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    Authors: Jackson, Hannah;

    Objectives: Chronic Fatigue Syndrome (CFS) is a medically unexplained condition characterized by severe and disabling fatigue. To date much research has focused on finding out whether CFS is caused by mainly physical or psychological factors. Perhaps as a result of this, few studies have examined the relationship between CFS and quality of life, in particular, more positive aspects of mental health, such as an individual's sense of purpose, autonomy and close relationships. This study will address these limitations by examining Ryff's (1989) six domains of psychological well-being (PWB), and other aspects of well-being including positive emotions, in CFS. It will also examine the relationship between measures of symptomology, emotional distress and PWB. Method: This is a cross-sectional, questionnaire-based study with a clinical sample of adults with CFS. Participants will complete valid measures of well-being and symptomology. Results: We expect to find that compared to general population norms, individuals with CFS score lower on measures of PWB. Secondly, we expect PWB dimensions will be related to symptom measures. There are however, no grounds for making strong predictions. Implications: This study will advance our understanding of quality of life in CFS. Clinically, it has the potential to enrich and inform therapeutic interventions.

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    OpenTrials
    Clinical Trial . 2014
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2014
      Data sources: OpenTrials
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    Authors: Woodson, B Tucker;

    It has been shown that there is an inconsistent response in serum cortisol levels in patients with Obstructive Sleep Apnea Syndrome (OSAS), but it is undetermined whether a change in hormone level was not seen due to compliance issues in these long-term studies. These investigators will be employing compliance monitoring continuous positive airway pressure (CPAP) machines and also assessing "sleepiness" before and after therapy. Sleepiness is the dependent variable in our study and will be measured subjectively using sleepiness scales and objectively using Psychomotor Vigilance Test (PVT) and an autonomic measure using pupillometry prior, during and after treatment. Patients with Obstructive Sleep Apnea Syndrome (OSAS) will evidence higher levels of salivary cortisol and alpha-amylase levels prior to use of placebo and continuous positive airway pressure (CPAP) and will evidence a decrease in these levels after consistent use of continuous positive airway pressure (CPAP) therapy as compared to placebo. Their level of sleepiness will also decrease with the use of CPAP therapy and will correlate with the levels of salivary cortisol and alpha-amylase in relation to their subjective sleepiness scale, Psychomotor Vigilance Test (PVT), and pupillometry.

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    OpenTrials
    Clinical Trial . 2010
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2010
      Data sources: OpenTrials
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    Authors: Diaz, George;

    Protein turnover is a cyclic process with a net loss of protein in the fasting state and a net gain in the fed state contributing to nitrogen balance. These physiologic processes are impacted during infection; whole-body protein catabolism exceeds protein synthesis, resulting in net loss of whole-body protein. Patients with urea cycle disorders suffer episodes of periodic hyperammonemic crisis, often in association with intercurrent infections. The immediate cause of this decompensation is the increase in endogenous protein catabolism that is the endpoint of a cascade triggered by intercurrent illness. This increase in protein catabolism leads to elevations of serum amino acids and ammonia production, which cannot be eliminated by a dysfunctional urea cycle. It is well known that infectious illnesses play a significant role in precipitating metabolic crises in urea cycle defects, presumably by triggering a cascade of events involving the release of inflammatory cytokines that lead to increased protein catabolism. Cytokines have also been implicated as distant mediators of oxidative stress. However, the correlation between oxidative stress, cytokine levels, and severity of a crisis is currently unclear. The primary purpose of the proposed study is to characterize the oxidative stress and inflammatory cytokine status in UCD during baseline and decompensated states. The investigators will undertake measurements of selected markers of oxidative stress and cytokines in serum and urine during baseline and decompensated states in subjects with UCD in order to establish their prognostic value as biomarkers for disease severity and/or predictors of metabolic decompensation. The primary purpose of the proposed study is to characterize the oxidative stress and inflammatory cytokine status in UCD during baseline and decompensated states.

