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The objective of this study is to determine the long-term safety of asoprisnil 10 mg (2-5mg tablets) when taken with Premarin® 0.625 mg, by postmenopausal women, for 6 months after an initial 12 weeks in Study M00-198. Pharmacodynamic effects to be assessed include uterine bleeding pattern, endometrial biopsy results, and endometrial thickness. Safety assessments will include clinical laboratory results, physical examination with vital signs, pelvic and breast examinations, ultrasound results, and adverse events.

The objective of this study is to determine the long-term safety of asoprisnil 10 mg when administered to postmenopausal women with Premarin® 0.625 mg

In this 4-month study, menopausal women are randomized to either placebo or oral micronized progesterone (Prometrium®). Participants maintain a daily diary to keep track of their vasomotor symptoms and other factors. Forearm blood flow will be assessed by venous occlusion plethysmography at baseline and after three months of therapy. Screening tests at baseline to rule out heart disease include measurement of blood pressure and heart rate, electrocardiogram (ECG) and blood tests - fasting blood glucose and lipid profile.~Collection of serum and plasma samples at baseline and end of therapy for analysis of cardiovascular markers (e.g., c-reactive protein) and clotting and fibrinolytic markers. Continued daily diary collection for one month after therapy discontinuation to look for possible rebound effects. Analysis of outcomes will be by analysis of covariates, with final value as the outcome, therapy as factor and baseline values as covariate.

The primary purpose of this study is to determine the effects of a full dose (300 mg at hs) of oral micronized progesterone (OMP) on vasomotor symptoms [VMS] (hot flushes/night sweats), on forearm blood flow and on lipid levels and blood pressure in menopausal women without cardiovascular disease and with moderate to severe VMS.~The hypotheses are that progesterone will improve hot flushes, increase endothelium-dependent forearm blood flow and will decrease blood pressure without change in lipid levels.

The purpose of this investigation is to evaluate the effectiveness of a car seat inspection at the time of a pediatric visit on the proper use of car seats 4-6 months later.~Motor vehicle-related injury is the leading cause of death of children. Proper restraint in a motor vehicle reduces the risk of fatality in a crash by approximately 70%. However, multiple studies have found approximately 85% of car seats are misused. Urban poor and minority populations have been found to have higher child passenger death rates, and may have lower car seat usage rates than the rest of the population. Child passenger safety (CPS) technicians trained by the National Highway Traffic Safety Administration (NHTSA) and certified by the American Automobile Association (AAA) capably check proper car seat usage in check up events, and operate recently established fitting stations. However, we are not aware of an attempt to provide the CPS technical services to families attending a routine checkup with their medical provider.~This project will involve implementing and evaluating a program providing car seat checks at the time of routine pediatric visits at the Friend Family Health Center (FFHC). To determine if the car seat checks improve proper car seat use, children who receive the intervention will have their car seat use reassessed at the time of a scheduled return visit to their medical provider. The frequency of routinely scheduled health maintenance visits is greatest for the youngest children. Opportunities to collect follow up car seat use data therefore will be greatest for the youngest children. This evaluation will focus on 0 year olds. While we will also assess the older children and booster seat use, the sample size calculation for this study was determined for these younger children.

The purpose of this research is to evaluate the effectiveness of checking car seats during pediatric well-child visits on the use and properness of use of car seats for children 0-8 years. We are following up with families when they return for the next pediatric check up to see if they are appropriately using car seats for their children.

This study has investigated various aspects of the physiology of the microcirculation in the past years and is still recruiting under parallel protocols of physiological investigations of the neurovascular control of the cutaneous microcirculation.

Microvascular dysfunctions are critical events in several diseases including diabetes. This study will develop a methodology for microvascular investigation in human skin. The purpose of the study is to investigate the physiological response of the cutaneous microcirculation to physical, thermal, mechanical or chemical stimulations.

OBJECTIVE: Responses to 23-valent polysaccharide pneumococcal vaccine (PPV23) are poor in organ transplant recipients. We have recently shown that the conjugate pneumococcal vaccine (PCV7) is immunogenic in this population but responses remain suboptimal. This is a clinical study designed to assess the immunogenicity of a novel pneumococcal vaccination strategy in a cohort of adult liver transplant recipients. The trial will compare a group of patients primed with the pneumococcal conjugate vaccine plus polysaccharide boost with a group primed with placebo plus the standard 23-valent polysaccharide vaccine.~Specific objectives of this study are:~To determine the quantitative antibody response using both vaccine strategies~To determine the functional antibody response by the opsonophagocytic assay. This assay has the advantage of assessing if patient antibody responses represent truly functional antibodies that display opsonic activity against pneumococcus and is likely better correlated with protective efficacy.~To determine the durability of response over two years In addition, the safety of the conjugate vaccine and a determination of whether time from transplant affects response to vaccination will be made.~HYPOTHESIS: It is hypothesized that the PCV7 priming will provide an enhanced response in these immunosuppressed individuals who may respond poorly to standard vaccination.~RESEARCH PLAN: We will enroll 130 liver transplant recipients from the out-patient transplant clinics at Toronto General Hospital, Toronto, Ontario. Recipients who have had pneumococcal vaccination in the past 5 years will be excluded. Upon enrolment, patients will be randomized to receive either placebo or PCV7 in a blinded fashion. Eight weeks later, all subjects will receive PPV23. Serum will be obtained at baseline, 8 weeks, 16 weeks, 6, 12, 18, and 24 months. Sera will be used to perform antibody testing to seven pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F). The baseline, 8, and 16 week sera will be used for opsonophagocytic assay to the above seven serotypes. A baseline nasopharyngeal swab will also be obtained to look for colonization with Streptococcus pneumoniae. Patient recruitment is expected to take two years and follow-up of all patients should be complete by year 3. An additional 4 months will be needed to complete all laboratory testing. The primary outcome will be anticapsular antibody concentration at 16 weeks. A serotype response will be defined as a 2-fold or greater rise in titer from the 8 week concentration. A vaccine response will be defined as response to at least one serotype of the seven measured.~FUTURE DIRECTIONS: Results of this trial will help to develop a rational and optimal pneumococcal vaccination strategy that would prevent significant morbidity in organ transplant recipients. We are currently studying the impact of pneumococcal disease in transplantation by: (i) a review of invasive pneumococcal disease in transplant recipients in Toronto-Peel region to determine incidence and predominating serotypes; (ii) a Canadian survey of vaccination practices in transplantation; (iii) a 3-year follow-up study to determine the sustainability of immune response to pneumococcal vaccine in renal transplant patients previously enrolled in a vaccine trial. We hope that these studies will form the basis of pneumococcal vaccination recommendations for organ transplant recipients.

The trial will compare a group of patients whose immune system is primed with the pneumococcal conjugate vaccine and then given a boost with polysaccharide vaccine (prime-boost strategy) vs. a group vaccinated with the standard 23-valent polysaccharide vaccine alone. It is hypothesized that the conjugate vaccine priming will provide an enhanced response in these immunosuppressed individuals who may respond poorly to standard vaccination.

This is a prospective cohort study at Children's Hospital and Brigham and Women's Hospital (BWH), before and after the introduction of two distinct interventions. The first intervention at Children's Hospital was the introduction of clinical pharmacists on inpatient pediatric wards to target errors at the stages of physician ordering and nurse transcription. The second intervention is technological: the introduction of physician computer order entry at the BWH neonatal intensive care unit (NICU). This intervention will most effectively target errors at the stage of physician ordering, and secondarily address errors at the stage of pharmacy dispensing and nurse transcription. Data on serious medication errors will be collected pre and post each intervention.

The purpose of this study is to determine how effective ward-based clinical pharmacists and computerized physician order entry systems are in reducing serious medication errors in pediatric inpatients.

The overall goal of the proposed research is to test the effectiveness of a theoretically-based interactive behavioral and health risk assessment system to improve the mental and physical health outcomes of the primary care provided for the adult multicultural members of a university health center-employee-based practice. The new system will include:~administration of a computerized behavioral and health risk assessment,~calculation of an individualized risk profile for each patient participant,~individual patient computerized video training in interaction focused on the risk profile,~physician training in patient-provider interaction, motivational interviewing and counseling, and in referral and triage focused on the risk profile, and~development of a negotiated care plan between patient and clinician for follow-up care.~Expected outcomes include changes in: risk category scores, utilization patterns, costs for health care services, and health stage of change indicators. Expected impacts (mediating variables) are: compliance with recommendations, health locus of control, differences in patient-provider interaction patterns and patient and clinician satisfaction. If successful, this methodology would contribute significantly to the health promotion goals of Healthy People 2010 and provide much needed evidence of how a behavioral and health risk assessment system can help to reduce ethnic health disparities of multi-cultural populations. This proposal is responsive to CDC's RFA for Health Promotion in the Workplace; in particular it responds to requests for strategy #6: Identification and evaluation of public health informatics and communication strategies and tools to improve health decisions, health alerting, health literacy, or health assessment among employees and employer.

This is a study to determine whether a computerized risk assessment and focused patient provider interaction can improve health outcomes in an employee population.

To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.

To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.

Evidence is accumulating that homelessness and housing may be important factors that influence human immunodeficiency virus (HIV) sex and drug risk behaviors. Despite this apparent connection, few studies have investigated whether homelessness or unstable housing, compared with stable and adequate housing, is linked with HIV risk behaviors, and whether change in housing status is associated with change in risk behaviors.~The Housing and Health Study is a multi-site, multi-agency research collaboration. This project is a unique collaboration between federal agencies (the Department of Housing and Urban Development and the Centers for Disease Control and Prevention), local government agencies, universities, and private not-for-profit organizations.~The goal of the project is to examine the impact of providing housing for people living with HIV who are homeless or at imminent risk of homelessness on their disease progression, their risks of transmitting HIV, and medical care access and utilization. A total of 630 people living with HIV from three study sites complete the baseline study sessions. Half the participants (n=315) are randomly assigned to each of the two study groups. Treatment group participants receive Housing and Health Study housing rental assistance, and comparison group participants receive assistance finding housing according to local standard practice.~At baseline, 6, 12, and 18 months after baseline, participants complete study questionnaires and provide blood specimens to test for CD4 and viral load. In addition, the cost effectiveness of the study will be investigated by examining the HIV-related costs averted by providing housing to persons at high risk for transmitting HIV.

The goal of the project is to examine the impact of providing housing for people living with HIV who are homeless or at imminent risk of homelessness on their HIV disease progression, risks of transmitting HIV, and medical care access and utilization.

Currently there is no consensus in how to improve the success rate of colonoscopy procedure given the fact that 10% of the procedures may fail. It has been suggested that using variable stiffness colonoscope (a colonoscope with a shaft that the stiffness can be altered), or even more sophisticated magnetic imaging colonoscopy (colonoscopy performed under a magnetic position detection sensor), could improve the success rate. However, these kinds of equipment are either expensive or not always available in the daily clinical practice. From some recent studies it was shown that adding a transparent cap to the tip of the colonoscope may improve the procedure success rate without increasing the complication rate of the procedure. The cost of the cap is cheap and it is available in almost every endoscopy center. Therefore the cap-assisted colonoscopy method may be an alternative which may improve the success rate of colonoscopy procedure, and reduce the pain and discomfort related to the procedure.

The primary aim of the study is to increase the success rate of cecal intubation in first colonoscopy and in repeated colonoscopy for the first failed procedure. The secondary aims are to assess the procedure time, the terminal ileum intubation rate, the endoscopist satisfaction score, the patients' acceptance, the complication rate of these two procedures, and the intravenous sedative drugs used.

Participants will be randomized to 1 of 3 groups: vitamin with omega-3, vitamin w/o omega-3, or omega-3 alone. They will take the vitamin 12 weeks, after which time they will return for all laboratory tests. Persons who are currently taking a supplement must undergo a 2-week washout period before beginning the study. Participants taking the Cooper Complete one-a-day vitamin plus omega-3 fatty acid will have greater improvement in homocysteine, LDL cholesterol, and C-reactive protein than those taking the other supplements.

The goal of the study is to evaluate the effectiveness of a new one-a-day Cooper complete vitamin supplement with or without a combined omega-3 fatty acid supplement on selected clinical risk factor measures. Participants taking the Cooper Complete one-a-day vitamin plus omega-3 fatty acid will have greater improvement in homocysteine, LDL cholesterol, and C-reactive protein than those taking the other supplements.

