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ClinicalTrialSummary

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Follow up of debanding patients regarding cardiometabolic risk factors	Follow up of debanding patients
The specific aims of this pilot study are to: 1) build a recruitment pool of older adults within the local community; 2) establish a protocol for long-term surveillance of falls for older adult chiropractic patients; 3) explore dose-response patterns to chiropractic care by comparing Berg Balance Scale scores at 12 months from baseline in three groups of older adults with impaired balance.	The purpose is to study the effect of chiropractic care on balance in older adults.
Obstructive sleep apnea syndrome (OSAS) is a common disease, which occurs in 4% middle-aged men and 2% middle-aged women. The characteristic of OSA is recurrent collapse of upper airway during sleep, which results in intermittent hypoxia and sympathetic activation. Cardiovascular complications associated with OSA include artherosclerosis, hypertension, coronary artery disease and congestive heart failure. Several inflammatory mediators including C-reactive protein (CRP), oxidative stress, adhesion molecules, vascular endothelial growth factor and proinflammatory cytokines, were found to be elevated in OSA, which attribute the developments of cardiovascular diseases in OSA. Our data showed serum levels of TNF were higher in OSA patients than in control subjects. And serum levels of TNF were inversely correlated with the lowest pulse oxygen saturation. After one-month CPAP treatment, serum of TNF could significantly go down. This finding suggested TNF was a good biomarker in studying OSA associated cardiovascular complications.~The presentations of sympathetic hyperactivity in OSA include hypercatecholaminemia and elevated sympathetic tone of peripheral nerve. Hypercatecholaminemia is known for attributing to the development of cardiovascular diseases. Our data showed plasma levels of both epinephrine and norepinephrine were higher in OSA patients than in control subjects. And the elevated catecholamine could go down after one-month CPAP treatment. Meanwhile, our data also showed the plasma levels of catecholamine were highly correlated with serum levels of TNF.~In vivo studies showed both epinephrine and norepinephrine could potentiate LPS-induced expression of TNF through 2 adrenergic receptors. However, the effect of catecholamine on TNF production in human monocytes in the hypoxic microenvironment has never been studied. Our preliminary data showed epinephrine had no effect on TNF expression in human monocyte cell line U937 under normoxic condition but could attenuate the TNF expression under hypoxic condition. Therefore, we hypothesize that catecholamines can modulate intermittent hypoxia induced TNF and further affect the developments of cardiovascular complications in OSA. In this project, we'll use peripheral blood monocytes from healthy subjects and OSA patients as the target cells, which were serially treated with catecholamine  or b antagonists in both normoxic and hypoxic microenvironments, to achieve the following 3 objectives:~. To examine the effect of catecholamines on the modulation of intermittent hypoxia induced TNF- in human monocytes from both healthy subjects and OSA patients~. To map the signaling pathway of catecholamines regulating the intermittent hypoxia induced TNF- expression.~. To explore the potential therapeutic effects of  or  agonists/antagonists on intermittent hypoxia induced TNF- expression	Specific aim To examine the effect of catecholamines on the modulation of intermittent hypoxia induced TNF- in human monocytes from both healthy subjects and OSA patients (2). To map the signaling pathway of catecholamines regulating the intermittent hypoxia induced TNF- expression.~(3). To explore the potential therapeutic effects of  or  agonists/antagonists on intermittent hypoxia induced TNF- expression
OBJECTIVES:~Primary~Determine the efficacy of Regenecare® wound gel in alleviating pain and itching in patients who develop an acneiform rash while undergoing treatment with cetuximab or other EGFR inhibitor therapy for cancer.~Secondary~Determine the efficacy of this drug in reducing the severity of rash in these patients.~Determine the efficacy of this drug in reducing the redness and appearance of the rash in these patients.~Determine the tolerability of this drug in these patients.~OUTLINE: This is a prospective study.~Observation: Patients undergo evaluation by full-face photography prior to development of skin rash (baseline). While undergoing concurrent cancer therapy, patients self-monitor for the appearance of an acneiform rash. Upon initial onset of rash, patients proceed to treatment.~Treatment: Patients apply topical Regenecare® wound gel to the face ≥ 4 times daily. Treatment continues for 4 weeks in the absence of unacceptable toxicity.~Patients are evaluated weekly by facial examination, full-face photography, and patient satisfaction questionnaires.	RATIONALE: Regenecare® wound gel may help relieve pain and itching in patients who develop an acne-like rash while undergoing treatment with cetuximab or another epidermal growth factor receptor inhibitor for cancer.~PURPOSE: This clinical trial is studying how well Regenecare® wound gel works in treating rash in patients receiving cetuximab or another epidermal growth factor receptor inhibitor therapy for cancer.
In daily practice the expiratory flow limitation is measured by body plethysmography. An open loop in body plethysmography shows expiratory flow limitation in COPD patients. But body plethysmography requires that the patient quietly sits in a closed box and is not able to follow changes breath by breath. The goal of this study is to validate the Forced oscillation technique (FOT) for measuring expiratory flow limitation in COPD patients.30 COPD patients with an open loop in body plethysmography are compared to 30 COPD patients with a closed loop. The methods used in this study are the maximal overlap discrete short time Fourier transform (MODFT) combined with a total least squares analysis. It is hypothesized that the obtained FOT parameters are able to distinguish the patients with expiratory flow limitation in body plethysmography from the patients without expiratory flow limitation in body plethysmography.Secondary study questions are: 1) to what extend are the FOT parameters distorted by breathing artifacts and measurement noise. 2)What changes can be detected by FOT in expiratory flow limitation after administration of salbutamol.	The aim of this study is to distinguish COPD patients with expiratory flow limitation in body plethysmography (open loop) from the patients without expiratory flow limitation in body plethysmography (closed loop) with the obtained FOT parameters.
To assess the efficacy and safety of efficacy of MTS compared to placebo, as determined by the change in the clinician completed ADHD Rating Scale - Version 4th Edition (ADHD-RS-IV), in the symptomatic treatment of adolescents (aged 13-17 years) diagnosed with ADHD.	To assess the efficacy and safety of efficacy of MTS compared to placebo
This study was designed to examine whether and how provoking thoughts of mortality among medical students can influence cardiac risk assessments depending on the religion of the target patient.	This study was designed to examine if provoking thoughts of mortality among medical students can influence cardiac risk assessments depending on the religion of the target patient.
To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in the symptomatic treatment of adolescents aged 13-17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. The evaluation of safety will be based on treatment-emergent adverse events (TEAEs), laboratory tests, vital signs, physical examinations, electrocardiograms (ECGs), and skin tolerability to MTS based on the dermal response score (DRS).	To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17 years diagnosed withADHD
The ADRIE study is an observational study on the clinical relevance of platelet reactivity in aspirin and clopidogrel treated cardiovascular patients.~Main objective:~to determine if platelet reactivity, assessed by specific and non-specific tests, is predictive of ischemic events during the 3-year follow-up.~Secondary objectives:~primary outcome in each pre-specified sub-group : patients with coronary artery disease, ischemic stroke or peripheral arterial disease as main qualifying disease at entry,~to determine if platelet reactivity, assessed by specific and non-specific tests, is predictive of bleeding events during the 3-year follow-up,~to investigate potential determinants of platelet reactivity at entry in the study	The ADRIE study is an observational study on the clinical relevance of platelet reactivity in aspirin and clopidogrel treated cardiovascular patients.
