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This R21 application for a 3-year exploratory/development grant for intervention research is designed to develop, standardize and provide a preliminary test of a novel intervention for children, ages 9-11, placed in out-of-home care. Children and adolescents with a history of maltreatment and subsequent placement in foster care are at risk for substantial mental health and behavioral problems of great public health significance. In the prior longitudinal work with children in foster care, the investigators have described the population, examined child welfare system impact, and identified modifiable psychosocial risk and protective factors. These pre-intervention activities, supported by the principal investigator's K01 award, have enabled the investigator to address important methodological issues that have hampered the development of intervention efforts targeting this high-risk population.~Based on this pre-intervention research, feedback from focus group participants, and a review of other efficacious programs for high-risk youth, the investigators propose to design an intervention for preadolescent youth in foster care consisting of three primary components: assessment and advocacy, mentoring, and therapeutic skills groups. The proposed R21 activities include developing the assessment battery and intervention protocol, manualizing the treatment, estimating recruitment and attrition rates, and conducting a small-scale randomized-controlled pilot study of the intervention. The goals of the intervention will be to improve mental health, social, academic and behavioral functioning and to reduce youths' initiation of, and participation in, problem behaviors. The investigators will conduct a preliminary examination of whether these proximal outcomes are moderated by baseline characteristics and/or mediated by the process variables targeted by the intervention. Estimates of effect size will be used to determine the sample size needed for adequate power to conduct a full-scale randomized controlled trial. The pilot study will also focus on issues of feasibility, program uptake, and replicability, and the investigators will modify the assessment battery, protocol, and manuals following the pilot phase and prior to the application for an R01 to conduct a large-scale efficacy trial.

The purpose of this study is to develop, standardize and provide a preliminary test of a novel intervention for preadolescent maltreated youth in out-of-home care. It is hypothesized that the preventive intervention, which is known as Fostering Healthy Futures (FHF) and which consists of therapeutic skills groups and mentoring, will improve mental health, social, academic and behavioral functioning and reduce youths' initiation of, and participation in, problem behaviors.

Primary Objective~To compare the pharmacokinetics parameter values (geometric mean Cmin and AUC) of raltegravir at 400 mg q12h alone to raltegravir at 400 mg q12h co-administered in combination with rifapentine 900 mg once weekly, and to raltegravir at 400 mg q12h co-administered in combination with rifapentine 600 mg per day, 5 days per week.~Secondary Objective~To assess the tolerability and safety of concomitant administration of raltegravir and rifapentine in healthy volunteers.~Design~This study is a three-period, one-sequence, open label, pharmacokinetic study of the raltegravir-rifapentine interactions in healthy, male and female volunteers. Up to 21 subjects may be enrolled to achieve the estimated sample size of 16 completing subjects. All study medication will be self-administered except on the days of pharmacokinetic sampling. All subjects will participate in three sampling periods and be studied in a day clinic or be admitted overnight to a hospital.

The aim of this study is to study the effect of rifapentine on plasma concentrations of raltegravir.

Blood transfusions may have opposite immune effects on patients. One is sensitization. The other is immunosuppression. The magnitude of this problem in patients who are not on chemotherapy is unknown.~Of patients who do receive donor blood, 50-90 percent become sensitized (make antibody) to HLA proteins present on white blood cells in the donor blood. This is an undesired effect in patients who need an organ or stem cell transplant, as it increases the risk of rejection. Another effect of receiving a blood transfusion, immunosuppression, causes a decreased immune response that compromises patients' ability to fight off infection or tumor cells.~These effects - sensitization and immunosuppression - are thought to be due largely to white blood cells present in the transfusion product. Doctors order specially pretreated blood transfusions that have been depleted of white blood cells with the aim of minimizing risks in an immunocompromised patient. Leukofiltration and gamma-irradiation are the special treatments that deplete white blood cells. A combination of leukofiltration and gamma-irradiation pretreatment of donor blood is thought to deplete the white blood cells most effectively. Therefore, blood is pretreated both ways before it is given to patients who need a stem cell transplant or others who are immunosuppressed.~Sometimes the pretreated leukofiltration and gamma-irradiated blood is used for regular patients who are not immunocompromised so the blood is used before it expires and not wasted. However, doctors do not know for sure whether these expensive pretreatments are really beneficial for regular patients such as those undergoing cardiac surgery and whether they would change the risk of developing sensitization or immunosuppression.~In this study, patients are randomly assigned to receive blood products pretreated in one of three ways: untreated, filtered or filtered and irradiated. If their physician orders transfusions, they will receive products assigned to their group. Patients are asked to provide two blood samples during the 4 weeks after surgery. Studies will measure changes in antibody to HLA and in cells that regulate the immune response.~It is unknown which treatment (leukofiltration with or without gamma-irradiation compared to no pretreatment) is most beneficial in patients who are not immunosuppressed.~This study is designed to provide information on patients' immune response after exposure to transfused blood. This information may be useful to caring for patients in the future who require transfusion for cardiac surgery.

This study is designed to provide information on patients' immune response after exposure to transfused blood.~Blood transfusions may have opposite immune effects on patients. One is sensitization. The other is immunosuppression. The magnitude of these effects in patients who are not on chemotherapy is unknown.~These effects are thought to be due largely to white blood cells present in the transfusion product. Leukofiltration and gamma-irradiation are the special treatments that deplete white blood cells. A combination of leukofiltration and gamma-irradiation pretreatment of donor blood is thought to deplete the white blood cells most effectively.~In this study, patients scheduled for cardiac surgery are randomly assigned to receive blood products pretreated in one of three ways: untreated, filtered or filtered and irradiated. If their physician orders transfusions, they will receive products assigned to their group. Patients are asked to provide two blood samples during the 4 weeks after surgery.~Studies will measure changes in antibody to HLA and in cells that regulate the immune response. The levels of sensitization and immunosuppression will be correlated to the transfusion products received.

To evaluate the importance of providing guidelines to patients via active telephone calls for blood pressure management and the discontinuation of treatment in hypertensive patients, using two treatment regimens with low-dose medications, which were offered for free to avoid the influence of the financial factor. We opted for a regimen called traditional based on diuretics and beta-blockers, and another one called current treatment based on the angiotensin II antagonist and calcium channel blocker.~Patients and Methods The patients studied were those with essential hypertension who could receive telephone calls to be reminded of the dates of their medical appointments and to receive guidance about hypertension; patients were of both genders, from any ethnic background, over 18 years old and with body mass index below 40 kg/m2, and were enrolled in the study after signing a free and informed consent term. The study was approved by the Ethics Committee of the Board of Directors in the General Hospital at the São Paulo University School of Medicine.~Exclusion criteria were patients with blood pressure < 140/90 mm Hg without antihypertensive medication, pregnant women or nursing mothers, patients with secondary hypertension, white-coat hypertension with systolic pressure ≥ 140 mm Hg and/or diastolic pressure ≥ 90 mm Hg at the doctor's office and awake mean systolic pressure < 135 mm Hg or awake mean diastolic pressure < 85 mm Hg without antihypertensive medication, malignant hypertension, presence of liver dysfunction evidenced by the patient's clinical history or by one of the liver function tests with levels twice the normal values (alkaline phosphatase, total bilirubin, aspartate aminotransferase), patients with clinical conditions that might interfere with the total conformity with the study or those who might have increased risk for participating in the study, patients with previous history of hypersensitivity reaction to the study medications, patients with a history of alcoholism, drug abuse or mental disorders that might invalidate the free and informed consent or limit the patient's ability to meet the protocol rules, patients who had participated in any other studies involving investigational drugs or drugs already marketed within the previous month, before enrollment in this study or concomitantly with this study.~Measurement of blood pressure was performed five times by the nursing staff in right upper limb, with patient sitting, using a cuff of appropriate size to the arm and a validated automatic oscillometric device (Dixtal, DX 2710, São Paulo, Brazil) The mean of the last two measurements was calculated and recorded as long as the difference between these measurements was less than 4 mm Hg. If after the 5 measurements the difference between the last two ones was higher than 4 mm Hg, the measurement was repeated until the difference between the two measurements was less than 4 mm Hg.~The diagnosis of hypertension was made when the mean values of the last two measurements were: systolic pressure ≥ 140 mm Hg and/or diastolic pressure ≥ 90 mm Hg with or without medication in the initial visit (Visit 0). Patients who were receiving antihypertensive medication at the initial visit and had systolic pressure < 140 mm Hg or diastolic pressure < 90 mm Hg were re-evaluated 8 weeks after discontinuation of their medication and introduction of placebo, and they were included in the study when the mean values were systolic pressure ≥ 140 mm Hg and/or diastolic pressure ≥ 90 mm Hg.~All the patients underwent Ambulatory Blood Pressure Monitoring (ABPM) performed with a validated oscillometric device (SpaceLabs 90207, SpaceLabs Inc, Richmond, WA, USA) , 5 weeks after start of the placebo to eliminate the cases of patients with white-coat hypertension and in patients who did not receive placebo to identify the white coat effect.~Patients were assigned to two groups: a) uncomplicated - composed of hypertensive patients without complications and without other concurrent diseases; and b) complicated, including patients with severe hypertension (mean diastolic pressure > 110 mm Hg with or without medication) or comorbidities such as diabetes mellitus 7, renal failure (serum creatinine > 1.4mg/dL), coronary insufficiency, congestive heart failure or prior history of cerebrovascular accident.~All patients, from both the complicated and the uncomplicated group, were open block randomized to receive active telephone calls (phone calls group) or not to receive telephone calls (no phone calls group) and to follow two treatment regimens: traditional and current.~Thus, after the first visit and randomization, patients from the phone calls group were invited to enroll by telephone in the program called Biosintética Assistance supported by Biosintética Laboratory. The patients who subscribed started receiving active telephone calls from appropriately trained operators as well as magazines with health-related information, which were sent periodically by mail. There were 6 contacts by telephone during the study. The patient was reminded to attend the next visit; he/she received instructions about hypertension as well as any necessary clarifications. All the patients randomized to the phone calls group were invited to attend occasional informative lectures with the participation of a multidisciplinary team.~At the initial stage of treatment, the uncomplicated group received, after 8 weeks of treatment with placebo, one of the following treatment regimens: a) traditional treatment with hydrochlorothiazide 6.25 mg 2x/day and atenolol 25 mg 2x/day; and b) current treatment with losartan 25 mg 2x/day and amlodipine 2.5 mg 2x/day. If blood pressure could not be controlled during the visits, the medications had their doses doubled or another antihypertensive was added. The complicated group did not undergo the treatment period with placebo and was randomized to receive traditional or current drug regimens similar to the ones administered to the uncomplicated group, considering the specificity of each condition. The addition of other antihypertensive agents in the uncomplicated group, as well as the specificities of regimens of patients in the complicated group, were performed according to the guidelines from the V Brazilian Guidelines on Arterial Hypertension. 5 All the patients were instructed to take the medication every day at 7:00 am and 7:00 pm, with a variation of up to one hour. All the medication necessary for 12 months of treatment was supplied to the patients by the physician at the end of the visit in sufficient amount at no cost until the next visit, in order to eliminate the financial factor in this analysis. Patients were instructed to bring the remaining pills during their subsequent visit to be counted by the nursing staff, without the patients' knowledge of this procedure.~Doctors' visits, preceded by the nursing staff visit, took place every 8 weeks for 56 weeks with measurements of blood pressure, heart rate and weight. The weight was checked with the patient wearing light clothes and barefoot on a scale (model 2096PP, Toledo do Brasil, São Paulo, SP, Brazil).~Study withdrawal was characterized by non-attendance to the medical visit up to 3 months after the scheduled date. The patients who returned within 3 months after the scheduled date would continue in the study and be evaluated in an unscheduled visit.~The tests performed during the treatment with placebo and after 40 weeks of active treatment included: fasting glucose, urea, creatinine, total cholesterol, fractions of cholesterol, triglycerides, uric acid, total bilirubin, CPK, Na+, K+, hemoglobin, TSH, alkaline phosphatase, AST, ALT and urinary excretion of sodium in 24 h.

The purpose of this study is to evaluate the importance of providing guidelines to patients via active telephone calls in blood pressure control and in the discontinuation of treatment among hypertensive patients. Hypertensives (N = 354) who could receive telephone calls to be reminded of the dates of their medical appointments and to be instructed about hypertension were distributed into two groups: a) uncomplicated - hypertensives with no other concurrent diseases; and b) complicated - severe hypertensives (mean diastolic ≥ 110 mm Hg with or without medication) or comorbidities. All patients, except those excluded (n=44), were open block randomized to follow two treatment regimens: traditional or current and to receive active telephone calls (phone calls group) or not to receive telephone calls (no phone calls group).

Although the majority of hospitalized VA smokers receive some form of cessation counseling during hospitalization, few receive outpatient cessation counseling and/or pharmacotherapy following discharge, which are key factors associated with long-term cessation. The primary objective of this research study is to determine whether a nurse-initiated intervention, which couples brief inpatient counseling and proactive telephone counseling by a centralized tobacco quitline, improves 6-month cessation rates in hospitalized VA smokers. Co-primary aims are to determine whether the intervention improves the prescription of recommended pharmacotherapy for smoking cessation and the referral of patients for telephone counseling (or other outpatient cessation counseling). We will perform a quasi-experimental before-after trial in hospitalized patients, aged 18 or older, who smoke at least one cigarette per day on average. After a 6-month baseline period, we will implement the intervention and enroll a separate cohort of patients over the subsequent 6 months. The intervention will include: 1) nurse training in delivery of bedside cessation counseling, 2) use of CPRS-based practice tools (to streamline nursing assessment and documentation, to facilitate prescription of pharmacotherapy), 3) computerized referral of motivated inpatients for proactive telephone counseling, and 4) use of nursing peer leaders to provide coaching and performance feedback to ward nurses. Enrolled patients will be contacted by telephone at 3 and 6 months to assess 7-day point prevalence abstinence and prolonged abstinence (with biochemical confirmation of self-reported quitters at 6 months). We will identify barriers and facilitators to implementation by using clinician focus groups, and will assess attitudes of staff nurses toward cessation counseling by questionnaire. We will also conduct semi-structured interviews in a subsample of patients and nurses to assess perceptions of the intervention, and will use content analysis to interpret the data.

The primary objective of this study is to determine whether a nurse-initiated intervention, which couples brief inpatient counseling and proactive telephone counseling by a centralized tobacco quitline, improves 6-month cessation rates in hospitalized VA smokers. If proven effective, the proposed intervention will provide a practical strategy to enhance the adoption and implementation of recommended smoking cessation procedures in VA hospitals, and will demonstrate the utility of quitlines in preventing relapse in hospitalized smokers once they leave the hospital.

This study is being done to find out if an endoscope (a small, flexible tube with a camera mounted on the end) passed down the throat, through the stomach, and into the abdomen can quickly and accurately examine the organs and tissue of the abdomen and take biopsies if needed. We wish to determine if this endoscopic route is as fast and efficient as the laparoscopic route, which is the current standard of care.

This study is being done to find out if an endoscope passed down the throat, through the stomach, and into the abdomen can quickly and accurately examine the organs and tissue of the abdomen and take biopsies if needed.

Children adopted internationally by parents in the United States often experience institutional care prior to adoption. Early institutional care may lead to inattention, deficits in inhibitory control, and insecure attachments in children. Many of these problems persist even after the child is adopted. This study will test the effectiveness of a parent training program called Attachment and Biobehavioral Catch-up for Children Adopted Internationally (ABC-I). This program is designed to enhance children's ability to regulate their attention, behavior, and physiology and to develop secure, organized attachments to their parents.~Participation in this study will begin when the child participant is between 12 and 20 months old, and it will end when the child is 4 years old. Participants, who will include parents and their adopted child, will meet with the study researchers 3 times before receiving the training program intervention, twice in their home and once at the research site. During these visits, the background and medical history of the child participant will be reviewed. Participants will then be randomly assigned to receive 1 of 2 parent training programs: ABC-I or Developmental Education for Families (DEF). Both programs will involve 10 weekly sessions, each lasting 60 to 90 minutes and occurring in the parents' homes. The DEF training program will focus on enhancing the intellectual and language development of the child participant, but it will not train parents to pay attention to and interpret their children's cues. The ABC-I training program will involve videotaping parents while they interact with their children, reviewing the videotapes, discussing strategies for interacting with children, and completing homework assignments.~Participants will undergo assessments before and after the training programs and at follow-up visits when each child turns 2, 3, and 4 years old. Assessments will be made of sensitivity in parents and of inattention, inhibitory control, attachment quality, and cortisol production in children. Parent sensitivity will be measured by observing parent-child interactions and coding them according to a pre-existing scale. Child inattention and inhibitory control will be measured through observing each child's behaviors on various structured tasks, such as watching a video with a distracter present or being told to wait to open a wrapped gift. Attachment will be measured through observation of child behavior and through parent ratings and diaries. Cortisol production will be measured through a saliva sample, collected via cotton swab. When children are 4 years old, they will also be evaluated for diagnosable behavioral disorders. For a subset of children, cheek swabs will be collected at age 5-6 for the assessment of telomere length.

This study will test the effectiveness of a parent training program aimed at helping children who are adopted internationally to develop secure, organized attachments to their parents.

24 participants (equally divided between participants with normal hepatic function and those with moderate hepatic impairment (defined by the protocol as a Child-Pugh classification of grade B score of 7-9)will be given a single injection of teduglutide (20mg) through subcutaneous injection into the abdomen. Blood samples would be taken within 30 minutes of dose through 24 hours post-dose. Participants in both groups are matched up by sex, age, BMI, and renal function.

This is a study to compare the pharmacokinetic profile of teduglutide in healthy participants with normal hepatic function with participants who have moderate hepatic impairment.

Healthy subjects are enrolled once they have been screened and it is determined they qualify. The subjects are randomized to either placebo or the dose of teduglutide as outlined by the protocol at a 1:3 ratio. They will be injected with investigational product for eight consecutive days, with measurements taken including safety.

