderline Personality Disorder - Concept and Efficacy].

PubMed

Taubner, Svenja; Volkert, Jana; Gablonski, Thorsten-Christian; Rossouw, Trudie

2017-07-01

Mentalization-Based Treatment for Adolescents with Borderline Personality Disorder - Concept and Efficacy In recent years, the concept of mentalization has become increasingly important in practice and research. It describes the imaginative ability to understand human behavior in terms of mental states. Mentalization is a central component to understand the etiology and to treat patients with borderline personality disorder (BPD). Both adult and adolescent patients with BPD have limited mentalization abilities, which can be reliably assessed using the Reflective Functioning Scale. Mentalization-Based Treatment (MBT) was originally developed as an integrative approach for the treatment of adult patients with BPD. It is a manualized psychotherapy with psychodynamic roots with the aim to increase mentalizing abilities of patients. Since then, MBT has been further developed for other mental disorders as well as for the treatment of different age groups. One of these developments is MBT for Adolescents (MBT-A). MBT-A includes both individual as well as family sessions and the average duration of therapy is about twelve months. MBT-A can be applied in inpatient and outpatient settings and aims to improve mentalizing abilities in emotionally important relationships and the whole family system. First studies have found evidence for the efficacy of MBT-A. A randomized controlled trial (RCT) is currently being carried out to evaluate the efficacy of MBT-A for adolescents with conduct disorder. However, further evidence for efficacy and further conceptual development is needed.

Efficacy of artesunate + sulphadoxine/pyrimethamine and artemether + lumefantrine and dhfr and dhps mutations in Somalia: evidence for updating the malaria treatment policy.

PubMed

Warsame, Marian; Hassan, Abdikarim Hussein; Hassan, Abdillahi Mohamed; Arale, Abdulkadir Mohamed; Jibril, Ali Mohamed; Mohamud, Said Abdulkadir; Barrette, Amy; Muse, Abdikarim Yusuf; Yusuf, Fahmi Essa; Nada, Rania A; Amran, Jamal Ghilan Hefzullah

2017-04-01

To determine the therapeutic efficacy of artesunate + sulphadoxine/pyrimethamine (AS + SP) and artemether + lumefantrine (AL), and to investigate the presence of molecular mutations associated with resistance, to inform national malaria treatment policy. One-arm prospective studies were conducted in three study sites in Somalia in 2013 and 2015 to evaluate the efficacy of AS + SP and AL among patients with uncomplicated falciparum malaria. Outcomes included clinical and parasitological response over 28 days, and the presence of dihydrofolate reductase (dfhr) and dihydropteroate synthase (dhps) and mutations. Among patients treated with AS + SP, the PCR-corrected treatment failure rate was 12.3%. The majority of patients (89%) carried either the quintuple mutations (51I/108N + 437G/540E/581G or 51I/59R/108N + 437G/540E) or the quadruple mutation (51I/108N + 437G/540E). All patients who failed treatment with AS + SP carried the quintuple mutation (51I/108N + 437G/540E/581G). In the studies of AL, the PCR-corrected treatment failure rate was <6%. All patients in both treatment groups cleared their parasitaemia by day 3. The findings demonstrate a failing first-line treatment (AS + SP), with a failure rate above the threshold (10%) for policy change, and a high prevalence of quintuple mutations. In contrast, AL was highly efficacious. Based on these findings and the results from a previous AS + SP study, AL was selected to replace AS + SP as the first-line treatment for uncomplicated malaria in Somalia in 2016. Dihydroartemisinin + piperaquine (DHA + PPQ) has been recommended as the second-line treatment. Routine monitoring of recommended ACTs should continue to inform treatment policy. © 2017 John Wiley & Sons Ltd.

A miniature, wearable activity/fall monitor to assess the efficacy of mobility therapy for children with cerebral palsy during everyday living.

PubMed

Smith, Warren D; Bagley, Anita

2010-01-01

Children with cerebral palsy may have difficulty walking and may fall frequently, resulting in a decrease in their participation in school and community activities. It is desirable to assess the effectiveness of mobility therapies for these children on their functioning during everyday living. Over 50 hours of tri-axial accelerometer and digital video recordings from 35 children with cerebral palsy and 51 typically-developing children were analyzed to develop algorithms for automatic real-time processing of the accelerometer signals to monitor a child's level of activity and to detect falls. The present fall-detection algorithm has 100% specificity and a sensitivity of 100% for falls involving trunk rotation. Sensitivities for drops to the knees and to the bottom are 72% and 78%, respectively. The activity and fall-detection algorithms were implemented in a miniature, battery-powered microcontroller-based activity/fall monitor that the child wears in a small fanny pack during everyday living. The monitor continuously logs 1-min. activity levels and the occurrence and characteristics of each fall for two-week recording sessions. Pre-therapy and post-therapy recordings from these monitors will be used to assess the efficacies of alternative treatments for gait abnormalities.

Heroin refusal self-efficacy and preference for medication-assisted treatment after inpatient detoxification.

PubMed

Kenney, Shannon R; Bailey, Genie L; Anderson, Bradley J; Stein, Michael D

2017-10-01

An individual's self-efficacy to refuse using heroin in high-risk situations is believed to minimize the likelihood for relapse. However, among individuals completing inpatient heroin detoxification, perceived refusal self-efficacy may also reduce one's perceived need for medication-assisted treatment (MAT), an effective and recommended treatment for opioid use disorder. In the current study, we examined the relationship between heroin refusal self-efficacy and preference for MAT following inpatient detoxification. Participants (N=397) were interviewed at the start of brief inpatient opioid detoxification. Multiple logistic regression was used to estimate the adjusted association of background characteristics, depressed mood, and perceived heroin refusal self-efficacy with preference for MAT. Controlling for other covariates, depressed mood and lower perceived refusal self-efficacy were associated with a significantly greater likelihood of expressing preference for MAT (versus no MAT). Perceived ability to refuse heroin after leaving detox is inversely associated with a heroin user's desire for MAT. An effective continuum of care model may benefit from greater attention to patient's perceived refusal self-efficacy during detoxification which may impact preference for MAT and long-term recovery. Copyright © 2017. Published by Elsevier Ltd.

Multidisciplinary evaluation at baseline and during treatment improves the rate of compliance and efficacy of deferasirox in elderly myelodysplastic patients.

PubMed

Del Corso, Lisette; Biale, Lucia; Parodi, Emanuele Luigi; Russo, Rodolfo; Filiberti, Rosa; Arboscello, Eleonora

2017-04-01

Deferasirox (DFX) is used to reduce iron levels in patients with myelodysplastic syndrome (MDS) who develop iron overload after chronic red blood cell infusions. However, DFX can be associated with renal and gastrointestinal toxicities, which may cause treatment interruption or discontinuation. This study aimed to determine the effectiveness and safety of DFX in patients with MDS. This multicenter, retrospective, observational study was conducted at two hospitals in Italy. Elderly patients with transfusion-dependent MDS received DFX for up to 12 months and were divided into two groups: group A comprised patients who were not under multidisciplinary assessment; group B comprised patients under multidisciplinary control. Treatment effectiveness was estimated by monitoring the serum ferritin (SF) levels throughout the study. Any treatment-related adverse events (AEs), clinically relevant analytical alterations, and reasons for treatment discontinuation were monitored. The study included 44 patients (13 female, 31 male; median age 77.0 years). At 3 months, SF levels decreased by ≥20 % in 29 and 31 % of patients in groups A and B, respectively, in 17 and 36 % of patients at 6 months, and in 22 and 58 % at 12 months. The most common AEs were diarrhea and increased serum creatinine, which were more frequent in group A. The discontinuation rate after renal AE was 15 and 5 % in groups A and B, respectively. Multidisciplinary evaluation can be an effective strategy for monitoring renal function in patients on DFX therapy, to improve treatment adherence and overall efficacy in elderly patients with MDS.

Monitoring tumor growth and treatment in small animals with magnetic resonance and optical tomographic imaging

NASA Astrophysics Data System (ADS)

Masciotti, J.; Provenzano, F.; Papa, J.; Klose, A.; Hur, J.; Gu, X.; Yamashiro, D.; Kandel, J.; Hielscher, A. H.

2006-02-01

Small animal models are employed to simulate disease in humans and to study its progression, what factors are important to the disease process, and to study the disease treatment. Biomedical imaging modalities such as magnetic resonance imaging (MRI) and Optical Tomography make it possible to non-invasively monitor the progression of diseases in living small animals and study the efficacy of drugs and treatment protocols. MRI is an established imaging modality capable of obtaining high resolution anatomical images and along with contrast agents allow the studying of blood volume. Optical tomography, on the other hand, is an emerging imaging modality, which, while much lower in spatial resolution, can separate the effects of oxyhemoglobin, deoxyhemoglobin, and blood volume with high temporal resolution. In this study we apply these modalities to imaging the growth of kidney tumors and then there treatment by an anti-VEGF agent. We illustrate how these imaging modalities have their individual uses, but can still supplement each other and cross validation can be performed.

AUTOMATED MONITORING OF WASTEWATER TREATMENT EFFICIENCY - PHASE I

EPA Science Inventory

Efficacy of an Emotion-Focused Treatment for Prolonged Fatigue

ERIC Educational Resources Information Center

Schutte, Nicola S.; Malouff, John M.; Brown, Rhonda F.

2008-01-01

Previous research findings have suggested a relationship between less adaptive emotional functioning and fatigue. The present study used a research design involving multiple baselines across participants to evaluate the efficacy of a new emotion-focused treatment for prolonged fatigue delivered in a cognitive behavioral therapy framework. The 13…

Efficacy of a Self-Help Treatment for At-Risk and Pathological Gamblers.

PubMed

Boudreault, Catherine; Giroux, Isabelle; Jacques, Christian; Goulet, Annie; Simoneau, Hélène; Ladouceur, Robert

2018-06-01

Available evidence suggests that self-help treatments may reduce problem gambling severity but inconsistencies of results across clinical trials leave the extent of their benefits unclear. Moreover, no self-help treatment has yet been validated within a French Canadian setting. The current study therefore assesses the efficacy of a French language self-help treatment including three motivational telephone interviews spread over an 11-week period and a cognitive-behavioral self-help workbook. At-risk and pathological gamblers were randomly assigned to the treatment group (n = 31) or the waiting list (n = 31). Relative to the waiting list, the treatment group showed a statistically significant reduction in the number of DSM-5 gambling disorder criteria met, gambling habits, and gambling consequences at Week 11. Perceived self-efficacy and life satisfaction also significantly improved after 11 weeks for the treatment group, but not for the waiting list group. At Week 11, 13% of participants had dropped out of the study. All significant changes reported for the treatment group were maintained throughout 1, 6 and 12-month follow-ups. Results support the efficacy of the self-help treatment to reduce problem gambling severity, gambling behaviour and to improve overall functioning among a sample of French Canadian problem gamblers over short, medium and long term. Findings from this study lend support to the appropriateness of self-help treatments for problem gamblers and help clarify inconsistencies found in the literature. The low dropout rate is discussed with respect to the advantages of the self-help format. Clinical and methodological implications of the results are put forth.

Percutaneous ethanol injection treatment in benign thyroid lesions: role and efficacy.

PubMed

Guglielmi, Rinaldo; Pacella, Claudio Maurizio; Bianchini, Antonio; Bizzarri, Giancarlo; Rinaldi, Roberta; Graziano, Filomena Maria; Petrucci, Lucilla; Toscano, Vincenzo; Palma, Enzo; Poggi, Maurizio; Papini, Enrico

2004-02-01

To establish the role of percutaneous ethanol injection (PEI) treatment in benign thyroid lesions by evaluating: (1) the long-term efficacy and side effects of the treatment, (2) the factors predictive of efficacy of PEI, and (3) the cost effectiveness of the procedure. Fifty-eight recurrent cystic nodules, 95 autonomously functioning nodules (AFTN), and 17 hyperfunctioning nodules causing thyrotoxicosis (toxic nodules) were treated by PEI from 1990 to 1996 in our center. Ultrasound (US) and color flow doppler (CFD) examinations were carried out before and after each treatment. In patients with AFTN, serum thyrotropin (TSH), free triiodothyronine (FT3), free thyroxine (FT4), thyroid peroxidase antibody (TPOAb) levels were tested before and after PEI. All patients were independently reexamined by two external reviewers after a minimum follow-up of 5 years (median, 6.9 years). The median number of treatments was 2.0 (range, 1.0-4.0) for cystic nodules, 4 (range, 2.0-6.0) for AFTN, and 5 (range, 3.0-7.0) for toxic nodules. At the 5-year evaluation cystic nodules showed a volume reduction greater than 75% versus baseline in 86.2% of cases and an improvement of local symptoms in 91.4% of cases. AFTN presented serum TSH within normal limits in 60.0% of patients. Toxic nodules showed a detectable serum TSH and normal FT3 and FT4 values in 35.3% of cases. Two cases of transient dysphonia were observed. In cystic lesions no significant correlation was found between the baseline and the final volume (r2 = 0.17) and no significant predictor of treatment efficacy was found. However, unilocularity was associated with a lower number of treatments than multilocularity (median, 2.0 vs. 3.0). Independent predictors of clinical efficacy in both AFTN and toxic nodules were a baseline volume less than 5.0 mL and a fluid component greater than 30% (odds ratio [OR] = 6.1 and 3.3, respectively). Most recurrent cystic lesions of the thyroid can be cured by PEI, which should become the

The Contribution of School-Related Parental Monitoring, Self-Determination, and Self-Efficacy to Academic Achievement

ERIC Educational Resources Information Center

Affuso, Gaetana; Bacchini, Dario; Miranda, Maria Concetta

2017-01-01

The aim of this study was to examine the contribution of school-related parental monitoring (SR-PM), self-determined motivation, and academic self-efficacy to academic achievement across time. The authors hypothesized that SR-PM would affect academic achievement indirectly via its effects on self-determined motivation and academic self-efficacy…

The Efficacy of Coerced Treatment for Offenders: An Evaluation of Two Residential Forensic Drug and Alcohol Treatment Programs.

ERIC Educational Resources Information Center

Baird, Francis X.; Frankel, Arthur J.

2001-01-01

Reviews the history of community-based treatment for offenders with drug and alcohol addiction. Describes the treatment regimen in two residential programs for offenders with drug and alcohol problems, including a description of the components of the residential treatment model utilized in these two programs. Findings support the efficacy of…

A Comprehensive Comparison of the Efficacy and Tolerability of Racecadotril with Other Treatments of Acute Diarrhea in Adults

PubMed Central

Fischbach, Wolfgang; Andresen, Viola; Eberlin, Marion; Mueck, Tobias; Layer, Peter

2016-01-01

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. The 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 S. 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 S. 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. PMID:27790616

Salicylic acid for the treatment of melasma: new acquisitions for monitoring the clinical improvement.

PubMed

Fabbrocini, Gabriella; De Vita, Valerio; Marasca, Claudio; Palmisano, Franco; Monfrecola, Giuseppe

2013-11-01

The Melasma Area and Severity Index (MASI) and the Melasma Severity Score (MSS) are calculated on the basis of only a subjective clinical assessment. This raises the need to have an objective score, uniform in the evaluation by different clinicians. The purpose of this study was to establish if the images by Canfield Reveal Imager can be correlated to MASI score to better evaluate the clinical efficacy of salicylic acid 33% peeling in the treatment of melasma respect to the clinical observation. The study was a voluntary observational study. Twenty female patients affected with melasma, aged between 30 and 60 years, were included in the study. Treatment with salicylic acid 33% was performed once a month, for a total of four times. The dermatologist (Doc A) examined each patient's melasma areas using MASI score, at the face-to-face observation and at Reveal images evaluation during the first (T0) and the end point time (T4). Digital photographs were also evaluated by another experienced dermatologist (Doc B), who has never seen clinically the patients before and who evaluated MASI score by Reveal images at time T0 and T4. Student's t-test and linear regression test were performed, showing statistically significant values comparing MASI score obtained by digital photo and MASI score obtained clinically. The monitoring of the improvement by Reveal images can optimize the treatment approach and the efficacy of same dermocosmetics procedures can be revised following standard criteria. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

High degree of efficacy in the treatment of cyclic vomiting syndrome with combined co-enzyme Q10, L-carnitine and amitriptyline, a case series

PubMed Central

2011-01-01

Background Cyclic vomiting syndrome (CVS), defined by recurrent stereotypical episodes of nausea and vomiting, is a relatively-common disabling and historically difficult-to-treat condition associated with migraine headache and mitochondrial dysfunction. Limited data suggests that the anti-migraine therapies amitriptyline and cyproheptadine, and the mitochondrial-targeted cofactors co-enzyme Q10 and L-carnitine, have efficacy in episode prophylaxis. Methods A retrospective chart review of 42 patients seen by one clinician that met established CVS diagnostic criteria revealed 30 cases with available outcome data. Participants were treated on a loose protocol consisting of fasting avoidance, co-enzyme Q10 and L-carnitine, with the addition of amitriptyline (or cyproheptadine in those < 5 years) in refractory cases. Blood level monitoring of the therapeutic agents featured prominently in management. Results Vomiting episodes resolved in 23 cases, and improved by > 75% and > 50% in three and one additional case respectively. Among the three treatment failures, two could not tolerate amitriptyline (as was also the case in the child with only > 50% efficacy) and one had multiple congenital gastrointestinal anomalies. Excluding the latter case, substantial efficacy (> 75% response) was 26/29 at the start of treatment, and 26/26 in those able to tolerate the regiment, including high dosages of amitriptyline. Conclusion Our data suggest that a protocol consisting of mitochondrial-targeted cofactors (co-enzyme Q10 and L-carnitine) plus amitriptyline (or possibly cyproheptadine in preschoolers) coupled with blood level monitoring is highly effective in the prevention of vomiting episodes. PMID:21846334

PRP Treatment Efficacy for Tendinopathy: A Review of Basic Science Studies

PubMed Central

2016-01-01

Platelet-Rich Plasma (PRP) has been widely used in orthopaedic surgery and sport medicine to treat tendon injuries. However, the efficacy of PRP treatment for tendinopathy is controversial. This paper focuses on reviewing the basic science studies on PRP performed under well-controlled conditions. Both in vitro and in vivo studies describe PRP's anabolic and anti-inflammatory effects on tendons. While some clinical trials support these findings, others refute them. In this review, we discuss the effectiveness of PRP to treat tendon injuries with evidence presented in basic science studies and the potential reasons for the controversial results in clinical trials. Finally, we comment on the approaches that may be required to improve the efficacy of PRP treatment for tendinopathy. PMID:27610386

Testing the Efficacy of Theoretically Derived Improvements in the Treatment of Social Phobia

ERIC Educational Resources Information Center

Rapee, Ronald M.; Gaston, Jonathan E.; Abbott, Maree J.

2009-01-01

Recent theoretical models of social phobia suggest that targeting several specific cognitive factors in treatment should enhance treatment efficacy over that of more traditional skills-based treatment programs. In the current study, 195 people with social phobia were randomly allocated to 1 of 3 treatments: standard cognitive restructuring plus in…

An optical microfluidic platform for spatiotemporal biofilm treatment monitoring

NASA Astrophysics Data System (ADS)

Kim, Young Wook; Mosteller, Matthew P.; Subramanian, Sowmya; Meyer, Mariana T.; Bentley, William E.; Ghodssi, Reza

2016-01-01

Bacterial biofilms constitute in excess of 65% of clinical microbial infections, with the antibiotic treatment of biofilm infections posing a unique challenge due to their high antibiotic tolerance. Recent studies performed in our group have demonstrated that a bioelectric effect featuring low-intensity electric signals combined with antibiotics can significantly improve the efficacy of biofilm treatment. In this work, we demonstrate the bioelectric effect using sub-micron thick planar electrodes in a microfluidic device. This is critical in efforts to develop microsystems for clinical biofilm infection management, including both in vivo and in vitro applications. Adaptation of the method to the microscale, for example, can enable the development of localized biofilm infection treatment using microfabricated medical devices, while augmenting existing capabilities to perform biofilm management beyond the clinical realm. Furthermore, due to scale-down of the system, the voltage requirement for inducing the electric field is reduced further below the media electrolysis threshold. Enhanced biofilm treatment using the bioelectric effect in the developed microfluidic device elicited a 56% greater reduction in viable cell density and 26% further decrease in biomass growth compared to traditional antibiotic therapy. This biofilm treatment efficacy, demonstrated in a micro-scale device and utilizing biocompatible voltage ranges, encourages the use of this method for future clinical biofilm treatment applications.

Monitoring blood flow and photobleaching during topical ALA PDT treatment

NASA Astrophysics Data System (ADS)

Sands, Theresa L.; Sunar, Ulas; Foster, Thomas H.; Oseroff, Allan R.

2009-02-01

Photodynamic therapy (PDT) using topical aminolevulinic acid (ALA) is currently used as a clinical treatment for nonmelanoma skin cancers. In order to optimize PDT treatment, vascular shutdown early in treatment must be identified and prevented. This is especially important for topical ALA PDT where vascular shutdown is only temporary and is not a primary method of cell death. Shutdown in vasculature would limit the delivery of oxygen which is necessary for effective PDT treatment. Diffuse correlation spectroscopy (DCS) was used to monitor relative blood flow changes in Balb/C mice undergoing PDT at fluence rates of 10mW/cm2 and 75mW/cm2 for colon-26 tumors implanted intradermally. DCS is a preferable method to monitor the blood flow during PDT of lesions due to its ability to be used noninvasively throughout treatment, returning data from differing depths of tissue. Photobleaching of the photosensitizer was also monitored during treatment as an indirect manner of monitoring singlet oxygen production. In this paper, we show the conditions that cause vascular shutdown in our tumor model and its effects on the photobleaching rate.

Comparative efficacy and safety of mavacoxib and carprofen in the treatment of canine osteoarthritis

PubMed Central

Payne-Johnson, M; Becskei, C; Chaudhry, Y; Stegemann, M R

2015-01-01

A multi-site, masked, randomised parallel group study employing a double dummy treatment design was performed in canine veterinary patients to determine the comparative efficacy and safety of mavacoxib and carprofen in the treatment of pain and inflammation associated with osteoarthritis for a period of 134 days. Treatments were administered according to their respective summaries of product characteristics. Of 139 dogs screened, 124 were suitable for study participation: 62 of which were dosed with mavacoxib and 62 with carprofen. Both treatments resulted in a very similar pattern of considerable improvement as indicated in all parameters assessed by both owner and veterinarian. The primary efficacy endpoint ‘overall improvement’ was a composite score of owner assessments after approximately six weeks of treatment. Both drugs were remarkably effective, with 57/61 (93.4 per cent) of mavacoxib-treated dogs and 49/55 (89.1 per cent) of carprofen-treated dogs demonstrating overall improvement and with mavacoxib's efficacy being non-inferior to carprofen. The treatments had a similar safety profile as evidenced by documented adverse events and summaries of clinical pathology parameters. The positive clinical response to treatment along with the safety and dosing regimen of mavacoxib makes it an attractive therapy for canine osteoarthritis. PMID:25433056

Comparative efficacy and safety of mavacoxib and carprofen in the treatment of canine osteoarthritis.

PubMed

Payne-Johnson, M; Becskei, C; Chaudhry, Y; Stegemann, M R

2015-03-14

A multi-site, masked, randomised parallel group study employing a double dummy treatment design was performed in canine veterinary patients to determine the comparative efficacy and safety of mavacoxib and carprofen in the treatment of pain and inflammation associated with osteoarthritis for a period of 134 days. Treatments were administered according to their respective summaries of product characteristics. Of 139 dogs screened, 124 were suitable for study participation: 62 of which were dosed with mavacoxib and 62 with carprofen. Both treatments resulted in a very similar pattern of considerable improvement as indicated in all parameters assessed by both owner and veterinarian. The primary efficacy endpoint 'overall improvement' was a composite score of owner assessments after approximately six weeks of treatment. Both drugs were remarkably effective, with 57/61 (93.4 per cent) of mavacoxib-treated dogs and 49/55 (89.1 per cent) of carprofen-treated dogs demonstrating overall improvement and with mavacoxib's efficacy being non-inferior to carprofen. The treatments had a similar safety profile as evidenced by documented adverse events and summaries of clinical pathology parameters. The positive clinical response to treatment along with the safety and dosing regimen of mavacoxib makes it an attractive therapy for canine osteoarthritis. British Veterinary Association.

[Successful cyclosporine treatment in 2 patients with refractory CIDP, involving monitoring of both AUC(0-4h) and trough levels].

PubMed

Takeuchi, Akiko; Shirai, Shinichi; Horiuchi, Kazuhiro; Takahashi, Ikuko; Matsushima, Masaaki; Hirotani, Makoto; Kano, Takahiro; Yabe, Ichiro; Matumoto, Akihisa; Sasaki, Hidenao

2012-01-01

Cyclosporine A (CYA) treatment has been reported to be probably useful for patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) that is resistant to conventional treatment. Although several studies have shown that appropriate area under the concentration-time curve (AUC) monitoring of CYA levels results in improved outcomes for refractory nephrotic syndrome patients, the importance of using AUC analysis for CIDP remains unclear. In this study, we measured both trough and AUC from 0 to 4 h (AUC(0-4 h)) levels of CYA in 2 patients with CIDP and compared the findings for the clinical parameters. On the basis of the CYA dosing recommendations for patients with nephrotic syndrome, we used a CYA concentration of 150 ng/ml for the trough level and an AUC(0-4 h) value of 2,500 ng/(ml·h). Patient 1 showed a significant increase in grip strength and a prolonged remission period. Patient 2 showed improvement in the modified Rankin scale and manual muscle test (MMT) scores. Monitoring both AUC(0-4 h) and trough levels of CYA seems to be a better option than monitoring the trough level alone because it leads to improved estimation of the efficacy and safety of CYA treatment in the case of CIDP patients.

Urinary incontinence at orgasm: relation to detrusor overactivity and treatment efficacy.

PubMed

Serati, Maurizio; Salvatore, Stefano; Uccella, Stefano; Cromi, Antonella; Khullar, Vik; Cardozo, Linda; Bolis, Pierfrancesco

2008-10-01

To understand the pathophysiological mechanism of incontinence during orgasm and to compare women affected by symptomatic detrusor overactivity (DO) with and without incontinence at orgasm in terms of efficacy of antimuscarinic treatment. All consecutive sexually active women with incontinence during intercourse were prospectively included and divided into two groups: women with coital incontinence at orgasm or at penetration. The two forms of coital incontinence were correlated to the urodynamic finding of DO. Women complaining of overactive bladder (OAB) symptoms, with urinary incontinence at orgasm and urodynamically proven DO (cases), were prescribed tolterodine 4 mg extended release for at least 12 wk. The cases were compared in terms of efficacy of treatment on OAB symptoms to consecutive patients with symptomatic DO without coital incontinence (control group). Among the 1133 women who underwent urodynamic testings during the study period, 132 patients were eligible for final analysis. A significant difference in DO was observed in women with incontinence at orgasm (34 of 49; 69.4%) compared with women with incontinence during penetration (24 of 83; 28.9%) (p<0.0001). The 34 women with incontinence at orgasm associated with DO were given antimuscarinics treatment and were compared with 53 controls. Fourteen of 34 (41.2%) and 9 of 53 (17%) women did not respond to antimuscarinics in the cases and in the control group, respectively (p=0.023). Incontinence at orgasm is associated with DO in the majority of cases. This is the first study showing an inferior efficacy of antimuscarinic treatment in women with DO complaining of incontinence at orgasm.

INVESTIGATING THE EFFICACY OF CLINICAL TRIAL MONITORING STRATEGIES: Design and Implementation of the Cluster Randomized START Monitoring Substudy

PubMed Central

Hullsiek, Katherine Huppler; Kagan, Jonathan M; Engen, Nicole; Grarup, Jesper; Hudson, Fleur; Denning, Eileen T; Carey, Catherine; Courtney-Rodgers, David; Finley, Elizabeth B; Jansson, Per O; Pearson, Mary T; Peavy, Dwight E; Belloso, Waldo H

2014-01-01

Background Trial monitoring protects participant safety and study integrity. While monitors commonly go on-site to verify source data, there is little evidence that this practice is efficient or effective. An ongoing international HIV treatment trial (START) provides an opportunity to explore the usefulness of different monitoring approaches. Methods All START sites are centrally monitored and required to follow a local monitoring plan requiring specific quality assurance activities. Additionally, sites were randomized (1:1) to receive, or not receive, annual on-site monitoring. The study will determine if on-site monitoring increases the identification of major protocol deviations (eligibility or consent violations, improper study drug use, primary or serious event underreporting, data alteration or fraud). Results The START study completed enrollment in December 2013, with planned follow-up through December 2016. The monitoring study is ongoing at 196 sites in 34 countries. Results are expected when the START study concludes in December 2016. PMID:25973346

[Assessment of antibacterial efficacy of ozone therapy in treatment of caries at the white spot stage].

PubMed

Makeeva, I M; Turkina, A Yu; Margaryan, E G; Paramonov, Yu O; Polyakova, M A

Effect on cariogenic flora is the key toremineralizing therapy efficacy in treatment of initial caries (at the white spot stage). Ozone in dentistry is used as a highly effective antibacterial agent. Treatment of white spot lesions with the ozone-air mixture leads to significant increase of efficacy in non-invasive treatment of initial caries. clinical and microbiological assessment of antibacterial efficacy of ozone therapy in treatment of caries at the white spot stage. The trial recruited 86 patients for non-invasive treatment of caries at the white spot stage which included the complex of professional oral hygiene, medicamental treatment of white spot lesions with hydrogen peroxide 3% and chlorhexidinedigluconate 0,2%, treatment with the ozone-air mixture and application of hydroxyapatite Са2+. Material for microbiological study was received before the treatment, after the complex of professional oral hygiene and medicamental treatment of white spot lesions conducted as well as after the treatment with the ozone-air mixture. Before the treatment up to 16 kinds of microorganisms on the surface of white spot lesion were detected with the following shares: S. mutans (19.9%), S. salivarius (15.1%), S. epidermidis (8.7%), S. mitis (6.5%), Lactobacillus (6.5%) and different kinds of staphylococci (10.8%). After the complex of professional oral hygiene and medicamental treatment conducted decrease in number of cariogenic microorganisms was indicated as follows: S. mutans - from 1·105 to 1·104, S. salivarius - from 1·107 to 1·106, S. epidermidis - from 1·105 to 1·104, S. mitis - from 1·104 to 1·103, Lactobacillus - from 1·104 tо 1·103. After the treatment of tooth enamel with the ozone-air mixture increase in microorganisms was not observed. The efficacy of ozone on cariogenic microorganisms exceeds significantly the efficacy of 3% hydrogen peroxide and 0,2% chlorhexidinedigluconate. It is strongly advisable to include ozone in protocol of non

Possible biomarkers modulating haloperidol efficacy and/or tolerability.

PubMed

Porcelli, Stefano; Crisafulli, Concetta; Calabrò, Marco; Serretti, Alessandro; Rujescu, Dan

2016-04-01

Haloperidol (HP) is widely used in the treatment of several forms of psychosis. Despite of its efficacy, HP use is a cause of concern for the elevated risk of adverse drug reactions. adverse drug reactions risk and HP efficacy greatly vary across subjects, indicating the involvement of several factors in HP mechanism of action. The use of biomarkers that could monitor or even predict HP treatment impact would be of extreme importance. We reviewed the elements that could potentially be used as peripheral biomarkers of HP effectiveness. Although a validated biomarker still does not exist, we underlined the several potential findings (e.g., about cytokines, HP metabolites and genotypic biomarkers) which could pave the way for future research on HP biomarkers.

[Efficacy of hyaluronic acid in the treatment of chronic gingivitis in children].

PubMed

Igić, Marija; Mihailović, Dragan; Kesić, Ljiljana; Apostolović, Mirjana; Kostadinović, Ljiljana; Janjić, Olivera Tricković; Milasin, Jelena

2011-12-01

Gingivitis is a common occurrence in children and may well be thought as a risk factor for the appearance and progression of the diseases of parodontal tissues. It is thus necessary to react in a timely and adequate fashion to prevent the disease to become serious and produce parodontopathy. The aim of the study was to establish the efficacy of hyaluronic acid in the treatment of chronic gingivitis in children. The study enrolled 130 children with permanent dentition. All of the examinees were divided into three groups: group I--50 patients with chronic gingivitis in which only the basic treatment was applied; group II--50 patients with chronic gingivitis in which hyaluronic acid was applied in addition to basic treatment; group III--30 examinees with healthy gingiva (control group). Assessment of oral hygiene and status of the gingiva and parodontium was done using the appropriate indexes before and after the treatment. Inflammation of the gingiva was monitored by way of cytomorphometric studies. The pretreatment values of the plaque index (PI) were high: in the group I PI was 1.94; in the group II PI was 1.68. After the treatment, the PI value was reduced to null in both groups (PI = 0). In the group III PI was 0.17. The bleeding index (B1) in the group I was 2.02 before and 0.32 after the treatment; the BI value in the group II was 1.74 before and 0.16 after the treatment. In the group III BI was 0. In the group I, the Community Periodontal Index of Treatment Needs (CPITN) was 1.66 before and 0.32 after the treatment; in the group II, the CPITN value was 1.5 before and 0.24 after the treatment. In the group III, the CPITN value was 0. In the group I, the size of the nuclei of the stratified squamous epithelium of the gingiva was reduced, although not so much as the nuclear size in the group II of examinees. CONCLUSION. Basic treatment is able to successfully treat chronic gingivitis in children. The use of hyaluronic acid together with the basic treatment can

[Treatment of hyperlipoidemia by xiaozhi capsule: a clinical efficacy research].

PubMed

Wang, Jian-Ping; Fan, Rui-Hong; Wang, Yan; Mei, Yan

2013-06-01

To observe the clinical effect and efficacy of Xiaozhi Capsule (XZC), a Chinese medicine preparation for tonifying Gan-Shen, invigorating Pi to dissipate dampness (TGSIPDD) on total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and endothelin (ET) in treating patients with hyperlipidemia. Totally 120 primary hyperlipidemia patients were randomly assigned to the treatment group (80 cases) and the control group (40 cases). Those in the treatment group took XZC, while those in the control group took Xuezhikang Capsule (XZKC). The serum TC, TG, HDL-C, LDL-C, and ET were detected and evaluated after 8 weeks of treatment. In the treatment group TC was reduced by 25.60%, TG by 33.70%, LDL-C by 32.90%, and ET by 11.02%, while HDL-C was elevated by 24.20%. In the control group, TC was reduced by 24.80%, TG by 33.50%, LDL-C by 31.30%, and ET by 12.05%, while HDL-C was elevated by 20.90%. There was statistical difference in the two groups when compared with before treatment (P < 0.01). But there was no statistical difference in the aforesaid indices between the two groups after treatment (P > 0.05). The integrals for main symptoms after treatment obviously decreased in the two groups, showing statistical difference when compared with before treatment in the same group (P < 0.01). But there was no statistical difference in the aforesaid indices between the two groups (P > 0.05). After 8 weeks of treatment, symptoms such as vertigo, heavy sensation of head, palpitation, chest distress, dry mouth and thirsty were obviously improved after treatment. There was statistical difference in the improvement of tinnitus after treatment in the treatment group (P < 0.01). The total effective rate was 86.25% in the treatment group and 82.50% in the control group, showing no statistical difference (P > 0.05). XZC showed certain effects on each blood lipid index and ET of hyperlipidemia patients. It had better

Electronic compliance monitoring of topical treatment after ophthalmic surgery.

PubMed

Hermann, Manuel Marcel; Ustündag, Can; Diestelhorst, Michael

2010-08-01

The success of many medical treatments is built on compliance. Electronic monitoring is the most accurate tool to quantify compliance by measuring adherence. In order to assess the efficiency of a recently introduced miniature monitoring device for eye drop application, we evaluated adherence in ophthalmic patients undergoing post-operative short-term topical treatment. This pilot study enrolled 30 outpatients (mean age 61.8 +/- 18.5 years) after cataract (n = 24) and glaucoma filtration surgery (n = 6) applying fixed-combination eye drops containing prednisolone and gentamicin five times daily for 2 weeks. Patients received eye drops in conventional bottles each equipped with a miniature monitoring device recording events of application. Two patients failed to bring back the monitoring device; therefore data collected from only 28 patients could be examined. Data showed highly variable results with a mean dose compliance of 50.2%. Dose compliance was below 25% in approximately one out of five patients. Four cataract patients, but no glaucoma patient, discontinued therapy prematurely. The observed mean dosage interval was calculated for each patient and ranged 4.6-19.7 h. Thirty percent of analysed dosage intervals exceeded 12.0 h. Different patterns of compliance behaviour-like early non-persistence, drug holiday and low treatment frequency could be identified and illustrated using electronic data. Age or gender did not significantly influence compliance rates. Our pilot study demonstrates successful electronic compliance monitoring using a technology capable of continuous data recording over weeks of treatment. The low compliance rate for a relevant part of the patients demonstrates the necessity to study and improve compliance in ophthalmology. In future, new application methods and electronic application devices may improve treatment response in eye care.

[Efficacy of HRV-biofeedback as additional treatment of depression and PTSD].

PubMed

Blase, K L; van Dijke, A; Cluitmans, P J M; Vermetten, E

2016-01-01

Heartrate variability biofeedback (HRVB) is a non-invasive treatment in which patients are assumed to self-regulate a physiological dysregulated vagal nerve. Although the therapeutic approach of HRVB is promising in various stress-related disorders, it has only been offered on a regular basis in a few mental health treatment settings. To analyse the efficacy of HRV biofeedback as an additional psychophysiological treatment for depression and PTSD. Systematic review with search terms HRV, biofeedback, PTSD, depression, panic disorder and anxiety disorder. Our search of the literature yielded 789 studies. After critical appraisal using the GRADE method, we selected 6 randomised controlled trials (RCTs) and 4 relevant studies. The RCTs with control groups 'treatment as usual' and muscle relaxation training revealed significant clinical efficacy and better results than control conditions after 4 to 8 weeks training. Although this systematic review shows the popularity of HRV in literature, it does not indicate that HRVB really has been reviewed systematically. Significant outcomes of this limited number of randomised studies indicate there may be a clinical improvement when HRVB training is integrated into treatment of PTSD and depression, particularly when this integration procedure is combined with psychotherapy. More research needs to be done with larger groups and further efforts are needed to integrate HRVB into treatment of stress-related disorders in psychiatry. Future research also needs to focus on the psychophysiological mechanisms involved.

A famciclovir + celecoxib combination treatment is safe and efficacious in the treatment of fibromyalgia

PubMed Central

Pridgen, William L; Duffy, Carol; Gendreau, Judy F; Gendreau, R Michael

2017-01-01

Objective Infections and other stressors have been implicated in the development of fibromyalgia. We hypothesized that these stressors could result in recurrent reactivations of latent herpes virus infections, which could lead to the development of fibromyalgia. This study evaluated a famciclovir + celecoxib drug combination (IMC-1), active against suspected herpes virus reactivation and infection, for the treatment of fibromyalgia. Methods A total of 143 fibromyalgia patients were enrolled at 12 sites in a 16-week, double-blinded, placebo-controlled proof-of-concept trial. Randomized patients received either IMC-1 or placebo in a 1:1 ratio. Outcome measures included a 24-hour recall pain Numerical Rating Scale, the Revised Fibromyalgia Impact Questionnaire (FIQ-R), the Patient’s Global Impression of Change (PGIC) questionnaire, the Multidimensional Fatigue Inventory, the NIH Patient-Reported Outcomes Measurement Information System (PROMIS), and the Beck Depression Inventory-II conducted at baseline and weeks 6, 12, and 16 of the study. Results A significant decrease in fibromyalgia-related pain was observed for patients on IMC-1 treatment versus placebo. PGIC response rates were significantly improved with IMC-1 treatment. Overall, patient self-reported functioning, as measured by the FIQ-R, was significantly improved. Fatigue was also significantly improved as measured by the PROMIS fatigue inventory. The safety profile was encouraging. Despite the celecoxib component of IMC-1, gastrointestinal and nervous system treatment emergent adverse events were reported less frequently in the IMC-1 group, and study completion rates favored IMC-1 treatment. Conclusion IMC-1 was efficacious and safe in treating symptoms of fibromyalgia, supporting the hypothesis that herpes virus infections may contribute to this syndrome. Improved retention rates, decreased adverse event rates, and evidence of efficacy on a broad spectrum of outcome measures are suggestive that IMC-1 may

Efficacy and toxicity profile of carfilzomib based regimens for treatment of multiple myeloma: A systematic review.

PubMed

Mushtaq, Adeela; Kapoor, Vikas; Latif, Azka; Iftikhar, Ahmad; Zahid, Umar; McBride, Ali; Abraham, Ivo; Riaz, Irbaz Bin; Anwer, Faiz

2018-05-01

Standard induction therapy for multiple myeloma is three-drug combination based on following classes of drugs: proteasome inhibitors, immunomodulators and steroids. Despite its notable efficacy, bortezomib has side effects like peripheral neuropathy (PNP) with reported incidence of grade ≥3 PNP between 2%-23% Schlafer et al., 2017. Carfilzomib (CFZ) has high selectivity and minimal off-target adverse effects including lower rates of PNP. CFZ is already approved for treatment of relapsed and refractory multiple myeloma (RRMM) as single agent as well as in combination with lenalidomide and/or dexamethasone. Extensive literature search identified a total of 1839 articles. Twenty-six articles (n = 5980) met the inclusion criteria, 15 in newly diagnosed multiple myeloma (NDMM) and 11 in RRMM group. CFZ demonstrates comparable or even better efficacy to bortezomib with much favorable AE profile. Deep, rapid and sustainable response using KRd with safer toxicity profile supports extension of KRd therapy to frontline therapy for all risk categories of MM. High incidence of grade ≥3 HTN underscores the importance of serial BP monitoring. In RRMM, CFZ has documented efficacy with standard 20-27mg/m2 dose. Further large-scale trials are needed to study benefit-to-risk profile of 20-56 and 20-70 mg/m2 dose of CFZ vs standard 20-27 mg/m2 dose in NDMM and RRMM. Copyright © 2018 Elsevier B.V. All rights reserved.

Efficacy of Monitoring Devices in Support of Prevention of Pressure Injuries: Systematic Review and Meta-analysis.

PubMed

Walia, Gurjot S; Wong, Alison L; Lo, Andrea Y; Mackert, Gina A; Carl, Hannah M; Pedreira, Rachel A; Bello, Ricardo; Aquino, Carla S; Padula, William V; Sacks, Justin M

2016-12-01

To present a systematic review of the literature assessing the efficacy of monitoring devices for reducing the risk of developing pressure injuries. This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care. After participating in this educational activity, the participant should be better able to:1. Explain the methodology of the literature review and its results.2. Discuss the scope of the problem and the implications of the research. OBJECTIVE: To assess the efficacy of monitoring devices for reducing the risk of developing pressure injuries (PIs). The authors systematically reviewed the literature by searching PubMed/MEDLINE and CINAHL databases through January 2016. Articles included clinical trials and cohort studies that tested monitoring devices, evaluating PI risk factors on patients in acute and skilled nursing settings. The articles were scored using the Methodological Index for Non-randomized Studies. Using a standardized extraction form, the authors extracted patient inclusion/exclusion criteria, care setting, key baseline, description of monitoring device and methodology, number of patients included in each group, description of any standard of care, follow-up period, and outcomes. Of the identified 1866 publications, 9 met the inclusion criteria. The high-quality studies averaged Methodological Index for Non-randomized Studies scores of 19.4 for clinical trials and 12.2 for observational studies. These studies evaluated monitoring devices that measured interface pressure, subdermal tissue stress, motion, and moisture. Most studies found a statistically significant decrease in PIs; 2 studies were eligible for meta-analysis, demonstrating that use of monitoring devices was associated with an 88% reduction in the risk of developing PIs (Mantel-Haenszel risk ratio, 0.12; 95% confidence interval, 0.04-0.41; I = 0%). Pressure injury monitoring devices are

The challenge of establishing treatment efficacy for cutaneous vascular manifestations of systemic sclerosis.

PubMed

Pauling, John D

2018-05-01

The cutaneous vascular manifestations of systemic sclerosis (SSc) comprise Raynaud's phenomenon, cutaneous ulceration, telangiectasia formation and critical digital ischaemia; each of which are associated with significant disease-related morbidity. Despite the availability of multiple classes of vasodilator therapy, many of which have been the subject of RCTs, a limited number of pharmacological interventions are currently approved for the management of cutaneous vascular manifestations of SSc. Areas covered: A major challenge has been demonstrating treatment efficacy with examples of promising therapies yielding contrasting results in controlled trial settings. Differences between consensus best-practice guidelines, evidence-based recommendations and marketing approvals in different jurisdictions has resulted in geographic variation in clinical practice concerning the management of cutaneous vascular manifestations of SSc. Difficulty demonstrating treatment efficacy risks waning industry engagement for drug development programmes in this field. This article highlights the key challenges in establishing treatment efficacy and barriers that must be overcome to support successful clinical trial programmes across the spectrum of cutaneous vascular manifestations of SSc. Expert commentary: The paucity of approved treatments for cutaneous vascular manifestations of SSc relates as much to challenges in clinical trial design and the need for reliable clinical trial endpoints, as to lack of therapeutic options.

Efficacy, acceptability and cost effectiveness of four therapeutic agents for treatment of scabies.

PubMed

Abdel-Raheem, Talal A; Méabed, Eman M H; Nasef, Ghada A; Abdel Wahed, Wafaa Y; Rohaim, Rania M A

2016-10-01

The aim of this study is to evaluate four drug regimens for treatment of scabies as regard their efficacy, acceptability and cost effectiveness. Two hundred cases with ordinary scabies were randomized into four groups. First group received ivermectin 200 μg/kg body weight single oral dose, repeated after one week. The second received benzyl benzoate 20% cream. The third received permethrin 2.5%-5% lotion, whereas the fourth group received 5-10% sulfur ointment. Topical treatments were applied for five consecutive nights. Patients were followed up for two weeks for cure rate and adverse effects. At the end of the study, permethrin provided a significant efficacy of 88% and acceptability in 100% of cases, but had higher cost to treat one case (20.25 LE). Ivermectin provided efficacy and acceptability rates of 84% and 96%, respectively, and had a cheaper cost (9.5 LE). Benzyl benzoate provided 80% for both rates and was the cheapest drug. Sulfur ointment provided the least rates, and it was the most expensive. Treatment choice will depend on the age, the general condition of cases, patient compliance to topical treatment and his ability to stick to its roles, and the economic condition of the patient.

The efficacy of cryolipolysis treatment on arms and inner thighs.

PubMed

Wanitphakdeedecha, Rungsima; Sathaworawong, Angkana; Manuskiatti, Woraphong

2015-11-01

Cryolipolysis has emerged as a new non-invasive body contouring method using controlled cooling to selectively destroy fat cells. Previous studies demonstrated the safety and efficacy of cryolipolysis for the reduction of localized subcutaneous fat on abdomen and flanks. Recently, the new flat cup vacuum applicator has been developed to treat localized subcutaneous fat on arms and inner thighs. The objective of this study was to determine the efficacy of non-invasive cryolipolysis for body contouring with a flat cup vacuum applicator on arms and inner thighs. Twenty females with excess localized subcutaneous fat on arms or inner thighs received a single cryolipolysis treatment. Forty treatment areas have been treated including 10 arms and 30 inner thighs. Subjects were evaluated using standardized photographs and measurements of body weight and circumference of arms or inner thighs at baseline, 3-month, and 6-month follow-up visits. Physicians' evaluation and patient's satisfaction of clinical improvement were also measured. Of all 20 subjects, 17 (10 arms and 24 inner thighs) completed the treatment protocol and attended all follow-up visits. Three subjects were withdrawn from the study, 1 subject could not complete the treatment session due to pain and numbness during treatment, 1 subject became pregnant after treatment, and the other subject could not attend all required follow-up visits. There was significant circumference reduction of 0.41 and 0.72 cm at 3-month and 6-month follow-up visits (p = 0.017), respectively. Most of the patients were rated to have 1-25% improvement at 6 months after treatment and were satisfied with the treatment outcome. The new cryolipolysis flat cup vacuum applicator provided beneficial effects for circumferential reduction of arms and inner thighs.

Long-term safety and efficacy of etanercept in the treatment of ankylosing spondylitis

PubMed Central

Senabre-Gallego, José Miguel; Santos-Ramírez, Carlos; Santos-Soler, Gregorio; Salas-Heredia, Esteban; Sánchez-Barrioluengo, Mabel; Barber, Xavier; Rosas, José

2013-01-01

To date, anti-tumor necrosis factor alfa (anti-TNF-α) therapy is the only alternative to nonsteroidal anti-inflammatory drugs for the treatment of ankylosing spondylitis. Etanercept is a soluble TNF receptor, with a mode of action and pharmacokinetics different to those of antibodies and distinctive efficacy and safety. Etanercept has demonstrated efficacy in the treatment of ankylosing spondylitis, with or without radiographic sacroiliitis, and other manifestations of the disease, including peripheral arthritis, enthesitis, and psoriasis. Etanercept is not efficacious in inflammatory bowel disease, and its efficacy in the treatment of uveitis appears to be lower than that of other anti-TNF drugs. Studies of etanercept confirmed regression of bone edema on magnetic resonance imaging of the spine and sacroiliac joint, but failed to reduce radiographic progression, as do the other anti-TNF drugs. It seems that a proportion of patients remain in disease remission when the etanercept dose is reduced or administration intervals are extended. Etanercept is generally well tolerated with an acceptable safety profile in the treatment of ankylosing spondylitis. The most common adverse effect of etanercept treatment is injection site reactions, which are generally self-limiting. Reactivation of tuberculosis, reactivation of hepatitis B virus infection, congestive heart failure, demyelinating neurologic disorders, hematologic disorders like aplastic anemia and pancytopenia, vasculitis, immunogenicity, and exacerbation or induction of psoriasis are class effects of all the anti-TNF drugs, and have been seen in patients with ankylosing spondylitis. However, etanercept is less likely to induce reactivation of tuberculosis than the other anti-TNF drugs and it has been suggested that etanercept might be less immunogenic, especially in ankylosing spondylitis. Acute uveitis, Crohn’s disease, and sarcoidosis are other adverse events that have been rarely associated with etanercept

Safety and efficacy of tinea pedis and onychomycosis treatment in people with diabetes: a systematic review

PubMed Central

2011-01-01

Background Effective treatment of tinea pedis and onychomycosis is crucial for patients with diabetes as these infections may lead to foot ulcers and secondary bacterial infections resulting in eventual lower limb amputation. Although numerous studies have assessed the effectiveness of antifungal drug and treatment regimens, most exclude patients with diabetes and examine otherwise healthy individuals. While these studies are useful, results cannot necessarily be extrapolated to patients with diabetes. The purpose of this study was to therefore identify the best evidence-based treatment interventions for tinea pedis or onychomycosis in people with diabetes. Methods The question for this systemic review was: 'what evidence is there for the safety and/or efficacy of all treatment interventions for adults with tinea pedis and/or onychomycosis in people with diabetes'? A systematic literature search of four electronic databases (Scopus, EbscoHost, Ovid, Web of Science) was undertaken (6/1/11). The primary outcome measure for safety was self-reported adverse events likely to be drug-related, while the primary outcome measures assessed for 'efficacy' were mycological, clinical and complete cure. Results The systematic review identified six studies that examined the safety and/or efficacy of treatment interventions for onychomycosis in people with diabetes. No studies were identified that examined treatment for tinea pedis. Of the studies identified, two were randomised controlled trials (RCTs) and four were case series. Based on the best available evidence identified, it can be suggested that oral terbinafine is as safe and effective as oral itraconazole therapy for the treatment of onychomycosis in people with diabetes. However, efficacy results were found to be poor. Conclusions This review indicates that there is good evidence (Level II) to suggest oral terbinafine is as safe and effective as itraconazole therapy for the treatment of onychomycosis in people with

Safety and efficacy of tinea pedis and onychomycosis treatment in people with diabetes: a systematic review.