Anemia associated with lung cancer and chemotherapy is an important factor effecting patient symptoms, functional status, and overall quality of life (Groopman and Itri 1999; Langer, Choy et al. 2002). Darbepoetin alfa (Aranesp®) has demonstrated a significant effect upon ameliorating chemotherapy-induced anemia in lung cancer (Vansteenkiste, Pirker et al. 2002; Vansteenkiste, Poulsen et al. 2002). This trial is designed to evaluate the association between the treatment of anemia with darbepoetin alfa and direct electronic capture of clinical benefits in cancer-related symptoms, functional status and overall quality of life. This trial uses a secure web-based design to capture the patient-associated symptoms, functional status and quality of life. This novel secure web-based system was selected to improve the efficiency and quality of clinical data capture. If our hypothesis is correct, treatment with darbepoetin alfa will be associated with improved palliation of cancer-related symptoms, improved functional status, and result in overall benefits to the patient's health-related quality of life. The development of a web-based system to directly capture patient-related symptoms, functional status and quality of life will permit us in the future to conduct a national or international trial addressing the effects of darbepoetin alfa on these factors. If our hypothesis is incorrect, it may be that these parameters are not affected by the correction of anemia with darbepoetin alfa or the measures are not sensitive enough to detect these differences. A notable finding would be a clearly defined improvement in symptom palliation, functional status, and quality of life associated with darbepoetin alfa therapy.

This is a web-based pilot study to evaluate the association between the treatment of anemia with darbepoetin alfa (aranesp) and the clinical benefits in symptom palliation, improved functional status and quality of life in patients with cancer. The feasibility of web-based assessments and data capture will be evaluated.

The aim of the study is to investigate the effect of oral rosiglitazone therapy on the vascular responsiveness of different vasoactive compounds (angiotensin II, insulin, histamine and glyceroltrinitrate) in healthy subjects. Rosiglitazone will be given orally (4 weeks 4mg/d, titrated to 8 mg/d for another 4 weeks) as treatment. Every subject will receive intravenous stimulation with angiotensin II, histamine, insulin and glyceroltrinitrate before and after an 8 weeks treatment interval with rosiglitazone.

The study is designed to test the hypothesis in healthy subjects that the oral antidiabetic drug rosiglitazone provides additional vascular relaxing or modulating effects in addition to its blood glucose level reducing ability.

Vascular responses to angiotensin II and histamine are compared before and after 30 days of systemic treatment with either irbesartan 150 mg or atorvastatin 20 mg.

Vascular responses to angiotensin II and histamine are compared before and after 30 days of systemic treatment with either irbesartan 150 mg or atorvastatin 20 mg.

The aim of the study is to investigate the effect of oral candesartan and/ or rosiglitazone therapy on the vascular responsiveness of different vasoactive compounds (angiotensin II, insulin, histamine and glyceroltrinitrate) in healthy subjects. Pioglitazone will be given orally (4 weeks 30mg/d, titrated to 45 mg/d for another 4 weeks). Candesartan will be given orally (4 weeks 8mg/d, titrated to 16 mg/d for another 4 weeks) as treatment. Every subject will receive intravenous stimulation with phenylephrine, angiotensin II, histamine, insulin and glyceroltrinitrate before and after an 8 weeks treatment interval with study medication or placebo. In addition, pulse wave velocity will me measured non-invasively before and after treatment.

The study is designed to test the hypothesis in healthy subjects that candesartan and pioglitazone provide additional vascular relaxing or modulating effects in addition to their blood-pressure and blood glucose level reducing ability, respectively.

This is a combined analysis using 81 patients randomized and treated in CRAD001A2419 (NCT00154284) with 33 randomized and treated in CRAD001A2423 (NCT00170807). This approach is reflected in the protocol amendments for each study, and the one clinical study report for both.

The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.

Hundreds of people came to our hospital requesting upper blepharoplasty every year. Taking advantage of the discarded soft tissue in the blepharoplasty surgery, samples of bilateral orbicularis oculi muscle can be easily obtained from patients of various ages. This study is designed to objectively evaluate the age-related changes in human orbicularis oculi muscle by analyzing the composition of isoforms of myosin heavy chain (MHC), which is the predominant protein in skeletal muscle. MHC isoforms exist in different types of muscle fibers, and determines the maximum contraction speed of the muscle fiber. Therefore, The composition of MHC isoforms represents the composition of different types of muscle fiber.~These muscle specimens are stored with liquid nitrogen right after surgery. In the lab, the specimens are sectioned to 40μm in thickness, and soaked in special buffer solution. After electrophoresis and staining, bands of different types of MHC can be visualized. The gel is scanned and processed with an image analysis system. The density of each band can be determined, and the ratio of the different types of MHC can be calculated.~By dividing the subjects who had their orbicularis oculi muscle sampled during upper blepharoplasty operation into age groups of 20, 30, 40, 50, 60 and 70 years, these MHC subtypes composition ratios can be compared among the different groups. Therefore, the age-related changes of the composition of different muscle types can be concluded.

Orbicularis oculi muscle is a key structure in the peri-orbital anatomy and is responsible for the major changes of aging in this area. Peri-orbital rejuvenation has been an issue of great interest in plastic surgery. We believe that understanding the age-related histomorphometric changes in orbicularis oculi muscle is important for improving the current rejuvenation techniques or developing the new ones. Nevertheless, a study focusing on this topic has never been performed before, simply because it is difficult and dangerous to perform needle biopsy on orbicularis oculi muscle.

This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced Magnetic Resonance Angiography (CE-MRA) of arteries (specified vessel segments) by analyzing the rate of agreement, image quality, and diagnostic confidence between a CE-MRA based diagnosis and the diagnosis achieved from the comparator procedure IA DSA using Ultravist.

This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced magnetic resonance angiography (CE-MRA) of the arteries.

This is an uncontrolled intervention study in which eligible male subjects (N=60), after a two-week washout, will be randomized to receive lycopene either 15 or 30 mg per day for 12 weeks. About equal numbers of subjects will be randomized to either 15 or 30 mg of lycopene (about 30 subjects for each arm). The study is expected to be finished in 2 year. The study is expected to be finished in 2 year. Concerning an expected dropout rate of 10%, 66 subjects will be recruited for the study.

Primary: To determine factors that affect absorption and serum levels of lycopene after supplementation.~Secondary:~To evaluate general safety and tolerability of oral lycopene 15 or 30 mg per day for 12 weeks.~To determine lycopene effects on reducing serum levels of prostate specific antigen (PSA) and on relieving lower urinary tract symptoms (LUTS) in relation to prostate hypertrophy as evaluated by the International Prostate Symptom Score (I-PSS).

Bone lengthening using distraction osteogenesis has found many clinical applications in the treatment of limb length discrepancies, limb deformities, bone defects and fracture nonunion. Animal studies have shown that mechanical conditions significantly affect the biological process of osteogenesis. Knowledge of the influence of mechanical stimuli on the formation of bone is thus essential for the improvement of the current technique, contributing to the treatment and care of patients receiving bone lengthening. Previous in vivo human studies have approached the problem by measuring the interfragmentary movement of bone fracture and the loading in the limb in terms of the ground reaction forces. The mechanical environment in the callus is not available with these approaches. As the stress and strain behavior of bone is critical to its normal function, the response to bone osteotomy and osteogenesis, a limited number of studies have used simplified FEM technique to examine the strain and stress patterns in the callus in two dimensions during simplified loading conditions. The calculated strain patterns, however, can be far from the real situation in the callus. No data are available for the stress and strain patterns during the process of distraction osteogenesis.~The present study is a further step of our current one-year NSC project, aiming to bridge the above-mentioned gap by continuously monitoring the mechanical stimuli applied to the limb and callus, both through experimental measurements and FEM calculations, and by correlating the observed quantity and quality of the mechanical stimuli with the calculated stress and strain patterns of the callus tissue. Specifically, in this proposed study, 3D finite element models of the osteogenesis at four temporal points during the limb lengthening process for each subject will be developed from CT data of the osteotomy sites. A 3D model of the musculoskeletal model of the lower limb will be used to calculate the forces transmitted by the bone and surrounding tissues, which will be used for subsequent FEM analysis. The purpose of the study is to determine the stress and strain patterns in the callus at different distraction stages and, with the data collected from gait laboratory experiments performed in our current NSC project, to provide a clearer picture of the influence of mechanical stimuli on distraction osteogenesis.~It is hoped that the present study will lead to a better understanding of the mechanisms of osteogenesis, which will be helpful in finding appropriate fixation methods in distraction osteogenesis that optimize the mechanical environment for bone formation.

a further step of our current one-year NSC project, aiming to bridge the above-mentioned gap by continuously monitoring the mechanical stimuli applied to the limb and callus, both through experimental measurements and FEM calculations, and by correlating the observed quantity and quality of the mechanical stimuli with the calculated stress and strain patterns of the callus tissue.

Understanding the age-related changes in periorbital adipose tissue is crucial for improving current rejuvenation techniques, or developing new ones. However, no such study has been reported in the literature.~Hundreds of people came to our hospital requesting upper blepharoplasty every year. Taking advantage of the discarded soft tissue in the blepharoplasty surgery, samples of bilateral pretarsal fat can be easily obtained from patients of various ages. This study is designed to objectively evaluate the age-related changes of the preadipocytes in human periorbital adipose tissue regarding their proliferation and differentiation capability.~The adipose samples taken during the surgery are sent to the lab immediately to separate the preadipocytes from the specimens. Their number is estimated under the microscope, and then the cells are cultured in vitro to evaluate their proliferation and differentiation capability. Proliferation is assessed by counting the number of preadipocyte everyday for 7 days, and differentiation is assessed by Glycerol-3-phosphate dehydrogenase (GPDH) assay.~A linear regression analysis is used to analyze correlations of the parameters with age. Moreover, by dividing the subjects who had their periorbital fat sampled during upper blepharoplasty operation into three age groups, the parameters are compared with ANOVA test. Therefore, the age-related changes of the proliferation and differentiation capability of the preadipocytes in human periorbital adipose tissue can be concluded.

Periorbital rejuvenation has been an issue of great interest in plastic surgery. Adipose tissue plays an important role in the periorbital anatomy, and has a great impact on the aging process of the region. We believe age-related atrophy of the facial adipose tissue may be related to the decreased proliferation and differentiation capability of the preadipocytes (adipose precursor cells).

Cervical multifidus has specific sensory and motion function. However, it was unclear about muscle architectural change of cervical multifidus during head retraction manoeuvre with progressive resistance. The validity and reliability of measuring cervical multifidus using ultrasonography hasn't been proven.~In the pilot study, thickness, width and area of multifidus were measured at C4, C5 and C6 were measured using MRI and ultrasonography. The limit of agreement and the regression analysis were used to compare the results of two modalities. Besides, muscle thickness was repeatedly measured during the static and head retraction manoeuvre using ultrasonography by the same rater on the same day; the CVw and CVb were used to investigate reliability. In the main study, multifidus architecture measured in twenty asymptomatic subjects (24.3±4.7 yo, 5 women and 15 men) during head retraction manoeuvre with progressive resistance and during relaxation using ultrasonography apparatus with 10MHz linear transducer. ANOVA with repeated measurement and post-hoc analysis were to investigate the difference among different cervical levels and resistance force levels.~The results of the pilot study showed that the limit of agreement was ±0.20 cm and the moderate level of correlation (R2 ranged in 0.42~0.64) for muscle thickness measured between MRI and ultrasonography. For muscle thickness, the CVw values under static and under head retraction against maximum resistance were lower than 10%. In the main study, there was a curvilinear relationship between muscle thickness change and resistance, and the quadratic equations were the proper curves for estimation. There was significant difference of muscle thickness change within 50% of maximum retraction against resistance; and there was no significant difference among three cervical levels. It was suggested that muscle at C6 relaxed more slowly during the period from the beginning of relaxation.~In conclusion, the present study built a valid and reliable method for measuring continuous and dynamic changes of muscle thickness using ultrasonography. The results supported muscle function of cervical multifidus for segmental stability but not for force production.

The purpose of this study is to investigate the validity and reliability of measurement for cervical multifidus using ultrasonography, and to investigate cervical multifidus muscle function by the change pattern of multifidus thickness, and to compare the changes in muscle thickness among different resistance levels (rest, 25%, 50%, 75% and 100%) and different cervical levels (C4, C5 and C6).

The goal of our contraception study (ACY-5) is to develop a hormonal regimen where in all individuals enrolled achieve azoospermia (zero sperm). However, early data demonstrated that some individuals have persistent sperm in their semen despite treatment. We hope to be able to determine whether differences in intratesticular hormone levels account for persistent sperm production in men who do not reach counts of zero as compared to those who do in the male contraceptive study. This study will measure testosterone levels in the testes of men who are participating in male contraceptive studies. Testosterone will be measured in a small amount of testicular fluid at the end of the study treatment phase after sperm counts have been reduced to zero or very low levels.