The primary objective of the study was to study the safety and tolerability of teduglutide following a once or possibly twice daily subcutaneous injection for eight consecutive days in healthy subjects. A secondary objective was to study the pharmacokinetics of teduglutide following a once or possibly twice daily injection for eight consecutive days in healthy subjects.

Background: Glucagon like peptide-1 (GLP-1) promotes satiety and reduces food intake. GLP-1 is secreted from intestinal L-cells into the splanchnic circulation, it is (i) subject to rapid breakdown and (ii) submitted to a high liver extraction. Highest concentrations of GLP-1 are therefore found in the splanchnic blood rather than in the systemic circulation. An oral delivery system would mimick the physiological path of endogenous secretion. Objective: We aimed to investigate the pharmacokinetic and pharmacodynamic effects of a single dose (2 mg) of oral GLP-1 administered prior to an oral glucose tolerance test (oGTT) in 16 healthy males.

The investigators aimed to investigate the pharmacokinetic and pharmacodynamic effects of a single dose (2 mg) of oral GLP-1 administered prior to an oral glucose tolerance test (oGTT) in 16 healthy males

No previous study attempted to characterize the pharmacodynamic, pharmacokinetic, and pharmacogenetic relationships of morphine in the early postoperative period, whereas it is the main clinical situation for severe pain and a unique model for its study (not possible in the healthy volunteer). Indeed, intravenous titration of morphine is the first step for pain control in the postanesthesia care unit. Administration of intravenous boluses of morphine enables to obtain complete pain relief in 98% of the patients. We intend to study the effects of morphine (intravenous titration then patient-controlled intravenous administration (PCA) for 24 hours), perform dosages of plasma concentration of morphine an its main metabolites, and also study gene polymorphisms coding for main proteins involved in the pharmacokinetic and pharmacodynamic profile of morphine (hepatic metabolism, distribution and elimination, interaction with morphine receptor). Five hundred patients scheduled for major orthopedic surgery will be included in this prospective study. The main objective of this study is to improve our knowledge on the pharmacodynamic, pharmacokinetic, and pharmacogenetic relationships of morphine administered to relief severe postoperative pain. The analysis will encompass the efficacy (acute during titration and subacute during the first 24 hours) and adverse effects of morphine. Our purpose is also to better characterize the age- and sex-related differences which probably markedly differ between the two periods (acute vs subacute). We consider that this knowledge is important to confirm or not several important concepts currently used to define the appropriate analgesic regimen to control severe pain in the postoperative period.

The main objective of this study is to improve our knowledge on the pharmacodynamic, pharmacokinetic, and pharmacogenetic relationships of morphine administered to relief severe postoperative pain. The analysis will encompass the efficacy (acute during titration and subacute during the first 24 hours) and adverse effects of morphine. Our purpose is also to better characterize the age- and sex-related differences which probably markedly differ between the two periods (acute vs sub acute).

This study is a prospective randomized clinical trial. The purpose of this 4-stage study is to explore the effects of patient-preferred music, relaxation music, and standard care environment on patients in intensive care units.~Stage 1: Recommendation of relaxation music by music therapists who serves as expert panel~Stage 2: Analysis of recommended relaxation music by music therapists~Stage 3: Content validation of relaxation music by healthy adults~Stage 4: Comparison of patients' physiological, psychological, and biological responses to patient-preferred music, relaxation music, and standard care environment

The purpose of this study is to investigate the effects of patient-preferred music, relaxation music, and standard care environment on patients in intensive care units.

To assess long term safety and tolerability of subjects who discontinue for any reason from UK-453,061 studies. The study will also assess efficacy of the subsequent regimens in these patients. The trial was terminated prematurely on January 29, 2013, due to the decision of the sponsor to discontinue development of lersivirine. The decision to terminate the trial was not based on any safety or efficacy concerns.

The purpose of the protocol is to assess long-term safety and tolerability of subjects who discontinue for any reason from UK-453,061 qualifying studies.

Currently, renal tissue hypoxia is the only widely accepted trigger for erythropoietin (EPO) production. However, previous studies in healthy subjects have demonstrated that a sudden and sustained decrease in tissue oxygen level, aside from an absolute low level of tissue oxygen tension, could also act as a trigger for EPO production. To confirm these observations and to clarify an eventual role of free oxygen radicals and antioxidants, hypobaric pure oxygen will be administered to healthy subjects.~The major physiologic function of EPO is thought to be the induction of erythropoiesis. However, a growing body of evidence indicates that EPO has tissue-protective effects and prevents tissue damage during ischemia. In an ex vivo proof-of-concept, protective effects of EPO have been shown in human myocardium.~The second goal of our study is to observe the cardioprotective effects of increased endogenous EPO, induced after normobaric oxygen breathing.

Tissue hypoxia is the only accepted trigger for erythropoietin (EPO) production. However, in healthy subjects EPO concentrations have also increased after oxygen breathing. The aim of our study is to confirm these observations.~Besides its main function in erythropoiesis, EPO has also shown tissue protective effects. The second goal of our study is to observe the cardioprotective effects of increased endogenous EPO, induced after normobaric oxygen breathing.

Despite advances in treatment of kidney diseases, morbidity and mortality of chronic dialysis patients remains unsatisfactory. Standard haemodialysis membranes remove middle-sized molecule solutes poorly such as beta2-microglobulin, which has a pathogenic role in dialysis-related amyloidosis. Pre-dialysis beta2-microglobulin concentration has been shown to be independently predictive of mortality. A new polyamide haemodialysis membrane has been developed with increased pore size to increase the removal of middle-sized uraemic toxins such as beta2-microglobulin. This study aims to evaluate the effectiveness of the new membrane in beta2-microglobulin removal compared with standard haemodialysis membrane in dialysis patients and the degree of increased loss of albumin as a potential limiting factor of its use.

The purpose of this study is to determine whether a novel haemodialysis membrane, compared with the standard dialysis membrane, will increase the removal of beta2-microglobulin in chronic dialysis patients.

Severe Mood Dysregulation(SMD) is a new construct in children and adolescents characterized by persistent and non episodic irritability, hyperarousal and emotional reactivity.~This is an open label trial using Risperidone in children and adolescents( 7-17 years old) diagnosed with SMD.~We hypothesized that Risperidone would improve externalizing symptoms as well as depressive and/or maniac symptomatology. We also consider the effect of the pharmacological intervention in the co-morbid disorders especially ADHD.

The purpose of this study is to investigate whether Risperidone is effective in children and adolescents with severe mood dysregulation.

Embryo transfer is the last step in the IVF process. it involves the insertion of a soft catheter through the uterine cervix. It is now recognized that this step should be done carefully and that it affects success rates. The embyos should be carefully deposited in the cavity. special care should be given to avoid touching the uterine fundus during the procedure. In recent years, sonographic guidance appears to increase success rates.

Embryo transfer is the last step in the IVF process. it is now recognized that this step should be done carefully and that it affects success rates. in recent years, sonographic guidance appears to increase success rates.

Platelets are a major component of clot formation which can lead to thrombotic events. Antiplatelet agents have been found to reduce cardiovascular events in different clinical settings. The commonest agent that has been used is aspirin which works by inhibiting the cyclooxygenase pathway within the platelet and consequently preventing the release of tromboxane A2. A second group of agents called thienopyridines can inhibit platelets by blocking the P2Y12 receptor. Clopidogrel (Plavix) is currently a widely used thienopyridine that has been used for the treatment of patients presenting with the acute coronary syndrome and patients undergoing percutaneous coronary angioplasty (PCI). Antiplatelet therapy has reduced the occurrence of thrombotic events following PCI, including myocardial infarction and stent thrombosis. However, despite dual therapy with aspirin and clopidogrel, a significant number of patients continue to experience cardiovascular events. There is a now growing body of evidence that recurrence of ischemic complications may be attributed to poor response to clopidogrel and that persistence of enhanced platelet reactivity despite the use of clopidogrel is believed to be clinically relevant.1 The mechanisms leading to poor clopidogrel effects are not fully explained.~Our pilot study will use the VerifyNow device as an ex vivo method to measure platelet inhibition in patients treated with clopidogrel in the setting of STEMI. Since July 2004, the standard of care at the University of Ottawa Heart Institute for the treatment of STEMI has been primary PCI in which all patients receive aspirin 160 mg po either in the field or on arrival in the emergency department and clopidogrel 600 mg po given on arrival to the hospital. Little is known of the pharmacokinetics of clopidogrel in the setting of STEMI. Clopidogrel must be absorbed and activated by the liver to be effective. The physiological mechanisms for these steps may be greatly disturbed in patients presenting with STEMI. Therefore, the purpose of this study will be to examine the degree of platelet inhibition at various time points in this select patient population using the current 600 mg dose of clopidogrel and comparing this dose to other doses of clopidogrel to determine the optimal loading dose in the context of STEMI.

Platelets are a major component of clot formation which can lead to clotting events such as heart attack. During treatment for a heart attack, doctors try to remove this blockage as quickly as possible so that the heart can recover and start to work properly again. The standard of care at the Heart Institute for patients having a heart attack is a procedure called a Percutaneous Coronary Angioplasty. A drug called Clopidogrel (Plavix) is routinely used prior to the angioplasty to prevent blood clots. Patients usually remain on Clopidogrel for at least one year following the angioplasty. Clopidogrel works by preventing the blood from forming sticky substances called platelets, which clump together to form clots. Despite the routine use of Clopidogrel, some patients still return to the hospital with another heart attack, or with more chest pain. There is a growing body of evidence that recurrence of these complications may be attributed to some patients having a poor response to Clopidogrel.~This pilot study will examine how platelets react to different doses of Clopidogrel given to patients having a heart attack.

Parents/guardians of children with incurable cancer face end-of-life decisions on behalf of their child including whether or not to enroll their child in a Phase I study, whether or not to agree to a 'do not resuscitate' status, or to begin terminal care. Descriptive research to date indicates that one of the factors that most helps parents to make these decisions and to remain satisfied with the decision afterward is their perception that they decided as a 'good parent' would decide. Parents define being a 'good parent' as making a decision that is in the best interest of their child. Parents' perception of their success in being a good parent is influenced by their interactions with the child's health care providers. Health care providers who are not fully informed about the decision and the parents' rationale for the decision are likely to convey doubt about the decision to parents and to other health care providers. Parents interpret this doubt as staff questioning the parents' ability to make good decisions. Lack of adequate information also creates staff tension. This single-site feasibility study will implement and evaluate a two-part communication intervention designed to identify parents' definition of being a good parent, and to communicate this definition and the rationale for the parents' decision to staff. The intervention will be implemented in 60 to 80 end-of-life clinical care situations in which parents have made a decision on behalf of a child who is still living. The feasibility study is guided by the Pediatric Quality of Life at End of Life model. The parent/guardian intervention includes a face-to-face interview with parents regarding their definition of a 'good parent' and their basis for the decision they made. Parents/guardians will be interviewed within 72 hours after making the end of life decision and again 1 to 3 weeks after making the decision. Health care professionals assigned to the terminally ill child will receive the communication intervention within hours of the parent interview, and will evaluate its usefulness 1 to 2 weeks after receiving it.~1.1 To assess the feasibility of delivering the two-part communication intervention. The definition of feasible is that 50% of all interventions are successfully implemented.~1.1.1 To identify all three types of difficult treatment decisions within the defined time frame (thus identifying eligible parents/guardians and obtaining consent within 72 hours after the decision was made), document the study team's ability to successfully implement the intervention before the child's death (obtaining the parent/guardian information and sharing that with the defined staff such that the family achieves the definition of being fully evaluable as a study participant), and document the participation rate by tracking the number of eligible parents/guardians who agree to participate, decline to participate or withdraw from the study.~1.2: To assess staff perceptions of the impact of the communication intervention on staff 1 to 2 weeks after the intervention.~1.2.1 to measure: a) staff recall of the definition of a good parent and the rationale for the decision; b) staff perception of how this knowledge influenced their care for the family; c) staff satisfaction with the verbal and written communication intervention forms; and d) the impact of the communication intervention on team tension and team communication about the parents' decisions.~1.3: To assess the impact of the communication on parents/guardians by recording their perceptions of the positive and negative aspects of the intervention at the time of the intervention and 1 to 3 weeks after the decision making.

The primary aim of this single site study was to assess the feasibility of implementing a staff/parent communication intervention within 72 hours of the parents making an end-of-life decision on behalf of their child.

Currently, medical professionals obtain respiratory rate for vital signs assessments either by counting the number of breaths during a 15, 30, or 60 second interval and multiplying to obtain breaths per minute, or by reading the respiratory rate off of a multiparameter vital signs monitor (such as a Welch Allyn Propaq Monitor), that provides respiratory effort information based on the change of AC impedance through ECG leads. The Respiration channel (RESP) of the Welch Allyn Propaq is intended to detect the rate or absence of respiratory effort, deriving the signal by measuring the AC impedance between the selected terminals of the ECG electrodes. The RSpot 100 Non-Contact Respiratory Rate Spot Check provides an alternative to the medical professional counting respiratory rate or reading the rate from a vital signs monitor designed for continuous respiratory rate monitoring. The Kai Sensors RSpot 100 Non-Contact Respiratory Rate Spot Check is used for a one-time measurement of respiratory rate as part of a vital signs assessment in the hospital or other clinical settings.~In this study, the RSpot is operated simultaneously with two other systems that provide a respiratory rate: Welch Allyn Propaq Encore model 242 and Embletta system with Universal XactTrace and Somnologica software. A respiratory rate is also obtained by counting respiratory excursions for the same duration as the RSpot measurement interval, 15, 30, or 60 seconds. The rates obtained from each of the four measurement methods are then compared.

The purpose of this study is to determine whether the respiratory rate provided by the Kai Sensors RSpot 100 Non-Contact Respiratory Rate Spot Check is as accurate as that provided by the Welch Allyn Propaq Encore model 242 and the Embla Embletta system with Universal XactTrace respiratory effort sensor and Somnologica for Embletta software.

Open label, single armed, cross over controlled study to evaluate comfort and IOP (Intraocular Pressure) changes of specific NSAIDs post SLT. Patients (n= 25, total 50 eyes) scheduled to undergo bilateral Selective Laser Trabeculoplasty (SLT) will instill bromfenac in the first eye to undergo SLT, and the contra lateral eye will receive nepafenac.

The objective of this study is to evaluate and compare the comfort of bromfenac or nepafenac following SLT.

Despite the remarkable strides made in the treatment of HIV-1-infected persons over the last decade, current first-line ART regimens are imperfect. The ideal combination, unlike some current first-line options, would have uncompromised efficacy in the presence of transmitted drug-resistant variants. The primary purpose of this study is to estimate the cumulative proportion of ART-naive participants experiencing virologic failure at or prior to week 24 after initiating raltegravir (RAL) plus darunavir/ritonavir (DRV/RTV).~The study will last 52 weeks. All participants will follow the same treatment schedule and take RAL plus DRV/RTV orally daily for the duration of the trial.~After entry, all participants will have scheduled visits at weeks 1, 4, 12, 24, 36, 48, and 52. Medical/medication history, blood and urine collection, and liver function tests will occur at screening. A targeted physical exam and concomitant medications history will occur at all study visits. Blood and urine collection and liver function tests will occur at most study visits. For females, a pregnancy test will occur at screening and study entry.~RAL and DRV were provided by the study. RTV was not provided by the study.

The purpose of this study is to assess the effectiveness and safety of an antiretroviral therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as first-line therapy in treatment-naïve participants.

Objective: To assess the behavior of Beta-2 microglobulin and serum cytokines TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure Design: Cross-sectional study. Methods: Eighty-nine HIV-1+ patients and 20 normal individuals were divided into 4 groups: G1- 15 HIV-1+ individuals, previously untreated or without HAART for at least six months and CD4+ < 350 cells/mm3; G2- 31 HIV-1+ individuals undergoing HAART without virological therapeutic failure (TF), G3- 43 HIV-1+ individuals undergoing HAART with TF, and GC- 20 normal individuals who served as controls for serum cytokines. Demographic, clinical and HAART data were reviewed, and Beta-2 microglobulin, serum cytokines (TNF-α, IFN-γ, IL-2, IL-4 and IL-10), HIV-1 genotyping, plasma viral load and CD4+ and CD8+ lymphocytes tests were performed.~Key words: Beta-2 microglobulin, serum cytokines, HIV-1, resistance, HAART, therapeutic failure, genotyping.

Cross-sectional study to assess the behavior of Beta-2 microglobulin and serum cytokines TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure.

It also aims to assess this rate among patients 1) when the geriatrics mobile unit is involved in the screening of these troubles and 2) when it is not.~All the patients (75 and older) hospitalised in the internal medicine department of a suburban Parisian hospital are included in the study and their psycho-cognitive functions assessed by a geriatrics physician, using 3 validated tests.~The result of this screening provides the rate of psycho-cognitive troubles among patients that would not have been tested by a geriatrics physician in usual care. It assesses the interest of a systematic evaluation of elderly patients by the geriatric mobile unit.

The main objective of the study is to assess the rate of patients with psycho-cognitive troubles among hospitalised elderly patients.

Alloimmunisation against the RhD (RH) red cell surface antigen is the commonest cause of haemolytic disease of the fetus and newborn. It can be avoided by anti D immunoglobulin administration (RhIg). At the end of year 2005, new recommendations about anti-D prophylaxis in France proposed that all RhD negative pregnant women should be given anti-D immunoglobulin at 28 weeks' gestation. However, about one third of these women would be carrying an RhD negative fetus and would receive the treatment unnecessarily. A non-invasive fetal RHD typing kit, CE labelled since June 2007, is available and could be proposed to all RhD negative pregnant women. Applicable from the end of the first trimester of pregnancy on fetal DNA isolated from maternal plasma, this assay allows RhIg to be specifically injected to unsensitized pregnancies with RhD positive fetus only, and to promote the use of antenatal RhIg prophylaxis in a rational approach with economical and ethical impact.The study is divided in two sub-studies. The first one is an economical and performance comparison between two antenatal management strategies of RhD negative pregnant women: the first one will comprise non invasive RhD fetal typing during the second trimester of pregnancy (GENIFERH 1 RhD typing group), and the second will be a conventional management, i.e. without RHD fetal typing (GENIFERH 1 control group). The two groups will consist of 13 maternity wards spread over French territory. The second study (GENIFERH 2) is an evaluation of RhD fetal typing diagnostic performance and biological feasibility in routine antenatal practice with development of knew technical support; it will be based on more than 3500 fetal genotypings performed during one year by the five laboratories participating at the two studies.

