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  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Roose, Steven P.;

    To compare the efficacy and safety of a select serotonin re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age of 60 who meet Diagnostic and Statistical Manuel-IV criteria for unipolar major depression, excluding patients who meet criteria for psychotic or atypical subtype. To test the hypothesis that medication condition interacts with diagnostic subtype (melancholic vs non-melancholic) in determining antidepressant response. To examine the roles of symptom severity and alternative diagnostic subtyping in contributing to this pattern. SSRIs are effective in the treatment of major depression. However, there is also evidence that SSRIs may be significantly less effective than TCAs for depressed patients with melancholia. This issue is of particular concern in late-life major depression. SSRIs have important safety advantages with respect to overdose and a benign cardiovascular profile. Furthermore, the SSRIs do not have significant anticholinergic effects, and appear to be better tolerated than the TCAs. Perhaps most important, the SSRIs currently are prescribed widely as the medication treatment of first choice for major depression in late life. Therefore, if it were determined that SSRIs are considerably less effective than TCAs in the treatment of melancholia in the elderly, there would be significant ramifications for clinical practice. Randomization to sertraline (a SSRI) or nortriptyline (a TCA) is stratified by the presence or absence of melancholia. Outcome measures for the 12-week acute phase include clinician and patient ratings of symptoms, side effects, and an evaluation of the health-related quality of life (HRQOL). At the end of the acute treatment phase, patients who meet criteria for clinical response participate in a 6-month continuation phase. The purpose of this study is to compare the safety and effectiveness of a select serotonin re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age of 60 who have major depression. SSRIs are effective in the treatment of major depression. However, there is also evidence that SSRIs may be significantly less effective than TCAs for patients with late-life major depression with melancholia. Since SSRIs seem to be easier to take than TCAs and are more widely prescribed, it is important to determine which of these types of antidepressants works best to treat these patients. Patients will be assigned randomly to receive either sertraline (a SSRI) or nortriptyline (a TCA) for 12 weeks. Patients will be monitored for symptoms, side effects, and quality of life. If a patient responds to treatment, he/she will participate in a 6-month continuation phase in which he/she will continue to receive the same medication. An individual may be eligible for this study if he/she: Has unipolar major depression (with some exceptions) and is over 60 years old.

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    image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    OpenTrials
    Clinical Trial . 1999
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 1999
      Data sources: OpenTrials
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  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Thurm, Audrey E;

    Objective This investigation will focus on two areas: 1) early communication impairments as predictors of autism spectrum disorder (ASD) and later developmental delays, and 2) the relationship between communication and evidence of CNS function (sleep, EEG) and structure (MRI DTI and volumetrics) in young children at risk for ASD. The objective is to delineate early communicative impairments that predict ASD vs. other developmental delays and to examine how these impairments correlate with brain abnormalities in both structure and function. Study Population We will recruit 64 children [n=32 at 12 months of age (plus or minus 2 months); n=32 at 18 months of age (plus or minus 2 months)] who are at-risk for ASD due to communication/language delays (at-risk group). The at-risk children will be matched at initial on chronological age, SES, and sex, to typically developing children (n=75) with no history of developmental delays. These 139 participants will hereafter be referred to as the toddler sample. At the 36 month final visit, diagnostic status (e.g. ASD, non-ASD specific delays, catch up) will be determined for children in the at-risk group. In addition, 10 healthy adults, aged 18-40 will serve as control participants for the purpose of piloting the functional paradigms for the MRI portion of the protocol. Design We propose to conduct a prospective, longitudinal study of toddlers at-risk for ASD compared to typically developing toddlers. Children will complete behavioral testing and an overnight Sleep/EEG as well as MRI at either a 12 or 18 month initial. Follow-up visits that include behavioral assessment will occur at 24 and 36 months for all children (and at 18 months of age for the 12-month cohort). The Sleep/EEG and MRI will be repeated at the 36 month final follow-up. Outcome Measures Autism symptoms, language status, and cognitive development at 36 months will serve as the primary outcome measures. The purpose of this study is to learn more about risk factors for autism by studying the behavior and brain functioning of toddlers with early communication delays and typically developing toddlers. Children 12 or 18 months of age with language delays (i.e., no words at 18 months, limited vocalizations at 12 months) and typically developing toddlers may be eligible to participate. This study will be conducted at the NIH Clinical Center in Bethesda, Maryland. There will be an initial screening evaluation that will include behavioral assessment. Eligible participants will then complete a baseline visit that includes an overnight sleep study that includes Electroencephalogram (EEG) test to measure brain electrical activity, and an MRI scan. Follow-up visits that include behavioral assessment will occur every 6-12 months, depending on age at study entry. The final study visit will occur at 36 months of age and will include behavioral assessment, sleep/EEG study, and MRI. There is no cost for participation. Compensation will be provided. To find out if your child qualifies or for more information, please call 301-451-7822 (TTY: 1-866-411-1010) or e-mail NIMH-ASD@mail.nih.gov. National Institute of Mental Health, National Institutes of Health, Department of Health & Human Services....