This study is being offered to all participants of the ACY-5 study as an optional addition to the male contraceptive study in which they participated. Participation is voluntary.~The purpose of this added procedure (Testicular Aspiration-HOP 3) is to determine the amount of testosterone (male hormone) in the testes of men who are on a male contraceptive regimen.

OBJECTIVES:~The primary objective of this project was to develop and evaluate a computerized program that would enhance Veterans Health Administration (VHA) employees� awareness of women veterans and their health-care needs. The program was designed to challenge negative stereotypes about female patients (gender-role ideology), increase empathy toward female patients� needs (gender sensitivity), and enhance knowledge regarding women veterans and aspects of their VHA care (knowledge).~DESIGN/METHODS:~Phases I involved generating content for the computerized interactive program. Phase II involved creating the 30-minute program. The Phase III evaluation of the program involved a two-group pretest�posttest�follow-up equivalent control group design at two facilities with a third facility comparison group. At the first two facilities, employees who provide either direct or ancillary care to patients were randomly assigned to either the treatment or the control group. Participants in the treatment group completed the program entitled Caring for Women Veterans. Participants in the control group and those at the third site completed a 30-minute program entitled Managing Stress. The data from the third site were included to test for infusion of the treatment effect within same-site groups. Gender awareness was evaluated at three time points using the Gender Awareness Inventory-VA (GAI-VA). Participants completed the GAI-VA several weeks prior to completing the computerized program (Time 1, n =339), immediately after completing the program (Time 2, n = 249), and approximately one month after the program (Time 3, n = 167). Participants also completed a qualitative evaluation of the program at Time 2.~STATUS:~Complete.

The purpose of this study was to develop and evaluate an educational program intended to raise staff awareness about women veterans and their health care needs and preferences.

Randomized, double blind, placebo controlled, prospective trial in patients, receiving a kidney transplantation. Patients will be randomized to receive either Epoetin Beta (Neorecormon; Roche) or placebo.~The primary endpoint will be delayed graft function. The anticipated duration of this trial is 2 year and the target sample size is 60 patients per arm.

Randomized, double blind, placebo controlled, prospective trial investigating the effect of erythropoietin in renal transplantation.~The investigators postulate that erythropoietin reduces the risk of delayed graft function.

The potential benefits of adolescent mentoring programs cannot be overemphasized. Mentoring may be especially beneficial to urban-living, minority adolescents who may lack role models. The Big Brothers Big Sisters (BBBS) organization administers a widely-praised and empirically-supported program that is committed to building successful mentoring relationships between adolescents and adults in their community. In collaboration with the BBBS affiliate agency in Chicago, the PI has developed an intervention called GirlPOWER! GirlPOWER! combines mentoring with self-esteem enhancement and health education and promotion strategies. This study will determine the effectiveness of the GirlPOWER! intervention and determine its feasibility in being applied to other populations.~Participants will be randomly assigned to receive either the GirlPOWER! intervention or traditional mentoring through BBBS and followed for 1 year. Participants in the GirlPOWER! group and their mentors will engage in structured activities that focus on strengthening the mentoring relationship, promoting self-esteem, reducing levels of health-compromising behaviors such as substance use and violence, and increasing levels of health-enhancing behaviors. Traditional mentoring comprises less structured activities and typically includes general discussion of an adolescent's day-to-day life and any accomplishments and challenges he or she may have experienced. Participants will be assessed at study entry, 3 months following entry, and at the end of one year. Assessments will include surveys completed by youth as well as their parents, mentors, and teachers; academic data also will be obtained from school records.

This study will be used to determine the effectiveness of GirlPOWER!, an innovative mentoring program for adolescent minority girls living in urban areas.

All subjects will be randomized into two groups. One group will receive DTPw vaccine co-administered with Hib and another group will receive DTPw vaccine alone. A specific follow-up of solicited local and general symptoms after each vaccination. A specific follow-up of unsolicited symptoms after each vaccination. Recording of serious adverse events reported during the study period.

To assess safety and reactogenicity of GSK Biologicals' Haemophilus influenza type b vaccine co-administered with or without Chinese DTPw vaccine administered alone in healthy infants (3, 4 and 5 months of age)

Asymptomatic smokers will be recruited by advertisement in newspapers and from posters displayed in the local community.Patients will be recruited from Hammersmith Hospital NHS Trust and local GP surgeries, where we shall display posters. We shall also directly ask patients whom we think may be suitable. This could be at a respiratory clinic, after they attend the lung function department for routine tests, and at GP and practice nurse appointments. After discussing the research outline with the subjects, either in person or by phone, we shall give them the information sheet and ask them to attend for a screening visit. This will be a chance for them to ask more questions, and for us to obtain informed consent. We will then carry out a brief medical examination and routine lung function tests. Providing they fulfil the inclusion criteria we shall then organise the subsequent visits, for 2 scans if they are patients with COPD or 3 if they are asymptomatic smokers. All participants will undergo chest X-ray to exclude other lung disease, unless they have had one in the past year. They must abstain for smoking for at least 12 hours prior to visit, and fast for 4 hours prior to scan. On the first day of attendance they will have a brief medical to assess whether they are clinically stable, and have spirometry and CO monitored, to confirm abstinence. For the scan visits the asymptomatic smokers will take the placebo or prednisolone the previous evening at 10pm and again the next morning with a light breakfast by 7:30am. On 2 scan days they will smoke 2 cigarettes 4h later, 60 minutes prior to scan. The PET scan takes about 90 minutes, and includes blood sampling throughout. They must be able to lie still in the scanner. We will aim to complete the scans at 1-2 week intervals, whilst clinically stable.~The COPD patients will not take prednisolone/placebo, but will either smoke 2 real or dummy cigarettes prior to scan. This protocol is similar to others used previously, which have proved acceptable to COPD patients and healthy smokers.

Neutrophil involvement in the development of COPD by smokers is well recognised. However not all smokers develop overt lung disease. We have previously shown that uptake of FDG is related to neutrophil activity and can be measured by PET and that uptake is greater in COPD patients than normal subjects. We have also shown that FDG-PET shows inflammatory changes in asymptomatic smokers after cigarette smoking. We plan to investigate the attenuation of this inflammation by steroid tablets and whether FDG PET can demonstrate this. We also wish to establish if similar changes are demonstrated after smoking by COPD patients.

Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss

Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss

Biomechanical aspects, including ground reaction forces, range of motion of involved extremities, EMG data and videotape records of human motion will be collected and stored as part of the normal clinical care of patients seen in the UF Biomechanics/Motion Analysis Laboratory. All persons seen in motion analysis laboratory will be told of study and asked to participate. Those agreeing to participation will give informed consent.

The purpose of the data bank is to collect data on joint motion.

The purpose of this study is to gather information about total knee replacement surgery using minimally invasive surgical procedures. The MIS™ Minimally Invasive Solutions™ Total Knee Arthroplasty System has been cleared for use by the Food and Drug Administration.~You are invited to participate in this data collection study, comparing the MIS system to standard knee replacement systems. The decision about which system and operation will be best for you has already been made by you and your orthopaedic surgeon.~The information will be used to compare minimally invasive surgery and the standard surgery procedures. The results of this study will provide information that will add to the knowledge base of knee replacement surgery.

The purpose of this study is to gather information about total knee replacement surgery using minimally invasive surgical procedures.

This will be a double-blind, placebo-controlled, oral single dose cross-over study. 18 healthy male volunteers will receive 250 mg SLV 317 or placebo in randomised order with a minimum wash-out period of one week between the two administrations.~Pharmacodynamic assessments will be performed up to 4.25 hours post-dose using the dorsal hand vein compliance technique. After obtaining venoconstriction via infusions of phenylephrine, substance P will be co-infused intermittently to induce venodilation. Substance P infusions will be separated by intervals of 45 minutes in order to prevent the well-known occurrence of tolerance.~Venous blood sampling for pharmacokinetic evaluation will be performed up to 24 hours post-dose.~Safety will be assessed by measuring ECG, pulse rate, blood pressure, haematology, blood chemistry, urinalysis, and by monitoring of adverse events.

The primary objective is to determine the effect of a single oral dose of 250 mg SLV 317 on substance P-induced venodilation in the hand vein of healthy male volunteers as compared to placebo.

Study I: Using the dorsal hand vein compliance technique dose-response curves to bradykinin and sodium nitroprusside will be obtained in healthy volunteers during preconstriction with phenylephrine and after pretreatment with a single dose of 500 mg i.v. acetylsalicylic acid.~Study II: Using venous occlusion plethysmography dose-response curves to acetylcholine, sodium nitroprusside and L-NG-monomethyl-arginine (L-NMMA) will be obtained in healthy volunteers pretreated with a single dose of 500mg i.v. acetylsalicylic acid.

The objective of the study is to assess the impact of genetic variation (especially polymorphisms of the gene coding endothelial nitric oxide synthase (eNOS) and the bradykinin B2 receptor gene) on venous and arterial responsiveness to vasodilators in healthy individuals without cardiovascular risk factors.

OBJECTIVES:~Determine the toxicity of irradiated allogeneic donor lymphocyte infusion in patients with relapsed or refractory hematological cancer or solid tumor.~Determine the response in patients treated with this regimen.~Determine the presence of disease or antigen-specific lymphocytes in patients treated with this regimen.~OUTLINE: This is a pilot, open-label, controlled study.~Patients undergo irradiated allogeneic donor lymphocyte infusion over 1 hour on day 1. Treatment repeats every 8-16 weeks for up to 6 infusions in the absence of disease progression or unacceptable toxicity.~Blood samples are collected periodically and analyzed for lymphocytotoxicity directed towards patients' cells (normal and malignant cells) and for disease or antigen-specific cells. Samples are also analyzed for survival of donor lymphocytes by chimerism studies.~PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

RATIONALE: When irradiated lymphocytes from a donor are infused into the patient they may help the patient's immune system kill cancer cells.~PURPOSE: This pilot study is looking at the side effects and how well irradiated donor lymphocyte infusion works in treating patients with relapsed or refractory hematologic cancer or solid tumor.

The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels. The primary objectives of the study are to measure the changes in tissue hormones and other biomarkers in the prostate tissue specimens.

The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels.

The overall purpose of this study was to evaluate the effectiveness of a psychosocial supportive intervention called Living with Hope Program (LWHP) in increasing hope and quality of life for older adult community-living terminally ill cancer patients. Using a mixed method concurrent nested experimental design, 60 terminally ill cancer patients over the age of 60 years were randomly assigned to a treatment and control group. Baseline hope [Herth Hope Index (HHI)] and quality of life scores [McGill Quality of Life Questionnaire, (MQOL)] were collected at the first visit in the patients' homes by trained research assistants. Those in the treatment group received the LWHP, which consisted of viewing an international award winning video on hope and a choice of one of three hope activities to work on over a one-week period. The control group received standard care. Hope and quality of life data were collected one week later from both groups. Qualitative data using open-ended hope questions were collected from the treatment group.~Subjects receiving the Living with Hope Program had statistically significant higher hope (U=255, p=.005) and quality of life scores at visit two (U=294.5, p=.027) than those in the control group. Qualitative data confirmed this finding with the majority (61.5%) of subjects in the treatment group reporting the LWHP increased their hope. This preliminary evaluation of the effectiveness of the LWHP suggests that it may increase hope and quality of life for older terminally ill cancer patients at home.

The Living with Hope program was developed by the research team, a panel of experts and palliative patients and their families. The program was evaluated with 60 advanced cancer patients 60 years of age and older. Thirty received the program and 30 did not. After one week, those receiving the Living with Hope Program had higher hope and quality of life scores compared to those who did not. This suggests that the program is effective in increasing hope and quality of life for older palliative care patients with cancer.

Research has established that there are relatively few days of the menstrual cycle that have a substantial probability of pregnancy from coitus, and that there are prospective biomarkers that allow a woman or couple to identify these fertile days. However, it remains unclear how this knowledge may improve a couple's chances of conceiving.~All couples participating in this study must have a history of previous pregnancy together and no history suggesting subfertility. Participants in this study will be randomly assigned to one of two groups. One group will receive instruction about identifying the days when a woman is mostly likely to get pregnant from intercourse, using the Creighton Model FertilityCare System, and the other group will receive instructions about the menstrual cycle, fertility, and preparing for pregnancy. Randomization is stratified by age.~All participants will keep a daily fertility chart and use a computerized device called the Fertility Monitor with urine dipsticks to monitor hormones of the menstrual cycle.~The primary outcome is time to pregnancy.

The purpose of this study is to determine how long it takes couples of normal fertility to get pregnant once they begin to try, and whether instruction in fertility awareness can decrease time to pregnancy in these couples.