The study is divided in two sub-studies. The first one is an economical and performance comparison between two antenatal management strategies of RhD negative pregnant women: the first one will comprise non invasive RhD fetal typing during the second trimester of pregnancy (GENIFERH 1 RhD typing group), and the second will be a conventional management, i.e. without RHD fetal typing (GENIFERH 1 control group). The two groups will consist of 13 maternity wards spread over French territory. The second study (GENIFERH 2) is an evaluation of RhD fetal typing diagnostic performance and biological feasibility in routine antenatal practice with development of knew technical support; it will be based on more than 3500 fetal genotypings performed during one year by the five laboratories participating at the two studies.

This is an open-label, randomized, single-dose, five-period, crossover study to evaluate the relative drug concentrations with different formulations of GSK1838262 in healthy volunteers. Four new formulations will be tested against the current formulation to identify the most promising new formulations for further development. Each subject will participate in five dosing periods and each period will be separated by at least seven days. Blood and urine samples will be collected over the 36 hour period following each dose administration to measure the drug concentrations.

The purpose of this study is to evaluate the relative drug concentrations achieved with different formulations of GSK1838262 in healthy volunteers.

A few tonometers are used today in clinical practice for measuring intra ocular pressure (IOP). Each tonometer is based on different technology.~Post penetrating keratoplasty (PK) eyes are at risk for developing secondary glaucoma (9-14%). Elevation of the IOP may cause rejection of the graft or alternately a loss in the endothelial cell layer count causing decompensation of the cornea. Therefore, measuring accurately the IOP in this population is of great importance.~Measuring IOP in post PK is not an easy challenge, mainly because of parameters like the central corneal thickness (CCT), the curvature of the cornea, the axial length and biomechanical properties which diverse from normal eyes.~The Goldmann applanation tonometer (GAT) is the gold standard tonometer for measuring IOP and is the most popular tonometer clinically used. IOP measurements via the GAT are based on the assumption that the CCT is constant. post PK eyes CCT might diverse from normal eyes causing GAT IOP measurements to be inaccurate. The Pascal dynamic contour tonometer (DCT) measures IOP independently of corneal parameters. The Ocular response analyzer (ORA) is based on a non contact technique of measurement. The tonometer is thought to be independent of factors such as CCT.~The aim of the study is to compare intraocular pressure (IOP) measured by the Reichert Ocular Response Analyzer (ORA), Pascal dynamic contour tonometer (DCT) and Goldmann applanation tonometer (GAT) in eyes after Penetrating Keratoplasty (KPL). In addition its aim is to discover the dependence of different parameters, like - CCT, curvature of the cornea, axial length and biomechanical properties on IOP measurement to elucidate the appropriate tonometer for this population.

To compare intraocular pressure (IOP) measured by the Reichert Ocular Response Analyzer (ORA), Pascal dynamic contour tonometer (DCT) and Goldmann applanation tonometer (GAT) in eyes after Penetrating Keratoplasty (KPL)

The study was conducted as an open-label, randomized, Single-Dose, Fully replicated, 4-way Crossover Study to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin_D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets, in Healthy adult Volunteers Under Fasting Conditions A total of 40 subjects (30 males and 10 females) were included in this study, of which 36 (27 males and 9 females) finished the study according to the protocol.

The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets, in a fully replicated design, under fasting conditions.

For over 4 years, our international collaborative research team has carried out a social network HIV prevention intervention trial with community populations of young men who have sex with men (YMSM), disadvantaged ethnic minority Roma (Gypsies), and high-risk heterosexual adult (YHA) women and men in Hungary, Bulgaria and Russia. Eastern Europe has seen a sharp increase in HIV incidence, and social network interventions are high in cultural relevance because post-communist populations have a long history of trusting and relying upon their personal networks more than their governments. Across the three countries represented in our research during the past funding period, we enrolled social networks of YMSM, Roma, and YHAs. This study will renew our international collaboration to extend this network intervention approach. Our study, to date, has worked with very small independent friendship groups (usually composed of 5-6 people) as egocentric social networks.

This grant involves 24 social networks of young men who have sex with men, Roma, and young high-risk heterosexual adult men and women living in Hungary, Bulgaria and Russia.

The bioavailability of once-daily trazodone extended-release 300 mg caplets (test product) and trazodone immediate-release 100 mg tablets administered q8h (reference product) will be compared in healthy adult volunteers in a randomized, crossover fashion. Morning doses will be administered after an overnight fast. Blood samples will be collected predose and at pre-defined times over 72 hours following the morning dose. Pharmacokinetic parameters will be analyzed using ANOVA. Comparative bioavailability will be assessed on the basis of the ratio of least-squares means and/or 90% confidence interval criteria.

The objective of the study is to compare the pharmacokinetic profiles of extended-release and immediate-release trazodone formulations

This study aimed to compare the effect of grape seed extract and ascorbic acid in oxidative stress induced by on pump coronary artery by pass grafting surgery.~There are three groups in the study. 75 candidate of coronary artery by pass grafting surgery were assigned random allocation on the groups (25 in each group).~Control~GSE (100 mg/6h - PO, 24h before surgery)~Vit C (25 mg/kg in pump circulation during surgery)

Study aimed to compare the effect of grape seed extract and ascorbic acid in oxidative stress induced by on pump coronary artery by pass grafting surgery.

To test if smoking reduction or cessation is induced with different nicotine products and to investigate the possible health benefits of smoking reduction

The purpose of this study is to test the success rate of smoking reduction or cessation with different nicotine products.

The purpose of this study is to confirm that the ClosureFAST system can be used as an alternative to the current ClosurePlus catheter for treating the GSV and to accumulate pivotal data for optimization of the operating parameters. The results from this study will be used to further evaluate the risks and benefits of the ClosureFAST device and to obtain clinical evidence that the treatment provides effective and durable clinical outcomes.

The purpose of this study is to confirm that the ClosureFAST system can be used as an alternative to the current ClosurePlus catheter for treating the GSV and to accumulate pivotal data for optimization of the operating parameters.

Social Anxiety Disorder (SAD) is a potentially debilitating condition affecting approximately 12% of the population at some point in their life (Ruscio et al., 2008). Nongeneralized SAD refers to individuals whose fears are limited to one or two social situations, most commonly public speaking. Empirically supported treatments for public speaking anxiety generally include an exposure component involving participation in anxiety-provoking public speaking situations (usually simulated situations using an audience of confederates and/or fellow participants, as well as actual public speaking situations in the community). Exposure is often presented within the context of habituation, but cognitively- based therapies utilize a rationale for exposure based on cognitive restructuring and belief modification. Research investigating the incremental benefit of adding other treatment components to exposure has yielded mixed results; however, there is preliminary evidence that the context in which exposure is presented can have an impact on treatment outcome. Recently, acceptance-based therapies have begun to frame exposure as an opportunity to increase one's willingness to experience anxiety while engaging in valued behaviors, rather than as a vehicle for modifying maladaptive cognitions and reducing anxiety. However, little research has been conducted on the efficacy of acceptance-based therapies for public speaking anxiety, and no component control studies have examined the utility of an acceptance/cognitive defusion rationale and context for exposure for public speaking anxiety. The present study will compare two exposure-based treatments for public speaking anxiety in a clinical sample. Specifically, exposure within an acceptance/defusion context will be compared to exposure with a habituation-based rationale.~Hypotheses:~Participants receiving exposure within an acceptance/defusion context will experience a greater reduction in anxiety and behavioral avoidance, and greater improvement in measures of quality of life, compared to participants receiving exposure within a habituation rationale, at post-treatment.~Acceptance, defusion, and mindfulness will mediate treatment outcome. Specifically, greater changes on measures of these three constructs will account for a significant portion of the effect of treatment condition on the dependent variables.~Lower baseline levels of public speaking anxiety and overall anxiety will be associated with higher baseline quality of life, mindfulness, acceptance, defusion, and social skills.~Baseline levels of acceptance, defusion, and mindfulness will predict overall treatment response, regardless of intervention condition.

The purpose of this study is to compare two exposure-based behavioral group treatments for public speaking anxiety. Specifically, exposure within the context of psychological acceptance will be compared to exposure within a standard habituation context. It is hypothesized that participants receiving exposure within the context of psychological acceptance will experience a greater decrease in anxiety and greater improvement in quality of life compared to the habituation-based group.

1.0 BACKGROUND~A common method for assessing the respiratory status of hospitalized pediatric and neonatal patients is the use of pulse oximetry. This noninvasive device uses a light emitting diode (LED) emitter, which is applied to an area of the body with good local blood flow. Red and infrared light is shined through the blood-perfused tissue under the sensor and the detected light information is sent back to a signal processing unit, or monitor, for calculation of oxygen saturation (SpO2)1. Typically the sensor may be placed either on the forehead, a finger, or in neonates - the foot, palm or toe. Use of this noninvasive method provides continuous information on the oxygenation status of patients and has greatly reduced the number of arterial blood gas punctures or samples required for patient care.~While the advantages of noninvasive pulse oximetry are significant, there are a number of factors that can negatively impact the performance of the device2. Patient monitoring during low saturation episodes has been one of the challenges to optimal device performance. Improvements to sensor technology over the last 20 years have progressively improved the accuracy and reliability of the device. Since their introduction to clinical care in the 1980's, a number of improvements have been made to increase the accuracy of pulse oximetry in oxygen saturations of 80% and below.~Nonetheless, while much of the clinical research on pulse oximetry sensors over the years has evaluated device accuracy and reliability, limited data are available in these conditions1,6.~The purpose of this study is to evaluate the accuracy of new pulse oximetry sensors specifically designed for low saturation episodes in pediatric and neonatal patients. Results of this study will provide basic information to drive further improvements in the technology.~2.0 PURPOSE AND OBJECTIVES~The general purpose of this study is to evaluate the feasibility, accuracy and performance of pediatric and neonatal oximetry sensors over clinically relevant ranges of arterial saturations between 60-100%.~The study objectives are as follows:~To evaluate the accuracy of a neonatal sensor in the saturation range of 70-80% in the following weight category: 0-5kg.~To evaluate the accuracy of neonatal and pediatric transmission (digit/foot/hand) sensors in the saturation range of 60-80% in the following weight categories: 0-5kg; and, 5-40kg.~To evaluate the accuracy of neonatal and pediatric transmission (digit/foot/hand) sensors in the saturation range of 80-100% in the following weight ranges: 0-5kg; and, 5-40kg.~These objectives will be achieved by enrolling hospitalized patients from several neonatal and pediatric units, including cardiac cath lab, OR and intensive care areas. Table 1 below outlines the specifics for data collection.~Table 1 60-80% Saturation Range 80-100% Saturation Range~Neonatal <5kg. Transmission sensor (20 data points targeted) Transmission sensor only (30 data points targeted)~Pediatric 5-40kg. Transmission sensor only (20 data points targeted) Transmission sensor only (30 data points targeted)~*Data required for 70-80% saturation range only~Data may be collected continuously from the test and reference devices by a validated computer data acquisition system and/or by Case Report Form (CRF) recording, for direct comparison to measurements taken from Co-Oximetry (or arterial blood gases (ABGs) if Co-Oximetry is not an option). Arterial blood sampling will be obtained as necessary for patient management as defined by the attending physician.~3.0 DEFINITION OF TERMS~3.1 Pulse oximetry sensors: Pulse oximetry sensors are devices, which are attached to the skin (hand, forehead, finger, toe, foot) with or without an adhesive material and connected to a signal-processing unit for the purpose of noninvasive oxygen saturation monitoring. For the purposes of this study, three different sensors will be simultaneously placed on each enrolled patient: a reference sensor and two test sensors (Nellcor Puritan Bennett LLC, Boulder, CO, and Masimo Corporation, Irvine, CA). The Masimo sensor will be a rainbow R25, R25-L, R20 or R20-L, and the Nellcor sensor will be an OxiMax MAX-A, MAX-P, MAX-I or MAX-N. All sensors are currently available on the market but the Masimo sensors have not been compared to the Nellcor sensors in head-to-head tests. During the study, a Masimo sensor will be connected to a Masimo bedside pulse oximetry monitor (the Radical-7) via a standard patient cable, and a Nellcor sensor will be connected to a Nellcor bedside pulse oximetry monitor (the N-600x) via a standard patient cable.~3.2 Sensor accuracy: Sensor accuracy is the capability of the tested sensor to reflect oxygen saturations that are consistent with those obtained directly from arterial blood sampling and evaluated with Co-Oximetry. 3.3 Skin color: For the purposes of this study, skin color will be assessed with Nellcor's visual inspection rating scale (i.e., 1 very light, 2 olive hue, 3 dark olive, 4 extremely dark).~3.4 Data point: Paired data value from Co-Oximetry and the test sensor. 3.5 Transmission sensor: A sensor where the emitter and photodetector are opposite of each other, with the measuring site (i.e., digit) in-between 3.6 Reflectance sensor: A sensor where the emitter and photodetector are next to each other and on top of the measuring site.~4.0 MATERIALS AND METHODS 4.1 Study Design. This is a multicenter observational study wherein the information collected on the test devices will not be used for clinical management. A repeated-measures experimental design will be used to compare the test sensors with conventional oximetry and Co-Oximetry, the defined Gold Standard. Both of the test sensors and a reference sensor will be simultaneously applied to each subject. The reference sensor will be applied for the patient's clinical management, while the test sensors will be applied to an extremity as indicated.~A minimum of 50 subjects with a minimum of 100 data points across sites will be necessary to address subject-to-subject variability and to yield a statistically significant RMSD. Enrollment in the study will be suspended as soon as both minimums are achieved. A data point is defined as a paired data value from Co-Oximetry and the test sensors. If high variability is observed, a need for more subjects or data-points may be determined.~5.0 STUDY PROCEDURE~All patients who meet the eligibility criteria for the study, after having signed the Informed Consent will have the following procedures carried out:~5.1 The reference sensor will be applied according to the product Directions For Use7 (DFU), while the test sensor or sensors will be applied to a recommended site per the test sensor's DFU.~5.2 Demographic (the patient's physical characteristics) and baseline data will be collected. 5.3 Skin color. For the purposes of this study, skin color will be assessed with Nellcor's visual inspection rating scale (i.e., 1 very light, 2 olive hue, 3 dark olive, 4 extremely dark).~5.4 The date, time, and test sensor tracking numbers will be recorded on the CRF.~5.5 Each sensor will be connected to a patient cable, which will be connected to a SpO2 monitor. The monitors connected to the Nellcor and Masimo test sensors will not be used for patient care management decisions. Alarms on the test sensors/monitors will be inactivated prior to study use to avoid patient management confusion.~5.6 Test sensors and data collection will be discontinued five to fifteen minutes after the last anticipated arterial blood draw. The date and time of sensor discontinuance will be recorded on the CRF.~A sample study procedure can be found in Attachment A. A sample Adverse Event Form can be found in Attachment B.~6.0 DATA ANALYSIS~Pulse oximetry measurements of saturation from the test devices (sensors) will be compared to Co-Oximetry measurements of arterial oxygen saturation to demonstrate that the test sensors meet the oxygen saturation accuracy specifications for SpO2 when used on neonatal and pediatric populations.~SpO2 accuracy will be determined by calculating the root mean square of the differences (RMSD) between test sensor and SaO2 CO-oximeter (or ABG) value to the following equation:~RMSD = where d is the difference between SpO2 and SaO2. Paired data values may then be plotted comparing the Pulse-Oximetry values and Co-Oximetry values, across the saturation range of interest (i.e., ≤80%).~7.0 ADVERSE EVENT REPORTING All known and anticipated adverse events associated with this study are identified in Section 8.0, Risk Analysis. All reportable anticipated, and unanticipated, adverse events will be documented on the Adverse Event Form.~8.0 RISK ANALYSIS~The risks to participation in this study are primarily physical. Involvement in this study requires the addition of two additional pulse oximetry sensors to the extremities of the subjects. There are no psychological, social, economic, legal or other risks that have been identified. We believe that the risks from the devices and the study procedure are non-significant.~Physical risks from the use of the devices may consist principally of a burn to the skin. Pulse oximetry sensors are attached to the fingers or other skin surfaces, and use light to measure saturation, generating a small amount of heat. Because of the low amount of current required to power the LED's, risk of burn is minimal. The long history of safe performance of Nellcor and Masimo Pulse Oximetry in the marketplace is evidence that this risk is very low. In addition, the short duration of this study makes this risk extremely unlikely.~The application and removal of oximetry or other non-invasive tissue sensors present a minimal risk to the subject. There may be minor discomfort associated with removal of adhesive sensors or a reaction to the standard adhesive. Injury from a reaction to a sensor adhesive is rare.~9.0 BENEFITS~There are no direct benefits to subjects who participate in these studies. Benefits from the study will be the overall improvement of patient care, as a sensor can be developed which is expected to be accurate and reliable in reporting saturations below the 80% saturation range. Future patients will benefit from the accurate and reliable products that are developed using the procedure described above.~10.0 STATEMENT OF NON-SIGNIFICANT RISK~Nellcor believes that this is a non-significant risk device study due to the nature of the devices being tested. Utilizing the information presented in Section 9.0 and the FDA criteria listed below to distinguish between significant and non-significant risk devices, Nellcor has determined that the devices referred to in the Protocol present no potential for serious risk to the health, safety, or welfare of a subject and are NOT:~Implants; or~Used in supporting or sustaining human life; or~Substantially important in diagnosing, curing, mitigating or treating disease or in preventing impairment of human health.~Nellcor requests that the IRB indicate its agreement with this determination of risk in its letter of approval for this study.~11.0 ETHICAL CONSIDERATIONS~No therapeutic modifications are proposed in this study. Written informed consent will be obtained from each participating patient. If the patient is a minor, written informed consent will be obtained from the subject's parents or legal guardian(s) and their permission sought for participation in this study. Federal policies for protection of human subjects will be followed at all times8.~12.0 CONFIDENTIALITY~Subject confidentiality will be kept at all times. Patient records may be made available to employees from Nellcor and the United States of America Food and Drug Administration (FDA) for data review only. The results of this study may be presented at meetings or in publications; however, subject identity will not be disclosed.~13.0 COMPENSATION TO THE STUDY SUBJECTS~None~14.0 FINANCIAL OBLIGATIONS~None

The general purpose of this study is to evaluate the feasibility, accuracy and performance of the Nellcor/Covidian 600-x and the Masimo rainbow technologypediatric and neonatal oximetry sensors over clinically relevant ranges of arterial saturations between 60-100%.~The study objectives are as follows:~To evaluate the accuracy of a neonatal sensor in the saturation range of 70-80% in the following weight category: 0-5kg.~To evaluate the accuracy of neonatal and pediatric transmission (digit/foot/hand) sensors in the saturation range of 60-80% in the following weight categories: 0-5kg; and, 5-40kg.~To evaluate the accuracy of neonatal and pediatric transmission (digit/foot/hand) sensors in the saturation range of 80-100% in the following weight ranges: 0-5kg; and, 5-40kg.