The aims of the present study were to investigate the association between adiponectin allele +45(T/G) and -11377(C/G) polymorphisms and the response to rosiglitazone monotherapy in T2D patients.~A total of 255 T2D patients (138 males, 117 females) aged from 25 to 70 years (mean 48.6 ± 10.7 years) and 120 healthy controls (53 females, 67 males) aged from 25 to 70 years(mean 47.1 ± 11.0 years) were enrolled to participate in this study. Physical examination, medical history and serum biochemical tests were performed to identify healthy or T2D subjects. The diagnosis criteria of T2D patients were made according to the World Health Organization in 1997 by fasting plasma glucose (FPG  7.0 mmol/L) and/or postprandial plasma glucose test (PPG  11.1 mmol/L). The inclusion criteria of all subjects were that subjects had the range of body mass index (BMI) from 18.5 to 30 kg/m2 and did not administrate any PPAR agonists in the last 3 months. Patients who were receiving insulin treatment, pregnant or lactating women, or with serious diseases such as acute myocardial infarction, cerebral vascular accident, trauma, and kidney disease or liver disease were excluded from this study. Table 1 showed the characteristic profiles of T2D patients and healthy controls. There were no statistical differences in the age, height, weight, and BMI value between T2D patients and healthy controls. All subjects were recruited from local residents in Changsha city, Hunan Province, P. R. China. The study protocol was approved by the Ethics Committee of Xiangya School of Medicine, Central South University and written informed consents were obtained before the start of this study. A total of 42 T2D patients (23 male, 19 female) were randomly selected to be only treated with 4mg rosiglitazone daily for 12 consecutive weeks without change in previous medications.	The aims of the present study were to investigate the association between adiponectin gene polymorphisms and the response to rosiglitazone monotherapy in T2D patients.~A total of 255 T2D patients and 120 health volunteers were enrolled in this study. 42 T2D patients with -11377(C/G) or +45(T/G) genotypes were selected to administrate orally 4mg rosiglitazone daily for 12 consecutive weeks.
The prevalence of diabetes is increasing in all countries, especially India at an alarming rate. Appropriate interventions in the form of weight reduction, changes in dietary habits and increased physical activity could help in preventing or delaying the onset of diabetes and reducing the burden due to non communicable diseases in India.~Plants or their extracts may also have a potential therapeutic role in the treatment for diabetes. Coccinia indica (synonym Coccinia cordifolia), a herb that belongs to the Cucurbitaceae family and that grows abundantly in India, is widely used in the traditional treatment of diabetes mellitus. Coccinia leaves, when administered orally twice a day for six weeks, to patients with untreated but uncomplicated maturity onset diabetes demonstrated hypoglycemic activity with significant improvement in glucose tolerance. The aim of the present study was to evaluate the effectiveness of Coccinia Cordifolia on the blood glucose levels of newly detected type 2 diabetic patients requiring only behavioral or lifestyle intervention.~The study was a double blind, placebo controlled, randomized trial. The study was carried out at Nutrition and Lifestyle Management Clinic, St. John's Medical College Hospital. After recruitment , the diabetic subjects were assigned either to the experimental or placebo group. They were provided with the extract for a period of 90 days. Prior to the intervention, the subjects underwent baseline investigations which included anthropometric, biochemical, dietary and physical activity assessment. These investigations were repeated at day 45 and day 90 of the study. The compliance of the subjects to the ingestion of capsules was documented every week when they reported to the Nutrition Clinic. All the study subjects were provided with standard dietary and physical activity advice for the control of their blood sugars. The compliance of the subjects to the prescribed diet and physical activity was assessed weekly by asking the subjects to rate their compliance on a scale of 0-100%.	The purpose of the study was to evaluate the effectiveness of Coccinia Cordifolia (synonym Coccinia indica) on the blood glucose levels of newly detected type 2 diabetic patients requiring only behavioral or lifestyle intervention. The hypothesis of the study is that there will be significant decrease in the blood glucose levels after a period of 90 days in the diabetic patients who consumed the coccinia extract.
Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea To show that the use of pessary makes it possible to lengthen the duration of the pregnancy of at least 10 days in patients with a twin pregnancy and a uterine collar length < = 25 mm measured by echography between 20 and 28 SA compared to the group controls.	Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea
Introduction.~After an episode of acute respiratory failure requiring mechanical ventilation, weaning the patient from the ventilator may be difficult. Discontinuation of ventilation is estimated to take up to 40% of the total duration of ventilatory support. Approximately two- thirds of patients can be disconnected from the ventilator after a spontaneous breathing trial. Prolongation of mechanical ventilation may increase the risk of adverse events such as infections and can increase morbidity and mortality.~Identifying weaning readiness early and reliably is therefore crucial. Weaning protocols developed to assist in identifying weaning readiness have been shown to shorten duration of mechanical ventilation, most notably the weaning period.~Closed loop knowledge-based systems serve as a continuously applied weaning process that automatically reduce ventilatory assistance according to patient ability and indicate when the patient is ready for disconnection. No data on the use of such a computer driven system (CDS) in elderly patients requiring prolonged ventilation in weaning centers (non ICU) have been reported.~Objective:~To evaluate the ability of a computer driven system to predict weaning readiness and to compare this to a physician-directed protocol. The CDS continuously adapts pressure support, gradually decreasing ventilator assistance according to patient ability, and thus indicates weaning readiness. Patients who maintain spontaneous breathing for 7 days following weaning will be considered to be successfully weaned from mechanical ventilation.~Design and setting:~A single center, randomized, controlled clinical study at the Beit Rivka regional weaning center (RWC).~Patients.~This study will be conducted at the Beit Rivka geriatric rehabilitation hospital, Petah Tikva. Written informed consent will be obtained from the patient or legal representative. The study will include 60 consecutive patients who meet all inclusion criteria after stabilization of the acute health problems that prompted admission to the referral hospital. Inclusion criteria are as follows: pressure support ventilation (PSV) for at least 48 h, plateau pressure less than 30 cmH2O, PEEP < 6 cmH2O, PaO2/FIO2 ratio > 150 or SaO2 > 94% with FIO2 < than 0.5, pCO2 <55 mm Hg for normal patients and < 65 m Hg for patients with COPD, no requirement for inotropic support, body temperature > 36.50C and < 38.50 C, stable neurological status with Glasgow Coma Score (GCS) > 6, HgB > 8 mg %, systolic blood pressure >90 mg Hg, mean arterial pressure >65 mg Hg, absence of sedative medications and availability of CDS at the time of patient admission or switching to pressure support ventilation (PSV). Patients younger than 60 or older than 85 years of age, patients on chronic ventilatory assistance at home, and patients with decision to limit life-sustaining treatments will be excluded.~Treatment group assignment will be by a sealed envelope upon admission to the hospital. Attending doctors will not be blinded as to the treatment groups.~Description of the computer driven system.~The CDS is a knowledge- based system embedded in a ventilator (EVITA XL) (15, 16, 17). It achieves three main goals. First, the CDS continuously adjusts the PSV level based on respiratory rate (RR), tidal volume (Vt) and end-tidal partial pressure of CO2 (PETCO2) acquired from the ventilator in real time and averaged over 2 min. Adjustment is such that the patient is kept within a comfort zone defined as a RR between 15-30 range (up to 34 within patients with neurological disorders), Vt greater than 300 ml (< 250 ml if body weight < 55 kg), and PETCO-2 less than 55 mm Hg (< 65 mmHg in patients with COPD). Second, the CDS gradually decreases ventilatory assistance by reducing PSV level after at least 30 min of stable ventilation within the comfort zone; the reduction is by 2 or 4 cm H20 depending on whether the initial level is below or above 20 cm H2O, respectively. Third, the CDS evaluates weaning readiness: when the PSV level reaches the preset minimal value (9 cm H2O in tracheotomized patients), the CDS starts an observational period, which serves as automatic spontaneous breathing trial. After uninterrupted ventilation at the minimal PSV level for 1 or 2 h (depending on whether the initial PSV level was above or below 15 cm H2O), the CDS displays a message that the patient is ready to be disconnected from the ventilator. The investigator will have perfect knowledge of the system.