The objective is to conduct a male contraceptive trial in which we will evaluate the suppressive effects of acyline when administered in combination with Testosterone (T) and the progestin depo-medroxyprogesterone acetate (DMPA).~We will be administering combinations of three drugs: Testosterone (T) by gel, Depot Medroxyprogesterone acetate (DMPA) and Acyline to see their effects on sperm production. The T/DMPA/Acyline combination will allow us to determine if the more rapid and complete gonadotropin suppression mediated by the early addition of a GnRH antagonist will accelerate and enhance suppression of spermatogenesis.~In prior studies with testosterone and DMPA these drug, which are hormones, have been found to be safe, and to reversibly suppress sperm counts to zero in about 80% of men. We hope to improve this to 100% of men by adding another drug, Acyline.~Acyline is an GnRH antagonist which blocks the release of LH and FSH from the pituitary. DMPA is approved by the FDA for use as a female contraceptive. The endpoint will be suppression of spermatogenesis to zero (azoospermia) by the end of the treatment phase.

The purpose of this research study is to help in the development of male contraception (birth control).

To explore and illuminate the cultural, social, and psychological factors that either facilitate or serve as barriers to behavioral change in angioplasty patients. Through a series of open-ended questions we will explore and build a better understanding of how culturally different patient groups perceive heart disease and the difficulties in changing health behavior. In addition, we hope to better understand and anticipate barriers and issues that participants face in successfully changing their behaviors.~To use the responses obtained in the qualitative interviews to inform how we should operationalize and tailor the positive affect induction and self-affirmation intervention methods in each of the populations under study. Specifically, this involves assessing what small gifts participants prefer to receive and what would be most effective in inducing positive affect.

To explore and illuminate the cultural, social, and psychological factors that either facilitate or serve as barriers to behavioral change in angioplasty patients. Through a series of open-ended questions we will explore and build a better understanding of how culturally different patient groups perceive heart disease and the difficulties in changing health behavior. In addition, we hope to better understand and anticipate barriers and issues that participants face in successfully changing their behaviors.

Pain is difficult to estimate in ICU because most of the patients are sedated. Bispectral index could be helpful in detecting this pain in ICU patients. Remifentanil is a morphinomimetic product with short half life that could be interesting for short nociceptive stimuli, as bronchoalveolar lavage.~The purpose of this study is to evaluate the impact of remifentanil infusion on bispectral index (BIS) variations during bronchoalveolar lavage.~It is a prospective, double blind study, versus placebo on 40 sedated and critically ill patients.~The hypothesis is that BIS can study analgesia in sedated patient.

The aim of this protocol is to study the prophylactic effect of remifentanil on bispectral index variation during a nociceptive stimuli.

The study shall be conducted according to a three-way, double-blind, placebo and active controlled crossover design. Treatment groups are identified as follows.~Rupatadine~Hydroxyzine~Placebo

The primary objective of this study is to measure and compare the acute effects of rupatadine 10 mg, relative to placebo and hydroxyzine 50 mg as an active control on healthy volunteers' performance on a standard over-the-road driving test and a car-following test.

This is a partly randomized open-label study in healthy postmenopausal women. Groups are treated in the following sequence: first a 2 mg estetrol group together with a 2 mg estradiol group. When the dose of 2 mg estetrol is safe and the tolerability is good, a next higher dose group of estetrol will start, possibly followed by two next higher dose groups if the previous dose group is safe and the tolerability is good.~The primary objective of this study is to investigate the safety and tolerability of estetrol during multiple dosing for 28 days. Furthermore steady state pharmacokinetics and some pharmacodynamic parameters of estetrol will be investigated. In addition, the pharmacokinetics and pharmacodynamic effects of the 2 mg estetrol group will be compared with those of the 2 mg estradiol group.~In each group 5 postmenopausal women will be included with > 50 hot flushes per week and 5 postmenopausal women with < 10 hot flushes per week. These criteria are set to get a more homologous composition in each group.

Estetrol is a natural compound that is produced by the fetus during fetal life and circulates in the unborn child and the mother. It is an estrogenic compound. In this study the safety and tolerability of 28 days of the oral administration of estetrol in healthy postmenopausal women are investigated. In addition, the pharmacokinetics and some pharmacodynamic parameters are studied. The lowest dose of 2 mg estetrol is directly compared with 2 mg estradiol.

PTA below the knee is limited due to subacute reocclusions and uncertain long-term results. This study is designed as a feasibility trial, which compares the two new treatment modalities: drug eluting stents and GP IIb/IIIa blockade.~Patients with current ulcers (Rutherford 5, or 6) are randomly assigned to one of the treatment groups: [1] ReoPro + Sirolimus coated stent, [2] ReoPro + bare Stent, [3] ReoPro + PTA, [4] PTA without ReoPro. Angiographic control will be at 2 and 6 months with block wise randomisation to the treatment groups.

The Below-Study is a randomized, prospective mono-centre trial on the efficacy and safety the adjunctive use of a GP IIb/IIIa antagonist for prevention of early reocclusion in arterial below-the knee interventions.

There are some compelling reasons to question the routine use of nitrous oxide (N2O), also known as laughing gas. Despite being the first anaesthetic drug introduced, and still widely used, there is sufficient doubt as to the risk-benefit profile.~There is strong evidence that N2O is a major risk factor for postoperative nausea and vomiting. It is clear that (even) brief exposure to N2O impairs methionine synthetase, an enzyme required for DNA production, red and white blood cell formation. Tissue hypoxia may be more common. These adverse effects are enhanced in sick patients (ie. those at highest risk, increased hospital length of stay and healthcare expenditure), and will be more likely in longer surgery. The extent of wound infection and cardiac morbidity associated with N2O is not known.~Large outcome trial data are lacking. When considering its widespread use in about 90% of all surgery around the world, small differences in outcome would have major implications for healthcare delivery. A large randomised controlled trial is necessary to answer this question.~We have recruited 2000 patients from about 25 centres around the world (mostly Australasia), who are undergoing major surgery.

We aim to investigate the effectiveness and safety of nitrous oxide (N2O) in anaesthesia.~Hypothesis In patients undergoing anaesthesia for major surgery, avoidance of N2O will reduce hospital length of stay when compared with otherwise identically managed surgical patients receiving N2O as a component of their anaesthesia.

Turning Point for Families in Hilo, Hawaii is developing, implementing, and evaluating a culturally-based intervention using Native Hawaiian values, beliefs, and practices to address intimate partner and sexual violence among Native Hawaiian perpetrators and victims/survivors.

The purpose of the project is to examine the efficacy of a culturally-based intervention, compared to standard agency services, in enhancing self-care among Native Hawaiian women and decreasing IPV/SV perpetration and related factors among Native Hawaiian men.

Targeted Area of Intervention: Social skills and development of best friend relationships. The specific intervention will be twelve small group sessions (90 minutes each) over a 6-week period. Child sessions consist of 4 components: 1) children report on homework assignments; 2) didactic presentation, behavioral rehearsal, and coaching, 3) coached play, and 4) new homework activities assigned with parent. Topics to be addressed across sessions include: reduction of maladaptive behaviors, information exchange techniques, places and times to make friends, group acceptance, praising other children, negotiation, play dates, dealing with teasing, and winner/loser skills. At the start of the intervention, parent and children will work with staff to develop a list of social skills, behaviors, and goals that they would like targeted for each child.~Parent component: Kathleen Mitchell (NOFAS) is an investigator to provide parent input to the study. Parent-only sessions will instruct them on key features being taught to their child. Concurrent parent sessions will include: 1) education on FAS/ARND, 2) parents present specific issues with their child, 3) review of current child session objectives and techniques, 4) new homework activities developed, 5) parent and child together review homework.~Evaluation Plan: Treatment and control (WL) groups will be compared using pre- and post-tests measures. Post-tests will be at the conclusion of the intervention and at a 4-month follow-up. Baseline parent measures include Social Skills Rating Scale, FAS Behavior Scale, and Test of Advocacy Knowledge. Baseline child measures include knowledge of social skills. Process (e.g., homework completion, attendance, etc) and outcome (e.g., social skills ratings, progress towards individual goals) measures will be evaluated.

Children will be randomly assigned to a Parent-assisted social skills training or Wait list. Baseline and post intervention rating will be obtained from teachers.

Adults with disabilities use primary preventive health care services (basic screenings, immunizations, and hevior health counseling) at rates below those recommended by the US Preventive Services Task Force and Healthy People 2010. This projects is to carry out a community-based campaign to increase preventive care knowledge and service use among adults with physical disabilities. Focus group methodology will be used to determine the specific preventive service priorities of the disability community so that targeted resource materials for consumers and physicians can be developed. Second, a randomized control group experiment will be implemented to evaluate the effectiveness of the targeted resource materials, followed by dissemination of the Preventive Services Resource Kits.

Project SHIELD (Strategies and health Interventions to Enhance Life with Disability) is a participatory action research project to test an intervention package combining a resource kit with peer mentoring in improving consumer education about primary preventive services

Approximately 1.2 million Americans are living with the loss of a limb and the incidence is increasing due to increases in the prevalence of diabetes. Pain, emotional distress, reduced functional abilities are common conditions following limb loss and reduce quality of life. Self-management interventions have been found to be effective in reducing the secondary conditions associated with arthritis and diabetes. Self management uses the principles of cognitive-behavioral therapy including education, self monitoring, problem solving, and skill acquisition.~The goal of the project is to develop and test the efficacy of a community based self management intervention for reducing pain, depression, and improving self efficacy and function in persons with limb loss using a randomized controlled design.~50 groups of 8-10 persons will be randomized to either a control group or a treatment group.

The goal of the project is to develop and test the efficacy of a community-based self-management intervention for reducing pain, depression, and improving self-efficacy and function in person with limb loss

Functional analysis of challenging behaviors will be conducted. Intervention will be an individualized, multimodal, behavioral consultation. The consultation will include: FAS education, emotional/practical support, and teaching child management strategies specific to children with FAS/ARND, advocacy assistance, and school consultation. Specific procedure will be based on previous findings and experience. In particular, specialized Behavior Support Plans will be developed for each child with input from parents, teachers, and clinicians.~Team consultations at the child's home during weekly visits. Instruction will include information on FAS, behavioral strategies, and information for advocating with service systems.~Evaluation Plan: Both interventions: Treatment and control groups will be compared using pre- and post-tests measures. Post-tests will be at the conclusion of the intervention and at a 9-month follow-up (end of school year).

Children diagnosed through the FAS DPN clinic (who receive non-study services through the clinic/referrals) will receive baseline assessment. The baseline assessment for the child will include: medical issues (including medication), intellectual assessment, academic achievement, language, social functioning, executive functioning, neurological assessment, perceived self-confidence, and behavioral observation of parent-child interactions (videotaped and coded). For caregivers, baseline assessment will include: demographics, medical histories, educational history, current services, satisfaction with services, knowledge of FAS, stress, parenting competence, and family functioning.

This initiative includes 4 major components: 1) A variety of arts based student activities related to violence prevention (during and after school theatre projects, during and/or after school visual arts project, and the web page design project. (All students will either directly participate in these activities or at least see them), 2) Curricular components for all 7th graders, 3) Violence prevention and early intervention student support/discussion groups, and 4) Faculty and staff training on the subject. The evaluation is a quasi-experimental pre/post test comparison group design (2 schools in each group), where our comparison schools convert to intervention schools one year after serving as comparison schools. We are using both group (student and teacher surveys) and school wide (climate of the school) measures pre and post intervention.

this project will evaluate a community and school based program to promote healthy relationships and prevent violence (physical, emotional and sexual dating violence) among predominately African American middle school adolescents in an urban setting (Baltimore, MD).

Eighteen counties in the state of South Carolina will be randomized to the dissemination of the Triple-P system or to a waitlist control condition. University of South Carolina staff will train health care professionals in the nine dissemination counties to use the Triple-P parenting programs. Triple-P is a parenting program that uses a tiered system of interventions of increasing strength depending on parents' and children's differing needs, ranging from media and information-based strategies, to two levels of moderate-intensity intervention using a brief consultation format, to two more intensive levels of parent training and behavioral family intervention targeting parenting skills and other family adversity factors such as marital conflict, depression and high levels of parenting stress. The evaluation of the dissemination of Triple-P will rely on two methods: the analysis of aggregate data on child maltreatment, injuries and hospitalizations, and annual surveys of families to examining parenting education, practices, and child behavior.

This is a population-based evaluation of the effectiveness of the Triple-P-Positive Parenting Program. Triple-P is a system of parenting programs with multiple levels that aims to provide parents with parenting skills and support.