People who live in rural areas are more likely to smoke cigarettes than people who live in urban and suburban areas. However, many smoking cessation resources and programs may not be available to residents of rural areas. Toll-free tobacco telephone quitlines are proven to help people stop smoking and are available to almost everyone living in the United States, but only 1% to 5% of smokers actually use them. Another option for helping people stop smoking may involve having doctors provide smoking cessation programs in their offices or clinics; however, most doctors' offices do not have the resources to provide this type of service. Telemedicine provides medical information over the phone or through the Internet by using various technologies, including Webcams or video conferencing equipment. It has been used successfully to provide psychiatric care and addictions counseling, but there have been no studies that have examined the effectiveness of a telemedicine smoking cessation program. The purpose of this study is to compare the effectiveness of a telemedicine smoking cessation program that takes place in a doctor's office versus the effectiveness of a traditional telephone quitline smoking cessation program among rural smokers.~The study will be conducted at 25 rural doctors' offices in Kansas. Participants will be randomly assigned to participate in a telephone quitline program or a telemedicine program. Participants in the telephone quitline program will receive four sessions of telephone quitline counseling from smoking cessation counselors over an 8-week period. Participants in the telemedicine program will receive four sessions of telemedicine counseling from smoking cessation counselors over an 8-week period, which will be delivered through two-way Webcams at computers in the doctors' offices. All participants will receive educational handouts and individually tailored quit plans, including information on smoking cessation medications. At baseline and Months 3, 6, and 12, all participants will take part in telephone interviews with study researchers to assess smoking habits. At baseline and Month 12, participants will mail a saliva sample to researchers for the purposes of determining the level of nicotine in the body.

People who smoke cigarettes and live in rural areas may not have access to a wide variety of resources to help them stop smoking. This study will evaluate two smoking cessation programs-an Internet-based telemedicine program and a telephone-based quitline program-among rural residents.

The purpose of this study is to examine the feasibility, acceptability and effectiveness of implementing the AAP's recommendation that clinicians provide developmental surveillance at all well child visits and institute developmental screening at critical developmental periods in childhood, namely at 9, 18, 24 and 30 months of age. The study will also examine its acceptance by pediatric practices, its adoption and adaptation in urban pediatric practices, and the effectiveness of a developmental screening protocol that conforms to the AAP and Maternal and Child Health Bureau (MCHB) recommendations compared with that of developmental surveillance alone.

The purpose of this study is to examine the feasibility, acceptability and effectiveness of implementing the American Academy of Pediatrics (AAP's) recommendation that clinicians provide developmental surveillance at all well child visits and institute developmental screening at critical developmental periods in childhood, namely at 9, 18, 24 and 30 months of age.

fMRI is a well established imaging technique that allows investigators to see regional brain function based off of actions like reading, speaking, playing music, etc. Even the type of language and format of that language can change the area of the brain that is active while performing that action. This study is meant to see the areas of the brain that become active both prior to and during the process of reading diacritic markings in arabic.

The purpose of this study is to determine brain function in reading arabic diacritics.

Many surgeries are performed under spinal anesthesia, including ambulatory surgeries. The standard agent used for spinal anesthesia is called bupivacaine. It's safe and effective, but has a major disadvantage. It has a long duration of action (up to 4 hours), witch can prolong unnecessarily the patient's stay in the recovery room and in hospital.~Another local anesthetic available for spinal anesthesia is 2-chloroprocaine. It has been used since many years, but some serious cases of toxicity in the 80's led to an interruption of its utilization. Those cases have been proven to be associated with the preservative agent (bisulfite) that was added and to the low pH (<3) of the drug.~Since then, 2-chloroprocaine exists in a preservative-free formulation and has been used in thousands of patients worldwide, without any problem. The major advantage of 2-chloroprocaine is its shorter duration of action, permitting a faster recovery from anesthesia, and also permitting a faster discharge from hospital (in a context of ambulatory surgery)~The purpose of this study is to compare the efficacity and the readiness for discharge (from the recovery room, and from hospital) between two local anesthetics, bupivacaine and 2-chloroprocaine, used for spinal anesthesia in elective ambulatory surgeries.~Patients, after consenting for the study, will be randomly assigned to the following groups:~spinal anesthesia with chloroprocaine 2% 40 mg (2 mL)~spinal anesthesia with bupivacaine 0,75% 7,5 mg (1 mL)~An executant anesthesiologist will be responsible for performing the spinal anesthesia, with a 25 gauge Sprotte needle, at the level L2L3, L3L4 or L4L5. The responsible anesthesiologist will only take charge of the patient after the technique, so he stays double-blinded to the local anesthetic used. During surgery, if the patient feels pain, he may receive iv fentanyl, 25-100 µg at every 5 minutes.~Measures will start immediately after the spinal block:~Evaluation of the sensory block height (with ice):~Every 3 minutes for 15 minutes (time to obtain a block a about T10)~Every 5 minutes for 45 minutes (surgery)~Every 10 minutes for 60 minutes, then every 15 minutes until the block regresses to S2 (recovery room and ambulatory surgery unit)~Evaluation of the motor block (using the Bromage scale):~Every 3 minutes for 15 minutes~At the beginning and at the end of the surgery~After the surgery:every 10 minutes for 60 minutes, then every 15 minutes until the block regresses to S2 (recovery room and ambulatory surgery unit)~(Bromage scale: full flexion of feet and knee = 0; able to move knee and feet, not hip = 1; able to move feet only = 2; unable to move feet or knee = 3)~When the block will have regressed to S2, the patient will be asked to urinate. If he isn't able to urinate, this demand will be repeated every 15 minutes. (not applicable if the patient goes home with a urinary catheter)~In the context of an ambulatory surgery, the patient will go home when he will meet the usual discharge criteria. All patients will receive a phone call from the research team the day after surgery, and 7 days later, to assess their satisfaction towards the analgesia and to inquire about potential complications of the spinal anesthesia.

The purpose of this study is to compare the efficacity and the readiness for discharge between two local anesthetics, bupivacaine and 2-chloroprocaine, used for spinal anesthesia.

Objectives:~To compare the addition of Hands on Training (HOT) to Web Based Training (WBT)on residents' skills, confidence, opinions and practice .~Methods: Pediatric residents participated in WBT on preventive oral health. Then the WBT subjects were randomly assigned to receive HOT by a dentist, or WBT alone. All subjects were assessed on skills in the performance of an oral exam, by direct observation. Residents' confidence regarding oral health counseling, and their opinions about the importance of the incorporation of oral health into the well child visit, was measured by surveys utilizing a Likert scale. Residents' change in practice was assessed by a retrospective chart audit.

The purpose of this study was to compare the effect of the addition of hands on training by a pediatric dentist on the pediatric residents skills, confidence, opinions and practice related to preventive oral health.

At this time there exist no studies that help Pulmonologists and Oncologists decide on the best time to perform diagnostic bronchoscopies in Bone Marrow Transplant patients with suspected pulmonary infections. Practice patterns vary from institution to institution and also vary widely within an institution based on the practice preferences of the attending physicians. This study is a prospective randomized trial comparing early ( within 24-36 hours of enrollment) to late ( day 5-6 after enrollment) bronchoscopy in Bone Marrow Transplant patients who develop pulmonary infiltrates or clinical evidence of respiratory infection. If patients in the late arm require earlier bronchoscopy or do not require bronchoscopy on day 5-6 then the care will be dictated by the attending physician. Only bronchoscopies that are clinically indicated will be performed.~The aim is to determine the optimal timing for performing bronchoscopy in this group of patients. The primary outcomes will be change of therapy as determined by addition or removal of antibiotics, antifungals, antivirals or steroids etc. as well as the oncologist's opinion on the impact the bronchoscopic results had on care of the patient. Patients will be followed throughout their hospitalization as well as receive a phone call 3 months after hospital discharge. Written consent will be obtained from the patients or health care power of attorney in relevant cases.~It is our hope that the results of this study will help better define the role of bronchoscopy in the management of Bone Marrow Transplant patients.

This study will evaluate the outcomes of bronchoscopy in Bome Marrow Transplant (BMT) patients who develop lung infiltrates suspicious for infections of the lungs. It will consist of two groups, one group will receive bronchoscopy within thirty six hours of enrollment, while the other group will receive bronchoscopy five days after enrollment. The purpose of this study is to determine the ideal time for bronchoscopy in this group of patients.

The neurotransmitter histamine appears to be involved in human cognitive performance. However, the exact role is very unclear. The role it plays in memory performance is highly disputed, as animal studies show decreased performance when the H1-receptor is blocked in the central nervous system while such findings in humans is scarce. To clarify the role of histamine in human memory and different processes in cognition, the effects of an H1-antagonist (dexchlorpheniramine) on memory, alertness and sensory and motor processes are measured. The study will be conducted according to a within subject cross-over design using healthy volunteers.

The purpose of this study is to determine whether histamine is involved in memory and specific processes in human cognition.

The purpose of this study is to evaluate the effectiveness of 3D (3 dimensional)renal ultrasound to check kidney perfusion (to see if the kidney is receiving enough blood flow to function as it should) in premature and/or very low birth weight babies.

The purpose of this study is to evaluate the effectiveness of renal ultrasound to check kidney perfusion in premature and/or very low birth weight babies.

The proposed study will focus on possible effects of statins on muscle strength and quality of life, and measurements to understand why muscles of statin users are not able to fully utilize fats. The investigators are specifically interested in statin users and the impact of muscle symptoms on daily activities and quality of life.~This study hypothesizes that patients with likely statin-associated myopathy have a metabolic dysregulation in fuel utilization such that compared to patients continuing statins, those on placebo will show:~improved INQoL and SF-36 scores (primary end point)~alleviation of muscle symptoms,~increased utilization of fatty acids as a fuel source reflected by the metabolic test results~decreased IMCL~improved insulin sensitivity.

The proposed study will focus on possible effects of statins on muscle strength and why they become tired more easily, quality of life, and measurements to understand why muscles are not able to fully utilize fats. The investigators are specifically interested in statin users and the impact of muscle symptoms on daily activities and quality of life.~This study hypothesize that patients with likely statin-associated myopathy have a metabolic dysregulation in fuel utilization such that compared to patients continuing statins, those on placebo will show:~improved Individualized Neuromuscular Quality of Life (INQoL) and Short Form-36 (SF-36) scores (primary end point)~alleviation of muscle symptoms,~increased utilization of fatty acids as a fuel source reflected by the metabolic test results~decreased intramyocellular lipid (IMCL)~improved insulin sensitivity.

Patients identified by selection criteria within 48 hours of intubation will be randomly assigned to one of three study arms: dexmedetomidine 0.2 mcg/kg/hr, dexmedetomidine 0.6 mcg/kg/hr, or placebo. If not already on, patients will be converted to propofol and fentanyl for sedation and analgesia, which will be titrated to a goal SAS score of 3-4.~Patients will be monitored, assessed, and evaluated by all regular policies and procedures of the institution. Extubation will be at the discretion of the physicians and medical team caring for the patient. If the patient is still intubated at five days study drug will then be stopped and further use of dexmedetomidine will be at the discretion of the physicians.~Primary objective will assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and propofol while maintaining sedation in a mechanically ventilated patient in a general medical intensive care unit.~Secondary objectives include total ventilation time, ICU length of stay, hospital length of stay, patient outcomes/mortality, and total pharmacy expenditures.

Assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and propofol while maintaining sedation in a mechanically ventilated patient in a general medical intensive care unit.

This is a Phase 1, dose escalation study of EC0489 administered by intravenous bolus (IV) during weeks 1 and 3 of a 4-week cycle in PART A and weekly on a 4-week cycle in PART B.~Both Parts are open to patients with refractory or metastatic cancer who have exhausted standard therapeutic options. EC0489 is a drug that is specifically designed to enter cells via a folate vitamin receptor. Experimental evidence shows that the target receptor is over-expressed in many human cancers. There are no previous human studies of EC0489; however, lab research (research in test tubes or animals) using EC0489 has shown activity against tumors in animals. This activity in animal models suggests that EC0489 may be useful as chemotherapy against human cancers. The primary objective of this study is to determine the safety and maximum tolerated dose of EC0489 given by intravenous bolus. The efficacy of treatment will also be measured.

This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0489 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.

Atelectasis formation during general anesthesia, leading to reduced end-expiratory lung volume, is an important cause of intrapulmonary shunt leading to impaired gas-exchange and hypoxemia. During general anesthesia and the immediate postoperative period, morbidly obese patients, who develop a larger amount of atelectasis than non-obese patient, are more likely to present impairment of gas exchange and respiratory mechanics. Noninvasive positive-pressure support ventilation (NIPPV) and positive end-expiratory pressure (PEEP) are effective to provide oxygenation during intubation of hypoxemic patients. Recent data suggest that NIPPV enhances preoxygenation in morbidly obese patients. Moreover, the application of PEEP during induction of anesthesia prevents atelectasis formation and increases nonhypoxic apnea duration in obese patients despite the use of high-inspired oxygen fraction. However, the use of both NIPPV is widely used in the operating room, because of technical and materials constraints.~Several trials have demonstrated that alveolar recruitment maneuvers (RM) are effective to remove atelectasis and improve lungs mechanics and gas-exchange.~The purpose of this randomized and controlled study is to compare the effects of two ventilatory strategies during anesthesia induction of morbidly obese patients on both gas-exchange and functional residual capacity (FRC) modifications: 1- Control group: preoxygenation using 100% O2 via a face-mask and PEEP 10 cmH2O after intubation; 2- NIPPV group: preoxygenation using NIPPV and PEEP 10 cmH2O after intubation; 3- RM group: preoxygenation using 100% O2 via a face-mask and early RM plus PEEP 10 cmH2O after intubation.

The purpose of this study is to compare the effects of noninvasive pressure support ventilation and early alveolar recruitment maneuver during anesthesia induction of morbidly obese patients on both oxygenation and functional residual capacity modifications.

EGT0001474 is an inhibitor of human sodium dependent glucose co-transporter II being developed for the treatment of Type II Diabetes mellitus.~This is a singe center, Phase-1, double blinded,placebo controlled, dose escalation study of single and multiple ascending doses of EGT0001474 in healthy male and female subjects.~In part-1, subjects were randomized to receive single doses of EGT0001474 at 2.5-150 mg or placebo in the ratio of 3:1. In part-2, subjects were randomized to receive 14 daily doses of EGT0001474 at 10, 50 and 150 mg or placebo in the ratio of 4:1. When the various doses were analysed, the maximum dose 150 mg was found to be tolerable. Although there was no serious adverse events, mild adverse events were observed.~This study provided information on human safety, tolerability, PK and pharmacodynamic effects of EGT0001474.

This study evaluated the safety, tolerability and pharmacokinetics of single or multiple doses of EGT0001474.

The major physiologic function of EPO is thought to be the induction of erythropoiesis. However, a growing body of evidence indicates that EPO has tissue-protective effects and prevents tissue damage during ischemia. In an ex vivo proof-of-concept, protective effects of EPO have been shown in human myocardium.~Several studies have demonstrated that acute normovolemic hemodilution before aortic cross clamping decreases perioperative myocardial damage. We hypothesized that the onset of acute anemia increases the endogenous EPO concentration, which explains the cardioprotective effects of acute normovolemic hemodilution.

Several studies have highlighted the cardioprotective effects of acute normovolemic hemodilution during cardiac surgery. The aim of our study is to show that an increase in endogenous erythropoietin (EPO) might explain the cardioprotective effects of acute normovolemic hemodilution against ischemia-reperfusion phenomena.

To prospectively assess the impact of surgical quality on the overall cost of major surgical procedures using the incidence and severity of complications as surrogate markers of quality

The purpose of this study is to prospectively assess the impact of surgical quality on the overall cost of major surgical procedures using the incidence and severity of complications as surrogate markers of quality.

The postpartum period is a very stressful experience for most mothers. It is generally accepted that women are physically and psychologically stressed during the postpartum. After delivery a woman may have worries about the health of her baby and her own health, as well as the changes in her body, their impact on her sexual life and her relationship with her husband. In addition, she may have financial concerns, concerns about breastfeeding, and be worried about bonding with her baby.~First-time mothers also have to adapt to their new role as mothers and may be worried about their abilities to take care of the baby. This may cause first-time mothers to develop postpartum depression and other emotional problems. First-time mothers can feel overwhelmed, exhausted, and isolated in their new roles.~We are conducting a study to look interventions that may reduce stress in the postpartum period for first- time mothers. One of these interventions is an educational film that describes the common stressors that first-time parents go through in the early postpartum period. The other is a hotline service that women can call at anytime during the first 3 months postpartum to ask about problems she or the baby may be experiencing. The hotline will be answered by a trained midwife.~Women will be recruited from all hospitals in Beirut after delivery and before they leave the hospital. If they agree to participate in the study, they will be randomly assigned to receive the film, the hotline service, both the film and the hotline service, or a CD containing children's songs. Women will be visited at home at 2 - 3 months after delivery by a researcher to complete questionnaires designed to measure stress, depression and anxiety in the postpartum.~Participants will not receive any financial compensation for participating in the study. Although women may benefit from the interventions, we will not know that until we complete the study. However, participation in this study may benefit mothers in the future if we find that the hotline or educational video are useful. There are no risks associated with participation in this study.~Confidentiality of the collected information will be ensured. All information collected will be used for research purposes and will be kept anonymous.