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    OpenTrials
    Clinical Trial . 2012
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2012
      Data sources: OpenTrials
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    Authors: Hazir, Tabish;

    INTRODUCTION: World Health Organization's (WHO) standard case management strategy for reducing ARI related mortality recommends oral cotrimoxazole and oral amoxicillin as first line drugs for the treatment of pneumonia. In 1989, the Pakistan Ministry of Health (MOH) adopted this strategy to control ARI mortality and recommended cotrimoxazole for treatment of outpatients pneumonia due to lower costs. A number of studies subsequently performed have shown significant in vivo and in vitro resistance of H. influenzae and S. pneumoniae, the commonest bacteria causing childhood pneumonia, to cotrimoxazole. This increase in clinical failure with oral cotrimoxazole has put a lot of pressure both at national and international forums on the National ARI Control Programme of Pakistan to change its recommendations from cotrimoxazole to amoxicillin as the first line of therapy. Besides being efficacious for non-severe pneumonia amoxicillin has shown good efficacy in children with severe pneumonia and bacteremic children. although on a case by case basis for pneumonia, in vitro resistance does not correlate very well with in vivo failures. One can hypothesize that if bacterial pneumonia is a certain proportion of all pneumonia cases, the rise in clinical failures may be related to increasing antimicrobial resistance of S. pneumoniae and H. influenzae to amoxicillin. It is felt that WHO criteria for treatment failure are too stringent. Improvement is defined as the return of respiratory rate to below the cut off for that particular age at 48 hours. Some of the children with viral pneumonia will continue to have respiratory rate above the cut off on the first follow-up. These children are otherwise well and show no signs of deterioration of the disease but according to WHO criteria they would be classified as treatment failure. The treatment failure rates hence are influenced by the definitions used. The existing data shows that if we increase the dose of amoxicillin to achieve higher MICs then the eradication of causative organism tend to be much more complete. As yet, no clinical trial has been conducted to address this important question in the treatment of childhood pneumonia. We propose a multicentre, randomized, controlled double blind trial in which we will compare standard versus double dose oral amoxicillin for three days for the treatment of non-severe pneumonia in children less than five years of age. Primary Objectives: 1. To compare the proportion of children 2 - 59 months of age presenting with non-severe pneumonia, who achieve clinical resolution on day 5 with standard (15 mg/kg/8hrly) versus double dose (30 mg/kg/8hrly) of oral amoxicillin therapy given for 3 days. Secondary Objective: To follow the clinical course of non-severe pneumonia with the alternative criteria of treatment failure (signs of deterioration i.e. lower chest indrawing and appearance of danger signs) on or before day 3 and compare them with other children who have persistent fast breathing (respiratory rate above the cut off for age) on day 3. Null Hypothesis: Therapy outcome with double dose of oral amoxicillin is not different than the standard dose of amoxicillin, when used for three days for the treatment of non-severe pneumonia in 2-59 months old children. STUDY POPULATION AND SITE: Patients: They will be recruited from those coming to outpatient departments (OPD) in large tertiary care hospitals in Pakistan. CONSENT: The purpose of the study will be explained to parents and oral informed consent to participate obtained. A proposed consent form is attached (Annex. 1). Study Design: This will be a randomized, double blind, multi-centre trial. Definitions: ARI is defined according to the WHO ARI Programme guidelines 2 for children who have either a cough or difficult breathing. A clinical resolution is defined as return of respiratory rate to normal (no pneumonia) according to WHO ARI standard case management classification 2. Clinical Failure is defined as development of chest indrawing; or any other danger sign; or persistence of fast breathing at day 5 follow-up or thereafter leading to therapy change. Improved will be defined as slower respiratory rate (either back to normal range for age, or lower by more than 5 compared to previous evaluation), feeding better according to mother and lower body temperature than previous assessment. Same will be defined as still breathing fast (respiratory rate ± 5 breaths/minute compared to previous evaluation or higher than that), with no chest indrawing and or danger sign. Worse will be defined as development of lower chest indrawing or any danger sign. A relapse is defined as development of recurrence signs of pneumonia till day 14 after fast breathing has disappeared initially. Follow-up: All children will be followed-up on day 3, 5 and 14. Sample size: Keeping in mind the overall treatment failure rate of 20.9% with amoxicillin from the MASCOT study (1999 - 2001), it is expected that the proportion of patients who will fail to respond with standard dose amoxicillin will be around 21.0%.7 In order for double dose to be more efficacious there should be a difference of more than 5% in the treatment success rate as compared to the standard dose. We assume that the failure rate will not be more than 13% with double dose amoxicillin. By using the power of 80% and the confidence interval of 95%, the estimated sample size comes to 369 for each group. Assuming the loss to follow up to be 15% (as it is an out patient study and having day 14 follow-up) the estimated sample size will be 425 patients in each group, a total of 850 patients. Thus 900 patients will be enrolled in one and a half ARI season. DATA ENTRY AND ANALYSIS: Data forms will all be filled on auto copy forms and will be reviewed by the site co-ordinator. Data will be entered using Epi Info 6 and will be entered twice by two separate operators and both data bases will be validated using Epi Info 6. Outcome measures: A clinical resolution is defined as return of respiratory rate to normal (no pneumonia) on day 5, according to WHO ARI standard case management classification. Clinical/treatment Failure is defined as development of chest indrawing; or any other danger sign; or persistence of fast breathing at day 5 follow-up or thereafter leading to therapy change. Data analysis: Analysis will be carried out on intention to treat basis. For primary outcome proportion of therapy failures and their 95% CI will be calculated for both the two regimens. Then we will compare proportion of therapy failure using alternative criteria and WHO defined conventional therapy failure criteria. Over a period of years there have been numerous reports from many developing countries including Pakistan showing a rising treatment failure rate with first line drugs (amoxicillin and cotrimoxazole) in non-severe pneumonia in children. The reasons for this rise in treatment failure rates are not entirely clear but one of the reasons is thought to be increasing antimicrobial resistance of H. influenzae and Strep. pneumoniae to first line drugs. There is microbiological data which suggests that this resistance can be overcome by increasing the dose of amoxicillin. The investigators propose to treat non-severe pneumonia with double dose amoxicillin in an attempt to demonstrate a decrease in treatment failure rates. This will be a multicentre, double blind randomized controlled trial in children 2-59 months of age with non-severe pneumonia comparing the clinical outcome between the standard and double dose groups. It has been felt that the WHO criteria for treatment failure in children with pneumonia are too stringent and have never been systematically evaluated in the community. The investigators also propose to modify WHO criteria and field test them in this trial in an attempt to demonstrate that less stringent treatment failure criteria would have an impact on the overall treatment failure rates in pneumonia. Hypothesis: Therapy outcome with double dose of oral amoxicillin is not different than the standard dose of amoxicillin, when used for three days for the treatment of non-severe pneumonia in 2-59 months old children.