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    OpenTrials
    Clinical Trial . 2011
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2011
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    Authors: Collinge, John;

    The human prion diseases have been traditionally classified into Creutzfeldt-Jakob disease (CJD), Gerstmann-Sträussler-Scheinker (GSS) disease and kuru. They can alternatively be classified into three causal categories: sporadic, acquired and inherited. The appearance of a new human prion disease, variant CJD (vCJD), in the United Kingdom from 1995 onwards, and the experimental evidence that this is caused by the same prion strain as that causing bovine spongiform encephalopathy (BSE) in cattle, has raised the possibility that a major epidemic of vCJD will occur in the United Kingdom and other countries as a result of dietary or other exposure to BSE prions. These concerns have led to intensified efforts to develop therapeutic interventions. Quinacrine has been previously used to treat other diseases such as malaria; however, it was found to have serious side effects and is no longer licensed in the United Kingdom. There is only very limited evidence from laboratory tests for the potential use of quinacrine in human prion disease, and the evidence to date for any possible clinical benefit is very scarce. The PRION-1 trial is being undertaken since there are no other drugs currently available which are considered suitable for human evaluation. PRION-1 aims to assess the activity and safety of Quinacrine (Mepacrine hydrochloride) in human prion disease. It also aims to establish an appropriate framework for the clinical assessment of therapeutic options for human prion disease that can be refined or expanded in the future, as new agents become available.

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    OpenTrials
    Clinical Trial . 2005
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2005
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  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Chamberlain, James;

    Textbooks and expert opinion recommend both diazepam and lorazepam as initial therapy for children in status epilepticus (SE) and provide recommended doses that are commonly used. However, unlike diazepam, lorazepam is only FDA-approved for treatment for SE in patients over 18 years of age. Despite this fact, many experts support the use of lorazepam over diazepam in pediatric SE. Increased duration of action, increased effectiveness in terminating SE, and a lower incidence of respiratory depression have been cited as potential advantages of lorazepam over diazepam. However, data to support firm recommendations for one medication over another are lacking. Thus, either diazepam (FDA-approved) or lorazepam can be considered first-line agents for pediatric SE, and the physician's choice of agent depends on local practice patterns and individual treatment styles. In the prehospital (Emergency Medical Services) setting, diazepam is commonly chosen because of a longer shelf life without refrigeration. The purpose of this study is to determine the differences in efficacy and safety between these two commonly used benzodiazepines, as requested by the FDA under the Best Pharmaceuticals for Children Act, using the Exception from Informed Consent provided by the FDA. Children with seizures are frequently seen in the emergency department. The drug lorazepam, which is commonly used, is not labeled by the US Food and Drug Administration for children for this use. The FDA, under the Best Pharmaceuticals for Children Act, has requested that a study comparing diazepam, a drug that is labeled by the FDA for this indication, with lorazepam be performed. The study will show whether one drug is more effective and safe than the other.

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    OpenTrials
    Clinical Trial . 2008
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2008
      Data sources: OpenTrials
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    Authors: Abdel-Rahman, Susan;