~Prediction of weaning. Weaning readiness as evaluated by the CDS and by the internist will be recorded daily, i.e., every morning between 10 and 11 a.m. The decision will be considered to be taken by the CDS before the physician when it was taken 1 day in advance, i.e., the preceding morning. Physicians will be aware of the PSV level delivered by the CDS and could take this level into account in their evaluation. Weaning protocols used routinely in the center recommend a daily assessment for weaning similar to that used by the CDS. Patients are declared weaned as soon as the physician or CDS predicts weaning readiness. The control group reflects the standard of care before CDS implementation. PS of 10 cm H2O or higher is set manually. After 20 min, in the absence of signs of poor tolerance, the PSV is reduced by 4 or 2 cm H20 (depending on initial PSV level > or < 20). If poor tolerance to weaning is evident, the progression of the weaning is stopped, and the patient is reassessed 20 min later for further reduction in PSV. The PSV level is decreased to 9 cm H2O. In the case of apnea, SIMV is reinstituted. If the evaluation is satisfactory, the patient is disconnected from the ventilator. The patient is closely monitored for signs of respiratory failure requiring reinstitution of mechanical ventilation, as well as for occurrence of any other complications. RWC length of stay on MV will be recorded.~Clinical characteristics including age, sex, anthropometrical data, APACHE II score, Functional Independence Measure (FIM), Mini Mental State Examination (MMSE), Geriatric Depression Scale (GDS), Mini Nutritional Assessment (MNA), temperature, ny concomitant medications, hand grip strength will be recorded.~Expired tidal volume, respiratory rate, Peak airway pressure, mean airway pressure, Compliance, Resistance, respiratory frequency to tidal volume ratio (f/Vt ), Negative Inspiratory Pressure (NIP), Maximal Inspiratory Pressure (MIP), Minute Ventilation (MV),inspiratory time will be recorded .~Other elements relevant to mechanical ventilation management include arterial blood gas estimation, the number of changes in the settings of the ventilator performed by the health care workers, the number of transitions from controlled to assisted ventilation, and the number of apnea and high pressure alarms.~The primary outcome variables will be the duration of mechanical ventilation .~Discontinuation from MV will be attempted when the primary physician judges that the patient is ready to be weaned, according to the standard criteria. Mechanical ventilation will be reinstituted in the following circumstances: respiratory rate above 35 breaths /min, P02 below 65 mm Hg with FIO2less than 0.6, ph 7.34 or less, heart rate equal to or above 1 10 beats min or Increased by 20 % or more, or if arrhythmias appear, systolic blood pressure without inotropes <90 mmHg or above 20% of usual blood pressure, uncoordinated thoraco-abdominal movements, activation of accessory muscles, agitation or depressed mental status, or excessive sweating.~A weaning trial will be considered a failure when the patient will be not tolerate the weaning trial, patients still in the use CDW at day 60 and patients requires reconnection to MV. Weaning trial will be considered successful if spontaneous breathing is sustained for more than 168 h (7 days) after disconnection from MV .	After an episode of acute respiratory failure requiring mechanical ventilation, weaning the patient from the ventilator may be difficult. Discontinuation of ventilation is estimated to take up to 40% of the total duration of ventilatory support. Approximately two- thirds of patients can be disconnected from the ventilator after a spontaneous breathing trial. Prolongation of mechanical ventilation may increase the risk of adverse events such as infections and can increase morbidity and mortality.~Identifying weaning readiness early and reliably is therefore crucial. Weaning protocols developed to assist in identifying weaning readiness have been shown to shorten duration of mechanical ventilation, most notably the weaning period.~Closed loop knowledge-based systems serve as a continuously applied weaning process that automatically reduce ventilatory assistance according to patient ability and indicate when the patient is ready for disconnection. No data on the use of such a computer driven system (CDS) in elderly patients requiring prolonged ventilation in weaning centers (non ICU) have been reported.~The Objective of the present study is to evaluate the ability of a computer driven system to predict weaning readiness and to compare this to a physician-directed protocol. The CDS continuously adapts pressure support, gradually decreasing ventilator assistance according to patient ability, and thus indicates weaning readiness. Patients who maintain spontaneous breathing for 7 days following weaning will be considered to be successfully weaned from mechanical ventilation.
Menitorix is a combined Hib conjugate and meningococcal C conjugate vaccine made by GlaxoSmithKline. It is currently licensed and recommended as a booster vaccination for UK children in the second year of life.~It is important that staff who have a potential occupational exposure to infectious disease are afforded protection where possible [HPA Occupational Health Policy [Appendix 1]; HSE Safe working and the prevention of infection in clinical laboratories and similar facilities, 2003]. The licensure and availability of Menitorix provides the opportunity to vaccinate such staff.~Immune responses that are indicative of protection have been established for both Hib and meningococcal C disease [Andrews et al., 2003; Kayhty et al., 1983]. It is therefore proposed that the immune responses of those laboratory staff taking part be measured as data currently available following Menitorix vaccination is in naïve children and adults [Tejedor et al., 2006a and b; Carmona et al., 2006; Habermehl et al., 2006; Pace et al., 2006]. This study will also allow us to provide occupational healthcare to laboratory workers.~Laboratory staff at Manchester have not received a Hib vaccine although they have received a number of meningococcal vaccines with the majority having received their meningococcal serogroup C conjugate vaccine in 1999. Certain staff would have received bivalent meningococcal A and C prior to the conjugate vaccine which has recently been demonstrated to hinder the induction of immunological memory by the conjugate vaccine [Vu et al., 2006]. Following the conjugate vaccine many staff have since received a quadrivalent A/C/Y/W135 polysaccharide vaccine in the following seven years, but little is known about the duration of protection in this age group.~Receiving a polysaccharide vaccine following a conjugate does induce an elevated antibody response but it is known that polysaccharide vaccination does not generate memory B cells and can result in the loss of the ability to mount subsequent memory antibody responses, as was observed by MacLennan et al. for Neisseria meningitidis group C anticapsular antibody responses [MacLennan et al., 2001]. The clinical importance of loss of immunological memory or induction of antibody hyporesponsiveness, is unknown. However, in addition to dampening antibody responses to a subsequent immunisation, a delay or impaired serum antibody response upon encountering an encapsulated pathogen could theoretically increase susceptibility to developing disease. Such a mechanism may explain the higher rate of otitis media observed after administration of 23-valent pneumococcal polysaccharide vaccine to Dutch children primed with a 7-valent pneumococcal polysaccharide protein conjugate vaccine as compared with the rate in controls given hepatitis B vaccine (P=0.0001) [Veenhoven et al., 2003]. In contrast, during the six months between the conjugate vaccination and booster there was a trend in favor of fewer episodes of otitis in the pneumococcal-vaccinated group.~It appears that staff will benefit from both the Hib and serogroup C conjugate vaccinations.~Assessments in this study:~Participation in the study would be offered to all those staff considered to be at occupational health risk of Hib or meningococcal C disease at the Manchester HPA site. The maximum number of participants would therefore be 30. This will be a single group study in that everyone enrolled will receive a single dose of Menitorix and will have blood collected prior to and 4-6 weeks following vaccination.~Local anaesthetic cream will be offered to minimise discomfort of the blood tests and fully trained staff will carry out all procedures.~Assessment of whether protective levels of antibody have been achieved will be made using the blood sample taken 4-6 weeks after vaccination. Extra dose(s) will be offered to any subjects whose levels are not considered to confer protection as described later in this protocol. Subjects receiving and extra vaccination will be offered and a further blood test 4-6 weeks later to allow antibody levels to be checked again.~Samples will be sent to collaborating laboratories of the National Vaccine Evaluation Consortium for assessment of responses to vaccinations.	Menitorix is a combined Hib conjugate and meningococcal C conjugate vaccine made by GlaxoSmithKline. It is currently licensed and recommended as a booster vaccination for UK children in the second year of life.~It is important that staff who have a potential occupational exposure to infectious disease are afforded protection where possible. The licensure and availability of Menitorix provides the opportunity to vaccinate such staff.~Immune responses that are indicative of protection have been established for both Hib and meningococcal C disease. It is therefore proposed that the immune responses of those laboratory staff taking part be measured as data currently available following Menitorix vaccination is in naïve children and adults. This study will also allow us to provide occupational healthcare to laboratory workers.~Participation in the study would be offered to all those staff considered to be at occupational health risk of Hib or meningococcal C disease at the Manchester HPA site. This will be a single group study in that everyone enrolled will receive a single dose of Menitorix and will have blood collected prior to and 4-6 weeks following vaccination.~Assessment of whether protective levels of antibody have been achieved will be made using the blood sample taken 4-6 weeks after vaccination. Extra dose(s) will be offered to any subjects whose levels are not considered to confer protection as described later in this protocol. Subjects receiving and extra vaccination will be offered and a further blood test 4-6 weeks later to allow antibody levels to be checked again.