PubMed

Matricciani, Lisa; Talbot, Kerwin; Jones, Sara

2011-12-04

Effective treatment of tinea pedis and onychomycosis is crucial for patients with diabetes as these infections may lead to foot ulcers and secondary bacterial infections resulting in eventual lower limb amputation. Although numerous studies have assessed the effectiveness of antifungal drug and treatment regimens, most exclude patients with diabetes and examine otherwise healthy individuals. While these studies are useful, results cannot necessarily be extrapolated to patients with diabetes. The purpose of this study was to therefore identify the best evidence-based treatment interventions for tinea pedis or onychomycosis in people with diabetes. The question for this systemic review was: 'what evidence is there for the safety and/or efficacy of all treatment interventions for adults with tinea pedis and/or onychomycosis in people with diabetes'? A systematic literature search of four electronic databases (Scopus, EbscoHost, Ovid, Web of Science) was undertaken (6/1/11). The primary outcome measure for safety was self-reported adverse events likely to be drug-related, while the primary outcome measures assessed for 'efficacy' were mycological, clinical and complete cure. The systematic review identified six studies that examined the safety and/or efficacy of treatment interventions for onychomycosis in people with diabetes. No studies were identified that examined treatment for tinea pedis. Of the studies identified, two were randomised controlled trials (RCTs) and four were case series. Based on the best available evidence identified, it can be suggested that oral terbinafine is as safe and effective as oral itraconazole therapy for the treatment of onychomycosis in people with diabetes. However, efficacy results were found to be poor. This review indicates that there is good evidence (Level II) to suggest oral terbinafine is as safe and effective as itraconazole therapy for the treatment of onychomycosis in people with diabetes. Further research is needed to

Monitoring the effects of different conservation treatments on paper-infecting fungi

PubMed Central

Michaelsen, Astrid; Pinzari, Flavia; Barbabietola, Nicoletta; Piñar, Guadalupe

2013-01-01

Fungi are among the most degradative organisms inducing biodeterioration of paper-based items of cultural heritage. Appropriate conservation measures and restoration treatments to deal with fungal infections include mechanical, chemical, and biological methods, which entail effects on the paper itself and health hazards for humans. Three different conservation treatments, namely freeze-drying, gamma rays, and ethylene oxide fumigation, were compared and monitored to assess their short- (one month, T1) and long-term (one year, T2) effectiveness to inhibit fungal growth. After the inoculation with fungi possessing cellulose hydrolysis ability — Chaetomium globosum, Trichoderma viride, and Cladosporium cladosporioides — as single strains or as a mixture, different quality paper samples were treated and screened for fungal viability by culture-dependent and -independent techniques. Results derived from both strategies were contradictory. Both gamma irradiation and EtO fumigation showed full efficacy as disinfecting agents when evaluated with cultivation techniques. However, when using molecular analyses, the application of gamma rays showed a short-term reduction in DNA recovery and DNA fragmentation; the latter phenomenon was also observed in a minor degree in samples treated with freeze-drying. When RNA was used as an indicator of long-term fungal viability, differences in the RNA recovery from samples treated with freeze-drying or gamma rays could be observed in samples inoculated with the mixed culture. Only the treatment with ethylene oxide proved negative for both DNA and RNA recovery. Therefore, DNA fragmentation after an ethylene oxide treatment can hamper future paleogenetic and archaeological molecular studies on the objects. PMID:24092956

Monitoring the effects of different conservation treatments on paper-infecting fungi.

PubMed

Michaelsen, Astrid; Pinzari, Flavia; Barbabietola, Nicoletta; Piñar, Guadalupe

2013-10-01

Fungi are among the most degradative organisms inducing biodeterioration of paper-based items of cultural heritage. Appropriate conservation measures and restoration treatments to deal with fungal infections include mechanical, chemical, and biological methods, which entail effects on the paper itself and health hazards for humans. Three different conservation treatments, namely freeze-drying, gamma rays, and ethylene oxide fumigation, were compared and monitored to assess their short- (one month, T1) and long-term (one year, T2) effectiveness to inhibit fungal growth. After the inoculation with fungi possessing cellulose hydrolysis ability - Chaetomium globosum , Trichoderma viride, and Cladosporium cladosporioides - as single strains or as a mixture, different quality paper samples were treated and screened for fungal viability by culture-dependent and -independent techniques. Results derived from both strategies were contradictory. Both gamma irradiation and EtO fumigation showed full efficacy as disinfecting agents when evaluated with cultivation techniques. However, when using molecular analyses, the application of gamma rays showed a short-term reduction in DNA recovery and DNA fragmentation; the latter phenomenon was also observed in a minor degree in samples treated with freeze-drying. When RNA was used as an indicator of long-term fungal viability, differences in the RNA recovery from samples treated with freeze-drying or gamma rays could be observed in samples inoculated with the mixed culture. Only the treatment with ethylene oxide proved negative for both DNA and RNA recovery. Therefore, DNA fragmentation after an ethylene oxide treatment can hamper future paleogenetic and archaeological molecular studies on the objects.

Pathogen Treatment Guidance and Monitoring Approaches fro ...

EPA Pesticide Factsheets

On-site non-potable water reuse is increasingly used to augment water supplies, but traditional fecal indicator approaches for defining and monitoring exposure risks are limited when applied to these decentralized options. This session emphasizes risk-based modeling to define pathogen log-reduction requirements coupled with alternative targets for monitoring enabled by genomic sequencing (i.e., the microbiome of reuse systems). 1. Discuss risk-based modeling to define pathogen log-reduction requirements 2. Review alternative targets for monitoring 3. Gain an understanding of how new tools can help improve successful development of sustainable on-site non-potable water reuse Presented at the Water Wastewater Equipment Treatment & Transport Show.

The Relationship between Relapse Prevention Treatment Outcome and Self-Efficacy.

ERIC Educational Resources Information Center

Cantrell, Peggy J.; And Others

The majority of alcoholics and drug addicts relapse after treatment, with many substance abusers developing a chronic relapse pattern. For this study, 43 patients, who went through a 3-week inpatient relapse prevention program, answered the Situational Confidence Questionnaire (a measure of self-efficacy for alcohol-related, high-risk situations)…

Efficacy of fipronil in the treatment of feline cheyletiellosis.

PubMed

Scarampella, F; Pollmeier, M; Visser, M; Boeckh, A; Jeannin, P

2005-05-15

The purpose of the present study was to confirm the efficacy of 10% (w/v) fipronil spot-on (Frontline spot-on for cats) in the treatment of feline cheyletiellosis under field conditions. A total of 16 cats of different breeds, sexes, 4 months to 14 years of age and weighing 0.5-6 kg were treated with a single topical application of 10% (w/v) fipronil spot-on according to label directions. The animals were naturally infested with Cheyletiella mites and housed in their normal environment throughout the study. Animals were selected based on clinical signs and infestation was confirmed by demonstration of mites. Mite counts and a clinical assessment of mite infestations (i.e. skin lesions and/or scales) were performed on days 0 and approximately days 14 and 28. Individual counts on day 0 ranged from 1 to 40 mites on individual animals. No mites were detected on cats treated with 10% (w/v) fipronil spot-on (Frontline spot-on for cats) at both post-treatment evaluations. Typical skin lesions and/or scales were present in all animals pre-treatment. In 56% of the cats, the lesions resolved within 14 days after treatment. At the final assessment, 75% cats were free of lesions. Two cats that still had clinical signs on day 28 were suspected of having allergic reactions to food or environmental allergens. The lesions on the remaining two cats could not be related to a specific cause. The efficacy of fipronil in elimination of mites was 100% on each occasion when compared to the pre-treatment count. The results of this study demonstrated that fipronil in a topical formulation is highly effective (100%) for the elimination of an existing Cheyletiella mite infestation under field conditions following a single topical application in cats.

Efficacy of ozone and other treatment modalities for retained placenta in dairy cows.

PubMed

Zobel, R; Tkalčić, S

2013-02-01

Retained placenta is a worldwide recognized clinical condition in puerperal cows, which can significantly affect their health and fertility. Available treatment modalities are often of questionable efficacy or associated with time constraints, practicality or monetary considerations for their wide application in a routine dairy practice. The objective of this study was to compare and assess the efficacy of different treatment options, including a novel ozone treatment, for the retained placenta. Two hundred cows diagnosed with retained placenta were divided into five treatment groups, each receiving a different treatment option. Group A (n = 40) was given a combination treatment of intrauterine ozone and parenteral cephalexin; group B (n = 40) was given intrauterine ozone; group C (n = 40) was given a combination of parenteral cephalexin and intrauterine antibiotic tablets; group D (n = 40) was given only parenteral cephalexin and group E (n = 40) was given parenteral prostaglandins in 11-day intervals. The control group (group Z, n = 200) included cows that gave birth without assistance and were not diagnosed with a retained placenta. The ozone treatment (groups A and B) was found to be the most effective modality resulting in the shortest period of days open, the smallest number of artificial inseminations until pregnancy, the smallest number of animals diagnosed with fever within 10 days post-calving, the highest percentage of animals pregnant within 200 days after calving and the smallest number of animals culled because of infertility, when compared to the other treatment groups. The intrauterine ozone flush therefore has a potential as an efficacious and cost-effective treatment option for retained placenta, with an overall positive effect on puerperal health and fertility in cows. © 2012 Blackwell Verlag GmbH.

Efficacy of pulsed radiofrequency medial branch treatment in low back pain patients.

PubMed

Kim, Do Hyoung; Han, Seong Rok; Choi, Chan Young; Sohn, Moon Jun; Lee, Chae Heuck

2016-04-27

It was thought that the efficacy of pulsed radiofrequency (PRF) treatment of the medial branch in patients with lower back pain was not as long lasting as that of continuous radiofrequency (CRF) thermo-coagulation techniques. The goal of this study was to determine the efficacy and the long-term effects of PRF treatment of the medial branch in selected low back pain patients. We retrospectively reviewed and analyzed patients with lower back pain who underwent PRF treatment on the medial branch at our institute. Pain relief was evaluated by visual analog scale (VAS) score at pretreatment, 2 weeks, 6 months, 1 year and 2 years post-treatment. Oswestry disability index (ODI) score was evaluated pretreatment and at 2 years post-treatment. We also recorded the satisfaction period after PRF treatment. Twenty-three patients were available for the 2-year follow-up analysis. None of the patients had any side effects or procedure-related complications during the follow up period. The average VAS score declined from 7.1 ± 2.4 pre-treatment to 2.9 ± 2.1 2 weeks post-treatment, 2.6 ± 1.8 at 6 months, 2.8 ± 2.1 at 1 year and 3.0 ± 2.5 at 2 years. The average ODI score decreased from 33.6 ± 13.6 pre-treatment to 15.3 ± 5.7 at 2 years post-treatment. Mean satisfaction period after PRF treatment was 16.6 ± 9.43 months. PRF treatment on the medial branch is an effective and safe treatment option for patients with lower back pain.

Plasma ctDNA RAS mutation analysis for the diagnosis and treatment monitoring of metastatic colorectal cancer patients

PubMed Central

Vidal, J; Muinelo, L; Dalmases, A; Jones, F; Edelstein, D; Iglesias, M; Orrillo, M; Abalo, A; Rodríguez, C; Brozos, E; Vidal, Y; Candamio, S; Vázquez, F; Ruiz, J; Guix, M; Visa, L; Sikri, V; Albanell, J; Bellosillo, B; López, R; Montagut, C

2017-01-01

Abstract Background RAS assessment is mandatory for therapy decision in metastatic colorectal cancer (mCRC) patients. This determination is based on tumor tissue, however, genotyping of circulating tumor (ct)DNA offers clear advantages as a minimally invasive method that represents tumor heterogeneity. Our study aims to evaluate the use of ctDNA as an alternative for determining baseline RAS status and subsequent monitoring of RAS mutations during therapy as a component of routine clinical practice. Patients and methods RAS mutational status in plasma was evaluated in mCRC patients by OncoBEAM™ RAS CRC assay. Concordance of results in plasma and tissue was retrospectively evaluated. RAS mutations were also prospectively monitored in longitudinal plasma samples from selected patients. Results Analysis of RAS in tissue and plasma samples from 115 mCRC patients showed a 93% overall agreement. Plasma/tissue RAS discrepancies were mainly explained by spatial and temporal tumor heterogeneity. Analysis of clinico-pathological features showed that the site of metastasis (i.e. peritoneal, lung), the histology of the tumor (i.e. mucinous) and administration of treatment previous to blood collection negatively impacted the detection of RAS in ctDNA. In patients with baseline mutant RAS tumors treated with chemotherapy/antiangiogenic, longitudinal analysis of RAS ctDNA mirrored response to treatment, being an early predictor of response. In patients RAS wt, longitudinal monitoring of RAS ctDNA revealed that OncoBEAM was useful to detect emergence of RAS mutations during anti-EGFR treatment. Conclusion The high overall agreement in RAS mutational assessment between plasma and tissue supports blood-based testing with OncoBEAM™ as a viable alternative for genotyping RAS of mCRC patients in routine clinical practice. Our study describes practical clinico-pathological specifications to optimize RAS ctDNA determination. Moreover, OncoBEAM™ is useful to monitor RAS in patients

Efficacy of Dapoxetine in the Treatment of Premature Ejaculation

PubMed Central

McMahon, Chris G.

2011-01-01

Introduction Premature ejaculation (PE) is a common male sexual disorder which is associated with substantial personal and interpersonal negative psychological factors. Pharmacotherapy of PE with off-label antidepressant SSRI drugs is common. Development and regulatory approval of drugs specifically for the treatment of PE will reduce reliance on off-label treatments and serve to fill a unmet treatment need. Aim To review evidence supporting the efficacy and safety of dapoxetine in the treatment of PE. Methods MEDLINE and the proceedings of major international and regional scientific meetings during the period 1994–2010 were searched for publications or abstracts using the word dapoxetine in the title, abstract or keywords. This search was then manually cross-referenced for all papers. This review encompasses studies of dapoxetine pharmacokinetics, animal studies, human phase 1, 2 and 3 efficacy and safety studies and drug-interaction studies. Results Dapoxetine is a potent selective serotonin re-uptake inhibitor, which is administered on-demand 1–3 hours prior to planned sexual contact. Dapoxetine is rapidly absorbed and eliminated, resulting in minimal accumulation and has dose-proportional pharmacokinetics, which are unaffected by multiple dosing. Dapoxetine 30 mg and 60 mg has been evaluated in 5 randomized, double-blind, placebo-controlled studies in 6081 men aged ≥18 years. Outcome measures included stopwatch-measured intravaginal ejaculatory latency time (IELT), Premature Ejaculation Profile (PEP) inventory items, clinical global impression of change (CGIC) in PE, and adverse events. Mean IELT, all PEP items and CGIC improved significantly with both doses of dapoxetine vs. placebo (P < 0.001 for all). The most common treatment related adverse effects included nausea (11.0% for 30 mg, 22.2% for 60 mg), dizziness (586% for 30 mg, 10.9% for 60 mg), and headache (5.6% for 30 mg, 8.8% for 60 mg), and evaluation of validated rated scales demonstrated no SSRI

Investigating self-efficacy, disease knowledge and adherence to treatment in adolescents with cystic fibrosis.

PubMed

Faint, Nicholas R; Staton, Janelle M; Stick, Stephen M; Foster, Juliet M; Schultz, André

2017-05-01

Patient adherence is integral to the effectiveness of prescribed treatment, and is associated with beneficial disease outcomes, yet in adolescents with cystic fibrosis, adherence is often sub-optimal. Multiple factors may contribute to treatment adherence, including disease knowledge and self-efficacy. In adolescents with cystic fibrosis: (i) to compare the disease knowledge of adolescents and their parents before transition to adult care; (ii) to determine the relationship between disease knowledge (adolescent, parent) and adherence; and (iii) to evaluate self-efficacy and its association with disease knowledge and adherence. Adolescents with cystic fibrosis and their parents were recruited from a tertiary children's hospital. Disease knowledge and self-efficacy was assessed using the Knowledge of Disease Management-CF and General Self-Efficacy Scales respectively. Using pharmacy records, medication possession ratio was calculated to measure treatment adherence in the preceding year. Thirty-nine adolescent (aged 12-17 (median 14) years) and parent pairs were recruited. Adherence to hypertonic saline, but not other medications, was significantly associated with disease knowledge in adolescents (r 2  = 0.40, P = 0.029). Mean (SD) adolescent self-efficacy was 30.8 (4.0), and not associated with disease knowledge or adherence. Mean (SD) disease knowledge was less in adolescents than parents (55 (16)% and 72 (14)% respectively, P < 0.001). Disease knowledge is sub-optimal in adolescents with cystic fibrosis, even in the 2 years immediately before transition to adult care. Given that adherence with some treatments has been associated with disease knowledge our results suggest the need for educational interventions in adolescents with cystic fibrosis to optimise self-management and health outcomes. © 2017 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).

HPV circulating tumor DNA to monitor the efficacy of anti-PD-1 therapy in metastatic squamous cell carcinoma of the anal canal: A case report.

PubMed

Cabel, Luc; Bidard, François-Clément; Servois, Vincent; Cacheux, Wulfran; Mariani, Pascale; Romano, Emanuela; Minsat, Mathieu; Bieche, Ivan; Farkhondeh, Fereshteh; Jeannot, Emmanuelle; Buecher, Bruno

2017-10-15

Squamous cell carcinoma of the anal canal (SCCA) is a rare HPV-associated cancer with limited sensitivity to standard chemotherapy. In a phase 2 study, nivolumab, an anti PD-1 immune checkpoint inhibitor, demonstrated significant efficacy as single-agent therapy in metastatic SCCA patients. Nevertheless, imaging assessment by standard RECIST criteria of the efficacy of immune therapy can be difficult in some patients due to tumor immune cell infiltration, and biomarkers of treatment efficacy are needed. We have previously developed a quantitative droplet digital PCR (ddPCR) technique to detect HPV circulating tumor DNA (HPV ctDNA), with excellent sensitivity and specificity. Here, we report, for the first time, the kinetics of HPV ctDNA during therapy in a patient with metastatic SCCA, who obtained sustained partial response to single-agent nivolumab. We observed an early and very significant decrease of HPV ctDNA during therapy from the baseline level of 3713 copies/ml plasma to 564 copies/ml plasma at 4 weeks, and 156 copies/ml at 6 weeks, followed by a plateau. This observation provides proof-of-concept that HPV ctDNA can be used as a noninvasive early dynamic biomarker to monitor the efficacy of new immunotherapy agents. © 2017 UICC.

Treatment efficacy of intramuscular promethazine for Space Motion Sickness

NASA Technical Reports Server (NTRS)

Davis, Jeffrey R.; Jennings, Richard T.; Beck, Bradley G.; Bagian, James P.

1993-01-01

Intramuscular promethazine and its efficacy in the treatment of Space Motion Sickness (SMS) were evaluated using standardized questions administered during postflight debriefings to crewmembers immediately after their first Shuttle flight. The comparison showed that 25 percent of crewmembers treated with IM promethazine were 'sick' on flight day 2, compared to 50 percent of crewmembers who did not receive promethazine, 90 percent reported immediate symptom relief as well. Untreated crewmembers typically have slow symptom resolution over 72-96 h, and those treated with oral scopolamine/dextroamphetamine show delayed symptom development. This study suggests that intramuscular promethazine is an effective treatment for SMS and merits continued use and further controlled investigations.

Methotrexate in psoriasis: a systematic review of treatment modalities, incidence, risk factors and monitoring of liver toxicity.

PubMed

Montaudié, H; Sbidian, E; Paul, C; Maza, A; Gallini, A; Aractingi, S; Aubin, F; Bachelez, H; Cribier, B; Joly, P; Jullien, D; Le Maître, M; Misery, L; Richard, M-A; Ortonne, J-P

2011-05-01

To define practical use and to specify the ideal method for monitoring the liver toxicity of MTX in the management of psoriasis. To systematically review the literature regarding treatment modalities with methotrexate (MTX) in psoriasis, risk of MTX-mediated liver fibrosis and monitoring of hepatic toxicity. A systematic literature search was carried out in Medline, Embase and Cochrane Library databases from 1980 to 2010 searching for randomized controlled trials and observational studies on methods of administering MTX in psoriasis and risk factors and assessment of liver toxicity. We limited the literature search to articles on human subjects over 19 years of age, articles in English or French on psoriasis and articles including psoriatic arthritis and original data. Among 949 references identified, 23 published studies were included. There were no studies focusing directly on the question of MTX treatment modalities. Treatment outcome appears to be dose dependent. A single study in rheumatoid arthritis showed the slightly superior efficacy of subcutaneous administration vs. oral dosing with a similar safety profile. Combination with folic acid may decrease the efficacy of MTX while improving tolerability. The extreme variability of the incidence of hepatic fibrosis in the literature does not allow the risk of hepatic fibrosis to be quantified. Type 2 diabetes and obesity, were associated with a significant increased risk of liver fibrosis. Hepatitis B and C and alcohol consumption were associated with a modest and non-significant increased risk of liver fibrosis. Procollagen III for detection of hepatic fibrosis dosing was the most extensively validated method to monitor liver fibrosis showing a sensitivity of 77.3% and a specificity of 91.5%. The Positive Predictive Value and Negative Predictive Value fluctuated depending on the prevalence of hepatic fibrosis. The sensitivities of the FibroTest and the fibroscan were of 83 and 50%, respectively, with specific

The role of the Data and Safety Monitoring Board in a clinical trial: the CRISIS study.

PubMed

Holubkov, Richard; Casper, T Charles; Dean, J Michael; Anand, K J S; Zimmerman, Jerry; Meert, Kathleen L; Newth, Christopher J L; Berger, John; Harrison, Rick; Willson, Douglas F; Nicholson, Carol

2013-05-01

Randomized clinical trials are commonly overseen by a Data and Safety Monitoring Board comprised of experts in medicine, ethics, and biostatistics. Data and Safety Monitoring Board responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. Data and Safety Monitoring Board decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate Data and Safety Monitoring Board oversight into the design, monitoring, and reporting of randomized trials. Case study, narrative review. The Data and Safety Monitoring Board's role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. The National Institutes of Health-appointed CRISIS Data and Safety Monitoring Board was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested Data and Safety Monitoring Board interim review before opening CRISIS to children below 1 yr of age. The first interim analysis found higher 28-day mortality in one treatment arm. The Data and Safety Monitoring Board maintained trial closure to younger children and requested a second interim data review 6 months later. At this second meeting, mortality was no longer of concern, whereas a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the Data and Safety Monitoring Board elected to examine conditional power and unmask treatment arm identities. On finding somewhat greater efficacy in the placebo arm, the Data and Safety Monitoring Board recommended stopping CRISIS due to futility. The design and operating procedures of a multicenter randomized trial must consider a pivotal Data and Safety Monitoring Board role. Maximum

Therapeutic Efficacy of Meropenem for Treatment of Experimental Penicillin-Resistant Pneumococcal Meningitis

PubMed Central

Kim, Shin-Woo; Jin, Joung Hwa; Kang, Soo Jung; Jung, Sook-In; Kim, Yeon-Sook; Kim, Choon-Kwan; Lee, Hyuck; Oh, Won Sup; Kim, Sungmin; Peck, Kyong Ran

2004-01-01

With the widespread emergence of antimicrobial resistance, combination regimens of ceftriaxone and vancomycin (C+V) or ceftriaxone and rifampin (C+R) are recommended for empirical treatment of pneumococcal meningitis. To evaluate the therapeutic efficacy of meropenem (M), we compared various treatment regimens in arabbit model of meningitis caused by penicillin-resistant Streptococcus pneumoniae (PRSP). Therapeutic efficacy was also evaluated by the final bacterial concentration in the cerebrospinal fluid (CSF) at 24 hr. Each group consisted of six rabbits. C+V cleared the CSF at 10 hr, but regrowth was noted in 3 rabbits at 24 hr. Meropenem monotherapy resulted in sterilization at 10 hr, but regrowth was observed in all 6 rabbits at 24 hr. M+V also resulted in sterilization at 10 hr, but regrowth was observed in 2 rabbits at 24 hr. M+V was superior to the meropenem monotherapy at 24 hr (reduction of 4.8 vs. 1.8 log10 cfu/mL, respectively; p=0.003). The therapeutic efficacy of M+V was comparable to that of C+V (reduction of 4.8 vs. 4.0 log10 cfu/mL, respectively; p=0.054). The meropenem monotherapy may not be a suitable choice for PRSP meningitis, while combination of meropenem and vancomycin could be a possible alternative in the treatment of PRSP meningitis. PMID:14966336

Determining efficacy of monitoring devices on ceramic bond to resin composite

PubMed Central

Osorio, Estrella; Aguilera, Fátima S.; Osorio, Raquel; García-Godoy, Franklin; Cabrerizo-Vilchez, Miguel A.; Toledano, Manuel

2012-01-01

Objectives: This paper aims to assess the effectiveness of 3D nanoroughness and 2D microroughness evaluations, by their correlation with contact angle measurements and shear bond strength test, in order to evaluate the effect of two different acids conditioning on the bonding efficacy of a leucite-based glass-ceramic to a composite resin. Study Design: Ceramic (IPS Empress) blocks were treated as follows: 1) no treatment, 2) 37% phosphoric acid (H3PO4), 15 s, 3) 9% hydrofluoric acid (HF), 5 min. Micro- and nano-roughness were assessed with a profilometer and by means of an atomic force microscopy (AFM). Water contact angle (CA) measurements were determined to assess wettability of the ceramic surfaces with the asixymetric drop shape analysis contact diameter technique. Shear bond strength (SBS) was tested to a resin composite (Z100) with three different adhesive systems (Scotchbond Multipurpose Plus, Clearfil New Bond, ProBOND). Scanning electron microscopy (SEM) images were performed. Results: Nanoroughness values assessed in 50x50 μm areas were higher for the HF group, these differences were not detected by profilometric analysis. HF treatment created the nano- roughest surfaces and the smallest CA (p<0.05), producing the highest SBS to the composite resin with all tested adhesive systems (p<0.05). No differences existed between the SBS produced by the adhesive systems evaluated with any of the surface treatments tested. Conclusions: Nano-roughness obtained in a 50x50 µm scan size areas was the most reliable data to evaluate the topographical changes produced by the different acid treatments on ceramic surfaces. Key words:Dental ceramic, acid etching, bonding efficacy, resin composite, adhesive systems, contact angle, roughness. PMID:22549693

Efficacy and safety of biologic therapies for systemic lupus erythematosus treatment: systematic review and meta-analysis.

PubMed

Borba, Helena Hiemisch Lobo; Wiens, Astrid; de Souza, Thais Teles; Correr, Cassyano Januário; Pontarolo, Roberto

2014-04-01

The objectives of this study were to evaluate the efficacy, safety, and tolerability of biologic drugs compared with placebo for systemic lupus erythematosus (SLE) treatment. A systematic review evaluating the efficacy and safety of biologic therapies compared with placebo in adult SLE patients treatment was performed. Data from studies performed before September 2013 were collected from several databases (MEDLINE, Cochrane Library, SCIELO, Scopus, and International Pharmaceutical Abstracts). Study eligibility criteria included randomized, double-blind, placebo-controlled trials; regarding treatment with biologic agents in SLE adult patients; and published in English, German, Portuguese, and Spanish. Extracted data were statistically analyzed in a meta-analysis using the Review Manager (RevMan) 5.1 software. Efficacy outcomes included the SELENA-SLEDAI (Safety of Estrogens in Lupus Erythematosus National Assessment version of the SLE Disease Activity Index) score, the SRI (Systemic Lupus Erythematosus Responder Index), normalization of low C3 (<90 mg/dL), anti-double-stranded DNA positive to negative, and no new BILAG (British Isles Lupus Assessment Group index) 1A or 2B flares. Data on safety profile included adverse events, serious and severe adverse events, death, malignancy, infections, and infusion reactions. We also evaluated withdrawals from treatment due to lack of efficacy or adverse events. Thirteen randomized placebo-controlled trials met the criteria for data extraction for systematic review. A meta-analysis regarding the efficacy and safety of belimumab compared with placebo involving four of these trials was undertaken and the remainder contributed to a meta-analysis of the safety of biologic agents. In addition, two trials allowed the performance of a meta-analysis regarding the efficacy and safety of rituximab compared with placebo. Belimumab was more effective than placebo in most evaluated outcomes. No significant differences in the safety and

Addressing Male Facial Skin Concerns: Clinical Efficacy of a Topical Skincare Treatment Product for Men.

PubMed

Makino, Elizabeth T; Jiang, Lily I; Tan, Priscilla; Cheng, Tsing; Mehta, Rahul C

2018-03-01

The growing male skincare market reflects the increased interest of men in addressing facial aging concerns and maintaining a healthy youthful appearance. Because of differences in skin structure and aging as well as in lifestyle and behavior, male facial skin presents unique challenges that may result in different priorities or treatment strategies compared to female skin. A clinical study was conducted to assess clinical efficacy and tolerability of a topical skincare treatment product that was developed to address several male facial skin concerns related to skin quality, skin aging, and shaving. The treatment product provided significant improvements in all clinical efficacy parameters including overall photodamage, tactile roughness, fine line/wrinkles, and coarse lines/wrinkles. Furthermore, significant improvements in erythema as well as dryness/scaling were observed. Subject self-assessment questionnaires showed that the treatment product was highly rated in both self-perceived efficacy as well as product attributes. Use of skincare treatment products that tackle specific male facial skin concerns could further optimize skin quality and support healthy and youthful looking skin in men.

J Drugs Dermatol. 2018;17(3):301-306.

Mechanical Harvesting Effectively Controls Young Typha spp. Invasion and Unmanned Aerial Vehicle Data Enhances Post-treatment Monitoring

PubMed Central

Lishawa, Shane C.; Carson, Brendan D.; Brandt, Jodi S.; Tallant, Jason M.; Reo, Nicholas J.; Albert, Dennis A.; Monks, Andrew M.; Lautenbach, Joseph M.; Clark, Eric

2017-01-01

The ecological impacts of invasive plants increase dramatically with time since invasion. Targeting young populations for treatment is therefore an economically and ecologically effective management approach, especially when linked to post-treatment monitoring to evaluate the efficacy of management. However, collecting detailed field-based post-treatment data is prohibitively expensive, typically resulting in inadequate documentation of the ecological effects of invasive plant management. Alternative approaches, such as remote detection with unmanned aerial vehicles (UAV), provide an opportunity to advance the science and practice of restoration ecology. In this study, we sought to determine the plant community response to different mechanical removal treatments to a dominant invasive wetland macrophyte (Typha spp.) along an age-gradient within a Great Lakes coastal wetland. We assessed the post-treatment responses with both intensive field vegetation and UAV data. Prior to treatment, the oldest Typha stands had the lowest plant diversity, lowest native sedge (Carex spp.) cover, and the greatest Typha cover. Following treatment, plots that were mechanically harvested below the surface of the water differed from unharvested control and above-water harvested plots for several plant community measures, including lower Typha dominance, lower native plant cover, and greater floating and submerged aquatic species cover. Repeated-measures analysis revealed that above-water cutting increased plant diversity and aquatic species cover across all ages, and maintained native Carex spp. cover in the youngest portions of Typha stands. UAV data revealed significant post-treatment differences in normalized difference vegetation index (NDVI) scores, blue band reflectance, and vegetation height, and these remotely collected measures corresponded to field observations. Our findings suggest that both mechanically harvesting the above-water biomass of young Typha stands and harvesting

Assessment of a neck-based treatment and monitoring device for positional obstructive sleep apnea.

PubMed

Levendowski, Daniel J; Seagraves, Sean; Popovic, Djordje; Westbrook, Philip R

2014-08-15

A majority of patients diagnosed with obstructive sleep apnea are position dependent whereby they are at least twice as severe when sleeping supine (POSA). This study evaluated the accuracy and efficacy of a neck-worn device designed to limit supine sleep. The study included nightly measurements of snoring, sleep/wake, time supine, and the frequency and duration of feedback to monitor compliance. Thirty patients between ages 18 and 75 years, BMI ≤ 35 with an overall apnea-hypopnea index (AHI) ≥ 5 and an overall AHI ≥ 1.5 times the non-supine AHI, and an Epworth score ≥ 5 were prospectively studied. Subjective reports and polysomnography were used to assess efficacy resulting from 4 weeks of in-home supine-avoidance therapy and to measure device accuracy. From 363 polysomnography reports, 209 provided sufficient positional data to estimate one site's prevalence of positional OSA. In 83% of participants exhibiting > 50% reduction in overall AHI, the mean and median reductions were 69% and 79%. Significant reductions in the overall and supine AHI, apnea index, percent time SpO2 < 90%, and snoring contributed to significant improvements in stage N1 and N2 sleep, reductions in cortical arousals and awakenings, and improved depression scores. Supine position was under-detected by > 5% in 3% of cases. Sleep efficiency by neck actigraphy was within 10% of polysomnography in 87% of the studies when position feedback was delivered. The prevalence of POSA was consistently > 70% when the overall AHI was < 60. The neck position therapy device is accurate and effective in restricting supine sleep, improving AHI, sleep architecture and continuity, and monitoring treatment outcomes.

ENVIRONMENTAL MONITORING OF A WASTEWATER TREATMENT PLANT

EPA Science Inventory

A wastewater aerosol monitoring program was conducted at an advanced wastewater treatment facility using the activated sludge process. This plant was recently constructed next to an elementary school in Tigard, Oregon. Wastewater aerosols containing pathogenic organisms are gener...

Remote Monitoring to Reduce Heart Failure Readmissions.

PubMed

Emani, Sitaramesh

2017-02-01

Rehospitalization for heart failure remains a challenge in the treatment of affected patients. The ability to remotely monitor patients for worsening heart failure may provide an avenue through which therapeutic interventions can be made to prevent a rehospitalization. Available data on remote monitoring to reduce heart failure rehospitalizations are reviewed within. Strategies to reduce readmissions include clinical telemonitoring, bioimpedance changes, biomarkers, and remote hemodynamic monitoring. Telemonitoring is readily available, but has low sensitivity and adherence. No data exist to demonstrate the efficacy of this strategy in reducing admissions. Bioimpedance offers improved sensitivity compared to telemonitoring, but has not demonstrated an ability to reduce hospitalizations and is currently limited to those patients who have separate indications for an implantable device. Biomarker levels have shown variable results in the ability to reduce hospitalizations and remain without definitive proof supporting their utilization. Remote hemodynamic monitoring has shown the strongest ability to reduce heart failure readmissions and is currently approved for this purpose. However, remote hemodynamic monitoring requires an invasive procedure and may not be cost-effective. All currently available strategies to reduce hospitalizations with remote monitoring have drawbacks and challenges. Remote hemodynamic monitoring is currently the most efficacious based on data, but is not without its own imperfections.

Future Directions for Monitoring Treatment Response in Colorectal Cancer

PubMed Central

Walker, Avery S.; Zwintscher, Nathan P.; Johnson, Eric K.; Maykel, Justin A.; Stojadinovic, Alexander; Nissan, Aviram; Avital, Itzhak; Brücher, Björn LDM; Steele, Scott R.

2014-01-01

Treatment of advanced colon and rectal cancer has significantly evolved with the introduction of neoadjuvant chemoradiation therapy so much that, along with more effective chemotherapy regimens, surgery has been considered unnecessary among some institutions for select patients. The tumor response to these treatments has also improved and ultimately has been shown to have a direct effect on prognosis. Yet, the best way to monitor that response, whether clinically, radiologically, or with laboratory findings, remains controversial. The authors' aim is to briefly review the options available and, more importantly, examine emerging and future options to assist in monitoring treatment response in cases of locally advanced rectal cancer and metastatic colon cancer. PMID:24396497

Safety and efficacy of peramivir for influenza treatment

PubMed Central

Hata, Atsuko; Akashi-Ueda, Ryoko; Takamatsu, Kazufumi; Matsumura, Takuro

2014-01-01

Objective This report presents a review of the efficacy and safety of peramivir, a neuraminidase inhibitor that was granted Emergency Use Authorization by the US Food and Drug Administration (FDA) from October 23, 2009 to June 23, 2010 during the 2009 H1N1 pandemic. Methods Literature was accessed via PubMed (January 2000–April 2014) using several search terms: peramivir; BCX-1812; RWJ 270201; H1N1, influenza; antivirals; and neuraminidase inhibitors. The peramivir manufacturers, Shionogi and Co Ltd and BioCryst Pharmaceuticals, were contacted to obtain unpublished data and information presented at recent scientific meetings. Information was obtained from the Centers for Disease Control and Prevention (CDC) and from US FDA websites. English-language and Japanese-language reports in the literature were reviewed and selected based on relevance, along with information from the CDC, US FDA, and the drug manufacturers. Results We obtained eleven clinical trial reports of intravenous peramivir, two of which described comparisons with oseltamivir. Seven of nine other recently reported published studies was a dose–response study. Clinical reports of critically ill patients and pediatric patients infected with pandemic H1N1 described that early treatment significantly decreased mortality. Peramivir administered at 300 mg once daily in adult patients with influenza significantly reduces the time to alleviation of symptoms or fever compared to placebo. It is likely to be as effective as other neuraminidase inhibitors. Conclusion Although peramivir shows efficacy for the treatment of seasonal and pH1N1 influenza, it has not received US FDA approval. Peramivir is used safely and efficiently in hospitalized adult and pediatric patients with suspected or laboratory-confirmed influenza. Peramivir might be a beneficial alternative antiviral treatment for many patients, including those unable to receive inhaled or oral neuraminidase inhibitors, or those requiring nonintravenous

Expression and Reception of Treatment Information in Breast Cancer Support Groups: How Health Self-Efficacy Moderates Effects on Emotional Well-Being

PubMed Central

Namkoong, Kang; Shah, Dhavan V.; Han, Jeong Yeob; Kim, Sojung Claire; Yoo, Woohyun; Fan, David; McTavish, Fiona M.; Gustafson, David H.

2010-01-01

Objectives To examine the effects of exchanging treatment information within computer-mediated breast cancer support groups on emotional well-being, and to explore whether this relationship is moderated by health self-efficacy. Methods Sample: 177 breast cancer patients using an electronic Health (eHealth) program with discussion group. Measure: expression and reception of treatment information; emotional well-being scale (0, 4 months). Analyses: hierarchical regression. Results Effects of expression and reception of treatment information on emotional well-being were significantly greater for those who have higher health self-efficacy. Conclusions Results conditionally support prior research finding positive effects of treatment information exchanges among breast cancer patients. Such exchanges had a positive impact on emotional well-being for those with higher health self-efficacy, but they had a negative influence for those with lower health self-efficacy. Practice implications Given that the association between emotional well-being and exchanging treatment information was moderated by health self-efficacy, clinicians should explain the role of health self-efficacy before encouraging patients to use eHealth systems for treatment exchanges. PMID:21044825

Molecular Tools for Monitoring the Ecological Sustainability of a Stone Bio-Consolidation Treatment at the Royal Chapel, Granada

PubMed Central

Jroundi, Fadwa; Gonzalez-Muñoz, Maria Teresa; Sterflinger, Katja; Piñar, Guadalupe

2015-01-01

Background Biomineralization processes have recently been applied in situ to protect and consolidate decayed ornamental stone of the Royal Chapel in Granada (Spain). While this promising method has demonstrated its efficacy regarding strengthening of the stone, little is known about its ecological sustainability. Methodology/Principal Findings Here, we report molecular monitoring of the stone-autochthonous microbiota before and at 5, 12 and 30 months after the bio-consolidation treatment (medium/long-term monitoring), employing the well-known molecular strategy of DGGE analyses. Before the bio-consolidation treatment, the bacterial diversity showed the exclusive dominance of Actinobacteria (100%), which decreased in the community (44.2%) after 5 months, and Gamma-proteobacteria (30.24%) and Chloroflexi (25.56%) appeared. After 12 months, Gamma-proteobacteria vanished from the community and Cyanobacteria (22.1%) appeared and remained dominant after thirty months, when the microbiota consisted of Actinobacteria (42.2%) and Cyanobacteria (57.8%) only. Fungal diversity showed that the Ascomycota phylum was dominant before treatment (100%), while, after five months, Basidiomycota (6.38%) appeared on the stone, and vanished again after twelve months. Thirty months after the treatment, the fungal population started to stabilize and Ascomycota dominated on the stone (83.33%) once again. Members of green algae (Chlorophyta, Viridiplantae) appeared on the stone at 5, 12 and 30 months after the treatment and accounted for 4.25%, 84.77% and 16.77%, respectively. Conclusions The results clearly show that, although a temporary shift in the bacterial and fungal diversity was observed during the first five months, most probably promoted by the application of the bio-consolidation treatment, the microbiota tends to regain its initial stability in a few months. Thus, the treatment does not seem to have any negative side effects on the stone-autochthonous microbiota over that time

Molecular Tools for Monitoring the Ecological Sustainability of a Stone Bio-Consolidation Treatment at the Royal Chapel, Granada.

PubMed

Jroundi, Fadwa; Gonzalez-Muñoz, Maria Teresa; Sterflinger, Katja; Piñar, Guadalupe

2015-01-01

Biomineralization processes have recently been applied in situ to protect and consolidate decayed ornamental stone of the Royal Chapel in Granada (Spain). While this promising method has demonstrated its efficacy regarding strengthening of the stone, little is known about its ecological sustainability. Here, we report molecular monitoring of the stone-autochthonous microbiota before and at 5, 12 and 30 months after the bio-consolidation treatment (medium/long-term monitoring), employing the well-known molecular strategy of DGGE analyses. Before the bio-consolidation treatment, the bacterial diversity showed the exclusive dominance of Actinobacteria (100%), which decreased in the community (44.2%) after 5 months, and Gamma-proteobacteria (30.24%) and Chloroflexi (25.56%) appeared. After 12 months, Gamma-proteobacteria vanished from the community and Cyanobacteria (22.1%) appeared and remained dominant after thirty months, when the microbiota consisted of Actinobacteria (42.2%) and Cyanobacteria (57.8%) only. Fungal diversity showed that the Ascomycota phylum was dominant before treatment (100%), while, after five months, Basidiomycota (6.38%) appeared on the stone, and vanished again after twelve months. Thirty months after the treatment, the fungal population started to stabilize and Ascomycota dominated on the stone (83.33%) once again. Members of green algae (Chlorophyta, Viridiplantae) appeared on the stone at 5, 12 and 30 months after the treatment and accounted for 4.25%, 84.77% and 16.77%, respectively. The results clearly show that, although a temporary shift in the bacterial and fungal diversity was observed during the first five months, most probably promoted by the application of the bio-consolidation treatment, the microbiota tends to regain its initial stability in a few months. Thus, the treatment does not seem to have any negative side effects on the stone-autochthonous microbiota over that time. The molecular strategy employed here is suggested as an

Mediated by Self-Efficacy Status, Positive Clinician Conveyed Expectations of Treatment Effect Reduces Pain in Knee Osteoarthritis

PubMed Central

Lo, Grace Hsiao-Wei; Balasubramanyam, Ajay S.; Barbo, Andrea; Street, Richard L.; Suarez-Almazor, Maria E.

2016-01-01

Objective A prior knee osteoarthritis (OA) trial found that provider conveyed expectations for treatment success were associated with pain improvement. We hypothesized this relationship was mediated by patient self-efficacy since expectations of improvement may enhance one’s ability to control health behaviors, and therefore health. Our aim was to examine whether self-efficacy was a mediator of the relationship observed in this trial. Methods A secondary analysis of a three arm (traditional acupuncture, sham acupuncture, and wait list) trial for knee OA was conducted. Those in the acupuncture groups were equally randomized to acupuncturists trained to communicate a high or neutral expectation of treatment success (e.g. used language conveying high or unclear likelihood that acupuncture would reduce knee pain). A modified Arthritis Self-Efficacy Questionnaire and the Western Ontario McMasters (WOMAC) pain subscale were administered. Linear regression analyses were used to examine whether patient self-efficacy mediated the relationship between provider communication style and knee pain at 3 months. Results High expectation provider communication was associated with patient self-efficacy, β coefficient of 0.14 (95%CI: 0.01, 0.28). Self-efficacy was associated with WOMAC pain, β coefficient of −9.29 (95%CI: −11.11, −7.47), while controlling for the provider communication style. The indirect effect a*b of −1.36 for high versus neutral expectation, (bootstrap 95% CI: −2.80, −0.15, does not include 0), supports that patient self-efficacy mediates the relationship between provider-communicated expectations of treatment effects and knee pain. Conclusion Our findings suggest that clinician-conveyed expectations can enhance the benefit of treatments targeting knee OA symptoms, mediated by improved patient self-efficacy. PMID:26554869

Efficacy and mechanism of action of turmeric supplements in the treatment of experimental arthritis.

PubMed

Funk, Janet L; Frye, Jennifer B; Oyarzo, Janice N; Kuscuoglu, Nesrin; Wilson, Jonathan; McCaffrey, Gwen; Stafford, Gregory; Chen, Guanjie; Lantz, R Clark; Jolad, Shivanand D; Sólyom, Aniko M; Kiela, Pawel R; Timmermann, Barbara N

2006-11-01

Scientific evidence is lacking for the antiarthritic efficacy of turmeric dietary supplements that are being promoted for arthritis treatment. Therefore, we undertook studies to determine the antiarthritic efficacy and mechanism of action of a well-characterized turmeric extract using an animal model of rheumatoid arthritis (RA). The composition of commercial turmeric dietary supplements was determined by high-performance liquid chromatography. A curcuminoid-containing turmeric extract similar in composition to these supplements was isolated and administered intraperitoneally to female Lewis rats prior to or after the onset of streptococcal cell wall-induced arthritis. Efficacy in preventing joint swelling and destruction was determined clinically, histologically, and by measurement of bone mineral density. Mechanism of action was elucidated by analysis of turmeric's effect on articular transcription factor activation, microarray analysis of articular gene expression, and verification of the physiologic effects of alterations in gene expression. A turmeric fraction depleted of essential oils profoundly inhibited joint inflammation and periarticular joint destruction in a dose-dependent manner. In vivo treatment prevented local activation of NF-kappaB and the subsequent expression of NF-kappaB-regulated genes mediating joint inflammation and destruction, including chemokines, cyclooxygenase 2, and RANKL. Consistent with these findings, inflammatory cell influx, joint levels of prostaglandin E(2), and periarticular osteoclast formation were inhibited by turmeric extract treatment. These translational studies demonstrate in vivo efficacy and identify a mechanism of action for a well-characterized turmeric extract that supports further clinical evaluation of turmeric dietary supplements in the treatment of RA.

Efficacy of terbinafine compared to lanoconazole and luliconazole in the topical treatment of dermatophytosis in a guinea pig model.

PubMed

Ghannoum, M A; Long, L; Kim, H G; Cirino, A J; Miller, A R; Mallefet, P

2010-05-01

The in vivo efficacy of terbinafine was compared to lanoconazole and luliconazole in the topical treatment of dermatophytosis caused by Trichophyton mentagrophytes using a guinea pig model. Topical antifungal treatment commenced three days post-infection, and each agent was applied once daily for seven consecutive days. Upon completion of the treatment period, evaluations of clinical and mycological efficacies were performed, as was scanning electron microscopy (SEM) analyses. Data showed that while all tested antifungals demonstrated significant mycological efficacy in terms of eradicating the fungi over untreated control, terbinafine and luliconazole showed superior clinical efficacy compared to lanoconazole (P-values < 0.001 & 0.003, respectively). Terbinafine demonstrated the highest clinical percent efficacy. SEM analysis revealed hairs from terbinafine and lanoconazole-treated animals had near complete clearance of fungi, while samples from luliconazole-treated animals were covered with debris and few conidia. This study demonstrates that, in general, terbinafine possessed similar efficacy to lanoconazole and luliconazole in the treatment of dermatophytosis. Terbinafine tended to have superior clinical efficacy compared to the azoles tested, although this difference was not statistically significant against luliconazole. This apparent superiority may be due to the fungicidal activity of terbinafine compared to the fungistatic effect of the other two drugs.

Efficacy of treatment with pseudoephedrine in men with retrograde ejaculation.

PubMed

Shoshany, O; Abhyankar, N; Elyaguov, J; Niederberger, C

2017-07-01

The use of pseudoephedrine, an alpha agonist, for the treatment of retrograde ejaculation is well-known, however, there is no clear consensus from the literature regarding its efficacy and treatment protocol. We evaluated the efficacy of pseudoephedrine treatment in patients with retrograde ejaculation, utilizing a yet undescribed short-period treatment protocol. Twenty men were medically treated with pseudoephedrine for retrograde ejaculation between January 2010 and May 2016 (12 with complete retrograde ejaculation and 8 with partial retrograde ejaculation). All patients had a semen analysis and post-ejaculatory urinalysis before and after treatment. The treatment protocol consisted of 60 mg of pseudoephedrine every 6 h on the day before semen analysis and two more 60 mg doses on the day of the semen analysis. Diabetes was the most common etiology for complete retrograde ejaculation (60%), whereas an idiopathic cause was the most common etiology for partial retrograde ejaculation (82%). Of the 12 complete retrograde ejaculation patients treated with pseudoephedrine prior to semen analysis, 7 (58.3%) recovered spermatozoa in the antegrade ejaculate, with a mean total sperm count of 273.5 ± 172.5 million. Of the eight patients with partial retrograde ejaculation, five (62.5%) had a ≥50% increase in the antegrade total sperm count. In this group, the mean total sperm count increased from 26.9 ± 8.5 million before treatment to 84.2 ± 24.6 million after treatment, whereas the percentage of spermatozoa in the urine declined from 43.2 ± 9% to 17 ± 10%, respectively (both p < 0.05). Overall, in men with retrograde ejaculation treated with a pseudoephedrine regimen prior to ejaculation, some improvement in seminal parameters occurred in 14 (70%) patients, with 10 patients (38.5% of all patients) achieving antegrade total sperm counts over 39 million. © 2017 American Society of Andrology and European Academy of Andrology.

The Efficacy of Social Skills Treatment for Children with Asperger Syndrome

ERIC Educational Resources Information Center

Elder, Lisa M.; Caterino, Linda C.; Chao, Janet; Shaknai, Dina; De Simone, Gina

2006-01-01

Children with Asperger Syndrome present with significant social skills deficits, which may contribute to clinical problems such as anxiety, depression, and/or other behavioral disorders. This article provides a description of the nature of Asperger Syndrome and provides possible treatment interventions, specifically focusing on the efficacy of…

Efficacy and safety of insulin pump treatment in adult T1DM patients--influence of age and social environment.

PubMed

Grzanka, Małgorzata; Matejko, Bartłomiej; Cyganek, Katarzyna; Kozek, Elżbieta; Małecki, Maciej T; Klupa, Tomasz

2012-01-01

Continuous subcutaneous insulin infusion (CSII) via personal insulin pump is a valuable therapeutic tool in T1DM patients. However, adherence to recommended CSII-related behaviours may be of concern to young adults with intensive, variable daily activities (students, young professionals). The aim of this observational study was to estimate treatment outcomes in young adult patients with T1DM, and compare them with older individuals. Overall, 140 adults with T1DM on CSII were examined, divided into 2 subgroups: 77 patients younger than 26 years of age (mean 20.6 years) and 63 older subjects (mean 39.0). We compared the glycaemic control in both groups of T1DM subjects and analyzed treatment attitudes to identify potentially modifiable behaviours influencing the efficacy of the treatment. The younger individuals were characterized by significantly worse treatment outcomes, compared to the older ones: the mean HbA1c levels were 7.6 ± 1.3% and 6.9±1.3% (p=0.00001), while the mean glucose levels based on glucometer downloads were 161±33.6 mg/dL and 136±21.8 mg/dL (p=0.00001), respectively. The frequency of self-monitoring of blood glucose (SMBG) was lower in younger individuals (5.3±2.1 vs. 7.0±2.8 daily, p=0.0005, respectively); they were also less frequently used advanced pump functions, e.g. the bolus calculator (48% vs. 67% users, p=0.0014, respectively). The efficacy of CSII treatment observed in young T1DM adults was worse than in older patients. The reason for this phenomenon remains unclear, it may be due simply to age-dependend behaviours, to social environment, or both.