    In 'real-world' health care settings there exist a number of circumstances where the weight of a child is desirable or even necessary but unavailable. The most conspicuous of these settings can be found in developing countries where many medical clinics lack suitable scales to obtain accurate infant and child weights. Though resource restrictions are less of an issue in developed countries, scenarios still exist where weight assessment is problematic. For example, accurate estimates of a child's weight are rarely available during emergency or trauma situations, and in some in-patient settings (e.g. critical care units, orthopedic clinics) obtaining an accurate patient weight can be impaired by the presence of external hoses, tubing, casts, and/or other medical equipment. Irrespective of the environment, the challenge that each of these settings present is the same; namely, the provision of age-appropriate, weight-based interventions which remain the most accurate approach to delivering therapy in children. Thus, techniques which permit accurate weight estimation address a critical medical need in both developing and developed countries. Numerous weight estimation strategies have been described with each used to varying degrees in clinical practice. Many of the published techniques have distinct advantages. For example; simple age-based equations can be used without the need for reference materials, strategies that utilize preprinted tables or tools limit the risk of calculation errors. Other techniques present unnecessary complexities for the end-user including; the need for subjective assessments of habitus, the requirement to solve exponential equations, the call for multiple formulae delineated by age bracket, or the reliance on one or more reference charts. Irrespective of their simplicity or complexity, almost all of the reported techniques have significant limitations. Relatively few methods have been evaluated in pediatric populations of varying races, ethnicities and nationalities and essentially no single previously described method provides accurate estimates of weight across broad age- and weight-bands. Apart from parental recall which can vary in accuracy, the most commonly used strategies for estimating weight rely on the child's age, length, or a combination of the two parameters. While simple and easy to integrate into a weight estimation technique, age based strategies fail to account for the extremes of body composition and stature that are observed in children of the same age. Similarly, length based strategies do not take into consideration that two children of the same height may demonstrate markedly discrepant weights based on underlying nutritional status (e.g. malnourished, underweight, overweight, obese). Consequently, many of the currently available weight estimation strategies perform well in only a small subset of children. As such, there remains a critical need for weight estimation methods that are accurate across a wide range of pediatric ages, weights, lengths, nationalities and body compositions despite the relative abundance of strategies that already exist. Investigators at Children's Mercy Hospitals and Clinics recently developed and validated a weight estimation method (the Mercy MethodTM) that addresses the principal limitations of previously published methods, requires no subjective assessment and performs robustly independently of age and length over a broad range of weights. As with other strategies, the Mercy Method incorporates growth velocity but uses humeral length as a surrogate for total body length. Total body length will be discrepant depending on whether the measurement is obtained with the child standing or lying down and can be difficult to obtain in a child who is uncooperative or obtunded. The Mercy Method also incorporates body habitus as a quantitative variable which improves the accuracy of the overall length-based weight estimate and removes the subjective nature of categorizing the child's body type into one of a few alternatives (e.g. "slim," "average," or "heavy"). By developing a model with these considerations in mind we were able to expand the age range to which our weight estimation method can be applied and remove length restrictions which are typically imposed because of the disproportionate increase in weight-for-height observed as children get older. In brief, demographic and anthropometric data on children 2 months to 16 years of age were extracted from the NHANES database and individual datasets were randomly assigned into a method development (n=17,328) or a method validation (n=1,938) set. Humeral length (HL) and mid-upper arm circumference (MUAC) were used to develop a weight estimation method by 1) collapsing length and habitus measurements into discrete bins, 2) examining the median population weight for each bin-pair, 3) statistically weighting the bin-pairs for age and sample size, and 4) calculating a fractional weight for each HL and MUAC. An individual weight estimate is generated by the simple addition of the MUAC and HL fractional bin value that corresponds to that individual child's measurements. The predictive performance this method was evaluated using the internal validation set and compared with the performance of 13 previously published weight estimation methods applied to the same data. The Mercy Method outperformed the 13 other published methods when evaluated for goodness-of-fit, mean error, mean percentage error, root mean square error and percentage of children in agreement within 10% of actual weight. Most of the age-and length-based strategies examined overestimated weight in children classified, by BMI, as underweight and significantly underestimated weight in children classified as overweight or obese. The degree to which this occurred depended largely on the constants driving their mathematical equations, with some methods biased toward more accurate prediction in children of lower weight (e.g. Broselow) and others performing better among children in the higher weight brackets (e.g. Theron). Irrespective of directionality, the bias observed with some methods at the extremes of weight represented as much as a 3-fold error between predicted and actual weights. Discrepancies of this magnitude can be dangerous, and potentially life-threatening, depending on how 'forgiving' the intervention or treatment that is being administered. The singular habitus-based method (i.e. Cattermole) ranked among the best (after the Mercy Method) with respect to absolute bias; however, it performed only moderately well when precision and MPE were factored into the assessment. This method, which was developed in Chinese children consistently overestimated weight at lower absolute weights and underestimated weight at higher absolute weight irrespective of BMI percentile. This suggests that while the relationship between weight and MUAC tends to be linear within any given population, the mathematical constants that define the relationship differ between populations having different height-for-weight averages. Given the nature of the data used to develop and validate the Mercy Method, comparative performance of the Devised Weight Estimation Method (DWEM, the only other method to incorporate both body length and body habitus) could not be assessed. Notably, the DWEM involves a subjective rating of "slim," "average," or "heavy". While DWEM has been shown to outperform other age-based methods, the categorical assignment of habitus coupled with inconsistencies in subjective assessment between and within observers [inter-rater agreement- 78% (range: 58-93%); intra-rater agreement- 86% (range: 81-94%)] contributed to bias and precision estimates that were larger than observed with strategies based solely on length. While the Mercy Method can be used as a reference table, a more practical application was the development of a simple and inexpensive device that can perform the two required measurements simultaneously and report the predicted weight directly from the device as opposed to consulting a separate table or chart. Consequently, the 3D Mercy TAPE was developed to perform both measurements simultaneously requiring no external references to arrive at the weight estimate for a given child. An alternative 2D Mercy TAPE was also designed . It requires two serial measurements with the same simple addition used with the 3D TAPE but does not require any folding or manipulation when removed from its packaging. Both devices are intended to be printed on any flexible, non-stretchable medium (e.g. paper, plastic coated paper, fiberglass) so as to be disposable or semi-permanent, inexpensive to mass produce and easy to store. In its numeric form, the Mercy TAPE would be expected have limited utility in settings where care providers are illiterate or do not use a written language. However, the tool can be easily revised with colors and/or symbols whose combination would correspond to a given dose, intervention strategy or weight target. While the Mercy Method is expected to perform well in U.S. children given its creation using data from a U.S. database, external validation of the in non-U.S. settings is currently ongoing with support of the World Health Organization to gauge its utility in children of varying ethnicity and geographic origin. The related 2D and 3D Mercy TAPE still awaits prospective evaluation. The requisite study to satisfy the validation requirements are described herein under the hypothesis: The Mercy TAPE will demonstrate the same predictive performance as the Mercy method in an independent pediatric assessment. In 'real-world' health care settings there exist a number of circumstances where the weight of a child is desirable or even necessary but unavailable. Numerous weight estimation strategies have been described but each has limitations. Investigators at Children's Mercy Hospitals and Clinics recently developed a weight estimation method and tool that addresses the limitations of previously published methods. This study is intended to validate the device in a population of children 2 months to 16 years of age.