We are conducting a study to look interventions that may reduce stress in the postpartum period for first- time mothers. One of these interventions is an educational film that describes the common stressors that first-time parents go through in the early postpartum period. The other is a hotline service that women can call at anytime during the first 3 months postpartum to ask about problems she or the baby may be experiencing.

The purpose of the study is to evaluate the efficacy of dynamic splinting for knee flexion contracture following a total knee arthroplasty.

The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for knee flexion contracture following a total knee arthroplasty.

Etomidate is a hypnotic widely used for patients in intensive care who require rapid induction, because of its short duration of action, its excellent cardiovascular tolerance and maintenance of cerebral perfusion pressure.~For this reason etomidate remains the hypnotic of choice for induction of unstable patients. Other hypnotics currently in existence do not provide adequate safety with a sufficiently predictable and stable effect in this situation. However, it may induce acute adrenal insufficiency by inhibition of 11-b-hydroxylase necessary for the synthesis of cortisol from compound S. An observational study conducted at the Grenoble University hospital in 2006 showed that the duration of this blockage can reach up to 48 hours. Acute adrenal insufficiency in intensive care patients is associated with a poor prognosis. The main objective of this study is to assess the value of substitution with 200mg/24h of hydrocortisone for 48 hours for patients in intensive care who have received a single injection of etomidate.~This is an interventional, prospective, randomized, placebo-controlled, double-blind, analytical study with a cohort of 100 patients between 18 and 80 years, of both sexes, who have had tracheal intubation in a pre-hospital or shock treatment setting with the administration of a single injection of etomidate.

the objective of the study is to assess the value of substitution with 200mg/24h of hydrocortisone for 48 hours for patients in intensive care who have received a single injection of etomidate

This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while both treatments are expected to be comparable with respect to efficacy.

This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while both treatments are expected to be comparable with respect to efficacy.

Due to their capacity to damage Deoxyribonucleic acid (DNA), Ultra-Violet (UV) radiation is one of the causes of skin cancers.~Until recently, the genotoxic effects of UV-A radiation, were poorly identified, in particular their capacity to lead to the dimerization of pyrimidine bases .~It is well known that the response to UV-A and UV-B radiations is different depending on the cutaneous phototype.~Thus, the aim of this study is to determine the correlation between cutaneous phototype and the quantity and nature (CPD or oxidative lesions) of damage caused to cutaneous DNA after an ex-vivo exposure to UV-A and UV-B radiations.

The DIMUVA study aims to evaluate the correlation between cutaneous phototype and the nature and quantity of damage caused to cutaneous DNA after exposure to UV-A radiation.

The primary hypothesis is that high dose vitamin D3 plus standard dose vitamin D3 prevents the worsening of musculoskeletal symptoms when compared to a standard dose vitamin D3 treatment. This protocol will examine the relationship between vitamin D levels (25-hydroxyvitamin D) and various quality of life measures in women being treated with letrozole as standard care for early stage breast cancer. All subjects received letrozole and a standard dose of vitamin D3 (600 IU daily). Randomization was between high dose vitamin D3 (30,000 IU once per week) vs. a blinded, matched placebo,

The primary purpose is to determine if high dose vitamin D3 reduces the incidence of musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with early stage breast cancer and low serum vitamin D levels.

In most cases of acute mallet finger, or avulsion of the extensor digitorum communis terminal tendon from the distal phalanx, splinting is the treatment strategy employed. These are considered Doyle I injuries- closed injuries with or without a small (<20%) avulsion fragment. Absolute and relative indications for surgical intervention include an open injury, or a bony mallet involving greater than 20% of the articular surface of the distal phalanx with volar subluxation of the distal phalanx relative to the proximal phalanx. The type of splint used to treat Doyle I mallet injuries continues to be controversial. Custom splints have recently been advocated though no strong comparative evidence is available.~Objectives. The primary objective of this investigation was to show superiority of the custom thermoplastic splint over both the dorsal and volar non-custom splints. The null hypothesis was that a radiographic lag difference greater than 5 degrees would not be observed between groups. The primary outcome measure is the residual extensor lag difference (compared to the contralateral equivalent digit) at 12 weeks post-splinting. Week-12 was chosen as a compromise between minimizing drop-out and the most distant timepoint reasonably obtainable.~A novel outcome lag measurement was developed for this study, using the contralateral normal digit as an internal control for establishing residual extensor lag. The residual extensor lag difference was calculated with a single radiograph obtained with the beam directed laterally at the affected digit and the contralateral equivalent digit (Figure 2). For example, if the injured mallet finger was the right index finger, a single lateral radiograph of the right and left index fingers on the same film was obtained. The patient was instructed to maximally extend the both digits. This allowed for accurate determination of extensor lag and comparison with the unaffected side . Adequacy of the lateral view was assessed by considering the superimposition of the phalangeal condyles of the affected digit. If they were not not superimposed, the radiograph was repeated.~A pilot study was performed to establish the most reliable technique for measuring residual lag radiographically. Three measurement techniques were trialled by individuals with three levels of training: resident, fellow, and consultant staff. A clearly defined technique was employed using digital images only (Inteleviewer, Intelerad, Montreal, Canada). The radiograph was enlarged on the viewing monitor so that the middle and distal phalanges maximally filled the screen. The techniques used bisecting lines for the middle and distal phalanges referencing either the volar cortex, dorsal cortex, or longitudinal axis of the phalanges (Figure 3). Twenty-six lateral finger radiographs were blinded and assessed, and then repeat measurements were obtained three weeks later. Inter-item correlation matrices and intraobserver Pearson's correlations showed extremely high correlation values ranging from 0.993 to 0.999 for the longitudinal axis technique. This pilot study established the longitudinal axis technique as the most reliable in measuring residual radiographic lag.~Several secondary objectives were investigated. These included correlations between residual lag and other factors, including patient age, Michigan Hand Outcome Questionnaire scores (MHQ) and the development of complications; incidence of complications in each splinting group; comparing radiographic to clinical extensor lag differences; and evaluating the course of residual lag after splinting has been discontinued. Exploratory analyses were performed as hypothesis generators only, including sub-group analysis.

In most cases of acute mallet finger, or avulsion of the extensor digitorum communis terminal tendon from the distal phalanx, splinting is the treatment strategy employed. The type of splint used to treat these injuries continues to be controversial. Custom splints have recently been advocated though no strong comparative evidence is available.~The primary objective of this investigation was to show superiority of the custom thermoplastic splint over both the dorsal and volar non-custom splints. The null hypothesis was that a radiographic lag difference greater than 5 degrees would not be observed between groups. The primary outcome measure is the residual extensor lag difference (compared to the contralateral equivalent digit) at 12 weeks post-splinting.

This was a randomized, double-blind, parallel-group, dose-finding study assessing the safety and efficacy of three dose levels of CNS 7056 compared with midazolam in patients undergoing diagnostic upper GI endoscopy.~Patients who met all study entry criteria and completed screening procedures were randomly assigned to 1 of 4 treatment groups: CNS 7056 0.10 mg/kg,0.15 mg/kg, or 0.20 mg/kg; or midazolam 0.075 mg/kg. Patients received their assigned treatment administered as a single intravenous injection by a syringe driver over 1 minute. The endoscopy started when a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of ≤3 has been reached, but no earlier than 90 seconds after Time 0 (the start of study drug injection). Rescue with sedative medication (midazolam 1-2 mg) was be permitted at the discretion of the administering physician.~Efficacy assessments consisted of the MOAA/S scores, Aldrete scores, and drowsiness measures using a Visual Analogue Scale (VAS). Cognitive function was assessed by the Hopkins Verbal Learning Test-Revised™ (HVLT-R™) and memory for the procedure by the Brice Questionnaire.~Safety assessments included adverse events, physical examinations, vital signs, ECGs, pulse oximetry measurements, clinical laboratory tests, and pain on injection using a VAS.

The purpose of this study was to assess the safety and efficacy of CNS 7056 as a procedural sedative at three dose levels compared to midazolam during a diagnostic upper GI endoscopy.

Obesity has not only been increasing over the past three decades (Wang & Beydoun, 2007; Wang & Zhang, 2002), it is predicted to increase in the future until by 2048 all American adults would be overweight (Wang, Beydoun, Liang, Caballero, Kumanyika, 2008). Moreover, the majority of Mexican American men and women are predicted to be overweight and obese by 2030 (91.1% and 86.7% respectively).~The proposed intervention research study is building from existing intervention strategies designed for the Mexican American population entitled Tu Salud Si Cuenta. This intervention highlights in the media successful role models who have changed their food choices and physical activity levels. In addition the intervention designs environmental changes to help community members carry out recommended behavior change strategies. Outcomes of interest for this study include increased physical activity so as to achieve the CDC/ACSM recommendations of 150 minutes of moderate to vigorous physical activity each week (Haskell et al., 2007), eating 5 servings of fruits and vegetables each day, reducing food portion sizes, and subsequent changes in biomarkers of health.~This proposed worksite pilot study will be testing a new feature to the TSSC intervention by designing worksite promotion intervention strategies to promote physical activity and healthful food choices through environmental change strategies at the worksite. The same full scope of behavioral and clinical outcomes of interest will be examined in this pilot.~The participants in this study will be male and female employees of two worksites, aged 18-65 years. A convenience sample will be used for this study. Employees from State Department of Public Health Region 11 Harlingen Office or City of Brownsville will be recruited. Supervisors from both sites have provided letters of support for this project and have agreed to allow recruitment. Employees will be contacted with informational flyers and e-mails sent by the supervisors providing the letters of support. Interested adults will be sent an interest letter and informed consent. Data collection will proceed after the participant completes the informed consent form and provides documentation of physician's clearance to participate in physical activity.~The purpose of this study is to test the efficacy of a worksite-based physical activity and healthful food choice, intervention among two worksites in the Lower Rio Grande Valley who employ primarily Mexican American personnel.~Persons will complete consent forms during an enrollment/pretest period of 4 weeks. This period will include an electronic pre-test survey using Survey Monkey online software (Finley, 2008) completed by each participant. Additionally, clinical measures such as blood pressure, anthropometrics, fasting total cholesterol, triglycerides and glucose will be collected for each participant. These exams will be conducted by the trained staff from the clinical research unit and follow the identical procedures used for members of the Hispanic Health Research Cohort. Finally, in line with the Centers for Disease Control and Prevention, each participant will be encouraged to visit their personal physician and discuss participation in the recommended 150 minutes of physical activity per week.~All individuals are given an exit interview with a registered phlebotomist or registered nurse to review immediate findings. All samples for laboratory testing and storage will be coded and identifiers removed. Participants will also provided with a written summary including their height, weight, waist circumference, blood pressure, fasting glucose, cholesterol and triglycerides. Values out of their expected range are flagged and referrals made as necessary. This interview is also used to address any questions or concerns that may be raised.~Descriptive analyses will be used to compare the characteristics of the participants in the intervention and control groups that we intend to compare with respect to any outcome of interests, (e.g., blood pressure). Specifically, we will compare the groups with respect to demographic and socio-economic factors such as age, sex, ethnicity, and education level. Since the outcome measurements at baseline and the follow up quarterly visit (at 3 months, 6 months, etc) are expected to be correlated, we will use Generalized Estimating Equations (GEE) models. GEE takes into account the correlation of an outcome measured repeatedly over time by treating it as a nuisance parameter (Zeger & Liang, 1986). As a result, the within-subjects correlation is not modeled explicitly. GEE uses a working correlation to treat the within-subjects correlation, and produces standard error estimates that take into account the correlation of responses with subjects. In addition, we will use Random effects models (Wolfinger & O'Connell, 1993) to adjust for the heterogeneity of subjects, which can be due to unmeasured predispositions, such as genetic factors, that account for the correlation within subjects across time. Estimated effects of a covariate of interest (e.g., males vs. females) are adjusted for these individual differences and model estimates should be interpreted in terms of the change due to the covariate in an individual at a given level of random subject effect. The random effects model is most useful when inferences about individual differences are the primary interest. Random effects models have been developed for both continuous and binary outcome variables (Wolfinger et al., 1993).~The study will take place over a 1 year time frame. Participants will have data collected prior to the intervention and four posttests at 3-month intervals. The immediate intervention group will receive the pilot worksite intervention for the initial 12 week period. The delayed intervention group will receive the pilot worksite intervention beginning in month 3 of the study.

Building on existing intervention strategies of the Tu Salud Si Cuenta media campaign, this proposed worksite pilot study will be testing a new feature by designing worksite promotion intervention strategies. The purpose of this study is to test the feasibility of a worksite-based physical activity and healthful food choice. The intervention will be among two worksites in the Lower Rio Grande Valley who employ primarily Mexican-American personnel.

Purpose: The aim of this study was to evaluate the role of 25-gauge transconjuntival sutureless vitrectomy (TSV) in patients with persistent vitreous floaters who underwent multifocal intraocular lens (IOL) implantation.~Setting: Hospital Oftalmológico de Brasília, Brasília, DF, Brazil.~Methods: Fourteen eyes of 11 patients with multifocal IOL implant associated with vitreous opacities that underwent 25-gauge vitrectomy were prospectively analyzed. Information collected included near and distance uncorrected visual acuity (UCDVA), best corrected distance visual acuity (BCDVA), and the spherical equivalent (SE) before and 3 months after vitrectomy. Patients were questioned about surgery satisfaction and visual improvement after vitrectomy.

The aim of this study was to evaluate the role of 25-gauge transconjuntival sutureless vitrectomy (TSV) in patients with persistent vitreous floaters who underwent multifocal intraocular lens (IOL) implantation.

Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.~Official Title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Actavis Group hf 50 mg Venlafaxine Hydrochloride Tablets and Wyeth Pharmaceuticals (Effexor®) 50 mg Venlafaxine Hydrochloride Tablets in Healthy Adult Volunteers under Fed Conditions.~Further study details as provided by Actavis Elizabeth LLC:~Primary Outcome Measures:~Rate and Extend of Absorption

The purpose of this study to assess the single-dose relative bioavailability of Actavis Group hf 50 mg venlafaxine hydrochloride tablets with Wyeth Pharmaceuticals (Effexor®) 50 mg venlafaxine (as venlafaxine hydrochloride) tablets under fed conditions.

The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Sumatriptan Succinate Tablets 100 mg (containing sumatriptan succinate equivalent to 100 mg sumatriptan) manufactured by OHM Laboratories Inc. with IMITREX® tablets 100 mg (containing sumatriptan succinate equivalent to 100 mg sumatriptan) manufactured by GlaxoSmithkline Research Triangle Park, NC 27709, Made in Canada in healthy, adult, male, human subjects under fasting condition.~Following an overnight fast of at least 10 hour, a single oral dose of sumatriptan succinate tablets 100 mg (containing 140 mg of sumatriptan succinate equivalent to 100 mg sumatriptan) of either test or reference formulation was administered during each period of the study, along with 240 mL of drinking water at ambient temperature under low light condition and supervision of trained study personnel.~32 subjects were enrolled into the study. However, twenty seven (27) subjects completed both the periods of the study. Pharmacokinetic and Statistical analysis was performed on twenty seven subjects (27) subjects.

An open label, bioequivalence study of sumatriptan succinate 100 mg tablets (containing 140 mg of sumatriptan succinate equivalent to 100 mg sumatriptan) under fasting Conditions

InFatTM is an advanced basic-fat ingredient, which mimics the fat composition and properties of human milk fat and enabling optimal intake of the essential calcium and energy (in the form of fatty acids) and easy digestion. These benefits are the results of a unique fatty acid composition on the glycerol backbone, which ensure high level of palmitic acid at the middle (sn-2) position.~The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on bone strength parameters, anthropometric parameters, wellbeing and stool characteristics in term and preterm infants.

The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on bone strength parameters.

Nutritional status may be important in achieving optimal physical performance. There is evidence of significant improvements in physical fitness, aerobic capacity and anaerobic threshold of children and adolescents with nutritional intervention, albeit in children with initial sub-optimal nutritional status. This may be of particular relevance in developing countries like India, where there is limited data on physical fitness and a wide-spread prevalence of concurrent micronutrient deficiencies even in apparently normal school age children. The present study therefore, is designed to assess the effect of a nutritional supplement on the physical performance measures of school going children. This is a randomized, double blind placebo-controlled study of three treatment groups (1 test, 1 positive control (placebo) and 1 'no intervention') conducted in equal numbers of male or female children [ages 7-11] attending day schools in Bangalore. Subjects in the intervention (test and positive control) groups will receive study treatments (fortified or un-fortified nutritional powder) once a day for 4 months. The treatments will be administered under supervision on all school working days; for the weekend and other holidays, sachets will be provided for home consumption. At baseline and 4months, physical performance tests will be administered and blood sample drawn to assess nutritional status. Other selected outcome measures such as nutrition status and muscle strength/ endurance will also be assessed. It is hypothesized that after 4 months of intervention, children consuming fortified nutritional powder will have statistically significant improvements in physical performance/ fitness measures as compared to the two control groups.

The purpose of this study is to evaluate the effect of nutritional supplement on physical performance measures of apparently healthy school going children in India.