A randomized controlled multi-component fall prevention study for older adults. The study integrates fall prevention into an existing community-based public health program for older adults. The study will evaluate the effectiveness of a fall prevention intervention among 552 seniors attending Preventive Health Care for the Aging (PHCA) clinics in two counties: urban San Diego county and rural Humboldt county. The intervention includes four elements: education about fall risk factors, referrals to community exercise programs to increase strength and balance, medication review, and home modification to reduce home hazards. The goal of the intervention is to reduce incidence of falls requiring hospitalization by 10%. Results of the study, which are expected to be completed by October 2004, will help guide future efforts to develop multifaceted fall prevention programs.

A randomized controlled multi-component fall prevention study for older adults. The study integrates fall prevention into an existing community-based public health program for older adults.

The early years of life (birth to age 5 years) are crucial in a child's development. Parents play a critical role in their children's development and are responsible for the environment in which they grow up. Past research shows that the personal characteristics of successful children consistently correlate to parental influences and behavior. Thus, the theoretical foundation in the Legacy study is that parents can positively influence their child's development. Also, parents are more likely to maintain positive parenting behaviors if they are part of a community greater than themselves. Legacy intervention activities are designed to enhance sensitive and responsive parenting, parent/child interaction, and promote a sense of community. Other activities include verbal and cognitive stimulation through parent and parent/child group meetings, visits to the home, and participation in community events. Legacy has both a pilot phase and a main study phase. There are 180 intervention and 120 comparison families in the main study phase and 60 of each in the pilot phase at each study site, Miami and Los Angeles. The 720 participating families are those whose children, on average, would be expected to fall below national norms on a range of developmental outcomes. Process, cost, and short- and long-term outcome data are being collected.~Comparison group: In addition to the current standard of care, the comparison families receive regular comprehensive child development and maternal assessments at 6 months, 1 yr, 2 yr, 3 yr, 4 yr, and 5 yr.

The purpose of this study is to determine if an intervention focused on promoting parent-child interaction, parental responsibility, parental commitment of time and energy, and sense of community results in better developmental outcomes for low-income children.

Patients will have a blood sample drawn that will be analyzed for altered BRCA1 or BRCA2 genes. An alteration of BRCA1 or BRCA2 gene means there is an increased risk of developing breast and ovarian cancer.~Patients participating in this study have either: 1) expressed an interest in testing for an underlying genetic factor that may account for the breast or ovarian cancer in their family; 2) have at least one relative that has been found to have a BRCA1 or BRCA2 alteration; 3) have a personal or family history of breast or ovarian cancer that is suggestive of a BRCA1 and BRCA2 alteration; or 4) has breast or ovarian cancer, or has at least one close relative with a history of breast or ovarian cancer and are a member of an ethnic group with increased frequency of BRCA1 and BRCA2 alterations.~Patients will be randomized into one of two counseling groups. Two visits with a specially trained genetic counselor or nurse in conjunction with a medical oncologist and/or a medical specialist will be done in which information will be given either about genetic counseling or enhanced informed consent. These visits will be audio-taped to monitor how the project staff is covering the important information about testing.~Throughout this study patients will be asked to complete questionnaires and psychological measures. These forms will be completed before and after the first visit, and a subset of them again at 2-4 weeks after the second visit, and at 4, 6, and 12 months.~In addition 30 women will be asked to complete a 20-30 minute telephone interview with the program psychologist.

To evaluate two different ways of providing information about genetic testing for BRCA1 and BRCA2 alterations. The two forms of counseling are genetic counseling and enhanced informed consent which cover similar material but are organized differently.

Patients will receive rhEndostatin intravenously continuously for 28 days and will be enrolled into one of 2 dosing groups.~During the initial course of treatment, subjects will be evaluated for treatment-related side effects. If there are no side effects or disease progression, they may receive an additional 28 days of continuous rhEndostatin.~During the infusion of rhEndostatin, blood samples will be collected before, during and after the drug is given to determine how much of the drug stays in the blood. Blood will be drawn on days 1, 8, 22 and 29. After the completion of therapy, a blood sample will be collected at least 3 days after to determine the level (if any) of rhEndostatin still in the patients blood.~Blood and/or urine samples to determine immune reactions against rhEndostatin as well as molecules that tumors may use to stimulate new blood vessel growth will be drawn at the start of the study as well as after the completion of each 28-day cycle and completion of the study.~When a tumor-specific marker that can be used to monitor the status of the disease is present, blood samples for the measurement marker will be obtained at the start of the study as well as after each cycle.~Appropriate imaging studies (MRI, CT scan, x-ray) will be done after the completion of the first two 28-day cycles and then at the completion of each 28-day cycle for the duration of therapy.~Treatment will be continued for 1 year and may be extended if the drugs are well tolerated and disease progression has not occured.

The purpose of this study is to assess the safety of rhEndostatin, to determine how much of the drug stays in the patients blood (pharmacokinetics), to assess the development of proteins in the blood that are produced by the body (antibodies)using rhEndostatin, to determine the effect of rhEndostatin on the formation of new blood vessel factors, and to perform an analysis of the effect of rhEndostatin on circulating endothelial precursor cells (cells in the body that help the tumor build more blood vessels).

Thalidomide will be given orally every evening and the daily dose will escalate until the patient reaches a dose on which they are comfortable and will given continuously for one year.~Celecoxib will be given orally twice a day and escalated as tolerated for one year.~Etoposide will be given orally once a day for 21 consecutive days. This medication will alternate with oral cyclophosphamide and will continue for one year.~Cyclophosphamide will be given orally once a day for 21 consecutive days and as stated above will alternate with etoposide for one year.~During the treatment, blood tests will be performed every three weeks except during the first 3 week cycle in which testing is performed every 2 weeks. Appropriate imaging studies will be performed every 9 weeks.~The duration of treatment is one year unless the side effects are too harmful or the tumor grows. Treatment may be continued past one year if the drugs are well tolerated and disease progression has not occured.

This study will use a combination of four oral drugs (thalidomide, cyclophosphamide, etoposide and celecoxib) to treat patients with relapsed or progressive cancer. These drugs are expected to target the blood vessels that supply the tumors with what they need to grow.

All eligible ER patients will be screened during study times for IPV victimization and perpetration. All victims will be followed at 1 week and 3 months to determine any adverse outcomes. Perpetrators will only be followed in the ED for adverse outcomes after screening. All patients who disclose IPV victimization or perpetration will get a list of community resources. Victims will be asked at follow up what resources they used.

The purpose of this study is to see if using a computer kiosk to screen men and women for intimate partner violence victimization and perpetration is safe and effective. We hypothesize that screening will not result in any adverse events.

For treatment with mycophenolate mofetil the contribution of TDM still has to be determined, although circumstantial evidence suggests the measurement of mycophenolic acid plasma concentrations adds to patient management.~A concerted effort to test the hypothesis that TDM will improve outcome in mycophenolate mofetil therapy in a prospective randomised trial is to be made if we want to have a solid base for the continued measurements of mycophenolic acid concentrations in the future. This trial aims to demonstrate the added value of TDM for mycophenolic acid, by comparing fixed dose treatment with concentration controlled mycophenolate mofetil treatment in kidney transplant recipients.

Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure.

Relatively few studies have been performed evaluating the variant allele frequencies in Spanish populations. To date, no studies evaluating the TPMT variant allele frequency in the Hispanic population have been reported. Hispanics are a growing part of the patient population treated in the United States. Characterization of the proportion of patients with variant genotypes in this population is important since Hispanic children represent a significant proportion of children being treated with thiopurines.~A single 3 cc heparinized blood sample will be obtained for TPMT genotyping. The sample will be obtained either simultaneously with a clinical sample, at the time of an otherwise medically indicated intravenous catheter placement or scavenged from excess blood remaining following clinical laboratory testing.

The purpose of the study is to determine the frequency of allelic variants in TPMT in the Hispanic population and to compare the frequency in the Hispanic population with the Caucasian Population.

The dose and pharmacokinetic of an immunosuppressant may differ in different ethnics, and different combinations.~The purpose of this study is to determine the dose-level relationship of sirolimus through pharmacokinetic study. The dose-level relationship of cyclosporine and tacrolimus was also assessed. From clinical outcome and blood level of sirolimus and cyclosporine or tacrolimus, we can design the most appropriate cyclosporine/sirolimus/steroid or tacrolimus/sirolimus/steroid dose regimen for Taiwanese.

The purpose of this study is to understand the pharmacokinetic of sirolimus in different regimens, as well as the dose-level relationship of cyclosporine and tacrolimus, and design the most appropriate cyclosporine/sirolimus/steroid or tacrolimus/sirolimus/steroid dose regimen for Taiwanese.

The controlled clinical trial held in NTUH in 2001 revealed that the bioavailability of tacrolimus when combined with sirolimus is lower than that reported in the literature where tacrolimus was not combined with sirolimus. To determine if the difference was due to the drug interaction between sirolimus and tacrolimus, a controlled clinical trial was proposed.~The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.

The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.

Sirolimus tablets will be available more than one year after the launch of sirolimus solution. Most patients on sirolimus solution will use sirolimus tablet instead.~The purpose of this study is to understand the pharmacokinetics of sirolimus tablets in different regimens in newly renal transplant patients, and the effect of dosage form conversion on the concentration of sirolimus in stable renal transplant patients. So that we can design a better tacrolimus or cyclosporine/sirolimus/steroid dose regimen for Taiwanese.

The purpose of this study is to understand the pharmacokinetics of sirolimus tablets in different regimens in newly renal transplant patients, and the effect of dosage form conversion on the concentration of sirolimus in stable renal transplant patients. So that we can design a better tacrolimus or cyclosporine/sirolimus/steroid dose regimen for Taiwanese.

All images in this study were acquired on a 1.5 T Sonata whole body scanner (Siemens Medical Inc., Erlangen, Germany) using 2D multi-echo gradient echo/spin echo sequence and 2D single-shot gradient echo-planar imaging sequence plus intravenous magnetic susceptibility contrast medium. The quantitative estimates and mapping of cerebral metabolic rate of oxygen utilization were calculated and plotted in all subjects.

All images in this study were acquired on a 1.5 T Sonata whole body scanner (Siemens Medical Inc., Erlangen, Germany) using 2D multi-echo gradient echo/spin echo sequence and 2D single-shot gradient echo-planar imaging sequence plus intravenous magnetic susceptibility contrast medium. The quantitative estimates and mapping of cerebral metabolic rate of oxygen utilization were calculated and plotted in all subjects.

Volunteers with normal and subnormal semen parameters receive a hormonal male contraceptive in order to investigate whether there are differences between normal and subnormal men in terms of suppressibility, rate of azoospermia and reversibility of suppression of spermatogenesis. Twenty-five men will be recruited for each group. They will be exposed to hormonal male contraception for six months.

Volunteers with normal and subnormal semen parameters receive a hormonal male contraceptive in order to investigate whether there are differences between normal and subnormal men in terms of suppressibility, rate of azoospermia and reversibility of suppression of spermatogenesis.

Acute inflammatory response occurring in cardiopulmonary bypass (CPB) patients has been clearly associated with deleterious clinical outcomes. Increasing understanding of the pathophysiology of systemic inflammatory response syndrome (SIRS) following CPB has facilitated the development of strategies to attenuate the damaging effects of cytokine-induced inflammation. For any strategy to be tested, one needs to clearly define and understand the inflammatory response occurring with CPB. Although this has been extensively studied, there is wide variation in the reported time course and magnitude of this response. This variation is, in part, due to the heterogeneous nature of the patient population studied (variable severity of illnesses, ejection fractions, co-morbidities, etc.). Hence, in our study, we propose to study the inflammatory response occurring in patients undergoing coronary artery bypass graft (CABG) with and without the use of CPB in our institution, and to determine whether the severity of inflammatory response seen in CABG patients is associated with impairment of any specific clinical parameter in the immediate post-operative period (i.e., ventricular dysfunction, lung injury, bleeding, renal failure, etc).

The purpose of this study is to determine if a difference exists in the inflammatory response which occurs related to coronary artery bypass graft (CABG)surgery performed on cardiopulmonary bypass as compared to CABG surgery performed off bypass at the University of Pittsburgh Medical Center.

Correlative studies: analysis of RT effect on genotoxicity by assessing cytogenetic changes (dicentrics), micronucleated lymphocytes (MN-lymph), and micronucleated reticulocytes (MN-RET) using peripheral blood of patients receiving radiation.~i) document the kinetics by which radiation-induced MN-RET enter the peripheral blood stream.~ii) benchmark the MN-RET endpoint against current gold-standard biodosimetry endpoints-dicentrics and MN-lymphocytes.~iii) measure inter-individual variation in baseline and radiation-induced MN-RET frequencies.~iv) in collaboration with several FCM-equipped laboratories, evaluate the transferability of the human MN-RET scoring assay.

The purpose of the research study is to evaluate an automated, laser-based technique for measuring DNA damage caused by radiation during cancer treatment in immature red blood cells.