Study hypothesis: Questionnaire responses about perceived barriers to implementation of diabetes care recommendations, administered to primary care providers and staff, will be shown to correlate with that provider's and practice's success at implementing care guidelines.~Diabetes care in the U.S. consistently fails to meet recommended quality standards. Barriers impede the translation of evidence-based guidelines into sustainable practice. Few studies have considered multiple barriers, and there is a lack of evidence-based strategy in choosing interventions to overcome barriers. This study involves a comprehensive assessment of practice barriers to diabetes guidelines adherence across a primary care network. The BAT based upon a framework proposed by Cabana, et al (1999) will be validated to correlate with provider and practice adherence to diabetes care guidelines. A Diabetes Flow Sheet implemented in our Network to track adherence to guidelines will be assessed and correlated with measured barriers. This organizational strategy will support an evidence-based approach to quality initiative interventions. The BAT will be administered to practice team members: providers, support staff, and practice managers in our Network of 25 primary care practices. Five hypotheses are tested:~A: The BAT measures perceived barriers to adherence to diabetes guidelines, while showing adequate internal consistency and an identifiable subscale structure.~B: The BAT results inversely correlate with practice and provider adherence to ADA guidelines.~C: BAT scores will inversely correlate with use of the Diabetes Flow Sheet.~D: The BAT scores inversely correlate with clinical outcomes (glycemic and lipid control.)~E: Use of the Diabetes Flow Sheet correlates with higher provider and practice adherence to ADA guidelines.~The BAT would then provide the structure for comprehensive assessment of barriers. Study of the Crozer-Keystone PBRN is a real-world laboratory for research in the translation of evidence into diverse practices. The Network is optimally positioned to implement and study this organizational strategy.	This project involves a comprehensive assessment of barriers to diabetes guidelines adherence across 25 practices in the Crozer-Keystone primary care PBRN. A Barrier Assessment Tool (BAT) will be validated to correlate with provider and practice adherence to diabetes care guidelines. The network is part of the Crozer-Keystone Health System located in Delaware County, Pennsylvania, in the southeast quadrant of the Philadelphia metropolitan region.
There is mounting evidence that successful allergen immunotherapy (SIT) functions through the induction of different subset of Treg including Foxp3 positive cells, therefore additional strategies to enhance this property are highly attractive. Since corticosteroids directly induce the development of an IL-10-synthesizing regulatory T-cell population (Tr1) and this effect can be greatly increased with vitamin D3 treatment we , we assumed that combine allergen immunotherapy with non-specific treatments such as glucocorticosteroids and vitamin D3 as well as montelukast sodium treatment might enhanced allergen tolerance induction and improved clinical effectiveness of allergen-specific immunotherapy, therefore we conducted the stud comparing the effect of glucocorticosteroid, glucocorticosteroid with vitamin D3 or montelukast sodium on early immunological and clinical effect of allergen-specific immunotherapy in asthmatic children.	There is mounting evidence that successful allergen immunotherapy (SIT) functions through the induction of different subset of Treg including Foxp3 positive cells, therefore additional strategies to enhance this property are highly attractive. Based on previous findings we assumed that combine allergen immunotherapy with non-specific treatments such as glucocorticosteroids and vitamin D3 as well as montelukast sodium treatment might enhanced allergen tolerance induction and improved clinical effectiveness of allergen-specific immunotherapy
Current research suggests that levels of brain-derived neurotrophic factor (BDNF) and certain excitatory neurotransmitters - specifically glutamate, D-serine, and glycine are low in participants with depression and other mental illnesses (Wolkowitz and Reus 2002, Tan et al., 2005; Shoval & Weizman, 2005; Hashimoto et al., 2005). Research also suggests that levels of both BDNF and excitatory transmitters can be enhanced by cognitive stimulation (Hynd et al., 2005; Wu et al., 2005; Yang et al., 2005; Mattson et al., 2004). BDNF is found in brain tissue and is also measurable in blood; it stimulates neuronal cell growth in certain brain regions (Duman, 2004). In Phase 1, we wish to measure the levels of specific neurotrophic factors in healthy, young participants. Phase 2 is intended to correlate similar levels with change in neurocognitive performance in healthy, older participants. Overall, this study is designed to obtain a raw measure of the impact that cognitive training has on the mature adult brain.	The overall goal of this study is to evaluate the impact of cognitive training on blood levels of neurotrophic factors in adults.