The Computer Program:~In this study, researchers will interview cancer patients receiving palliative care, their caregivers, and doctors and nurses who work in palliative care.~The computer program will be designed to help doctors and nurses monitor the symptoms of patients. The program will also be designed to help doctors and nurses make decisions about how to care for patients.~Interview Session:~If you agree to take part in this study, you will be interviewed by a research staff member. The study chair may also attend the interview. The interview will be held at the Palliative Care outpatient clinic.~The interview session will be done in 3 steps, which are described below. Each step will take about 10 minutes.~First, you will read questionnaires about patient symptoms. These questionnaires are drafts of the ones that will be included in the software program.~You will then look at a draft of the computer program's layout.~Last, you will be interviewed. You will be asked to discuss your experiences as a patient or caregiver in reporting symptoms and health status to doctors and nurses. You will also be asked to discuss what might make the program more usable.~During the interview, you may also be asked to answer sample questions on the draft questionnaires and discuss how readable you think the questions are. For example, you will discuss your opinion about the font size, text placement, and color scheme.~Study Data:~The interview session will be audio-taped. To protect your confidentiality, only your first name will be used during the interview session. Patients and their caregivers will also be interviewed separately to protect privacy.~Patient responses will not be disclosed to caregivers, and caregiver responses will not be disclosed to patients. The patient's palliative care doctor will be told, however, if patients or caregivers show signs of emotional difficulties.~When the audio recording is transcribed (typed) by the research staff, all names will be coded so that no one can be identified by name. The audio recordings will be stored in password-protected files that are available only to the study chair and staff.~After the results of the study are published, the audio recordings will be destroyed by the study staff.~Length of Study:~Your study participation will be over after the interview session.~This is an investigational study.~Up to 26 participants will be enrolled in this study. This includes up to 9 patients and 9 caregivers in this part of the study, and up to 4 doctors and 4 nurses in a second part of the study. All will be enrolled at M. D. Anderson.

The goal of this research study is to collect information to plan how to design a computer program for cancer patients receiving palliative care, their caregivers, and doctors and nurses who work in palliative care. Researchers want to learn how to make this program practical for use by future patients, caregivers, doctors, and nurses.

FMR1 is a gene associated with fragile X syndrome-the most common cause of mental retardation-and with social, emotional, and cognitive deficits. The chance of developing these deficits depends on the number of times the FMR1 gene is repeated on the X chromosome. Individuals with more than 200 copies of the FMR1 gene have the full fragile X mutation, putting them at most risk for mental retardation. Individuals with between 55 and 200 copies of the FMR1 gene have the fragile X premutation; they are much less likely to develop mental retardation, but they may have subtle social, emotional, and cognitive deficits and their children are more likely to have the full fragile X mutation. A theory, which this study will test, holds that the deficits of people with the fragile X premutation are caused by dysfunction in the limbic system. The limbic system consists of a group of structures in the brain that govern emotions and behavior. This study will examine people with the fragile X premutation to determine whether and to what extent they have emotional, social, and memory deficits. The study will also determine whether changes in fragile X gene function are related to increased deficits and how the brain, and specifically the limbic system, may be involved in these deficits.~Participation in this study will last 2 days. Participants will undergo several hours of testing at a lab on back-to-back days. Testing on the first day will include the following: providing several saliva samples; undergoing neuropsychological testing, in which participants will solve different types of problems and be interviewed about their emotional and social experiences; and undergoing a physical exam and blood draw.~Testing on the second day will include the following: an MRI scan, which will take pictures of the brain both while participants are resting and while they are performing certain tasks; more neuropsychological testing similar to that from the day before; and questionnaires about emotional and social experiences. A family member will also be asked to fill out a questionnaire about the participant. On 2 other days, participants will be asked to collect saliva samples while at their homes and send the samples to the study researchers. In addition, the researchers will keep in contact with participants in case any follow-up is needed over the next few years.

This study will examine whether individuals with the fragile X genetic premutation are likely to have emotional, social, and memory deficits and how the brain may be involved in these deficits.

The purpose of this study is to determine the absorption, metabolism, and excretion kinetics of Proellex and to determine and characterize metabolites present in plasma and urine following a single oral dose of 25 mg. The 25 mg dose selected for this study has been included in all previous clinical trials. This dose was well tolerated and demonstrated efficacy against uterine fibroids and endometriosis.

This study was to determine the ADME and metabolites of Proellex following a single oral dose of 25 mg.

There are clinical trials show that paclitaxel is common option for the treatment of solid tumors. Liposomal paclitaxel has different pharmacokinetic features comparing with conventional paclitaxel. However,the tolerance of this new dosage form of paclitaxel (liposomal paclitaxel) has never been studied in Chinese cancer patients. This study is designed to find the maximum tolerated dose and dose limiting toxicities of liposomal paclitaxel in Chinese cancer patients.

The purpose of this study is to determine the maximum tolerated dose and dose limiting toxicities of liposomal paclitaxel in Chinese patients with solid tumors in advanced stages.

This is an open-label non-randomized study of CS-7017 designed to allow participants who completed participation in a clinical study of CS-7017 without experiencing disease progression or unacceptable toxicity to continue treatment with study drug.

This is a study of CS-7017 designed to allow participants who completed participation in a clinical study of CS-7017 without experiencing disease progression or unacceptable toxicity to continue treatment with study drug. Participants who have not progressed while receiving CS-7017 will continue to benefit from longer administration of the agent.

Methamphetamine (meth) is second only to alcohol as the primary drug of abuse in persons entering substance use disorders (SUD) treatment in rural Nebraska 1 . The National Survey on Drug Use and Health 2002-2005 (NSDUH) found meth use increased as the setting became more rural 2 . In a previous study comparing rural and urban persons with meth use disorders (MUD), we found significant differences, with rural persons reporting earlier first regular use of meth, greater meth-related psychotic symptoms, more alcoholism, and more intravenous (IV) use 3 . No studies have compared frequency of other behavioral risk factors in rural and urban meth users. Similarly, no studies have compared risk factors for methamphetamine dependence in this uniquely rural drug use disorder. It is critical that other high risk behaviors (in addition to IV use) be identified in rural persons with MUD and that risk factors for MUD be identified as a crucial first step in providing resources to tailor prevention efforts in rural populations.~In addition to the need for further research on risk factors, scholars have called for more studies on protective factors to develop more effective intervention programs 4 . Researchers have identified factors that mitigate negative outcomes among individuals at high risk. In general, active coping and high levels of social support and empathy have been linked to better health outcomes whereas avoidance coping and low levels of social support and empathy have been associated with worse health outcomes 4, 5 . However, no factors have been identified in rural meth users which are protective for worse health outcomes.~Meth distribution has been linked to Mexican Drug Trafficking Organizations and Hispanic polydrug trafficking organizations 6, 7 , but there is little research examining meth use in Latinos. In a previous study of Hispanic and non-Hispanic white individuals with MUD, Hispanics reported less education and more employment problems, 8 but the study did not address rural MUD. This proposed study of rural and urban Latinos with meth dependence will provide initial data to begin to inform prevention efforts targeting rural Latinos with MUD and may be useful in rural Latinos with other SUD.~Our interdisciplinary investigative team proposes to address the following Specific Aims over a two-year period: 1) compare socio-demographic, bio-psychosocial and behavioral risk and protective factors between rural and urban persons with methamphetamine dependence (Year One); 2) identify factors that place persons with methamphetamine dependence at risk for greater psychopathology and identify factors that mitigate those persons from psychopathology (Year One); 3) compare severity of methamphetamine dependence between Latino and non-Latino populations and urban and rural Latino populations (Year Two). Our hypothesis is that rural persons with methamphetamine dependence will have greater socio-demographic, bio-psychosocial and behavioral risk factors than their urban counterparts.~The targeted populations will be adults with methamphetamine dependence. We will enroll 150 individuals (75 rural and 75 urban) 75 of whom will be Latinos from substance abuse treatment sites. Data analyses will focus on comparing MUD across urban/rural and Latinos/non-Latinos. Thus, this study will identify factors which may place rural, urban, Latino, and non-Latino persons with MUD at greater risk for, or protect them from, psychopathology, infectious complications, and poorer treatment outcome. The long-term goals of this study are to: a) provide data that will strengthen a re-submission to the National Institute on Drug Abuse (Behavioral and Social Science Research on Understanding and Reducing Health Disparities, PAR-07-379 ); b) establish relationships with providers of substance abuse treatment to Latinos facilitating enrollment of Latinos in future research studies; and c) identify specific factors that can be incorporated into prevention strategies in underserved populations (e.g. Latinos, rural populations).

The primary goal of this study is to identify factors which may put a person that has used methamphetamine at greater risk for mental and physical health problems and social problems and factors that may lessen the risk for these problems. This study will also compare methamphetamine use between Latino and non-Latino persons and those that live in a rural area or urban area. The investigators hypothesis is that rural persons with methamphetamine dependence will have greater socio-demographic, bio-psychosocial and behavioral risk factors than their urban counterparts.

This is a clinical study testing PRF-108 and PRF-110 (a new extended release 4% gel formulations of ropivacaine) in an experimentally induced pain model in healthy volunteers. PRF-108 and PRF-110 are designed to deliver slow release of ropivacaine over 72 hours.~The purpose of this study is to investigate the safety (side effects if any occurs) associated with the single administration of PRF-108 or PRF-110 and evaluate their analgesic effect in an experimentally induced pain model compared with ropivacaine Solution 0.5% and Vehicle Gel.

This is a clinical study testing PRF-108 and PRF-110 (a new extended release 4% gel formulations of ropivacaine) in an experimentally induced pain model in healthy volunteers. PRF-108 and PRF-110 are designed to deliver slow release of ropivacaine over 72 hours.

Colorectal cancer (CRC) is the third leading cause of cancer death in women. Although there are a variety of options for colon cancer screening, colonoscopy is thought to be the best modality for women. Despite recommendations by multiple societies, adherence to CRC screening among women is suboptimal. One possible barrier to adherence may be the gender of the endoscopist. Recent studies have shown that a large proportion of surveyed women would prefer a woman endoscopist. These studies suggest that having the option of a woman endoscopist would increase adherence to colonoscopy; however, there is no published literature that addresses this question.~Hypothesis~Women who are offered screening colonoscopy will be more likely to schedule and complete this procedure if they are given the option of a woman endoscopist.~Specific Aims~Primary~Determine whether the option of a woman endoscopist is associated with increased woman patient adherence to screening colonoscopy.~Assess the proportion of women who request a woman endoscopist when this option is made available to them.~Secondary~* Identify socio-demographic predictors of (a) completing a screening colonoscopy and (b) requesting a woman endoscopist (e.g. race/ethnicity, age, health insurance, marital status).

The purpose of this study is to determine whether women who are offered screening colonoscopy will be more likely to schedule and complete this procedure if they are given the option of a woman endoscopist.

This is a pilot study to compare systemic concentrations of cobalt and chromium in patients that have previously undergone total hip arthroplasties with ceramic on metal and metal on metal bearing surfaces. Secondary goals include an assessment of osteolysis on radiographs, potential long term analysis of implant survivability, and cancer rates in the two patient populations.~Increased metal ion production has been documented in metal-on-metal arthroplasty articulations. There are several concerns over metal ion production. First, even though there is a decreased histiocytic response to metallic debris, a dose dependent cytotoxic response with Interleukin 6, Prostaglandin E2, and Tumor Necrosis Factor alpha persists and may cause osteolysis in the long term. Second, increased levels of cobalt, chromium and nickel has been shown to correlate with increased cancer rates in several animal models, and the carcinogenic risk in humans has not been fully elucidated as yet. Third, hypersensitivity reactions to metal ion develop in up to 25% of these patients, and 60% of patients with poorly functioning hip.~Ceramic on metal avoids many of these problems due to the improved wear characteristics. If the level of metal ion production is significantly reduced and the implant survivability is proven in long term studies, this articulation may become the preferred method.

This is a pilot study to compare systemic concentrations of cobalt and chromium in patients that have previously undergone total hip arthroplasties with ceramic on metal and metal on metal bearing surfaces.

Glucagon-like peptide 1 (GLP-1) is a 30-amino acid peptide produced in the intestinal epithelial endocrine L-cells. It stimulates insulin and suppresses glucagons secretion, inhibits gastric emptying, and reduces appetite and food intake. In the fasting state, the plasma concentrations of GLP-1 are very low. Levels of circulating GLP-1 rise rapidly after food intake. The GLP-1 meal response depends on ingested nutrients. Carbohydrates are strong stimuli of GLP-1 release. Protein stimulates GLP-1 release, even more than carbohydrates. GLP-1 concentrations also increase after intake of fat, although the elevation is delayed compared to the stimulation of carbohydrates. Dietary fibers may also modify the postprandial GLP-1 response. Therefore, it is essential for us to characterize nutrient compositions of test meals for further studies of meal response of GLP-1.~Other sampling conditions of the meal tests are also needed to be taking care of. GLP-1 is rapidly degraded by the enzyme dipeptidyl peptidase IV (DPP-4). During the meal tests, it is important adding enzyme inhibitors into sampling tubes to avoid hormone degradation. Lugari et al. collected blood samples into tubes containing EDTA and aprotinin during a meal test. They could obtain samples from the same tube for both glucagons and GLP-1 assays. Other study groups reported that samples for GLP-1 needed to be collected into Vacutainer tubes prepared with EDTA and DPP-4 inhibitor for preventing degradation of GLP-1. Another aim of the present study is to compare the differences in GLP-1 concentrations in samples collected by EDTA tubes containing aprotinin or a DPP-4 inhibitor during the meal tests.~Racial differences in GLP-1 levels during oral glucose challenge have been demonstrated recently that severely obese African Americans exhibited lower GLP-1 concentrations than Caucasians. It is worthwhile to examine the meal response of GLP-1 across ethnicities. The current study proposes to observe the GLP-1 response during standardized meal tests in a group of Chinese subjects.~The purpose of the study is to standardize a meal test to facilitate future studies of the postprandial GLP-1 response in Chinese subjects. Eighteen healthy Chinese subjects, aged between 20-65 years old, without history of diabetes, will be recruited for the study. Each subject will receive two mixed meal tests for postprandial GLP-1 excursion at random order: 60 % carbohydrate (CHO)/20 % fat vs. 50 % CHO/30 % fat. The postprandial glucose, insulin, glucagon and other related hormones responses will also be measured. Through the study, we hope to build up a platform for the study of the postprandial GLP-1 response and insulin secretion.

The purpose of the study is to standardize a meal test to facilitate future studies of the postprandial glucagons-like peptide 1 (GLP-1) response in Chinese subjects. Eighteen healthy Chinese subjects, aged between 20-65 years old, without history of diabetes, will be recruited for the study. Each subject will receive two mixed meal tests for postprandial GLP-1 excursion at random order: 60 % carbohydrate (CHO)/20 % fat vs. 50 % CHO/30 % fat. The postprandial glucose, insulin, glucagon and other related hormones responses will also be measured. Through the study, we hope to build up a platform for the study of the postprandial GLP-1 response and insulin secretion.

Context:~Whether the performance of cardiopulmonary resuscitation can be positively influenced by teaching leadership with a short debriefing remains largely unknown~Objective:~To test the hypothesis that (1) leadership instruction are effective and (2) improved leadership results in better performance in a high fidelity simulated cardiopulmonary resuscitation.~Design:~Prospective, randomized-controlled superiority trial~Setting:~Simulator Center of the University Hospital Basel in Switzerland~Patients or Other Participants:~237 volunteer medical students in teams of 3~Intervention:~During a baseline visit, the medical students participate in a video-taped simulated witnessed cardiac arrest. Participants are randomized to receive thereafter a short video-assisted debriefing focusing either on correct positions of arms and shoulders (technical debriefing) or on leadership and communication to enhance team coordination (leadership debriefing). A follow-up simulation is conducted after 4 months. Leadership utterances, technical skills and the resuscitation performance of the teams are compared based on videotapes coded by two independent researchers.~Main Outcome Measures:~The primary outcomes for this study are the amount of hands-on time in the first 180 seconds after the onset of the cardiac arrest and the time elapsed until cardiopulmonary resuscitation was started. Secondary endpoints are the effectiveness of the technical and leadership instructions, respectively.

Whether teaching leadership with a short debriefing has a positive influence on the performance of cardiopulmonary resuscitation remains largely unknown. The investigators will assess the sustained efficacy of a short leadership debriefing compared to a technical debriefing in a high fidelity simulated cardiopulmonary resuscitation.

Meal ingestion releases gut hormones which stimulate insulin secretion. A most important gut hormone is the incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 is rapidly degraded and inactivated after its release by the enzyme dipeptidyl peptidase-4 (DPP-4). Inhibition of DPP-4 therefore increases the concentration of active GLP-1 after meal ingestion, which augments insulin secretion. How this process is regulated after ingested of different individual macronutrients is not known. Therefore, this study examines the influence of ingestion of fat, protein, glucose or mixed meal on the concentrations of incretin hormones and insulin secretion with or without concomitant administration of a DPP-4 inhibitor (sitagliptin).

The regulation by DPP-4 inhibition after ingested of different individual macronutrients is not known. Therefore, this study examines the influence of ingestion of fat, protein, glucose or mixed meal on the concentrations of incretin hormones and insulin secretion with or without concomitant administration of a DPP-4 inhibitor (sitagliptin).

This research is designed to test the efficacy of a computer based virtual simulation for teaching ear surgery. Subjects will be randomized to training in the usual fashion and training in the simulation environment. Subjects performance will be tested in a standard fashion by dissecting cadaveric temporal bones (human ears) before and after training. The subjects will also perform a dissection in the virtual environment before and after training. The results will be tabulated to compare the different training arms. There is minimal risk associated with the projects and is limited to exposure to cadaveric material. Current training techniques utilize cadaveric material so exposure to this type of material is already a part of the standard training process and this study should not constitute an increased risk beyond what is encountered during their regular training. Demographic information will be obtained for each of the study subject on age, sex, information regarding previous otologic training, year of training and prior experience using computers. The anticipated benefits to society will be that future otologic surgeons can obtain operative experience in a controlled and non threatening environment. They will have access to a greater number of variations in pathology. This will allow each novice surgeon to obtain significantly more experience outside the operating room prior to working with live patients. This will result in less risk to the patient and better trained ear surgeons.