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    OpenTrials
    Clinical Trial . 2005
    Data sources: OpenTrials
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    OpenTrials
    Clinical Trial . 2011
    Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2005
      Data sources: OpenTrials
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      OpenTrials
      Clinical Trial . 2011
      Data sources: OpenTrials
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    Authors: Ernst, Armin;

    TBM is an abnormal collapse of the tracheal and bronchial walls. It is characterized by flaccidity of the supporting tracheal and bronchial structures and a significant reduction of airway diameter on expiration seen in the trachea and/or in the mainstem bronchi. Currently there is no available data on the efficacy of central airway stabilization for treating TBM. Our study would provide this important information and would establish the effect of central airway stabilization on symptoms, functional status, quality of life, lung function and exercise capacity in patients with symptomatic and severe TBM. The purpose of this study is to evaluate respiratory symptoms and their impact in the quality of life and after treatment of the respiratory condition (tracheobronchomalacia - TBM).

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    OpenTrials
    Clinical Trial . 2007
    Data sources: OpenTrials
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      Clinical Trial . 2007
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    Authors: Rama, Paolo;

    This is a multinational, multicentre, prospective, open label, uncontrolled clinical trial. Patients will be screened according to the Study Inclusion and Exclusion criteria and will be candidates for the ACLSCT if all eligibility criteria are met. Patients then will undergo limbal biopsy for the collection of limbal stem cells for product manufacturing. The confirmation of the eligibility criteria is followed by a roll-in phase of approximately 6 months. At the end of the roll-in period, Holoclar will be implanted through a specific surgical procedure. After ACLSCT, efficacy assessments will be performed at 1, 3, 6, 9 and 12 months for both first and second treatment (the latter only when applicable). One year after the transplantation, efficacy will be adjudicated by two independent assessors (primary and key secondary endpoints) and the study completion will be reached when 1 year of follow-up after the last transplant in the last patient will be accomplished. The purpose of this trial is to confirm the efficacy of Holoclar at one year after the first treatment in patients suffering from moderate to severe LSCD (Limbal Stem Cell Deficiency) secondary to ocular burns. In case of failure of the treatment and upon clinical indication of the Principal Investigator, a second transplant with Holoclar will be offered if eligibility will be confirmed. The efficacy of two treatments with Holoclar at one year after the last treatment will be also evaluated. All patients will be followed-up for 12 months after each implant to determine the treatment efficacy by an Independent Assessor.