Meta-Analysis of Biofeedback for Tension-Type Headache: Efficacy, Specificity, and Treatment Moderators

ERIC Educational Resources Information Center

Nestoriuc, Yvonne; Rief, Winfried; Martin, Alexandra

2008-01-01

The aims of the present meta-analysis were to investigate the short- and long-term efficacy, multidimensional outcome, and treatment moderators of biofeedback as a behavioral treatment option for tension-type headache. A literature search identified 74 outcome studies, of which 53 were selected according to predefined inclusion criteria.…

Assessment of treatment efficacy and sebosuppressive effect of fractional radiofrequency microneedle on acne vulgaris.

PubMed

Lee, Kyung Real; Lee, Eo Gin; Lee, Hee Jung; Yoon, Moon Soo

2013-12-01

A minimally invasive fractional radiofrequency microneedle (FRM) device has been used in skin rejuvenation and acne scars, and a recent pilot study demonstrated the positive therapeutic effect on acne. We evaluated the efficacy of FRM device for acne vulgaris in Asians and conducted objective measurement to assess its effect on sebum production. Twenty Korean patients with acne vulgaris received a single full-face FRM treatment. Outcome assessments included standardized photography, physician's global assessment, patient's satisfaction scores, acne lesion count, and objective measurements of casual sebum level (CSL) and sebum excretion rate (SER). They were evaluated at baseline and 2, 4, 8 weeks after the treatment. After a single FRM treatment, the CSL and the SER showed 30-60% and 70-80% reduction, respectively, at week 2 (P < 0.01), and remained below the baseline level until week 8. Physician's global improvement scores for acne severity and acne lesion count also revealed clinical improvement with maximum efficacy at week 2, but returned to the baseline in most patients by week 8. Patients' satisfaction scores (0-4) were above 2 on average, and adverse effects were minimal. This prospective study demonstrated the sebosuppressive effect from a single FRM treatment, but its therapeutic efficacy in acne requires further evaluation. © 2013 Wiley Periodicals, Inc.

Clinical efficacy of a new ciclopiroxolamine/zinc pyrithione shampoo in scalp seborrheic dermatitis treatment.

PubMed

Lorette, Gérard; Ermosilla, Valérie

2006-01-01

Ciclopiroxolamine (CPO) and Zinc Pirythione (ZP) antifungals are efficient at treating scalp seborrheic dermatitis. This multicentre, single-blind, clinical study was conducted to evaluate the efficacy of a shampoo containing the 1.5% CPO/1% ZP association compared to the vehicle shampoo and to 2% ketoconazole foaming gel in the treatment of seborrheic dermatitis. In 189 patients randomised to apply 1 of the 3 products twice a week for 28 days, the global lesional score, erythema, pruritus, global efficacy, quality of life (SF12 and DLQI questionnaires) and tolerance were measured at 0, 7, 14 and 28 days. The 3 products reduced lesional score, erythema and pruritus from day 7 (p < 0.0001). The 2 antifungal treatments were significantly more efficient than the vehicle in reducing lesional score, erythema and pruritus at day 14 (p < 0.0001). At day 7, the CPO/ZP shampoo was more efficient in reducing pruritus than ketoconazole gel and vehicle (p = 0.032 and p < 0.001, respectively). The global efficacy of the 2 antifungal treatments assessed at day 28 by both investigator and patient was significantly better than that of the vehicle. Only the CPO/ZP shampoo improved all DLQI questionnaire dimensions. The CPO/ZP shampoo was as rapid and efficient as ketoconazole gel in SD treatment.

Relationship between internalized stigma and treatment efficacy in mixed neurotic spectrum and depressive disorders.

PubMed

Ociskova, Marie; Prasko, Jan; Kamaradova, Dana; Grambal, Ales; Latalova, Klara; Sigmundova, Zuzana

2014-01-01

Many psychiatric patients suffer from self-stigma. One consequence of these internalized prejudices is decreased treatment efficacy. Much has been written about the effects of self-stigma in patients with severe mental disorders. However, individuals with minor psychiatric disorders also suffer from self-stigma. It is therefore necessary to explore the effect of self-stigma on treatment efficacy of neurotic patients. Aim of out study was to investigate relationship between self-stigma, severity of symptoms, and presence of comorbidit disorder and treatment outcome in neurotic patients. Patients were treated by combined psycho and pharmacotherapy. Level of self-stigma was measured by Internalized Stigma Of Mental Illness scale. Severity of anxiety and depressive symptoms was assed by Beck Anxiety Inventory, Beck Depressive Inventory and Clinical Global Impression Scale. Level of self-stigma was significantly correlated with the levels of anxiety, depression and global evalutions of a mental state on the beginnig of the therapy. Up to our results patients with higher level of self-stigmatization had lower improvement after combined treatmet in respect to perceived anxiety symptoms. Self-stigma seems to be an important factor influencing efficacy of combined treatment. More researches focused on self-stigmatization should be done to find an optimal therapeutic strategy for patients with higher level of self-stigmatization.

Efficacy of a multidisciplinary treatment program in patients with severe fibromyalgia.

PubMed

Casanueva-Fernández, Benigno; Llorca, Javier; Rubió, Josep Blanch I; Rodero-Fernández, Baltasar; González-Gay, Miguel A

2012-08-01

The purpose of this study was to evaluate the efficacy of a multidisciplinary treatment program in patients severely affected by fibromyalgia. Thirty-four fibromyalgia patients were randomly divided into two groups. The control group: 17 women who continued their medical treatment and participated in four educational sessions and the experimental group that included 17 patients who besides the former medical treatment also underwent a weekly 1-h session program for 8 weeks including massage therapy, ischemic pressure on the 18 tender points, aerobic exercise and thermal therapy. At the beginning of the program, there were no significant differences between the two groups in any of the parameters. At the end of treatment, there was a significant improvement in the experimental group in the following items: vitality, social functioning, grip strength and the 6-min walk test. At 1 month after the end of treatment, the experimental group showed significant differences in overall health perception, social functioning, grip strength and the 6-min walk test. At that time, considering the threshold for clinical efficacy set at an improvement of 30% or above for the analyzed variables, 25% of the patients met the requirement for improvement of the following: number of symptoms: Visual Analogic Scale for fatigue, Fibromyalgia Impact Questionnaire and Beck Anxiety Inventory. In conclusion, patients with severe manifestations of fibromyalgia can obtain improvement with a short-term, low-cost and simple-delivery multidisciplinary program. However, additional studies including higher numbers of patients are needed to confirm the beneficial effect of this treatment program.

Therapeutic efficacy of chloroquine and chloroquine plus primaquine for the treatment of Plasmodium vivax in Ethiopia.

PubMed

Yeshiwondim, Asnakew K; Tekle, Afework H; Dengela, Dereje O; Yohannes, Ambachew M; Teklehaimanot, Awash

2010-02-01

Plasmodium vivax is the second most important cause of morbidity in Ethiopia. There is, however, little information on P. vivax resistance to chloroquine and chloroquine plus primaquine treatment although these drugs have been used as the first line treatment for over 50 years. We assessed the efficacy of standard chloroquine and chloroquine plus primaquine treatment for P. vivax infections in a randomized open-label comparative study in Debre Zeit and Nazareth in East Shoa, Ethiopia. A total of 290 patients with microscopically confirmed P. vivax malaria who presented to the outpatient settings of the two laboratory centers were enrolled: 145 patients were randomized to receive CQ and 145 to receive CQ+PQ treatment. Participants were followed-up for 28-157 days according to the WHO procedures. There were 12 (6.5%) lost to follow-up patients and 9 (3.1%) withdrawals. In all, 96% (277/290) of patients were analysed at day 28. Baseline characteristics were similar in all treatment groups. In all, 98.6% (275/277) of patients had cleared their parasitemia on day 3 with no difference in mean parasite clearance time between regimens (48.34+/-17.68, 50.67+/-15.70 h for the CQ and CQ+PQ group, respectively, P=0.25). The cumulative incidence of therapeutic failure at day 28 by a life-table analysis method was 5.76% (95% CI: 2.2-14.61) and 0.75% (95% CI: 0.11-5.2%) in the CQ and CQ+PQ group, respectively (P=0.19). The relapse rate was 8% (9/108) for the CQ group and 3% (4/132) for the comparison group (P=0.07). The cumulative risk of relapse at day 157 by a life-table method was 61.8% (95% CI: 20.1-98.4%) in the CQ group, compared with 26.3% (95% CI: 7.5-29.4%) in the CQ+PQ group (P=0.0038). The study confirms the emergence of CQ and PQ resistance/treatment failure in P. vivax malaria in Ethiopia. Although treatment failures were detected, they were similar between the treatment groups. We recommend regular monitoring and periodic evaluation of the efficacy of these

Therapeutic drug monitoring for drugs used in the treatment of substance-related disorders: literature review using a therapeutic drug monitoring appropriateness rating scale.

PubMed

Brünen, Sonja; Vincent, Philippe D; Baumann, Pierre; Hiemke, Christoph; Havemann-Reinecke, Ursula

2011-10-01

The efficacy of drugs for the treatment of substance-related disorders is moderate at best. Therapeutic drug monitoring (TDM) could be an instrument to improve outcomes. Because TDM for most of those drugs is not established, the authors reviewed the literature and built a rating scale to detect the potential added value of TDM for these pharmacologic agents. A literature search was performed for acamprosate, bupropion, buprenorphine, clomethiazole, disulfiram, methadone, naltrexone, and varenicline. The rating scale included 22 items and was divided in five categories: efficacy, toxicity, pharmacokinetics, patient characteristics, and cost-effectiveness. Three reference substances with established TDM were similarly assessed for comparison: clozapine, lithium, and nortriptyline. The three reference substances achieved scores of 15, 12, and 14 points, respectively. Drugs for treatment of substance-related disorders achieved 3 to 17 points, 17 for methadone, 11 for buprenorphine, 10 for disulfiram, also 10 for naltrexone for the indication opioid-dependence and 9 for the indication alcohol dependence as well as bupropion, 7 points for acamprosate, 6 points for clomethiazole, and 3 for varenicline. It is concluded that systematic evaluation of drug- and patient-related variables with the new rating scale can estimate the appropriateness of TDM. Because their rating revealed similar scores as the three reference drugs, it is proposed that TDM should be established for bupropion, buprenorphine, disulfiram or a metabolite, methadone, and naltrexone. An objective rating of drug- and patient-related characteristics could help laboratories focus their method development on the most likely drugs to require TDM along with a thorough drug use evaluation.

The efficacy of topical and oral ivermectin in the treatment of human scabies.

PubMed

Panahi, Yunes; Poursaleh, Zohreh; Goldust, Mohamad

2015-01-01

Scabies is an itchy skin condition caused by the microscopic mite Sarcoptes scabei. The itching is caused by an allergic reaction to the mites. The treatment of choice is still controversial. It is commonly treated with topical insecticides. The aim of this study was to assess the efficacy of topical and oral ivermectin in the treatment of human scabies. We searched electronic databases (Cochrane Occupational Safety and Health Review Group Specialised Register, CENTRAL (The Cochrane Library), MEDLINE (Ovid), Pubmed, EMBASE, LILACS, CINAHL, Open Grey and WHO ICTRP) up to September 2014. Randomized controlled trials (RCTs) or cluster RCTs which compared the efficacy of ivermectin with other medications in the treatment of scabies. Interventions could be compared to each other, or to placebo or to no treatment. The author intended to extract dichotomous data (developed infection or did not develop infection) for the effects of interventions. We intended to report any adverse outcomes similarly. It has been sated that ivermectin was as effective as permethrin in the treatment of scabies. In comparison to other medications such as lindane, benzyl benzoate, crotamiton and malathion, ivermectin was more effective in the treatment of scabies. Ivermectin is an effective and cost-comparable alternative to topical agents in the treatment of scabies infection.

Apatinib for metastatic breast cancer in non-clinical trial setting: Satisfying efficacy regardless of previous anti-angiogenic treatment.

PubMed

Lin, Ying; Wu, Zheng; Zhang, Jian; Hu, Xichun; Wang, Zhonghua; Wang, Biyun; Cao, Jun; Wang, Leiping

2017-06-01

Apatinib is a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2. This study aimed to evaluate the efficacy and safety of apatinib in metastatic breast cancer (MBC) under non-clinical trial setting, and to study the impact of previous antiangiogenic treatment to the efficacy of apatinib. 52 MBC patients treated with apatinib under non-clinical trial setting in Fudan University Shanghai Cancer Center between January 1st 2015 and October 1st 2016 were included. All patients were included in time-to-treatment failure (TTF) analysis, while 45 patients were enrolled for progression-free survival (PFS) and overall survival (OS) analysis because 7 of the patients with treatment discontinuation due to intolerable toxicities had too short time for efficacy assessment. Impact of previous exposure to antiangiogenic treatment and other factors to patients' survival were analyzed by Log-rank analysis and Cox multivariate analysis. The median PFS, median OS, and median TTF were 4.90 (95% confidence interval [CI] 3.44 - 6.36), 10.3 (unable to calculate 95% CI), and 3.93 (95% CI 1.96 - 5.90) months, respectively. Previous treatment of bevacizumab did not affect the efficacy of apatinib. Previous exposure to anthracycline, age of 60 years or older and palmar-plantar erythrodysesthesia syndrome were independent predictors for prolonged PFS. Discontinuation of treatment was more common in age group of 60 years or older than that in younger group, although the difference was not significant. Although toxicities were generally managable, a previously unrecorded grade 3~4 adverse event of dyspnea has been observed. This study confirmed the encouraging efficacy and manageable safety of apatinib on pretreated MBC patients in non-clinical trial setting. For the first time to our knowledge, this study found that previous treatment of bevacizumab did not affect the efficacy of apatinib, and reported an undocumented severe adverse effect of dyspnea.

A meta-analysis of the efficacy of fibromyalgia treatment according to level of care

PubMed Central

Garcia-Campayo, Javier; Magdalena, Jesus; Magallón, Rosa; Fernández-García, Esther; Salas, Montserrat; Andrés, Eva

2008-01-01

Introduction The aim of this paper was to compare the efficacy of the treatments for fibromyalgia currently available in both primary care and specialised settings. Methods Published reports of randomised controlled trials (RCTs) researching pharmacological and non-pharmacological treatments in patients with fibromyalgia were found in the MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and PsychInfo databases. The most recent electronic search was undertaken in June 2006. Results We identified a total of 594 articles. Based on titles and abstracts, 102 full articles were retrieved, 33 of which met the inclusion criteria. These RCTs assessed 120 treatment interventions in 7789 patients diagnosed with primary fibromyalgia. Of them, 4505 (57.8%) were included in the primary care group of our study and 3284 (42.2%) in the specialised intervention group. The sample was mostly made up of middle-aged women, who have had fibromyalgia for a mean period of 6 to 10 years. The mean effect size of the efficacy of the 120 treatment interventions in patients with fibromyalgia compared with controls was 0.49 (95% confidence interval [CI] = 0.39 to 0.58; p < 0.001). In the primary care group it was 0.46 (95% CI = 0.33 to 0.58) while in specialised care it was 0.53 (95% CI = 0.38 to 0.69), with no statistical significance in the differences. We analysed the efficacy of treatments by comparing primary and specialised care in the different fibromyalgia groups and there were no significant differences. The variables of the studies that affected the improvements in the efficacy of fibromyalgia treatment were low quality of the studies and a shorter duration of treatment. However, both factors were biased by the heterogeneity of the studies. Other variables that also improved outcome and were not biased by the heterogeneity of the studies, were younger age of the patients and shorter duration of the disorder. On the contrary, gender and type of treatment

Comparison of clinical efficacy between 3-day combined clavulanate/amoxicillin preparation treatment and 10-day amoxicillin treatment in children with pharyngolaryngitis or tonsillitis.

PubMed

Kuroki, Haruo; Ishiwada, Naruhiko; Inoue, Nobue; Ishikawa, Nobuyasu; Suzuki, Hiroshi; Himi, Kyoko; Kurosaki, Tomomichi

2013-02-01

The efficacy of 3-day treatment with a combined clavulanate/amoxicillin preparation (Clavamox combination dry syrup for pediatric cases) and 10-day treatment with amoxicillin against pediatric pharyngolaryngitis and tonsillitis caused by Group A β-hemolytic Streptococcus was compared. Among the patients included in the efficacy evaluation (54 from the clavulanate/amoxicillin group and 43 from the amoxicillin group), the clinical response rate on completion of treatment was 98.1 % in the clavulanate/amoxicillin group and 92.9 % in the amoxicillin group, thus supporting the equivalent efficacy of these two therapies. The Group A β-hemolytic Streptococcus eradication rate at approximately 1-2 weeks after completion/discontinuation of treatment was 65.4 % in the clavulanate/amoxicillin group and 85.4 % in the amoxicillin group. Even in cases from which the pathogen continued to be isolated, relapse/recurrence of clinical symptoms was seldom seen. Urinalysis, conducted to assess the presence or absence of acute glomerulonephritis, revealed no abnormality in any patient. These results suggest that 3-day treatment with this clavulanate/amoxicillin preparation is expected to provide a valid means of treating pediatric pharyngolaryngitis and tonsillitis caused by Group A β-hemolytic Streptococcus.

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

PubMed

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.

Current Approaches, Challenges and Future Directions for Monitoring Treatment Response in Prostate Cancer

PubMed Central

Wallace, T.J.; Torre, T.; Grob, M.; Yu, J.; Avital, I.; Brücher, BLDM; Stojadinovic, A.; Man, Y.G.

2014-01-01

Prostate cancer is the most commonly diagnosed non-cutaneous neoplasm in men in the United States and the second leading cause of cancer mortality. One in 7 men will be diagnosed with prostate cancer during their lifetime. As a result, monitoring treatment response is of vital importance. The cornerstone of current approaches in monitoring treatment response remains the prostate-specific antigen (PSA). However, with the limitations of PSA come challenges in our ability to monitor treatment success. Defining PSA response is different depending on the individual treatment rendered potentially making it difficult for those not trained in urologic oncology to understand. Furthermore, standard treatment response criteria do not apply to prostate cancer further complicating the issue of treatment response. Historically, prostate cancer has been difficult to image and no single modality has been consistently relied upon to measure treatment response. However, with newer imaging modalities and advances in our understanding and utilization of specific biomarkers, the future for monitoring treatment response in prostate cancer looks bright. PMID:24396494

Efficacy of combination of glycolic acid peeling with topical regimen in treatment of melasma.

PubMed

Chaudhary, Savita; Dayal, Surabhi

2013-10-01

Various treatment modalities are available for management of melasma, ranging from topical and oral to chemical peeling, but none is promising alone. Very few studies are available regarding efficacy of combination of topical treatment with chemical peeling. Combination of chemical peeling and topical regimen can be a good treatment modality in the management of this recalcitrant disorder. To assess the efficacy of combination of topical regimen (2% hydroquinone, 1% hydrocortisone and 0.05% tretinoin) with serial glycolic acid peeling in the treatment of melasma in Indian patients. Forty Indian patients of moderate to severe epidermal variety melasma were divided into two groups of 20 each. One Group i.e. peel group received topical regimen (2% hydroquinone, 1% hydrocortisone and 0.05% tretinoin) with serial glycolic acid peeling and other group i.e. control group received topical regimen (2% hydroquinone, 1% hydrocortisone, 0.05% tretinoin). There was an overall decrease in MASI from baseline in 24 weeks of therapy in both the groups (P value < 0.05). The group receiving the glycolic acid peel with topical regimen showed early and greater improvement than the group which was receiving topical regimen only. This study concluded that combining topical regimen (2% hydroquinone, 1% hydrocortisone and 0.05% tretinoin) with serial glycolic acid peeling significantly enhances the therapeutic efficacy of glycolic acid peeling. The combination of glycolic acid peeling with the topical regimen is a highly effective, safe and promising therapeutic option in treatment of melasma.

Treatment options for demodex blepharitis: patient choice and efficacy.

PubMed

Hirsch-Hoffmann, S; Kaufmann, C; Bänninger, P B; Thiel, M A

2015-04-01

Demodex mites are microscopic parasites that live around hair follicles or sebaceous glands and may cause chronic blepharitis. The aim of this outcome analysis was to assess the efficacy and patient preferences with regard to the currently recommended treatment options. All patients with microscopic evidence for Demodex blepharitis were informed about the currently published treatments and instructed about daily lid hygiene. Additional topical treatment options included tea tree oil (TTO) 5%, a cleansing foam containing 0.02% TTO (Naviblef®), and metronidazole 2% ointment. Systemic treatment options included oral ivermectin 6 mg on day 1 and 14 and metronidazole 500 mg twice daily for 10 days. All patients were reviewed after 2 months for symptoms and for a mite count on 10 epilated lashes. Ninety-four of 96 patients with Demodex blepharitis opted for an additional treatment. The mean mite count after 2 months of treatment were 13.3 with 5% TTO (n=6), 12.0 with 0.02% TTO (n=38), 9.4 with metronidazole ointment (n=5), 12.8 with ivermectin (n=27) and 22.0 with oral metronidazole (n=5). While there are several published treatment options available, none of these options seem to be clearly effective in Demodex blepharitis. Georg Thieme Verlag KG Stuttgart · New York.

Monitoring guidance for patients with hypophosphatasia treated with asfotase alfa.

PubMed

Kishnani, Priya S; Rush, Eric T; Arundel, Paul; Bishop, Nick; Dahir, Kathryn; Fraser, William; Harmatz, Paul; Linglart, Agnès; Munns, Craig F; Nunes, Mark E; Saal, Howard M; Seefried, Lothar; Ozono, Keiichi

2017-09-01

Hypophosphatasia (HPP) is a rare, inherited, systemic, metabolic disorder caused by autosomal recessive mutations or a single dominant-negative mutation in the gene encoding tissue-nonspecific alkaline phosphatase (TNSALP). The disease is associated with a broad range of signs, symptoms, and complications, including impaired skeletal mineralization, altered calcium and phosphate metabolism, recurrent fractures, pain, respiratory problems, impaired growth and mobility, premature tooth loss, developmental delay, and seizures. Asfotase alfa is a human, recombinant enzyme replacement therapy that is approved in many countries for the treatment of patients with HPP. To address the unmet need for guidance in the monitoring of patients receiving asfotase alfa, an international panel of physicians with experience in diagnosing and managing HPP convened in May 2016 to discuss treatment monitoring parameters. The panel discussions focused on recommendations for assessing and monitoring patients after the decision to treat with asfotase alfa had been made and did not include recommendations for whom to treat. Based on the consensus of panel members, this review provides guidance on the monitoring of patients with HPP during treatment with asfotase alfa, including recommendations for laboratory, efficacy, and safety assessments and the frequency with which these should be performed during the course of treatment. Recommended assessments are based on patient age and include regular monitoring of biochemistry, skeletal radiographs, respiratory function, growth, pain, mobility and motor function, and quality of life. Because of the systemic presentation of HPP, a coordinated, multidisciplinary, team-based, patient-focused approach is recommended in the management of patients receiving asfotase alfa. Monitoring of efficacy and safety outcomes must be tailored to the individual patient, depending on medical history, clinical manifestations, availability of resources in the clinical

The Schistosomiasis Clinical Trials Landscape: A Systematic Review of Antischistosomal Treatment Efficacy Studies and a Case for Sharing Individual Participant-Level Data (IPD)

PubMed Central

Vaillant, Michel; Lang, Trudie A.; Guérin, Philippe J.; Olliaro, Piero L.

2016-01-01

Background Schistosomiasis control mainly relies on preventive chemotherapy with praziquantel (PZQ) distributed through mass drug administration. With a target of 260 million treatments yearly, reliably assessing and monitoring efficacy is all-important. Recommendations for treatment and control of schistosomiasis are supported by systematic reviews and meta-analyses of aggregated data, which however also point to limitations due to heterogeneity in trial design, analyses and reporting. Some such limitations could be corrected through access to individual participant-level data (IPD), which facilitates standardised analyses. Methodology A systematic literature review was conducted to identify antischistosomal drug efficacy studies performed since 2000; including electronic searches of the Cochrane Infectious Diseases Group specialised register and the Cochrane Library, PubMed, CENTRAL and Embase; complemented with a manual search for articles listed in past reviews. Antischistosomal treatment studies with assessment of outcome within 60 days post-treatment were eligible. Meta-data, i.e. study-level characteristics (Schistosoma species, number of patients, drug administered, country, etc.) and efficacy parameters were extracted from published documents to evaluate the scope of an individual-level data sharing platform. Principal findings Out of 914 documents screened, 90 studies from 26 countries were included, enrolling 20,517 participants infected with Schistosoma spp. and treated with different PZQ regimens or other drugs. Methodologies varied in terms of diagnostic approaches (number of samples and test repeats), time of outcome assessment, and outcome measure (cure rate or egg reduction rate, as an arithmetic or geometric mean), making direct comparison of published data difficult. Conclusions This review describes the landscape of schistosomiasis clinical research. The volume of data and the methodological and reporting heterogeneity identified all indicate

The Schistosomiasis Clinical Trials Landscape: A Systematic Review of Antischistosomal Treatment Efficacy Studies and a Case for Sharing Individual Participant-Level Data (IPD).

PubMed

Julé, Amélie M; Vaillant, Michel; Lang, Trudie A; Guérin, Philippe J; Olliaro, Piero L

2016-06-01

Schistosomiasis control mainly relies on preventive chemotherapy with praziquantel (PZQ) distributed through mass drug administration. With a target of 260 million treatments yearly, reliably assessing and monitoring efficacy is all-important. Recommendations for treatment and control of schistosomiasis are supported by systematic reviews and meta-analyses of aggregated data, which however also point to limitations due to heterogeneity in trial design, analyses and reporting. Some such limitations could be corrected through access to individual participant-level data (IPD), which facilitates standardised analyses. A systematic literature review was conducted to identify antischistosomal drug efficacy studies performed since 2000; including electronic searches of the Cochrane Infectious Diseases Group specialised register and the Cochrane Library, PubMed, CENTRAL and Embase; complemented with a manual search for articles listed in past reviews. Antischistosomal treatment studies with assessment of outcome within 60 days post-treatment were eligible. Meta-data, i.e. study-level characteristics (Schistosoma species, number of patients, drug administered, country, etc.) and efficacy parameters were extracted from published documents to evaluate the scope of an individual-level data sharing platform. Out of 914 documents screened, 90 studies from 26 countries were included, enrolling 20,517 participants infected with Schistosoma spp. and treated with different PZQ regimens or other drugs. Methodologies varied in terms of diagnostic approaches (number of samples and test repeats), time of outcome assessment, and outcome measure (cure rate or egg reduction rate, as an arithmetic or geometric mean), making direct comparison of published data difficult. This review describes the landscape of schistosomiasis clinical research. The volume of data and the methodological and reporting heterogeneity identified all indicate that there is scope for an individual participant

Turner syndrome in Albania and the efficacy of its treatment with growth hormone.

PubMed

Hoxha, Petrit; Babameto-Laku, Anila; Vyshka, Gentian; Gjoka, Klodiana; Minxuri, Dorina; Myrtaj, Elira; Çakërri, Luljeta

2015-11-01

The aim of this study was the evaluation of Turner syndrome inside the Albanian population, its clinical, cytological and genetic characteristics, the accompanying pathologies, and the efficacy of the treatment with the growth hormone. We performed a retrospective analysis of 59 patients suffering from this syndrome (aging from 5 to 23 years old). The diagnosis of female patients suffering from Turner syndrome is delayed, with a mean age at the moment of diagnosis of 13.74 years (5-23 years). The main reason for seeking medical advice was the growth retardation or a delayed puberty. Available data for 52 patients showed that the most frequent accompanying pathologies were the following: thyroid autoimmune disorders (59%), cardiovascular anomalies (43%), renal pathologies (41%), hearing impairment (4.3%) and hypertension (3.3%). Follow-up for the growth rate was possible for 52 patients out of the total of 59 patients. Twenty-five of the female patients suffering Turner syndrome and forming part of our study sample were treated with growth hormone for a period averaging 3 years and 4 months. A variety of reasons was identified as responsible for the missed treatment in 27 patients. We saw an enhanced growth (in terms of body height) within the treated subgroup, when compared with the untreated subgroup (27 patients), especially during the first 3 years of the follow-up. No side effects of this treatment were reported. Both groups of patients initiated as well a sexual hormone therapy (estrogens and progesterone) for inducing puberty at the age of 12 years. Further work is needed for an early diagnosis of this syndrome, the prompt treatment with growth hormone and the monitoring of accompanying disorders. This will ensure a better quality of life and an improvement of the longevity of patients suffering from the Turner syndrome.

Efficacy of chloroquine for the treatment of uncomplicated Plasmodium falciparum malaria in Honduras.

PubMed

Mejia Torres, Rosa Elena; Banegas, Engels Ilich; Mendoza, Meisy; Diaz, Cesar; Bucheli, Sandra Tamara Mancero; Fontecha, Gustavo A; Alam, Md Tauqeer; Goldman, Ira; Udhayakumar, Venkatachalam; Zambrano, Jose Orlinder Nicolas

2013-05-01

Chloroquine (CQ) is officially used for the primary treatment of Plasmodium falciparum malaria in Honduras. In this study, the therapeutic efficacy of CQ for the treatment of uncomplicated P. falciparum malaria in the municipality of Puerto Lempira, Gracias a Dios, Honduras was evaluated using the Pan American Health Organization-World Health Organization protocol with a follow-up of 28 days. Sixty-eight patients from 6 months to 60 years of age microscopically diagnosed with uncomplicated P. falciparum malaria were included in the final analysis. All patients who were treated with CQ (25 mg/kg over 3 days) cleared parasitemia by day 3 and acquired no new P. falciparum infection within 28 days of follow-up. All the parasite samples sequenced for CQ resistance mutations (pfcrt) showed only the CQ-sensitive genotype (CVMNK). This finding shows that CQ remains highly efficacious for the treatment of uncomplicated P. falciparum malaria in Gracias a Dios, Honduras.

Efficacy of Chloroquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in Honduras

PubMed Central

Torres, Rosa Elena Mejia; Banegas, Engels Ilich; Mendoza, Meisy; Diaz, Cesar; Bucheli, Sandra Tamara Mancero; Fontecha, Gustavo A.; Alam, Md Tauqeer; Goldman, Ira; Udhayakumar, Venkatachalam; Zambrano, Jose Orlinder Nicolas

2013-01-01

Chloroquine (CQ) is officially used for the primary treatment of Plasmodium falciparum malaria in Honduras. In this study, the therapeutic efficacy of CQ for the treatment of uncomplicated P. falciparum malaria in the municipality of Puerto Lempira, Gracias a Dios, Honduras was evaluated using the Pan American Health Organization—World Health Organization protocol with a follow-up of 28 days. Sixty-eight patients from 6 months to 60 years of age microscopically diagnosed with uncomplicated P. falciparum malaria were included in the final analysis. All patients who were treated with CQ (25 mg/kg over 3 days) cleared parasitemia by day 3 and acquired no new P. falciparum infection within 28 days of follow-up. All the parasite samples sequenced for CQ resistance mutations (pfcrt) showed only the CQ-sensitive genotype (CVMNK). This finding shows that CQ remains highly efficacious for the treatment of uncomplicated P. falciparum malaria in Gracias a Dios, Honduras. PMID:23458957

[Efficacy of chondroitin sulphate in the treatment of elderly patients with gonarthrosis and coxarthrosis].

PubMed

Lazebnik, L B; Drozdov, V N

2005-01-01

To study chondroitin sulphate (CS) efficacy, tolerance and response duration in elderly patients with osteoarthrosis (OA) with consideration of OA duration and stage. A total of 97 patients aged 65-85 years with stage II-IV OA by Kellgren-Lawrence received CS treatment. The treatment efficacy was assessed by functional Lecken's index, pain intensity at walking and rest, general functional condition, need in nonsteroid anti-inflammatory (NSAI) drugs. Standardization was achieved with visual analogue scale (VAS). Positive effects (pain relief, better functional parameters, lower intake of NSAI drugs) were more pronounced and stable in patients with OA stage 1 and 2. In OA of stage 3 and 4, a beneficial effect of a 6-month CS course was unstable. Side effects were at the level of mean statistics. CS (structum) is recommended for treatment of OA stage 1-4 by Kellgren-Lawrence. Duration of the treatment depends on severity of x-ray symptoms of the disease.

Synergistic efficacy of salicylic acid with a penetration enhancer on human skin monitored by OCT and diffuse reflectance spectroscopy

NASA Astrophysics Data System (ADS)

Zhao, Qingliang; Dai, Cuixia; Fan, Shanhui; Lv, Jing; Nie, Liming

2016-10-01

Salicylic acid (SA) has been frequently used as a facial chemical peeling agent (FCPA) in various cosmetics for facial rejuvenation and dermatological treatments in the clinic. However, there is a tradeoff between therapeutic effectiveness and possible adverse effects caused by this agent for cosmetologists. To optimize the cosmetic efficacy with minimal concentration, we proposed a chemical permeation enhancer (CPE) azone to synergistically work with SA on human skin in vivo. The optical properties of human skin after being treated with SA alone and SA combined with azone (SA@azone) were successively investigated by diffuse reflectance spectroscopy (DRS) and optical coherence tomography (OCT). Our results revealed that as the SA concentration increased, the light reflectance decreased and the absorption increased. We also found that SA@azone exhibited a synergistic effect on enhancing light penetration and OCT imaging depth. We demonstrated that the combination of DRS and OCT techniques could be used as a noninvasive, rapid and accurate measurement method to monitor the subtle changes of skin tissue after treatment with FCPA and CPE. The approach will greatly benefit the development of clinical cosmetic surgery, dermatosis diagnosis and therapeutic effect inspection in related biomedical studies.

Ovicidal efficacy of fenbendazole after treatment of horses naturally infected with cyathostomins.

PubMed

Daniels, S P; Proudman, C J

2016-08-30

The ovicidal activity of benzimidazole (BZ) anthelmintics is unique and not seen in other drug classes. Such ovicidal efficacy is not widely reported for equine cyathostomins, nor has this activity been tested in the face of BZ resistance. Although the product label states that fenbendazole is for use against BZ-susceptible cyathostomins, susceptibility testing is rarely performed. In this field-based study, the ovicidal efficacy of fenbendazole in horses (n=39) harbouring BZ-resistant cyathostomins was compared when dosed at 7.5mg/kg body weight (BW) orally, as a single dose per os (n=21) or daily for five consecutive days in feed (n=18). Suppression of egg hatch rate was observed in the single and five- day treatment groups; a significant difference between pre- and post-treatment egg hatch rates (P<0.05) was observed for three days after treatment with a single dose of fenbendazole (on premises with BZ-resistant cyathostomins), and for three days after treatment for five consecutive days with fenbendazole (on premises with BZ-resistant cyathostomins). Post treatment numbers of eggs and larvae remained significantly lower (P<0.05) than pre-treatment levels to the end of the trial. We conclude that in the face of BZ-resistant cyathostomins the ovicidal effect of fenbendazole persist for three days after both a single oral dose of 7.5mg/kg per os and after treatment orally for five consecutive daily doses at 7.5mg/kg in feed. Copyright © 2016 Elsevier B.V. All rights reserved.

Efficacy and safety of liquid nitrogen cryotherapy for treatment of Barrett’s esophagus

PubMed Central

Suchniak-Mussari, Kristen; Dye, Charles E; Moyer, Matthew T; Mathew, Abraham; McGarrity, Thomas J; Gagliardi, Eileen M; Maranki, Jennifer L; Levenick, John M

2017-01-01

AIM To evaluate the efficacy and safety of liquid nitrogen cryotherapy as a primary or rescue treatment for BE, with and without dysplasia, or intramucosal adenocarcinoma (IMC). METHODS This was a retrospective, single-center study carried out in a tertiary care center including 45 patients with BE who was treatment-naïve or who had persistent intestinal metaplasia (IM), dysplasia, or IMC despite prior therapy. Barrett’s mucosa was resected via EMR when clinically appropriate, then patients underwent cryotherapy until eradication or until deemed to have failed treatment. Surveillance biopsies were taken at standard intervals. RESULTS From 2010 through 2014, 33 patients were studied regarding the efficacy of cryotherapy. Overall, 29 patients (88%) responded to cryotherapy, with 84% having complete regression of all dysplasia and cancer. Complete eradication of cancer and dysplasia was seen in 75% of subjects with IMC; the remaining two subjects did not respond to cryotherapy. Following cryotherapy, 15 patients with high-grade dysplasia (HGD) had 30% complete regression, 50% IM, and 7% low-grade dysplasia (LGD); one subject had persistent HGD. Complete eradication of dysplasia occurred in all 5 patients with LGD. In 5 patients with IM, complete regression occurred in 4, and IM persisted in one. In 136 cryotherapy sessions amongst 45 patients, adverse events included chest pain (1%), stricture (4%), and one gastrointestinal bleed in a patient on dual antiplatelet therapy who had previously undergone EMR. CONCLUSION Cryotherapy is an efficacious and safe treatment modality for Barrett’s esophagus with and without dysplasia or intramucosal adenocarcinoma. PMID:28979713

Efficacy of Brief Behavioral Treatment for Chronic Insomnia in Older Adults

PubMed Central

Buysse, Daniel J.; Germain, Anne; Moul, Douglas E.; Franzen, Peter L.; Brar, Laurie K.; Fletcher, Mary E.; Begley, Amy; Houck, Patricia R.; Mazumdar, Sati; Reynolds, Charles F.; Monk, Timothy H.

2011-01-01

Background Chronic insomnia is a common health problem with substantial consequences in older adults. Cognitive behavioral treatments are efficacious but not widely available. The aim of this study was to test the efficacy of brief behavioral treatment for insomnia (BBTI) vs an information control (IC) condition. Methods A total of 79 older adults (mean age, 71.7 years; 54 women [70%]) with chronic insomnia and common comorbidities were recruited from the community and 1 primary care clinic. Participants were randomly assigned to either BBTI, consisting of individualized behavioral instructions delivered in 2 intervention sessions and 2 telephone calls, or IC, consisting of printed educational material. Both interventions were delivered by a nurse clinician. The primary outcome was categorically defined treatment response at 4 weeks, based on sleep questionnaires and diaries. Secondary outcomes included self-report symptom and health measures, sleep diaries, actigraphy, and polysomnography. Results Categorically defined response (67% [n=26] vs 25% [n=10]; χ2=13.8) (P<.001) and the proportion of participants without insomnia (55% [n=21] vs 13% [n=5]; χ2=15.5) (P<.001) were significantly higher for BBTI than for IC. The number needed to treat was 2.4 for each outcome. No differential effects were found for subgroups according to hypnotic or antidepressant use, sleep apnea, or recruitment source. The BBTI produced significantly better outcomes in self-reported sleep and health (group × time interaction, F5,73=5.99, P<.001), sleep diary (F8,70= 4.32, P<.001), and actigraphy (F4,74=17.72, P<.001), but not polysomnography. Improvements were maintained at 6months. Conclusion We found that BBTI is a simple, efficacious, and durable intervention for chronic insomnia in older adults that has potential for dissemination across medical settings. PMID:21263078

Pharmacokinetic variability, efficacy and tolerability of eslicarbazepine acetate-A national approach to the evaluation of therapeutic drug monitoring data and clinical outcome.

PubMed

Svendsen, Torleiv; Brodtkorb, Eylert; Reimers, Arne; Molden, Espen; Sætre, Erik; Johannessen, Svein I; Johannessen Landmark, Cecilie

2017-01-01

Eslicarbazepine acetate (ESL) is a new antiepileptic drug (AED), still insufficiently studied regarding pharmacokinetic variability, efficacy and tolerability. The purpose of this study was to evaluate therapeutic drug monitoring (TDM) data in Norway and relate pharmacokinetic variability to clinical efficacy and tolerability in a long-term clinical setting in patients with refractory epilepsy. This retrospective observational study included TDM-data from the main laboratories and population data from the Norwegian Prescription Database in Norway, in addition to clinical data from medical records of adult patients using ESL for up to three years, whenever possible. TDM-data from 168 patients were utilized for assessment of pharmacokinetic variability, consisting of 71% of the total number of patients in Norway using ESL, 2011-14. Median daily dose of ESL was 800mg (range 400-1600mg), and median serum concentration of ESL was 53μmol/L (range 13-132μmol/L). Inter-patient variability of ESL was extensive, with 25-fold variability in concentration/dose ratios. Additional clinical data were available from 104 adult patients out of the 168, all with drug resistant focal epilepsy. After 1, 2 and 3 years follow-up, the retention rate of ESL was 83%, 72% and 64%, respectively. ESL was generally well tolerated as add-on treatment, but sedation, cognitive impairment and hyponatremia were reported. Hyponatremia (sodium <137mmol/L) was present in 36% of the patients, and lead to discontinuation in three. Pharmacokinetic variability of ESL was extensive and the demonstration of usefulness of TDM requires further studies. In patients with drug resistant focal Epilepsy, the high retention rate indicated good efficacy and tolerability. Hyponatremia was observed in one third of the patients. The present results point to a need for individualization of treatment and TDM may be useful. Copyright © 2016 Elsevier B.V. All rights reserved.

Preliminary data on validity of the Drug Addiction Treatment Efficacy Questionnaire.

PubMed

Kastelic, Andrej; Mlakar, Janez; Pregelj, Peter

2013-09-01

This study describes the validation process for the Slovenian version of the Drug Addiction Treatment Efficacy Questionnaire (DATEQ). DATEQ was constructed from the questionnaires used at the Centre for the Treatment of Drug Addiction, Ljubljana University Psychiatric Hospital, and within the network of Centres for the Prevention and Treatment of Drug Addiction in Slovenia during the past 14 years. The Slovenian version of the DATEQ was translated to English using the 'forward-backward' procedure by its authors and their co-workers. The validation process included 100 male and female patients with established addiction to illicit drugs who had been prescribed opioid substitution therapy. The DATEQ questionnaire was used in the study, together with clinical evaluation to measure psychological state and to evaluate the efficacy of treatment in the last year. To determinate the validity of DATEQ the correlation with the clinical assessments of the outcome was calculated using one-way ANOVA. The F value was 44.4, p<0.001 (sum of squares: between groups 210.4, df=2, within groups 229.7, df=97, total 440.1, df=99). At the cut-off 4 the sensitivity is 81% and specificity 83%. The validation process for the Slovenian DATEQ version shows metric properties similar to those found in international studies of similar questionnaires, suggesting that it measures the same constructs, in the same way and as similar questionnaires. However, the relatively low sensitivity and specificity suggests caution when using DATEQ as the only measure of outcome.

Personality modulates the efficacy of treatment in patients with major depressive disorder.

PubMed

Wardenaar, Klaas J; Conradi, Henk Jan; Bos, Elisabeth H; de Jonge, Peter

2014-09-01

Effects of depression treatment are obscured by heterogeneity among patients. Personality types could be one source of heterogeneity that explains variability in treatment response. Clinically meaningful variations in personality patterns could be captured with data-driven subgroups. The aim of this study was to identify such personality types and to explore their predictive value for treatment efficacy. Participants (N = 146) in the current exploratory study came from a randomized controlled trial in primary care depressed patients, conducted between January 1998 and June 2003, comparing different treatments. All participants were diagnosed with a major depressive disorder (MDD) according to the DSM-IV. Primary (care as usual [CAU] or CAU plus a psychoeducational prevention program [PEP]) and specialized (CAU + PEP + psychiatric consultation or cognitive-behavioral therapy) treatment were compared. Personality was assessed with the Neuroticism-Extraversion-Openness Five-Factor Inventory (NEO-FFI). Personality classes were identified with latent profile analysis (LPA). During 1 year, weekly depression ratings were obtained by trimonthly assessment with the Composite International Diagnostic Interview. Mixed models were used to analyze the effects of personality on treatment efficacy. A 2-class LPA solution fit best to the NEO-FFI data: Class 1 (vulnerable, n = 94) was characterized by high neuroticism, low extraversion, and low conscientiousness, and Class 2 (resilient, n = 52) by medium neuroticism and extraversion and higher agreeableness and conscientiousness. Recovery was quicker in the resilient class (class × time: P < .001). Importantly, specialized treatment had added value only in the vulnerable class, in which it was associated with quicker recovery than primary treatment (class × time × treatment: P < .001). Personality profile may predict whether specialized clinical efforts have added value, showing potential implications for planning of treatments

Efficacy and safety of chloroquine for treatment in patients with uncomplicated Plasmodium vivax infections in endemic countries.

PubMed

Naing, Cho; Aung, Kyan; Win, Daw-Khin; Wah, Mak Joon

2010-11-01

Chloroquine (CQ) is a relatively inexpensive drug for treatment of malaria. If efficacy of CQ is still assumed, then it should be indicated in malaria treatment policies as the drug of choice for uncomplicated Plasmodium vivax malaria in endemic countries with resource constraints. The objective of this review is to summarize the existing evidence on the relative efficacy and safety of CQ in treating patients with uncomplicated P. vivax malaria in endemic countries. We searched online data bases (PUBMED, MEDLINE, EMBASE, The Cochrane Library) and the reference lists of the retrieved articles. Fifteen randomized controlled trials (n=6215) assessing the relative efficacy and safety of CQ for treatment of uncomplicated P. vivax malaria were included. CQ monotherapy was compared to CQ plus primaquine (PQ), artemisinin/artemether, artemisinin based combination therapy, quinine, CQ plus tafenoquine, chlorguanil plus dapsone, azithromycin, or placebo. Treatment efficacy was not significantly different between the CQ monotherapy group and that of the CQ with PQ 14 day group at 28 day follow-up (55/711, 7.7% vs 35/712, 4.9%; P=0.16). Evidence from the trials identified for this review draw a fairly clear conclusion about the relative efficacy and safety of CQ for treating uncomplicated P. vivax malaria infection. However, further research in this field with well powered, randomized, non-inferiority design, using the standardized protocol is needed. Copyright © 2010 Royal Society of Tropical Medicine and Hygiene. Published by Elsevier Ltd. All rights reserved.

Efficacy of Clindamycin Vaginal Ovule (3-Day Treatment) vs. Clindamycin Vaginal Cream (7-Day Treatment) in Bacterial Vaginosis

PubMed Central

Peipert, Jeffrey F.; McGregor, James A.; Livengood, Charles; Martin, Maureen; Robbins, Jill; Wajszczuk, Charles P.

2001-01-01

Objective: To compare the efficacy and safety of a 3-day regimen of clindamycin vaginal ovules with a 7-day regimen of clindamycin vaginal cream for the treatment of bacterial vaginosis (BV) Methods: Women with a clinical diagnosis of BV were treated with a 3-day course of clindamycin ovules or a 7-day course of clindamycin cream administered intravaginally. Three hundred and eighty-four patients received study drug and were included in the evaluable patient population (ovule group, n = 204; cream group, n = 180). Assessments included pelvic examination and diagnostic testing. Primary efficacy endpoints were a resolution of two of three diagnostic criteria at the first follow-up visit and three of three diagnostic criteria at the second. Results: Cure rates in the evaluable patient population were similar between treatment groups: 53.7% (109/204) for the ovule group and 47.8% (85/180) for the cream group (p = 0.2471, 95% CI– 4.1–16.0%). The most commonly reported medical event, vulvovaginal pruritus, had similar incidence in both treatment groups. Conclusions: A 3-day course of clindamycin vaginal ovules is as effective and well-tolerated as a 7-day course of clindamycin vaginal cream in the treatment of BV. PMID:11368263

Efficacy of treatments with toltrazuril 7.5% and lasalocid sodium in sheep naturally infected with Eimeria spp.

PubMed

Rodrigues, Fernando de Souza; Tavares, Luiz Eduardo Roland; Paiva, Fernando

2016-01-01

The objective of this study was to evaluate the efficacy of an experimental formulation of toltrazuril 7.5% + Trimix™ on a naturally acquired infection of Eimeria spp. in suckling lambs kept on pasture and, in another trial, evaluate the comparative efficacy between lasalocid and toltrazuril 7.5% + Trimix™ in newly weaned sheep under feedlot conditions that had been naturally infected with Eimeria spp. In the first experiment, 30 suckling lambs were divided into two groups: A - treated with toltrazuril 7.5% + Trimix™ and B- control. In experiment 2, 30 weaned sheep were divided into three groups: I - treated with toltrazuril 7.5% + Trimix™, II - treated with lasalocid and III - control. Treatment group A showed an efficacy of 90, 99.4 and 87.3% on days 5, 10 and 20, respectively. Treatment group I had an efficacy of 98.2, 92.6 and 94.5%, while group II had an efficacy of 72.7, 81.6 and 95.9% on days 7, 21 and 42, respectively. Eight Eimeria species were identified; E. ovinoidalis was the most common. Treatment with the toltrazuril 7.5% +Trimix ™ formulation was effective against Eimeria spp. in suckling lambs in field conditions and lambs weaned in under feedlot conditions.

Pharmacokinetics, efficacy and safety of glyburide for treatment of gestational diabetes mellitus.

PubMed

Malek, Rana; Davis, Stephen N

2016-06-01

Gestational diabetes mellitus (GDM) complicates 10% of all pregnancies and is defined as hyperglycemia first noted during pregnancy. Rates of GDM are rising and untreated GDM results in complications for both mother and fetus. GDM is often managed by diet and exercise but 30-40% of women will require pharmacological intervention. Insulin has traditionally been the treatment of choice but since 2007, glyburide, a second generation sulfonylurea has become the most prescribed medication for GDM. This review will cover the pharmacokinetics, efficacy, and safety of glyburide for the management of GDM. Management of GDM is challenging secondary to the stringent glycemic goals that mimic the lower glucose levels in pregnancy. Glyburide is generally effective in treating hyperglycemia. However, several studies have raised safety concerns showing higher neonatal intensive care unit (NICU) admissions, higher rates of macrosomia, large for gestational age and pre-eclampsia in the mother. For this reason, insulin should be first-line therapy for GDM. In areas of limited resources where the self-monitoring needed for accurate insulin dosing is not possible, where access to refrigeration for insulin storage is not universal, or severe needle phobia then the benefits of glyburide (controlling hyperglycemia) outweighs the harm of NICU admissions and macrosomia.

Practice Patterns in the Treatment and Monitoring of Acute T Cell-Mediated Kidney Graft Rejection in Canada.