Designed to test the efficacy of a computer based virtual simulation for teaching ear surgery.

This multi-center study evaluates the safety and efficacy of four different doses of RT001 compared to vehicle applied as a single, bilateral topical application in at least 60 subjects with moderate to severe lateral canthal lines. Subjects will be randomized to one of the five treatment groups in a 1:1:1:1:1 ratio. Follow-up visits are scheduled through 28 days post-treatment. The safety and efficacy of Cohort 1 (through the Day 14 visit) will be assessed prior to the decision to enroll subjects into Cohort 2 if additional doses or treatment regimens need to be evaluated.

The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults.

The study will evaluate the use of CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft, with the use of Puros Cancellous Particulate Allograft (Puros Cancellous), a mineralized allograft, for the augmentation of localized alveolar ridge defects in edentulous sites. The purpose of the study will be to determine placement time, ease of use, stability, esthetics and to clinically evaluate the efficacy of the list products. A biopsy will be taken from a subset of the patient population, at one investigational site, to evaluate the grafted site's formation of new bone. The study hypothesis is that if CopiOs Pericardium and Puros Cancellous are used, the a single, localized alveolar ridge defect will clinically improve at an edentulous site.

This is a prospective, multi-center study to evaluate the use of CopiOs Pericardium Membrane, a bovine xenograft, with use of Puros Cancellous Particulate Allograft, for the augmentation of localized alveolar ridge defects on either the maxilla or mandible.

Currently all women are invited for breast screening between the ages of 50 and 70. In 2007 the Cancer Reform Strategy announced that from 2012 the NHS Breast Screening Programme would be extended to cover women between the ages of 47 and 73. This means that all women will get two extra screening invitations in their lifetime. It also means that all women will get their first invitation before age 50. As capacity does not allow for full immediate roll out across the whole of England, the age extension will be phased-in with full coverage from 2012. Randomising this phasing-in would provide unbiased evidence on the extent to which it is beneficial to extend the age range for breast screening and whether an extra screen at younger or older ages is more worthwhile. To date there is no clear evidence on this as no trial has looked at the added value of one extra screen within an existing screening programme. This pilot study will assess the feasibility and acceptability of randomising the phasing-in of the age extension in six volunteer sites in different areas of England.

The purpose of this pilot study is to assess the feasibility and acceptability of randomising the phasing-in of the age extension of the NHS Breast Screening Programme in six volunteer sites in different areas of England.

The purpose of this study is to apply concepts from behavioral economics to increase the effectiveness of incentives for preventative health care.~Health risk assessments are an important part of preventative healthcare. Employees fill out these forms and are given feedback about their health risks and steps they can take to improve their health. This study will be run in an employer setting in which rates of health risk assessment completion are suboptimal. This study would be conducted within a workplace setting in which the firm is divided into a number of geographically situated and functionally related subunits. We will run a complete your health risk assessment now! program for 4 weeks. Each work unit will obtain a symbol. Every week, one symbol will be randomly drawn, publicly announced, and anyone in that work unit at the firm who has received their preventive screening would receive a $100 prize. In addition, if all of employees in that unit have completed their forms, then the prize will be increased to $125.~This program plays on a number of psychological factors: 1) avoidance of regret, which one will experience if the number/symbol of the unit one is a member of is drawn and one does not win a prize because one is not participating in the wellness program 2) amplification of such regret by social means - because other people around you who are participating will receive cash prizes 3) mild social pressure, because high enrollments will yield benefits for all participants.

The purpose of this study is to understand using incentives to encourage employees to increase participation in an aspect of a corporate wellness program - filling out health risk assessments. This study will test whether lottery-linked incentives are more effective than guaranteed incentives in encouraging people to fill out health risk assessments.~This study will be run in an employer setting in which rates of health risk assessment completion are suboptimal. This study would be conducted within a workplace setting in which the firm is divided into a number of geographically situated and functionally related subunits. The investigators will run a complete your health risk assessment now! program for 4 weeks. Each work unit will obtain a symbol. Every week, one symbol will be randomly drawn, publicly announced, and anyone in that work unit at the firm who has received their preventive screening would receive a $100 prize. In addition, if all of employees in that unit have completed their forms, then the prize will be increased to $125.~The investigators expect this condition to result in greater compliance compared to a control condition in which employees would receive weekly reminders and a direct payment of a $25 gift card for completing the form at anytime during the 4 weeks of the study. This is analogous to direct payments that have been used by insurers to encourage completion of such forms in other contexts.

Pain after hemorrhoidectomy remains a major postsurgical complication.Therefore pain management in patients is an important goal.Many studies have focused on surgical techniques,preoperative and postoperative regimes.We assessed a randomised double blind placebo-controlled trial to evaluate the effect of diltiazem ointment after surgery.

The purpose of this study is to evaluate the effectiveness of diltiazem ointment 2 percent in reducing pain after hemorrhoidectomy.

The purpose of the research is to study the level of visual functioning in individuals with various eye conditions when using different types of eyeglass lenses. Therefore, the goal of this study is to determine factors that may account for variability in the visual functioning of individuals with a range of refractive errors and their ability to perform everyday activities when equipped with different types of lenses. We hypothesize that the subjects will perform visual tasks of function better when using iZon™ Wavefront-Guided Glasses than with conventional glasses. This hypothesis is based upon the glasses yielding better visual acuity and because the design of the glasses reduces the effects of glare. This research is important so that alternate treatments and vision correction may be implemented which will have a more beneficial impact on those with refractive errors and visual impairment.

The purpose of this study is to assess the level of visual functioning in patients with various eye conditions while wearing different types of eyeglasses.

The neuropsychological benefits, especially executive function impacts, of four weeks of a low intensity, strengthening exercise program will be examined for community residing older adults.

This study aims to examine the benefits to thinking processes of a low intensity, strengthening exercise program for older adults.

Muscle relaxants are integral part of modern anesthesia. They optimize intubating conditions, reduce laryngeal trauma and improve operating conditions. Drawback is a possible pharmacological (muscle relaxing) effect of these drugs beyond the end of the operation (i.e. post-operative residual curarization: PORC). Reportedly about 30% of all patients who received muscle relaxants show signs of PORC when arriving in the post-anesthesia care unit. PORC comprises the risk of impaired post-operative fine motor and coordinative skills with a possible impairment of swallowing pharyngeal secretions with an increased risk of aspiration after extubation. Possible deleterious effects of this could be pneumonia, bronchitis, myocardial infarction, cardiac insufficiency, stroke or re-operation.~In order to avoid PORC patients with residual neuromuscular block receive a muscle relaxant antagonist from the anesthetist at the end of the operation. However, these drugs (neostigmine, pyridostigmine, etc.) from the class of cholinesterase inhibitors have unwanted effects such as bradycardia, increased gastro-intestinal motility, post-operative nausea and vomiting, salivation etc. To decrease these unwanted side effects cholinesterase inhibitors have to be given in combination with parasympatholyics e.g. atropine or glycopyrrolate with their own spectrum of unwanted side effects.~From October 2008 on, Sugammadex, a completely new reversal drug was introduced in to clinical practice. Sugammadex, is a modified gamma-cyclodextrine able to specifically bind rocuronium (a steroidal muscle relaxant). The complex is eliminated via the kidneys. However, all studies so far have focussed on reversal of profound or deep neuromuscular blockade. This study is designed to compare recovery times after reversal of a residual neuromuscular block (TOF-ratio 0.5) with different doses of either the neostigmine or sugammadex.

This study is designed to compare recovery times after reversal of a residual neuromuscular block (TOF-ratio 0.5) with different doses of either neostigmine or sugammadex.

Muscle relaxants are part of a balanced anesthesia regimen. So far, evidence is given that a neuromuscular block improves intubating conditions and protects against laryngeal morbidity. The doctrine, however, that a neuromuscular block improves surgical conditions and consequently patient care, is lacking any evidence based on clinical trials.~This study, therefore, is designed to test the clinically hypothesis that a neuromuscular block improves surgical conditions. One major problem in such a setting, however, is that it is difficult to measure what good or better surgical conditions are. We therefore suggest surrogates to test the hypothesis. The primary endpoint is the postoperative patient-controlled analgesic demand for adequate pain control. The secondary endpoints are the incidence of intraoperative events reflecting muscle relaxation during anesthesia, defined as movements of limbs or the abdominal wall, or as breathing, bucking or coughing against the ventilator, the incision-to-suture-time, the surgeon's and the anesthesiologist's opinion about the operating conditions assessed by a visual analogue scale (VAS), and the postoperative pulmonary function.~We will investigate patients scheduled for elective laparoscopic cholecystectomy under general anesthesia. The study is designed to allow optimal conditions to test the hypothesis. This results in two experimental groups representing two established anesthesia regimen (n = 25 per group). Patients of the group no NMB are anesthetized without any muscle relaxant. Patients of the group NMB are anesthetized using the same drugs as the no NMB group but additionally receive a neuromuscular blocking agent to induce a deep neuromuscular block from induction of anesthesia until skin suture.~Anesthesia will be induced with propofol and fentanyl. Airway will be managed using a ProSeal® Laryngeal mask which allows insertion of a gastric tube. Anesthesia will be maintained with desflurane inhalation and remifentanil infusion under BIS control. The group NMB will receive rocuronium to maintain a deep neuromuscular block (T2 < 2) until the fascia is sutured. Neuromuscular block will be reversed with sugammadex. Saline boli will be applied to the patients of the group no NMB every 25-35 min in order to keep the anesthesiologist blinded.~Post-operatively, in 15 min intervals during their stay and before discharge from the recovery room patients' level of consciousness will be assessed, and the updated Aldrete score will be obtained. In co-operative patients a 5-s head lift test, a 5-s arm lift test, swallowing of 20 ml water, and 5-s eye opening test will be performed. To achieve pain control, a microprocessor-controlled PCA system will be used.~The patients' respiratory function will be assessed before induction of anesthesia, 5 minutes after tracheal extubation, 30 minutes later in the postanesthesia care unit, and six hours later on the ward using a portable using spirometry device.

This study is designed to test the clinical hypothesis that a neuromuscular block improves surgical conditions, operation time, and post-operative pain.

Prebiotics are naturally occurring carbohydrates found in a variety of edible plants. They are not digested by mammalian enzymes, and so reach the gut intact, where they are fermented by some species of intestinal bacteria. This fermentation is thought to have several benefits for the host including improving the immune response. Inulin-type fructans (oligofructose and inulin) are classified as prebiotics. Inulin is found naturally in significant amounts in a variety of plants foods, such as bananas, leeks, onions, artichokes, wheat and chicory. Synergy1 is a prebiotic preparation produced by Beneo-Orafti, and containing a mixture of oligofructose and inulin derived from chicory. Fructooligosaccharides including Synergy1 are widely used by the food industry and are commonly found as a source of insoluble fibre in many biscuit, bakery, cereal and dairy products.~There is increasing evidence that the changes in the intestinal microflora that occur with the consumption of fructooligosaccharides can modulate immune parameters, not only in the gut-associated lymphoid tissue, but also secondary lymphoid tissues and the peripheral circulation. Much of the evidence for beneficial effects of fructooligosaccharides on immune function comes from animal models e.g. rats, mice, dogs and pigs. Results from these studies show that the innate and adaptive immune systems of both the gut associated lymphoid tissue and the systemic immune system can be modified by fructooligosaccharides. However, there are few human studies so far which have investigated the effects of prebiotics on immune function, and these studies mostly rely on systemic markers of immunity. The results show little effect of fructooligosaccharides on innate immune function, but mixed results are reported regarding the adaptive immune system, suggesting that there may by improvement on this aspect of immunity with increased intake of fructooligosaccharides. The small number of published human studies led Watzl et al. (2005) to suggest that more human studies are needed to find out whether inulin and/or oligofructose have the potential to modulate systemic immunity in well-nourished individuals.~There are numerous methods available for assessing the human immune response. These have been evaluated by a panel of European experts (Albers et al. 2005). Based on its biological relevance, sensitivity and practical feasibility, response to vaccination was identified by this panel as the gold standard for measuring the functioning of the immune system in vivo (Albers et al. 2005). A small number of studies have studied the effect of fructooligosaccharides on the human immune response using vaccination response as the outcome, but only four of these examined fructooligosaccharides in the absence of other additional nutrients and of these two studies were in infants. Thus, the number of studies examining the immunologic impact of fructooligosaccharides in adult humans and using the gold standard outcome is very limited. From a public health perspective, it would be of importance, if fructooligosaccharides can improve immune function especially in older adults who are at risk of age-related immune decline. Thus, we propose to use a commercially available influenza vaccine (Imuvac®) to stimulate the immune response in healthy human adults, and to use this to assess the effect of a well defined prebiotic preparation commonly used in the food industry (Synergy1).

Prebiotics are naturally occurring carbohydrates found in a variety of edible plants. They are not digested by mammalian enzymes, and so reach the gut intact, where they are fermented by some species of intestinal bacteria. This fermentation is thought to have several benefits for the host including improving immune function. There are numerous methods available for assessing the human immune response. Response to vaccination is thought to be a good method for this. Not many studies have examined the effect of prebiotics on the human immune response to vaccination. Thus the investigators propose to test the effect of a prebiotic on the immune response in healthy volunteers including their response to the current flu vaccine. The investigators hypothesise that the prebiotic will enhance the immune response including the response to the vaccine.

Study title:~Functional evaluation of a standard and a high-flexion knee prosthesis using thigh-calf contact force measurements.~Objective:~The objective of this study is to investigate whether subjects receiving a high flexion knee prosthesis (Sigma RP-F, J&J, UK) show a better knee function than patients receiving a standard knee prosthesis (Sigma FB, J&J, UK).~Study Design:~Prospective double blind randomized study.~Study population:~Subjects who will receive total knee arthroplasty (TKA) because of invalidating gonarthritis based on primary osteoarthritis or rheumatic disorders or trauma.~Intervention:~28 subjects will receive the standard Sigma FB knee prosthesis.~28 subjects will receive the high flexion Sigma RP-F knee prosthesis.

The purpose of this study is to investigate whether subjects receiving a high-flexion knee prosthesis show a better knee function than patients receiving a standard knee prosthesis. Thigh-calf contact force measurements are used to quantify knee function. The investigators' hypothesis is that high-flexion knees show a better knee function.

Identification of those patients with cancer who will or will not respond to a specific chemotherapy is important for making decisions regarding chemotherapy regimens as well as alternative management approaches. A laboratory test that could help to determine the sensitivity of an individual patient's tumor cells to specific chemotherapeutic agents would be valuable in choosing the optimal chemotherapy regimen for that patient with an expectation of increasing the response rate to the therapy. Several types of in vitro assays that measure tumor cell survival following exposure to cytotoxic agents have been evaluated for their ability to predict chemotherapy outcomes. As a group, these assays are referred to as drug resistance assays. In a resistance assay, the surviving tumor cells can be detected directly by their exclusion or metabolism of specific dyes. Alternatively, since some of tumor cells are proliferating, their survival can be detected by measurement of DNA synthesis by radiolabeled precursor incorporation or demonstration of clonogenic potential by growth into colonies in semi-solid culture medium. In several clinical studies, these assays were useful in detecting drug resistance and in predicting a poor prognosis for cancer patients. However, these resistance assays cannot detect sensitivity of an individual patient's tumor cells to a specific drug. Therefore, new methods determining drug-sensitivity of the tumor cells of an individual patient and, thus, capable of both predicting a positive treatment outcome and guiding chemotherapy, would be of significant value.~Recently, an automated microculture kinetic (MiCK) assay for measuring drug induced apoptosis in tumor cells has been developed1-4. Apoptosis is a distinct mode of cell death which occurs under physiological conditions and yet can be induced in malignant cells by chemical and physical factors including antitumor drugs5-7. During the last decade, it has been recognized that chemotherapeutic agents exert their antitumor activity by triggering apoptosis in susceptible tumor cells8-17. This implies that the MiCK assay for apoptosis provides a mechanism-based approach to studying effects of cytotoxic agents on tumor cells. Unlike resistance assays that measure a fraction of cells surviving drug exposure, the MiCK assay measures a fraction of tumor cells killed by a chemotherapeutic agent via mechanism of apoptosis. Therefore the MiCK assay determines drug sensitivity, rather than resistance. Recently the MiCK assay has been shown to predict complete remission rate and survival in acute myeloid leukemia patients better than clinical criteria did18-20. In a limited study, the MiCK assay has been used to direct chemotherapy of the leukemia patients 21.~The MiCK assay has also been used to study drug-induced apoptosis in solid tumors, including neuroblastoma and colon adenocarcinoma cell lines22-23. More recent data accumulated by DiaTech has demonstrated that the MiCK assay can detect drug induced apoptosis in primary cultures of tumor cells isolated from patients with ovarian carcinoma, gastric carcinoma, metastatic breast cancer and high grade soft tissue sarcoma. The purpose of this study is to correlate the results of the MICK assay with short- and long-term results of treatments in cancer patients and evaluate the role of the MiCK assay in guiding chemotherapy of cancer patients.

The purpose of this study is to correlate the results of the MICK assay with short- and long-term results of treatments in cancer patients and evaluate the role of the MiCK assay in guiding chemotherapy of cancer patients.

The study is a phase I, single center, double-blind, placebo-controlled dose finding clinical study to evaluate the safety, tolerability and immunogenicity of the live attenuated, oral vaccine ACE527. The study is designed to evaluate 2 doses of the ACE527 in 2 cohorts. Each cohort will consist of approximately 18 subjects (healthy subjects), approximately 12 of them receiving ACE527 and approximately 6 receiving placebo.~Within a cohort, the second dose will only be given if safety and tolerability of the first dose is acceptable. This assessment will be based on evaluation of data up until Day 7 by the Independent Safety Committee (ISC) as per written guidance. The first dose of each cohort will be administered during an inpatient stay. Escalation to the next dose level will be dependent on an acceptable safety profile of the first dose at the previous dose level, based on evaluation of safety data by an Independent Safety Committee (ISC). The decision to administer the second dose at the higher level will also require review of the safety and tolerability of the second dose at the lower level.~The second dose will be administered at the outpatient clinic and the subjects will be observed for at least 60 minutes after vaccination prior to discharge from unit.