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    OpenTrials
    Clinical Trial . 2015
    Data sources: OpenTrials
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      Clinical Trial . 2015
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    Authors: Kuo, Hann-Chorng; Chuang, Yao-Chi;

    Overactive bladder (OAB) is a symptom syndrome characterized by urgency frequency with or without urgency incontinence, usually no metabolic or anatomical disorders can be found and it may have great impact on quality of life. Traditional medication for OAB is antimuscarinic agent which targets at the muscarinic receptors. There are several adverse events such as dry mouth, constipation, blurred vision, and dizziness related to antimuscarinics, therefore, some patients cannot tolerated this treatment. Intravesical botulinum toxin A (BoNT-A) has recently emerged as novel treatment for OAB refractory to antimuscarinics, however, BoNT-A injection can cause acute urinary retention and large postvoid residual. Urinary tract infection usually occurred following large postvoid residual and urinary retention. If we can deliver BoNT-A through the urothelium to the suburothelial space, but not into the detrusor layer, we might have therapeutic effects on the urothelial sensory nerves without compromising the detrusor contractility. This treatment will enable us to prevent the undesired detrusor underactivity after BoNT-A injection, especially in the elderly patients who had impaired detrusor contractility and OAB. Liposomes are vesicles, composed of concentric phospholipid bilayers separated by aqueous compartments. Because liposomes adsorb to cell surfaces and fuse with cells, they are being used as vehicles for drug delivery and gene therapy. In this grant we will evaluate liquid liposome delivery of BoNT-A (Liposome encapsulated BoNT-A) into the bladder without the need for cystoscopic-guided needle injection for refractory OAB, and study the mechanism of action of intravesical liposomal drug delivery. If successful, we will leverage our technology transfer expertise and bring the science from the bench top to the bed side to apply for a physician sponsored Investigational New Drug (IND) trial using liposome-BoNT in patients with OAB or DO. Overactive bladder (OAB) is a bothered symptom syndrome. Traditional medication for OAB is antimuscarinic agent. However, adverse events such as dry mouth, constipation, blurred vision, and dizziness may prohibit patient to take this drug for OAB. Intravesical botulinum toxin A (BoNT-A) is a novel treatment however, BoNT-A can cause acute urinary retention and large postvoid residual. In this grant we will evaluate liquid liposome delivery of BoNT-A (Liposome encapsulated BoNT-A) into the bladder without the need for cystoscopic-guided needle injection for refractory OAB.

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    OpenTrials
    Clinical Trial . 2010
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      Clinical Trial . 2010
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  • Authors: A F, Parisi;
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    Authors: Vullo, Vincenzo;

    Combined antiretroviral therapy (cART)-treated patients have increased mortality and morbidity compared to age-matched seronegative individuals. This increased mortality and morbidity has been associated to immune activation that persists also in patients under cART even with undetectable levels of HIV-RNA in blood. Indeed, HIV-infected patients, irrespective of cART treatment, show higher levels of activated T cells, inflammatory monocytes and proinflammatory cytokines than seronegative individuals. Several putative causes of this residual inflammation have been proposed and include ongoing HIV replication at low levels, the presence of coinfections such as cytomegalovirus, and microbial translocation. None of these causes are mutually exclusive and understanding the degree to which of these three cause residual inflammation in cART-treated individuals will require novel therapeutic interventions aimed at alleviated each putative cause. In this longitudinal study we aim: 1. to reduce microbial translocation induced inflammation in cART-treated individuals with supplementation of cART with the probiotics. 2. to investigate the potential benefits of 24 weeks of probiotics supplementation on immune function and on immune activation status Indeed, the early stage of HIV infection is associated with dysbiosis of the GI tract microbiome with reducted levels of bifidobacteria and lactobacillus species with increased levels of potentially pathogenic proteobacteria species.