PubMed

Leblanc, Julie; Subrt, Peter; Paré, Michèle; Hartell, David; Sénécal, Lynne; Blydt-Hansen, Tom; Cardinal, Héloïse

2018-01-01

One of the goals of the Canadian National Transplant Research Program (CNTRP) is to develop novel therapies for acute rejection that could positively affect graft outcomes with greater efficacy or less toxicity. To develop innovative management strategies for kidney graft rejection, new modalities need to be compared with current clinical practices. However, there are no standardized practices concerning the management of acute T cell-mediated rejection (TCMR). To describe clinicians' practice patterns in the diagnosis, treatment, and monitoring of acute TCMR in Canada. Survey. Canadian transplant nephrologists and transplant surgeons involved in the management of acute TCMR. We developed an anonymous, web-based survey consisting of questions related to the diagnosis, treatment, and monitoring of TCMR. The survey was disseminated on 3 occasions between June and October 2016 through the Canadian Society of Transplantation (CST) kidney group electronic mailing list. Forty-seven respondents, mostly transplant nephrologists (97%), originating from at least 18 of the 25 Canadian centers offering adult or pediatric kidney transplantation, participated in the study. Surveillance biopsies were used by 28% of respondents to screen for kidney graft rejection. High-dose steroids were used by most of the respondents to treat clinical and subclinical Banff grade 1A and 1B rejections. Nine percent (95% confidence interval [CI]: 1-17) of practitioners used lymphocyte-depleting agents as the first-line approach for the treatment of Banff grade 1B acute rejection. Eighteen percent (95% CI: 7-29) and 36% (95% CI: 8-65) of respondents reported that they would not use high-dose steroids for treating clinical and subclinical borderline rejections, respectively. Seventy percent (95% CI: 54-83) of respondents answered that there was no indication to assess histological response to treatment independent of the change in kidney function. The limitations of this study are its limited sample

Efficacy and Safety of Low-field Synchronized Transcranial Magnetic Stimulation (sTMS) for Treatment of Major Depression.

PubMed

Leuchter, Andrew F; Cook, Ian A; Feifel, David; Goethe, John W; Husain, Mustafa; Carpenter, Linda L; Thase, Michael E; Krystal, Andrew D; Philip, Noah S; Bhati, Mahendra T; Burke, William J; Howland, Robert H; Sheline, Yvette I; Aaronson, Scott T; Iosifescu, Dan V; O'Reardon, John P; Gilmer, William S; Jain, Rakesh; Burgoyne, Karl S; Phillips, Bill; Manberg, Paul J; Massaro, Joseph; Hunter, Aimee M; Lisanby, Sarah H; George, Mark S

2015-01-01

Transcranial Magnetic Stimulation (TMS) customarily uses high-field electromagnets to achieve therapeutic efficacy in Major Depressive Disorder (MDD). Low-field magnetic stimulation also may be useful for treatment of MDD, with fewer treatment-emergent adverse events. To examine efficacy, safety, and tolerability of low-field magnetic stimulation synchronized to an individual's alpha frequency (IAF) (synchronized TMS, or sTMS) for treatment of MDD. Six-week double-blind sham-controlled treatment trial of a novel device that used three rotating neodymium magnets to deliver sTMS treatment. IAF was determined from a single-channel EEG prior to first treatment. Subjects had baseline 17-item Hamilton Depression Rating Scale (HamD17) ≥ 17. 202 subjects comprised the intent-to-treat (ITT) sample, and 120 subjects completed treatment per-protocol (PP). There was no difference in efficacy between active and sham in the ITT sample. Subjects in the PP sample (N = 59), however, had significantly greater mean decrease in HamD17 than sham (N = 60) (-9.00 vs. -6.56, P = 0.033). PP subjects with a history of poor response or intolerance to medication showed greater improvement with sTMS than did treatment-naïve subjects (-8.58 vs. -4.25, P = 0.017). Efficacy in the PP sample reflects exclusion of subjects who received fewer than 80% of scheduled treatments or were inadvertently treated at the incorrect IAF; these subgroups failed to separate from sham. There was no difference in adverse events between sTMS and sham, and no serious adverse events attributable to sTMS. Results suggest that sTMS may be effective, safe, and well tolerated for treating MDD when administered as intended. Copyright © 2015 Elsevier Inc. All rights reserved.

Enhanced clinical outcome with manual massage following cryolipolysis treatment: a 4-month study of safety and efficacy.

PubMed

Boey, Gerald E; Wasilenchuk, Jennifer L

2014-01-01

Cryolipolysis procedures have been shown to safely and effectively reduce the thickness of fat in a treated region. This study was conducted to determine whether the addition of post-treatment manual massage would improve efficacy while maintaining the safety profile of the original cryolipolysis treatment protocol. The study population consisted of an efficacy group (n = 10) and a safety group (n = 7). Study subjects were treated on each side of the lower abdomen with a Cooling Intensity Factor of 42 (-72.9 mW/cm(2) ) for 60 minutes. One side of the abdomen was massaged post-treatment and the other side served as the control. Immediately post-treatment, the massage side was treated for 1 minute using a vigorous kneading motion followed by 1 minute of circular massage using the pads of the fingers. For the efficacy group, photos and ultrasound measurements were taken at baseline, 2 months, and 4 months post-treatment. For the safety group, histological analysis was completed at 0, 3, 8, 14, 30, 60, and 120 days post-treatment to examine the effects of massage on subcutaneous tissue over time. Post-treatment manual massage resulted in a consistent and discernible increase in efficacy over the non-massaged side. At 2 months post-treatment, mean fat layer reduction was 68% greater in the massage side than in the non-massage side as measured by ultrasound. By 4 months, mean fat layer reduction was 44% greater in the massage side. Histological results showed no evidence of necrosis or fibrosis resulting from the massage. Post-treatment manual massage is a safe and effective technique to enhance the clinical outcome from a cryolipolysis procedure. © 2013 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

Cognitive-Behavioral Treatment of Panic Disorder in Adolescence

ERIC Educational Resources Information Center

Pincus, Donna B.; May, Jill Ehrenreich; Whitton, Sarah W.; Mattis, Sara G.; Barlow, David H.

2010-01-01

This investigation represents the first randomized controlled trial to evaluate the feasibility and efficacy of Panic Control Treatment for Adolescents (PCT-A). Thirteen adolescents, ages 14 to 17, were randomized to 11 weekly sessions of PCT-A treatment, whereas 13 were randomized to a self-monitoring control group. Results indicate that…

Social context, parental monitoring, and multisystemic therapy outcomes.

PubMed

Robinson, Brittany A; Winiarski, D Anne; Brennan, Patricia A; Foster, Sharon L; Cunningham, Phillippe B; Whitmore, Elizabeth A

2015-03-01

Multisystemic therapy (MST) and other evidence-based treatments targeting juvenile delinquency have been well substantiated in the literature. Although these treatments have been demonstrated to be effective overall at reducing juvenile delinquency, it is well known that they do not benefit all treated youth. Research has yet to examine the potential influence of contextual factors, such as socioeconomic status (SES) and neighborhood characteristics, on treatment outcomes, particularly as they influence parental monitoring, which is often a focus of interventions targeting juvenile delinquency. A primary goal of these treatments is to help parents develop the requisite skills to adequately monitor and discipline their children; however, this goal may be compromised by contextual factors affecting parental effectiveness and, ultimately, treatment efficacy. The objective of this study was to explore the role of SES and neighborhood factors in moderating the effects of parental monitoring across treatment. Using hierarchical linear modeling (HLM), we analyzed these contextual and family predictors of response to MST treatment within a sample of 185 youth (65.4% male) ages 12-18 (M = 15.35; SD = 1.28). Neighborhood factors interacted with parental monitoring, such that monitoring predicted decreases in externalizing behavior only for youth residing in better neighborhoods. In contrast, SES was unrelated to changes in externalizing behaviors in response to MST. Taken together, these results demonstrate a need for further understanding the potential role of the youth's larger social context in predicting MST outcomes. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

Efficacy of nystatin for the treatment of oral candidiasis: a systematic review and meta-analysis.

PubMed

Lyu, Xin; Zhao, Chen; Yan, Zhi-Min; Hua, Hong

2016-01-01

To systematically review and assess the efficacy, different treatment protocols (formulation, dosage, and duration), and safety of nystatin for treating oral candidiasis. Four electronic databases were searched for trials published in English till July 1, 2015. Randomized controlled trials comparing nystatin with other antifungal therapies or a placebo were included. Clinical and/or mycological cure was the outcome evaluation. A meta-analysis or descriptive study on the efficacy, treatment protocols, and safety of nystatin was conducted. The meta-analysis showed that nystatin pastille was significantly superior to placebo in treating denture stomatitis. Nystatin suspension was not superior to fluconazole in treating oral candidiasis in infants, children, or HIV/AIDS patients. The descriptive investigations showed that administration of nystatin suspension and pastilles in combination for 2 weeks might achieve a higher clinical and mycological cure rate, and using the nystatin pastilles alone might have a higher mycological cure rate, when compared with using nystatin suspensions alone. Nystatin pastilles at a dose of 400,000 IU resulted in a significantly higher mycological cure rate than that administrated at a dose of 200,000 IU. Furthermore, treatment with nystatin pastilles for 4 weeks seemed to have better clinical efficacy than treatment for 2 weeks. Descriptive safety assessment showed that poor taste and gastrointestinal adverse reaction are the most common adverse effects of nystatin. Nystatin pastille was significantly superior to placebo in treating denture stomatitis, while nystatin suspension was not superior to fluconazole in treating oral candidiasis in infants, children, or HIV/AIDS patients. Indirect evidence from a descriptive study demonstrated that administration of nystatin pastille alone or pastille and suspension in combination is more effective than that of suspension alone; prolonged treatment duration for up to 4 weeks can increase the

Current status of epilepsy treatment and efficacy of standard phenobarbital therapy in rural areas of Northern China.

PubMed

Yu, Jinbei; Luo, Nan; Wang, Zan; Lin, Weihong

2017-08-01

To investigate the current status of epilepsy treatment and the efficacy and adverse effects of phenobarbital therapy in rural areas of Northern China. A total of 2192 patients diagnosed with convulsive epilepsy were recruited from seven different rural regions in Jilin Province, China to investigate the current status of epilepsy treatment, and 1379 of them were enrolled in a standard phenobarbital therapy trial. Patients were selected according to strict inclusion and exclusion criteria, and medical records for all patients were collected and analyzed before the standard treatment was started. Patients were followed up monthly, and efficacy in 1218 patients was analyzed at 1, 3, 6 and 12 months of treatment. More patients had the initial seizure in juveniles than in adults, and 40.72% of the 2192 patients were not receiving any treatment before the treatment trial. The efficacy of phenobarbital increased and adverse effects decreased within the treatment period. Among the 349 patients who were followed up for 12 months from the beginning of the phenobarbital treatment, seizures were decreased by more than 75% in 71.3% of patients using a low-to-medium dose of phenobarbital. Major adverse effects of phenobarbital included mild exhaustion, drowsiness, dizziness and headache. Standardized long-term and regular administration of phenobarbital at a low-to-medium dose can be used as an effective, economic and safe treatment against epilepsy in rural areas.

Efficacy of octenidine dihydrochloride and 2-phenoxyethanol in the topical treatment of inflammatory acne.

PubMed

Mayr-Kanhäuser, Sigrid; Kränke, Birger; Aberer, Werner

2008-09-01

With the increase in antibiotic-resistant strains of microorganisms in acne lesions, the search for alternative treatment methods has become important. We studied the efficacy of a combination of the antiseptic substances octenidine dihydrochloride and 2-phenoxyethanol (O/P) in mild to moderate inflammatory acne vulgaris. Thirty patients were instructed to apply O/P once or twice daily for a 6-week treatment period. Determination of efficacy included the numerical documentation of inflammatory and non-inflammatory lesions within defined regions of the face by the investigator, and photodocumentation of the clinical picture as well as the fluorescence pattern under Wood's light. Twenty-four patients completed the study. The number of papules and pustules decreased more than 50% in seventeen and nineteen patients, respectively. Acne lesions worsened in only one patient. Mild adverse reactions (erythema, burning, and scaling) were seen in two patients. Therefore, O/P was highly effective in treating inflammatory lesions of facial acne, but there was no essential efficacy in the non-inflammatory primary acne lesions. Topical O/P is a good and cost-effective alternative in the treatment of mild to moderate inflammatory acne lesions and may allow reduced application of anti-acne antibiotics to prevent development of resistance.

Influence of a Dissection Video Clip on Anxiety, Affect, and Self-Efficacy in Educational Dissection: A Treatment Study.

PubMed

Randler, Christoph; Demirhan, Eda; Wüst-Ackermann, Peter; Desch, Inga H

2016-01-01

In science education, dissections of animals are an integral part of teaching, but they often evoke negative emotions. We aimed at reducing negative emotions (anxiety, negative affect [NA]) and increasing positive affect (PA) and self-efficacy by an experimental intervention using a predissection video to instruct students about fish dissection. We compared this treatment with another group that watched a life history video about the fish. The participants were 135 students studying to become biology teachers. Seventy received the treatment with the dissection video, and 65 viewed the life history video. We applied a pre/posttest treatment-comparison design and used the Positive and Negative Affect Schedule (PANAS), the State-Trait-Anxiety Inventory for State (STAI-S), and a self-efficacy measure three times: before the lesson (pretest), after the film treatment (posttest 1), and after the dissection (posttest 2). The dissection film group scored higher in PA, NA, and state anxiety (STAI-S) after the dissection video treatment and higher in self-efficacy after the dissection. The life history group showed no differences between the pretest and posttest 1. The dissection film has clear benefits - increasing PA and self-efficacy - that come at the cost of higher NA and higher STAI-S.

Efficacy of omeprazole/sodium bicarbonate treatment in gastroesophageal reflux disease: a systematic review.

PubMed

Higuera-de-la-Tijera, Fátima

2018-03-14

Proton pump inhibitors are the most effective medical therapy for gastroesophageal reflux disease, but their onset of action may be slow. To assess the available literature regarding the efficacy of omeprazole/sodium bicarbonate in gastroesophageal reflux patients. A systematic review was conducted. A systematic literature search starting from 2000. Reviewed manuscripts concerning the effectiveness of omeprazole/sodium bicarbonate treatment in gastroesophageal reflux disease were reviewed and the data were extracted. Data were subsequently analyzed with descriptive statistics. This review included information of four studies. Two trials compared the efficacy of omeprazole/sodium bicarbonate versus omeprazole. One study compared the efficacy of once-daily morning or nighttime dosing. And another study compared omeprazole/sodium bicarbonate/alginate versus omeprazole. In total, there was no difference between omeprazole/sodium bicarbonate and omeprazole. However, there is a trend towards more sustained response and a greater proportion of patients with sustained total relief by 30 minutes with omeprazole/sodium bicarbonate. Omeprazole/sodium bicarbonate therapy is not more effective than omeprazole in the treatment of gastroesophageal reflux disease. However, data obtained suggest that it can have a more sustained response and sustained total relief.

Linagliptin: farmacology, efficacy and safety in type 2 diabetes treatment

PubMed Central

2013-01-01

Type 2 diabetes mellitus (T2DM) has a high prevalence and incidence around the world. The complex pathophysiology mechanism is among the barriers for diabetes treatment. Type 2 diabetes patients have dysfunction in incretin hormones (as glucagon-like peptide-1 or GLP-1, and glucose-dependent insulinotropic polypeptide or GIP). By inhibiting the dipeptidyl peptidase-4 (DPP-4) enzyme, it is possible to slow the inactivation of GLP-1 and GIP, promoting blood glucose level reduction in a glucose-dependent manner. Linagliptin is a highly specific and potent inhibitor of DPP-4 that is currently indicated for the treatment of type 2 diabetes. Clinical studies with linagliptin demonstrated efficacy in reducing glycated hemoglobin (HbA1c) levels in type 2 diabetes patients, while maintaining a placebo-like safety and tolerability profile. Linagliptin has an interesting pharmacokinetic profile in terms of its predominantly non-renal elimination and the main implication of this characteristic is that no dose adjustment is necessary in patients with renal disease. Also, no dose adjustment is required in patients with hepatic insufficiency, as well in elderly or obese patients. This article will review the pharmacokinetic profile, efficacy data and safety aspects of linagliptin in type 2 diabetes patients. PMID:23697612

Physician Burnout: Improving Treatment Efficacy with Virtual Reality.

PubMed

Wiederhold, Brenda K; Riva, Giuseppe; Gaggioli, Andrea; Wiederhold, Mark D

2016-01-01

Creating a significant negative impact on both their quality of life and the quality of patient care with an evident economical burden for the healthcare system, there is a growing concern over physician burnout. The range of interventions and treatments that have been used to address this problem, however, appear quite fragmented and lack compelling efficacy. We describe the main factors known to contribute to the development of physician burnout as well as currently available treatments. Studies seem to indicate that both specialisation area as well as personality traits may contribute to the manifestation. The highest risk specialties appear to be critical care physicians, emergency physicians, oncologists and internal medicine physicians, while the highest risk personality attributes are high neuroticism, low agreeableness, introversion, and negative affectivity. In addition, being exceedingly enthusiastic about one's work and having high aspirations at work, with an idealistic approach, also serve as factors which contribute to increased risk of burnout, and in particular for those who are new to the occupation.

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

PubMed

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 of osmoprotectants on prevention and treatment of murine dry eye.

PubMed

Chen, Wei; Zhang, Xin; Li, Jinyang; Wang, Yu; Chen, Qi; Hou, Chao; Garrett, Qian

2013-09-19

To evaluate the efficacy of osmoprotectants on prevention and treatment of dry eye in a murine model. Dry eye was induced in mice by using an intelligently controlled environmental system (ICES). Osmoprotectants betaine, L-carnitine, erythritol, or vehicle (PBS) were topically administered to eyes four times daily following two schedules: schedule 1 (modeling prevention): dosing started at the beginning of housing in ICES and lasted for 21 or 35 days; schedule 2 (modeling treatment): dosing started after ICES-housed mice developed dry eye (day 21), continuing until day 35. Treatment efficacy was evaluated for corneal fluorescein staining; corneal epithelial apoptosis by TUNEL and caspase-3 assays; goblet cell numbers by PAS staining; and expression of inflammatory mediators, TNF-α, IL-17, IL-6, or IL-1β by using RT-PCR on days 0, 14, 21, and/or 35. Compared with vehicle, prophylactic administration of betaine, L-carnitine, or erythritol significantly decreased corneal staining and expression of TNF-α and IL-17 on day 21 (schedule 1). Treatment of mouse dry eye with osmoprotectants significantly reduced corneal staining on day 35 compared with day 21 (schedule 2). Relative to vehicle, L-carnitine treatment of mouse dry eye for 14 days (days 21 to 35) resulted in a significant reduction in corneal staining, number of TUNEL-positive cells, and expression of TNF-α, IL-17, IL-6, or IL-1β, as well as significantly increased the number of goblet cells. Topical application of betaine, L-carnitine, or erythritol systematically limited progression of environmentally induced dry eye. L-carnitine can also reduce the severity of such dry-eye conditions.

Safety and Efficacy of Catheter Direct Thrombolysis in Management of Acute Iliofemoral Deep Vein Thrombosis: A Systematic Review.

PubMed

Elbasty, Ahmed; Metcalf, James

2017-12-01

Catheter direct thrombolysis (CDT) has been shown to be an effective treatment for deep venous thrombosis. The objective of the review is to improve safety and efficacy of the CDT by using ward based protocol, better able to predict complications and treatment outcome through monitoring of haemostatic parameters and clinical observation during thrombolysis procedure. MEDLINE, EMBASE, CENTRAL and Web of Science were searched for all articles on deep venous thrombosis, thrombolysis and correlations of clinical events (bleeding, successful thrombolysis) during thrombolysis with hemostatic parameters to March 2016. The risk of bias in included studies was assessed by Cochrane Collaboration's tool and Cochrane Risk of Bias Assessment Tool: for Non-Randomized Studies of Interventions. Twenty-four studies were included in the review and we found that improving safety and efficacy of CDT by using ward based protocol depending on eight factors; strict patient selection criteria, types of fibrinolytic drugs, mode of fibrinolytic drug injection, biochemical markers monitoring (fibrinogen, D-dimer, activated partial thromboplastin time, plasminogen activator inhibitor-1), timing of intervention, usage of intermittent pneumatic calf, ward monitoring and thrombolysis imaging assessment (intravascular ultrasound). These factors may help to improve safety and efficacy by reducing total thrombolytic drug dosage and at the same time ensure successful lysis. There is a marked lack of randomized controlled trials discussing the safety and efficacy of catheter direct thrombolysis. CDT can be performed safely and efficiently in clinical ward, providing that careful nursing, biochemical monitoring, proper selection and mode of infusion of fibrinolytic drugs, usage of Intermittent pneumatic calf and adequate thrombolysis imaging assessment are ensured.

Efficacy of Diverse Antiparasitic Treatments for Cysticercosis in the Pig Model

PubMed Central

Gonzalez, Armando E.; Bustos, Javier A.; Jimenez, Juan A.; Rodriguez, Mary L.; Ramirez, Mercy G.; Gilman, Robert H.; Garcia, Hector H.

2012-01-01

Taenia solium cysticercosis infects pigs and humans. Because antiparasitic treatment for human cysticercosis has sub-optimal efficacy, alternative regimes are needed. Seven antiparasitic regimens were tested in 42 naturally infected pigs with cysticercosis, and compared with prednisone alone (n = 6) or no treatment (n = 6). The numbers of viable cysts in muscles and in the brain were examined after necropsy and were significantly decreased in pigs receiving combined albendazole plus praziquantel, albendazole alone, or oxfendazole. Pigs receiving praziquantel alone and nitazoxanide had numerous surviving cysts. Control (untreated) pigs and prednisone-treated pigs had many more viable cysts, suggesting no effect. Combined albendazole plus praziquantel, and oxfendazole, showed a strong cysticidal effect and provide suitable alternative treatments to be further explored for their use for treatment of human neurocysticercosis. PMID:22855760

Combination Treatment of Citral Potentiates the Efficacy of Hyperthermic Intraperitoneal Chemoperfusion with Pirarubicin for Colorectal Cancer.

PubMed

Fang, Zhiyuan; Wang, Yu; Li, Hao; Yu, Shuaishuai; Liu, Ziying; Fan, Zhichao; Chen, Xiaomin; Wu, Yuying; Pan, Xuebo; Li, Xiaokun; Wang, Cong

2017-10-02

Citral is a widely used penetration enhancer that has been used to assist the delivery of drugs through the skin. In this study we aimed to investigate the effectiveness of combination treatments of citral with hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer and to unravel the underlying mechanism by which citral increased the efficacy of HIPEC. In vitro experiments indicated that citral increased cytoplasmic absorption of pirarubicin and potentiated the effects of pirarubicin on colorectal cancer cells to induce apoptosis. Intracellular reactive oxygen species (ROS) activity was elevated after single or combo treatments with pirarubicin, leading to compromised NF-κB signaling. Therefore, the results suggested that the effects of citral were mediated by increasing cell permeability and ROS productions. Furthermore, the colorectal xenograft model was used to evaluate the efficacy of the combo treatment at the histological and molecular levels, which showed that the cotreatment with citral for colorectal cancer increased the efficacy of HIPEC with pirarubicin with respect to both ascite control and tumor load. The results indicated that citral was an effective additive for HIPEC with pirarubicin for colorectal cancer, which warrant further effort to explore the translational application of this new treatment regimen.

Fully-automated, high-throughput micro-computed tomography analysis of body composition enables therapeutic efficacy monitoring in preclinical models.

PubMed

Wyatt, S K; Barck, K H; Kates, L; Zavala-Solorio, J; Ross, J; Kolumam, G; Sonoda, J; Carano, R A D

2015-11-01

The ability to non-invasively measure body composition in mouse models of obesity and obesity-related disorders is essential for elucidating mechanisms of metabolic regulation and monitoring the effects of novel treatments. These studies aimed to develop a fully automated, high-throughput micro-computed tomography (micro-CT)-based image analysis technique for longitudinal quantitation of adipose, non-adipose and lean tissue as well as bone and demonstrate utility for assessing the effects of two distinct treatments. An initial validation study was performed in diet-induced obesity (DIO) and control mice on a vivaCT 75 micro-CT system. Subsequently, four groups of DIO mice were imaged pre- and post-treatment with an experimental agonistic antibody specific for anti-fibroblast growth factor receptor 1 (anti-FGFR1, R1MAb1), control immunoglobulin G antibody, a known anorectic antiobesity drug (rimonabant, SR141716), or solvent control. The body composition analysis technique was then ported to a faster micro-CT system (CT120) to markedly increase throughput as well as to evaluate the use of micro-CT image intensity for hepatic lipid content in DIO and control mice. Ex vivo chemical analysis and colorimetric analysis of the liver triglycerides were performed as the standard metrics for correlation with body composition and hepatic lipid status, respectively. Micro-CT-based body composition measures correlate with ex vivo chemical analysis metrics and enable distinction between DIO and control mice. R1MAb1 and rimonabant have differing effects on body composition as assessed by micro-CT. High-throughput body composition imaging is possible using a modified CT120 system. Micro-CT also provides a non-invasive assessment of hepatic lipid content. This work describes, validates and demonstrates utility of a fully automated image analysis technique to quantify in vivo micro-CT-derived measures of adipose, non-adipose and lean tissue, as well as bone. These body composition

Dalteparin: an update of its pharmacological properties and clinical efficacy in the prophylaxis and treatment of thromboembolic disease.

PubMed

Dunn, C J; Jarvis, B

2000-07-01

Dalteparin is a low molecular weight heparin (LMWH) with a mean molecular weight of 5000. Compared with unfractionated heparin (UFH), the drug has markedly improved bioavailability and increased plasma elimination half-life, and exerts a greater inhibitory effect on plasma activity of coagulation factor Xa relative to its effects on other coagulation parameters. Dalteparin also has less lipolytic activity than UFH. Dalteparin 2500U once daily subcutaneously is of similar antithrombotic efficacy to UFH 5000IU twice daily, and 2 studies have shown superiority over UFH 2 or 3 times daily of dalteparin 5000U once daily in patients requiring surgical thromboprophylaxis. After total hip arthroplasty, dalteparin was superior to adjusted-dosage warfarin and was of greater thromboprophylactic efficacy when given for 35 than for 7 days. Intravenous or subcutaneous dalteparin is as effective as intravenous UFH when given once or twice daily in the initial management of established deep vein thrombosis (DVT). The drug is also effective in long term home treatment. Dalteparin has been shown to be effective in combination with aspirin in the management of unstable coronary artery disease (CAD), with composite end-point data from 1 study suggesting benefit for up to 3 months. Current data indicate potential of the drug in the management of acute myocardial infarction (MI). Dalteparin is also of similar efficacy to UFH, with a single bolus dose being sufficient in some patients, in the prevention of clotting in haemodialysis and haemofiltration circuits. Pharmacoeconomic data indicate that overall costs relative to UFH from a hospital perspective can be reduced through the use of dalteparin in patients receiving treatment for venous thromboembolism. Dalteparin has also been shown to be cost effective when used for surgical thromboprophylaxis. Overall, rates of haemorrhagic complications in patients receiving dalteparin are low and are similar to those seen with UFH. Dalteparin is

Impact of disease heterogeneity on treatment efficacy of immunotherapy in Type 1 diabetes: different shades of gray.

PubMed

Woittiez, Nicky J C; Roep, Bart O

2015-01-01

Type 1 diabetes results from selective destruction of insulin-producing pancreatic β-cells by a progressive autoimmune process. Type 1 diabetes proves very heterogeneous in pathology, disease progression and efficacy of therapeutic intervention. Indeed, several immunotherapies that appear ineffective for the entire treated patient population in fact look promising in subgroups of patients. It therefore seems inconceivable that one standard therapy will provide the golden bullet of disease intervention. Instead, personalized medicine may improve immune intervention efficacy rates. We discuss the effect of disease heterogeneity on treatment outcome of immunotherapies, identifying apparent gaps in our understanding of treatment efficacy in subgroups of Type 1 diabetic patients as well as identifying future opportunities for immunotherapy.

Efficacy of Naltrexone for the Treatment of Alcohol Dependence in Latino Populations.

PubMed

López, Cristina M; Barr, Simone C; Reid-Quiñones, Kathryn; de Arellano, Michael A

2017-05-01

Naltrexone has been identified as a promising psychopharmacological treatment for alcohol dependence. Previous studies have suggested that its efficacy may vary based on ethnic background. The current study examined the efficacy of naltrexone in the treatment of alcohol dependence in Latino adults, a previously unexplored population. This was a secondary analysis of the Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence (COMBINE) Study. The overall COMBINE sample consisted of 1,383 adult participants who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for alcohol dependence, including 155 Latinos, who are the focus of this report. Consistent with the main trial, primary drinking outcomes, including percentage of days abstinent (PDA) and time to first heavy drinking day (TTHD), were examined. In addition, we examined the effects of naltrexone on a clinically relevant secondary outcome measure, global clinical outcome of alcohol consumption and alcohol-related problems. As seen with the subsample of African Americans from the COMBINE Study, results of the present analysis indicated that there were no significant effects of naltrexone on PDA and TTHD despite these significant effects in the original study. However, contrary to findings in the African American subsample, for Latino participants naltrexone was a significant predictor of a good global clinical outcome (i.e., abstinence or moderate drinking without problems). Naltrexone was not significantly associated with improvements in the primary drinking outcomes of PDA or TTHD at the end of treatment or at follow-up. However, Latinos appeared to benefit from naltrexone as demonstrated by improved ratings of global clinical outcome. These results indicate mixed findings for the efficacy of naltrexone among Latinos in the COMBINE Study.

Continuous event monitoring via a Bayesian predictive approach.

PubMed

Di, Jianing; Wang, Daniel; Brashear, H Robert; Dragalin, Vladimir; Krams, Michael

2016-01-01

In clinical trials, continuous monitoring of event incidence rate plays a critical role in making timely decisions affecting trial outcome. For example, continuous monitoring of adverse events protects the safety of trial participants, while continuous monitoring of efficacy events helps identify early signals of efficacy or futility. Because the endpoint of interest is often the event incidence associated with a given length of treatment duration (e.g., incidence proportion of an adverse event with 2 years of dosing), assessing the event proportion before reaching the intended treatment duration becomes challenging, especially when the event onset profile evolves over time with accumulated exposure. In particular, in the earlier part of the study, ignoring censored subjects may result in significant bias in estimating the cumulative event incidence rate. Such a problem is addressed using a predictive approach in the Bayesian framework. In the proposed approach, experts' prior knowledge about both the frequency and timing of the event occurrence is combined with observed data. More specifically, during any interim look, each event-free subject will be counted with a probability that is derived using prior knowledge. The proposed approach is particularly useful in early stage studies for signal detection based on limited information. But it can also be used as a tool for safety monitoring (e.g., data monitoring committee) during later stage trials. Application of the approach is illustrated using a case study where the incidence rate of an adverse event is continuously monitored during an Alzheimer's disease clinical trial. The performance of the proposed approach is also assessed and compared with other Bayesian and frequentist methods via simulation. Copyright © 2015 John Wiley & Sons, Ltd.

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

PubMed Central

Huss, Michael; Duhan, Praveen; Gandhi, Preetam; Chen, Chien-Wei; Spannhuth, Carsten; Kumar, Vinod

2017-01-01

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. PMID:28740389

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

PubMed

Huss, Michael; Duhan, Praveen; Gandhi, Preetam; Chen, Chien-Wei; Spannhuth, Carsten; Kumar, Vinod

2017-01-01

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.

Efficacy and safety of haloperidol versus atypical antipsychotic medications in the treatment of delirium.

PubMed

Yoon, Hyung-Jun; Park, Kyoung-Min; Choi, Won-Jung; Choi, Soo-Hee; Park, Jin-Young; Kim, Jae-Jin; Seok, Jeong-Ho

2013-09-30

Most previous studies on the efficacy of antipsychotic medication for the treatment of delirium have reported that there is no significant difference between typical and atypical antipsychotic medications. It is known, however, that older age might be a predictor of poor response to antipsychotics in the treatment of delirium. The objective of this study was to compare the efficacy and safety of haloperidol versus three atypical antipsychotic medications (risperidone, olanzapine, and quetiapine) for the treatment of delirium with consideration of patient age. This study was a 6-day, prospective, comparative clinical observational study of haloperidol versus atypical antipsychotic medications (risperidone, olanzapine, and quetiapine) in patients with delirium at a tertiary level hospital. The subjects were referred to the consultation-liaison psychiatric service for management of delirium and were screened before enrollment in this study. A total of 80 subjects were assigned to receive either haloperidol (N = 23), risperidone (N = 21), olanzapine (N = 18), or quetiapine (N = 18). The efficacy was evaluated using the Korean version of the Delirium Rating Scale-Revised-98 (DRS-K) and the Korean version of the Mini Mental Status Examination (K-MMSE). The safety was evaluated by the Udvalg Kliniske Undersogelser side effect rating scale. There were no significant differences in mean DRS-K severity or K-MMSE scores among the four groups at baseline. In all groups, the DRS-K severity score decreased and the K-MMSE score increased significantly over the study period. However, there were no significant differences in the improvement of DRS-K or K-MMSE scores among the four groups. Similarly, cognitive and non-cognitive subscale DRS-K scores decreased regardless of the treatment group. The treatment response rate was lower in patients over 75 years old than in patients under 75 years old. Particularly, the response rate to olanzapine was poorer in the older age group

Efficacy of Artemisinin-Based Combination Treatments of Uncomplicated Falciparum Malaria in Under-Five-Year-Old Nigerian Children

PubMed Central

Oguche, Stephen; Okafor, Henrietta U.; Watila, Ismaila; Meremikwu, Martin; Agomo, Philip; Ogala, William; Agomo, Chimere; Ntadom, Godwin; Banjo, Olajide; Okuboyejo, Titilope; Ogunrinde, Gboye; Odey, Friday; Aina, Olugbemiga; Sofola, Tolulope; Sowunmi, Akintunde

2014-01-01

The efficacy of 3-day regimens of artemether-lumefantrine and artesunate-amodiaquine were evaluated in 747 children < 5 years of age with uncomplicated malaria from six geographical areas of Nigeria. Fever clearance was significantly faster (P = 0.006) and the proportion of children with parasitemia 1 day after treatment began was significantly lower (P = 0.016) in artesunate-amodiaquine—compared with artemether-lumefantrine-treated children. Parasite clearance times were similar with both treatments. Overall efficacy was 96.3% (95% confidence interval [CI] 94.5–97.6%), and was similar for both regimens. Polymerase chain reaction-corrected parasitologic cure rates on Day 28 were 96.9% (95% CI 93.9–98.2%) and 98.3% (95% CI 96.1–99.3%) for artemether-lumefantrine and artesunate-amodiaquine, respectively. Gametocyte carriage post treatment was significantly lower than pretreatment (P < 0.0001). In anemic children, mean time to recovery from anemia was 10 days (95% CI 9.04–10.9) and was similar for both regimens. Both treatments were well tolerated and are safe and efficacious treatments of uncomplicated falciparum malaria in young Nigerian children. PMID:25246693

Efficacy of two wastewater treatment plants in removing genotoxins.

PubMed

Jolibois, B; Guerbet, M

2005-04-01

The genotoxic potential of influents and effluents of two different wastewater treatment plants (WTP-A and WTP-B) located in the Rouen, France, area was evaluated by the SOS chromotest without metabolic activation (on Escherichia coli PQ37) and the Ames fluctuation test (on Salmonella typhimurium strains TA 98, 100, TA 102) with and without metabolic activation. The wastewater samples were taken during two 1-week periods in January and April 2003. The simultaneous use of the SOS chromotest and Ames fluctuation test allowed us to evaluate the efficacy of the wastewater treatment plants at removing genotoxins. Genotoxins were detected with the Ames test but not with the SOS chromotest. Out of a total of 24 influents tested (14 for WTP-A and 10 for WTP-B), almost all were genotoxic in at least one Ames test strain (71% for WTP-A and 100% for WTP-B). In contrast, all of the tested effluents were nongenotoxic. This work showed that the treatment process used in the 2 wastewater treatment plants studied (activated sludge) was able to remove the genotoxins detected in their influents. Nevertheless, studies could be undertaken to determine which step of the treatment process removes genotoxins and whether WTP sludge use could be a source of genotoxic contamination for humans and the environment.

Predictors of treatment efficacy in a clinical trial of three psychosocial treatments for adolescent depression.

PubMed

Brent, D A; Kolko, D J; Birmaher, B; Baugher, M; Bridge, J; Roth, C; Holder, D

1998-09-01

To assess the predictors of treatment outcome across treatments, as well as those associated with differential treatment response. One hundred seven adolescent outpatients, aged 13 to 18 years, with DSM-III-R major depression were randomly assigned to one of three manual-based, brief (12 to 16 sessions) psychosocial treatments: cognitive-behavioral therapy (CBT), systemic-behavioral family therapy, or nondirective supportive therapy. Those with good and poor outcomes were compared. Continued depression was predicted by clinical referral (versus via advertisement) and was in part mediated by hopelessness. Other predictors of depression were comorbid anxiety disorder and higher levels of cognitive distortion and hopelessness at intake. Achievement of clinical remission was predicted by a higher level of self-reported depression. Poorer functional status was predicted by a higher level of initial interviewer-rated depression. Comorbid anxiety and maternal depressive symptoms predicted differential treatment efficacy. CBT's performance continued to be robust with respect to nondirective supportive therapy, even in the presence of the above-noted adverse predictors. Predictors of poor outcome may give clues as to how to boost treatment response. Subjects who come to treatment for clinical trials via advertisement (versus clinical referral) may show more favorable treatment responses. CBT is likely to be a robust intervention even in more complex and difficult-to-treat patients.

Volumetric optoacoustic monitoring of endovenous laser treatments

NASA Astrophysics Data System (ADS)

Fehm, Thomas F.; Deán-Ben, Xosé L.; Schaur, Peter; Sroka, Ronald; Razansky, Daniel

2016-03-01

Chronic venous insufficiency (CVI) is one of the most common medical conditions with reported prevalence estimates as high as 30% in the adult population. Although conservative management with compression therapy may improve the symptoms associated with CVI, healing often demands invasive procedures. Besides established surgical methods like vein stripping or bypassing, endovenous laser therapy (ELT) emerged as a promising novel treatment option during the last 15 years offering multiple advantages such as less pain and faster recovery. Much of the treatment success hereby depends on monitoring of the treatment progression using clinical imaging modalities such as Doppler ultrasound. The latter however do not provide sufficient contrast, spatial resolution and three-dimensional imaging capacity which is necessary for accurate online lesion assessment during treatment. As a consequence, incidence of recanalization, lack of vessel occlusion and collateral damage remains highly variable among patients. In this study, we examined the capacity of volumetric optoacoustic tomography (VOT) for real-time monitoring of ELT using an ex-vivo ox foot model. ELT was performed on subcutaneous veins while optoacoustic signals were acquired and reconstructed in real-time and at a spatial resolution in the order of 200μm. VOT images showed spatio-temporal maps of the lesion progression, characteristics of the vessel wall, and position of the ablation fiber's tip during the pull back. It was also possible to correlate the images with the temperature elevation measured in the area adjacent to the ablation spot. We conclude that VOT is a promising tool for providing online feedback during endovenous laser therapy.

Increasing the efficacy of cue exposure treatment in preventing relapse of addictive behavior.

PubMed

Havermans, Remco C; Jansen, Anita T M

2003-07-01

Theoretically, cue exposure treatment should be able to prevent relapse by extinguishing conditioned drug responding (e.g. cue-elicited craving). According to contemporary learning theory, though, extinction does not eliminate conditioned responding. Analogous cue exposure with response prevention (CERP) as a treatment of addictive behavior might not eliminate the learned relation between drug-related cues and drug use. This does not necessarily mean that cue exposure cannot successfully prevent relapse. Various suggestions for increasing the efficacy of cue exposure treatment are being discussed from a contemporary learning theory perspective. It is suggested that cue exposure treatment incorporating retrieval cues can be a beneficial treatment in preventing relapse of addictive behavior.

Cysticidal Efficacy of Combined Treatment With Praziquantel and Albendazole for Parenchymal Brain Cysticercosis.

PubMed

Garcia, Hector H; Lescano, Andres G; Gonzales, Isidro; Bustos, Javier A; Pretell, E Javier; Horton, John; Saavedra, Herbert; Gonzalez, Armando E; Gilman, Robert H

2016-06-01

The efficacy of current antiparasitic treatment for cerebral Taenia solium cysticercosis with either albendazole (ABZ) or praziquantel (PZQ) is suboptimal. A recent study demonstrated that combining these 2 antiparasitic drugs improves antiparasitic efficacy. We present here the parasiticidal efficacy data obtained during a previous phase II pharmacokinetic study that compared combined ABZ plus PZQ with ABZ alone. The study was a randomized, double-blinded, placebo-controlled phase II evaluation of the pharmacokinetics of ABZ (15 mg/k/d, for 10 days) and PZQ (50 mg/k/d, for 10 days) in intraparenchymal brain cysticercosis. Patients received the usual concomitant medications, including an antiepileptic drug (phenytoin or carbamazepine), dexamethasone, and ranitidine. Randomization was stratified by antiepileptic drug. Patients underwent safety laboratory evaluations at days 4, 7, and 11, as well as magnetic resonance (MR) imaging at 6 months to assess parasiticidal efficacy. Thirty-two patients were included, 16 in each arm. All of them completed antiparasitic treatment and underwent follow-up brain MR imaging. Cysticidal efficacy was strikingly higher in the combined ABZ-plus-PZQ group than in the ABZ-alone group (proportion of cysts resolved, 78 of 82 [95%] vs 23 of 77 [30%] [relative risk {RR}, 3.18; 95% confidence interval {CI}, 2.08-4.88; P < .001]; patients with complete cyst clearance, 12 of 16 [75%] vs 4 of 16 [25%] [RR, 3.00; 95% CI, 1.23-7.34; P = .005]). The combination of ABZ plus PZQ is more effective in destroying viable brain cysticercosis cysts than ABZ alone. NCT00441285. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Metabolomics for in situ environmental monitoring of surface waters impacted by contaminants from both point and non-point sources

EPA Science Inventory

We investigated the efficacy of metabolomics for field-monitoring of fish exposed to waste water treatment plant (WWTP) effluents and non-point sources of chemical contamination. Lab-reared male fathead minnows (Pimephales promelas, FHM) were held in mobile monitoring units and e...

Pharmacokinetic monitoring of chronic treatment with digoxin from Primary Health Care.

PubMed

García-Iranzo, Emma M; Rodríguez-Lucena, Francisco J; Matoses-Chirivella, Carmen; García-Monsalve, Ana; Murcia-López, Ana Cristina; Navarro-Ruiz, Andrés

2017-07-01

The serum digoxin concentration (SDC) should be between 0.8 and 2 ng/ml. The objective is to assess the pharmacokinetic monitoring of SDC performed from primary healthcare (PH) in patients with chronic treatment. Cross-sectional retrospective study of patients with chronic treatment with digoxin belonging to the department of a General University Hospital.Data were analized: age, sex, diagnosis, number of serum digoxin concentration determinations, date and origin of the request for monitoring, analytical result and pharmacokinetic assessment are collected. 624 patients are undergoing chronic treatment with digoxin, 68% women, mean age 78.4 (39-98) years. 308 (49.4%) patients haven't analytical determination of SDC (Group 1), 183 (29.3%) patients have a SDC occasionally performed with a request from specialist care (Group 2) and 133 (21,3%) patients have CSD performed with a request from primary healthcare doctors, with an average of 2.42 monitoring per patient and year (Group 3). These are those patients who have pharmacokinetic monitoring of chronic treatment with digoxin. Of the group 2.25 (13.6%) patientes were hospital admission from emergency department for presenting digitalis intoxication with CSD>2 ng/ml, and 39 (21.3%) patients for low dosing with CSD<0.5 ng/ml. Group 3.4 (3%) patients presented digitalis intoxication and 5 (3.8%) for insufficient dosing. A small proportion of patients undergoing chronic treatment with digoxin are under pharmacokinetic monitoring and a reduction in complications derived from inappropriate CSD compared to those not under pharmacokinetic follow-up is observed. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Diffusion-sensitive optical coherence tomography for real-time monitoring of mucus thinning treatments

NASA Astrophysics Data System (ADS)

Blackmon, Richard L.; Kreda, Silvia M.; Sears, Patrick R.; Ostrowski, Lawrence E.; Hill, David B.; Chapman, Brian S.; Tracy, Joseph B.; Oldenburg, Amy L.

2016-03-01

Mucus hydration (wt%) has become an increasingly useful metric in real-time assessment of respiratory health in diseases like cystic fibrosis and COPD, with higher wt% indicative of diseased states. However, available in vivo rheological techniques are lacking. Gold nanorods (GNRs) are attractive biological probes whose diffusion through tissue is sensitive to the correlation length of comprising biopolymers. Through employment of dynamic light scattering theory on OCT signals from GNRs, we find that weakly-constrained GNR diffusion predictably decreases with increasing wt% (more disease-like) mucus. Previously, we determined this method is robust against mucus transport on human bronchial epithelial (hBE) air-liquid interface cultures (R2=0.976). Here we introduce diffusion-sensitive OCT (DS-OCT), where we collect M-mode image ensembles, from which we derive depth- and temporally-resolved GNR diffusion rates. DS-OCT allows for real-time monitoring of changing GNR diffusion as a result of topically applied mucus-thinning agents, enabling monitoring of the dynamics of mucus hydration never before seen. Cultured human airway epithelial cells (Calu-3 cell) with a layer of endogenous mucus were doped with topically deposited GNRs (80x22nm), and subsequently treated with hypertonic saline (HS) or isotonic saline (IS). DS-OCT provided imaging of the mucus thinning response up to a depth of 600μm with 4.65μm resolution, over a total of 8 minutes in increments of >=3 seconds. For both IS and HS conditions, DS-OCT captured changes in the pattern of mucus hydration over time. DS-OCT opens a new window into understanding mechanisms of mucus thinning during treatment, enabling real-time efficacy feedback needed to optimize and tailor treatments for individual patients.

Therapeutic efficacy of artemether-lumefantrine combination in the treatment of uncomplicated malaria among children under five years of age in three ecological zones in Ghana.

PubMed

Abuaku, Benjamin; Duah, Nancy; Quaye, Lydia; Quashie, Neils; Koram, Kwadwo

2012-11-22

In 2008, artemether - lumefantrine (AL) and dihydroartemisinin - piperaquine (DHAP) were added to artesunate - amodiaquine (AS-AQ) as first-line drugs for uncomplicated malaria in Ghana. The introduction of new drugs calls for continuous monitoring of these drugs to provide timely information on trends of their efficacy and safety to enhance timely evidence-based decision making by the National Malaria Control Programme. In this regard, the therapeutic efficacy of AL was monitored from September 2010 to April 2011 in four sentinel sites representing the three main ecological zones of the country. The study was a one-arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria among children aged 6 months to 59 months using the 2009 WHO protocol for surveillance of anti-malarial drug efficacy. Children recruited into the study received weight-based 20/120 mg AL at 0, 8, 24, 36, 48, and 60 hrs. Parasitaemia levels were assessed on days 2, 3, 7, 14, 21, 28, and at any time a study child was brought to the clinic with fever. A total of 175 children were enrolled into the study: 56 in the savanna zone, 78 in the forest zone and 41 in the coastal zone. Per-protocol analysis showed that the overall PCR-corrected cure rates on day 14 and day 28 were 96.5% (95% CI: 92.1, 98.6) and 95.4% (95% CI: 90.3, 98.0), respectively, with statistically significant differences between the ecological zones. The 90.4% day-28 cure rate observed in the savannah zone (95% CI: 78.2, 96.4) was significantly the lowest compared with 100% (95% CI: 93.2, 99.9) in the forest zone and 93.8% (95% CI: 77.8, 98.9) in the coastal zone (P = 0.017). Fever and parasite clearance were slower among children enrolled in the savannah zone. Gametocytaemia after day-3 post-treatment was rare in all the zones. The study has shown that AL remains efficacious in Ghana with significant ecologic zonal differences. The savannah zone may be

Feasibility of antiretroviral treatment monitoring in the era of decentralized HIV care: a systematic review.

PubMed

Pham, Minh D; Romero, Lorena; Parnell, Bruce; Anderson, David A; Crowe, Suzanne M; Luchters, Stanley

2017-01-19

Regular monitoring of HIV patients who are receiving antiretroviral therapy (ART) is required to ensure patient benefits and the long-term effectiveness and sustainability of ART programs. Prompted by WHO recommendations for expansion and decentralization of HIV treatment and care in low and middle income countries, we conducted a systematic review to assess the feasibility of treatment monitoring in these settings. A comprehensive search strategy was developed using a combination of MeSH and free text terms relevant to HIV treatment and care, health service delivery, health service accessibility, decentralization and other relevant terms. Five electronic databases and two conference websites were searched to identify relevant studies conducted in LMICs, published in English between Jan 2006 and Dec 2015. Outcomes of interest included the proportion of patients who received treatment monitoring and health system factors related to monitoring of patients on ART under decentralized HIV service delivery models. From 5363 records retrieved, twenty studies were included in the review; all but one was conducted in sub-Saharan African countries. The majority of studies (15/20) had relatively short follow-up duration (≤24 months), and only two studies were specifically designed to assess treatment monitoring practices. The most frequently studied follow-up period was 12 months and a wide range of treatment monitoring coverage was observed. The reported proportions of patients on ART who received CD4 monitoring ranged from very low (6%; N = 2145) to very high (95%; N = 488). The median uptake of viral load monitoring was 86% with studies in program settings reporting coverage as low as 14%. Overall, the longer the follow-up period, the lower the proportion of patients who received regular monitoring tests; and programs in rural areas reported low coverage of laboratory monitoring. Moreover, uptake in the context of research had significantly better where monitoring

Impact of hepatitis C virus polymorphisms on direct-acting antiviral treatment efficacy: Regulatory analyses and perspectives.

PubMed

Harrington, Patrick R; Komatsu, Takashi E; Deming, Damon J; Donaldson, Eric F; O'Rear, Julian J; Naeger, Lisa K

2018-06-01

Several highly effective, interferon-free, direct-acting antiviral (DAA)-based regimens are available for the treatment of chronic hepatitis C virus (HCV) infection. Despite impressive efficacy overall, a small proportion of patients in registrational trials experienced treatment failure, which in some cases was associated with the detection of HCV resistance-associated substitutions (RASs) at baseline. In this article, we describe methods and key findings from independent regulatory analyses investigating the impact of baseline nonstructural (NS) 3 Q80K and NS5A RASs on the efficacy of current United States Food and Drug Administration (FDA)-approved regimens for patients with HCV genotype (GT) 1 or GT3 infection. These analyses focused on clinical trials that included patients who were previously naïve to the DAA class(es) in their investigational regimen and characterized the impact of baseline RASs that were enriched in the viral population as natural or transmitted polymorphisms (i.e., not drug-selected RASs). We used a consistent approach to optimize comparability of results across different DAA regimens and patient populations, including the use of a 15% sensitivity cutoff for next-generation sequencing results and standardized lists of NS5A RASs. These analyses confirmed that detection of NS3 Q80K or NS5A baseline RASs was associated with reduced treatment efficacy for multiple DAA regimens, but their impact was often minimized with the use of an intensified treatment regimen, such as a longer treatment duration and/or addition of ribavirin. We discuss the drug resistance-related considerations that contributed to pretreatment resistance testing and treatment recommendations in drug labeling for FDA-approved DAA regimens. Independent regulatory analyses confirmed that baseline HCV RASs can reduce the efficacy of certain DAA-based regimens in selected patient groups. However, highly effective treatment options are available for patients with or without

Evaluating the Role of Total Organic Carbon in Predicting the Treatment Efficacy of Biosand Filters for the Removal of Vibrio cholerae in Drinking Water During Startup.