Vitamin A supplementation (VAS) to children above 6 months of age reduces all-cause mortality with 23 %1 to 30 % in low-income countries. WHO recommends VAS at vaccination contacts. The currently recommended doses to be administered every 3-6 months are 100,000 IU for infants between 6 and 11 months of age and 200,000 IU for children 12 months and older. There is no clear evidence that a large dose is better than a small dose, the tendency being the opposite in the two studies of different doses of VAS that have been published so far.~With the global effort to eradicate polio, national immunization days with oral polio vaccine (OPV) offer an additional opportunity to provide vitamin A. In Guinea-Bissau, a combined OPV and VAS campaign took place in November 2002. Given the uncertainty about the best dose of VAS, we aimed to examine whether the dose of vitamin A currently recommended by WHO or half this dose gives a better protection against childhood morbidity and mortality.

Vitamin A supplementation reduces all-cause mortality. It is therefore given with oral polio vaccine in national campaigns. However, it is not clear which dose is optimal. The two studies that have investigated the impact of different doses of vitamin A have both found that a smaller dose was better than a large dose. We therefore investigated if a smaller dose given with oral polio vaccine gives equal or better effect.

Vitamin A deficiency is common in low-income countries. Vitamin A supplementation to children above 6 months of age reduces all-cause mortality with 23 % to 30 %. Studies on vitamin A supplementation in infants younger than 6 months of age have reported inconsistent effects on mortality. Studies providing supplementation between 1 and 5 months of age have found no effect or even a negative effect. However, the only two studies of supplementation at birth, both conducted in Asia, showed substantial significant reductions in infant all-cause mortality.~The beneficial effect of neonatal vitamin A supplementation may be a result of correcting the congenital vitamin A deficiency resulting from maternal vitamin A deficiency. On the other hand, it has been speculated that the beneficial effect of vitamin A supplementation given at birth may in part be explained by a synergistic effect of vitamin A supplementation and BCG vaccination given at the time of birth.~The protective effect on mortality of vitamin A supplementation given at birth needs to be confirmed in an African population. Furthermore, none of the two previous studies have reported data on vaccination status of the included infants.~In this study, the effect on mortality and morbidity of given vitamin A supplementation simultaneously with BCG vaccination at birth to normal birth weight infants will be investigated in an African population. Furthermore, the effects of vitamin A supplementation will be evaluated with respect to effect on growth, the response to BCG vaccination, infant vitamin A status and infant cytokine profile. Furthermore the effect on specific diseases such as malaria, measles and rotavirus infections. The mechanisms behind the effects of vitamin A will be evaluated.~We will include 4,800 normal birth weight infants (> 2500 g) infants randomized to 50,000 IU of vitamin A or placebo given simultaneously with BCG vaccine. The study take place in Guinea-Bissau, West Africa. The study area consists of five districts in the capital of Guinea-Bissau. The Bandim Health Project has been working in the study area for almost 25 years, and a demographic surveillance system has been established and functioned for many years.

Two studies from Asia have suggested a beneficial effect of vitamin A supplementation given at birth. Hypotheses: Vitamin A supplementation administered at birth together with BCG vaccination is associated with a 30% reduction in infant mortality and morbidity during the first year of life in normal birth weight children in an African setting.

Vitamin A supplementation (VAS) acts as an adjuvant to vaccines, and VAS has been shown to enhance both cellular and humoral immune responses in animals and in humans. Routine childhood vaccinations have recently been shown to have important non-targeted effects on mortality, i.e. effects that cannot be explained merely by the prevention of the targeted disease. We have hypothesized that the improved survival after VAS may depend not only on the prevention of vitamin A deficiency, but also on vitamin A amplifying the non-specific immune modulation induced by routine vaccinations.~In the present study we used information collected in connection with a national vitamin A campaign in Guinea-Bissau during which different doses of VAS was provided together with missing doses of DTP, OPV, and measles vaccines. We aimed to study the potential interactions between VAS and vaccine type.

Vitamin A supplementation (VAS) is important for the immune system and may interact with different childhood vaccinations. We have hypothesized that the improved survival after VAS may depend on vitamin A amplifying the non-specific immune modulation induced by vaccinations.~In the present study we used information collected in connection with a national vitamin A campaign in Guinea-Bissau during which different doses of VAS was provided together with missing doses of DTP, OPV, and measles vaccines. We aimed to study the potential interactions between VAS and vaccine type.

In Guinea-Bissau, a combined OPV and VAS campaign took place in November 2002. Given the uncertainty about the best dose of VAS, we examined whether the half dose compared with the full dose currently recommended by WHO gave an equally good protection against childhood morbidity and mortality. Mortality after supplementation was lower, though not significantly so, for children who had received the half dose. However, there was a highly significant inversion of the effect for boys and girls; while the low dose was clearly better for girls, the full dose might have been slightly better for boys. The girls' responses to the high versus the low dose of vitamin A might have depended on the last vaccine received before the OPV and VAS campaign.~We believe that these findings call for confirmation. In connection with the OPV and VAS campaign in November 2004 in Guinea-Bissau, we intend to examined whether half the dose of the dose currently recommended by WHO as compared to the full dose has a more beneficial effect on mortality and morbidity in girls, and furthermore address the potential effect modification by the last vaccine received before the supplementation.

We previously compared the effect on mortality of the half dose and the full dose currently recommended by WHO. Unexpectedly, the low dose was clearly better for girls, but not for boys. The girls' response might have depended on the last vaccine received before the OPV and VAS campaign. We believe that these findings call for confirmation. In connection with a new campaign, we will examine whether half the dose or the full dose has a more beneficial effect on mortality and morbidity in girls, and furthermore address the potential effect modification by the last vaccine received before the supplementation.

Vitamin A given as treatment and pre-treatment has reduced the severity of symptoms after infusion with endotoxin in several animal models. We intend to examine the effect of vitamin A as pre-treatment on the response to endotoxin in humans. As studies in children in low-income countries have indicated that vitamin A has long-term effects on the immune system, we furthermore wish to examine the long-term effects of vitamin A on the response to endotoxin. This will be done in an established model using infusion with endotoxin to male human volunteers. We hypothesise that vitamin A decreases endotoxin levels and TNF-alfa responses. Furthermore, we hypothesise that it reduces oxidative stress and injury.

Vitamin A given as treatment and pre-treatment has reduced the severity of symptoms after infusion with endotoxin in several animal models. We intend to examine the effect of vitamin A as pre-treatment on the response to endotoxin in humans. We furthermore wish to examine the long-term effects of vitamin A on the response to endotoxin. We hypothesise that vitamin A decreases endotoxin levels and TNF-alfa responses.

The current study will test a community-based, tobacco intervention. The project will compare the effects of a proactive, personally-tailored, biologically-based motivational intervention to those of a proactive, generic motivational intervention for smoking cessation. The biologically-based motivational treatment will include feedback on participants' carbon monoxide (CO) exposure (expired CO and estimated carboxyhemoglobin levels), pulmonary functioning assessed via spirometry, and self-reported smoking-related symptoms. All participants will be given equal access to action-oriented treatment.

The goal of this study is to understand how information about smokers' health risks affects their attitudes, mood, and behavior.

OBJECTIVES:~Primary~Compare the effects of internet-based nutrition education through untailored websites vs tailored websites (TW) vs TW and tailored human online behavioral interaction (HOBI) on the change in the number of daily fruit and vegetable servings consumed in participants of health maintenance organizations.~Secondary~Compare the proportion of participants reporting consumption of 5 or more servings of fruits and vegetables per day at each 3-month interval.~Compare the change in fruit and vegetable servings consumed from baseline to each intermediate time point.~Compare the effects of intervention and observation time in these participants.~Determine the effect of HOBI in these participants.~Compare the impact of participant characteristics, in terms of the effect of the intervention on the change in fruit and vegetable intake, in these participants.~OUTLINE: This is a randomized, controlled, single-blind, multicenter study. Participants are stratified according to participating site, gender, and the participant's stage of change readiness. Participants are randomized to 1 of 3 intervention arms.~Arm I (untailored websites): Participants are given unlimited access to an internet-based nutrition education program for up to 6 months. They are provided with 4 serial educational websites at 1, 3, 13, and 15 weeks after initial login. These internet sites provide general information about fruits and vegetables, new recipes with emphasis on fruits and vegetables, and how participants can incorporate them into their diet. Participants complete an online survey at 3 months.~Arm II (tailored websites): Participants are given unlimited access to an internet-based nutrition education program for up to 6 months. They are provided with 4 serial educational websites, at the same timepoints as in arm I, with emphasis on vegetable consumption in weeks 1 and 13 and fruit consumption in weeks 3 and 15. Materials in these websites, including new recipes with emphasis on fruits and vegetables, are tailored and then revised (or retailored) based on individual health-risk information obtained at baseline and at the 3-month online survey.~Arm III (tailored websites and human online behavioral interaction [HOBI]): Participants are given unlimited access to an internet-based nutrition education program for up to 6 months. Participants are provided with 4 serial educational websites with tailored materials as in arm II. They also receive HOBI (tailored e-mail messages) developed and then revised based on health-risk information obtained at baseline and the 3-month online survey.~In all arms, participants complete online surveys at 3, 6, and 12 months to measure fruit and vegetable intake and change in long-term risk behavior. For each survey, participants receive up to 6 automatically generated reminder e-mails and 1 mailed announcement.~PROJECTED ACCRUAL: A total of 2,619 participants were accrued for this study.

RATIONALE: Websites for nutrition education may be an effective method to help people eat more fruits and vegetables which may lower their risk of cancer.~PURPOSE: This randomized trial is studying how well an internet-based nutrition education program works in preventing cancer in participants of health maintenance organizations.

40 pregnant smoking and 40 pregnant nonsmoking women will be included at the end of the 2nd trimester.~Assessments: smoking characteristics, plasma cotinine, DHPG, DOPAC, 5HIAA concentrations reflecting MAOA activity and platelet MAOB activity will be measured just after inclusion (end of 2nd trimester), just before delivery in venous maternal blood and just after delivery in cord blood.~The newborns' behavior (wellbeing) will be assessed every 8 hour after birth for 2 days.~Comparisons will be made between smoking and nonsmoking women and their newborns.

Smoking substantially inhibits the activities of both monamine oxidase (MAO) A and B enzymes.~Aims of this study: to compare MAO activities and nicotine and cotinine in peripheral blood of smoking and nonsmoking pregnant women, in their placenta and in cord blood and relate them with the behavior of their newborns being observed during 48 hours after birth.

Primed group: 50 subjects who previously received 4 doses of GSK Biologicals' 11Pn-PD vaccine will receive 1 dose of Pneumo 23 Unprimed group (Control): 50 subjects who received GSK Biologicals' Havrix™ vaccine will receive 1 dose of Pneumo 23

Evaluate the immunological memory induced by 4 doses of GSK Biologicals' 11valent pneumococcal vaccine; study antibody persistence 30 months after the 4 dose vaccination with GSK Biologicals' 11-valent pneumococcal vaccine in Undeca-Pn-010 study.

This article on the main outcome is available. Maltais F, Bourbeau J, Shapiro S, Lacasse Y, Perrault H, Baltzan M, Hernandez P, Rouleau M, Julien M, Parenteau S, Paradis B, Levy RD, Camp P, Lecours R, Audet R, Hutton B, Penrod JR, Picard D, Bernard S. Effects of home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Ann Int Med 2008;149:869-878.

Short term efficacy of pulmonary rehabilitation for improving functional capacity and quality of life of chronic obstructive respiratory disease (COPD) patient is well known. However, there is an important gap between the scientific knowledge and the clinical use of pulmonary rehabilitation since a a very small number of patients benefit from this therapeutic intervention. We estimate that less than 1% of the 750 000 canadians suffering from COPD have access to a pulmonary rehabilitation program. We want to study the efficacy of a home-based rehabilitation program as a way to facilitate the access to rehabilitation.

The purpose of this study is to determine if there is a perceived benefit from adding a restorative yoga class as a method of stress reduction for the HFA Addiction Medicine Clinic staff. Working in a busy clinic can be very stressful. While it is not always possible to completely eliminate stress from our lives, it is known that stress reduction techniques help to diminish the negative consequences of stress. This study was designed to answer the following question How much change in perceived stress is obtained through weekly Restorative Yoga sessions? Study population were members of the HFA Addiction Medicine Clinic. All staff completed the Spielberger Job Stress Survey and the State-Trait Anxiety Inventory at baseline and at six months following intervention onset. Volunteers from the Addiction Medicine Clinic attended weekly restorative yoga sessions 45 minutes in length held over the noon hour. Serial State-Trait Anxiety Inventory and weekly questionnaire regarding the perceived effects of the restorative yoga on aspects fo patient care were completed by study volunteers.