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    Clinical Trial . 2014
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      Clinical Trial . 2014
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150,105 Research products
  • 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: Jackson, Hannah;

    Objectives: Chronic Fatigue Syndrome (CFS) is a medically unexplained condition characterized by severe and disabling fatigue. To date much research has focused on finding out whether CFS is caused by mainly physical or psychological factors. Perhaps as a result of this, few studies have examined the relationship between CFS and quality of life, in particular, more positive aspects of mental health, such as an individual's sense of purpose, autonomy and close relationships. This study will address these limitations by examining Ryff's (1989) six domains of psychological well-being (PWB), and other aspects of well-being including positive emotions, in CFS. It will also examine the relationship between measures of symptomology, emotional distress and PWB. Method: This is a cross-sectional, questionnaire-based study with a clinical sample of adults with CFS. Participants will complete valid measures of well-being and symptomology. Results: We expect to find that compared to general population norms, individuals with CFS score lower on measures of PWB. Secondly, we expect PWB dimensions will be related to symptom measures. There are however, no grounds for making strong predictions. Implications: This study will advance our understanding of quality of life in CFS. Clinically, it has the potential to enrich and inform therapeutic interventions.

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    OpenTrials
    Clinical Trial . 2014
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      Clinical Trial . 2014
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    Authors: Woodson, B Tucker;

    It has been shown that there is an inconsistent response in serum cortisol levels in patients with Obstructive Sleep Apnea Syndrome (OSAS), but it is undetermined whether a change in hormone level was not seen due to compliance issues in these long-term studies. These investigators will be employing compliance monitoring continuous positive airway pressure (CPAP) machines and also assessing "sleepiness" before and after therapy. Sleepiness is the dependent variable in our study and will be measured subjectively using sleepiness scales and objectively using Psychomotor Vigilance Test (PVT) and an autonomic measure using pupillometry prior, during and after treatment. Patients with Obstructive Sleep Apnea Syndrome (OSAS) will evidence higher levels of salivary cortisol and alpha-amylase levels prior to use of placebo and continuous positive airway pressure (CPAP) and will evidence a decrease in these levels after consistent use of continuous positive airway pressure (CPAP) therapy as compared to placebo. Their level of sleepiness will also decrease with the use of CPAP therapy and will correlate with the levels of salivary cortisol and alpha-amylase in relation to their subjective sleepiness scale, Psychomotor Vigilance Test (PVT), and pupillometry.

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    OpenTrials
    Clinical Trial . 2010
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      OpenTrials
      Clinical Trial . 2010
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    Authors: Diaz, George;

    Protein turnover is a cyclic process with a net loss of protein in the fasting state and a net gain in the fed state contributing to nitrogen balance. These physiologic processes are impacted during infection; whole-body protein catabolism exceeds protein synthesis, resulting in net loss of whole-body protein. Patients with urea cycle disorders suffer episodes of periodic hyperammonemic crisis, often in association with intercurrent infections. The immediate cause of this decompensation is the increase in endogenous protein catabolism that is the endpoint of a cascade triggered by intercurrent illness. This increase in protein catabolism leads to elevations of serum amino acids and ammonia production, which cannot be eliminated by a dysfunctional urea cycle. It is well known that infectious illnesses play a significant role in precipitating metabolic crises in urea cycle defects, presumably by triggering a cascade of events involving the release of inflammatory cytokines that lead to increased protein catabolism. Cytokines have also been implicated as distant mediators of oxidative stress. However, the correlation between oxidative stress, cytokine levels, and severity of a crisis is currently unclear. The primary purpose of the proposed study is to characterize the oxidative stress and inflammatory cytokine status in UCD during baseline and decompensated states. The investigators will undertake measurements of selected markers of oxidative stress and cytokines in serum and urine during baseline and decompensated states in subjects with UCD in order to establish their prognostic value as biomarkers for disease severity and/or predictors of metabolic decompensation. The primary purpose of the proposed study is to characterize the oxidative stress and inflammatory cytokine status in UCD during baseline and decompensated states.