The Standard Days Method® is a fertility awareness-based method of family planning. Users avoid unprotected intercourse during cycle day 8 through cycle day 19. The method is most effective for women with cycles that usually range 26-32 days. It was developed by applying various formulae (i.e. various numbers of days and various sets of days) to over 7500 menstrual cycles in an existing data set from the World Health Organization, to determine which formula would provide the optimal balance between he length of the identified fertile period and the efficacy in avoiding unplanned pregnancy.~The purpose of the clinical trial was to test the efficacy of the method in preventing pregnancy.~Participants were from five sites in Bolivia, Peru, and the Philippines. In all sites, the Institute for Reproductive Health trained 5-10 health workers (service providers) in teaching the Standard Days Method to study subjects and in study procedures. Method provision involved a counseling session in which the woman (or the couple, if her partner was available) was instructed in the use of the method, and counseled on the importance of following the method recommendations to avoid pregnancy.~To assist women in monitoring their cycles, the provider gave them CycleBeads® a mnemonic device, a string of 32 beads in which each beads represents a day of the menstrual cycle. The first bead is red, representing the first day of menses; the next 6 beads are brown, representing the additional non-fertile days preceding the fertile window; the next 12 beads are white, representing days that should be considered fertile (8-19); and the remaining 13 beads are brown, again representing non-fertile days. It also has a moveable, tight-fitting rubber ring that is used to mark the current day of the cycle. Women were instructed to place the ring on the red bead on the day their menses began, and move the ring one bead per day until their menses returned. They also were told that to avoid pregnancy they should not have unprotected intercourse on the days the ring was on a white bead. If they had menstrual bleeding before day 27 of the cycle (i.e., a cycle shorter than 26 days), or if their menses had not occurred by the day after they completed all 32 beads (i.e., a cycle longer than 32 days), they were instructed to contact their provider for further assessment and advice. Women who had two cycles outside the 26 through 32 day range during the study period were advised to use another method, and were withdrawn from the study.~A total of 478 women wishing to use the Standard Days Method and meeting the eligibility criteria were admitted to the study after signing an informed consent form and interviewed monthly until they either completed 13 cycles of method use or left the study for other reasons. The first level of data collection was administered by the clients themselves. Each woman was asked to keep a daily diary to record menstrual bleeding, intercourse, and use of any other contraceptive method. The information on the diary card was reviewed by the clients and the service provider during each of the monthly follow-up contacts. In addition, follow-up forms were administered, which included questions concerning method use, satisfaction, and willingness to continue in the study.~Women who had not had their menses by day 42 of their cycle were tested for pregnancy. If results were negative, they were followed until they tested positive or their menses returned. Loss to follow-up was minimized by interviewing study participants in their homes and actively seeking out each participant, with a minimum of three attempts per cycle.~Single-decrement multi-censoring life tables were used to calculate pregnancy rates.	The Standard Days Method® is a fertility awareness-based method of family planning in which users avoid unprotected intercourse during cycle day 8 through 19. The method is most appropriate for women with cycles that usually range 26-32 days. The clinical trial tested the contraceptive efficacy of the Standard Days Method. A total of 478 women, age 18-39 years, in Bolivia, Peru, and the Philippines, with self-reported cycles of 26-32 days, desiring to delay pregnancy at least one year were admitted to the study and followed for up to 13 cycles of method use.
This research is interested in using Dermabond skin adhesive as a closure for repeat cesarean incisions. The current standard of practice is to close these incisions with either skin surgical staples or suture. We will compare the use of Dermabond vs. the use of skin surgical staples in the closure of these incisions.~Eightenn-50 year old pregnant patients are eligible for this study. Other inclusion criteria are history of a previous Pfannenstiel (transverse) incision and no evidence of infection at the incision site. Exclusion criteria include a previous vertical incision and active infection at the incision site. Patients will be enrolled during their prenatal appointments and the Texas Tech OB/GYN clinic, Grand Expectations, and the Southwest OB/GYN Associates offices. They will be consented by faculty, residents, and nursing staff. This is a preliminary study of 50 patients (25 in experimental arm, i.e. Dermabond and 25 in the control group, i.e. surgical skin staples). Patients will be randomized in a 1:1 fashion by placing the terms Dermabond and Staples in a sealed envelope. The envelopes will be kept in the Family Birth Center under lock and key. The envelopes will be opened at the time of repeat c-section. A data set will be collected prior to randomization and include: gravidity, parity, age, BMI (weight and height), comorbid diseases and ethnic background.~At the time of closure, there will be subcutaneous reapproximation of tissue to take the tension off of the skin. This will occur for all subjects. The type of suture used and the suturing technique will be recorded. The skin edges will be closed with either Dermabond per label directions or with skin staples, depending on randomization. The length of the incision, the type of suture used, the type of stitch used and the total number of layers closed will also be documented. The number of staples will also be documented.~During the hospital stay, the patients wound will be examined on post operative day one and three. At this time, wound characteristics will be documented using a modified Hollander scale. A digital photograph of the incision will also be taken. The patient will also be given a patient satisfaction survey about their wound. The patients will then be seen at two weeks post partum and again at six weeks post partum. The wound characteristics and patient satisfaction will again be documented using the above materials.~Other data that will be collected includes the incidence of wound infection, as documented by wound culture, wound separation rates as documented by need for wound packing and wound dehiscence.	The use of dermabond skin adhesive vs. skin staples for the closure of repeat c-section incisions.
Hair transplantation is an well-documented way of treating hair loss. Hair transplantation is based on redistribution of hair follicles without any new follicle formation. It has been long that a lot of researchers have focused on developing skills in regenerating hair follicles. However, cultured dermal papilla cells lose the ability of inducing hair follicle formation after several generations in vitro culture. Our study is aiming in culturing dermal papilla cells in vitro and maintain their spherical structure before transplanting into dermis in vivo. Meantime, this study may help clarify the actual mechanism of inducing hair follicle by dermal papilla cells.	This study is to try to maintain cultured dermal papilla cells in spherical structure in vitro before transplanting into dermis in vivo. Also, this study is aimed in clarifying actual mechanism of inducing hair follicle by dermal papilla cells.
Rationale/context:~Long term management of anticoagulant treatment is not straightforward, especially in patients bearing mechanical heart valves due to the requirement of maintaining a high INR over a narrow range.~Due to the narrow therapeutic window of AVK, undesirable events (hemorrhages, thromboembolic accidents) tend to be both serious and common leading to frequent admissions to hospital The self-monitoring of AVK, in addition to conventional monitoring of INR in the laboratory, is now being introduced in several countries (USA and Europe).~Main objective To evaluate the benefit economic and medical of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.~Secondary objectives~To compare over one year the effect of self-monitoring of coagulation with conventional follow-up of anticoagulation on:~the impact of complications stemming from oral anticoagulant treatment (bleeding, thromboembolic episodes or death~the proportion of monthly values of INR within the target range,~the inherent cost of each strategy of monitoring of anticoagulation,~the incidence of death, bleeding and thromboembolic episodes (each studied separately)~The quality of life and the satisfaction of the patient To evaluate the patients' learning to be autonomous Diagram of the study Progress of the trial~A national, multicenter, randomized, blind trial, designed to examine the type of strategy used for monitoring anticoagulation in two parallel groups:~a conventional follow-up of anticoagulation (monthly checks and adjustment of INR by the family doctor (GP))~a self-measurement of anticoagulation by the patient at home using a Roche Diagnostics Laboratories test CoaguChek XS® or the Hemosense laboratories test INRatio® (weekly measurements and adjustment of INR by the family doctor) + a monthly laboratory check of INR~Inclusion criteria:~adults (age ≥ 18 years), either sex~patients fitted with one or more mechanical heart valves either alone or in combination with myocardial revascularization~oral anticoagulant treatment~patients with social security cover~written informed consent signed by both patient and investigator Exclusion criteria~women pregnant or liable to become pregnant during the study~nursing women~patients unable to master the self-monitoring procedures~individuals under judicial control or enquiry~patients consuming excessive amounts of alcohol ((>40g/j for men et >30g/j for women femmes ; 1 glass = 10g)~patients on dialysis~patients with incomplete understanding of instructions~blind patients and those unable to read~presence of circulating anticoagulant~Treatments/Strategies/Procedures:~1.1. Strategies of anticoagulation monitoring~After signature of informed consent and verification of criteria of eligibility, patients are randomly allocated into the following groups:~1.1.1. Conventional follow-up of anticoagulation In this group, the patients are instructed in the use of oral anticoagulants. INR is measured once a month in the laboratory. INR must lie in the therapeutic range designated by the investigative center as a function of the type and the location of the valve and any associated risk factors. If necessary, the family doctor adjusts INR on the day of the blood test and a new measurement is taken 48 hours later if dosage has been changed.~This algorithm is applied until the INR comes into the designated range.~1.1.2. Self-measurement of anticoagulation In this group, the patients are instructed in the use and monitoring of oral anticoagulants. They are further trained in the use of the self-monitoring test system.~Reference INR will be INR labo during first post operatives weeks up to the return at home because the self-measurement of anticoagulation maybe for lack of the fact of the anaemia, the inflammatory syndrome and the residues of heparin.~When the patients return at home, they take a measurement every week and if the result is abnormal, inform their family doctor. The INR must lie within the therapeutic range designated by the investigative center as a function of the type and the location of the valve and any associated risk factors. If necessary, the family doctor adjusts the INR on the same day as the self-measurement. A measurement is taken 48 hours later if the dosage has been changed.~This algorithm is applied until the INR comes into the designated range. INR is measured in the laboratory every month.~Main evaluation criteria:~Economic and medical evaluation of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.~Main secondary evaluation criteria:~the impact of complications stemming from oral anticoagulant treatment (bleeding, thromboembolic episodes or death) within a population recently fitted with a mechanical hear valve.~the proportion of monthly measurements of INR within the designated range,~the inherent cost of each strategy of anticoagulation monitoring,~the impact of death, bleeding and thromboembolic episodes (each studied separately),~Evaluation of patients' learning of monitoring procedures.~Planned population size: 1050 patients, i.e.~350 in the group Conventional follow-up of anticoagulation~700 in the group Self-measurement of anticoagulation :~350 using the Roche Diagnostics laboratories test CoaguChek XS®~350 using the Hemosense laboratories test INRatio®~Time-line:~Period of inclusion: 12-18 months~Duration of participation by patients: 12 months~Duration of trial: 30 months	To evaluate the benefit economic and medical of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.
