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Stress contributes to health and behavioral issues in students, but will not be integrated into schools without evidence of benefit. This study was conducted to determine if a 6-week relaxation response (RR) curriculum improves cognitive performance in ninth grade students. | Stress contributes to health and behavioral issues in students, but will not be integrated into schools without evidence of benefit. This study was conducted to determine if a 6-week relaxation response (RR) curriculum improves cognitive performance in ninth grade students. |
Hot flashes occur in 75% of menopausal women and impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The effect of a daidzein-rich isoflavone-aglycone supplement from soy germ fermentation with Koji fungus, on the severity and frequency of hot flashes in postmenopausal women is being examined in a randomized, placebo controlled, double-blinded clinical trial. The study is a 13 week trial in which subjects record their hot flash frequency and severity in a diary. Subjects are given 40 mg or 60 mg of isoflavones (or placebo) once a day. This isoflavone-aglycone extract (Agly-Max TM, Nichimo, Shinagawa, Tokyo, Japan) is a product prepared from soybean germ fermentation with Koji fungus (Aspergliius awamori) producing ß-glycosidase efficiency, followed by ethanol and water extraction and purification by using a proprietary extraction procedure. The product is rich in daidzein (70% daidzein, 10% genistein, and 20% glycitein). | Hot flashes occur in three quarters of menopausal women, and can negatively impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The study examines the effect of a new soy supplement, as compared to a placebo, in menopausal women on hot flash symptoms. |
The purposes of this study are:~To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.~To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.~Since stress is a factor in the development of many health conditions, a further understanding of the mechanisms of the RR should be developed. The project is designed to determine how the RR can improve the quality of life that has been adversely affected by stress. | The purposes of this study are:~To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.~To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.~Since stress is a factor in the development of many health conditions, a further understanding of the mechanisms of the RR should be developed. The project is designed to determine how the RR can improve the quality of life that has been adversely affected by stress. |
Therapies that have brought about sharp decreases in neonatal mortality have not brought about similar decreases in neurodevelopmental morbidity for preterm infants. Developmentally supportive care is NICU care that seeks to optimize the developmental course and outcomes for preterm infants. While other staff training programs for developmentally supportive care exist, it is the Newborn Developmental Care and Assessment Program (NIDCAP) that has been the methodology used in randomly controlled trials that demonstrate positive medical and neurobehavioral outcomes for preterm infants receiving developmentally supportive care. NICUs that care for all out-born or transported infants face unique challenges in balancing developmentally supportive nursing care with the high-technological medical needs of the most critically ill and extremely premature infants. Yet it is these most fragile infants who can most benefit from the positive impact the NIDCAP program can offer. Yet, there are no published studies documenting the impact of the NIDCAP program on neurobehavioral outcomes of these transported preterm infants exclusively.~Objectives: The objective of this project is to study the impact of implementing the NIDCAP program of individualized patient consultation on the neurobehavioral organization of transported preterm infants in the NICU of a major pediatric medical center.~Research Methods: A random sample of approximately 40 preterm infants will be recruited to participate in this descriptive study. In this phase-lag design, 20 infants will participate in the pre-NIDCAP intervention phase and 20 infants will participate in the post-NIDCAP intervention phase. Each infant within each phase will be videotaped during 2 routine nurse-caregiving sessions. The first session will occur within 72 hours of admission to the NICU at Children's Memorial Hospital (CMH). The second session will occur when the infant is 34-36 weeks corrected gestational age. The videotapes will be collected so that observations of the infant's physical environment and caregiving and an assessment of the infant's behavioral function can be scored randomly at the end of the study by an outside consultant without bias as to what phase the infant participated. In addition, demographic data will be collected on the sample infants. Data will be subjected to descriptive statistics, inferential statistics and correlational procedures. | The purpose of this study is to evaluate the impact of the NIDCAP program of individualized patient consultation on the neurobehavioral organization of transported preterm infants in the NICU. Behavioral response to routine caregiving will be compared between infants in the pre-NIDCAP group to infants in the post-NIDCAP group. And it is this behavioral response that will be used to evaluate the effectiveness of the NIDCAP program. |
The subjects will be investigated as outpatients. For each subject, 4 individual dates with a duration of approximately 30 minutes each are scheduled - at the end of the first trimenon, at the end of the second trimenon, 4 weeks prior to the calculated date of birth, and 6 weeks after the effective date of birth. | This is a single-centre, open, parallel-group study with three age groups; no study medication or intervention will be provided. This is a longitudinal follow-up of physiological parameters. |