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    OpenTrials
    Clinical Trial . 2012
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      Clinical Trial . 2012
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  • addClaim

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    Authors: Hazir, Tabish;

    INTRODUCTION: World Health Organization's (WHO) standard case management strategy for reducing ARI related mortality recommends oral cotrimoxazole and oral amoxicillin as first line drugs for the treatment of pneumonia. In 1989, the Pakistan Ministry of Health (MOH) adopted this strategy to control ARI mortality and recommended cotrimoxazole for treatment of outpatients pneumonia due to lower costs. A number of studies subsequently performed have shown significant in vivo and in vitro resistance of H. influenzae and S. pneumoniae, the commonest bacteria causing childhood pneumonia, to cotrimoxazole. This increase in clinical failure with oral cotrimoxazole has put a lot of pressure both at national and international forums on the National ARI Control Programme of Pakistan to change its recommendations from cotrimoxazole to amoxicillin as the first line of therapy. Besides being efficacious for non-severe pneumonia amoxicillin has shown good efficacy in children with severe pneumonia and bacteremic children. although on a case by case basis for pneumonia, in vitro resistance does not correlate very well with in vivo failures. One can hypothesize that if bacterial pneumonia is a certain proportion of all pneumonia cases, the rise in clinical failures may be related to increasing antimicrobial resistance of S. pneumoniae and H. influenzae to amoxicillin. It is felt that WHO criteria for treatment failure are too stringent. Improvement is defined as the return of respiratory rate to below the cut off for that particular age at 48 hours. Some of the children with viral pneumonia will continue to have respiratory rate above the cut off on the first follow-up. These children are otherwise well and show no signs of deterioration of the disease but according to WHO criteria they would be classified as treatment failure. The treatment failure rates hence are influenced by the definitions used. The existing data shows that if we increase the dose of amoxicillin to achieve higher MICs then the eradication of causative organism tend to be much more complete. As yet, no clinical trial has been conducted to address this important question in the treatment of childhood pneumonia. We propose a multicentre, randomized, controlled double blind trial in which we will compare standard versus double dose oral amoxicillin for three days for the treatment of non-severe pneumonia in children less than five years of age. Primary Objectives: 1. To compare the proportion of children 2 - 59 months of age presenting with non-severe pneumonia, who achieve clinical resolution on day 5 with standard (15 mg/kg/8hrly) versus double dose (30 mg/kg/8hrly) of oral amoxicillin therapy given for 3 days. Secondary Objective: To follow the clinical course of non-severe pneumonia with the alternative criteria of treatment failure (signs of deterioration i.e. lower chest indrawing and appearance of danger signs) on or before day 3 and compare them with other children who have persistent fast breathing (respiratory rate above the cut off for age) on day 3. Null Hypothesis: Therapy outcome with double dose of oral amoxicillin is not different than the standard dose of amoxicillin, when used for three days for the treatment of non-severe pneumonia in 2-59 months old children. STUDY POPULATION AND SITE: Patients: They will be recruited from those coming to outpatient departments (OPD) in large tertiary care hospitals in Pakistan. CONSENT: The purpose of the study will be explained to parents and oral informed consent to participate obtained. A proposed consent form is attached (Annex. 1). Study Design: This will be a randomized, double blind, multi-centre trial. Definitions: ARI is defined according to the WHO ARI Programme guidelines 2 for children who have either a cough or difficult breathing. A clinical resolution is defined as return of respiratory rate to normal (no pneumonia) according to WHO ARI standard case management classification 2. Clinical Failure is defined as development of chest indrawing; or any other danger sign; or persistence of fast breathing at day 5 follow-up or thereafter leading to therapy change. Improved will be defined as slower respiratory rate (either back to normal range for age, or lower by more than 5 compared to previous evaluation), feeding better according to mother and lower body temperature than previous assessment. Same will be defined as still breathing fast (respiratory rate ± 5 breaths/minute compared to previous evaluation or higher than that), with no chest indrawing and or danger sign. Worse will be defined as development of lower chest indrawing or any danger sign. A relapse is defined as development of recurrence signs of pneumonia till day 14 after fast breathing has disappeared initially. Follow-up: All children will be followed-up on day 3, 5 and 14. Sample size: Keeping in mind the overall treatment failure rate of 20.9% with amoxicillin from the MASCOT study (1999 - 2001), it is expected that the proportion of patients who will fail to respond with standard dose amoxicillin will be around 21.0%.7 In order for double dose to be more efficacious there should be a difference of more than 5% in the treatment success rate as compared to the standard dose. We assume that the failure rate will not be more than 13% with double dose amoxicillin. By using the power of 80% and the confidence interval of 95%, the estimated sample size comes to 369 for each group. Assuming the loss to follow up to be 15% (as it is an out patient study and having day 14 follow-up) the estimated sample size will be 425 patients in each group, a total of 850 patients. Thus 900 patients will be enrolled in one and a half ARI season. DATA ENTRY AND ANALYSIS: Data forms will all be filled on auto copy forms and will be reviewed by the site co-ordinator. Data will be entered using Epi Info 6 and will be entered twice by two separate operators and both data bases will be validated using Epi Info 6. Outcome measures: A clinical resolution is defined as return of respiratory rate to normal (no pneumonia) on day 5, according to WHO ARI standard case management classification. Clinical/treatment Failure is defined as development of chest indrawing; or any other danger sign; or persistence of fast breathing at day 5 follow-up or thereafter leading to therapy change. Data analysis: Analysis will be carried out on intention to treat basis. For primary outcome proportion of therapy failures and their 95% CI will be calculated for both the two regimens. Then we will compare proportion of therapy failure using alternative criteria and WHO defined conventional therapy failure criteria. Over a period of years there have been numerous reports from many developing countries including Pakistan showing a rising treatment failure rate with first line drugs (amoxicillin and cotrimoxazole) in non-severe pneumonia in children. The reasons for this rise in treatment failure rates are not entirely clear but one of the reasons is thought to be increasing antimicrobial resistance of H. influenzae and Strep. pneumoniae to first line drugs. There is microbiological data which suggests that this resistance can be overcome by increasing the dose of amoxicillin. The investigators propose to treat non-severe pneumonia with double dose amoxicillin in an attempt to demonstrate a decrease in treatment failure rates. This will be a multicentre, double blind randomized controlled trial in children 2-59 months of age with non-severe pneumonia comparing the clinical outcome between the standard and double dose groups. It has been felt that the WHO criteria for treatment failure in children with pneumonia are too stringent and have never been systematically evaluated in the community. The investigators also propose to modify WHO criteria and field test them in this trial in an attempt to demonstrate that less stringent treatment failure criteria would have an impact on the overall treatment failure rates in pneumonia. Hypothesis: Therapy outcome with double dose of oral amoxicillin is not different than the standard dose of amoxicillin, when used for three days for the treatment of non-severe pneumonia in 2-59 months old children.