The study examined Restorative Yoga as a method of stress reduction for the HFA Addiction Medicine Clinic staff volunteers.

Streptococcus pyogenes (GrAS) is a human pathogen that leads to great disease burden throughout the world. In the United States, an estimated 30 million infections occur yearly. Most of these are local infections of the skin or the throat but still lead to considerable use of health-care resources. These common, simple forms of GrAS disease may progress to or be followed by the more serious GrAS-related illnesses acute rheumatic fever, post-streptococcal glomerulonephritis, streptococcal toxic shock syndrome, sepsis, pneumonia, or other invasive illnesses. Outside the U.S., in the developing world, the burden of GrAS-related disease is presumed to be even higher, but is not completely elucidated in many of the poorer regions of the world. It is known, though, that rheumatic heart disease causes more cardiovascular morbidity in the children of the world than any other illness. Although the incidence of rheumatic fever in the U.S. has fallen to levels of approximately 0.5 per 100,000 per year, in some areas, the developing world's children still have rates over 100 per 100,000 per year. The percentage of cardiac admissions attributable to rheumatic heart disease in hospitals located in the developing world remains in the range of 30 to 50%, where it has been studied. GrAS is one of the best characterized human pathogens with regards to its microbiology, its spectrum of diseases, and its ability to lead to serious sequelae such as rheumatic fever and glomerulonephritis. Yet, efforts to control it through the use of antibiotics have been only partially successful in the United States and largely unsuccessful in the developing world. The health impact of uncomplicated streptococcal infections, such as pharyngitis, and the less common but more severe diseases, such as rheumatic heart disease, must be better studied in order to move forward with control measures. In this study, patients aged 3-15 presenting with sore throat, fever and cervical lymphadenopathy will be examined and a throat swab will be submitted to the lab for culture. All of these patients will be treated with either benzathine penicillin or, if they have a history of allergy to penicillin, oral erythromycin. The parent will be given a follow-up appointment to convey the result of the culture and to evaluate the course of the child's illness. Children presenting with sore throat only will be cultured and given a follow-up appointment to return after the result of the culture is known. Antibiotic treatment is given only if the culture is positive for group A streptococci. Within this algorithm is latitude for the physician to treat any patient based on clinical signs and symptoms and the concern that a particular child may not return for treatment if it is delayed based on the culture result. The overriding goal is the prevention of acute rheumatic fever and suppurative complications. The primary objective of this study is to characterize the GrAS isolates genotypically (emm type or sub-type). The secondary objective is to describe the epidemiology of throat isolates of GrAS among 3- to 15- year old children with pharyngitis living in Leon, Nicaragua. Primary endpoint of the study is the frequency and proportion of each emm-type among children with pharyngitis. Secondary Endpoints for the study are as follows: The proportion of children with pharyngitis from whom GrAS is isolated. The minimal incidence of GrAS pharyngitis in children based on annual cases per 100,000 children in the catchment areas. The age, gender, and ethnicity-specific minimal incidence rates of GrAS pharyngitis in children living in the catchment areas.

The purpose of this study is to determine the epidemiology of throat isolates of group A streptococci among 3-15 year-old children with pharyngitis (sore throat) living in Leon, Nicaragua.

Tai Chi, a traditional Chinese martial art that has been practiced for many centuries, has only recently gained the interest of researchers in Western countries as an alternative form of exercise. Tai Chi combines deep diaphragmatic breathing and relaxation with many fundamental postures that flow imperceptibly and smoothly from one to the other through slow, gentle, and graceful movements. Based on the maximum oxygen consumption (VO2max) measured during the practice, Tai Chi is characterized as a low- to moderate-intensity form of exercise. Tai Chi has been applied as a rehabilitation program in patients with heart failure, hypertension, acute myocardial infarction, arthritis, and multiple sclerosis. Improvements in cardiorespiratory function, balance, muscular strength, flexibility in older subjects; preventing falls in the frail elderly; stress reduction, and mood state with Tai Chi practices have been well established. A potential immune response effect of Tai Chi practice is a frequent claim; however, this is an under-researched area. A nonrandomized controlled study of 60 elderly subjects found that the total number of circulating T cells were significantly higher in the Tai Chi group (who regularly practiced Tai Chi for 4 or more years) than in the untrained group. Irwin et al. demonstrated that older adults with no previous Tai Chi experience after practicing for 15 wks (1-3 times/wk), a nearly 50% increase in varicella zoster virus specific, cell-mediated immunity was found. Thus in this proposed study, we will examine the effects of regular Tai Chi practitioners on innate and adaptive immune function.

Tai Chi is a traditional Chinese martial art that has been practiced for many centuries. Improvements in cardiorespiratory function, balance, muscular strength, flexibility in older subjects; preventing falls in the frail elderly; stress reduction, and mood state with Tai Chi practices have been well established. A potential immune response effect of Tai Chi practice is a frequent claim; however, this is an under-researched area. Therefore, in this study, the researchers will examine the effects of Tai Chi on innate and adaptive immune function.

This study is to investigate the effect of the cyclic mechanical strain on the osteogenic differentiation of mesenchymal stem cells. Mesenchymal stem cells will be cultured from the periodontal ligament tissue of the premolars extracted due to orthodontic reason.

The purpose of this study is to observe cyclic tensional force on the osteogenic differentiation of human periodontal ligament stem cells.

Large breasts cause neck and back pain, irritating grooves, cut in the skin of the shoulders by the pressure of brassiere straps, breast pain, and maceration and dermatoses in the inframammary region. From a psychological point of view, excessively large breasts can be troublesome focus of embarrassment for the teenager as well as the woman in her senior years. Unilateral hypertrophy with asymmetry heightens embarrassment. Thus, patients seek to reduce the size of their breasts.~In the human female, variant receptors were detected in epithelial cells in normal breast tissue, benign breast lesions, breast carcinoma tissue, and breast cancer cell lines2-11. The cause of the difference in breast development status is still unclear. Abnormalities at the tissue receptor level may be important in the pathophysiology of macromastia. This study aimed to make clear the difference in variant receptor levels between breast hypertrophy patients and macromastia ones by examining the receptor levels in breast tissue. Then, we could explore the possible etiology of mammary hypertrophy and macromastia.

There are more and more macromastic women in Taiwan, which may due to the high cholesterol foods. Patients with macromastia not only suffered from physical problems but also psychological discomforts.

This was a 6-week, open-label, single-center study conducted in 78 subjects who were smokers with visible staining of teeth and who were motivated to quit smoking through use of Nicorette Freshmint gum.~The subjects were assigned, per label instructions, to either Nicorette Freshmint gum 2 mg or 4 mg based on the number of cigarettes smoked per day. Subjects who smoked at least 25 or more cigarettes per day were assigned to the 4 mg gum group; those who smoked less than 25 cigarettes per day were assigned to the 2 mg gum group.~A total of 3 study visits were planned: Screening/Baseline, Week 2 and Week 6. A telephone screening prior to Baseline and the Screening/Baseline visit was performed to confirm subject eligibility. At each visit an oral examination, including a stain index measurement used to rate tooth-staining (MacPherson Modification of the Lobene Stain Index), was conducted; and smoking status and motivation to quit smoking were assessed. The safety evaluation at each visit included an oral tissue assessment in addition to assessment for any adverse events.

The purpose of this research study is to evaluate the effects on existing tooth stain of nicotine gum. The study will enroll adults who have visible tooth staining.

Research Method:~In a within subjects, randomized, cross-over design, 50 stable preterm infants born between 30-36 weeks gestational age will be studied. Infants will be randomized to two interventions which will take place during two separate blood collections that are required for clinical management. For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection. For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.

The purpose of this study is to compare the effects of mothers' breastfeeding with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure~Hypothesis:~When breast fed by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier.~Following breast feeding during the blood collection, mothers will find no differences in their infants' breast feeding ability.

Patients who have been seen by one of the 5 paediatric orthopaedic surgeons at British Columbia's Children's Hospital and have been referred to the Shriner's gait lab for assessment of idiopathic toe walking will be eligible for the study.

The purpose of this study is to compare the effect of Botox and casting to placebo and casting for reducing toe walking problems in children who are idiopathic toe walkers.

Vascular disease is an important cause of morbidity and mortality in patients with chronic kidney disease (CKD), of which a large proportion is diabetic. Diabetics have complex and multiple reasons for vascular disease, and there is accumulating evidence of associated poor endothelial cell function, particularly in those with kidney disease. One important mechanism through which this might occur relates to changes in shear rate and stress resulting from different viscosity levels. Such fluctuations are increasingly recognized to affect endothelial cell function and hence vessel-wall adaptability in both the short and long term.~Little is known of the consequence of different shear effects on endothelial cell function at various hemoglobin levels in kidney disease. There is some evidence to suggest however that, in the presence of micro-vascular disease, a relative anemia, with associated lower viscosity and shear stress, may be of benefit compared to higher hemoglobin levels.~Diabetics account for almost 40% of dialysis patients worldwide, and are the fastest growing component of the epidemic of CKD. Thus, an understanding of optimal treatment targets for anemia therapy, and the impact of different target levels of hemoglobin on vascular wall function is imperative.

The purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients.~Hypothesis: The expansile capacity of blood vessels is affected by different hemoglobin concentrations in diabetic hemodialysis patients.

Outcome: Validation and comparison of 2 severity of illness scores in a Canadian PICU population.

This is a study of the validation of severity of illness scoring systems in Paediatric Intensive Care Units (PICUs) in Canada.

In a randomized, four-phase cross-over study the effect of simulated microgravity (13 days of bed rest), energetic restriction (-25%, fat reduced), and their combination on endothelium-dependent and -independent vasodilation will be compared with ambulatory control conditions. Using venous occlusion plethysmography cumulative intraarterial dose-response curves to endothelium-dependent (acetylcholine) and -independent (sodium nitroprusside) vasodilators will be constructed in 10 healthy male volunteers before and on day 13 of each of the four intervention periods.

Aim of the study is to assess the impact of the factors ´bed rest´ and ´hypocaloric nutrition´ on endothelium-dependent vasoreactivity in healthy volunteers.

In a randomised, double-blind, placebo-controlled, cross-over study in healthy men we will assess the effect of oral fluvoxamine (50mg qd on day 1-3; 100mg qd on day 4-10) on sildenafil kinetics (single oral 50mg dose on day 11). Sildenafil plasma concentrations will be determined by LC/MS. We will also assess the effect of sildenafil on venodilation induced by a constant dose-rate of the NO-donor sodium nitroprusside (SNP) during preconstriction with phenylephrine (dorsal hand vein compliance technique).

Aim of the study is to assess the interaction between sildenafil and fluvoxamine and its effect on the venous response to sodium nitroprusside.

Using electrical nerve stimulation in performing peripheral nerve helps to control the needle position in relation to the nerve and therefore may increase the likelihood of a successful nerve block. Defining the minimal stimulating current accepted also may help to avoid direct contact between nerve and needle or accidental endoneural injection and subsequent nerve lesion.~In recent years there have been many reports where several nerves, parts thereof or plexuses have been anesthetised using a multiple injection approach. That is, nerves in close proximity of each other have been subsequently blocked after using a nerve stimulator to locate them.~It is not clear though, whether a nerve may already be partially anesthetised in this situation and whether that would impair the correct use of a peripheral nerve stimulator.~The aim of this study is to examine the excitability of a peripheral nerve after injecting a small amount of local anesthetic agent or saline solution into the proximity of the nerve.

In this study we want to examine the effect of a small amount of local anesthetic or saline solution on nerve conduction using a peripheral nerve stimulator.

The prevalence of pediatric obesity has increased significantly, and approximately 11% of American children and adolescents are obese. Of particular concern, the greatest increase in prevalence has occured among the heaviest children. Severe pediatric obesity (defined as > 150% of ideal body weight for height) is associated with higher rates of medical and psychosocial morbidity than milder obesity is. Moreover, severely obese children are likelier than less severely obese children are to become obese adults and suffer the long-term health consequences of obesity. Although the efficacy of family-based behavioral weight control programs in the treatment of moderate pediatric obesity is well established, few studies have focused on the treatment of severe obesity. Thus in this application, we propose a randomized controlled trial to evaluate the efficacy of a family-based behavioral weight control program in the management of severe pediatric obesity.~Two hundred children aged 8-12 will be randomized to a six-month family-based program or usual care, and will complete assessments at pre- and post- treatment and 6-month and 12-month follow-ups. We hypothesized that: 1) Children who participate in the family-based program, when compared to children who receive usual care, will show favorable changes in body mass index, body composition, food intake, activity level, and cardiovascular risk factors. 2) Children who participate in the family-based program, when compared to children who receive usual care, will report higher levels of self-esteem, social competence and health-related quality of life, and report fewer psychiatric symptoms. A secondary aim of the the proposed investigation is to examine the relationships among gender, race, compliance to diet and exercise. level of parent adherence and treatment outcome. The proposed investigation is significant as the first effort to systematically evaluate a treatment program for severely obese children. It will provide data about a serious public health problem and establish a foundation for programmatic research to develop effective treatments for an underserved population.