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    OpenTrials
    Clinical Trial . 2012
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2012
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    Authors: Currier, Glenn W.;

    There are subgroups of patients who only seek care in emergency settings. An effective strategy to link that group to ambulatory care involves extending contact with psychiatric emergency services beyond the initial hospital-based visit. The "window of opportunity" to promote successful treatment linkage is brief. This is a study of a novel treatment format that seeks to expand the concept of the emergency contact, the study patients method of entering the mental health system of care, and by doing this, enhance retention in prescribed outpatient care. The effects of the intervention on patient symptoms and mental health service use will be examined. The purpose of this study is to compare two different kinds of follow-up care and their effects on psychiatric service use and psychological well-being. This randomized, controlled trial of subjects discharged from the psychiatric emergency services to outpatient care receive traditional hospital-based outpatient clinic referrals (treatment as usual) or appointments for community-based follow-up by a mobile crisis team.

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    OpenTrials
    Clinical Trial . 2006
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      Clinical Trial . 2006
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    Authors: Azzopardi, Denis;

    This is a multicentre prospective randomised controlled trial to determine whether a reduction of body temperature by 3-4°C following perinatal asphyxia improves survival without neurodevelopmental disability. Full term infants will be randomised within 6 hours of birth to either a control group with the rectal temperature kept at 37 ± 0.2°C or to whole body cooling with the rectal temperature kept at 33.5 ± 0.5°C for 72 hours followed by slow rewarming. The outcome will be assessed at 18 months of age by survival and neurological and neurodevelopmental testing. Eligibility criteria: Term infants less than 6 hours after birth with moderate or severe perinatal asphyxia (a combination of clinical and EEG criteria). Exclusion criteria: Infants expected to be 6 hours of age at the time of randomisation or infants with major congenital abnormalities. Intervention: Intensive care with whole body cooling versus intensive care without whole body cooling (babies are cooled to 33.5°C for 72 hours) Main Outcomes: Death and severe neurodevelopmental impairment at 18 months of age Secondary Outcomes: Cerebral thrombosis or haemorrhage, persistent hypotension, pulmonary hypertension, abnormal coagulation, arrhythmia and sepsis in the neonatal period. Neurological impairments at 18 months Number of patients required: 236. On 30th November 2006, when recruitment closed, 325 babies had been recruited. Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial encephalopathy reduces death and severe neurodevelopmental disability. This study aims to determine whether whole body cooling to 33-34°C is a safe treatment that improves survival, without severe neurological or neurodevelopmental impairments at 18 months, of term infants suffering perinatal asphyxial encephalopathy.

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    OpenTrials
    Clinical Trial . 2005
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      Clinical Trial . 2005
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    Authors: Epperson, Cynthia N;

    The purpose of the study proposed is to investigate the role of neurosteroids and GABA in the pathophysiology and treatment of premenstrual dysphoric disorder (PMDD) by 1) measuring cortical gama-aminobutyric acid levels (GABA levels) using nuclear magnetic resonance spectroscopy (MRS) during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the selective serotonin reuptake inhibitor (SSRI) fluoxetine (Prozac®, Sarafem®), and 2) correlating cerebrospinal fluid (CSF) and plasma GABA and neurosteroid levels with cortical GABA levels at these same time points. Neurosteroids to be measured include allopregnanolone, pregnenolone, and pregnenolone sulfate. Findings from women with PMDD will be compared to those of healthy subjects.