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    Clinical Trial . 2005
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    Clinical Trial . 2011
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      Clinical Trial . 2005
      Data sources: OpenTrials
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      Clinical Trial . 2011
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    Authors: Ernst, Armin;

    TBM is an abnormal collapse of the tracheal and bronchial walls. It is characterized by flaccidity of the supporting tracheal and bronchial structures and a significant reduction of airway diameter on expiration seen in the trachea and/or in the mainstem bronchi. Currently there is no available data on the efficacy of central airway stabilization for treating TBM. Our study would provide this important information and would establish the effect of central airway stabilization on symptoms, functional status, quality of life, lung function and exercise capacity in patients with symptomatic and severe TBM. The purpose of this study is to evaluate respiratory symptoms and their impact in the quality of life and after treatment of the respiratory condition (tracheobronchomalacia - TBM).

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    Clinical Trial . 2007
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      OpenTrials
      Clinical Trial . 2007
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    Authors: Rama, Paolo;

    This is a multinational, multicentre, prospective, open label, uncontrolled clinical trial. Patients will be screened according to the Study Inclusion and Exclusion criteria and will be candidates for the ACLSCT if all eligibility criteria are met. Patients then will undergo limbal biopsy for the collection of limbal stem cells for product manufacturing. The confirmation of the eligibility criteria is followed by a roll-in phase of approximately 6 months. At the end of the roll-in period, Holoclar will be implanted through a specific surgical procedure. After ACLSCT, efficacy assessments will be performed at 1, 3, 6, 9 and 12 months for both first and second treatment (the latter only when applicable). One year after the transplantation, efficacy will be adjudicated by two independent assessors (primary and key secondary endpoints) and the study completion will be reached when 1 year of follow-up after the last transplant in the last patient will be accomplished. The purpose of this trial is to confirm the efficacy of Holoclar at one year after the first treatment in patients suffering from moderate to severe LSCD (Limbal Stem Cell Deficiency) secondary to ocular burns. In case of failure of the treatment and upon clinical indication of the Principal Investigator, a second transplant with Holoclar will be offered if eligibility will be confirmed. The efficacy of two treatments with Holoclar at one year after the last treatment will be also evaluated. All patients will be followed-up for 12 months after each implant to determine the treatment efficacy by an Independent Assessor.

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    OpenTrials
    Clinical Trial . 2015
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