PubMed

Danley-Thomson, Ashley A; Huang, Ellen C; Worley-Morse, Thomas; Gunsch, Claudia K

2018-05-09

In biosand filters (BSF), treatment is largely driven by the development of a biolayer (schmutzdecke) which establishes itself during the startup phase. In the present study, the effect of changing influent total organic carbon (TOC) loading on the removal efficiency of Vibrio cholerae in laboratory-operated BSFs was quantified. BSFs were charged with high, medium or low TOC influents and removal efficacy and schmutzdecke composition was monitored over two months. The highest V. cholerae removal efficiencies were observed in the BSF receiving the lowest TOC. Schmutzdecke composition was found to be influenced by influent TOC, in terms of microbial community structure and amount of extracellular polymeric substance (EPS). Physical/chemical attachment was shown to be important during startup. The BSF receiving influent water with lower TOC had a higher attachment coefficient than the BSF receiving high TOC water, suggesting more physical/chemical treatment in the lower TOC BSF. The high TOC BSF had more EPS than did the biofilm from the low TOC BSF, suggesting that schmutzdecke effects may be more significant at high TOC. Overall, this study confirms that influent water characteristics will affect BSF treatment efficacy of V. cholerae especially during the startup phase. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Treatment of Chronic Migraine with OnabotulinumtoxinA: Mode of Action, Efficacy and Safety.

PubMed

Szok, Délia; Csáti, Anett; Vécsei, László; Tajti, János

2015-07-17

Chronic migraine is a common, highly disabling, underdiagnosed and undertreated entity of migraine. It affects 0.9%-2.2% of the general adult population. The present paper overviews the preclinical and clinical data regarding the therapeutic effect of onabotulinumtoxinA in chronic migraineurs. A literature search was conducted in the database of PubMed up to 20 May 2015 for articles related to the pathomechanism of chronic migraine, the mode of action, and the efficacy, safety and tolerability of onabotulinumtoxinA for the preventive treatment of chronic migraine. The pathomechanism of chronic migraine has not been fully elucidated. The mode of action of onabotulinumtoxinA in the treatment of chronic migraine is suggested to be related to the inhibition of the release of calcitonin gene-related peptide and substance P in the trigeminovascular system. Randomized clinical trials demonstrated that long-term onabotulinumtoxinA fixed-site and fixed-dose (155-195 U) intramuscular injection therapy was effective and well tolerated for the prophylactic treatment of chronic migraine. Chronic migraine is a highly devastating entity of migraine. Its exact pathomechanism is unrevealed. Two-third of chronic migraineurs do not receive proper preventive medication. Recent clinical studies revealed that onabotulinumtoxinA was an efficacious and safe treatment for chronic migraine.

Treatment of Chronic Migraine with OnabotulinumtoxinA: Mode of Action, Efficacy and Safety

PubMed Central

Szok, Délia; Csáti, Anett; Vécsei, László; Tajti, János

2015-01-01

Background: Chronic migraine is a common, highly disabling, underdiagnosed and undertreated entity of migraine. It affects 0.9%–2.2% of the general adult population. The present paper overviews the preclinical and clinical data regarding the therapeutic effect of onabotulinumtoxinA in chronic migraineurs. Methods: A literature search was conducted in the database of PubMed up to 20 May 2015 for articles related to the pathomechanism of chronic migraine, the mode of action, and the efficacy, safety and tolerability of onabotulinumtoxinA for the preventive treatment of chronic migraine. Results: The pathomechanism of chronic migraine has not been fully elucidated. The mode of action of onabotulinumtoxinA in the treatment of chronic migraine is suggested to be related to the inhibition of the release of calcitonin gene-related peptide and substance P in the trigeminovascular system. Randomized clinical trials demonstrated that long-term onabotulinumtoxinA fixed-site and fixed-dose (155–195 U) intramuscular injection therapy was effective and well tolerated for the prophylactic treatment of chronic migraine. Conclusions: Chronic migraine is a highly devastating entity of migraine. Its exact pathomechanism is unrevealed. Two-third of chronic migraineurs do not receive proper preventive medication. Recent clinical studies revealed that onabotulinumtoxinA was an efficacious and safe treatment for chronic migraine. PMID:26193319

Canine Angiostrongylosis in Naturally Infected Dogs: Clinical Approach and Monitoring of Infection after Treatment

PubMed Central

Capogna, Antonio; Lia, Riccardo Paolo; Sasanelli, Mariateresa

2013-01-01

Canine angiostrongylosis is an increasingly reported disease in Europe which can be fatal if left untreated. The wide range of clinical presentation along with the absence of pathognomonic alterations can make the diagnosis challenging; thus any additional information that may provide clues to an early diagnosis may be of value, in order to ensure adequate anthelmintic treatment. Aim of the study was to assess a clinicopathological scoring system associated with natural Angiostrongylus vasorum infection diagnosed in canine patients during clinical practice, to clinically and paraclinically monitor infected dogs after treatment, and to monitor the presence of L1 larvae in faecal samples by Baermann's test. Of the total 210 enrolled animals A. vasorum infection was diagnosed in 7 dogs. These dogs were clinically and paraclinically investigated and monitored after specific treatment. Further 3 symptomatic dogs were retrospectively included in the monitoring. Results suggest that the computed scoring system can help to increase the clinical suspicion of infection particularly in asymptomatic dogs before the onset of potentially lethal lesions. Data of faecal monitoring suggested that treatment may control parasite burden but be unable to eradicate infection. Thus, a continued faecal monitoring after treatment is advisable for identification of still infected or reinfected dogs. PMID:24459443

Predictors for the efficacy of naltrexone treatment in alcohol dependence: sweet preference.

PubMed

Laaksonen, E; Lahti, J; Sinclair, J D; Heinälä, P; Alho, H

2011-01-01

To analyse the possible associations between sweet preference and the efficacy of naltrexone treatment of alcohol dependence. The preference for different concentrations of sucrose was evaluated in 78 participants diagnosed with alcohol dependence after treatment for 32 weeks with naltrexone or placebo without prior detoxification. A significant difference between naltrexone and placebo groups was found in the association between the preference for higher sucrose concentrations and relapses to heavy drinking. Higher sweet preference was significantly related to successful treatment measures in the naltrexone group but not in the placebo group. Sweet preference has a strong correlation to treatment outcomes with naltrexone, and sweet preference might be used as a predictor for better treatment results in alcoholics. Our study offers one possible new explanation of the clinical observation that naltrexone is not effective for every patient.

Efficacy of using radio transmitters to monitor least tern chicks

USGS Publications Warehouse

Whittier, Joanna B.; Leslie, David M.

2005-01-01

Little is known about Least Tern (Sterna antillarum) chicks from the time they leave the nest until fledging because they are highly mobile and cryptically colored. We evaluated the efficacy of using radiotelemetry to monitor Interior Least Tern (S. a. athalassos) chicks at Salt Plains National Wildlife Refuge, Oklahoma. In 1999, we attached radio transmitters to 26 Least Tern chicks and tracked them for 2-17 days. No adults abandoned their chicks after transmitters were attached. Transmitters did not appear to alter growth rates of transmittered chicks (P = 0.36) or prevent feather growth, although dermal irritation was observed on one chick. However, without frequent reattachment, transmitters generally did not remain on chicks <1 week old for more than 2 days because of feather growth and transmitter removal, presumably by adult terns. Although the presence of transmitters did not adversely affect Least Tern chicks, future assessments should investigate nonintrusive methods to improve retention of transmitters on young chicks and reduce the number of times that chicks need to be handled.

Illness perception, treatment beliefs, self-esteem, and self-efficacy as correlates of self-management in multiple sclerosis.

PubMed

Wilski, M; Tasiemski, T

2016-05-01

Self-management of a disease is considered one of the most important factors affecting the treatment outcome. The research on the correlates of self-management in multiple sclerosis (MS) is limited. The aim of this study was to determine if personal factors, such as illness perception, treatment beliefs, self-esteem and self-efficacy, are correlates of self-management in MS. This cross-sectional study included 210 patients with MS who completed Multiple Sclerosis Self-Management Scale - Revised, Brief Illness Perception Questionnaire, Treatment Beliefs Scale, Rosenberg Self-Esteem Scale, and Generalized Self-Efficacy Scale. The patients were recruited from a MS rehabilitation clinic. Demographic data and illness-related problems of the study participants were collected with a self-report survey. Correlation and regression analyses were performed to determine associations between variables. Four factors: age at the time of the study (β = 0.14, P = 0.032), timeline (β = 0.16, P = 0.018), treatment control (β = 0.17, P = 0.022), and general self-efficacy (β = 0.19, P = 0.014) turned out to be the significant correlates of self-management in MS. The model including these variables explained 25% of variance in self-management in MS. Personal factors, such as general self-efficacy, perception of treatment control and realistic MS timeline perspective, are more salient correlates of self-management in MS than the objective clinical variables, such as the severity, type, and duration of MS. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Efficacy of chloramphenicol, enrofloxacin, and tetracycline for treatment of experimental Rocky Mountain spotted fever in dogs.

PubMed Central

Breitschwerdt, E B; Davidson, M G; Aucoin, D P; Levy, M G; Szabados, N S; Hegarty, B C; Kuehne, A L; James, R L

1991-01-01

Dogs were experimentally inoculated with Rickettsia rickettsii to characterize the comparative efficacies of chloramphenicol, enrofloxacin, and tetracycline for the treatment of Rocky Mountain spotted fever (RMSF). All three antibiotics were equally effective in abrogating the clinical, hematologic, and vascular indicators of rickettsial infection. Antibiotic treatment for 24 h was sufficient to decrease the rickettsemia to levels below detection by Vero cell culture. Early treatment with all three antibiotics resulted in a similar decrease in antibody titer, but acute and convalescent serum samples taken at appropriate times would have still facilitated an accurate diagnosis of RMSF in all but one dog, which did not seroconvert. We conclude that chloramphenicol, enrofloxacin, and tetracycline are equally efficacious for treating experimental canine RMSF. PMID:1666498

Efficacy of elagolix in the treatment of endometriosis.

PubMed

Perricos, Alexandra; Wenzl, René

2017-09-01

Much research has gone into developing medications that can be used to alleviate endometriosis-associated symptoms. In addition to already established medications, a new GnRH antagonist, elagolix, is in development. The novelty of this drug compared to other GnRH antagonists, is its nonpeptide structure, allowing it to be administered orally. Areas covered: We analyzed several Phase I, II and III clinical trials that have evaluated the safety and efficacy of this new medication. Expert opinion: Since many medications have been put on the market and have gained popularity for the treatment of endometriosis-associated symptoms, the demonstration of equality or superiority of effect, tolerability, as well as patient compliance should be assessed when introducing a new drug. While elagolix may have an advantage over established GnRH agonists, in that it does not lead to a 'flare-up' effect, it too, takes a toll on bone mineral density. Nevertheless, studies have shown that this new oral GnRH antagonist is well tolerated, and the side effects have been described as 'mild or moderate'. However, in order to examine whether elagolix can compete with or even surpass established gold-standard medical treatments in this field, further studies that directly compare elagolix to said treatments, might be necessary.

Efficacy of chemical treatments in eliminating Salmonella and Escherichia coli O157:H7 on scarified and polished alfalfa seeds.

PubMed

Holliday, S L; Scouten, A J; Beuchat, L R

2001-10-01

Alfalfa seeds are sometimes subjected to a scarification treatment to enhance water uptake, which results in more rapid and uniform germination during sprout production. It has been hypothesized that this mechanical abrasion treatment diminishes the efficacy of chemical treatments used to kill or remove pathogenic bacteria from seeds. A study was done to compare the effectiveness of chlorine (20,000 ppm), H2O, (8%), Ca(OH)2 (1%), Ca(OH)2 (1%) plus Tween 80 (1%), and Ca(OH)2 (1%) plus Span 20 (1%) treatments in killing Salmonella and Escherichia coli O157:H7 inoculated onto control, scarified, and polished alfalfa seeds obtained from two suppliers. The influence of the presence of organic material in the inoculum carrier on the efficacy of sanitizers was investigated. Overall, treatment with 1% Ca(OH)2 was the most effective in reducing populations of the pathogens. Reduction in populations of pathogens on seeds obtained from supplier I indicate that chemical treatments are less efficacious in eliminating the pathogens on scarified seeds compared to control seeds. However, the effectiveness of chemical treatment in removing Salmonella and E. coli O157:H7 from seeds obtained from supplier 2 was not markedly affected by scarification or polishing. The presence of organic material in the inoculum carrier did not have a marked influence on the efficacy of chemicals in reducing populations of test pathogens. Additional lots of control, scarified, and polished alfalfa seeds of additional varieties need to be tested before conclusions can be drawn concerning the impact of mechanical abrasion on the efficacy of chemical treatment in removing or killing Salmonella and E. coli O157:H7.

Interventions for post-infectious irritable bowel syndrome: a systematic review of treatment efficacy.

PubMed

Torbicki, Emma; Oh, Justin; Mishra, Sharmistha; Page, Andrea V; Boggild, Andrea K

2015-01-01

Post-infectious irritable bowel syndrome (PI-IBS) due to traveler's diarrhea is the second most common illness seen in post-travel clinics, yet its optimal management remains unknown. We performed a systematic review to evaluate treatment efficacy in PI-IBS. We searched Medline, EMBASE, LILACS, CINAHL, CAB abstracts, and the Cochrane Library to February 3, 2014 for intervention studies of the pharmacologic and non-pharmacologic management of PI-IBS and examined the evidence according to a modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE) scale. Of 336 records, 9 studies were included. Eight studies of pharmacologic interventions examined 5 agents (mesalazine or mesalamine, ondansetron, prednisolone, cholestyramine, and metronidazole). One study examined the non-pharmacologic intervention of different infant nutritional formulas following acute gastroenteritis. The quality of the evidence to date was low, with small sample size (fewer than 50 participants) and short duration of follow-up. Overall, the efficacy of pharmacological treatment ranged from no benefit (ondansetron and prednisolone) to moderately beneficial (cholestyramine and metronidazole). The evidence for mesalazine was equivocal: one study showed benefit, two others showed none. Heterogeneity in outcome measures and low strength of evidence preclude recommendations on the optimal management of PI-IBS by a specific agent. More comparative intervention research into PI-IBS treatment is needed for consistent best practice in PI-IBS management. Clinicians may elect to pursue therapeutic trials of mesalazine, cholestyramine, or metronidazole in individual patients, but should be aware that data supporting the efficacy of these agents is limited.

Use of shear waves for diagnosis and ablation monitoring of prostate cancer: a feasibility study

NASA Astrophysics Data System (ADS)

Gomez, A.; Rus, G.; Saffari, N.

2016-01-01

Prostate cancer remains as a major healthcare issue. Limitations in current diagnosis and treatment monitoring techniques imply that there is still a need for improvements. The efficacy of prostate cancer diagnosis is still low, generating under and over diagnoses. High intensity focused ultrasound ablation is an emerging treatment modality, which enables the noninvasive ablation of pathogenic tissue. Clinical trials are being carried out to evaluate its longterm efficacy as a focal treatment for prostate cancer. Successful treatment of prostate cancer using non-invasive modalities is critically dependent on accurate diagnostic means and is greatly benefited by a real-time monitoring system. While magnetic resonance imaging remains the gold standard for prostate imaging, its wider implementation for prostate cancer diagnosis remains prohibitively expensive. Conventional ultrasound is currently limited to guiding biopsy. Elastography techniques are emerging as a promising real-time imaging method, as cancer nodules are usually stiffer than adjacent healthy prostatic tissue. In this paper, a new transurethral approach is proposed, using shear waves for diagnosis and ablation monitoring of prostate cancer. A finite-difference time domain model is developed for studying the feasibility of the method, and an inverse problem technique based on genetic algorithms is proposed for reconstructing the location, size and stiffness parameters of the tumour. Preliminary results indicate that the use of shear waves for diagnosis and monitoring ablation of prostate cancer is feasible.

[Safety and short-term efficacy of renal sympathetic denervation in the treatment of resistant hypertension].

PubMed

Jiang, Xiong-jing; Liang, Tuo; Dong, Hui; Peng, Meng; Ma, Wen-jun; Guan, Ting; Zhang, Hui-min; Bian, Jin; Xu, Bo; Gao, Run-lin

2012-12-11

Transcatheter renal sympathetic denervation (RDN) is a novel technology/therapy in treating resistant hypertension. The present study aims to evaluate the safety and short-term efficacy of RDN for the treatment of resistant hypertension in a Chinese population. This prospective single-center pilot study was the first one conducted in China with Medtronic Ardian Symplicity Catheter System. Eight patients (6 males and 2 females) with resistant hypertension underwent RDN at our hospital from February to April 2012. All patients were followed up at one month and three months post-RDN. Blood pressure, use of antihypertensive medications, renal function and complications were recorded and analyzed. At one month and three months post-RDN, 24-hour ambulatory blood pressure monitoring showed mean systolic blood pressure and diastolic blood pressure decreased 10 (0 - 18) 13 (3 - 19) and 8 (-2 - 15), 9 (2 - 16) mm Hg throughout 24 hours respectively (P < 0.05, vs baseline). The number of drugs decreased from 4.3 ± 0.5 to 2.8 ± 0.9 and 2.5 ± 0.7 post-RSD respectively (P < 0.01). There was no significant change of renal function (P > 0.05). No complications were observed. The preliminary results revealed that RDN was safe and effective for the treatment of resistant hypertension in the Chinese population during a 3-month follow-up. Further large and long-term studies are warranted.

A Meta-Analysis of Cognitive Behavior Therapy and Medication for Child Obsessive Compulsive Disorder: Moderators of Treatment Efficacy, Response, and Remission

PubMed Central

McGuire, Joseph F.; Piacentini, John; Lewin, Adam B.; Brennan, Erin A; Murphy, Tanya K.; Storch, Eric A.

2015-01-01

Background Individual randomized controlled trials (RCTs) have demonstrated the efficacy of cognitive behavioral therapy (CBT) and serotonin reuptake inhibitors (SRIs) for the treatment of youth with obsessive-compulsive disorder (OCD). While meta-analyses have confirmed these results, there has been minimal examination of treatment moderators or an examination of treatment response and symptom/diagnostic remission for these two treatment types. The present report examined the treatment efficacy, treatment response, and symptom/diagnostic remission for youth with OCD receiving either CBT or SRIs relative to comparison conditions, and examined treatment moderators. Method A comprehensive literature search identified 20 RCTs that met inclusion criteria, and produced a sample size of 507 CBT participants and 789 SRI participants. Results Random effects meta-analyses of CBT trials found large treatment effects for treatment efficacy (g=1.21), treatment response [relative risk (RR)=3.93], and symptom/diagnostic remission (RR=5.40). Greater co-occurring anxiety disorders, therapeutic contact, and lower treatment attrition were associated with greater CBT effects. The number needed to treat (NNT) was three for treatment response and symptom/diagnostic remission. Random effects meta-analyses of SRI trials found a moderate treatment effect for treatment efficacy (g=0.50), treatment response (RR=1.80), and symptom/diagnostic remission (RR=2.06). Greater methodological quality was associated with a lower treatment response for SRI trials. The NNT was five for treatment response and symptom/diagnostic remission. Conclusions Findings demonstrate the treatment effects for CBT and SRIs across three important outcome metrics, and provide evidence for moderators of CBT across trials. PMID:26130211

New treatment options for chronic constipation: Mechanisms, efficacy and safety

PubMed Central

Camilleri, Michael

2011-01-01

The present review has several objectives, the first of which is to review the pharmacology and selectivity of serotonergic agents to contrast the older serotonergic agents (which were withdrawn because of cardiac or vascular adverse effects) with the newer generation serotonin receptor subtype 4 agonists. Second, the chloride ion secretagogues that act through the guanylate cyclase C receptor are appraised and their pharmacology is compared with the approved medication, lubiprostone. Third, the efficacy and safety of the application of bile acid modulation to treat constipation are addressed. The long-term studies of surgically induced excess bile acid delivery to the colon are reviewed to ascertain the safety of this therapeutic approach. Finally, the new drugs for opiate-induced constipation are introduced. Assuming these drugs are approved, practitioners will have a choice; however, patient responsiveness will be based on trial and error. Nevertheless, the spectrum of mechanisms and demonstrated efficacy and safety augur well for satisfactory treatment outcomes. PMID:22114755

Efficacy of face-to-face versus self-guided treatments for disordered gambling: A meta-analysis.

PubMed

Goslar, Martina; Leibetseder, Max; Muench, Hannah M; Hofmann, Stefan G; Laireiter, Anton-Rupert

2017-06-01

Background and aims In the light of growing traditional and novel forms of gambling, the treatment of disordered gambling is gaining increasing importance and practical relevance. Most studies have examined face-to-face treatments. Although trials implementing self-guided treatments have recently been conducted, these options have not yet been systematically examined. The primary objective of this meta-analysis, therefore, was to analyze the efficacy of all types of psychological face-to-face and self-guided treatments. Methods A multilevel literature search yielded 27 randomized controlled studies totaling 3,879 participants to provide a comprehensive comparative evaluation of the short- and long-term efficacies of face-to-face and self-guided treatments for disordered gambling. Results As expected, the results revealed significantly higher effect sizes for face-to-face treatments (16 studies with Hedges's g ranging from 0.67 to 1.15) as compared with self-guided treatments (11 studies with Hedges's g ranging from 0.12 to 0.30) regarding the reduction of problematic gambling behavior. The intensity of treatment moderated the therapy effect, particularly for self-guided treatments. Discussion and Conclusions The results of this meta-analysis favor face-to-face treatments over self-guided treatments for the reduction of disordered gambling. Although the findings broaden the scope of knowledge about psychological treatment modalities for disordered gambling, further research is needed to identify the reasons for these differences with the goal to optimize the treatment for this disabling condition.

Monitoring photodynamic therapy with photoacoustic microscopy

NASA Astrophysics Data System (ADS)

Shao, Peng; Chapman, David W.; Moore, Ronald B.; Zemp, Roger J.

2015-10-01

We present our work on examining the feasibility of monitoring photodynamic therapy (PDT)-induced vasculature change with acoustic-resolution photoacoustic microscopy (PAM). Verteporfin, an FDA-approved photosensitizer for clinical PDT, was utilized. With a 60-μm-resolution PAM system, we demonstrated the capability of PAM to monitor PDT-induced vasculature variations in a chick chorioallantoic membrane model with topical application and in a rat ear with intravenous injection of the photosensitizer. We also showed oxygen saturation change in target blood vessels due to PDT. Success of the present approach may potentially lead to the application of PAM imaging in evaluating PDT efficacy, guiding treatment, and predicting responders from nonresponders.

Efficacy and optimal dose of daily polyethylene glycol 3350 for treatment of constipation and encopresis in children.

PubMed

Pashankar, D S; Bishop, W P

2001-09-01

To determine efficacy, safety, and optimal dose of a laxative, polyethylene glycol (PEG) 3350, in children with chronic constipation. Children with chronic constipation (n = 24) were treated with PEG for 8 weeks at an initial dose of 1 g/kg/d. The dose was adjusted every 3 days as required to achieve 2 soft stools per day. A diary was kept to monitor dose, stool frequency and consistency, soiling, and other symptoms. Stool consistency was rated from 1 (hard) to 5 (watery). Subjects were examined for fecal retention. The Student t test and the Fisher exact test were used for data analysis. All 20 children who completed the study found PEG to be palatable and were satisfied with the treatment. There were no significant adverse effects. Weekly stool frequency increased from 2.3 +/- 0.4 to 16.9 +/- 1.6 (P <.0001) during treatment and stool consistency from 1.2 +/- 0.1 to 3.3 +/- 0.1 (P <.0001). In 9 children with soiling, weekly soiling events declined from 10.0 +/- 2.4 to 1.3 +/- 0.7 (P =.003). The mean effective dose was 0.84 g/kg/d (range, 0.27-1.42 g/kg/d). Daily administration of PEG at a mean dose of 0.8 g/kg is an effective, safe, and palatable treatment for constipation.

Efficacy and Safety of Immediate-Release Methylphenidate Treatment for Preschoolers with ADHD

ERIC Educational Resources Information Center

Greenhill, Laurence; Kollins, Scott; Abikoff, Howard; McCracken, James; Riddle, Mark; Swanson, James; McGough, James; Wigal, Sharon; Wigal, Tim; Vitiello, Benedetto; Skrobala, Anne; Posner, Kelly; Ghuman, Jaswinder; Cunningham, Charles; Davies, Mark; Chuang, Shirley; Cooper, Tom

2006-01-01

Objective: The Preschool ADHD Treatment Study (PATS) was a NIMH-funded, six-center, randomized, controlled trial to determine the efficacy and safety of immediate-release methylphenidate (MPH-IR), given t.i.d. to children ages 3 to 5.5 years with attention-deficit/hyperactivity disorder (ADHD). Method: The 8-phase, 70-week PATS protocol included…

Efficacy of nystatin for the treatment of oral candidiasis: a systematic review and meta-analysis

PubMed Central

Lyu, Xin; Zhao, Chen; Yan, Zhi-min; Hua, Hong

2016-01-01

Objective To systematically review and assess the efficacy, different treatment protocols (formulation, dosage, and duration), and safety of nystatin for treating oral candidiasis. Methods Four electronic databases were searched for trials published in English till July 1, 2015. Randomized controlled trials comparing nystatin with other antifungal therapies or a placebo were included. Clinical and/or mycological cure was the outcome evaluation. A meta-analysis or descriptive study on the efficacy, treatment protocols, and safety of nystatin was conducted. Results The meta-analysis showed that nystatin pastille was significantly superior to placebo in treating denture stomatitis. Nystatin suspension was not superior to fluconazole in treating oral candidiasis in infants, children, or HIV/AIDS patients. The descriptive investigations showed that administration of nystatin suspension and pastilles in combination for 2 weeks might achieve a higher clinical and mycological cure rate, and using the nystatin pastilles alone might have a higher mycological cure rate, when compared with using nystatin suspensions alone. Nystatin pastilles at a dose of 400,000 IU resulted in a significantly higher mycological cure rate than that administrated at a dose of 200,000 IU. Furthermore, treatment with nystatin pastilles for 4 weeks seemed to have better clinical efficacy than treatment for 2 weeks. Descriptive safety assessment showed that poor taste and gastrointestinal adverse reaction are the most common adverse effects of nystatin. Conclusion Nystatin pastille was significantly superior to placebo in treating denture stomatitis, while nystatin suspension was not superior to fluconazole in treating oral candidiasis in infants, children, or HIV/AIDS patients. Indirect evidence from a descriptive study demonstrated that administration of nystatin pastille alone or pastille and suspension in combination is more effective than that of suspension alone; prolonged treatment duration

Safety and efficacy outcomes of long-term treatment up to 4 years with 5% lidocaine medicated plaster in patients with post-herpetic neuralgia.

PubMed

Sabatowski, Rainer; Hans, Guy; Tacken, Ingrid; Kapanadze, Sofia; Buchheister, Bettina; Baron, Ralf

2012-08-01

Prospective evaluation of the long-term efficacy and safety of the 5% lidocaine medicated plaster in patients with post-herpetic neuralgia (PHN). Patients with persisting pain for ≥3 months after acute herpes zoster and a baseline pain intensity of at least 4 on an 11-point numerical rating scale (NRS 0-10) were treated with 5% lidocaine medicated plasters for up to 5 years and monitored in regular intervals. Efficacy parameters are presented for the first 4 years and include patients' recall of pain relief (6-point verbal rating scale (VRS), clinical global impression of change (CGIC), patients' global impression of change PGIC), and the global evaluations of study medication. Safety parameters (clinical examination, skin evaluation, laboratory) and adverse events (AEs) were assessed at regular visits. KF10004/02. A total of 102 patients continuing from a 1 year main study period were included in an extension phase of up to 3 years. Ten patients (9.8%) dropped out due to lack of efficacy and 9 patients (8.8%) due to treatment-related AEs; 56 patients (54.9%) left the study for non-treatment-related reasons. Twenty-seven patients (26.4%) were still under treatment after a total treatment period of 4 years. On average, a pain relief of at least 4.3 (between moderate and a lot) was achieved throughout the study. At all visits the CGIC and the PGIC were much or very much improved in about 80% of patients. At the final visit, study medication was rated at least to be good by 91% of physicians and 89% of patients. Drug-related adverse events (DRAEs) were reported in 19 of 102 patients, mainly mild to moderate localized skin reactions. There were no hints for a reduced analgesic effect or an increase of DRAEs with long-term treatment. This study demonstrates that long-term treatment of ≥12 months with the 5% lidocaine medicated plaster is effective and well tolerated in PHN patients. These findings support the recommendations to use the 5% lidocaine medicated plaster

Efficacy of treatment of trochanteric bursitis: a systematic review.

PubMed

Lustenberger, David P; Ng, Vincent Y; Best, Thomas M; Ellis, Thomas J

2011-09-01

Trochanteric bursitis (TB) is a self-limiting disorder in the majority of patients and typically responds to conservative measures. However, multiple courses of nonoperative treatment or surgical intervention may be necessary in refractory cases. The purpose of this systematic review was to evaluate the efficacy of the treatment of TB. A literature search in the PubMed, MEDLINE, CINAHL, and ISI Web of Knowledge databases was performed for all English language studies up to April 2010. Terms combined in a Boolean search were greater trochanteric pain syndrome, trochanteric bursitis, trochanteric, bursitis, surgery, therapy, drug therapy, physical therapy, rehabilitation, injection, Z-plasty, Z-lengthening, aspiration, bursectomy, bursoscopy, osteotomy, and tendon repair. All studies directly involving the treatment of TB were reviewed by 2 authors and selected for further analysis. Expert opinion and review articles were excluded, as well as case series with fewer than 5 patients. Twenty-four articles were identified. According to the system described by Wright et al, 2 studies, each with multiple arms, qualified as level I evidence, 1 as level II, 1 as level III, and the rest as level IV. More than 950 cases were included. The authors extracted data regarding the type of intervention, level of evidence, mean age of patients, patient gender, number of hips in the study, symptom duration before the study, mean number of injections before the study, prior hip surgeries, patient satisfaction, length of follow-up, baseline scores, and follow-up scores for the visual analog scale (VAS) and Harris Hip Scores (HHS). Symptom resolution and the ability to return to activity ranged from 49% to 100% with corticosteroid injection as the primary treatment modality with and without multimodal conservative therapy. Two comparative studies (levels II and III) found low-energy shock-wave therapy (SWT) to be superior to other nonoperative modalities. Multiple surgical options for

Safety and Efficacy of Catheter Direct Thrombolysis in Management of Acute Iliofemoral Deep Vein Thrombosis: A Systematic Review

PubMed Central

Elbasty, Ahmed; Metcalf, James

2017-01-01

Purpose Catheter direct thrombolysis (CDT) has been shown to be an effective treatment for deep venous thrombosis. The objective of the review is to improve safety and efficacy of the CDT by using ward based protocol, better able to predict complications and treatment outcome through monitoring of haemostatic parameters and clinical observation during thrombolysis procedure. Materials and Methods MEDLINE, EMBASE, CENTRAL and Web of Science were searched for all articles on deep venous thrombosis, thrombolysis and correlations of clinical events (bleeding, successful thrombolysis) during thrombolysis with hemostatic parameters to March 2016. The risk of bias in included studies was assessed by Cochrane Collaboration’s tool and Cochrane Risk of Bias Assessment Tool: for Non-Randomized Studies of Interventions. Results Twenty-four studies were included in the review and we found that improving safety and efficacy of CDT by using ward based protocol depending on eight factors; strict patient selection criteria, types of fibrinolytic drugs, mode of fibrinolytic drug injection, biochemical markers monitoring (fibrinogen, D-dimer, activated partial thromboplastin time, plasminogen activator inhibitor-1), timing of intervention, usage of intermittent pneumatic calf, ward monitoring and thrombolysis imaging assessment (intravascular ultrasound). These factors may help to improve safety and efficacy by reducing total thrombolytic drug dosage and at the same time ensure successful lysis. There is a marked lack of randomized controlled trials discussing the safety and efficacy of catheter direct thrombolysis. Conclusion CDT can be performed safely and efficiently in clinical ward, providing that careful nursing, biochemical monitoring, proper selection and mode of infusion of fibrinolytic drugs, usage of Intermittent pneumatic calf and adequate thrombolysis imaging assessment are ensured. PMID:29354622

Posttreatment attrition and its predictors, attrition bias, and treatment efficacy of the anxiety online programs.

PubMed

Al-Asadi, Ali M; Klein, Britt; Meyer, Denny

2014-10-14

Although relatively new, the field of e-mental health is becoming more popular with more attention given to researching its various aspects. However, there are many areas that still need further research, especially identifying attrition predictors at various phases of assessment and treatment delivery. The present study identified the predictors of posttreatment assessment completers based on 24 pre- and posttreatment demographic and personal variables and 1 treatment variable, their impact on attrition bias, and the efficacy of the 5 fully automated self-help anxiety treatment programs for generalized anxiety disorder (GAD), social anxiety disorder (SAD), panic disorder with or without agoraphobia (PD/A), obsessive-compulsive disorder (OCD), and posttraumatic stress disorder (PTSD). A complex algorithm was used to diagnose participants' mental disorders based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition, Text Revision; DSM-IV-TR). Those who received a primary or secondary diagnosis of 1 of 5 anxiety disorders were offered an online 12-week disorder-specific treatment program. A total of 3199 individuals did not formally drop out of the 12-week treatment cycle, whereas 142 individuals formally dropped out. However, only 347 participants who completed their treatment cycle also completed the posttreatment assessment measures. Based on these measures, predictors of attrition were identified and attrition bias was examined. The efficacy of the 5 treatment programs was assessed based on anxiety-specific severity scores and 5 additional treatment outcome measures. On average, completers of posttreatment assessment measures were more likely to be seeking self-help online programs; have heard about the program from traditional media or from family and friends; were receiving mental health assistance; were more likely to learn best by reading, hearing and doing; had a lower pretreatment Kessler-6 total score; and were older

Feasibility of tuberculosis treatment monitoring by video directly observed therapy: a binational pilot study.

PubMed

Garfein, R S; Collins, K; Muñoz, F; Moser, K; Cerecer-Callu, P; Raab, F; Rios, P; Flick, A; Zúñiga, M L; Cuevas-Mota, J; Liang, K; Rangel, G; Burgos, J L; Rodwell, T C; Patrick, K

2015-09-01

Although directly observed therapy (DOT) is recommended worldwide for monitoring anti-tuberculosis treatment, transportation and personnel requirements limit its use. To evaluate the feasibility and acceptability of 'video DOT' (VDOT), which allows patients to record and transmit medication ingestion via videos watched remotely by health care providers to document adherence. We conducted a single-arm trial among tuberculosis (TB) patients in San Diego, California, USA, (n = 43) and Tijuana, Mexico (n = 9) to represent high- and low-resource settings. Pre-/post-treatment interviews assessed participant characteristics and experiences. Adherence was defined as the proportion of observed doses to expected doses. The mean age was 37 years (range 18-86), 50% were male, and 88% were non-Caucasian. The mean duration of VDOT use was 5.5 months (range 1-11). Adherence was similar in San Diego (93%) and Tijuana (96%). Compared to time on in-person DOT, 92% preferred VDOT, 81% thought VDOT was more confidential, 89% never/rarely had problems recording videos, and 100% would recommend VDOT to others. Seven (13%) participants were returned to in-person DOT and six (12%) additional participants had their phones lost, broken or stolen. VDOT was feasible and acceptable, with high adherence in both high- and low-resource settings. Efficacy and cost-effectiveness studies are needed.

Comparative efficacy, acceptability, and safety of medicinal, cognitive-behavioral therapy, and placebo treatments for acute major depressive disorder in children and adolescents: a multiple-treatments meta-analysis.

PubMed

Ma, Dongfeng; Zhang, Zhijun; Zhang, Xiangrong; Li, Lingjiang

2014-06-01

New generation antidepressant therapies, including serotonin-norepinephrine reuptake inhibitor (SNRIs) and selective serotonin reuptake inhibitors (SSRIs) were introduced in the late 1980s; however, few comprehensive studies compared the benefits and risks of various contemporary treatments for major depressive disorder (MDD) in pediatric patients. Multiple-treatments meta-analysis (MTM) was conducted to assess efficacy, acceptability, and safety of contemporary interventions in children and adolescents with MDD. Cochrane Library, AMED, CINAHL, EMBASE, LiLACS, MEDLINE, PSYCINFO, PSYNDEX, and Journal of Medicine and Pharmacy databases were searched for randomized controlled trials (RCTs) comparing medicinal interventions (citalopram, escitalopram, fluoxetine, mirtazapine, paroxetine, sertraline, venlafaxine), cognitive behavioral therapy (CBT), combined fluoxetine with CBT, and placebo treatment for acute MDD from January 1988 to March 2013. Treatment success, dropout rate, and suicidal ideation/attempt outcomes were measured. Bayesian methods were used to conduct a MTM including age and funding subgroups. A total of 21 RCTs (4969 participants) were identified. Combined fluoxetine/CBT exhibited the highest efficacy, with fluoxetine alone superior to CBT, paroxetine, sertraline, citalopram, escitalopram, and placebo treatment. Sertraline, paroxetine, escitalopram, and venlafaxine showed superior acceptability to fluoxetine and combined fluoxetine/CBT. Combined fluoxetine/CBT combination was less safe, though CBT was safer than fluoxetine alone. Combined fluoxetine/CBT, fluoxetine, and mirtazapine exhibited the highest efficacy; sertraline, escitalopram, venlafaxine, and paroxetine were the best tolerated; and mirtazapine and venlafaxine were the safest. Sertraline and mirtazapine exhibited optimally balanced efficacy, acceptability, and safety for first-line acute treatment of child and adolescent MDD.

Convection-enhanced delivery of maghemite nanoparticles: Increased efficacy and MRI monitoring

PubMed Central

Perlstein, Benny; Ram, Zvi; Daniels, Dianne; Ocherashvilli, Aharon; Roth, Yiftach; Margel, Shlomo; Mardor, Yael

2008-01-01

Convection-enhanced drug delivery (CED) is a novel approach to delivering drugs into brain tissue. Drugs are delivered continuously via a catheter, enabling large volume distributions of high drug concentrations with minimum systemic toxicity. Previously we demonstrated that CED formation/extent of small molecules may be significantly improved by increasing infusate viscosities. In this study we show that the same methodology can be applied to monodispersed maghemite nanoparticles (MNPs). For this purpose we used a normal rat brain model and performed CED of MNPs over short infusion times. By adding 3% sucrose or 3%–6% polyethylene glycol (PEG; molecular weight 400) to saline containing pristine MNPs, we increased infusate viscosity and obtained increased CED efficacy. Further, we show that CED of dextran-coated MNPs (dextran-MNPs) resulted in increased efficacy over pristine MNPs (p < 0.007). To establish the use of MRI for reliable depiction of MNP distribution, CED of fluorescent dextran-MNPs was performed, demonstrating a significant correlation between the distributions as depicted by MRI and spectroscopic images (r2 = 0.74, p < 0.0002). MRI follow-up showed that approximately 80%–90% of the dextran-MNPs were cleared from the rat brain within 40 days of CED; the rest remained in the brain for more than 4 months. MNPs have been tested for applications such as targeted drug delivery and controlled drug release and are clinically used as a contrast agent for MRI. Thus, combining the CED method with the advantages of MNPs may provide a powerful tool to treat and monitor brain tumors. PMID:18316474

Vilazodone in the treatment of major depressive disorder: efficacy across symptoms and severity of depression.

PubMed

Khan, Arif; Sambunaris, Angelo; Edwards, John; Ruth, Adam; Robinson, Donald S

2014-03-01

Vilazodone is a potent selective serotonin reuptake inhibitor and serotonin 1A receptor partial agonist approved for the treatment of major depressive disorder in adults. To assess the efficacy of vilazodone across a range of symptoms and severities of depression, data from two phase III, 8-week, randomized, double-blind, placebo-controlled trials were pooled for analysis. Overall improvement in depressive symptoms measured using the Montgomery-Åsberg Depression Rating Scale (MADRS) and the 17-item Hamilton Depression Rating Scale was statistically significant (P<0.05) for vilazodone treatment compared with placebo as early as Week 1 and continued throughout double-blind treatment. Vilazodone treatment compared with placebo showed significant improvement on all 10 individual MADRS symptom items at end of treatment (P<0.01). Rates of response and remission were significantly greater in the vilazodone group relative to the placebo group, with numbers needed to treat ranging from eight to nine for response and 12-17 for remission. Between-group treatment differences in MADRS and the other outcome measures were similar among all depression subgroups, with no consistent pattern associated with depression severity. These findings support the efficacy of vilazodone across a broad range of depressive symptoms and severities for the treatment of major depressive disorder.

Efficacy of stem injection treatments on striped maple in central West Virginia

Treesearch

Jeffrey D. Kochenderfer; James N. Kochenderfer

2008-01-01

Hack-and-squirt injection treatments were applied to individual striped maple (Acer pennsylvanicum L.) stems and to the largest stem in sprout clumps in a 25-year-old clearcut in central West Virginia to evaluate seasonal efficacy of imazapyr as Arsenal (28.7%) and glyphosate as Glypro Plus (41.0%) in water carriers. Complete control of injected...

Safety and efficacy of collagen crosslinking for the treatment of keratoconus.

PubMed

Kolli, Sai; Aslanides, Ioannis M

2010-11-01

Keratoconus is a condition that causes corneal ectasia and reduced vision in young adults. A proportion of these patients have progressive disease requiring corneal transplantation. A revolutionary new treatment that is purported to halt progression of keratoconus, known as collagen crosslinking (CXL), has recently been introduced into clinical practice. CXL involves the treatment of the cornea with riboflavin followed by photoactivation with UVA light leading to corneal strengthening. This article reviews the basic science, clinical protocols, safety aspects and clinical results of CXL. The reader will gain a comprehensive understanding of: i) the basic science of CXL; ii) the optimised protocols for clinical use of CXL; iii) the results of all the main clinical trials in the literature; iv) contraindications to treatment and v) full clinical safety profile of CXL. CXL represents a new treatment that uniquely allows the halt of progression of keratoconus, thus preventing visual loss and the need for surgical intervention. Available data suggest that this treatment has high efficacy and is very safe and may represent the future standard treatment for progressive keratoconus.

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

PubMed

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 < 0.01). After treatment, T level in serum was reduced apparently in the western medication group (P < 0.05). Before and after treatment, the differences in body mass and BMI in the EA group were more significant than those in the western 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.

Field efficacy and safety of fluralaner solution for administration in drinking water for the treatment of poultry red mite (Dermanyssus gallinae) infestations in commercial flocks in Europe.

PubMed

Thomas, Emmanuel; Chiquet, Mathieu; Sander, Björn; Zschiesche, Eva; Flochlay, Annie Sigognault

2017-10-09

Welfare concerns, production losses caused by Dermanyssus gallinae, the poultry red mite (PRM), and widespread mite resistance to environmentally applied acaricides continue to drive an urgent need for new and effective control measures. Fluralaner is a novel systemic acaricide developed to address that need. A series of field studies was initiated to investigate the safety and efficacy of a fluralaner solution (10 mg/ml) administered in drinking water at a dose rate of 0.5 mg/kg on two occasions with a 7-day interval, for treatment of natural PRM infestations in chickens. Blinded, negative-controlled studies were completed in Europe across eight layer, two breeder, and two replacement chicken farms. At each farm, two similar flocks were housed in similar PRM-infested units (either rooms within a building, or separate buildings) varying from 550 to 100,000 birds per unit. One unit at each farm was allocated to fluralaner treatment, administered in drinking water on Days 0 and 7. One unit remained untreated. Mite traps were placed throughout each unit on Days -1, 0 or 1, 3, 6, 9, and 13 or 14, then at weekly or two-weekly intervals, retrieved after 24 h and processed for mite counts. Efficacy at each farm was assessed by mean PRM count reductions from traps in treated units compared with those from control units. Production parameters and safety were also monitored. Efficacy was 95.3 to 99.8% on Day 3 and 97.8 to 100% on Day 9, thereafter remaining above 90% for 56 to 238 days after treatment initiation. Post-treatment improvement in egg-laying rate was greater by 0.9 to 12.6% in the treated group at 9 of the 10 layer or breeder farms. There were no treatment-related adverse events. Fluralaner administered at 0.5 mg/kg via drinking water twice, 7 days apart, was well tolerated and highly efficacious against the PRM in naturally infested chickens representing a range of production types and management systems. The results indicate that this novel treatment has

Comparative efficacy and acceptability of electroconvulsive therapy versus repetitive transcranial magnetic stimulation for major depression: A systematic review and multiple-treatments meta-analysis.

PubMed

Chen, Jian-Jun; Zhao, Li-Bo; Liu, Yi-Yun; Fan, Song-Hua; Xie, Peng

2017-03-01

The effects of electroconvulsive therapy (ECT) and bilateral, left prefrontal, and right prefrontal repetitive transcranial magnetic stimulation (rTMS) on major depressive disorder (MDD) have not been adequately addressed by previous studies. Here, a multiple-treatments meta-analysis, which incorporates evidence from direct and indirect comparisons from a network of trials, was performed to assess the efficacy and acceptability of these four treatment modalities on MDD. The literature was searched for randomized controlled trials (RCTs) on ECT, bilateral rTMS, and unilateral rTMS for treating MDD up to May 2016. The main outcome measures were response and drop-out rates. Data were obtained from 25 studies consisting of 1288 individuals with MDD. ECT was non-significantly more efficacious than B-rTMS, R-rTMS, and L-rTMS. Left prefrontal rTMS was non -significantly less efficacious than all other treatment modalities. In terms of acceptability, R-rTMS was non-significantly better tolerated than ECT, B-rTMS, and L-rTMS. ECT was the most efficacious treatment with the cumulative probabilities of being the most efficacious treatment being: ECT (65%), B-rTMS (25%), R-rTMS (8%), and L-rTMS (2%). R-rTMS was the best-tolerated treatment with the cumulative probabilities of being the best-tolerated treatment being: R-rTMS (52%), B-rTMS (17%), L-rTMS (16%), and ECT (14%). Coherence analysis detected no statistically significant incoherence in any comparisons of direct with indirect evidence for the response rate and drop-out rate. ECT was the most efficacious, but least tolerated, treatment, while R-rTMS was the best tolerated treatment for MDD. B-rTMS appears to have the most favorable balance between efficacy and acceptability. Copyright © 2016 Elsevier B.V. All rights reserved.

Link Between Positive Clinician-Conveyed Expectations of Treatment Effect and Pain Reduction in Knee Osteoarthritis, Mediated by Patient Self-Efficacy.

PubMed

Hsiao-Wei Lo, Grace; Balasubramanyam, Ajay S; Barbo, Andrea; Street, Richard L; Suarez-Almazor, Maria E

2016-07-01

A prior knee osteoarthritis (OA) trial found that provider-conveyed expectations for treatment success were associated with pain improvement. We hypothesized this relationship was mediated by patient self-efficacy, since expectations of improvement may enhance one's ability to control health behaviors, and therefore health. Our aim was to examine whether self-efficacy was a mediator of the relationship observed in this trial. A secondary analysis of a 3-arm (traditional acupuncture, sham acupuncture, and wait list) trial for knee OA was conducted. Those in the acupuncture groups were equally randomized to acupuncturists trained to communicate a high or neutral expectation of treatment success (e.g., using language conveying high or unclear likelihood that acupuncture would reduce knee pain). A modified Arthritis Self-Efficacy Questionnaire and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale were administered. Linear regression analyses were used to examine whether patient self-efficacy mediated the relationship between provider communication style and knee pain at 3 months. High-expectation provider communication was associated with patient self-efficacy, β coefficient of 0.14 (95% confidence interval [95% CI] 0.01, 0.28). Self-efficacy was associated with WOMAC pain, β coefficient of -9.29 (95% CI -11.11, -7.47), while controlling for the provider communication style. The indirect effect a × b of -1.36 for high versus neutral expectation (bootstrap 95% CI -2.80, -0.15; does not include 0), supports the conclusion that patient self-efficacy mediates the relationship between provider-communicated expectations of treatment effects and knee pain. Our findings suggest that clinician-conveyed expectations can enhance the benefit of treatments targeting knee OA symptoms, mediated by improved patient self-efficacy. © 2016, American College of Rheumatology.

Efficacy and Safety of Fish Oil in Treatment of Knee Osteoarthritis.

PubMed

Peanpadungrat, Pornrawee

2015-04-01

To study efficacy and safety of fish oil in treatment of knee osteoarthritis. 75 participants had divided into three groups of 25 people to study efficacy results after taking fish oil 1,000 mg and 2,000 mg once a day for 8 weeks. 1,000 mg of fish oil have EPA 400 mg and DHA 200 mg. All participants had complete visual analog scale for measuring knee pain and knee function. They also had measured 100 meters walking velocity and three steps walking time before taking fish oil. Then they had re-measured all parameters again at 8-12 weeks after taking fish oil to compare the results. All parameters had statistically significant better differences in the group of participants who had taken fish oil when compared to the control group. The average score of patient's satisfaction was 9.06 of 10 and also by verbal response of 50 participants; everyone felt good and happy with fish oil. One participant had hematuriafrom silent CA bladder at 10th week but the other 49 participants were safe without any complications from fish oil. Fish oil 1,000-2,000 mg daily supplementation had significant efficacy to improve knee performance and also are safe in mild to moderate stages of knee osteoarthritics patients. However higher dose 2,000 mg of fish oil had not significant higher efficacy than 1,000 mg of fish oil.

Efficacy of Topical Therapy with Newly Developed Terbinafine and Econazole Formulations in the Treatment of Dermatophytosis in Cats.

PubMed

Ivaskiene, M; Matusevicius, A P; Grigonis, A; Zamokas, G; Babickaite, L

2016-09-01

In the field of veterinary dermatology dermatophytosis is one of the most frequently occurring infectious diseases, therefore its treatment should be effective, convenient, safe and inexpensive. The aim of this study was to evaluate the efficacy of newly developed topical formulations in the treatment of cats with dermatophytosis. Evaluation of clinical efficacy and safety of terbinafine and econazole formulations administered topically twice a day was performed in 40 cats. Cats, suffering from the most widely spread Microsporum canis-induced dermatophytosis and treated with terbinafine hydrochloride 1% cream, recovered within 20.3±0.88 days; whereas when treated with econazole nitrate 1% cream, they recovered within 28.4±1.14 days. A positive therapeutic effect was yielded by combined treatment with local application of creams and whole coat spray with enilconazole 0.2% emulsion "Imaverol". Most cats treated with econazole cream revealed redness and irritation of the skin at the site of application. This study demonstrates that terbinafine tended to have superior clinical efficacy (p<0.001) in the treatment of dermatophytosis in cats compared to the azole tested.

Efficacy, safety and predictive indicators of apatinib after multilines treatment in advanced nonsquamous nonsmall cell lung cancer: Apatinib treatment in nonsquamous NSCLC.