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    Clinical Trial . 2008
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      Clinical Trial . 2008
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    Authors: Neville, Kathleen;

    This was an open label assessment of hydroxyurea pharmacokinetics and relative bioavailability conducted in two independent cohorts of pediatric patients with sickle cell anemia or sickle beta-zero thalassemia. A total of 42 participant were enrolled, out of which 39 were enrolled and dosed. A one-compartment population PK model was successfully developed to describe the time course of hydroxyurea concentrations after oral administration in sickle cell anemia participants from both study arms. The relative bioavailability analysis showed very similar pharmacokinetics for peroral liquid and capsule formulations. No adverse events (AEs) were classified as being caused by the study drug, and no AEs led to study drug interruption. Lastly, no significant changes from baseline in laboratory values, vital signs, or physical examination results were found. Hydroxyurea was well tolerated as evidenced by safety monitoring and reporting.

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    Clinical Trial . 2011
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      Clinical Trial . 2011
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    Authors: Rowe, Cynthia;

    This study is a 2 (treatments) by 5 (time points), repeated measures intent-to-treat randomized control design with multiple dependent variables. The sample includes a total of 150 ethnically diverse adolescents who are clinically referred for substance abuse treatment throughout St. Charles Parish, a New Orleans area parish that was heavily impacted by Hurricane Katrina. The parish has high rates of teen substance abuse as documented in school surveys (State of Louisiana Office for Addictive Disorders, 2002, 2004). Eligible youth, who meet American Society of Addiction Medicine (ASAM) criteria for outpatient substance abuse treatment and report trauma symptoms related to Hurricane Katrina, will be randomized to a family-based treatment (MDFT) or group CBT. Both treatments will be delivered approximately twice weekly over 4 months. Assessments of youth and family functioning across several domains will be conducted at intake, 2, 4, 6, and 12 month follow-up. Measuring multiple domains at several assessment points within and following treatment (Brown, 2004) will enable investigators to examine trajectories of change as well as mediators and moderators of treatment effects. The study has four aims: Aim 1: To explore links between hurricane-related stress and trauma and youths' substance abuse. Hypothesis 1: Severity of youths' substance use at intake to treatment will be predicted by level of exposure to Hurricane Katrina, stressful life events following Katrina, trauma symptoms, and coping. Aim 2: To investigate in a community based randomized control trial the effectiveness of a family-based intervention (MDFT) vs. group CBT for teen substance abusers impacted by Hurricane Katrina. Hypothesis 2a: Family-based treatment (MDFT) will more effectively reduce youths' substance abuse, delinquency, trauma, and school problems up to one year post-intake than a group CBT approach. Hypothesis 2b: Family-based treatment (MDFT) will more effectively reduce parents' stress and family conflict up to one year post-intake than group CBT. Hypothesis 2c: Youth assigned to MDFT will be less likely to meet diagnostic criteria for PTSD at 12 month post-intake than group CBT. Aim 3: To examine teen and parent coping as mediators of treatment effects. Hypothesis 3a: Youth in MDFT will develop more effective coping strategies than those in group CBT through improved parental coping and parenting practices, and lower family conflict, as well as directly through intervention effects. Hypothesis 3b: Youth in MDFT will achieve greater reductions in substance abuse and trauma symptoms than those in group treatment through more effective coping during the 12 month follow-up period. Aim 4: To explore moderators of treatment effects based on post-Katrina stress and trauma symptoms. Hypothesis 4: The advantage of MDFT over group CBT in decreasing substance abuse will be more pronounced with youth who report higher levels of disaster-related stress and trauma symptoms at intake. This protocol seizes this rare scientific opportunity to test an integrative family based model to address youths' coexisting substance abuse and trauma in the wake of Hurricane Katrina. The study would address a number of gaps in the current evidence base related to understanding and treating comorbid teen drug abuse and trauma that may be initiated or exacerbated in the wake of disasters such as Hurricane Katrina. This study would compare two promising interventions for youth with comorbid trauma and substance abuse, family-based treatment and group Cognitive Behavioral Therapy (CBT), potentially yielding new and vital information about effective treatment for substance abusing youth following traumatic events.

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    OpenTrials
    Clinical Trial . 2013
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  • image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
    Authors: Roose, Steven P.;