The purpose of this study is to determine if a family based diet and exercise program is helpful for extremely overweight children aged 8-12, and to compare this approach to standard medical management of severe pediatric obesity.

This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas. Docetaxel 30mg/m2 will be administered on days 1 and 8 of each cycle and capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14) of each cycle. Each cycle is 21 days. Subjects will receive unlimited cycles of docetaxel and capecitabine until there is evidence of disease progression or unacceptable side effects.

This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas.

The goal of this project is to test the efficacy of restricting time in bed and education in healthy sleep practices for maintaining or even enhancing sleep consolidation and depth in subjects aged 75+ who are at risk for decay in sleep quality and daytime well being; to determine the associated benefits for health; and to examine the persistence of such effects for 12 months beyond the end of the 18-month intervention. This project focuses not on pathology but on prevention of sleep decay and preservation of sleep in individuals who have already evidenced successful aging.

The purpose of this study is to see whether protecting sleep quality in later life is important in continued healthy aging. The value of education in healthy sleep practices along with reducing time in bed each night by going to bed 30 minutes later, and of healthy dietary practices will be tested for their effects on sleep quality, health, and well being.

We will randomly assign participants to interact with one of two video doctor programs which have been been developed to convey messages appropriate for women of reproductive age.~The video doctor is an actress (not UCSF staff) following a script that has been designed through interdisciplinary collaboration here at UCSF. These particular video programs have not been used before, but similar ones have been studied and shown to be effective by Dr. Gerber in providing patients with information about how to decrease sexual risks and the harms of alcohol and drug use. Before interacting with the video doctor program, we will assess participants baseline knowledge of the importance of peri-conception folate and the option of emergency contraception. Participants will then interact with their video doctor and be provided with a free sample of the pills their video doctor discussed.~The first video doctor will educate women about the ability of folate to reduce birth defects. The discovery that peri-conception folate supplementation significantly decreases rates of neural tube defects has inspired multiple educational campaigns. However, recent work has shown that knowledge of the benefits of folate remains low, especially among minority populations.~The second video doctor message will inform women of the option of emergency contraception. Emergency contraception using high doses of progesterone has been shown to reduce the risk of pregnancy to less than 2% when used up to five days after a condom failure or an episode of unprotected sex.~This medication is not teratogenic and will not cause a miscarriage if used by a woman who does not know she is pregnant. Use of emergency contraception poses no long-term health risks to women and is available over-the-counter in seven European countries. Prior studies in family planning clinics , as well as the post-partum setting have shown that education about and advance provision of emergency contraceptive pills can increase knowledge and appropriate use of these pills, without adversely affecting sexual risk taking or other health behaviors. However, knowledge of emergency contraception remains limited, leading some to call it America's best kept secret. Participants will be contacted by phone six months after interacting with the video doctor and asked to provide information about their use of folate and/or emergency contraception. One year after interacting with the video doctor participants will be contacted again and asked to provide further information about their use of folate and/or emergency contraception.

The purpose of this study is to determine whether video doctor programs can effectively deliver preventive health messages to women of reproductive age while they wait to be seen in urgent care settings. In this study, the specific hypotheses being tested are: 1) is the video doctor program effective in improving women's knowledge about emergency contraception, and 2) is the video doctor program effective in improving women's knowledge about the importance of folate.

The use of cefepime in liver transplant patients at conventional doses used for other patient populations leads to non-optimal drug exposure among liver transplant patients. Furthermore, using serum creatinine as a method of estimating creatinine clearance is not the optimal way to determine the best cefepime dose. The consequence of this non-optimal exposure is the unattainability of therapeutic targets. These therapeutic targets are correlated with positive microbiologic outcome and clinical cure.

The purposes of this study are to:~I. Characterize the plasma concentration-time profile of cefepime in liver transplant patients to determine the pharmacokinetic parameters in this patient population.~II. Perform stochastic modeling using the population pharmacokinetic parameters obtained in Specific Aim I to determine the ideal dose and dosing regimen of cefepime required to attain predetermined therapeutic targets in liver transplant patients.

The purpose of this study is to measure the amount of MMF and tacrolimus concentration in the blood at a given time. Currently MMF is ordered as a set dose and tacrolimus is given based on body weight. While the deceased donor transplant receives the complete liver, in the live donor just over half of the liver is given (about 60%). The way these different types of transplants break down drugs could be different. Measuring the drug levels allows us to know what happens to the medication in between the morning and the evening dose.~12 subjects with live liver donors and 12 subjects with deceased donors will be included in the study.~Each patient will have 12 (twelve) blood samples (half a teaspoon) drawn at 0,1, 2, 3, 4, 4½; 5, 6, 7, 8, 10 and 12 hours from an intravenous line placed during the operation. At the same time, 24-hour urine will be collected to measure your kidney function. After 4 to 6 days post transplant when the will be switched to oral MMF, again 10 (ten) blood samples a half teaspoon each will be drawn at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours. Blood will be drawn with the routine daily blood work for the first 14 days and then at 1 and 3 months after transplant. Total blood drawn over 3 months will be about 7 tablespoons. A 24-hour urine will be collected in a container given to you starting one day before the routine clinic visit (as a standard of care). The 24-hour urine will be collected at 1 and 3 months after transplant as well.~If a woman, who could become pregnant, a pregnancy test will be done before your transplant. They would also have to use birth control during the study period and 6 months after the completion of study.

The purpose of this study is to measure the amount of MMF and tacrolimus concentration in the blood at a given time. Currently MMF is ordered as a set dose and tacrolimus is given based on body weight. While the deceased donor transplant receives the complete liver, in the live donor just over half of the liver is given (about 60%). The way these different types of transplants break down drugs could be different. Measuring the drug levels allows us to know what happens to the medication in between the morning and the evening dose.

Despite improvements made to the traditional laryngoscope blade since its invention, occasionally intubation of the trachea cannot be accomplished with facility, even in patients with anatomy that does not predict difficult intubation. It is estimated that endotracheal intubation is performed on some 8 million patients per year in the United States. Of these endotracheal intubations, approximately 80% are performed by direct laryngoscopy with transoral placement of the endotracheal tube (ET) into the trachea. There is fairly uniform reporting of the incidence of failed intubation in the literature; it occurs in approximately 0.05% or 1:2230 of surgical patients and in approximately 0.13% to 0.35%, or 1:750 to 1:280, of the obstetric patients. The incidence of unsuspected difficult intubation is estimated to be higher at 3%. One factor that contributes to difficult intubation is poor visualization.~The VL is designed to optimize visualization by presenting to the operator an enlarged video image of airway structures. In contrast, using conventional laryngoscopy, anesthesiologists have only a keyhole view of the airway structures; a view that may be further obscured during attempts to pass the ET.~The VL consists of a laryngoscope handle and Macintosh blade that have been modified to provide a video image of airway structures on a screen, which can be conveniently located directly in front of the anesthesiologist. A micro video module is contained in the modified handle. An image/light bundle is introduced into the standard blade. This system has been previously tested in which the consensus was that the device is extremely easy to learn to use because most anesthesiologists are familiar with the use of the Macintosh blade. It has also been useful in the instruction of laryngoscopy by non-anesthesiologists.~There are several potential advantages of a video image in the context of direct laryngoscopy. The system provides high quality video images that are enlarged on the video monitor for easier visualization. If laryngeal manipulation is required to improve visualization of laryngeal structures, the intubator and the person assisting can coordinate movements as they observe, simultaneously, the image on the video monitor. With the video image projected from the distal end of the laryngoscope blade, laryngeal structures are kept in view as the ET is passed through the oropharynx into the trachea.~Comparison: Video Laryngoscope as a conduit for possible difficult intubation compared to the traditional Macintosh blade.

The purpose of this study is to determine if the Video Laryngoscope (VL) is a useful instrument in patients at risk for difficult intubation. We will compare this device to the traditional Macintosh Laryngoscope.

It is possible to utilize epidural anesthesia as the sole anesthetic technique for thoracic, abdominal, and lower extremity surgeries, as a method of postoperative pain management after surgery, and for pain relief during labor and delivery. However, despite the various benefits of epidural anesthesia, this procedure is not utilized to its maximum potential in the operating room. One reason for inadequate utilization of this procedure is the difficulty in properly identifying the epidural space. Current techniques for identifying the epidural space rely on the subjective perception of the operator on loss of resistance to air or saline as the needle passes from the ligamentum flavum into the epidural space. CompuFlo®'s pressure-sensing technology provides an objective measurement for proper placement of the epidural.~Very little advancement has been made in improving training to identify the correct location of the epidural space. Epidural anesthesia has a relatively higher failure rate when performed by residents in training. The skills of trainees differ greatly, and there are no standard teaching methods to teach epidural anesthesia. Statistical analysis conducted by Naik et al. concluded that some residents may need as many as 75 attempts at epidural anesthesia to ensure proficiency.~The CompuFlo® is a computerized syringe pump capable of volume and pressure-controlled infusion. It has a pressure sensor and a mathematical algorithm capable of determining the pressure at the needle tip. Pressures are continuously monitored and displayed, which are reflected by acoustic changes in tone. A dramatic pressure decrease and a high tissue compliance (pressure does not increase despite continuous infusion) signifies entrance into the epidural space. Combining a program with a low upper pressure limit and a high infusion rate mimics the technique used by the loss of resistance with saline proponents (constant pressure on the plunger). It combines the feel of inserting an epidural needle with the visualization of the pressure level, as well as a sound indicator to indicate proper placement.

The purpose of this study is to compare how well the CompuFlo® computerized syringe pump works as compared to the traditional method of inserting an epidural (a needle placed in one's back to give pain medicine).

Cocaine use in the general population is a significant and costly problem. Novel and innovative interventions targeting cocaine abuse are needed. The Transtheoretical Model of behavior change (TTM) offers a comprehensive framework for understanding, measuring, and intervening in behavior change and provides a strong theoretical foundation upon which effective treatments for substance abuse can be developed. The proposed Stage 1 research will pilot test a novel and innovative behavioral group therapy for cocaine users based on the TTM. In Phase 1, investigators will modify the newly developed Group Treatment for Substance Abuse: A Stages-of-Change Therapy Manual (Velasquez, Maurer, Crouch & DiClemente, 2001) to specifically target cocaine abuse resulting in a twelve-session, group intervention and accompanying therapy manual based on the TTM stages and processes of change: six early stage sessions targeting the experiential processes of change, and six later stage sessions targeting the behavioral processes of change. Phase 2 will consist of a pilot trial to evaluate the TTM group therapy with cocaine abusing patients. A randomized, controlled, between groups design will be used in which cocaine abusers (N=80) are assigned to one of two group treatment conditions: TTM therapy or Education/Advice. Participants will be recruited from Houston and surrounding communities through the Substance Abuse Research Center at the University of Texas Health Science Center Mental Sciences Institute. We expect the delivery of the TTM therapy for cocaine users to be feasible and acceptable, and to produce significant patient improvement. Cocaine outcomes will be assessed via objective (urine and drug analysis) and self-report measures. This Stage I research will contribute important theoretical and empirical information concerning the promise of a new and innovative intervention for cocaine abusers, and will provide the basis for a larger efficacy trial.

The purpose of this study is to determine the feasibility and promise of a recently manualized group therapy based on the Transtheoretical Model for cocaine use disorders.

Patients scheduled for partial hepatectomy/liver surgery are asked permission to use their discarded liver tissue for purposes of studying:~how drugs/medicines affect the liver and~the effects of storing liver cells in the cold or freezing.

This is a registry of human hepatocytes (liver cells) for research purposes.

Intercessory prayer is widely believed to influence recovery from illness, but claims of benefits are not supported by well-controlled clinical trials. Prior studies have not addressed whether prayer itself or knowledge/certainty that prayer is being provided may influence outcome. We evaluated whether (1) receiving intercessory prayer or (2) being certain of receiving intercessory prayer was associated with uncomplicated recovery after coronary artery bypass graft (CABG) surgery.

Intercessory prayer is widely believed to influence recovery from illness, but claims of benefits are not supported by well-controlled clinical trials. Prior studies have not addressed whether prayer itself or knowledge/certainty that prayer is being provided may influence outcome. We evaluated whether (1) receiving intercessory prayer or (2) being certain of receiving intercessory prayer was associated with uncomplicated recovery after coronary artery bypass graft (CABG) surgery.