This study aims to enhance pediatric primary care to make it more responsive to psychosocial needs facing many families. We hypothesized that by identifying and addressing certain problems, such as depressed mothers, parental drug use, and domestic violence, we would help decrease child abuse and neglect.~The first step was to train pediatric residents on the importance of addressing the targeted problems. Then, we developed a brief screening tool to use when children under six years came in for the regular checkups. Parents would complete this while waiting for their doctor. Finally, the doctor and/or social worker would try address any problems the parent identified.	This study aims to enhance pediatric primary care to make it more responsive to psychosocial needs facing many families. We hypothesized that by identifying and addressing certain problems, such as depressed mothers, parental drug use, and domestic violence, we would help decrease child abuse and neglect.
Multiple retrospective reports have verified the overall utility of post-treatment sentinel lymph node (SLN) mapping and biopsy for assessing the final axillary lymph node status in breast cancer patients who have undergone preoperative neoadjuvant systemic chemotherapy. However, to date, only one report, in abstract form, currently exists within the literature which specifically assesses the utility of post-treatment SLN mapping and biopsy after completion of preoperative neoadjuvant systemic chemotherapy in patients with biopsy-proven positive axillary lymph nodes at initial presentation.~The purpose of the present proposed clinical trial will be to assess the utility of SLN mapping and biopsy for predicting the final axillary status after completion of preoperative neoadjuvant systemic chemotherapy in patients who had biopsy-proven positive axillary lymph nodes at initial presentation.~All eligible patients must have biopsy-proven invasive breast cancer and must also have biopsy-proven involvement of the axillary lymph nodes at initial presentation. Biopsy-proven involvement of the axillary lymph nodes at initial presentation will be based on fine needle aspiration (FNA) cytology, core/Tru-cut biopsy, or pre-treatment SLN biopsy. All eligible patients will have undergone preoperative neoadjuvant systemic chemotherapy.~After completion of preoperative neoadjuvant systemic chemotherapy and on the day of definitive breast cancer surgery, patients will be injected intradermally with approximately 400 microcuries of Tc-99m sulfur colloid. Patients will undergo preoperative lymphoscintigraphy in the nuclear medicine department to access axillary and extra-axillary sites of localization. Intraoperatively, patients will also be injected with approximately 4 to 5 mL of 1% isosulfan blue dye (by intradermal, intraparenchymal, or subareolar route). Patients will undergo intraoperative identification and biopsy of all SLN candidates. A confirmatory axillary lymph node dissection will then be performed on all patients.~The SLN mapping and biopsy procedure that we are proposing to perform on these breast cancer patients with known positive axillary lymph nodes at initial presentation will be done in an identical fashion to the SLN mapping and biopsy procedure that is currently performed as a routine and acceptable standard of care on every breast cancer patient with a clinically negative axilla at presentation.~The primary endpoints of this study would be address the success of identification of the SLN and the accuracy of the SLN mapping and biopsy procedure in women having undergone preoperative neoadjuvant systemic chemotherapy who had biopsy-proven involvement of their axillary lymph nodes at initial presentation. We would like to show that the proportion of women with false negative SLN biopsy results is less than 10%.~The study will require a minimum of 49 women with newly diagnosed breast cancer with biopsy-proven involvement of their axillary lymph nodes at initial presentation that have undergone preoperative neoadjuvant systemic chemotherapy. The study accrual time may take in the range of approximately 24 to 36 months to complete.	The purpose of the present proposed clinical trial will be to assess the utility of SLN mapping and biopsy for predicting the final axillary status after completion of preoperative neoadjuvant systemic chemotherapy in patients who had biopsy-proven positive axillary lymph nodes at initial presentation
To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients. Cyclosporine blood levels, graft rejection rates and renal function will be assessed.	To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients.
For skin diseases, the most convincing method for diagnosis to date is surgical biopsy. However, a skin biopsy is an invasive procedure which carries the risk of tissue damage, wound infection and scar formation. To solve the inconvenience from surgical biopsy, multiphoton laser scanning microscopy is a developing, non-invasive method for observing the cutaneous anatomy and pathology. Multiphoton laser scanning microscopy is good in tissue penetration and resolution with less tissue damage. The study aims to compare surgical specimen by conventional pathology slice with the image by non-invasive multiphoton laser scanning microscopy. A good correlation in multiphoton image may serve as optical biopsy for cutaneous pathology and spare the invasive procedure of skin biopsy.	We use multiphoton laser scanning microscopy to observe cutaneous anatomy and pathology. The study aims to compare surgical specimen by conventional pathology slice with the image by non-invasive multiphoton laser scanning microscopy.
This study is an open label, single center, single-dose study to assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers. This study will be conducted in two cohorts. The first cohort of subjects will be selected based on body mass index (BMI) and weight criteria. The second cohort of subjects will be selected based on age.	The purpose of this study is to assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers.