    To compare the efficacy and safety of a select serotonin re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age of 60 who meet Diagnostic and Statistical Manuel-IV criteria for unipolar major depression, excluding patients who meet criteria for psychotic or atypical subtype. To test the hypothesis that medication condition interacts with diagnostic subtype (melancholic vs non-melancholic) in determining antidepressant response. To examine the roles of symptom severity and alternative diagnostic subtyping in contributing to this pattern. SSRIs are effective in the treatment of major depression. However, there is also evidence that SSRIs may be significantly less effective than TCAs for depressed patients with melancholia. This issue is of particular concern in late-life major depression. SSRIs have important safety advantages with respect to overdose and a benign cardiovascular profile. Furthermore, the SSRIs do not have significant anticholinergic effects, and appear to be better tolerated than the TCAs. Perhaps most important, the SSRIs currently are prescribed widely as the medication treatment of first choice for major depression in late life. Therefore, if it were determined that SSRIs are considerably less effective than TCAs in the treatment of melancholia in the elderly, there would be significant ramifications for clinical practice. Randomization to sertraline (a SSRI) or nortriptyline (a TCA) is stratified by the presence or absence of melancholia. Outcome measures for the 12-week acute phase include clinician and patient ratings of symptoms, side effects, and an evaluation of the health-related quality of life (HRQOL). At the end of the acute treatment phase, patients who meet criteria for clinical response participate in a 6-month continuation phase. The purpose of this study is to compare the safety and effectiveness of a select serotonin re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age of 60 who have major depression. SSRIs are effective in the treatment of major depression. However, there is also evidence that SSRIs may be significantly less effective than TCAs for patients with late-life major depression with melancholia. Since SSRIs seem to be easier to take than TCAs and are more widely prescribed, it is important to determine which of these types of antidepressants works best to treat these patients. Patients will be assigned randomly to receive either sertraline (a SSRI) or nortriptyline (a TCA) for 12 weeks. Patients will be monitored for symptoms, side effects, and quality of life. If a patient responds to treatment, he/she will participate in a 6-month continuation phase in which he/she will continue to receive the same medication. An individual may be eligible for this study if he/she: Has unipolar major depression (with some exceptions) and is over 60 years old.

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    OpenTrials
    Clinical Trial . 1999
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      Clinical Trial . 1999
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    Authors: Thurm, Audrey E;

    Objective This investigation will focus on two areas: 1) early communication impairments as predictors of autism spectrum disorder (ASD) and later developmental delays, and 2) the relationship between communication and evidence of CNS function (sleep, EEG) and structure (MRI DTI and volumetrics) in young children at risk for ASD. The objective is to delineate early communicative impairments that predict ASD vs. other developmental delays and to examine how these impairments correlate with brain abnormalities in both structure and function. Study Population We will recruit 64 children [n=32 at 12 months of age (plus or minus 2 months); n=32 at 18 months of age (plus or minus 2 months)] who are at-risk for ASD due to communication/language delays (at-risk group). The at-risk children will be matched at initial on chronological age, SES, and sex, to typically developing children (n=75) with no history of developmental delays. These 139 participants will hereafter be referred to as the toddler sample. At the 36 month final visit, diagnostic status (e.g. ASD, non-ASD specific delays, catch up) will be determined for children in the at-risk group. In addition, 10 healthy adults, aged 18-40 will serve as control participants for the purpose of piloting the functional paradigms for the MRI portion of the protocol. Design We propose to conduct a prospective, longitudinal study of toddlers at-risk for ASD compared to typically developing toddlers. Children will complete behavioral testing and an overnight Sleep/EEG as well as MRI at either a 12 or 18 month initial. Follow-up visits that include behavioral assessment will occur at 24 and 36 months for all children (and at 18 months of age for the 12-month cohort). The Sleep/EEG and MRI will be repeated at the 36 month final follow-up. Outcome Measures Autism symptoms, language status, and cognitive development at 36 months will serve as the primary outcome measures. The purpose of this study is to learn more about risk factors for autism by studying the behavior and brain functioning of toddlers with early communication delays and typically developing toddlers. Children 12 or 18 months of age with language delays (i.e., no words at 18 months, limited vocalizations at 12 months) and typically developing toddlers may be eligible to participate. This study will be conducted at the NIH Clinical Center in Bethesda, Maryland. There will be an initial screening evaluation that will include behavioral assessment. Eligible participants will then complete a baseline visit that includes an overnight sleep study that includes Electroencephalogram (EEG) test to measure brain electrical activity, and an MRI scan. Follow-up visits that include behavioral assessment will occur every 6-12 months, depending on age at study entry. The final study visit will occur at 36 months of age and will include behavioral assessment, sleep/EEG study, and MRI. There is no cost for participation. Compensation will be provided. To find out if your child qualifies or for more information, please call 301-451-7822 (TTY: 1-866-411-1010) or e-mail NIMH-ASD@mail.nih.gov. National Institute of Mental Health, National Institutes of Health, Department of Health & Human Services....

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    OpenTrials
    Clinical Trial . 2011
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    Authors: Collinge, John;

    The human prion diseases have been traditionally classified into Creutzfeldt-Jakob disease (CJD), Gerstmann-Sträussler-Scheinker (GSS) disease and kuru. They can alternatively be classified into three causal categories: sporadic, acquired and inherited. The appearance of a new human prion disease, variant CJD (vCJD), in the United Kingdom from 1995 onwards, and the experimental evidence that this is caused by the same prion strain as that causing bovine spongiform encephalopathy (BSE) in cattle, has raised the possibility that a major epidemic of vCJD will occur in the United Kingdom and other countries as a result of dietary or other exposure to BSE prions. These concerns have led to intensified efforts to develop therapeutic interventions. Quinacrine has been previously used to treat other diseases such as malaria; however, it was found to have serious side effects and is no longer licensed in the United Kingdom. There is only very limited evidence from laboratory tests for the potential use of quinacrine in human prion disease, and the evidence to date for any possible clinical benefit is very scarce. The PRION-1 trial is being undertaken since there are no other drugs currently available which are considered suitable for human evaluation. PRION-1 aims to assess the activity and safety of Quinacrine (Mepacrine hydrochloride) in human prion disease. It also aims to establish an appropriate framework for the clinical assessment of therapeutic options for human prion disease that can be refined or expanded in the future, as new agents become available.