The purpose of this study is to evaluate the safety and immune response to ACE527.

To establish a multidisciplinary research structure that facilitates projects that bridge specialties that normally may or may not interact. The tissue bank will build the platform for a novel application of translational research that links cutting edge molecular laboratory techniques to clinical outcome studies in a fast and direct manner. Tissue banks can be used for numerous discovery applications such as the identification and structural characterization of human genes, expression analysis, or discovery proteomics. Biological specimens, when coupled with standardized treatment and outcome data, will be essential resources for the identification, characterization, and validation of biomarkers that are predictive of disease and treatment.

To establish a multidisciplinary research structure for tissue repository that facilitates projects that bridge specialties that normally may or may not interact.

Objectives:~To study the validity and reliability of estimation of the central venous pressure by measurement of internal jugular vein size using 2-dimensional ultrasound.~To evaluate the correlation of internal jugular vein cross sectional area and central venous pressure.~Methods:~The study design is prospective observational study.~We will include all patients scheduled for cardiac surgery in Siriraj Hospital and record both internal jugular size using 2-dimensional ultrasound just before central venous catheter insertion. The central venous pressure will be recorded and the ultrasound picture will be measured.~The data will be analyzed.

To study the validity and reliability of estimation of the central venous pressure by measurement of internal jugular vein size using 2-dimensional ultrasound.

HIV/AIDS is a major contributor to morbidity and mortality in Uganda. Despite aggressive advances in HIV prevention efforts, recent data suggest that HIV prevalence is increasing generally, and HIV knowledge, a direct contributor to behavior, is on the decline among young people specifically as compared to a decade ago.~The Internet is a promising mode of intervention delivery in resource poor-settings because the costs associated with scaling up are minimal; dissemination online is the same if one person or 100,000 people use the program. Just as important, it provides access to important health information in a stigma-free, anonymous atmosphere. Our recent data indicate that 45% of adolescents in Mbarara, Uganda have used the Internet, 78% of whom went online at least once in the previous week. Eighty-one percent of respondents in the same survey indicated they would go to an HIV prevention web site if it existed. Based upon these data, we propose to develop a culturally appropriate, Internet-based HIV prevention program designed specifically for Ugandan adolescents between the ages of 12 and 18 years. Our specific aims are as follows:~Specific Aim 1: Design a 6-hour, Internet-based HIV prevention program for adolescents. Content will be culturally tailored to the HIV preventive information, motivation, and behavioral skills needs of Ugandan adolescents.~Specific Aim 2: Test the intervention in a randomized controlled trial (n=500) among adolescents attending grades Secondary 1-4 (similar to US high school grades 8th - 11th) at day schools in Mbarara.~This project has the potential to develop low-cost and salable interventions to HIV transmission risk behaviors among adolescents in Uganda.

The investigators propose to design and test an Internet-based HIV prevention program for adolescents in Uganda.

OBJECTIVES: Primary~To determine the pharmacokinetic profiles of oral doses of AZD7295 capsules administered to healthy subjects~To study the effect of food on the pharmacokinetic profiles of oral doses of AZD7295 capsules in healthy subjects~To assess the safety and tolerability profiles of oral daily doses of AZD7295 capsules in healthy subjects TYPE AND DESIGN: Part A A phase I, single-centre, double-blind, randomised, placebo-controlled, crossover, food effect study in healthy subjects~Part B A phase I, single-centre, double-blind, randomised, placebo-controlled, ascending dose study in healthy subjects~NUMBER OF SUBJECTS: 16 subjects will take part in a total of 4 treatment periods.~SUBJECT CHARACTERISTICS: Healthy males and females of non-child bearing potential aged 18 to 65 years.~Recruitment will not be balanced for gender or any other variable.~TREATMENT: Part A~Subjects will be randomised to receive AZD7295 or placebo (14 active; 2 placebo) in either the fed or fasted state according to the treatment allocation:~Treatment A: 260 mg (4 x 65 mg) AZD7295 capsules or placebo dosed in the fed state~Treatment B: 260 mg (4 x 65 mg) AZD7295 capsules or placebo dosed in the fasted state~Following dosing of the first two periods there will be a period of interim analysis, during which the pharmacokinetic data will be reviewed in order to determine whether the remaining treatments will be dosed either in the fed or fasted state.~Subjects from Part A will continue into Part B of the study.~Part B~Subjects will be allocated to two groups of n=8 (Group 1 and Group 2) and randomised to receive AZD7295 or placebo (6 active; 2 placebo). Subjects will receive two of the ascending dose treatments in the following order according to group allocation:~Group 1:~Treatment C: 455 mg (7 x 65 mg) AZD7295 or placebo dosed either in the fed or fasted state;~Group 2:~Treatment D: 650 mg (10 x 65 mg) AZD7295 or placebo dosed either in the fed or fasted state;~Group 1:~Treatment E: 650 mg (10 x 65 mg) AZD7295 or placebo, twice a day (q12h) dosed either in the fed or fasted state (total administered dose: 1300 mg);~Group 2:~Treatment F: 650 mg (10 x 65 mg) AZD7295 or placebo, three times a day (q8h) dosed either in the fed or fasted state (total administered dose: 1950 mg).~Safety data and limited PK data will be reviewed by the data review group prior to proceeding to the next dose level.~During the dose escalation phase a maximum of 4 subjects will be dosed per day.~MAIN OUTCOME MEASURES: The primary outcome will be to determine the pharmacokinetic profiles of AZD7295 when dosed in the fed and fasted state and to assess the safety and tolerability of higher daily doses of AZD7295.~GENERAL SCHEDULE: Screening is planned to start in April 2009, with the clinical phase due to be completed by the end of July 2009

The purpose of this study is to determine the pharmacokinetic profile of oral doses of AZD7295 capsules in healthy subjects, and also to assess the effects of food as well as safety and tolerability.

PURPOSE: The purpose of this placebo controlled study is to determine the efficacy, safety, and gender differences in using varenicline for smoking cessation in a population of stable methadone maintenance patients being treated for Opioid Dependence.~HYPOTHESIS:~1.Stable methadone maintenance patients receiving varenicline will be more likely to maintain abstinence than patients receiving placebo 2.There will be no differences in the type and number of symptoms reported between stable methadone maintenance patients receiving varenicline and placebo 3.There will be no changes in methadone dosage between abstinent and non-abstinent smokers 4.There will be no differences in efficacy, withdrawal symptoms, and safety of varenicline between male and female participants~3. JUSTIFICATION: Patients on methadone maintenance treatment have smoking prevalence rates of up 80-90% and consequently disproportionately high mortality compared to the general population. A majority of these patients express a desire to quit but are generally more heavily dependent on nicotine. Randomized controlled trials in non-drug using populations have shown varenicline to be more efficacious for smoking cessation than placebo and other smoking cessation medications. This placebo controlled research protocol will examine varenicline's effect on smoking cessation/reduction and potential sex and gender differences in a population of methadone maintained patients.~4. OBJECTIVES:~Primary outcome:~Continuous abstinence from smoking during the last 4 weeks of treatment (weeks 9-12).~Secondary outcomes:~7-day point prevalence of abstinence~Continuous abstinence Weeks 9-26~Sex and gender differences~Psychological assessment (Beck Depression Inventory)~Adverse effects (Nausea, Dry mouth, Flatulence, Constipation, Insomnia, -Abnormal dreams, Irritability, Sleep disorder, Headaches, Dizziness e.t.c.)~5. RESEARCH METHOD: This pilot randomized, double-blind, placebo-controlled trial will be conducted at Vancouver Coastal Health Tobacco Dependence Clinic Vancouver, BC with a 12-week treatment period and follow-up of smoking status to week 26. The intervention will include the use of Varenicline titrated to 1 mg twice daily or placebo for 12 weeks, plus weekly brief smoking cessation counseling.~6. All significance tests will be 2-tailed with an overall level of significance of a = 0.05. The primary outcome will be the analysis of continuous abstinence using a logistic regression model. The secondary outcomes will be:~the analysis of 7-day abstinence and 9-26 week continuous abstinence using logistic regression analysis.~Minnesota Nicotine Withdrawal Scale, Beck's Depression Inventory, and changes in methadone dose outcome using repeated measures analysis, and~Chi-square tests and t-tests (or Mann-Whitney U) to determine sex and gender differences (male vs female) as well as differences in adverse effects of treatment (varenicline vs placebo)

The main hypotheses guiding the study are:~Stable methadone maintenance patients receiving varenicline will be more likely to maintain abstinence than patients receiving placebo~There will be no differences in the type and number of symptoms reported between stable methadone maintenance patients receiving varenicline and placebo~There will be no changes in methadone dosage between abstinent and non-abstinent smokers~There will be no differences in efficacy, withdrawal symptoms, and safety of varenicline between male and female participants

The MagnaSafe Registry is an investigator initiated study designed to determine the risks of performing MRI for patients with pacemakers and Implantable Cardioverter-Defibrillators (ICDs). We hope that the results of the registry will provide physicians the risk-assessment data needed to assess the use of MRI as a diagnostic tool when no alternative diagnostic imaging technology is appropriate.~The number of patients living with permanent pacemakers or ICD devices in the United States is increasing dramatically as a result of expanded indications. Between 1990 and 2005, an estimated 2.8 million pacemakers and 690,000 ICDs were implanted in the United States. The number of implanted devices continues to increase without an apparent plateau.~Magnetic resonance is the imaging modality of choice for the diagnosis of many diseases of the brain, spinal cord, and musculoskeletal system. For some disease states, no acceptable alternative diagnostic imaging method is available. As the number of implanted cardiac devices is increasing, the clinical indications for MRI are expanding as well. Marketing research estimates that approximately 27.5 million MRI procedures were completed in 2007 (The Medical Information Division of IMV, LTD). It is predicted that there is a 50-75% probability that a patient with a pacemaker or ICD will have the need for an MRI over the lifetime of the device.~Most physicians consider the presence of a pacemaker or ICD to be an absolute contraindication to an MRI study. Patients are denied the examination, even when MR is clearly the superior diagnostic modality or when there is no acceptable alternative imaging test available. To provide optimal care to the increasing number of patients with an implanted cardiac device, health care professionals must have the capability to perform MR imaging with minimal risk and full knowledge of the possible complications.~The present study will create a registry of patients with pacemakers and ICDs who will undergo clinically indicated MRI and will document any adverse event or change in device parameters that may be associated with the imaging procedure. The results of this registry will provide the medical community with an accurate documentation of risk to patients and will establish a protocol of patient screening and device reprogramming for the purpose of maximizing the safe performance of MRI as a diagnostic tool in patients with implantable cardiac devices when indicated.~This is a physician-initiated study that will be coordinated by Scripps Clinic, Green Hospital. It is being performed under an IDE from the FDA. Funding for the MagnaSafe Registry comes from multiple sources including competitive grants, institutional grants, foundation fellowship support, unrestricted educational grants from industry, and philanthropy.~Scripps Clinic/Green Hospital, La Jolla, CA, has performed more than 125 MRIs on patients with implanted cardiac devices. Results of retrospective clinical observations at Scripps Clinic were presented at the American Heart Association 2008 Scientific and American College of Cardiology 2009 Scientific Sessions.~Up to 35 sites will be recruited to participate in the registry. The registry uses a protocol designed to minimize potential risk to the patient and device. MRI compatible equipment will be required to monitor vital signs (non-invasive blood pressure monitoring, pulse oximeter, and single lead cardiac rhythm monitor) while performing scans on patients with implanted devices. Recommendations from the American Heart Association for performance of MR examination in patients with pacemakers or ICDs will be followed.~The MRI procedures will be conducted for clinical purposes at the discretion of the ordering physician. MR examination of patients with permanent implanted cardiac devices will only be performed if there are highly compelling circumstances and when the benefits clearly outweigh the risks in the opinion of the ordering physician. The decision to have an MRI must be based on clinical indication, and is not part of the research protocol.~Those wishing to participate in the registry as an investigational site will be required to obtain approval of the FDA-authorized protocol from their reviewing IRB, and complete a written investigator agreement.

This study will create a registry of patients with pacemakers and implantable ICDs who will undergo clinically indicated MRI and will document the incidence of any adverse events or changes in device parameters that might be associated with the procedure.

This protocol represents the first in human study of SRX246, and is being conducted to begin to establish a safety profile, and collect human tolerability and pharmacokinetic data of orally administered SRX246.

This is the first study of SRX246 in humans, and is being conducted to begin to establish a safety profile of orally administered SRX246.

Salbutamol (VentolinTM) is a short acting beta agonist (SABA) which is used to treat wheezing, dyspnea and breathing difficulties caused by asthma and COPD. Further, it is also used to prevent bronchospasm during exercise.~Ipratropium bromide (Atrovent® HFA) is a short acting anticholinergic bronchodilator (short acting muscarinic antagonist (SAMA)) that improves lung function, dyspnea, exercise tolerance and health-related quality of life in patients with COPD. Studies have also shown that ipratropium bromide might reduce COPD exacerbations and related hospitalisations because the extended bronchodilatation might reduce infection rates by improving clearance of respiratory secretions.~In this open, randomized, two-way crossover, pilot study the effect of salbutamol in patients with moderate and severe COPD will be examined in comparison with the effects of ipratropium bromide. These patients will receive 400 µg salbutamol and 80 µg ipratropium bromide in a randomized crossover design.~The objectives of this study are to assess the effect of salbutamol in comparison with ipratropium bromide on the geometry of central and peripheral airways and to correlate spirometric indices (as Forced Expiratory Volume in one second (FEV1) and Tiffeneau index) with the Computational Fluid Dynamics (CFD) based calculated airway volumes and resistances for both compounds.

The objectives of this study are to assess the effect of salbutamol in comparison with ipratropium bromide on the geometry of central and peripheral airways and to correlate spirometric indices with the Computational Fluid Dynamics (CFD) based calculated airway volumes and resistances for both compounds.

Summary and aims:~Normal fetal growth is a critical component of a healthy pregnancy and the long-term health of the offspring. Pivotal to understanding the dynamics of human fetal growth and to defining normal and abnormal fetal growth is the development of standards for fetal anthropometric parameters measured longitudinally throughout gestation, which, in turn, can be used to develop interval velocity curves and customized for genetic and physiological factors. We propose to conduct a multi-center prospective observational study (1) to establish a standard for normal fetal growth (velocity) and size for gestational age in the U.S. population; (2) to create an individualized standard for fetal growth potential; and (3) to improve accuracy of fetal weight estimation.~Eligibility:~• Healthy, low-risk pregnant women (both obese and nonobese) between the ages of 18 and 40 from each of the following four self-identified race/ethnicity backgrounds: African American, Asian, Caucasian, and Hispanic.~Design:~Observational cohort design where pregnant women are recruited prior to 13 weeks gestation and followed throughout pregnancy and delivery for women having livebirths.~After a sonogram at enrollment (10-13 weeks), women were randomized to receive sonograms according to one of the following four schedules: schedule A: 16, 24, 30, 34, and 38 weeks; schedule B: 18, 26, 31, 35, and 39 weeks; schedule C: 20, 28, 32, 36, and 40 weeks; schedule D: 22, 29, 33, 37, and 41 weeks.~An enrollment interview was followed by depression screening, physical activity, anthropometric assessment and ultrasonology screening for measurement of fetal growth, and at each of the 5 subsequent visits.~Uterine artery and fetal Doppler studies at selected gestational weeks.~Women were asked to provide blood samples at enrollment and at follow-up visits at 16-22 weeks, 24-29 weeks, and 34-37 weeks of gestation.~Neonatal anthropometry completed for all infants within 12-24 hours after birth.~Cord blood, plasma, and placenta samples were collected for a smaller subsample of newborns.~Post-study evaluations: Women who were diagnosed with gestational diabetes during pregnancy were asked to return for a follow-up visit 6 weeks after delivery.~Enrollment:~Final recruitment included 2,802 women with singleton pregnancies of which 2,334 were healthy, low-risk women with pre-pregnancy body mass indices (BMI) between 19-29.9 kg/m2. The racial/ethnic distribution of participating women were: Caucasians (n=614), African American (n=611), Hispanics (n=649), and Asians (n=460), and reflects natality characteristics of contemporary U.S. births. An additional 468 obese women (BMI 30-44.9 kg/m2) were also recruited.~Quality Control:~The quality of the ultrasound measures was guaranteed by implementation of: (1) a comprehensive quality control protocol for ante hoc training and credentialing of all site sonographers, developed by the sonology center at Columbia University, and (2) a rigorous protocol for post hoc quality control, whereby a random sample of all scans, stratified by clinical site and visit, was re-measured for accuracy and reliability.

Normal fetal growth is a critical component of a healthy pregnancy and the long-term health of the offspring. Pivotal to understanding the dynamics of human fetal growth and to defining normal and abnormal fetal growth is the development of standards for fetal growth. The study's purpose was to establish standards for normal fetal growth and size for gestational age for 4 racial/ethnic groups of pregnant women with the eventual creation of individualized standards for fetal growth and improvements in fetal weight estimation. These data for a contemporary cohort of pregnant women should provide data for clinical management.

Sedative and analgesic drugs are used in most patients related to pain and anxiety during the colonoscopy. Analgesia and sedation has adverse effects such as central respiratory depression, obstruction of the upper airways, hypoxia, hypotension and bradycardia. Non-pharmacological interventions had beneficial effects during percutaneous vascular or renal procedures. In this study we test the hypothesis that the adjunction of hypnosis to pharmacological sedation will decrease the quantity of sedative drugs used and will reduce the patient's anxiety and discomfort.

The purpose of this study is to determine whether a non-pharmacological intervention reduces consumption of sedative drugs during colonoscopy. A reduction of sedative drugs may reduce side effects. This non-pharmacological intervention may increase patient's comfort and security.