Abstract~Background: On the last few years there is a rise in the public awareness of the danger potential that lies in the exposure to hazardous dust in different professions. The examination of induced sputum has been used from the early eighties to research and diagnose inflammatory lung diseases. We assess here patients with lung disease and occupational history, in order to undergo work up to assess hazardous dust exposure.~Aim : to validate the qualitative analysis by Scanning Electron Microscope (SEM) of lung samples first in induced sputum in correlation to disease second by comparing hazardous particles in induced sputum to the analysis in lung tissue and finally by assessing if the particles present in transplanted patients correlated with occupational history.~Methods: 40 patients referred with occupational history were included. For 24 of them SEM analysis was done in induced sputum (IS) together with questionnaires and in 11 among them the SEM analysis was done both from lung tissue (TS) and IS. In addition 11 lung biopsies from patients with occupational history were scanned by SEM and compared to 10 biopsies from patients with no occupational history.	Aim : to validate the qualitative analysis by Scanning Electron Microscope (SEM) of lung samples first in induced sputum in correlation to disease second by comparing hazardous particles in induced sputum to the analysis in lung tissue and finally by assessing if the particles present in transplanted patients correlated with occupational history.
This was a prospective, multicenter, open-label, non-control group design Phase 3 clinical study. Approximately 880 participants who were to complete former studies in this program (370 participants from studies MRZ 60201-0520/1 (8) and MRZ 60201-0527/1 (8) as well as approximately 510 participants from studies MRZ 60201-0724/1 (10) and MRZ 60201-0741/1) (11) were expected to enroll in this study in 26 centers in the United States, Canada and Germany. Participants with moderate to severe glabellar frown lines at maximum frown who completed participation in one of these four feeder studies in the frown line program were eligible to participate in this repeated dose study. Each participant received a dose of 20 units incobotulinumtoxinA (Xeomin) intramuscular injection on Visit 1 (Day 0 of Cycle 1). Re-injections with 20 U NT 201 could be performed on Day 0 of a subsequent cycle for up to 8 cycles (one cycle >= 85 days). Intervals between treatments were at least three months or 12 weeks, i.e., >= 85 days. For a new treatment cycle to start, the participant had to request a re-injection. The investigator then had to assess if the glabellar frown lines had relapsed to 'moderate' or 'severe'. In this case, a new injection could be administered. The treatment duration per participant was 24 months and up to eight cycles for participants enrolled from studies MRZ 60201-0520/1 and MRZ 60201-0527/1 and 6 months and up to two cycles for participants enrolled from studies MRZ 60201-0724/1 and MRZ 60201-0741/1, respectively. Participants enrolled from studies MRZ 60201-0520/1 and MRZ 60201-0527/1 participated at least one year in the study whereas participants enrolled from studies MRZ 60201-0724/1 and MRZ 60201-0741/1 participated for six months and up to two cycles.	The study objective was to investigate the safety and efficacy of incobotulinumtoxinA (Xeomin) during repeat dose treatment of glabellar frown lines. 801 participants with moderate to severe glabellar frown lines at maximum frown who completed participation in one of the studies in this program, i.e. MRZ 60201-0520/1, MRZ 60201-0527/1, MRZ 60201-0724/1, or MRZ 60201-0741/1 were eligible to participate in this repeat-dose study.
Despite intensive research efforts, there are still no simple and effective screening tools to detect early lung cancer. The majority of newly diagnosed patients have higher stage, often disseminated, non-resectable disease. A better understanding of the natural biology and molecular abnormalities in early lung lesions may aid in the development of more effective screening tools. The Lung Imaging Fluorescence Endoscopy (LIFE) is FDA approved as an adjunct to WL bronchoscopy for the screening of lung cancer.~Using the LIFE unit, this study will set the stage for the collection of a unique set of biopsy specimens that will be used to learn more about the natural biology and molecular changes in early lung lesions. We will study abnormalities in p53 by immunohistochemistry and by molecular analyses. The p53 results will be compared with histological grade and with genomic instability. Measures for genomic instability will be the loss of chromosomal information and cellular aneuploidy. Recent advances in molecular pathology, such as the development of Laser Capture Microdissection (LCM), have made the molecular profiling of these extremely small lesions feasible. The information obtained by these techniques will be used for comparison with clinical and exposure information. Future plans include the culturing of bronchial epithelial cells to study genomic instability in the multistep process of cancer progression. It is our hope that the application of these new technologies will improve the early detection of human lung cancer and provide insight into the natural biology and molecular changes of early lung lesions which may progress towards overt cancers.	Despite intensive research efforts, there are still no simple and effective screening tools to detect early lung cancer. The majority of newly diagnosed patients have higher stage, often disseminated, non-resectable disease. A better understanding of the natural biology and molecular abnormalities in early lung lesions may aid in the development of more effective screening tools. This study will investigate the effectiveness of bronchoscopy by white light (WL) alone and in combination with Lung Imaging Fluorescence Endoscopy (LIFE) for the detection of early lung lesions in patients with a high risk for developing lung cancer. LIFE is a FDA approved adjunct to WL bronchoscopy for the screening of lung cancer and this study will provide a standardized setting in which a direct comparison between a combination of WL and LIFE versus traditional WL bronchoscopy can be made.~In addition, the study will set the stage for the collection of a unique set of biopsy specimens that will be used to learn more about the natural biology and the molecular changes in early lung lesions. We will study abnormalities in p53 by immunohistochemistry and by molecular analyses. The p53 results will be compared with histological grade and with genomic instability. Measures for genomic instability will be the loss of chromosomal information and cellular aneuploidy. Recent advances in molecular pathology, such as the development of Laser Capture Microdissection (LCM), have made the molecular profiling of these extremely small lesions feasible. The information obtained by these techniques will be used for comparison with clinical and exposure information. Future plans include the culturing of bronchial epithelial cells to study genomic instability in the multistep process of cancer progression. It is our hope that the application of these new technologies will improve the early detection of human lung cancer and provide insight into the natural biology and molecular changes of early lung lesions which may progress towards overt cancers.
The Dairy Council of California has developed two dietary calcium questionnaires, one electronic and one in print, using known dietary sources of calcium including frequency of consumption and portion size. For these questionnaires to be effective in clinical and research settings they must be a valid measurement of dietary calcium intake. To measure the validity of the dietary calcium questionnaires one hundred seventy three women will complete the two dietary calcium questionnaires and one 3-day food record. The dietary calcium questionnaires will be validated against this established method of dietary intake measurement. The objective of this study is to validate two dietary calcium questionnaires that can be used in clinical and research settings against an established method of dietary intake measurement.	Dairy products continue to be an important source of calcium, providing over half the calcium intake for most individuals. Educational interventions promoting adequate calcium intake with tools estimating dietary calcium that can be easily utilized by consumers would be a valuable asset to promoting skeletal health. Validation of these tools against standard dietary assessment methods enhances their utility. The Dairy Council of California has developed two dietary calcium questionnaires, one electronic and one in print, using known dietary sources of calcium including frequency of consumption and portion size. For these questionnaires to be effective in clinical and research settings they must be a valid measurement of dietary calcium intake. To measure the validity of the dietary calcium questionnaires one hundred seventy three women will complete the two dietary calcium questionnaires and one 3-day food record. The dietary calcium questionnaires will be validated against this established method of dietary intake measurement. The objective of this study is to validate two dietary calcium questionnaires that can be used in clinical and research settings against an established method of dietary intake measurement. It is hypothesized that both dietary calcium questionnaires will be a valid measurement of dietary calcium intake in women.