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    OpenTrials
    Clinical Trial . 2005
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2005
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    Authors: Chamberlain, James;

    Textbooks and expert opinion recommend both diazepam and lorazepam as initial therapy for children in status epilepticus (SE) and provide recommended doses that are commonly used. However, unlike diazepam, lorazepam is only FDA-approved for treatment for SE in patients over 18 years of age. Despite this fact, many experts support the use of lorazepam over diazepam in pediatric SE. Increased duration of action, increased effectiveness in terminating SE, and a lower incidence of respiratory depression have been cited as potential advantages of lorazepam over diazepam. However, data to support firm recommendations for one medication over another are lacking. Thus, either diazepam (FDA-approved) or lorazepam can be considered first-line agents for pediatric SE, and the physician's choice of agent depends on local practice patterns and individual treatment styles. In the prehospital (Emergency Medical Services) setting, diazepam is commonly chosen because of a longer shelf life without refrigeration. The purpose of this study is to determine the differences in efficacy and safety between these two commonly used benzodiazepines, as requested by the FDA under the Best Pharmaceuticals for Children Act, using the Exception from Informed Consent provided by the FDA. Children with seizures are frequently seen in the emergency department. The drug lorazepam, which is commonly used, is not labeled by the US Food and Drug Administration for children for this use. The FDA, under the Best Pharmaceuticals for Children Act, has requested that a study comparing diazepam, a drug that is labeled by the FDA for this indication, with lorazepam be performed. The study will show whether one drug is more effective and safe than the other.

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    Clinical Trial . 2008
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      Clinical Trial . 2008
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    Authors: Abdel-Rahman, Susan;