PubMed

Wu, Di; Liang, Li; Nie, Ligong; Nie, Jun; Dai, Ling; Hu, Weiheng; Zhang, Jie; Chen, Xiaoling; Han, Jindi; Ma, Xiangjuan; Tian, Guangming; Han, Sen; Long, Jieran; Wang, Yang; Zhang, Ziran; Xin, Tao; Fang, Jian

2018-03-24

Patients with advanced nonsquamous nonsmall cell lung cancer (NSCLC) who experienced progression with two or more lines chemotherapy have no treatment options that clearly confer a survival benefit. As a novel vascular endothelial growth factor receptor-2 tyrosine kinase inhibitor, apatinib has a certain antitumor effect for various solid tumors. The present study evaluated the efficacy and safety of apatinib in advanced nonsquamous NSCLC as salvage treatment in Chinese real-world practice. Twenty-eight patients were enrolled in this observational study from October 2015 to May 2017. Progression-free survival (PFS) and overall survival (OS) were graphed by Kaplan-Meier curve and intergroup comparisons were carried out by log-rank test. Objective response rate (ORR), disease control rate (DCR) and adverse effects (AEs) were also evaluated. Seven patients obtained partial response, and 18 obtained stable disease, representing an ORR of 26% and a DCR of 93%. Median PFS and OS were 3 (95% confidence interval [CI] 2.6-3.4) and 7.4 (95% CI 1.3-13.5) months, respectively. The efficacy analysis showed that Eastern Cooperative Oncology Group (ECOG) performance status 0-1 was correlated with prolonged OS and PFS (P < 0.05), and hypertension during apatinib treatment was correlated with prolonged OS (P < 0.05). Cox regression showed that ECOG performance status (P < 0.01) (RR = 0.231) (95% CI 0.083-0.642) and hypertension during apatinib treatment (P = 0.05) were predictive indicators for apatinib treatment. Grade 3-4 AEs with incidences of 10% or greater were hypertension (21%), hand-foot syndrome (14%) and proteinuria (11%) which could be relieved by dose reduction. In conclusion, apatinib has a certain therapeutic effect in patients with advanced nonsquamous NSCLC. ECOG performance status and hypertension during apatinib might be predictive indicators for treatment efficacy. © 2018 John Wiley & Sons Australia, Ltd.

Exercise Therapy for Management of Type 2 Diabetes Mellitus: Superior Efficacy of Activity Monitors over Pedometers.

PubMed

Miyauchi, Masaaki; Toyoda, Masao; Kaneyama, Noriko; Miyatake, Han; Tanaka, Eitaro; Kimura, Moritsugu; Umezono, Tomoya; Fukagawa, Masafumi

2016-01-01

We compared the efficacy of activity monitor (which displays exercise intensity and number of steps) versus that of pedometer in exercise therapy for patients with type 2 diabetes. The study subjects were divided into the activity monitor group ( n = 92) and pedometer group ( n = 95). The primary goal was improvement in hemoglobin A1c (HbA1c). The exercise target was set at 8,000 steps/day and 20 minutes of moderate-intensity exercise (≥3.5 metabolic equivalents). The activity monitor is equipped with a triple-axis accelerometer sensor capable of measuring medium-intensity walking duration, number of steps, walking distance, calorie consumption, and total calorie consumption. The pedometer counts the number of steps. Blood samples for laboratory tests were obtained during the visits. The first examination was conducted at the start of the study and repeated at 2 and 6 months. A significant difference in the decrease in HbA1c level was observed between the two groups at 2 months. The results suggest that the use of activity level monitor that displays information on exercise intensity, in addition to the number of steps, is useful in exercise therapy as it enhances the concept of exercise therapy and promotes lowering of HbA1c in diabetic patients.

Impact of Water Management on Efficacy of Insecticide Seed Treatments Against Rice Water Weevil (Coleoptera: Curculionidae) in Mississippi Rice

PubMed Central

Adams, A.; Gore, J.; Musser, F.; Cook, D.; Catchot, A.; Walker, T.; Awuni, G. A.

2015-01-01

Two experiments were conducted at the Delta Research and Extension Center in Stoneville, MS, during 2011 and 2012 to determine the impact of water management practices on the efficacy of insecticidal seed treatments targeting rice water weevil, Lissorhoptrus oryzophilus Kuschel. Larval densities and yield were compared for plots treated with labeled rates of thiamethoxam, chlorantraniliprole, and clothianidin and an untreated control. In the first experiment, plots were subjected to flood initiated at 6 and 8 wk after planting. Seed treatments significantly reduced larval densities with the 8-wk flood timing, but not the 6-wk flood timing. Overall, the treated plots yielded higher than the control plots. In the second experiment, the impact of multiple flushes on the efficacy of insecticidal seed treatments was evaluated. Plots were subjected to zero, one, or two flushes with water. All seed treatments reduced larval densities compared with the untreated control. Significantly fewer larvae were observed in plots that received one or two flushes compared with plots that did not receive a flush. All seed treatments resulted in higher yields compared to the untreated control in the zero and one flush treatments. When two flushes were applied, yield from the thiamethoxam and clothianidin treated plots was not significantly different from those of the control plots, while the chlorantraniliprole treated plots yielded significantly higher than the control. These data suggest that time from planting to flood did not impact the efficacy of seed treatments, but multiple flushes reduced the efficacy of thiamethoxam and clothianidin. PMID:26470232

Efficacy of Biofeedback Therapy in the Treatment of Dyssynergic Defecation in Community-Dwelling Elderly Women.

PubMed

Simón, Miguel A; Bueno, Ana M

The aim of this study was to evaluate the efficacy of biofeedback therapy in the treatment of dyssynergic defecation in chronically constipated community-dwelling elderly women. After an initial assessment phase carried out during 1 month, 20 chronically constipated women with dyssynergic defecation were randomly assigned to either electromyographic biofeedback (EMG-BF) group (n=10) or control group (n=10). Outcome measures used to evaluate the efficacy of treatment were weekly stool frequency, sensation of incomplete evacuation, difficulty evacuation level, mean EMG-activity (μV) of the external anal sphincter during straining to defecate and Anismus index. The results obtained in this randomized controlled trial showed significant differences between the groups in all the dependent variables after 1 month of treatment. Moreover, there was no difference between the groups neither in age nor in the duration of chronic constipation symptoms. At the follow-up, 3 months later, clinical gains were maintained. This study demonstrates that the EMG-BF is an effective behavioral therapy for the treatment of dyssynergic defecation in community-dwelling elderly women.

Efficacy of Barabasz's Instant Alert Hypnosis in the Treatment of ADHD with Neurotherapy.

ERIC Educational Resources Information Center

Anderson, Kathryn; Barabasz, Marianne; Barabasz, Arreed; Warner, Dennis

2000-01-01

Tested use of instant alert hypnosis on 16 children diagnosed with attention deficit disorder. Found that EEG beta-theta ratio means were significantly higher in trials of neurotherapy combined with alert hypnosis than neurotherapy alone. Beta was significantly enhanced, whereas theta was inhibited. Identified improved treatment efficacy and…

Cognitive Restructuring in the Treatment of Social Phobia: Efficacy and Mode of Action.

ERIC Educational Resources Information Center

Taylor, Steven; Woody, Sheila; Koch, William J.; McLean, Peter; Paterson, Randy J.; Anderson, Kent W.

1997-01-01

Examines whether cognitive restructuring (CR) contributes to treatment efficacy and investigates its mode of action for therapeutic effects. Results, based on 60 persons with generalized social phobia, indicate that CR reduced social phobia and negative social cognitions and increased positive cognitions. CR did not enhance the effects of…

Pharmacists' perspectives on monitoring adherence to treatment in Cystic Fibrosis.

PubMed

Mooney, Karen; Ryan, Cristín; Downey, Damian G

2016-04-01

Cystic Fibrosis (CF) management requires complex treatment regimens but adherence to treatment is poor and has negative health implications. There are various methods of measuring adherence, but little is known regarding the extent of adherence measurement in CF centres throughout the UK and Ireland. To determine the adherence monitoring practices in CF centres throughout the UK and Ireland, and to establish CF pharmacists' views on these practices. UK and Ireland Cystic Fibrosis Pharmacists' Group's annual meeting (2014). A questionnaire was designed, piloted and distributed to pharmacists attending the UK and Ireland Cystic Fibrosis Pharmacists' Group's annual meeting (2014). The main outcome measures were the methods of inhaled/nebulised antibiotic supply and the methods used to measure treatment adherence in CF centres. The questionnaire also ascertained the demographic information of participating pharmacists. Closed question responses were analysed using descriptive statistics. Open questions were analysed using content analysis. Twenty-one respondents (84 % response) were included in the analysis and were mostly from English centres (66.7 %). Detailed records of patients receiving their inhaled/nebulised antibiotics were lacking. Adherence was most commonly described to be measured at 'every clinic visit' (28.6 %) and 'occasionally' (28.6 %). Patient self-reported adherence was the most commonly used method of measuring adherence in practice (90.5 %). The availability of electronic adherence monitoring in CF centres did not guarantee its use. Pharmacists attributed an equal professional responsibility for adherence monitoring in CF to Consultants, Nurses and Pharmacists. Seventy-six percent of pharmacists felt that the current adherence monitoring practices within their own unit were inadequate and associated with the absence of sufficient specialist CF pharmacist involvement. Many suggested that greater specialist pharmacist involvement could facilitate

Therapeutic Efficacy of Chloroquine for the Treatment of Uncomplicated Plasmodium falciparum in Haiti after Many Decades of its Use

PubMed Central

Okech, Bernard A.; Existe, Alexandre; Romain, Jean R.; Memnon, Gladys; Victor, Yves Saint; de Rochars, Madsen Beau; Fukuda, Mark

2015-01-01

Chloroquine (CQ) has been used for malaria treatment in Haiti for several decades, but reports of CQ resistance are scarce. The efficacy of CQ in patients with uncomplicated Plasmodium falciparum undergoing treatment in Haiti was evaluated. Malaria patients were enrolled, treated with CQ, and monitored over a 42-day period. The treatment outcomes were evaluated on day 28 by microscopy. The P. falciparum slide-confirmed rate was 9.5% (121 of 1,277). Malaria infection was seasonal, with peak observations between October and January; 88% (107 of 121) of patients consented to participate. Sixty patients successfully completed the 42-day follow-up, whereas 47 patients withdrew consent or were lost to follow-up. The mean parasite density declined rapidly within the first few days after treatment. Seven patients did not clear their malaria infections and were clinically asymptomatic; therefore, they were considered late parasitological failures. About 90% (95% confidence interval = 84.20–97.90) of patients had no detectable parasitemia by day 28 and remained malaria-free to day 42. Testing for recrudescence, reinfection, and CQ serum levels was not done in the seven patients, and therefore, their CQ resistance status is unresolved. CQ resistance surveillance by patient follow-up, in vitro drug sensitivity studies, and molecular markers is urgently needed in Haiti. PMID:25601993

The efficacy and safety of cold-induced lipolysis in the treatment of pseudogynecomastia.

PubMed

Park, Jung Tae; Kwon, Soon Hyo; Shin, Jung Won; Park, Kyoung Chan; Na, Jung Im; Huh, Chang Hun

2016-08-01

The treatment options for pseudogynecomastia have been limited. Cold-induced lipolysis provides a noninvasive, localized subcutaneous adipocyte destruction by inducing adipocyte apoptosis. This study has been designed to evaluate the efficacy of cold-induced lipolysis as a treatment modality for pseudogynecomastia. In this 28-week prospective trial, a total of 12 male pseudogynecomastia patients (Korean) were treated twice with cold-induced lipolysis. Efficacy was determined by chest circumference, ultrasonographic measurement of fat thickness, Simon's Gynecomastia class (SGC), photographic assessment, and the patient's satisfaction (baseline, weeks 4, 8, 16, and 28). Using a questionnaire, safety was evaluated at each visit. For 10 subjects that completed the trial, chest circumference and fat thickness significantly improved by week 8. This same improvement was gradually noticed through week 28. The patients SGC scores continuously decreased after two sessions. Photographic assessment showed an improvement until week 28. The result of the patient's satisfaction score was also meaningful. While there were no adverse events observed, transient pain and bruising at the treatment site were noticed. We recruited a limited number of participants. Also, we could not exclude there might be other individual factors in association with the patients pseudogynecomastia. Cold-induced lipolysis is a safe, effective therapeutic option in the treatment of pseudogynecomastia. Lasers Surg. Med. 48:584-589, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Evaluation of the efficacy of photodynamic therapy for the treatment of actinic cheilitis.

PubMed

Chaves, Yuri N; Torezan, Luis Antonio; Lourenço, Silvia Vanessa; Neto, Cyro Festa

2017-01-01

Actinic cheilitis (AC) is a lip intraepithelial neoplasia, whose cells present alterations similar to those presented by invasive squamous cell carcinomas (SCCs). To conduct clinical and laboratory evaluation by histopathology and immunohistochemistry of the efficacy of actinic cheilitis treatment using photodynamic therapy (PDT) with methyl aminolevulinate (MAL) and noncoherent red light. Patients with actinic cheilitis detected by histopathological examination were submitted to two sessions of photodynamic therapy with a two-week interval between them. They were examined immediately after the sessions, four, six, and twelve weeks after beginning treatment when a new biopsy was carried out. Clinical histopathological and immunohistochemical parameters were evaluated before and after treatment. Of the 23 patients who underwent biopsy, 16 completed two photodynamic therapy sessions and the material of one patient was insufficient for immunohistochemistry. Complete clinical response was achieved in 62.5% (10 of 16 patients) and 37.5% still remained with clinical evidence of AC. In spite of this, no case of cure by histopathological analysis was found. There was no significant statistical change among the values of Ki-67, survivin, and p53 observed before and after treatment. Photodynamic therapy, as carried out in this trial, was not an efficacious therapeutic option for treating patients with actinic cheilitis included in this sample. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The efficacy of fractional carbon dioxide (CO2) laser combined with terbinafine hydrochloride 1% cream for the treatment of onychomycosis.

PubMed

Shi, Jian; Li, Jin; Huang, He; Permatasari, Felicia; Liu, Juan; Xu, Yang; Wu, Di; Zhou, Bing-Rong; Luo, Dan

2017-10-01

Although systemic and topical antifungal agents are widely used to treat onychomycosis, oral medications can cause adverse effects and the efficacy of topical agents is not satisfying. Currently, laser treatment has been studied for its efficacy in the treatment of onychomycosis. Our study was aimed to evaluate the efficacy of fractional carbon dioxide (CO 2 ) laser treatment combined with terbinafine cream for 6 months in the treatment of onychomycosis and to analyze the influencing factors. A total of 30 participants (124 nails) with clinical and mycological diagnosis of onychomycosis received fractional CO 2 laser treatment at 2-week interval combined with terbinafine cream once daily for 6 months. The clinical efficacy rate (CER) was assessed from the percentage of fully normal-appearing nails or nails with ≤5% abnormal appearance, and the mycological clearance rate (MCR) was assessed from the percentage of nails with negative fungal microscopy. The CER was evaluated at 3 time points: at the end of treatment (58.9%), at 1 month after the last treatment (63.5%), and at 3 months after the last treatment (68.5%). The MCRs at 1 month and 3 months after the last treatment were 77.4 and 74.2%, respectively. The evaluation of influencing factors showed significantly higher CER (p < 0.05) in nails of participants with age <50 years, distal lateral subungual onychomycosis (DLSO), superficial white onychomycosis (SWO), nail thickness <2 mm, affected first-to-fourth finger/toenails, Trichophyton rubrum, and Trichophyton mentagrophytes. All participants experienced tolerable mild burning sensation during laser treatment, but there were no other adverse reactions reported. Fractional CO 2 laser treatment combined with terbinafine cream for 6 months was an effective and safe method for the treatment of onychomycosis. There were 5 factors that positively influenced the treatment outcome: age, clinical type of onychomycosis, nail thickness, involved nail, and species of

Efficacy and Safety of Sirolimus in the Treatment of Complicated Vascular Anomalies

PubMed Central

Trenor, Cameron C.; Hammill, Adrienne M.; Vinks, Alexander A.; Patel, Manish N.; Chaudry, Gulraiz; Wentzel, Mary Sue; Mobberley-Schuman, Paula S.; Campbell, Lisa M.; Brookbank, Christine; Gupta, Anita; Chute, Carol; Eile, Jennifer; McKenna, Jesse; Merrow, Arnold C.; Fei, Lin; Hornung, Lindsey; Seid, Michael; Dasgupta, A. Roshni; Dickie, Belinda H.; Elluru, Ravindhra G.; Lucky, Anne W.; Weiss, Brian; Azizkhan, Richard G.

2016-01-01

BACKGROUND AND OBJECTIVES: Complicated vascular anomalies have limited therapeutic options and cause significant morbidity and mortality. This Phase II trial enrolled patients with complicated vascular anomalies to determine the efficacy and safety of treatment with sirolimus for 12 courses; each course was defined as 28 days. METHODS: Treatment consisted of a continuous dosing schedule of oral sirolimus starting at 0.8 mg/m2 per dose twice daily, with pharmacokinetic-guided target serum trough levels of 10 to 15 ng/mL. The primary outcomes were responsiveness to sirolimus by the end of course 6 (evaluated according to functional impairment score, quality of life, and radiologic assessment) and the incidence of toxicities and/or infection-related deaths. RESULTS: Sixty-one patients were enrolled; 57 patients were evaluable for efficacy at the end of course 6, and 53 were evaluable at the end of course 12. No patient had a complete response at the end of course 6 or 12 as anticipated. At the end of course 6, a total of 47 patients had a partial response, 3 patients had stable disease, and 7 patients had progressive disease. Two patients were taken off of study medicine secondary to persistent adverse effects. Grade 3 and higher toxicities attributable to sirolimus included blood/bone marrow toxicity in 27% of patients, gastrointestinal toxicity in 3%, and metabolic/laboratory toxicity in 3%. No toxicity-related deaths occurred. CONCLUSIONS: Sirolimus was efficacious and well tolerated in these study patients with complicated vascular anomalies. Clinical activity was reported in the majority of the disorders. PMID:26783326

Efficacy and safety of available treatments for visceral leishmaniasis in Brazil: A multicenter, randomized, open label trial

PubMed Central

Costa, Dorcas Lamounier; Costa, Carlos Henrique Nery; de Almeida, Roque Pacheco; de Melo, Enaldo Viera; de Carvalho, Sílvio Fernando Guimarães; Rabello, Ana; de Carvalho, Andréa Lucchesi; Sousa, Anastácio de Queiroz; Leite, Robério Dias; Lima, Simone Soares; Amaral, Thais Alves; Alves, Fabiana Piovesan; Rode, Joelle

2017-01-01

Background There is insufficient evidence to support visceral leishmaniasis (VL) treatment recommendations in Brazil and an urgent need to improve current treatments. Drug combinations may be an option. Methods A multicenter, randomized, open label, controlled trial was conducted in five sites in Brazil to evaluate efficacy and safety of (i) amphotericin B deoxycholate (AmphoB) (1 mg/kg/day for 14 days), (ii) liposomal amphotericin B (LAMB) (3 mg/kg/day for 7 days) and (iii) a combination of LAMB (10 mg/kg single dose) plus meglumine antimoniate (MA) (20 mg Sb+5/kg/day for 10 days), compared to (iv) standard treatment with MA (20 mg Sb+5/kg/day for 20 days). Patients, aged 6 months to 50 years, with confirmed VL and without HIV infection were enrolled in the study. Primary efficacy endpoint was clinical cure at 6 months. A planned efficacy and safety interim analysis led to trial interruption. Results 378 patients were randomized to the four treatment arms: MA (n = 112), AmphoB (n = 45), LAMB (n = 109), or LAMB plus MA (n = 112). A high toxicity of AmphoB prompted an unplanned interim safety analysis and this treatment arm was dropped. Per intention-to-treat protocol final analyses of the remaining 332 patients show cure rates at 6 months of 77.5% for MA, 87.2% for LAMB, and 83.9% for LAMB plus MA, without statistically significant differences between the experimental arms and comparator (LAMB: 9.7%; CI95% -0.28 to 19.68, p = 0.06; LAMB plus MA: 6.4%; CI95% -3.93 to 16.73; p = 0.222). LAMB monotherapy was safer than MA regarding frequency of treatment-related adverse events (AE) (p = 0.045), proportion of patients presenting at least one severe AE (p = 0.029), and the proportion of AEs resulting in definitive treatment discontinuation (p = 0.003). Conclusions Due to lower toxicity and acceptable efficacy, LAMB would be a more suitable first line treatment for VL than standard treatment. ClinicalTrials.gov identification number: NCT01310738. Trial registration

Efficacy of chlorine and calcinated calcium treatment of alfalfa seeds and sprouts to eliminate Salmonella.

PubMed

Gandhi, Megha; Matthews, Karl R

2003-11-01

The efficacy of a 20,000 ppm calcium hypochlorite treatment of alfalfa seeds artificially contaminated with Salmonella was studied. Salmonella populations reached >7.0 log on sprouts grown from seeds artificially contaminated with Salmonella and then treated with 20,000 ppm Ca(OCl)(2). The efficacy of spray application of chlorine (100 ppm) to eliminate Salmonella during germination and growth of alfalfa was assessed. Alfalfa seed artificially contaminated with Salmonella was treated at germination, on day 2 or day 4, or for the duration of the growth period. Spray application of 100 ppm chlorine at germination, day 2, or day 4 of growth was minimally effective resulting in approximately a 0.5-log decrease in population of Salmonella. Treatment on each of the 4 days of growth reduced populations of Salmonella by only 1.5 log. Combined treatment of seeds with 20,000 ppm Ca(OCl)(2) and followed by 100 ppm chlorine or calcinated calcium during germination and sprout growth did not eliminate Salmonella.

Within-person associations between daily motivation and self-efficacy and drinking among problem drinkers in treatment.

PubMed

Morgenstern, Jon; Kuerbis, Alexis; Houser, Jessica; Muench, Frederick J; Shao, Sijing; Treloar, Hayley

2016-09-01

Gaining a better understanding of the change process holds promise to improve alcohol treatment. Ecological momentary assessment (EMA) coupled with intensive longitudinal data (ILD) approaches have been proposed as promising methods that can advance change process research but have been used infrequently in alcohol use disorder (AUD) treatment research. The current study used these approaches to examine the within-person associations of motivation and self-efficacy and drinking among treatment-seeking problem drinkers. Participants (N = 96) received daily EMA surveys before, during, and after treatment for 7 weeks spread over a 9-month period. Multilevel modeling was used to test the within-person relationships between the change processes and drinking, controlling for between-person associations and prior drinking. Results indicated that daily fluctuations in motivation and self-efficacy significantly predicted drinking over the next 24 hours; however, several theory-driven hypotheses regarding factors that might moderate that relationship were not supported. Overall, results support the advantages of EMA and ILD as methods that can advance AUD treatment research. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Update on the efficacy of extracorporeal shockwave treatment for myofascial pain syndrome and fibromyalgia.

PubMed

Ramon, Silvia; Gleitz, Markus; Hernandez, Leonor; Romero, Luis David

2015-12-01

Chronic muscle pain syndrome is one of the main causes of musculoskeletal pathologies requiring treatment. Many terms have been used in the past to describe painful muscular syndromes in the absence of evident local nociception such as myogelosis, muscle hardening, myalgia, muscular rheumatism, fibrositis or myofascial trigger point with or without referred pain. If it persists over six months or more, it often becomes therapy resistant and frequently results in chronic generalized pain, characterized by a high degree of subjective suffering. Myofascial pain syndrome (MPS) is defined as a series of sensory, motor, and autonomic symptoms caused by a stiffness of the muscle, caused by hyperirritable nodules in musculoskeletal fibers, known as myofascial trigger points (MTP), and fascial constrictions. Fibromyalgia (FM) is a chronic condition that involves both central and peripheral sensitization and for which no curative treatment is available at the present time. Fibromyalgia shares some of the features of MPS, such as hyperirritability. Many treatments options have been described for muscle pain syndrome, with differing evidence of efficacy. Extracorporeal Shockwave Treatment (ESWT) offers a new and promising treatment for muscular disorders. We will review the existing bibliography on the evidence of the efficacy of ESWT for MPS, paying particular attention to MTP (Myofascial Trigger Point) and Fibromyalgia (FM). Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

Kundalini Yoga for Generalized Anxiety Disorder: An Exploration of Treatment Efficacy and Possible Mechanisms.

PubMed

Gabriel, M G; Curtiss, Joshua; Hofmann, Stefan G; Khalsa, Sat Bir S

2018-04-26

The aim of this study was to examine the efficacy of Kundalini Yoga in reducing symptoms of generalized anxiety disorder (GAD) compared to a common treatment-as-usual condition using cognitive techniques. A secondary objective was to explore potential treatment mechanisms. Females aged 24 to 75 years with GAD ( n = 49) received either an 8-week Kundalini Yoga intervention ( n = 34) or an 8-week treatment-as-usual condition ( n = 15). The yoga condition resulted in lower levels of anxiety relative to the treatment-as-usual condition. Furthermore, changes in somatic symptoms mediated treatment outcome for Kundalini Yoga. Kundalini Yoga may show promise as a treatment for GAD, and this treatment might convey its effect on symptom severity by reducing somatic symptoms.

Monitoring stimulated cycles during in vitro fertilization treatment with ultrasound only--preliminary results.

PubMed

Wiser, Amir; Gonen, Ofer; Ghetler, Yehudit; Shavit, Tal; Berkovitz, Arie; Shulman, Adrian

2012-06-01

To evaluate if monitoring patients by ultrasound (US) only during in vitro fertilization (IVF) treatment is safe. Randomized prospective study. Patients undergoing their first IVF treatment were randomized into two groups. The ultrasound only group (study group) was monitored by US for follicle size and endometrial thickness without blood tests. In this group, only one blood test was taken before human chorionic gonadotropin (hCG) injection, to ensure a safe level of estradiol (E(2)) regarding ovarian hyperstimulation syndrome (OHSS) risk. The control group was monitored by ultrasound plus serum estradiol and progesterone concentration at each visit. Clinical pregnancy rate. No differences were found between the groups in the parameters of IVF treatment, induction days, number of ampoules, E(2) level of hCG, as well as embryo quality. The clinical pregnancy rate was not statistically different between the groups, 57.5% vs. 40.0%, respectively (p = 0.25). No OHSS cases were found among the study or control groups. Ultrasound as a single monitoring tool for IVF cycles is reliable, safe, patient friendly, and reduces treatment expenses. In an era of cost effectiveness awareness, this regimen should be considered for routine management in IVF programs.

Efficacy and tolerability of combination therapy with valsartan/hydrochlorothiazide in the initial treatment of severe hypertension.

PubMed

Calhoun, David A; Glazer, Robert D; Pettyjohn, Frank S; Coenen, P D M; Zhao, Yanxing; Grosso, Amie

2008-08-01

Most patients with severe hypertension are at high risk for cardiovascular events and require prompt blood pressure (BP)-lowering and combination therapy to achieve BP goals. This study evaluated the therapeutic efficacy and tolerability of initial treatment with the combination of valsartan and hydrochlorothiazide (HCTZ) compared with valsartan monotherapy in patients with severe hypertension. This was a 6-week, randomized, double-blind, multicenter, forced titration study that compared initial therapy with the combination of valsartan/HCTZ 160/12.5 mg (force titrated to 160/25 mg after 2 weeks and to 320/25 mg after 4 weeks) to monotherapy with valsartan 160 mg (force titrated to 320 mg after 2 weeks and sham-titrated to 320 mg after 4 weeks). Eligible patients were 18-80 years old with severe essential hypertension (mean sitting diastolic BP > or = 110 mmHg and < 120 mmHg and mean sitting systolic BP > or = 140 mmHg and < 200 mmHg). The Clinical Trial Registry number was NCT00273299. The primary efficacy variable was the rate of BP control (mean sitting BP < 140/90 mmHg) at Week 4. Tolerability was evaluated by monitoring all adverse events, vital signs, and laboratory tests including hematology and biochemistry. A total of 608 patients were randomized to either valsartan/HCTZ (n = 307) or valsartan monotherapy (n = 301). Significantly more patients achieved overall BP control (< 140/90 mmHg) with valsartan/HCTZ compared to monotherapy at Week 4 (primary efficacy variable and timepoint) (39.6% vs. 21.8%; p < 0.0001) and Week 6 (48.2% vs. 27.2%; p < 0.0001). Mean reductions in BP at Week 4 were significantly greater for valsartan/HCTZ (30.8/22.7 mmHg vs. 21.7/17.5 mmHg; p < 0.0001), with further reductions at Week 6. BP control rates were greater with combination therapy as early as Week 2. The overall incidence of adverse events was comparable between the combination therapy (34.9%) and monotherapy (36.7%) treatment groups. A potential limitation of the forced

[Efficacy, tolerability and safety of paliperidone extended-release in the treatment of schizophrenia and schizoaffective disorder].

PubMed

Bellantuono, Cesario; Santone, Giovanni

2012-01-01

The paper represents a systematic review on the efficacy, tolerability and safety of paliperidone, an antipsychotic drug recently approved in Italy for the treatment of schizophrenia and of schizoaffective disorder. A comprehensive PubMed search using the term "paliperidone" was performed from January 1980 to February 2011. Papers reporting data on efficacy in the treatment of schizophrenia and of schizoaffective disorder were included, also if published as abstracts and all retrieved articles were manually searched for other references of interest. Paliperidone was found to be effective in short and long-term treatment of schizophrenia, as well as in the treatment of schizoaffective disorder. For both disorders, paliperidone showed to be effective in improving psychotic and affective symptoms. In the studies analyzed it was well tolerated and the most frequent reported adverse events were mild extrapyramidal symptoms and an increase in serum prolactin levels. Paliperidone has been shown to be an effective and safe medication for the treatment of schizophrenia and schizoaffective disorder. Further controlled clinical trials are needed to confirm this clinical profile in the long-term treatment, as well as for specific conditions such as schizophrenic patients with medical comorbidities.

Efficacy of water treatment processes and endemic gastrointestinal illness - A multi-city study in Sweden.

PubMed

Tornevi, Andreas; Simonsson, Magnus; Forsberg, Bertil; Säve-Söderbergh, Melle; Toljander, Jonas

2016-10-01

Outbreaks of acute gastrointestinal illnesses (AGI) have been linked to insufficient drinking water treatment on numerous occasions in the industrialized world, but it is largely unknown to what extent public drinking water influences the endemic level of AGI. This paper aimed to examine endemic AGI and the relationship with pathogen elimination efficacy in public drinking water treatment processes. For this reason, time series data of all telephone calls to the Swedish National Healthcare Guide between November 2007 and February 2014 from twenty Swedish cities were obtained. Calls concerning vomiting, diarrhea or abdominal pain (AGI calls) were separated from other concerns (non-AGI calls). Information on which type of microbial barriers each drinking water treatment plant in these cities have been used were obtained, together with the barriers' theoretical pathogen log reduction efficacy. The total log reduction in the drinking water plants varied between 0.0 and 6.1 units for viruses, 0.0-14.6 units for bacteria and 0.0-7.3 units regarding protozoans. To achieve one general efficacy parameter for each plant, a weighted mean value of the log reductions (WLR) was calculated, with the weights based on how commonly these pathogen groups cause AGI. The WLR in the plants varied between 0.0 and 6.4 units. The effect of different pathogen elimination efficacy on levels of AGI calls relative non-AGI calls was evaluated in regression models, controlling for long term trends, population size, age distribution, and climatological area. Populations receiving drinking water produced with higher total log reduction was associated with a lower relative number of AGI calls. In overall, AGI calls decreased by 4% (OR = 0.96, CI: 0.96-0.97) for each unit increase in the WLR. The findings apply to both groundwater and surface water study sites, but are particularly evident among surface water sites during seasons when viruses are the main cause of AGI. This study proposes that the

Lack of efficacy of moclobemide or imipramine in the treatment of recurrent brief depression: results from an exploratory randomized, double-blind, placebo-controlled treatment study.

PubMed

Baldwin, David S; Green, Mary; Montgomery, Stuart A

2014-11-01

'Recurrent brief depression' (RBD) is a common, distressing and impairing depressive disorder for which there is no current proven pharmacological or psychological treatment. This multicentre, randomized, fixed-dose, parallel-group, placebo-controlled study of the reversible inhibitor of monoamine oxidase moclobemide (450 mg/day) and the tricyclic antidepressant imipramine (150 mg/day) evaluated the potential efficacy of active medication, when compared with placebo, in patients with recurrent brief depression, recruited in the mid-1990s. After a 2-4-week single-blind placebo run-in period, a total of 35 patients were randomized to receive double-blind medication for 4 months, but only 16 completed the active treatment period. An intention-to-treat analysis of the 34 evaluable patients found no evidence for the efficacy of moclobemide or imipramine, when compared with placebo, in significantly reducing the severity, duration or frequency of depressive episodes. A total of 28 patients experienced at least one adverse event, and four patients engaged in nonfatal self-harm. Limitations of the study include the small sample size and the high rate of participant withdrawal. The lack of efficacy of these antidepressant drugs and the previous finding of the lack of efficacy of the selective serotonin reuptake inhibitor fluoxetine together indicate that medications other than antidepressant drugs should be investigated as potential treatments for what remains a common, distressing and potentially hazardous condition.

Persistence and efficacy of termiticides used in preconstruction treatments to soil in Mississippi

Treesearch

J.E. Mulrooney; M.K. Davis; T.L. Wagner; R.L. Ingram

2006-01-01

Laboratory and field studies were conducted to determine the persistence and efficacy of termiticides used as preconstruction treatments against subterranean termites. Bifenthrin (0.067%), chlorpyrifos (0.75%), and imidacloprid (0.05%) ( [AI]; wt:wt) were applied to soil beneath a monolithic concrete slab at their minimum labeled rates. Soil samples were taken from...

Efficacy of Treatment of Trochanteric Bursitis: A Systematic Review

PubMed Central

Lustenberger, David P; Ng, Vincent Y; Best, Thomas M; Ellis, Thomas J

2013-01-01

Objective Trochanteric bursitis (TB) is a self-limiting disorder in the majority of patients and typically responds to conservative measures. However, multiple courses of nonoperative treatment or surgical intervention may be necessary in refractory cases. The purpose of this systematic review was to evaluate the efficacy of the treatment of TB. Data Sources A literature search in the PubMed, MEDLINE, CINAHL, and ISI Web of Knowledge databases was performed for all English language studies up to April 2010. Terms combined in a Boolean search were greater trochanteric pain syndrome, trochanteric bursitis, trochanteric, bursitis, surgery, therapy, drug therapy, physical therapy, rehabilitation, injection, Z-plasty, Z-lengthening, aspiration, bursectomy, bursoscopy, osteotomy, and tendon repair. Study Selection All studies directly involving the treatment of TB were reviewed by 2 authors and selected for further analysis. Expert opinion and review articles were excluded, as well as case series with fewer than 5 patients. Twenty-four articles were identified. According to the system described by Wright et al, 2 studies, each with multiple arms, qualified as level I evidence, 1 as level II, 1 as level III, and the rest as level IV. More than 950 cases were included. Data Extraction The authors extracted data regarding the type of intervention, level of evidence, mean age of patients, patient gender, number of hips in the study, symptom duration before the study, mean number of injections before the study, prior hip surgeries, patient satisfaction, length of follow-up, baseline scores, and follow-up scores for the visual analog scale (VAS) and Harris Hip Scores (HHS). Data Synthesis Symptom resolution and the ability to return to activity ranged from 49% to 100% with corticosteroid injection as the primary treatment modality with and without multimodal conservative therapy. Two comparative studies (levels II and III) found low-energy shock-wave therapy (SWT) to be

The Impact of Depression on Abstinence Self-Efficacy and Substance Use Outcomes among Emerging Adults in Residential Treatment

PubMed Central

Greenfield, Brenna L.; Venner, Kamilla L.; Kelly, John F.; Slaymaker, Valerie; Bryan, Angela D.

2012-01-01

A large proportion of emerging adults treated for substance use disorder (SUD) present with symptoms of negative affect and major depressive disorder (MDD). However, little is known regarding how these comorbidities influence important mechanisms of treatment response, such as increases in abstinence self-efficacy (ASE). This study tested the degree to which MDD and/or depressive symptoms interacted with during-treatment changes in ASE and examined these variables' relation to outcome at 3-months post-treatment. Participants (N = 302; 74% male) completed measures at intake, mid-treatment, end-of-treatment, and at 3-month follow-up. ASE was measured with the Alcohol and Drug Use Self-Efficacy (ADUSE) scale; depressive symptoms were assessed with the Brief Symptom Inventory 18 (BSI 18) Depression scale; and current MDD diagnoses were deduced from the Structured Clinical Interview for the DSM-IV. Random coefficient regression analyses focused on during-treatment changes in ASE, with BSI 18 scores and MDD diagnosis included as moderators. At intake, individuals with MDD or high levels of depressive symptoms had significantly lower ASE, particularly in negative affect situations. No evidence for moderation was found: ASE significantly increased during treatment regardless of MDD status. There was a main effect of BSI 18 Depression scores: those with lower BSI 18 scores had lower ASE scores at each time point. MDD and BSI 18 Depression did not predict three-month outcome, but similar to previous findings ASE did predict abstinence status at three months. Treatment-seeking emerging adults with MDD merit particular clinical attention because of their lower reported self-efficacy throughout treatment. PMID:22288980

Influence of a Dissection Video Clip on Anxiety, Affect, and Self-Efficacy in Educational Dissection: A Treatment Study

PubMed Central

Randler, Christoph; Demirhan, Eda; Wüst-Ackermann, Peter; Desch, Inga H.

2016-01-01

In science education, dissections of animals are an integral part of teaching, but they often evoke negative emotions. We aimed at reducing negative emotions (anxiety, negative affect [NA]) and increasing positive affect (PA) and self-efficacy by an experimental intervention using a predissection video to instruct students about fish dissection. We compared this treatment with another group that watched a life history video about the fish. The participants were 135 students studying to become biology teachers. Seventy received the treatment with the dissection video, and 65 viewed the life history video. We applied a pre/posttest treatment-comparison design and used the Positive and Negative Affect Schedule (PANAS), the State–Trait–Anxiety Inventory for State (STAI-S), and a self-efficacy measure three times: before the lesson (pretest), after the film treatment (posttest 1), and after the dissection (posttest 2). The dissection film group scored higher in PA, NA, and state anxiety (STAI-S) after the dissection video treatment and higher in self-efficacy after the dissection. The life history group showed no differences between the pretest and posttest 1. The dissection film has clear benefits—increasing PA and self-efficacy—that come at the cost of higher NA and higher STAI-S. PMID:27290738

Review of Efficacy of Complementary and Alternative Medicine Treatments for Menopausal Symptoms.

PubMed

Moore, Thea R; Franks, Rachel B; Fox, Carol

2017-05-01

Complementary and alternative medicine (CAM) treatments have been used for thousands of years around the world. There has been increased interest in utilizing CAM for menopausal symptoms since the release of results of the Women's Health Initiative elucidated long-term adverse effects associated with hormone therapy. Women looking for more natural or safer means to treat hot flushes, night sweats, and other menopausal symptoms often turn to CAM such as yoga, phytoestrogens, or black cohosh. Yet there have been few well-conducted studies looking at the efficacy of these treatments. This review examines randomized clinical trials, systematic reviews, and meta-analyses evaluating the effectiveness of commonly used CAM for the treatment of menopausal symptoms. © 2017 by the American College of Nurse-Midwives.

PERMEABLE TREATMENT WALL EFFECTIVENESS MONITORING PROJECT, NEVADA STEWART MINE

EPA Science Inventory

This report summarizes the results of Mine Waste Technology Program (MWTP) Activity III, Project 39, Permeable Treatment Wall Effectiveness Monitoring Project, implemented and funded by the U.S. Environmental Protection Agency (EPA) and jointly administered by EPA and the U.S. De...

The efficacy of azithromycin and doxycycline for the treatment of rectal chlamydia infection: a systematic review and meta-analysis.

PubMed

Kong, Fabian Yuh Shiong; Tabrizi, Sepehr N; Fairley, Christopher Kincaid; Vodstrcil, Lenka A; Huston, Wilhelmina M; Chen, Marcus; Bradshaw, Catriona; Hocking, Jane S

2015-05-01

There are increasing concerns about treatment failure following treatment for rectal chlamydia with 1 g of azithromycin. A systematic review and meta-analysis was conducted to investigate the efficacy of 1 g of azithromycin as a single dose or 100 mg of doxycycline twice daily for 7 days for the treatment of rectal chlamydia. Medline, Embase, PubMed, Cochrane Controlled Trials Register, Australia New Zealand Clinical Trial Register and ClinicalTrials.gov were searched to the end of April 2014. Studies using 1 g of azithromycin or 7 days of doxycycline for the treatment of rectal chlamydia were eligible. Gender, diagnostic test, serovar, symptomatic status, other sexually transmitted infections, follow-up time, attrition and microbial cure were extracted. Meta-analysis was used to calculate pooled (i) azithromycin and doxycycline efficacy and (ii) efficacy difference. All eight included studies were observational. The random-effects pooled efficacy for azithromycin (based on eight studies) was 82.9% (95% CI 76.0%-89.8%; I(2) = 71.0%; P < 0.01) and for doxycycline (based on five studies) was 99.6% (95% CI 98.6%-100%; I(2) = 0%; P = 0.571), resulting in a random-effects pooled efficacy difference (based on five studies) of 19.9% (95% CI 11.4%-28.3%; I(2) = 48.5%; P = 0.101) in favour of doxycycline. The efficacy of single-dose azithromycin may be considerably lower than 1 week of doxycycline for treating rectal chlamydia. However, the available evidence is very poor. Robust randomized controlled trials are urgently required. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Monitoring propranolol treatment in periocular infantile haemangioma.

PubMed

Burne, R; Taylor, R

2014-11-01

To develop a tool for assessing amblyopic risk and monitoring the treatment effect of propranolol in periocular haemangioma management. We present a study of nine children with periocular haemangioma who underwent propranolol treatment at York Hospital between 2009 and 2013.A proposed measure of amblyogenic risk based on the induced anisometropia resulting from a periocular haemangioma was calculated in the form of a single quantitative value, measured in dioptres. This calculation used published work and developed it to produce a new function, termed the delta defocus equivalent (DFE-∂).Refraction measurements were retrospectively collected from patients' notes in order to measure the trend of DFE-∂ over the treatment period with propranolol. The average DFE-∂ at commencement of propranolol was 1.54 (±0.62) D. The average at the end of treatment was 0.39 (±0.38) D. This work presents a possible tool for assessing amblyopic risk in cases of periocular infantile haemangioma. The DFE-∂ gives a measure in dioptres, which may represent the true amblyopic risk, and so be useful in supporting treatment decisions in paediatric ophthalmology.

Treatment of pediatric Clostridium difficile infection: a review on treatment efficacy and economic value.

PubMed

D'Ostroph, Amanda R; So, Tsz-Yin

2017-01-01

The incidence of Clostridium difficile infection (CDI) in pediatric patients continues to rise. Most of the pediatric recommendations for CDI treatment are extrapolated from the literature and guidelines for adults. The American Academy of Pediatrics recommends oral metronidazole as the first-line treatment option for an initial CDI and the first recurrence if they are mild to moderate in severity. Oral vancomycin is recommended to be used for severe CDI and the second recurrent infection. Additional pulsed regimen of oral vancomycin, which is tapered, may increase efficacy in refractory patients. However, there is lack of large studies evaluating the use of fidaxomicin in pediatrics to know whether it could be a safe and effective treatment option for difficult-to-treat patients. Fidaxomicin is associated with higher total drug costs compared to metronidazole and vancomycin, but the literature supports its use due to a lower rate of CDI recurrence, which may result in cost savings. Further studies are warranted to evaluate the use of fidaxomicin in patients <18 years old and to understand its role in the standard of care for pediatric patients with CDI.

Treatment of pediatric Clostridium difficile infection: a review on treatment efficacy and economic value

PubMed Central

D’Ostroph, Amanda R; So, Tsz-Yin

2017-01-01

The incidence of Clostridium difficile infection (CDI) in pediatric patients continues to rise. Most of the pediatric recommendations for CDI treatment are extrapolated from the literature and guidelines for adults. The American Academy of Pediatrics recommends oral metronidazole as the first-line treatment option for an initial CDI and the first recurrence if they are mild to moderate in severity. Oral vancomycin is recommended to be used for severe CDI and the second recurrent infection. Additional pulsed regimen of oral vancomycin, which is tapered, may increase efficacy in refractory patients. However, there is lack of large studies evaluating the use of fidaxomicin in pediatrics to know whether it could be a safe and effective treatment option for difficult-to-treat patients. Fidaxomicin is associated with higher total drug costs compared to metronidazole and vancomycin, but the literature supports its use due to a lower rate of CDI recurrence, which may result in cost savings. Further studies are warranted to evaluate the use of fidaxomicin in patients <18 years old and to understand its role in the standard of care for pediatric patients with CDI. PMID:29089778

High treatment efficacy by dual targeting of Burkitt's lymphoma xenografted mice with a (177)Lu-based CD22-specific radioimmunoconjugate and rituximab.

PubMed

Weber, Tobias; Bötticher, Benedikt; Mier, Walter; Sauter, Max; Krämer, Susanne; Leotta, Karin; Keller, Armin; Schlegelmilch, Anne; Grosse-Hovest, Ludger; Jäger, Dirk; Haberkorn, Uwe; Arndt, Michaela A E; Krauss, Jürgen

2016-03-01

Dual-targeted therapy has been shown to be a promising treatment option in recurrent and/or refractory B-cell non-Hodgkin's lymphoma (B-NHL). We generated radioimmunoconjugates (RICs) comprising either a novel humanized anti-CD22 monoclonal antibody, huRFB4, or rituximab, and the low-energy β-emitter (177)Lu. Both RICs were evaluated as single agents in a human Burkitt's lymphoma xenograft mouse model. To increase the therapeutic efficacy of the anti-CD22 RIC, combination therapy with unlabelled anti-CD20 rituximab was explored. The binding activity of CHX-A″-DTPA-conjugated antibodies to target cells was analysed by flow cytometry. To assess tumour targeting of (177)Lu-labelled antibodies, in vivo biodistribution experiments were performed. For radioimmunotherapy (RIT) studies, non-obese diabetic recombination activating gene-1 (NOD-Rag1 (null) ) interleukin-2 receptor common gamma chain (IL2rγ (null) ) null mice (NRG mice) were xenografted subcutaneously with Raji Burkitt's lymphoma cells. (177)Lu-conjugated antibodies were administered at a single dose of 9.5 MBq per mouse. For dual-targeted therapy, rituximab was injected at weekly intervals (0.5 - 1.0 mg). Tumour accumulation of RICs was monitored by planar scintigraphy. Conjugation of CHX-A"-DTPA resulted in highly stable RICs with excellent antigen-binding properties. Biodistribution experiments revealed higher tumour uptake of the (177)Lu-labelled anti-CD22 IgG than of (177)Lu-labelled rituximab. Treatment with (177)Lu-conjugated huRFB4 resulted in increased tumour growth inhibition and significantly longer survival than treatment with (177)Lu-conjugated rituximab. The therapeutic efficacy of the anti-CD22 RIC could be markedly enhanced by combination with unlabelled rituximab. These findings suggest that dual targeting with (177)Lu-based CD22-specific RIT in combination with rituximab is a promising new treatment option for refractory B-NHL.

Efficacy of Intraoperative Neurophysiologic Monitoring for Pediatric Cervical Spine Surgery.

PubMed

Tobert, Daniel G; Glotzbecker, Michael P; Hresko, Michael Timothy; Karlin, Lawrence I; Proctor, Mark R; Emans, John B; Miller, Patricia E; Hedequist, Daniel J

2017-07-01

Clinical case series. To investigate the efficacy of intraoperative neuromonitoring in pediatric cervical spine surgery. Intraoperative neuromonitoring (IONM) consisting of somatosensory-evoked potentials (SSEP) and transcranial motor-evoked potentials (tcMEP) has been shown to effectively prevent permaneny neurologic injury in deformity surgery. The role of IONM during pediatric cervical spine surgery is not well documented. Advances in cervical spine instrumentation have expanded the surgical options in pediatric populations. The goal of this study is to report the ability of IONM to detect neurologic injury during pediatric cervical spine instrumentation. A single institution database was queried for pediatric-aged patients who underwent cervical spine instrumentation and fusion between 2011 and 2014. Age, diagnosis, surgical indication, number of instrumented levels, and a complete IONM were extracted. Sensitivity and specificity for the detection of neurologic deficits were calculated with exact 95% confidence intervals. Positive and negative predictive values were calculated with estimated 95% confidence intervals. Sixty-seven patients who underwent cervical spine instrumentation were identified with a mean age of 11.6 years (range 1-18). Diagnoses included instability (27), congenital (11), kyphosis (8), fracture (7), tumor (7), arthritis (4), and basilar invagination (3). Mean number of vertebral levels fused was 4 (range 2-7). All patients underwent cervical instrumentation with SSEP and tcMEP monitoring. A significant change in tcMEP monitoring was observed in 7 subjects (10%). There were no corresponding SSEP changes in these patients. The sensitivity of combined IONM was 75% [95% CI = 24.9, 98.7] and the specificity was 98.5% [92.7, 99.9]. tcMEP is a more sensitive indicator to spinal cord injury than SSEP, which is consistent with previous studies. IONM changes in 10% of a patient population are significant enough to warrant intraoperative

Evaluation of barium hydroxide treatment efficacy on a dolomitic marble.

PubMed

Toniolo, L; Colombo, C; Realini, M; Peraio, A; Positano, M

2001-01-01

The Arch of Peace, by Luigi Cagnola, is one of the most famous neoclassical monuments in Milan. It has been subjected to conservative intervention in 1998. In the present paper the efficacy of the consolidation by means of barium hydroxide has been evaluated. The stone material showed severe degradation phenomena as: erosion, pulverisation, exfoliation. The analytical data acquired through X-ray diffraction (XRD), infrared spectrophotometry (FTIR) and scanning electron microscopy (SEM-EDX), allowed to compare the conditions of stone before and after the treatment with barium hydroxide. The presence of barium has been put in evidence mainly on the surface as barium sulphate, whereas barium is only sporadically present within the thickness of the decayed material. The treatment was judged not satisfying and its inefficacy is, most probably, due to a not suitable cleaning procedure carried out before the consolidation.

Efficacy of peroral endoscopic myotomy compared with other invasive treatment options for the different esophageal motor disorders.

PubMed

Estremera-Arévalo, Fermín; Albéniz, Eduardo; Rullán, María; Areste, Irene; Iglesias, Rosa; Vila, Juan José

2017-08-01

Peroral endoscopic myotomy (POEM) has been performed since 2008 on more than 5,000 patients. It has proven to be highly effective in the treatment of achalasia and has shown promising outcomes for other esophageal motility spastic disorders. A literature review of the efficacy of POEM compared to the previous invasive treatments for different esophageal motility disorders was performed. The application in the pediatric and elderly populations and its role as a rescue therapy after other procedures are also outlined. Short-term outcomes are similar to laparoscopic Heller myotomy (LHM) and pneumatic endoscopic dilation (PD) (clinical success > 90%) for achalasia subtypes I and II. Mid-term outcomes are comparable to LHM and overcome the results obtained after PD (> 90% vs ~50%). With regard to type III achalasia, POEM efficacy is 98% compared to 80.8% for LHM and the PD success remains at 40%. With regard to spastic esophageal disorders (SED), POEM has an effectiveness of 88% and 70% for distal esophageal spasm (DES) and jackhammer esophagus (JE) respectively. A response of 95% in patients with sigmoid esophagus has been reported. POEM has been performed in pediatric and elderly populations and has obtained a higher efficacy than PD in pediatric series (100% vs 33%) without greater adverse events. Previous treatments do not seem to hinder POEM results with excellent response rates, including 97% in post LHM and 100% in a re-POEM series. Final considerations: POEM has shown excellent short and mid-term results for all subtypes of achalasia but long-term results are not yet available. The promising results in SED may make POEM the first-line treatment for SED. A high-safety profile and efficacy have been shown in elderly and pediatric populations. Previous treatments do not seem to diminish the success rate of POEM. Core tip: POEM has emerged as an efficient treatment option for all subtypes of achalasia and other scenarios (including previous treatments and elderly

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

PubMed

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.

Balanced: a randomised trial examining the efficacy of two self-monitoring methods for an app-based multi-behaviour intervention to improve physical activity, sitting and sleep in adults.