From all K-vitamins, menaquinone-7 has been identified as the most effective cofactor for the carboxylation reaction of Gla-proteins. In this respect it is important to quantify the dose-response relationship of the interaction between oral anticoagulants and menaquinone-7. The primary objective of the study is to demonstrate at what menaquinone-7 intake the vitamin will interfere with oral anticoagulants in a clinically relevant way. Clinically relevant is defined as a decrease in level of anticoagulation that would require a change in oral anticoagulant treatment in order to stay within target levels. Secondary objective of the study is to investigate changes in carboxylation level of osteocalcin and matrix-gla protein after menaquinone-7 supplementation during the oral anticoagulation treatment period. This will demonstrate whether during oral anticoagulation menaquinone-7 will be transported preferentially to the liver or to other target tissues.	Oral anticoagulants that are widely used for the treatment of thrombo-embolic disease exert their effect by blocking the recycling of vitamin K. Vitamin K acts as a co-factor in the posttranslational carboxylation of vitamin K-dependent proteins such as osteocalcin and matrix-gla protein. It is important to quantify the dose-response relationship of the interaction between vitamin K and oral anticoagulants and to investigate at what dosage vitamin K will interfere with oral anticoagulants in a clinically relevant way.
Dark chocolate is one of the richest sources of polyphenols, for example, a standard 40g portion of dark chocolate contains 400-800 mg of polyphenols, compared to red wine (170 mg /100ml) or an apple (200 mg/piece). Cocoa polyphenols, most notably the catechins, can exist in both lipid and water-based environments (amphipathic), meaning they can spare both lipophilic and hydrophilic vitamins. There have been a number of human trials conducted using chocolate or cocoa and measuring various endpoints. Most have been conducted with dark chocolate. An article in Nature found that the bioavailability of epicatechin from milk chocolate was substantially reduced compared to dark, and even dark taken with a glass of milk (Serafini et al 2003). The hypothesis was that the milk proteins bind to polyphenols, making them unavailable. Subsequent studies have not been able to reproduce this, but none have been conducted using solid chocolate as the first study, all have been done using a drink matrix, which may completely alter the binding interactions of the polyphenols and protein. To this end, this study is designed to compare solid chocolates as a source of polyphenols for improving a risk biomarker for vascular disease.~This study is designed as a blinded, three arm crossover trial. The primary outcome measure is to compare endothelial function after consumption of 3 chocolates (1 milk, 1 dark, 1 polyphenol-free control) with a secondary outcome of arterial stiffness. All volunteers will take all chocolate types in a crossover design. Subjects will undergo medical screening, anthropometry, physical activity and dietary assessments before randomization for the order of consumption.	Dark chocolate is one of the richest sources of polyphenols though it has been hypothesised that the bioavailability and therefore probably the bioefficacy of epicatechin from milk chocolate was reduced compared to dark. This study is designed to compare milk and dark chocolate as a source of polyphenols with a control chocolate for improving a risk biomarker for vascular disease.
Multicenter, open-label, phase 1, cohort dose escalation.~The study will open with Dosing Schedule 1 (S1) (OSI-906 Once Daily (QD) Days 1-3 every 14 days). Dosing Schedule 2 (S2) (OSI-906 QD Days 1-5 every 14 days) will be initiated following observation of clinically significant related toxicity ≥ grade 2 in S1 or after a review of preliminary safety and pharmacokinetic data from ≥ 6 dose levels in S1 indicate that toxicity is acceptable and potential improvement in exposure may be achieved by an increased number of dosing days. Dosing Schedule 3 (S3) (OSI-906 QD Days 1-7 every 14 days) will occur upon observation of clinically significant related toxicity ≥ grade 2 in S2 or after ≥ 1 dose level in S2 has been examined.~A 3-patient bridging dose cohort will be opened in S1 to qualitatively compare the 25 mg capsule with 100 mg capsule dosage strengths in order to confirm that no gross differences in safety or exposure exist between the formulations. In order to characterize the tablet, a 6-patient dose cohort will be opened to qualitatively examine the pharmacokinetics of this dosage form.~Once the MTD has been determined for S1 and once the safety and pharmacokinetic data from the tablet cohort have been reviewed, a Fed-Fasted Expansion Cohort will be opened.	Multicenter, open-label, phase 1, cohort dose escalation study to determine the maximum tolerated dose (MTD) of 3 intermittent OSI-906 dosing schedules.
This is an observational retrospective study where data will be collected from a medical claims database derived from a large national managed care organization with over five million members. Members enrolled in a Medicare supplement program will also be included. The objective of this study is to determine the incidence of cancer among patients who have used REGRANEX (becaplermin) compared to patients who have not used REGRANEX (becaplermin). REGRANEX (becaplermin) is an FDA-approved prescription medicine that contains a platelet-derived growth factor that is used for the treatment of foot ulcers in patients with diabetes. Patients who were treated with REGRANEX (becaplermin) between January 1998 and June 2003 will be identified in a health insurance claims database. Another group of patients who have not been treated with REGRANEX (becaplermin) but have similar characteristics to patients treated with REGRANEX (becaplermin) will also be identified during the same time frame in the database. Medical record abstraction and review will be conducted to verify all incident cancers identified. Follow-up for study outcomes will be conducted from the date of accrual through termination of health-plan membership or December 2003 (whichever comes first). The date of accrual is the date of REGRANEX (becaplermin) exposure for each exposed patient and his or her matched unexposed comparison patients. Any incidence of death from cancer will also be identified. The primary outcome measure in the study will be the incidence rate of cancers of all kinds, grouped by organ site in patients who have used REGRANEX (becaplermin) and patients who have not used REGRANEX (becaplermin). A secondary objective is a similar comparison of the incidence of death from cancer. This is an observational study; no investigational drug will be administered.	The purpose of this study is to compare the risk of cancers in patients who have used REGRANEX (becaplermin) to that of patients with similar characteristics and health issues who have not used REGRANEX (becaplermin). REGRANEX (becaplermin) is topical medication used to treat non-healing neuropathic foot ulcers in patients with diabetes.
This study aims to determine the possible effects of ASA and Terbutalin on ART treatment.	This study aims to determine the possible effects of Acetyl Salicylic Acid (ASA) and Terbutalin on ART treatment.
This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids. Blood serum creatinine, the incidence of biopsy-confirmed acute graft rejection, and patient and graft survival were also evaluated at 6 months post transplantation.	This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids.
This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after kidney transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine (CsA) in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months after transplantation were evaluated also.	This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months were evaluated also.
The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids. The two treatment groups were also compared with respect to the incidence of acute graft rejection at 6 months and patient and graft survival at 6 months after transplantation.	The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids.
To evaluate the efficacy and safety of modafinil in reducing methamphetamine use in subjects with methamphetamine dependence. It is hypothesized that modafinil, compared to placebo, will be associated with an increase in the number of methamphetamine non-use weeks over time as measured by quantitative urine analysis for methamphetamine.	The purpose of this study will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence.
Dark chocolate contains a high amount of flavonoids. Flavonoids hold the possibilities to improve oxidative stress and hence the possibility to improve endothelium-dependent coronary vasomotion, which is a powerful surrogate for clinical prognosis. Coronary atherosclerosis is promoted by impaired endothelial function and increased platelet activation. High oxidative stress and reduced antioxidant defenses play a crucial role in the pathogenesis of atherosclerosis, in particular in transplanted hearts. The aim of the present study is to investigate whether the ingestion of a flavonoid-rich dark chocolate compared to flavonoid-free placebo chocolate will improve coronary vasomotion in heart transplanted patients.	The aim of the present study is to investigate whether the ingestion of a flavonoid-rich dark chocolate compared to flavonoid-free placebo chocolate will improve coronary vasomotion in heart transplanted patients.