    In 'real-world' health care settings there exist a number of circumstances where the weight of a child is desirable or even necessary but unavailable. The most conspicuous of these settings can be found in developing countries where many medical clinics lack suitable scales to obtain accurate infant and child weights. Though resource restrictions are less of an issue in developed countries, scenarios still exist where weight assessment is problematic. For example, accurate estimates of a child's weight are rarely available during emergency or trauma situations, and in some in-patient settings (e.g. critical care units, orthopedic clinics) obtaining an accurate patient weight can be impaired by the presence of external hoses, tubing, casts, and/or other medical equipment. Irrespective of the environment, the challenge that each of these settings present is the same; namely, the provision of age-appropriate, weight-based interventions which remain the most accurate approach to delivering therapy in children. Thus, techniques which permit accurate weight estimation address a critical medical need in both developing and developed countries. Numerous weight estimation strategies have been described with each used to varying degrees in clinical practice. Many of the published techniques have distinct advantages. For example; simple age-based equations can be used without the need for reference materials, strategies that utilize preprinted tables or tools limit the risk of calculation errors. Other techniques present unnecessary complexities for the end-user including; the need for subjective assessments of habitus, the requirement to solve exponential equations, the call for multiple formulae delineated by age bracket, or the reliance on one or more reference charts. Irrespective of their simplicity or complexity, almost all of the reported techniques have significant limitations. Relatively few methods have been evaluated in pediatric populations of varying races, ethnicities and nationalities and essentially no single previously described method provides accurate estimates of weight across broad age- and weight-bands. Apart from parental recall which can vary in accuracy, the most commonly used strategies for estimating weight rely on the child's age, length, or a combination of the two parameters. While simple and easy to integrate into a weight estimation technique, age based strategies fail to account for the extremes of body composition and stature that are observed in children of the same age. Similarly, length based strategies do not take into consideration that two children of the same height may demonstrate markedly discrepant weights based on underlying nutritional status (e.g. malnourished, underweight, overweight, obese). Consequently, many of the currently available weight estimation strategies perform well in only a small subset of children. As such, there remains a critical need for weight estimation methods that are accurate across a wide range of pediatric ages, weights, lengths, nationalities and body compositions despite the relative abundance of strategies that already exist. Investigators at Children's Mercy Hospitals and Clinics recently developed and validated a weight estimation method (the Mercy MethodTM) that addresses the principal limitations of previously published methods, requires no subjective assessment and performs robustly independently of age and length over a broad range of weights. As with other strategies, the Mercy Method incorporates growth velocity but uses humeral length as a surrogate for total body length. Total body length will be discrepant depending on whether the measurement is obtained with the child standing or lying down and can be difficult to obtain in a child who is uncooperative or obtunded. The Mercy Method also incorporates body habitus as a quantitative variable which improves the accuracy of the overall length-based weight estimate and removes the subjective nature of categorizing the child's body type into one of a few alternatives (e.g. "slim," "average," or "heavy"). By developing a model with these considerations in mind we were able to expand the age range to which our weight estimation method can be applied and remove length restrictions which are typically imposed because of the disproportionate increase in weight-for-height observed as children get older. In brief, demographic and anthropometric data on children 2 months to 16 years of age were extracted from the NHANES database and individual datasets were randomly assigned into a method development (n=17,328) or a method validation (n=1,938) set. Humeral length (HL) and mid-upper arm circumference (MUAC) were used to develop a weight estimation method by 1) collapsing length and habitus measurements into discrete bins, 2) examining the median population weight for each bin-pair, 3) statistically weighting the bin-pairs for age and sample size, and 4) calculating a fractional weight for each HL and MUAC. An individual weight estimate is generated by the simple addition of the MUAC and HL fractional bin value that corresponds to that individual child's measurements. The predictive performance this method was evaluated using the internal validation set and compared with the performance of 13 previously published weight estimation methods applied to the same data. The Mercy Method outperformed the 13 other published methods when evaluated for goodness-of-fit, mean error, mean percentage error, root mean square error and percentage of children in agreement within 10% of actual weight. Most of the age-and length-based strategies examined overestimated weight in children classified, by BMI, as underweight and significantly underestimated weight in children classified as overweight or obese. The degree to which this occurred depended largely on the constants driving their mathematical equations, with some methods biased toward more accurate prediction in children of lower weight (e.g. Broselow) and others performing better among children in the higher weight brackets (e.g. Theron). Irrespective of directionality, the bias observed with some methods at the extremes of weight represented as much as a 3-fold error between predicted and actual weights. Discrepancies of this magnitude can be dangerous, and potentially life-threatening, depending on how 'forgiving' the intervention or treatment that is being administered. The singular habitus-based method (i.e. Cattermole) ranked among the best (after the Mercy Method) with respect to absolute bias; however, it performed only moderately well when precision and MPE were factored into the assessment. This method, which was developed in Chinese children consistently overestimated weight at lower absolute weights and underestimated weight at higher absolute weight irrespective of BMI percentile. This suggests that while the relationship between weight and MUAC tends to be linear within any given population, the mathematical constants that define the relationship differ between populations having different height-for-weight averages. Given the nature of the data used to develop and validate the Mercy Method, comparative performance of the Devised Weight Estimation Method (DWEM, the only other method to incorporate both body length and body habitus) could not be assessed. Notably, the DWEM involves a subjective rating of "slim," "average," or "heavy". While DWEM has been shown to outperform other age-based methods, the categorical assignment of habitus coupled with inconsistencies in subjective assessment between and within observers [inter-rater agreement- 78% (range: 58-93%); intra-rater agreement- 86% (range: 81-94%)] contributed to bias and precision estimates that were larger than observed with strategies based solely on length. While the Mercy Method can be used as a reference table, a more practical application was the development of a simple and inexpensive device that can perform the two required measurements simultaneously and report the predicted weight directly from the device as opposed to consulting a separate table or chart. Consequently, the 3D Mercy TAPE was developed to perform both measurements simultaneously requiring no external references to arrive at the weight estimate for a given child. An alternative 2D Mercy TAPE was also designed . It requires two serial measurements with the same simple addition used with the 3D TAPE but does not require any folding or manipulation when removed from its packaging. Both devices are intended to be printed on any flexible, non-stretchable medium (e.g. paper, plastic coated paper, fiberglass) so as to be disposable or semi-permanent, inexpensive to mass produce and easy to store. In its numeric form, the Mercy TAPE would be expected have limited utility in settings where care providers are illiterate or do not use a written language. However, the tool can be easily revised with colors and/or symbols whose combination would correspond to a given dose, intervention strategy or weight target. While the Mercy Method is expected to perform well in U.S. children given its creation using data from a U.S. database, external validation of the in non-U.S. settings is currently ongoing with support of the World Health Organization to gauge its utility in children of varying ethnicity and geographic origin. The related 2D and 3D Mercy TAPE still awaits prospective evaluation. The requisite study to satisfy the validation requirements are described herein under the hypothesis: The Mercy TAPE will demonstrate the same predictive performance as the Mercy method in an independent pediatric assessment. In 'real-world' health care settings there exist a number of circumstances where the weight of a child is desirable or even necessary but unavailable. Numerous weight estimation strategies have been described but each has limitations. Investigators at Children's Mercy Hospitals and Clinics recently developed a weight estimation method and tool that addresses the limitations of previously published methods. This study is intended to validate the device in a population of children 2 months to 16 years of age.

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    OpenTrials
    Clinical Trial . 2012
    Data sources: OpenTrials