PubMed

Duncan, Mitch J; Vandelanotte, Corneel; Trost, Stewart G; Rebar, Amanda L; Rogers, Naomi; Burton, Nicola W; Murawski, Beatrice; Rayward, Anna; Fenton, Sasha; Brown, Wendy J

2016-07-30

Many adults are insufficiently physically active, have prolonged sedentary behaviour and report poor sleep. These behaviours can be improved by interventions that include education, goal setting, self-monitoring, and feedback strategies. Few interventions have explicitly targeted these behaviours simultaneously or examined the relative efficacy of different self-monitoring methods. This study aims to compare the efficacy of two self-monitoring methods in an app-based multi-behaviour intervention to improve objectively measured physical activity, sedentary, and sleep behaviours, in a 9 week 2-arm randomised trial. Participants will be adults (n = 64) who report being physically inactive, sitting >8 h/day and frequent insufficient sleep (≥14 days out of last 30). The "Balanced" intervention is delivered via a smartphone 'app', and includes education materials (guidelines, strategies to promote change in behaviour), goal setting, self-monitoring and feedback support. Participants will be randomly allocated to either a device-entered or user-entered self-monitoring method. The device-entered group will be provided with a activity tracker to self-monitor behaviours. The user-entered group will recall and manually record behaviours. Assessments will be conducted at 0, 3, 6, and 9 weeks. Physical activity, sedentary behaviour and sleep-wake behaviours will be measured using the wrist worn Geneactiv accelerometer. Linear mixed models will be used to examine differences between groups and over time using an alpha of 0.01. This study will evaluate an app-based multi-behavioural intervention to improve physical activity, sedentary behaviour and sleep; and the relative efficacy of two different approaches to self-monitoring these behaviours. Outcomes will provide information to inform future interventions and self-monitoring targeting these behaviours. ACTRN12615000182594 (Australian New Zealand Clinical Trials Registry. Registry URL: www.anzctr.org.au ; registered

Efficacy of CBD-enriched medical cannabis for treatment of refractory epilepsy in children and adolescents - An observational, longitudinal study.

PubMed

Hausman-Kedem, Moran; Menascu, Shay; Kramer, Uri

2018-04-16

The objective of this observational study was to evaluate the efficacy of medical cannabis for the treatment of refractory epilepsy. Fifty-seven patients (age 1-20 years) with epilepsy of various etiologies were treated with Cannabis oil extract (CBD/THC ratio of 20:1) for at least 3 months (Median follow up time-18 months). Forty-Six Patients were included in the efficacy analysis. Average CBD dose was11.4 mg/kg/d. Twenty-six patients (56%) had ≤50% reduction in mean monthly seizure frequency. There was no statistically significant difference in response rate among various epilepsy etiologies, and cannabis strain used. Younger age at treatment onset (<10 years) and higher CBD dose (>11 mg/kg/d) were associated with better response to treatment. Adverse reactions were reported in 46% of patients and were the main reason for treatment cessation. Our results suggest that adding CBD-enriched cannabis extract to the treatment regimen of patients with refractory epilepsy may result in a significant reduction in seizure frequency according to parental reports. Randomized controlled trials are necessary to assess its true efficacy. Copyright © 2018 Elsevier B.V. All rights reserved.

Multidrug-resistant tuberculosis treatment failure detection depends on monitoring interval and microbiological method

PubMed Central

White, Richard A.; Lu, Chunling; Rodriguez, Carly A.; Bayona, Jaime; Becerra, Mercedes C.; Burgos, Marcos; Centis, Rosella; Cohen, Theodore; Cox, Helen; D'Ambrosio, Lia; Danilovitz, Manfred; Falzon, Dennis; Gelmanova, Irina Y.; Gler, Maria T.; Grinsdale, Jennifer A.; Holtz, Timothy H.; Keshavjee, Salmaan; Leimane, Vaira; Menzies, Dick; Milstein, Meredith B.; Mishustin, Sergey P.; Pagano, Marcello; Quelapio, Maria I.; Shean, Karen; Shin, Sonya S.; Tolman, Arielle W.; van der Walt, Martha L.; Van Deun, Armand; Viiklepp, Piret

2016-01-01

Debate persists about monitoring method (culture or smear) and interval (monthly or less frequently) during treatment for multidrug-resistant tuberculosis (MDR-TB). We analysed existing data and estimated the effect of monitoring strategies on timing of failure detection. We identified studies reporting microbiological response to MDR-TB treatment and solicited individual patient data from authors. Frailty survival models were used to estimate pooled relative risk of failure detection in the last 12 months of treatment; hazard of failure using monthly culture was the reference. Data were obtained for 5410 patients across 12 observational studies. During the last 12 months of treatment, failure detection occurred in a median of 3 months by monthly culture; failure detection was delayed by 2, 7, and 9 months relying on bimonthly culture, monthly smear and bimonthly smear, respectively. Risk (95% CI) of failure detection delay resulting from monthly smear relative to culture is 0.38 (0.34–0.42) for all patients and 0.33 (0.25–0.42) for HIV-co-infected patients. Failure detection is delayed by reducing the sensitivity and frequency of the monitoring method. Monthly monitoring of sputum cultures from patients receiving MDR-TB treatment is recommended. Expanded laboratory capacity is needed for high-quality culture, and for smear microscopy and rapid molecular tests. PMID:27587552

Efficacy, tolerability, and safety of aripiprazole once-monthly versus other long-acting injectable antipsychotic therapies in the maintenance treatment of schizophrenia: a mixed treatment comparison of double-blind randomized clinical trials.

PubMed

Majer, Istvan M; Gaughran, Fiona; Sapin, Christophe; Beillat, Maud; Treur, Maarten

2015-01-01

Treatment with long-acting injectable (LAI) antipsychotic medication is an important element of relapse prevention in schizophrenia. Recently, the intramuscular once-monthly formulation of aripiprazole received marketing approval in Europe and the United States for schizophrenia. This study aimed to compare aripiprazole once-monthly with other LAI antipsychotics in terms of efficacy, tolerability, and safety. A systematic literature review was conducted to identify relevant double-blind randomized clinical trials of LAIs conducted in the maintenance treatment of schizophrenia. MEDLINE, MEDLINE In-Process, Embase, the Cochrane Library, PsycINFO, conference proceedings, clinical trial registries, and the reference lists of key review articles were searched. The literature search covered studies dating from January 2002 to May 2013. Studies were required to have ≥24 weeks of follow-up. Patients had to be stable at randomization. Studies were not eligible for inclusion if efficacy of acute and maintenance phase treatment was not reported separately. Six trials were identified (0.5% of initially identified studies), allowing comparisons of aripiprazole once-monthly, risperidone LAI, paliperidone palmitate, olanzapine pamoate, haloperidol depot, and placebo. Data extracted included study details, study duration, the total number of patients in each treatment arm, efficacy, tolerability, and safety outcomes. The efficacy outcome contained the number of patients that experienced a relapse, tolerability outcomes included the number of patients that discontinued treatment due to treatment-related adverse events (AEs), and that discontinued treatment due to reasons other than AEs (e.g., loss to follow-up). Safety outcomes included the incidence of clinically relevant weight gain and extrapyramidal symptoms. Data were analyzed by applying a mixed treatment comparison competing risks model (efficacy) and using binary models (safety). There was no statistically significant

Self-Efficacy for Coping with Cancer Enhances the Effect of Reiki Treatments During the Pre-Surgery Phase of Breast Cancer Patients.

PubMed

Chirico, Andrea; D'Aiuto, Giuseppe; Penon, Antonella; Mallia, Luca; DE Laurentiis, Michelino; Lucidi, Fabio; Botti, Gerardo; Giordano, Antonio

2017-07-01

Self-efficacy for coping with cancer plays a critical role in influencing psychological cancer-related outcomes, some studies suggested its role in enhancing or reducing the effects of psychological interventions in cancer patients. Reiki has recently been included among the efficacious complementary therapeutic intervention for cancer patients. The present study evaluated the role of self-efficacy for coping with cancer as buffer of the Reiki treatment effects on cancer-related symptoms in a randomized controlled trial (intervention versus control group) of breast cancer patients (N=110) during the pre-surgery phase. Results showed that self-efficacy for coping with cancer can influence the effect of a Reiki treatment. Higher efficacious patients showed a more powerful effect of the Reiki intervention on both anxiety and mood than the low efficacious patients. From a practical perspective, the study provides insightful results for healthcare professionals. Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

The safety and efficacy of ledipasvir/sofosbuvir with or without ribavirin in the treatment of orthotopic liver transplant recipients with recurrent hepatitis C: real-world data.

PubMed

Pyrsopoulos, Nikolaos; Trilianos, Panagiotis; Lingiah, Vivek A; Fung, Phoenix; Punnoose, Merlin

2018-07-01

Recurrent hepatitis C (RHC) in orthotopic liver transplantation (OLT) population is associated with accelerated rates of fibrosis, low efficacy and decreased tolerability with traditional therapies. The aim of this study was to evaluate the safety and efficacy of ledipasvir/sofosbuvir (LED/SOF) with or without ribavirin (RBV) in OLT patients with RHC. Patients at least 3 months post-OLT and with documented RHC were treated with LED/SOF with or without RBV for either 12 or 24 weeks. End-of-treatment and sustained virological response 12 weeks after the completion of treatment were documented. Patients were closely monitored for treatment-related adverse effects and the potential need for adjustment in their immunosuppression. Seventy-one patients were included in the study. Median age was 62 years. Median time from OLT was 55 months. Twenty-six (36.6%) patients were treatment-naive and 45 (63.4%) had previously failed interferon-based therapies. The majority of patients (57.7%) had stage F0-F2 fibrosis. Sixty-seven (94.3%) patients completed 12 weeks of LED/SOF with RBV, three patients completed 12 or 24 weeks of LED/SOF without RBV, and one patient completed only 8 weeks of LED/SOF without RBV owing to severe allograft dysfunction. Sustained virological response was near universal in our cohort (98.5%) regardless of genotype, fibrosis stage, and regimen or treatment duration. Most commonly reported side effects were malaise and gastrointestinal upset. No patient required adjustment in immunosuppression and no episodes of rejection were documented during treatment. The combination of LED/SOF with RBV for 12 weeks or LED/SOF for 24 weeks is very effective and safe in treating OLT recipients with RHC.

Efficacy and Safety of ATX-101 by Treatment Session: Pooled Analysis of Data from the Phase 3 REFINE Trials.

PubMed

Dayan, Steven H; Schlessinger, Joel; Beer, Kenneth; Donofrio, Lisa M; Jones, Derek H; Humphrey, Shannon; Carruthers, Jean; Lizzul, Paul F; Gross, Todd M; Beddingfield, Frederick C; Somogyi, Christine

2018-02-01

ATX-101 (deoxycholic acid injection) is the only injectable drug approved for submental fat (SMF) reduction. In the phase 3 REFINE trials, adults with moderate or severe SMF who were dissatisfied with the appearance of their face/chin were eligible to receive up to 6 treatment sessions with ATX-101 (2 mg/cm2) or placebo. Primary and secondary endpoints, evaluated at 12 weeks after last treatment, significantly favored ATX-101 supporting its efficacy for reducing SMF and the psychological impact of SMF, and increasing satisfaction with the appearance of the face/chin. To evaluate the efficacy and safety of ATX-101 by treatment session. This post-hoc analysis used pooled data from the REFINE trials to evaluate efficacy endpoints and adverse events following each treatment session to further characterize the ATX-101 treatment response and safety profile. In both treatment groups, mean injection volume declined over subsequent treatment sessions, though more markedly in the ATX-101 group. The majority of ATX-101-treated subjects achieved a ≥1-grade improvement in SMF within 2 to 4 treatment sessions based on either clinician or subject assessment. Furthermore, 19.1% of ATX-101-treated subjects (vs 3.9% of placebo-treated subjects) received fewer than 6 treatment sessions owing to subject satisfaction with treatment or lack of sufficient SMF for further treatment. In both treatment groups, the incidence/severity of common injection-site adverse events declined over subsequent treatment sessions. Although up to 6 treatment sessions were permitted in the REFINE trials, most ATX-101-treated subjects achieved an improvement in SMF within 2 to 4 treatment sessions. © 2018 The American Society for Aesthetic Plastic Surgery, Inc.

The safety and efficacy of safinamide mesylate for the treatment of Parkinson's disease.

PubMed

Perez-Lloret, Santiago; Rascol, Olivier

2016-01-01

Safinamide (brand name Xadago®, Zambon S.p.A) is a third-generation reversible MAO-B inhibitor, which also blocks sodium voltage-sensitive channels and modulates stimulated release of glutamate. Safinamide was recently licensed by EMA for the treatment of PD as add-on therapy to a stable dose of levodopa alone or in combination with other PD medicinal products in mid-to advanced-stage fluctuating patients. It is also under review by the US FDA. Studies in 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP)-treated monkeys and 6OHDA-lesioned rats suggest antiparkinsonian efficacy and antidyskinesic effects. Randomized, double-blind, placebo-controlled trials have shown efficacy for the treatment of motor symptoms in stable PD patients on dopamine agonists and in fluctuating PD patients on levodopa. Significant improvement in daily ON time was also observed in the latter. This effect was maintained for at least 2 years in double-blind conditions and, interestingly, without significant worsening of dyskinesia. Clinical studies have not detected any specific safety issue other than those already known with MAO-B inhibitors.

Long-term safety and efficacy of budesonide in the treatment of ulcerative colitis

PubMed Central

Iborra, Marisa; Álvarez-Sotomayor, Diego; Nos, Pilar

2014-01-01

Ulcerative colitis (UC) is a chronic, relapsing, and remitting inflammatory disease involving the large intestine (colon). Treatment seeks to break recurrent inflammation episodes by inducing and maintaining remission. Historically, oral systemic corticosteroids played an important role in inducing remission of this chronic disease; however, their long-term use is limited and can lead to adverse events. Budesonide is a synthetic steroid with potent local anti-inflammatory effects and low systemic bioavailability due to high first-pass hepatic metabolism. Several studies have demonstrated oral budesonide’s usefulness in treating active mild to moderate ileocecal Crohn’s disease and microscopic colitis and in an enema formulation for left sided UC. However, there is limited information regarding oral budesonide’s efficacy in UC. A novel oral budesonide formulation using a multimatrix system (budesonide-MMX) to extend drug release throughout the colon has been developed recently and seems to be an effective treatment in active left sided UC patients. This article summarizes budesonide’s long-term safety and efficacy in treating UC. PMID:24523594

Novel Composite Efficacy Measure To Demonstrate the Rationale and Efficacy of Combination Antiviral–Anti-Inflammatory Treatment for Recurrent Herpes Simplex Labialis

PubMed Central

Levin, Myron J.; Tyring, Stephen K.; Spruance, Spotswood L.

2014-01-01

Historically, the primary target for research and treatment of recurrent herpes simplex labialis (HSL) has been limited to inhibiting herpes simplex virus (HSV) replication. Antiviral monotherapy, however, has proven only marginally effective in curtailing the duration and severity of recurrent lesions. Recently, the role of inflammation in the progression and resolution of recurrences has been identified as an additional target. This was evaluated in a randomized study comparing combination topical 5% acyclovir-1% hydrocortisone cream (AHC) with 5% acyclovir alone (AC; in the AHC vehicle) and the vehicle. The efficacy of each topical therapy was evaluated for cumulative lesion size—a novel composite efficacy endpoint incorporating episode duration, lesion area, and proportion of nonulcerative lesions. In that study, cumulative lesion area was significantly decreased with AHC compared with AC (25% decrease; P < 0.05) and the vehicle (50% decrease; P < 0.0001). As research continues in this arena, cumulative lesion area should be included as a measure of efficacy in clinical trials of recurrent HSL therapies. PMID:24342632

Efficacy and treatment satisfaction with on-demand tadalafil (Cialis) in men with erectile dysfunction.

PubMed

Skoumal, René; Chen, Juza; Kula, Krzysztof; Breza, Jan; Calomfirescu, Nicolae; Basson, Bruce R; Kopernicky, Vladimir

2004-09-01

Tadalafil (Cialis) is an inhibitor of phosphodiesterase type 5, which mediates relaxation of vascular smooth muscle in the corpus cavernosum thus facilitating erection. The purpose of this multicentre, randomized, double-blind, parallel group, placebo-controlled study was to evaluate efficacy and treatment satisfaction of on-demand Cialis in men with mild-to-severe erectile dysfunction (ED). Following a 4-week treatment-free run in period, patients stratified into three severity groups by the International Index of Erectile Function (IIEF) Erectile Function (EF) domain score were randomized to receive either placebo or Cialis 20 mg taken on demand over a 12-week period. Efficacy endpoints were change from baseline in IIEF EF domain scores, responses to Sexual Encounter Profile diary (SEP) questions, and responses to the Global Assessment Questions (GAQ). Treatment satisfaction was evaluated using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire in two of seven participating countries where validated translations were available. Of the 443 men who entered the trial, 409 (mean age, 52 years) formed the intent-to-treat population. Mean baseline demographics and ED severity measures were balanced between treatment groups except for a higher percentage of patients naïve to sildenafil in the tadalafil group compared to placebo (50% versus 36%). The percentage of patients in each IIEF EF severity class (mild, moderate and severe) was 47%, 30% and 23% for placebo patients and 48%, 29% and 23% for tadalafil patients, respectively. Tadalafil was significantly superior to placebo on all primary efficacy measures (IIEF EF domain scores, SEP15, GAQ1; p < 0.001); notably 64% of tadalafil patients achieved a normal IIEF EF domain score at endpoint compared to 16% of placebo patients (p < 0.001). Of the 185 patients completing the EDITS questionnaire (137 receiving Cialis and 48 receiving placebo), tadalafil-treated patients had a median EDITS

Role for a sense of self-worth in weight-loss treatments: helping patients develop self-efficacy.

PubMed

Cochrane, Gordon

2008-04-01

To recommend strategies for enhancing patients' sense of self-worth and self-efficacy in order to give them sufficient faith in themselves to make healthier choices about their weight. PubMed, PsycINFO, Google Scholar, and APA Journals Online were searched for original research articles on treatment models and outcome review articles from 1960 to the present. Key search terms were weight loss, weight-loss treatments, diets and weight loss, psychology and obesity, physiology and obesity, and exercise and weight loss. Most evidence was level I and level II. In spite of extensive research, there is widespread belief that the medical system has failed to stem the tide of weight gain in North America. The focus has been on physiologic, behavioural, and cultural explanations for what is seen as a relatively recent phenomenon, while the self-perception of overweight individuals has been largely overlooked. Professional treatments have consisted mainly of cognitive behavioural therapies and rest on the premise that overweight patients will effectively apply the cognitive behavioural therapy principles. In the long run, professional and commercial programs are often ineffective. We need treatments that include strategies to repair ego damage, enhance the sense of self-worth, and develop self-efficacy so that overweight patients can become the agents of change in their pursuit of well-being. Self-efficacy correlates positively with success in all realms of personal endeavour, and we can help our overweight patients become more self-reliant.

The efficacy of N-acetylcysteine as an adjunctive treatment in bipolar depression: an open label trial.

PubMed

Berk, Michael; Dean, Olivia; Cotton, Sue M; Gama, Clarissa S; Kapczinski, Flavio; Fernandes, Brisa S; Kohlmann, Kristy; Jeavons, Susan; Hewitt, Karen; Allwang, Christine; Cobb, Heidi; Bush, Ashley I; Schapkaitz, Ian; Dodd, Seetal; Malhi, Gin S

2011-12-01

Evidence is accumulating to support the presence of redox dysregulation in a number of psychiatric disorders, including bipolar disorder. This dysregulation may be amenable to therapeutic intervention. Glutathione is the predominant non-enzymatic intracellular free radical scavenger in the brain, and the most generic of all endogenous antioxidants in terms of action. N-acetylcysteine (NAC) is a glutathione precursor that effectively replenishes brain glutathione. Given the failure of almost all modern trials of antidepressants in bipolar disorder to demonstrate efficacy, and the limited efficacy of mood stabilisers in the depressive phase of the disorder, this is a major unmet need. This study reports data on the treatment of 149 individuals with moderate depression during the 2 month open label phase of a randomised placebo controlled clinical trial of the efficacy of 1g BID of NAC that examined the use of NAC as a maintenance treatment for bipolar disorder. In this trial, the estimated mean baseline Bipolar Depression Rating Scale (BDRS) score was 19.7 (SE=0.8), and the mean BDRS score at the end of the 8 week open label treatment phase was 11.1 (SE=0.8). This reduction was statistically significant (p<0.001). Improvements in functioning and quality of life were similarly evident. These open label data demonstrate a robust decrement in depression scores with NAC treatment. Large placebo controlled trials of acute bipolar depression are warranted. Copyright © 2011 Elsevier B.V. All rights reserved.

Feasibility of Tuberculosis Treatment Monitoring by Video Directly Observed Therapy: A Binational Pilot Study

PubMed Central

Garfein, Richard S.; Collins, Kelly; Muñoz, Fátima; Moser, Kathleen; Cerecer-Callu, Paris; Raab, Fredrick; Rios, Phillip; Flick, Allison; Zúñiga, María Luisa; Cuevas-Mota, Jazmine; Liang, Krystal; Rangel, Gudelia; Burgos, José Luis; Rodwell, Timothy; Patrick, Kevin

2017-01-01

Objective Directly observed therapy is recommended worldwide for monitoring tuberculosis (TB) treatment; yet transportation and personnel requirements limit its use. We evaluated the feasibility and acceptability of “Video DOT” (VDOT), which allowed patients to record and transmit medication ingestion videos that were watched remotely by healthcare providers to document adherence. Methods We conducted a single-arm trial among TB patients in San Diego, CA (n=43) and Tijuana, B.C., Mexico (n=9) to represent high- and low-resources settings. Pre/post treatment interviews assessed participant characteristics and experiences. Adherence was defined as the proportion of observed doses to expected doses. Results Mean age was 34 years (range: 18–86), 54% were male, and 77% were non-Caucasian. Mean duration of VDOT use was 5.5 months (range: 1–11). Adherence was similar in San Diego (93%) and Tijuana (96%). Compared to time on in-person DOT, 92% preferred VDOT; 81% thought VDOT was more confidential; 89% never/rarely had problems recording videos; and 100% would recommend VDOT to others. Overall, 7 (13%) participants were returned to in-person DOT and 6 (12%) separate participants had their phone lost, broken or stolen. Conclusions VDOT was feasible and acceptable with high adherence in high- and low-resource settings. Efficacy and cost-effectiveness studies are needed. PMID:26260824

Experiences with SCRAMx alcohol monitoring technology in 100 alcohol treatment outpatients.

PubMed

Alessi, Sheila M; Barnett, Nancy P; Petry, Nancy M

2017-09-01

Transdermal alcohol monitoring technology allows for new research on alcohol use disorders. This study assessed feasibility, acceptability, and adherence with this technology in the context of two clinical research trials. Participants were the first 100 community-based alcohol treatment outpatients enrolled in randomized studies that monitored drinking with the secure continuous remote alcohol monitor (SCRAMx ® ) for 12 weeks. Study 1 participants were randomized to usual care (n=36) or usual care with contingency management incentives for treatment attendance (CM-Att; n=30). Study 2 participants were randomized to usual care (n=17) or usual care with CM for each day of no drinking per SCRAMx (CM-Abst; n=17). After 12 weeks, participants completed a survey about the bracelet. Nine percent of individuals screened (54 of 595) declined participation because of the bracelet. Of participants, 84% provided 12weeks of data, and 96% of bracelets were returned fully intact. Ninety-four equipment tampers occurred, affecting 2% of monitoring days; 56% (67) of tampers coincided with detected drinking. Common concerns reported by participants were skin marks (58%), irritation (54%), and interfered with clothing choices (51%), but severity ratings were generally mild (60%-94%). Eighty-one percent of participants reported that the bracelet helped them reduce drinking, and 75% indicated that they would wear it for longer. A common suggestion for improvement was to reduce the size of the bracelet. Results support the viability of transdermal monitoring in voluntary substance abuse treatment participants for an extended duration. Issues to consider for future applications of this technology are discussed. Copyright © 2017 Elsevier B.V. All rights reserved.

Efficacy of azithromycin in the treatment of bronchiectasis.

PubMed

Lourdesamy Anthony, Albert I; Muthukumaru, Umadevi

2014-11-01

We evaluated the efficacy of a 12-week oral treatment with azithromycin in adult patients with bronchiectasis. The objectives were to demonstrate that this treatment reduces sputum volume, improves quality of life and to assess the lengths of effects after cessation of therapy. Seventy-eight patients with bronchiectasis confirmed by high-resolution computed tomography were included in this study. Subjects received oral azithromycin or placebo in a randomized manner for 12 weeks followed by placebo for another 12 weeks. Sputum volume, St George's Respiratory Questionnaire (SGRQ) score and spirometry were recorded at baseline, 12 weeks and 24 weeks, respectively. End-point measurements were compared from baseline to the end of each study phase. Sixty-eight subjects were included in the analysis. Mean 24-h sputum volume significantly decreased (P < 0.01) during the active treatment phase and remained low during the control phase (P < 0.01). The mean SGRQ total score with azithromycin decreased (i.e. improved health status) from baseline by more than the 4 points at the end of 12 and 24 weeks. Lung functions remained stable during oral azithromycin therapy and the subsequent control phase. Twelve weeks administration of azithromycin in bronchiectasis produces significant reductions in mean sputum volume, health status and stabilization of lung function values. Sputum volume reduction and the improvement of quality of life were sustained for 12 weeks after cessation of azithromycin. (Clinicaltrials.gov number NCT02107274). © 2014 Asian Pacific Society of Respirology.

Therapeutic efficacy trial of artemisinin-based combination therapy for the treatment of uncomplicated malaria and investigation of mutations in k13 propeller domain in Togo, 2012-2013.

PubMed

Dorkenoo, Améyo M; Yehadji, Degninou; Agbo, Yao M; Layibo, Yao; Agbeko, Foli; Adjeloh, Poukpessi; Yakpa, Kossi; Sossou, Efoe; Awokou, Fantchè; Ringwald, Pascal

2016-06-22

Since 2005, the Togo National Malaria Control Programme has recommended two different formulations of artemisinin-based combination therapy (ACT), artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL), for the treatment of uncomplicated malaria. Regular efficacy monitoring of these two combinations is conducted every 2 or 3 years. This paper reports the latest efficacy assessment results and the investigation of mutations in the k13 propeller domain. The study was conducted in 2012-2013 on three sentinel sites of Togo (Lomé, Sokodé and Niamtougou). Children aged 6-59 months, who were symptomatically infected with Plasmodium falciparum, were treated with either AL (Coartem(®), Novartis Pharma, Switzerland) or ASAQ (Co-Arsucam(®), Sanofi Aventis, France). The WHO standard protocol for anti-malarial treatment evaluation was used. The primary end-point was 28-day adequate clinical and parasitological response (ACPR), corrected to exclude reinfection using polymerase-chain reaction (PCR) genotyping. A total of 523 children were included in the study. PCR-corrected ACPR was 96.3-100 % for ASAQ and 97-100 % for AL across the three study sites. Adverse events were negligible: 0-4.8 % across all sites, for both artemisinin-based combinations. Upon investigation of mutations in the k13 propeller domain, only 9 (1.8 %) mutations were reported, three in each site. All mutant parasites were cleared before day 3. All day 3 positive patients were infected with k13 wild type parasites. The efficacy of AL and ASAQ remains high in Togo, and both drugs are well tolerated. ASAQ and AL would be recommended for the treatment of uncomplicated malaria in Togo.

Efficacy of Ballast Water Treatment Systems: A Report by the EPA Science Advisory Board

DTIC Science & Technology

2011-07-12

efficacy of the treatment program needs to be placed into this broader context. Cargo may contain insects , fungi, seeds and spores that can be...dioxide) the great majority and in some cases, nearly all organisms ≥ 50 µm; UV irradiation kills or inactivates unicellular organisms and viruses

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

PubMed Central

Oluoch, George O.; Ainsworth, Stuart; Alsolaiss, Jaffer; Bolton, Fiona; Arias, Ana-Silvia; Gutiérrez, José-María; Rowley, Paul; Kalya, Stephen; Ozwara, Hastings; Casewell, Nicholas R.

2017-01-01

Background 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. Methods 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. Findings 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

Estimated cost efficacy of systemic treatments that are approved by the US Food and Drug Administration for the treatment of moderate to severe psoriasis.

PubMed

D'Souza, Logan S; Payette, Michael J

2015-04-01

Newer psoriasis treatments tout higher efficacy but are generally more expensive. We sought to estimate the cost efficacy of systemic psoriasis treatments that have been approved by the US Food and Drug Administration (FDA). A literature review of systemic psoriasis treatments that have been approved by the FDA was performed for the primary end point of a 75% reduction in the Psoriasis Area and Severity Index score (PASI 75). Medication cost was referenced by wholesale acquisition cost (WAC), laboratory fees were obtained from the American Medical Association, and office visit fees are standard at our university. Total expenses were standardized by calculating cost per month of treatment considering the number needed to treat (NNT) to achieve PASI 75. Methotrexate ($794.05-1502.51) and cyclosporine ($1410.14-1843.55) had the lowest monthly costs per NNT to achieve PASI 75. The most costly therapies were infliximab ($8704.68-15,235.52) and ustekinumab 90 mg ($12,505.26-14,256.75). Monthly costs per NNT to achieve PASI 75 for other therapies were as follows: narrowband ultraviolet B light phototherapy ($2924.73), adalimumab ($3974.61-7678.78), acitretin ($4137.71-14,148.53), ustekinumab 45 mg ($7177.89-7263.99), psoralen plus ultraviolet A light phototherapy ($7499.46-8834.98), and etanercept ($8284.71-10,674.89). Drug rebates and incentives, potential adverse effects, comorbidity risk reduction, ambassador programs, and combination therapies were excluded. Our study provides meaningful cost efficacy data that may influence psoriasis treatment selection. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Efficacy and Safety of Atomoxetine in the Treatment of Children and Adolescents with Attention Deficit Hyperactivity Disorder

PubMed Central

Kohn, Michael R.; Tsang, Tracey W.; Clarke, Simon D.

2012-01-01

Several non-stimulant medications have been used in the treatment of attention deficit hyperactivity disorder (ADHD). Atomoxetine, was introduced in 2002. The safety and efficacy of atomoxetine in the treatment of ADHD for children, adolescents, and adults has been evaluated in over 4000 patients in randomized controlled studies and double blinded studies as well as in recent large longitudinal studies. This paper provides an updated summary of the literature on atomoxetine, particularly in relation to findings on the short- and long-term safety of atomoxetine in children and adolescents arising from recent large longitudinal cohort studies. Information is presented about the efficacy, safety, and tolerability of this medication. PMID:23641171

[Almotriptan vs. ergotamine plus caffeine for acute migraine treatment. A cost-efficacy analysis].

PubMed

Slof, J; Láinez, J M; Comas, A; Heras, J

2009-04-01

Almotriptan has proven to be more efficacious and tolerable than ergotamine plus caffeine but is more expensive, thus raising the question about its cost-efficacy. The course of migraine attacks during 24 hours treated with almotriptan and ergotamine plus caffeine was modelled with a decision tree, using efficacy data from a recent randomized, double-blind clinical trial comparing the two drugs. Costs were calculated from the social perspective (including indirect costs due to absenteeism and loss of productivity) and from the Spanish National Health System (NHS) perspective (only including drug costs). The impact on quality of life was estimated using utilities assigned in the literature to different health states of migraine patients. Treatment response was 57.7% for patients treated with almotriptan vs. 44.5% with ergotamine plus caffeine. Sustained pain-free status was achieved by 20.3% vs. 11.5%. Working days lost due to absenteeism and reduced productivity amounted to 0.24 vs. 0.38 days. Quality of life during attacks was estimated at an average utility of 0.548 vs. 0.422. From the NHS perspective, incremental costs per attack treated with almotriptan vs. ergotamine plus caffeine was euro 5.05, rendering an incremental cost-efficacy ratio of euro38.26 per additional response, euro57.39 per additional complete response, and euro14,709 per quality- adjusted life-year gained. From the social perspective almotriptan saved euro7.50 vs. ergotamine plus caffeine. Almotriptan can be considered cost-efficacious vs. ergotamine plus caffeine from the NHS perspective and is the dominant option (both more efficacious and more economical) from the social perspective.

Paracetamol in Patent Ductus Arteriosus Treatment: Efficacious and Safe?

PubMed Central

Bardanzellu, Flaminia; Neroni, Paola; Fanos, Vassilios

2017-01-01

In preterm infants, failure or delay in spontaneous closure of Ductus Arteriosus (DA), resulting in the condition of Patent Ductus Arteriosus (PDA), represents a significant issue. A prolonged situation of PDA can be associated with several short- and long-term complications. Despite years of researches and clinical experience on PDA management, unresolved questions about the treatment and heterogeneity of clinical practices in different centers still remain, in particular regarding timing and modality of intervention. Nowadays, the most reasonable strategy seems to be reserving the treatment only to hemodynamically significant PDA. The first-line therapy is medical, and ibuprofen, related to several side effects especially in terms of nephrotoxicity, is the drug of choice. Administration of oral or intravenous paracetamol (acetaminophen) recently gained attention, appearing effective as traditional nonsteroidal anti-inflammatory drugs (NSAIDs) in PDA closure, with lower toxicity. The results of the studies analyzed in this review mostly support paracetamol efficacy in ductal closure, with inconstant low and transient elevation of liver enzymes as reported side effect. However, more studies are needed to confirm if this therapy shows a real safety profile and to evaluate its long-term outcomes, before considering paracetamol as first-choice drug in PDA treatment. PMID:28828381

Using mixed treatment comparisons and meta-regression to perform indirect comparisons to estimate the efficacy of biologic treatments in rheumatoid arthritis.

PubMed

Nixon, R M; Bansback, N; Brennan, A

2007-03-15

Mixed treatment comparison (MTC) is a generalization of meta-analysis. Instead of the same treatment for a disease being tested in a number of studies, a number of different interventions are considered. Meta-regression is also a generalization of meta-analysis where an attempt is made to explain the heterogeneity between the treatment effects in the studies by regressing on study-level covariables. Our focus is where there are several different treatments considered in a number of randomized controlled trials in a specific disease, the same treatment can be applied in several arms within a study, and where differences in efficacy can be explained by differences in the study settings. We develop methods for simultaneously comparing several treatments and adjusting for study-level covariables by combining ideas from MTC and meta-regression. We use a case study from rheumatoid arthritis. We identified relevant trials of biologic verses standard therapy or placebo and extracted the doses, comparators and patient baseline characteristics. Efficacy is measured using the log odds ratio of achieving six-month ACR50 responder status. A random-effects meta-regression model is fitted which adjusts the log odds ratio for study-level prognostic factors. A different random-effect distribution on the log odds ratios is allowed for each different treatment. The odds ratio is found as a function of the prognostic factors for each treatment. The apparent differences in the randomized trials between tumour necrosis factor alpha (TNF- alpha) antagonists are explained by differences in prognostic factors and the analysis suggests that these drugs as a class are not different from each other. Copyright (c) 2006 John Wiley & Sons, Ltd.

Therapeutic Drug Monitoring of Lacosamide in Norway: Focus on Pharmacokinetic Variability, Efficacy and Tolerability.

PubMed

Svendsen, Torleiv; Brodtkorb, Eylert; Baftiu, Arton; Burns, Margrete Larsen; Johannessen, Svein I; Johannessen Landmark, Cecilie

2017-07-01

Lacosamide (LCM) is a new antiepileptic drug (AED). Experience from therapeutic drug monitoring (TDM) in clinical practice is limited. The purpose of this study is to evaluate the pharmacokinetic variability of LCM in relation to efficacy and tolerability in patients with refractory epilepsy in a real-life setting. Variables included age, gender, daily doses and serum concentrations of LCM and other AEDs from the TDM-database at the National Center for Epilepsy in Norway. Clinical data regarding efficacy and tolerability were collected from medical records. The Norwegian Prescription Database (NorPD) was used to include population-based numbers of users. TDM-data from 344 patients were included. The median dose, serum concentration, and concentration/dose (C/D)-ratio of LCM was 350 (range 25-700) mg/day, 19.7 (range 8.1-56.2) µmol/L, and 0.06 (0.02-0.82) µmol/L/mg, respectively. Serum concentrations were reduced by 28% by concomitant use of enzyme inducers and increased by 30% in patients aged >65 years. Efficacy and tolerability were assessed in 227 patients: 29% had >50% seizure reduction (eight seizure free), 30% had no effect, and 44% reported adverse effects. In Norway, there were on average 500 patients per year using LCM in this period based on NorPD. The study demonstrated pharmacokinetic variability and use of TDM of LCM in Norway. Data were collected from multiple sources for improved pharmacovigilance. Serum concentrations were influenced by enzyme inducers and ageing, indicating the usefulness of TDM. Effect and tolerability were favorable within a suggested reference range of 10-40 µmol/L given drug-fasting conditions.

Safety and efficacy of dual-wavelength laser (1064 + 595 nm) for treatment of non-treated port-wine stains.

PubMed

Wang, T; Chen, D; Yang, J; Ma, G; Yu, W; Lin, X

2018-02-01

Patients with port-wine stain (PWS) suffer physically and psychologically because of the high incidence (0.3%-0.5%) of the disease. Pulsed-dye laser (PDL) at 595 nm is the gold standard of the treatment for PWS. Nevertheless, clinicians intend to determine whether the dual-wavelength laser (DWL; 595-nm PDL + 1064-nm Nd:YAG) is an adequate choice in the treatment of non-treated PWS. This study is the first prospective within-patient controlled research seeking to investigate the safety and efficacy of DWL for the treatment of non-treated PWS. A total of 61 patients with non-treated flat facial PWS, who were treated using the Cynergy laser system in our clinic, were included in this study. Each PWS lesion was divided into two adjacent test treatment sites of similar size and colour. The two sites were randomly assigned to PDL or DWL treatment in a blinded manner of participants. In each case, two sets of treatment parameters were used: (i) 595-nm PDL and (ii) 595-nm PDL + 1064-nm Nd:YAG. Both had a 10 mm spot size, an epidermal cooling system and 1-s interpulse interval between two pulses. Clinical efficacy and safety outcomes were evaluated by visual assessment 2 months after treatment. Comparison by visual evaluation suggests that the responses of non-treated PWS to treatment by PDL and DWL were not significantly different. Moreover, three patients developed scarring after DWL treatment. Compared with PDL, DWL exhibits a higher risk of potential scarring and has no advantage in efficacy of treating non-treated PWS. © 2017 European Academy of Dermatology and Venereology.

EMP-induced BBB-disruption enhances drug delivery to glioma and increases treatment efficacy in rats.

PubMed

Li, Kangchu; Zhang, Keying; Xu, Shenglong; Wang, Xiaowu; Zhou, Yongchun; Zhou, Yan; Gao, Peng; Lin, Jiajin; Ding, Guirong; Guo, Guozhen

2018-01-01

Chemotherapy on gliomas is not satisfactorily efficient because the presence of blood-brain barriers (BBB) leads to inadequate exposure of tumor cells to administered drugs. In order to facilitate chemotherapeutics to penetrate BBB and increase the treatment efficacy of gliomas, electromagnetic pulse (EMP) was applied and the 1-(2-Chlorethyl)-cyclohexyl-nitrosourea (CCNU) lomustine concentration in tumor tissue, tumor size, tumor apoptosis, and side effects were measured in glioma-bearing rat model. The results showed that EMP exposure could enhance the delivery of CCNU to tumor tissue, facilitate tumor apoptosis, and inhibit tumor growth without obvious side effects. The data indicated that EMP-induced BBB disruption could enhance delivery of CCNU to glioblastoma multiforme and increase treatment efficacy in glioma-bearing rats. Bioelectromagnetics. 39:60-67, 2018. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

[Pharmacokinetic alterations in pregnancy and use of therapeutic drug monitoring].

PubMed

Panchaud, Alice; Weisskopf, Etienne; Winterfeld, Ursula; Baud, David; Guidi, Monia; Eap, Chin B; Csajka, Chantal; Widmer, Nicolas

2014-01-01

Following the thalidomide tragedy, pharmacological research in pregnant women focused primarily on drug safety for the unborn child and remains only limited regarding the efficacy and safety of treatment for the mother. Significant physiological changes during pregnancy may yet affect the pharmacokinetics of drugs and thus compromise its efficacy and/or safety. Therapeutic drug monitoring (TDM) would maximize the potential effectiveness of treatments, while minimizing the potential risk of toxicity for the mother and the fetus. At present, because of the lack of concentration-response relationship studies in pregnant women, TDM can rely only on individual assessment (based on an effective concentration before pregnancy) and remains reserved only to unexpected situations such as signs of toxicity or unexplained inefficiency. © 2014 Société Française de Pharmacologie et de Thérapeutique.

Efficacy and cost of micronutrient treatment of childhood psychosis

PubMed Central

Rodway, Megan; Vance, Annette; Watters, Amany; Lee, Helen; Bos, Elske; Kaplan, Bonnie J

2012-01-01

Psychosis is difficult to treat effectively with conventional pharmaceuticals, many of which have adverse long-term health consequences. In contrast, there are promising reports from several research groups of micronutrient treatment (vitamins, minerals, amino acids and essential fatty acids) of mood, anxiety and psychosis symptoms using a complex formula that appears to be safe and tolerable. We review previous studies using this formula to treat mental symptoms, and present an 11-year-old boy with a 3-year history of mental illness whose parents chose to transition him from medication to micronutrients. Symptom severity was monitored in three clusters: anxiety, obsessive compulsive disorder and psychosis. Complete remission of psychosis occurred, and severity of anxiety and obsessional symptoms decreased significantly (p<0.001); the improvements are sustained at 4-year follow-up. A cost comparison revealed that micronutrient treatment was <1% of his inpatient mental healthcare. Additional research on broad-spectrum micronutrient treatment is warranted. PMID:23144350

Efficacy of topical latanoprost versus minoxidil and betamethasone valerate on the treatment of alopecia areata.

PubMed

El-Ashmawy, Amal Ahmad; El-Maadawy, Iman Hamed; El-Maghraby, Gamal Mohamed

2018-02-01

Alopecia areata (AA) is one of the most common causes of localized hair loss. There is no universally proven therapy that induces and sustains remission of hair growth in AA. To compare the efficacy and safety of topical latanoprost, minoxidil and betamethasone valerate on hair growth in patients with AA. Hundred patients with AA classified into five groups of 20 treated with: Group I, latanoprost 0.1% lotion; Group II, minoxidil 5% lotion; Group III, betamethasone valerate 0.1% solution; Group IV, combination of latanoprost lotion and betamethasone valerate solution and Group V, a vehicle lotion control group. There was a statistically significant improvement in all therapeutic groups when compared with control group and reduction of severity of alopecia tool score of scalp and beard before and after treatment for all therapeutic groups. Latanoprost, minoxidil and betamethasone valerate are effective and safe in the treatment of patchy AA. The use of latanoprost added to the therapeutic efficacy of topical betamethasone valerate in the treatment of AA and could be an effective adjunctive topical therapy for AA.

Necrosis avid near infrared fluorescent cyanines for imaging cell death and their use to monitor therapeutic efficacy in mouse tumor models

PubMed Central

Xie, Bangwen; Stammes, Marieke A.; van Driel, Pieter B.A.A.; Cruz, Luis J.; Knol-Blankevoort, Vicky T.; Löwik, Martijn A.M.; Mezzanotte, Laura; Que, Ivo; Chan, Alan; van den Wijngaard, Jeroen P.H.M.; Siebes, Maria; Gottschalk, Sven; Razansky, Daniel; Ntziachristos, Vasilis; Keereweer, Stijn; Horobin, Richard W.; Hoehn, Mathias; Kaijzel, Eric L.; van Beek, Ermond R.; Snoeks, Thomas J.A.; Löwik, Clemens W.G.M.

2015-01-01

Quantification of tumor necrosis in cancer patients is of diagnostic value as the amount of necrosis is correlated with disease prognosis and it could also be used to predict early efficacy of anti-cancer treatments. In the present study, we identified two near infrared fluorescent (NIRF) carboxylated cyanines, HQ5 and IRDye 800CW (800CW), which possess strong necrosis avidity. In vitro studies showed that both dyes selectively bind to cytoplasmic proteins of dead cells that have lost membrane integrity. Affinity for cytoplasmic proteins was confirmed using quantitative structure activity relations modeling. In vivo results, using NIRF and optoacoustic imaging, confirmed the necrosis avid properties of HQ5 and 800CW in a mouse 4T1 breast cancer tumor model of spontaneous necrosis. Finally, in a mouse EL4 lymphoma tumor model, already 24 h post chemotherapy, a significant increase in 800CW fluorescence intensity was observed in treated compared to untreated tumors. In conclusion, we show, for the first time, that the NIRF carboxylated cyanines HQ5 and 800CW possess strong necrosis avid properties in vitro and in vivo. When translated to the clinic, these dyes may be used for diagnostic or prognostic purposes and for monitoring in vivo tumor response early after the start of treatment. PMID:26472022

Internet-Delivered Psychological Treatments for Mood and Anxiety Disorders: A Systematic Review of Their Efficacy, Safety, and Cost-Effectiveness

PubMed Central

Arnberg, Filip K.; Linton, Steven J.; Hultcrantz, Monica; Heintz, Emelie; Jonsson, Ulf

2014-01-01

Background Greater access to evidence-based psychological treatments is needed. This review aimed to evaluate whether internet-delivered psychological treatments for mood and anxiety disorders are efficacious, noninferior to established treatments, safe, and cost-effective for children, adolescents and adults. Methods We searched the literature for studies published until March 2013. Randomized controlled trials (RCTs) were considered for the assessment of short-term efficacy and safety and were pooled in meta-analyses. Other designs were also considered for long-term effect and cost-effectiveness. Comparisons against established treatments were evaluated for noninferiority. Two reviewers independently assessed the relevant studies for risk of bias. The quality of the evidence was graded using an international grading system. Results A total of 52 relevant RCTs were identified whereof 12 were excluded due to high risk of bias. Five cost-effectiveness studies were identified and three were excluded due to high risk of bias. The included trials mainly evaluated internet-delivered cognitive behavioral therapy (I-CBT) against a waiting list in adult volunteers and 88% were conducted in Sweden or Australia. One trial involved children. For adults, the quality of evidence was graded as moderate for the short-term efficacy of I-CBT vs. waiting list for mild/moderate depression (d = 0.83; 95% CI 0.59, 1.07) and social phobia (d = 0.85; 95% CI 0.66, 1.05), and moderate for no efficacy of internet-delivered attention bias modification vs. sham treatment for social phobia (d = −0.04; 95% CI −0.24, 0.35). The quality of evidence was graded as low/very low for other disorders, interventions, children/adolescents, noninferiority, adverse events, and cost-effectiveness. Conclusions I-CBT is a viable treatment option for adults with depression and some anxiety disorders who request this treatment modality. Important questions remain before broad implementation can

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

PubMed

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

2016-02-01

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

Parenting Efficacy and Support in Mothers With Dual Disorders in a Substance Abuse Treatment Program.

PubMed

Brown, Suzanne; Hicks, Laurel M; Tracy, Elizabeth M

2016-01-01

Approximately 73% of women entering treatment for substance use disorders are mothers of children younger than 18, and the high rate of mental health disorders among mothers with substance use disorders increases their vulnerability to poor parenting practices. Parenting efficacy and social support for parenting have emerged as significant predictors of positive parenting practices among families at risk for child maltreatment. The purpose of the current study was to examine the impact of parenting support and parenting efficacy on the likelihood of out-of-home placement and custody status among the children of mothers with dual substance use and mental health disorders. This study examined the impact of parenting efficacy and assistance with childcare on the likelihood of child out-of-home placement and custody status among 175 mothers with diagnosed dual substance and mental health disorder and in treatment for substance dependence. Logistic regression was utilized to assess the contributions of parenting efficacy and the number of individuals in mothers' social networks who assist with childcare to the likelihood of out-of-home placement and custody loss of children. Parenting efficacy was also examined as a mediator using bootstrapping in PROCESS for SPSS. Greater parenting efficacy was associated with lower likelihood of having at least one child in out-of-home placement (B = -.064, SE = .029, p = .027) and lower likelihood of loss of child custody (B = -.094, SE = .034, p = .006). Greater number of children in the 6 to 18 age range predicted greater likelihood of having at least one child in the custody of someone else (B = .409, SE = .171, p = .017) and in out-of-home placement (B = .651, SE = .167, p < .001). In addition, mothers who identified as African American were less likely to have a child in out-of-home placement (B = .927, SE = .382, p = .015) or to have lost custody of a child (B = -1.31, SE = .456, p = .004). Finally, parenting efficacy mediated

Parenting Efficacy and Support in Mothers with Dual Disorders in a Substance Abuse Treatment Program

PubMed Central

Brown, Suzanne; Hicks, Laurel M.; Tracy, Elizabeth M.

2016-01-01

Objective Approximately 73% of women entering treatment for substance use disorders are mothers of children under the age of 18 (SAMHSA, 2009), and the high rate of mental health disorders among mothers with substance use disorders increases their vulnerability to poor parenting practices. Parenting efficacy and social support for parenting have emerged as significant predictors of positive parenting practices among families at risk for child maltreatment. The purpose of the current study was to examine the impact of parenting support and parenting efficacy on the likelihood of out-of-home placement and custody status among the children of mothers with dual substance use and mental health disorders. Methods This study examined the impact of parenting efficacy, and assistance with child-care on the likelihood of child out-of-home placement and custody status among 175 mothers diagnosed with a dual substance and mental health disorder and in treatment for substance dependence. Logistic regression was utilized to assess the contributions of parenting efficacy, and the number of individuals in mothers’ social networks who assist with child-care, to the likelihood of out-of-home placement and custody loss of children. Parenting efficacy was also examined as a mediator using bootstrapping in PROCESS for SPSS. Results Greater parenting efficacy was associated with lower likelihood of having at least one child in out-of-home placement (B = −.064, SE =.029, p = .027), and lower likelihood of loss of child custody (B = −.094, SE =.034, p = .006). Greater number of children in the 6–18 age range predicted greater likelihood of having at least one child in the custody of someone else (B = .409, SE = .171, p = .017) and in out-of-home placement (B = .651, SE = .167, p < .001). Additionally, mothers who identified as African-American were less likely to have a child in out-of-home placement (B = .927, SE = .382, p = .015) or to have lost custody of a child (B = −1

Antiangiogenic treatment in hepatocellular carcinoma: the balance of efficacy and safety

PubMed Central

Welker, Martin-Walter; Trojan, Joerg

2013-01-01

Hepatocellular carcinoma (HCC) is a severe complication of advanced liver disease with a worldwide incidence of more than 600,000 patients per year. Liver function, clinical performance status, and tumor size are considered in the Barcelona Clinic Liver Cancer (BCLC) system. While curative treatment options are available for early stages, most patients present with intermediate- or advanced-stage HCC, burdened with a poor prognosis, substantially influenced by the degree of liver-function impairment. Hypervascularization is a major characteristic of HCC, and antiangiogenic treatments are the basis of treatment in noncurative stages, including interventional and pharmacological treatments. Currently, the tyrosine-kinase inhibitor sorafenib is still the only approved drug for HCC. Further improvements in survival in patients with intermediate- and advanced-stage HCC may be anticipated by both multimodal approaches, such as combination of interventional and systemic treatments, and new systemic treatment options. Until now, the Phase III development of other tyrosine-kinase inhibitors in patients with advanced HCC has failed due to minor efficacy and/or increased toxicity compared to sorafenib. However, promising Phase II data have been reported with MET inhibitors in this hard-to-treat population. This review gives a critical overview of antiangiogenic drugs and strategies in intermediate- and advanced-stage HCC, with a special focus on safety. PMID:24204170

Imaging agents for monitoring changes of dopamine receptors and methods of using thereof

DOEpatents

Mukherjee, Jogeshwar; Chandy, George; Milne, Norah; Wang, Ping H.; Easwaramoorthy, Balu; Mantil, Joseph; Garcia, Adriana

2017-05-30

The present invention is related generally to a method for screening subjects to determine those subjects more likely to develop diabetes by quantization of insulin producing cells. The present invention is also related to the diagnosis of diabetes and related to monitor disease progression or treatment efficacy of candidate drugs.

Salivary uric acid as a noninvasive biomarker for monitoring the efficacy of urate-lowering therapy in a patient with chronic gouty arthropathy.

PubMed

Zhao, Jianxing; Huang, Ying

2015-10-23

Monitoring blood uric acid (UA) is important in all patients on urate-lowering therapy so that the selection of the effective drugs and dosage adjustments could be made until the target level is reached. The issue is that frequent needle jabs are unacceptable. Reported mean levels of salivary UA were 185-240 μmol/l in healthy adults. A linear correlation was demonstrated between UA concentrations in saliva and plasma. We monitored salivary UA instead of plasmatic UA in a patient with gout. Allopurinol and benzbromarone were used as the therapeutic drugs. Salivary UA; urinary UA and creatinine; and plasmatic UA, creatinine, kynurenine and tryptophan were measured by HPLC. Salivary UA indicated the efficacy of therapy accurately and conveniently. After eight weeks therapy, the weekly mean levels of salivary UA were reduced and maintained to <300 μmol/l, which was equivalent to <360 μmol/l of plasmatic UA according to the salivary UA/plasmatic UA ratio of this patient. Measurement of salivary UA is a noninvasive and useful way for monitoring the status of hyperuricemia and the therapeutic efficacy of urate-lowering therapy. It has value for the management of hyperuricemia and gout. Copyright © 2015 Elsevier B.V. All rights reserved.

[Efficacy of entropy index in monitoring nociceptive stimulus in patients undergoing propofol-remifentanil general anesthesia].

PubMed

Xue, Zhao-jing; Quan, Xiang; Zhao, Jing; Huang, Yu-guang

2014-02-01

To evaluate the efficacy of reflex entropy (RE)/state entropy (SE) in monitoring the response to nociceptive stimulus during propofol-remifentanil infusion. After the approval of the hospital ethics committee, sixty American Society of Anesthesiologists (ASA) classification 1-2 patients, aged 18-65 years, receiving the hypogastrium operation undergoing general anesthesia, were randomly allocated to groups A and B with different remifentanil concentrations. After the concentration of propofol and remifentanil reached balance, tetanic stimulation, intubation, and incision were performed respectively with certain intervals. RE and SE were monitored during this procedure. Twelve patients were withdrawn from this study due to the use of vasoactive drugs. Finally, there were 28 cases in group A and 20 cases in group B. The RE and SE were not significantly changed before and after the tetanic stimulation in both groups (all P>0.05). Both RE and SE were significantly increased after intubation in group B (both P<0.05) and after skin incision in both groups (all P<0.05). Under the same stimulation, RE and SE showed no significant difference among groups administered with different levels of remifentanil (P>0.05). Under the anesthesia with propofol+remifentanil, nociceptive response may cause the increase of RE and SE. Therefore, RE and SE may be useful parameters for monitoring the nociceptive response during general anaesthesia.

Neratinib shows efficacy in the treatment of HER2 amplified carcinosarcoma in vitro and in vivo

PubMed Central

Schwab, Carlton L.; English, Diana P.; Black, Jonathan; Bellone, Stefania; Lopez, Salvatore; Cocco, Emiliano; Bonazzoli, Elena; Bussi, Beatrice; Predolini, Federica; Ferrari, Francesca; Ratner, Elena; Silasi, Dan-Arin; Azodi, Masoud; Rutherford, Thomas; Schwartz, Peter E.; Santin, Alessandro D.

2015-01-01

Objective Carcinosarcoma is a deadly gynecologic malignancy with few effective treatment options. The study of new therapies is difficult because of its rarity. The objective of this study was to determine the efficacy of neratinib in the treatment of HER2 amplified carcinosarcoma. Methods The efficacy of neratinib in the treatment of HER2 amplified carcinosarcoma was determined in vitro using seven primary carcinosarcoma cell lines with differential expression of HER2/neu. Data regarding IC50, cell cycle distribution, and cell signaling changes were assessed by flow cytometry. The efficacy of neratinib was determined in treating mice harboring HER2 amplified carcinosarcoma xenografts. Results Two of seven (28.5%) carcinosarcoma cell lines were HER2/neu amplified. HER2/neu amplified cell lines SARARK6 and SARARK9 were significantly more sensitive to neratinib than the five non-HER2/neu amplified carcinosarcoma cell lines (mean±SEM IC50: 0.014μM±0.004 vs. 0.164μM±0.019 p=0.0003). Neratinib treatment caused a significant build up in G0/G1 phase of the cell cycle, arrest auto phosphorylation of HER2/neu and activation of S6. Neratinib inhibited tumor growth (p=0.012) and prolonged survival in mice harboring HER2 amplified carcinosarcoma xenografts (p=0.0039). Conclusions Neratinib inhibits HER2 amplified carcinosarcoma proliferation, signaling, cell cycle progression and tumor growth in vitro. Neratinib inhibits HER2/neu amplified xenograft growth and improves overall survival. Clinical trials are warranted. PMID:26260909

Neratinib shows efficacy in the treatment of HER2 amplified carcinosarcoma in vitro and in vivo.

PubMed

Schwab, Carlton L; English, Diana P; Black, Jonathan; Bellone, Stefania; Lopez, Salvatore; Cocco, Emiliano; Bonazzoli, Elena; Bussi, Beatrice; Predolini, Federica; Ferrari, Francesca; Ratner, Elena; Silasi, Dan-Arin; Azodi, Masoud; Rutherford, Thomas; Schwartz, Peter E; Santin, Alessandro D

2015-10-01

Carcinosarcoma is a deadly gynecologic malignancy with few effective treatment options. The study of new therapies is difficult because of its rarity. The objective of this study was to determine the efficacy of neratinib in the treatment of HER2 amplified carcinosarcoma. The efficacy of neratinib in the treatment of HER2 amplified carcinosarcoma was determined in vitro using seven primary carcinosarcoma cell lines with differential expression of HER2/neu. Data regarding IC50, cell cycle distribution, and cell signaling changes were assessed by flow cytometry. The efficacy of neratinib was determined in treating mice harboring HER2 amplified carcinosarcoma xenografts. Two of seven (28.5%) carcinosarcoma cell lines were HER2/neu amplified. HER2/neu amplified cell lines SARARK6 and SARARK9 were significantly more sensitive to neratinib than the five non-HER2/neu amplified carcinosarcoma cell lines (mean±SEM IC50:0.014μM±0.004vs.0.164μM±0.019 p=0.0003). Neratinib treatment caused a significant build up in G0/G1 phase of the cell cycle, arrest auto phosphorylation of HER2/neu and activation of S6. Neratinib inhibited tumor growth (p=0.012) and prolonged survival in mice harboring HER2 amplified carcinosarcoma xenografts (p=0.0039). Neratinib inhibits HER2 amplified carcinosarcoma proliferation, signaling, cell cycle progression and tumor growth in vitro. Neratinib inhibits HER2/neu amplified xenograft growth and improves overall survival. Clinical trials are warranted. Copyright © 2015 Elsevier Inc. All rights reserved.

Potential Efficacy of Citicoline as Adjunct Therapy in Treatment of Cerebral Malaria

PubMed Central

El-Assaad, Fatima; Combes, Valery; Grau, Georges Emile Raymond

2014-01-01

Cerebral malaria (CM) is characterized by a dysregulated immune response that results in endothelial membrane destabilization and increased microparticle (MP) production. Citicoline (CTC) is a membrane stabilizer used for the treatment of neurological disorders. We evaluated the efficacy of CTC as adjunct therapy to aid recovery from experimental CM. We show that CTC reduces MP production in vitro; in combination with artesunate in vivo, confers partial protection against CM; and prolongs survival. PMID:24165175

The role of the Data and Safety Monitoring Board in a clinical trial: The CRISIS Study

PubMed Central

Holubkov, Richard; Casper, T. Charles; Dean, J. Michael; Anand, K. J. S.; Zimmerman, Jerry; Meert, Kathleen L.; Newth, Christopher J. L.; Berger, John; Harrison, Rick; Willson, Douglas F.; Nicholson, Carol

2012-01-01

Objective Randomized clinical trials are commonly overseen by a data and safety monitoring board (DSMB) comprised of experts in medicine, ethics, and biostatistics. DSMB responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. DSMB decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate DSMB oversight into the design, monitoring, and reporting of randomized trials. Design Case study, narrative review. Methods The DSMB’s role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. Findings The NIH-appointed CRISIS DSMB was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested DSMB interim review before opening CRISIS to children below one year of age. The first interim analysis found higher 28-day mortality in one treatment arm. The DSMB maintained trial closure to younger children, and requested a second interim data review six months later. At this second meeting, mortality was no longer of concern, while a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the DSMB elected to examine conditional power, and unmask treatment arm identities. Upon finding somewhat greater efficacy in the placebo arm, the DSMB recommended stopping CRISIS due to futility. Conclusions The design and operating procedures of a multicenter randomized trial must consider a pivotal DSMB role. Maximum study design flexibility must be allowed, and investigators must be prepared for protocol modifications due to interim findings. The DSMB must have sufficient clinical and statistical expertise to assess potential importance of interim

Efficacy of a brief treatment for nightmares and sleep disturbances for veterans.

PubMed

Balliett, Noelle E; Davis, Joanne L; Miller, Katherine E

2015-11-01

Nightmares and sleep disturbances are common complaints among military Veterans (Plumb & Zelman, 2009) and may be difficult to eradicate (Forbes, Phelps, & McHugh, 2001). A treatment protocol (Exposure, Relaxation, and Rescription Therapy [ERRT]) targeting nightmares and sleep disturbances, which has been used effectively in civilian populations, was adapted for the military (ERRT-M). A pilot study evaluated the efficacy of ERRT-M in improving sleep quality and quantity and reducing nightmares, symptoms of posttraumatic stress disorder, and depression in a trauma-exposed, Veteran sample (N = 19). At 1 week after treatment, analyses revealed improvements in nightmare frequency and severity, depression, sleep quality, and insomnia severity. Treatment gains were maintained at a 2-month follow-up. Fifty percent of the sample was considered treatment responders (i.e., no nightmares in the previous week). Results of this pilot study suggest that directly targeting sleep and nightmares is successful in alleviating sleep disturbances and related psychopathology in some Veterans. (c) 2015 APA, all rights reserved).

Enhancing the Therapeutic Efficacy of Cancer Treatment With Cannabinoids

PubMed Central

Yasmin-Karim, Sayeda; Moreau, Michele; Mueller, Romy; Sinha, Neeharika; Dabney, Raymond; Herman, Allen; Ngwa, Wilfred

2018-01-01

Over the years, many in vitro and in vivo studies have shown the antineoplastic effects of cannabinoids (CBDs), with reports advocating for investigations of combination therapy approaches that could better leverage these effects in clinical translation. This study explores the potential of combination approaches employing CBDs with radiotherapy (RT) or smart biomaterials toward enhancing therapeutic efficacy during treatment of pancreatic and lung cancers. In in vitro studies, clonogenic assay results showed greater effective tumor cell killing, when combining CBDs and RT. Meanwhile, in vivo study results revealed major increase in survival when employing smart biomaterials for sustained delivery of CBDs to tumor cells. The significance of these findings, considerations for further research, and viable roadmap to clinical translation are discussed. PMID:29740535

Advanced Mucinous Colorectal Cancer: Epidemiology, Prognosis and Efficacy of Chemotherapeutic Treatment.

PubMed

Ott, Claudia; Gerken, Michael; Hirsch, Daniela; Fest, Petra; Fichtner-Feigl, Stefan; Munker, Stefan; Schnoy, Elisabeth; Stroszczynski, Christian; Vogelhuber, Martin; Herr, Wolfgang; Evert, Matthias; Reng, Michael; Schlitt, Hans Jürgen; Klinkhammer-Schalke, Monika; Teufel, Andreas

2018-06-05

The clinicopathological significance of the mucinous subtype of colorectal cancer (CRC) remains controversial. As of today, none of the current guidelines differentiate treatment with respect to mucinous or nonmucinous cancer. Due to the lack of substantiated data, best treatment remains unclear and the mucinous subtype of CRC is usually treated along the lines of recommendations for adenocarcinoma of the colon. We investigated an East-Bavarian cohort of 8,758 patients with CRC. These included 613 (7.0%) patients with a mucinous subtype, who were analyzed for assessing their characteristics in clinical course and for evaluating the efficacy of common chemotherapy protocols. Mucinous CRC was predominantly located in the right hemicolon; it was diagnosed at more advanced stages and occurred with preponderance in women. A higher rate of G3/4 grading was observed at diagnosis (all p < 0.001). An association of mucinous CRC with younger age at initial diagnosis, previously reported by other groups, could not be confirmed. Patients with mucinous stage IV colon cancer demonstrated poorer survival (p = 0.006). In contrast, no differences in survival were observed for specific stages I-III colon cancer. Stage-dependent analysis of rectal cancer stages I-IV also showed no differences in survival. However, univariable overall analysis resulted in significant poorer survival of mucinous compared to nonmucinous rectal cancer (p = 0.029). Also, combined analysis of all patients with mucinous CRC revealed poorer overall survival (OS) of these patients compared to nonmucinous CRC patients (median 48.4 vs. 60.2 months, p = 0.049) but not in multivariable analysis (p = 0.089). Chemotherapeutic treatment showed comparable efficacy regarding OS for mucinous and nonmucinous cancers in both an adjuvant and palliative setting for colon cancer patients (p values comparing mucinous and nonmucinous cancers < 0.001-0.005). © 2018 S. Karger AG, Basel.

Residue age and tree attractiveness influence efficacy of insecticide treatments against ambrosia beetles (Coleoptera: Curculionidae)

USDA-ARS?s Scientific Manuscript database

Management of ambrosia beetles in ornamental nurseries relies, in part, on treatments of insecticides to prevent beetles from boring into trees emitting stress-induced ethanol. However, data on residual efficacy of commonly used pyrethroid insecticides is warranted to gauge the duration that trees ...

Clinical efficacy and safety of mesenchymal stem cell transplantation for osteoarthritis treatment: A meta-analysis

PubMed Central

Li, Li; Tao, Sun; Bo, Lin; Lin, Chen

2017-01-01

Purpose The aim of this study was to evaluate the therapeutic efficacy and safety of mesenchymal stem cells (MSCs) for the treatment of patients with knee osteoarthritis (OA). Materials We performed a meta-analysis of relevant published clinical studies. An electronic search was conducted for randomized controlled trials (RCTs) of MSC-based therapy in knee OA. The visual analogue scale (VAS), International Knee Documentation Committee (IKDC) form, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne algofunctional indices (Lequesne), Lysholm knee scale (Lysholm), Tegner activity scale (Tegner) and adverse events (AEs) were evaluated. Results Eleven eligible trials with 582 knee OA patients were included in the present meta-analysis. We demonstrated that MSC treatment could significantly decrease VAS and increase IKDC scoresafter a 24-month follow-up compared with controls (P<0.05). MSC therapy also showed significant decreases in WOMAC and Lequesne scores after the 12-month follow-up (P<0.01). Analysis of Lysholm (24-month) and Tegner (12- and 24-month) scores also demonstrated favorable results for MSC treatment (P<0.05). Conclusion Overall, MSC transplantation treatment was shown to be safe and has great potential as an efficacious clinical therapy for patients with knee OA. PMID:28448518

Monitoring the lesion formation during histotripsy treatment using shear wave imaging

NASA Astrophysics Data System (ADS)

Arnal, Bastien; Lee, Wei-Ning; Pernot, Mathieu; Fink, Mathias; Tanter, Mickael

2012-11-01

Monitoring the lesion formation induced by histotripsy has mainly relied on the quantitative change in backscatter intensity using ultrasound B-mode imaging. However, how the mechanical properties of the histotripsy-treated tissue region alter during the procedure is yet to be fully investigated. We thus proposed here to monitor such a therapeutic process based on shear modulus estimated by shear wave imaging (SWI). In the therapeutic procedure, a single-element piezo-composite focused transducer (Imasonic, Besançon, France) with a center frequency of 660 kHz, a focal length of 45 mm, and an fnumber of 1 was driven by a function generator (AFG 3101, Tektronix, Beaverton, OR) and a gated RF power amplifier (GA-2500A, RITEC Inc., USA) to generate ultrasound histotripsy pulses. Histotripsy pulses were delivered for 20 seconds and then followed by a 30-second pause and a rapid monitoring step. Such a treatment and monitoring scheme was repeated for 10 mins. Both the reference measurement and monitoring were realized by SWI, where plane shear waves were generated by an 8 MHz linear array probe connected to a prototype ultrasound scanner, and acquired at a frame rate of 10000 Hz. Shear modulus was estimated and mapped in 2D through a time-of-flight algorithm. Gelatin (8%)-agar (2%) phantoms and ex-vivo porcine liver samples were tested. Regions of interests (ROI's) of 2 mm-by-2 mm in both untreated and treated regions were selected to compute the contrast-to-noise ratio (CNR). In all three scenarios where different PD's and PRF's were implemented, during the first 100 seconds of the treatment, 50% decrease in the shear modulus within the histotripsy-targeted zone was already observed, and the CNR of the shear modulus increased by 18 dB. In contrast, the backscatter intensity began to reduce and the corresponding CNR was found to increase by 6 dB only after 120 seconds of treatment. The results demonstrated that SWI can map quantitatively the change of mechanical

Treatment of obsessive morbid jealousy with cognitive analytic therapy: An adjudicated hermeneutic single-case efficacy design evaluation.

PubMed

Curling, Louise; Kellett, Stephen; Totterdell, Peter; Parry, Glenys; Hardy, Gillian; Berry, Katherine

2018-03-01

The evidence base for the treatment of morbid jealousy with integrative therapies is thin. This study explored the efficacy of cognitive analytic therapy (CAT). An adjudicated hermeneutic single-case efficacy design evaluated the cognitive analytic treatment of a patient meeting diagnostic criteria for obsessive morbid jealousy. A rich case record was developed using a matrix of nomothetic and ideographic quantitative and qualitative outcomes. This record was then debated by sceptic and affirmative research teams. Experienced psychotherapy researchers acted as judges, assessed the original case record, and heard the affirmative-versus-sceptic debate. Judges pronounced an opinion regarding the efficacy of the therapy. The efficacy of CAT was supported by all three judges. Each ruled that change had occurred due to the action of the therapy, beyond any level of reasonable doubt. This research demonstrates the potential usefulness of CAT in treating morbid jealousy and suggests that CAT is conceptually well suited. Suggestions for future clinical and research directions are provided. The relational approach of CAT makes it a suitable therapy for morbid jealousy. The narrative reformulation component of CAT appears to facilitate early change in chronic jealousy patterns. It is helpful for therapists during sessions to use CAT theory to diagrammatically spell out the patterns maintaining jealousy. © 2017 The British Psychological Society.

Efficacy, end points and eventualities: sumatriptan/naproxen versus butalbital/paracetamol/caffeine in the treatment of migraine.

PubMed

Fox, Anthony W

2012-09-01

Migraine is a widespread, relapsing, remittent syndrome. No animal model predicts whether test medications will be clinically useful. Using a modern, well-controlled, sophisticated study design, Derosier et al. demonstrates not only that a butalbital formulation has modest efficacy as an acute treatment for migraine but also that a sumatriptan-naproxen combination is superior. These conclusions are reached using a variety of internally consistent secondary efficacy end points. The primary end point chosen (highly conservative and fashionable in some academic circles) was a technical failure (and not a negative experimental finding). Migraine is intrinsically pleiomorphic: diverse treatment options help match patient with therapy. This study does not justify blanket bans on (admittedly hazardous) barbiturate therapies, and regulators should not impose end point conservatism to an extent that will stifle further progress.

The efficacy of radiofrequency ablation in the treatment of pediatric arrhythmia and its effects on serum IL-6 and hs-CRP

PubMed Central

Li, Chunli; Jia, Libo; Wang, Zhenzhou; Niu, Ling; An, Xinjiang

2017-01-01

The aim of this study was to investigate the efficacy of radiofrequency ablation in the treatment of pediatric arrhythmia and to assess the changes in serum interleukin-6 (IL-6) and hs-CRP levels after treatment. Hundred and six children with tachyarrhythmia who were admitted to Xuzhou Children's Hospital from November, 2014 to December, 2015 were recruited for study. The efficacies of radiofrequency in the treatment of different types of arrhythmia were analyzed. Successful ablation was found in 104 cases (98.11%) and recurrence was found in 7 cases (6.73%). Among 62 cases of atrioventricular reentrant tachycardia (AVRT), successful ablation was found in 60 cases (96.77%) and recurrence was found in 3 cases (4.84%). Among 33 cases of atrioventricular nodal reentrant tachycardia (AVNRT), successful ablation was found in 33 cases (100%) and recurrence was found in 2 cases (6.06%). Among 5 cases of ventricular tachycardia (VT), successful ablation was found in 5 cases (100%) and no recurrence was found. Among 4 cases of atrial tachycardia (AT), successful ablation was found in 4 cases (100%) and recurrence was found in 1 case (25%). Among 2 cases of atrial flutter (AFL), successful ablation was found in both (100%) and recurrence was found in 1 case (50%). After operation, the levels of IL-6 and hs-CRP were increased and were continually increased within 6 h after operation. The levels of IL-6 and hs-CRP at 24 h after operation were reduced but still higher than preoperative levels. The duration of radiofrequency and ablation energy were positively correlated with the levels of IL-6 and hs-CRP, while the number of discharges was not significantly correlated with either. In conclusion, radiofrequency ablation is a safe and effective treatment for pediatric arrhythmia. Postoperative monitoring of IL-6 and hs-CRP levels is conducive to understanding postoperative myocardial injury and inflammatory response. PMID:29042948

The efficacy of radiofrequency ablation in the treatment of pediatric arrhythmia and its effects on serum IL-6 and hs-CRP.

PubMed

Li, Chunli; Jia, Libo; Wang, Zhenzhou; Niu, Ling; An, Xinjiang

2017-10-01

The aim of this study was to investigate the efficacy of radiofrequency ablation in the treatment of pediatric arrhythmia and to assess the changes in serum interleukin-6 (IL-6) and hs-CRP levels after treatment. Hundred and six children with tachyarrhythmia who were admitted to Xuzhou Children's Hospital from November, 2014 to December, 2015 were recruited for study. The efficacies of radiofrequency in the treatment of different types of arrhythmia were analyzed. Successful ablation was found in 104 cases (98.11%) and recurrence was found in 7 cases (6.73%). Among 62 cases of atrioventricular reentrant tachycardia (AVRT), successful ablation was found in 60 cases (96.77%) and recurrence was found in 3 cases (4.84%). Among 33 cases of atrioventricular nodal reentrant tachycardia (AVNRT), successful ablation was found in 33 cases (100%) and recurrence was found in 2 cases (6.06%). Among 5 cases of ventricular tachycardia (VT), successful ablation was found in 5 cases (100%) and no recurrence was found. Among 4 cases of atrial tachycardia (AT), successful ablation was found in 4 cases (100%) and recurrence was found in 1 case (25%). Among 2 cases of atrial flutter (AFL), successful ablation was found in both (100%) and recurrence was found in 1 case (50%). After operation, the levels of IL-6 and hs-CRP were increased and were continually increased within 6 h after operation. The levels of IL-6 and hs-CRP at 24 h after operation were reduced but still higher than preoperative levels. The duration of radiofrequency and ablation energy were positively correlated with the levels of IL-6 and hs-CRP, while the number of discharges was not significantly correlated with either. In conclusion, radiofrequency ablation is a safe and effective treatment for pediatric arrhythmia. Postoperative monitoring of IL-6 and hs-CRP levels is conducive to understanding postoperative myocardial injury and inflammatory response.

A randomized, double-blind, vehicle-controlled efficacy and safety study of naftifine 2% cream in the treatment of tinea pedis.

PubMed

Parish, Lawrence Charles; Parish, Jennifer L; Routh, Hirak B; Fleischer, Alan B; Avakian, Edward V; Plaum, Stefan; Hardas, Bhushan

2011-11-01

Naftifine HCl 2% cream (NAFT-2) is a topical allylamine antifungal agent under development in the United States. This randomized, double-blind, vehicle-controlled, phase 3 trial evaluated the efficacy and safety of two weeks of NAFT-2 treatment in subjects with tinea pedis. Naftifine 1% cream (NAFT-1) treatment for four weeks and vehicle were also evaluated as a positive control. 709 subjects were randomly assigned 2:1:2:1 to one of four treatment groups: (i) NAFT-2 (n= 235), (ii) two-week vehicle (n=118), (iii) NAFT-1 (n=237), or (iv) four-week vehicle (n=119). Efficacy was evaluated at baseline, week 2, week 4, and week 6 and consisted of mycology determination (KOH and dermatophyte culture) and scoring of clinical symptom severity (erythema, scaling, and pruritus). Efficacy was only analyzed in 425 subjects with positive baseline dermatophyte culture. Safety was evaluated by adverse events (AE) and laboratory values in 707 subjects. At week 6, NAFT-2 subjects achieved 18 percent complete cure rate, 67 percent mycological cure rate, 57 percent treatment effectiveness, 22 percent clinical cure rate, and 78 percent clinical success rate compared to respective vehicle rates of seven percent (one-sided, P<0.01), 21 percent (P<0.001), 20 percent (P<0.001), 11 percent (P=0.04) and 49 percent (P<0.001). Week 6 efficacy responses in NAFT-1-treated subjects were significantly higher than vehicle subjects and almost identical to NAFT-2 subjects. Mycological cure and clinical response rates in both NAFT-2 and NAFT-1 increased from week 2 to week 6. Treatment-related AEs occurred in five percent of NAFT-2 subjects, seven percent of vehicle subjects, four percent of NAFT-1 subjects and eight percent of vehicle subjects. The most common AEs for all groups were application site pruritus and skin irritation. Topical NAFT-2 for two weeks is safe and provides significantly superior antifungal treatment than vehicle in tinea pedis subjects. NAFT-2 produces equivalent efficacy

Self-efficacy in weight management.

PubMed

Clark, M M; Abrams, D B; Niaura, R S; Eaton, C A; Rossi, J S

1991-10-01

Self-efficacy is an important mediating mechanism in advancing understanding of the treatment of obesity. This study developed and validated the Weight Efficacy Life-Style Questionnaire (WEL), improving on previous studies by the use of clinical populations, cross-validation of the initial factor analysis, exploration of the best fitting theoretical model of self-efficacy, and examination of change in treatment. The resulting 20-item WEL consists of five situational factors: Negative Emotions, Availability, Social Pressure, Physical Discomfort, and Positive Activities. A hierarchical model was found to provide the best fit to the data. Results from two separate clinical treatment studies (total N = 382) show that the WEL is sensitive to changes in global scores as well as to a subset of the five situational factor scores. Treatment programs may be incomplete if they change only a subset of the situational dimensions of self-efficacy. Theoretical and clinical implications are discussed.

Evaluating efficacy of filtration + UV-C radiation for ballast water treatment at different temperatures

NASA Astrophysics Data System (ADS)

Casas-Monroy, Oscar; Linley, Robert D.; Chan, Po-Shun; Kydd, Jocelyn; Vanden Byllaardt, Julie; Bailey, Sarah

2018-03-01

To prevent new ballast water-mediated introductions of aquatic nonindigenous species (NIS), many ships will soon use approved Ballast Water Management Systems (BWMS) to meet discharge standards for the maximum number of viable organisms in ballast water. Type approval testing of BWMS is typically conducted during warmer seasons when plankton concentrations are highest, despite the fact that ships operate globally year-round. Low temperatures encountered in polar and cool temperate climates, particularly during the winter season, may impact treatment efficacy through changes in plankton community composition, biological metabolic rates or chemical reaction rates. Filtration + UV irradiance is one of the most common ballast water treatment methods, but its effectiveness at low temperatures has not been assessed. The objective in this study was to examine the efficacy of filtration + UV-C irradiation treatment at low temperatures for removal or inactivation of phytoplankton and zooplankton populations during simulated ballast water treatment. Organisms from two size classes (≥ 10 to < 50 μm and ≥ 50 μm) were identified and enumerated using microscope and culture techniques. The response of organisms in both size categories to UV-C irradiation was evident across a range of temperatures (18 °C, 12 °C and 2 °C) as a significant decrease in concentration between controls and treated samples. Results indicate that filtration + UV-C irradiation will be effective at low temperatures, with few viable organisms ≥ 10 to < 50 μm recorded even 21 days following UV exposure (significantly lower than in the control treatment).

Efficacy and Safety of Gabapentin in the Treatment of Chronic Cough: A Systematic Review.

PubMed

Shi, Guanglin; Shen, Qin; Zhang, Caixin; Ma, Jun; Mohammed, Anaz; Zhao, Huan

2018-06-19

Despite recent clinical guidelines, the optimal therapeutic strategy for the management of refractory chronic cough is still a challenge. The present systematic review was designed to assess the evidence for efficacy and safety of gabapentin in the treatment of chronic cough. A systematic search of PubMed, Embase, Cochrane Library databases, and publications cited in bibliographies was performed. Articles were searched by two reviewers with a priori criteria for study selection. Seven relevant articles were identified, including two randomized controlled trials, one prospective case-series designed with consecutive patients, one retrospective case series of consecutive patients, one retrospective case series with unknown consecutive status, and two case reports comprising six and two patients, respectively. Improvements were detected in cough-specific quality of life (Leicester Cough Questionnaire score) and cough severity (visual analogue scale score) following gabapentin treatment in randomized controlled trials. The results of prospective case-series showed that the rate of overall improvement of cough and sensory neuropathy with gabapentin was 68%. Gabapentin treatment of patients with chronic cough showed superior efficacy and a good safety record compared with placebo or standard medications. Additional randomized and controlled trials are needed. Copyright©2018. The Korean Academy of Tuberculosis and Respiratory Diseases.

Perceived treatment efficacy of the last experienced illness episode in a community sample in the northern Province, South Africa.

PubMed

Peltzer, K

2000-03-01

This study determined the perceived efficacy of various health care providers for the last illness episode patients had suffered. 104 African/Black participants (50 male and 54 female), chosen by quota sampling from the general public (urban population of Mankweng), Northern Province, were interviewed. The research design was a one-shot case study. Medical treatment (68%) was the major choice of treatment for minor, major and chronic medical condition as well as psychological/mental disorders. The second most important treatment choice was the herbalist (19%) for minor and chronic conditions as well as traditional illness, followed by the diviner (9%) prophet or faith healer (4%) and psychologist (2%). Combined traditional or faith healing was utilized by 32% of the sample and combined western treatment by 68%. Regarding the self-rated treatment efficacy for the last illness episode western treatment was generally perceived as more effective than traditional or faith healing. However, traditional or faith healing was considered almost as long lasting as western therapy.

Closing the praziquantel treatment gap: new steps in epidemiological monitoring and control of schistosomiasis in African infants and preschool-aged children

PubMed Central

STOTHARD, J. RUSSELL; SOUSA-FIGUEIREDO, JOSÉ C.; BETSON, MARTHA; GREEN, HELEN K.; SETO, EDMUND Y. W.; GARBA, AMADOU; SACKO, MOUSSA; MUTAPI, FRANCISCA; VAZ NERY, SUSANA; AMIN, MUTAMAD A.; MUTUMBA-NAKALEMBE, MARGARET; NAVARATNAM, ANNALAN; FENWICK, ALAN; KABATEREINE, NARCIS B.; GABRIELLI, ALBIS F.; MONTRESOR, ANTONIO

2011-01-01

SUMMARY Where very young children come into contact with water containing schistosome cercariae, infections occur and schistosomiasis can be found. In high transmission environments, where mothers daily bathe their children with environmentally drawn water, many infants and preschool-aged children have schistosomiasis. This ‘new’ burden, inclusive of co-infections with Schistosoma haematobium and Schistosoma mansoni, is being formally explored as infected children are not presently targeted to receive praziquantel (PZQ) within current preventive chemotherapy campaigns. Thus an important PZQ treatment gap exists whereby infected children might wait up to 4–5 years before receiving first treatment in school. International treatment guidelines, set within national treatment platforms, are presently being modified to provide earlier access to medication(s). Although detailed pharmacokinetic studies are needed, to facilitate pragmatic dosing in the field, an extended ‘dose pole’ has been devised and epidemiological monitoring has shown that administration of PZQ (40 mg/kg), in either crushed tablet or liquid suspension, is both safe and effective in this younger age-class; drug efficacy, however, against S. mansoni appears to diminish after repeated rounds of treatment. Thus use of PZQ should be combined with appropriate health education/water hygiene improvements for both child and mother to bring forth a more enduring solution. PMID:21861945

Safety and efficacy of antibiotics compared with appendicectomy for treatment of uncomplicated acute appendicitis: meta-analysis of randomised controlled trials

PubMed Central

Varadhan, Krishna K; Neal, Keith R

2012-01-01

Objective To compare the safety and efficacy of antibiotic treatment versus appendicectomy for the primary treatment of uncomplicated acute appendicitis. Design Meta-analysis of randomised controlled trials. Population Randomised controlled trials of adult patients presenting with uncomplicated acute appendicitis, diagnosed by haematological and radiological investigations. Interventions Antibiotic treatment versus appendicectomy. Outcome measures The primary outcome measure was complications. The secondary outcome measures were efficacy of treatment, length of stay, and incidence of complicated appendicitis and readmissions. Results Four randomised controlled trials with a total of 900 patients (470 antibiotic treatment, 430 appendicectomy) met the inclusion criteria. Antibiotic treatment was associated with a 63% (277/438) success rate at one year. Meta-analysis of complications showed a relative risk reduction of 31% for antibiotic treatment compared with appendicectomy (risk ratio (Mantel-Haenszel, fixed) 0.69 (95% confidence interval 0.54 to 0.89); I2=0%; P=0.004). A secondary analysis, excluding the study with crossover of patients between the two interventions after randomisation, showed a significant relative risk reduction of 39% for antibiotic therapy (risk ratio 0.61 (0.40 to 0.92); I2=0%; P=0.02). Of the 65 (20%) patients who had appendicectomy after readmission, nine had perforated appendicitis and four had gangrenous appendicitis. No significant differences were seen for treatment efficacy, length of stay, or risk of developing complicated appendicitis. Conclusion Antibiotics are both effective and safe as primary treatment for patients with uncomplicated acute appendicitis. Initial antibiotic treatment merits consideration as a primary treatment option for early uncomplicated appendicitis. PMID:22491789

Ultrasound monitoring of the treatment of clinically significant knee osteoarthritis.

PubMed

Vojtassak, J; Vojtassak, J

2014-01-01

The study presented an ultrasound (US) monitoring of treatment as a new imaging US method with the results of therapy of clinically significant knee osteoarthritis. X-ray is widely used for knee osteoarthritis classification, which does not involve the evaluation of the soft tissue. High frequency and high resolution US of joints (arthrosonography, echoarthrography) assess not only morphologic but also functional changes in the knee joint. In the prospective study, 110 patients with clinically significant knee osteoarthritis were treated non-operative. US examination and US monitoring of therapy was performed during 24 weeks therapy period. A remission of pathomorphologic (marginal osteofytes) and pathophysiologic (effusion in anterior knee and Baker´s cyst) attributes were evaluated according the US classification. Pathomorphologic attributes changes showed a static state, without remission or progression. Pathophysiologic attributes changes showed a remission during the study period. The highest remission was in the first three weeks, 60 % anterior knee effusion and 62 % Baker´s cyst. At the end of study, no changes from the initial US grade was observed in 16 % of effusion in anterior knee and 22 % of Baker´s cyst. Therapeutic resistant Baker´s cyst was present at the end of study in 36 %. We demonstrated a new method - US monitoring of therapy, which can objectivize the efficiency of treatment of clinically significant knee osteoarthritis. We would recommend US monitoring of therapy for the routine use in orthopedic clinical praxis (Tab. 6, Graph 3, Fig. 3, Ref. 15).

Self-Efficacy and Short-Term Adherence to Continuous Positive Airway Pressure Treatment in Children.

PubMed

Xanthopoulos, Melissa S; Kim, Ji Young; Blechner, Michael; Chang, Ming-Yu; Menello, Mary Kate; Brown, Christina; Matthews, Edward; Weaver, Terri E; Shults, Justine; Marcus, Carole L

2017-07-01

Infants, children, and adolescents are increasingly being prescribed continuous positive airway pressure (CPAP) for treatment of obstructive sleep apnea syndrome (OSAS), yet adherence is often poor. The purpose of this study was to examine the relationship between caregiver and patient-reported health cognitions about CPAP prior to starting CPAP and CPAP adherence at 1 month. We hypothesized that greater caregiver-reported self-efficacy would be positively associated with CPAP adherence in children. We also evaluated patient-reported self-efficacy and caregiver- and patient-reported risk perception and outcome expectations as they related to adherence, as well as how demographic factors influenced these relationships. A pediatric modification of the Self-Efficacy Measure for Sleep Apnea Questionnaire was administered to children and adolescents with OSAS-prescribed CPAP and their caregivers during the clinical CPAP-initiation visit. The primary outcome variable for adherence was the average total minutes of CPAP usage across all days from the date that CPAP was initiated to 31 days later. Unadjusted ordinary least-square regression showed a significant association between caregiver-reported self-efficacy and adherence (p = .007), indicating that mean daily CPAP usage increased by 48.4 minutes when caregiver-reported self-efficacy increased by one point (95% confidence interval 13.4-83.4 minutes). No other caregiver- or patient-reported cognitive health variables were related to CPAP use. This study indicates that caregiver CPAP-specific self-efficacy is an important factor to consider when starting youth on CPAP therapy for OSAS. Employing strategies to improve caregiver self-efficacy, beginning at CPAP initiation, may promote CPAP adherence. © Sleep Research Society 2017. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

Efficacy of Chloroquine as a first line agent in the treatment of uncomplicated malaria due to Plasmodium vivax in children and treatment practices in Pakistan: A Pilot study.

PubMed

Waqar, Talal; Khushdil, Arshad; Haque, Khalid

2016-01-01

To ascertain the efficacy of chloroquine as first line agent in treatment of uncomplicated malaria -caused by Plasmodium vivax in children---and to determine its current treatment practice in Pakistan. This pilot study was conducted at the Paediatrics Department of Combined Military Hospital (CMH), Lahore, Pakistan. Forty-eight children between six months and twelve years of age having positive blood film for Plasmodium vivax were included. They were treated with chloroquine as a drug of - choice. Efficacy of chloroquine was assessed by clinical response, absence of parasitaemia on day seven and twenty-eight after initiation of therapy. A survey was also conducted to determine the first line therapeutic choice of Paediatricians in the treatment of uncomplicated Plasmodium vivax malaria in children in Pakistan. The results showed 100% efficacy of chloroquine in treating uncomplicated malaria caused by Plasmodium vivax in children. Artemisin was preferred by 74.28% Paediatricians' in combination therapy as 1st line treatment. Guidelines proposed by Malaria Control Programme Pakistan (MCPP) in collaboration with World Health Organization (WHO) are comprehensive but not being adhered to. The recently reported resistance of Plasmodium vivax to artemisin should urge measures to implement WHO guidelines.

Thiamine transporter-2 deficiency: outcome and treatment monitoring.

PubMed

Ortigoza-Escobar, Juan Darío; Serrano, Mercedes; Molero, Marta; Oyarzabal, Alfonso; Rebollo, Mónica; Muchart, Jordi; Artuch, Rafael; Rodríguez-Pombo, Pilar; Pérez-Dueñas, Belén

2014-06-23

The clinical characteristics distinguishing treatable thiamine transporter-2 deficiency (ThTR2) due to SLC19A3 genetic defects from the other devastating causes of Leigh syndrome are sparse. We report the clinical follow-up after thiamine and biotin supplementation in four children with ThTR2 deficiency presenting with Leigh and biotin-thiamine-responsive basal ganglia disease phenotypes. We established whole-blood thiamine reference values in 106 non-neurological affected children and monitored thiamine levels in SLC19A3 patients after the initiation of treatment. We compared our results with those of 69 patients with ThTR2 deficiency after a review of the literature. At diagnosis, the patients were aged 1 month to 17 years, and all of them showed signs of acute encephalopathy, generalized dystonia, and brain lesions affecting the dorsal striatum and medial thalami. One patient died of septicemia, while the remaining patients evidenced clinical and radiological improvements shortly after the initiation of thiamine. Upon follow-up, the patients received a combination of thiamine (10-40 mg/kg/day) and biotin (1-2 mg/kg/day) and remained stable with residual dystonia and speech difficulties. After establishing reference values for the different age groups, whole-blood thiamine quantification was a useful method for treatment monitoring. ThTR2 deficiency is a reversible cause of acute dystonia and Leigh encephalopathy in the pediatric years. Brain lesions affecting the dorsal striatum and medial thalami may be useful in the differential diagnosis of other causes of Leigh syndrome. Further studies are needed to validate the therapeutic doses of thiamine and how to monitor them in these patients.

The impact of depression on abstinence self-efficacy and substance use outcomes among emerging adults in residential treatment.

PubMed

Greenfield, Brenna L; Venner, Kamilla L; Kelly, John F; Slaymaker, Valerie; Bryan, Angela D

2012-06-01

A large proportion of emerging adults treated for substance use disorder (SUD) present with symptoms of negative affect and major depressive disorder (MDD). However, little is known regarding how these comorbidities influence important mechanisms of treatment response, such as increases in abstinence self-efficacy (ASE). This study tested the degree to which MDD and/or depressive symptoms interacted with during-treatment changes in ASE and examined these variables' relation to outcome at 3 months' posttreatment. Participants (N = 302; 74% male) completed measures at intake, midtreatment, end-of-treatment, and at 3-month follow-up. ASE was measured with the Alcohol and Drug Use Self-Efficacy (ADUSE) scale; depressive symptoms were assessed with the Brief Symptom Inventory 18 (BSI 18) Depression scale; and current MDD diagnoses were deduced from the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). Random coefficient regression analyses focused on during-treatment changes in ASE, with BSI 18 scores and MDD diagnosis included as moderators. At intake, individuals with MDD or high levels of depressive symptoms had significantly lower ASE, particularly in negative affect situations. No evidence for moderation was found: ASE significantly increased during treatment regardless of MDD status. There was a main effect of BSI 18 Depression scores: those with lower BSI 18 scores had lower ASE scores at each time point. MDD and BSI 18 Depression did not predict 3-month outcome, but similar to previous findings ASE did predict abstinence status at 3 months. Treatment-seeking emerging adults with MDD merit particular clinical attention because of their lower reported self-efficacy throughout treatment.

Comparison between the efficacy of ginger and sumatriptan in the ablative treatment of the common migraine.

PubMed

Maghbooli, Mehdi; Golipour, Farhad; Moghimi Esfandabadi, Alireza; Yousefi, Mehran

2014-03-01

Frequency and torment caused by migraines direct patients toward a variety of remedies. Few studies to date have proposed ginger derivates for migraine relief. This study aims to evaluate the efficacy of ginger in the ablation of common migraine attack in comparison to sumatriptan therapy. In this double-blinded randomized clinical trial, 100 patients who had acute migraine without aura were randomly allocated to receive either ginger powder or sumatriptan. Time of headache onset, its severity, time interval from headache beginning to taking drug and patient self-estimation about response for five subsequent migraine attacks were recorded by patients. Patients(,) satisfaction from treatment efficacy and their willingness to continue it was also evaluated after 1 month following intervention. Two hours after using either drug, mean headaches severity decreased significantly. Efficacy of ginger powder and sumatriptan was similar. Clinical adverse effects of ginger powder were less than sumatriptan. Patients' satisfaction and willingness to continue did not differ. The effectiveness of ginger powder in the treatment of common migraine attacks is statistically comparable to sumatriptan. Ginger also poses a better side effect profile than sumatriptan. Copyright © 2013 John Wiley & Sons, Ltd.

Evaluation of the efficacy of cysteamine 5% cream in the treatment of epidermal melasma: a randomized double-blind placebo-controlled trial.

PubMed

Mansouri, P; Farshi, S; Hashemi, Z; Kasraee, B

2015-07-01

Melasma is a difficult-to-treat hyperpigmentary disorder. While cysteamine is a known potent depigmenting agent, its efficacy in treating melasma has not been tested. To study the efficacy of cysteamine 5% cream in the treatment of patients with epidermal melasma. In this double-blind randomized study, participating patients (n = 50) received either placebo (n = 25) or cysteamine cream (n = 25). Cysteamine cream or placebo were applied on the lesions once a day at bedtime over 4 months. The efficacy of treatments was determined through Mexameter skin colorimetry, Melasma Area Severity Index (MASI) score, Investigator's Global Assessment (IGA) and patients' questionnaires, all performed at baseline and after 2 and 4 months of treatment. At baseline, the mean differences between pigmented and normal skin (calculated by Mexameter) were 75.2 ± 37 and 68.9 ± 31 in the cysteamine and placebo groups, respectively. After 2 and 4 months of application of cysteamine and placebo cream, the mean differences were 39.7 ± 16.6 and 26.2 ± 16 in the cysteamine group, and 63.8 ± 28.6 and 60.7 ± 27.3 in the placebo group, respectively. Statistically significant differences were found between the group outcomes at both points (P = 0.001 and P < 0.001). At the end of the treatment, the MASI scores were significantly lower in the cysteamine group vs. placebo (7.2 ± 5.5 vs. 11.6 ± 7.9, P = 0.02). The IGA and patients' viewpoints indicated significant efficacy of cysteamine cream vs. placebo. Cysteamine cream showed significant efficacy in the treatment of melasma. © 2014 British Association of Dermatologists.

Intensive social cognitive treatment (can do treatment) with participation of support partners in persons with relapsing remitting multiple sclerosis: observation of improved self-efficacy, quality of life, anxiety and depression 1 year later.

PubMed

Jongen, Peter Joseph; Heerings, Marco; Ruimschotel, Rob; Hussaarts, Astrid; Duyverman, Lotte; van der Zande, Anneke; Valkenburg-Vissers, Joyce; van Droffelaar, Maarten; Lemmens, Wim; Donders, Rogier; Visser, Leo H

2016-07-29

In persons with multiple sclerosis (MS) self-efficacy positively affects health-related quality of life (HRQoL) and physical activity. In a previous study we observed that 6 months after an intensive 3-day social cognitive treatment (Can Do treatment) with the participation of support partners, self-efficacy and HRQoL had improved in persons with relapsing remitting MS (RRMS). Given the chronic nature of the disease, it is important to know whether these beneficial changes may last. Can Do treatment was given to 60 persons with MS and their support partners. At baseline and 12 months after treatment self-efficacy control, self-efficacy function, physical and mental HRQoL, anxiety, depression and fatigue were assessed via self-report questionnaires. Differences were tested via a paired t test. Of the 57 persons with MS that completed the baseline assessment and the 3-day treatment, 38 filled in the 12th month questionnaires (response rate 66.7 %), 22 with RRMS and 14 with progressive MS. In the RR group self-efficacy control had increased by 20.2 % and physical HRQoL by 15.0 %, and depression and anxiety had decreased by 29.8 and 25.9 %, respectively (all P < 0.05); the changes in mental HRQoL (+17 %) and fatigue (-20 %) failed to be statistically significant (P = 0.087, P = 0.080, respectively). In the progressive group no changes suggestive of improvement were seen. The findings suggest that a 3-day intensive social cognitive treatment (Can Do treatment) with the participation of support partners may have long lasting beneficial effects on the self-efficacy and HRQoL in persons with RRMS; and that improvements in anxiety and depression, not seen in the 6-month study, may yet develop at 12 months.

A systematic review of the efficacy of venlafaxine for the treatment of fibromyalgia.

PubMed

VanderWeide, L A; Smith, S M; Trinkley, K E

2015-02-01

Fibromyalgia is a painful disease affecting 1-2% of the United States population. Serotonin and norepinephrine reuptake inhibitors (SNRIs), such as duloxetine and milnacipran, are well studied and frequently used for treating this disorder. However, efficacy data are limited for the SNRI venlafaxine despite its use in nearly a quarter of patients with fibromyalgia. Accordingly, we systematically reviewed the efficacy of venlafaxine for treatment of fibromyalgia. PubMed, Web of Science and the Cochrane Database were searched using the terms 'venlafaxine' and 'fibromyalgia'. Results were classified as primary studies or review articles based on abstract review. References of review articles were evaluated to ensure no primary studies evaluating venlafaxine were overlooked. All clinical studies that investigated venlafaxine for the treatment of fibromyalgia were included and graded on strength of evidence. Five studies met the inclusion criteria, including 4 open-label cohort studies and 1 randomized, controlled trial. Study durations ranged from 6 weeks to 6 months, and study sizes ranged from 11 to 102 participants. Four of the five published studies reported improvement in at least one outcome. Generally consistent improvements were observed in pain-related outcome measures, including the Fibromyalgia Impact Questionnaire (range, 26-29% reduction; n = 2 studies), Visual Analog Scale (range, 36-45% reduction; n = 2 studies), McGill Pain Questionnaire (48% reduction; n = 1 study) and Clinical Global Impression scale (51% had significant score change; n = 1 study). However, the few studies identified were limited by small sample size, inconsistent use of outcomes and methodological concerns. Studies assessing the efficacy of venlafaxine in the treatment of fibromyalgia to date have been limited by small sample size, inconsistent venlafaxine dosing, lack of placebo control and lack of blinding. In the context of these limitations, venlafaxine appears to be at least

Feasibility of A-mode ultrasound attenuation as a monitoring method of local hyperthermia treatment.

PubMed

Manaf, Noraida Abd; Aziz, Maizatul Nadwa Che; Ridzuan, Dzulfadhli Saffuan; Mohamad Salim, Maheza Irna; Wahab, Asnida Abd; Lai, Khin Wee; Hum, Yan Chai

2016-06-01

Recently, there is an increasing interest in the use of local hyperthermia treatment for a variety of clinical applications. The desired therapeutic outcome in local hyperthermia treatment is achieved by raising the local temperature to surpass the tissue coagulation threshold, resulting in tissue necrosis. In oncology, local hyperthermia is used as an effective way to destroy cancerous tissues and is said to have the potential to replace conventional treatment regime like surgery, chemotherapy or radiotherapy. However, the inability to closely monitor temperature elevations from hyperthermia treatment in real time with high accuracy continues to limit its clinical applicability. Local hyperthermia treatment requires real-time monitoring system to observe the progression of the destroyed tissue during and after the treatment. Ultrasound is one of the modalities that have great potential for local hyperthermia monitoring, as it is non-ionizing, convenient and has relatively simple signal processing requirement compared to magnetic resonance imaging and computed tomography. In a two-dimensional ultrasound imaging system, changes in tissue microstructure during local hyperthermia treatment are observed in terms of pixel value analysis extracted from the ultrasound image itself. Although 2D ultrasound has shown to be the most widely used system for monitoring hyperthermia in ultrasound imaging family, 1D ultrasound on the other hand could offer a real-time monitoring and the method enables quantitative measurement to be conducted faster and with simpler measurement instrument. Therefore, this paper proposes a new local hyperthermia monitoring method that is based on one-dimensional ultrasound. Specifically, the study investigates the effect of ultrasound attenuation in normal and pathological breast tissue when the temperature in tissue is varied between 37 and 65 °C during local hyperthermia treatment. Besides that, the total protein content measurement was also

Feasibility of using a personal digital assistant to self-monitor diet and fluid intake: a pilot study.