Hypothesis: This investigation is based upon the hypothesis that psychological intervention may counteract the detrimental effects of stress both on psychological well-being and on general health.~Background: HIV infection may be considered to be a life-long biological and psychological stressor leading to detrimental outcomes associated with disease progression. Stress reduction in these patients may have beneficial effects through delaying disease progression via the proposed interactive psycho-neuro-endocrine-immune network.~Inclusion Criteria:~HIV infected individuals CD4 T-cell counts above 200 cells/mcl Receiving no anti-retroviral drugs Individuals who signed the informed consent form~Investigative approach: Self-hypnosis and a Japanese non-touching, laying-on-of hands-like technique, called Johrei, were used to investigate the effects of psychological intervention upon immune parameters (especially in CD4 counts) associated with disease progression along with phenomenological associations between stress perception and stress hormone levels in HIV-infected patients receiving no medication. | This study examines the hypothesis that psychological interventions have beneficial effects on quality of life including psychological well-being and disease progression in early HIV patients recieving no medication. |
Peripheral muscle dysfunction is well recognised in COPD. We wish to study patients who we have found to have weak quadriceps muscles and study the molecular mechanisms underlying this problem. Patients will be well characterised with regard to their physiologic parameters and quadriceps muscle biopsies will be taken. These biopsy samples will be analysed with respect to NFkappaB activity and HDAC activity by nuclear extraction and for muscle inflammatory cytokines. We know that in the lung tissue of COPD patients there is evidence of a reduction in HDAC activity which might be responsible for the higher levels of pronflammatory cytokines in the lung. We will also study a healthy control group and a small selection of patients who are in respiratory failure due to idiopathic scoliosis in the same way. | We wish to study the effect of Chronic Obstructive Pulmonary Disease on the activity of the nuclear transcription pathway in peripheral skeletal muscle to determine whether altered activity of this pathway may be responsible for the muscle dysfunction observed in these patients. |
This single-center study is conducted to compare the effect of peroperative transfusion of allogeneic unmodified RBC (UN-RBC) versus leuko-reduced RBC (RED-RBC) on recipient immunity. Patients undergoing cancer surgery are randomly assigned peroperatively to receive UN-RBC or RED-RBC. Groups are stratified for age, sex, tumor characteristics, prior transfusion and prior cancer treatment. Blood sampless are collected before anesthesia (d0) and at days 3, 7, 14 , 28 after transfusion/surgery and analyzed for complete cell blood count, lymphocyte subsets, cytokine production (IL4, IL10, IFNgamma, IL12), T-cells repertoire (TCR) analysis and detection of circulating donor cells. Main study endpoint is the influence of the treatment arm on IL4/IFNgamma ratio. The effect of transfusion type on any given biological parameters is also tested (peripheral blood mononuclear cell phenotyping (PBMC), cytokine production by stimulated PBMC, T cell repertoire analysis and microchimerism assessment). | There is evidence to suggest that red blood cell concentrate (RBC) transfusion may have immunomodulatory effects. The aim of this randomized single-center trial is to compare immune responses in patients undergoing cancer surgery and given either an unmodified RBC (UN-RBC) or a leuko-reduced RBC (LR-RBC) transfusion perioperatively. |
Acute and chronic allograft rejection are two of the common problems limiting and complicating the utility of lung transplantation. The timing and frequency of acute rejection has been shown to be a significant risk factor for the development of chronic allograft rejection. As an adjunct to standard triple immunosuppressive therapy, induction therapy is thought to decrease the incidence of acute rejection.Daclizumab is an interleukin 2 receptor (IL-2) antagonist which is FDA approved as an immunosuppressive agent. Thymoglobulin is an anti-lymphocyte immunosuppressive agent that has been shown in other solid organ transplant studies to be successful in delaying the first episode of rejection but has not decreased the incidence of Obliterative Bronchiloitis (chronic rejection)in lung transplantation. | The purpose of this study is to compare outcomes in patients undergoing lung transplantation, using 2 different induction therapies. Primary outcome is survival and secondary outcomes include freedom from infection and freedom from rejection. |
Hysterectomy is the most common major gynaecological operation performed worldwide.~The overall average rate of hysterectomy in the United States is 5.6 per 1000 women. There are three different procedures to perform a hysterectomy. The surgery can be approached abdominally, vaginally or as a laparoscopically assisted hysterectomy.~This study will contribute to the improvement of knowledge in short and long term complications and especially the prevalence of occult and subclinical haematomas and vaginal abscesses after abdominal or vaginal hysterectomy. The occurrence of short and long term complications will have an influence on the general well being of the patient. We will also evaluate the physical and mental well being of the patient after a hysterectomy.~After statistical analysis of the study outcome parameters, some conclusions can be drawn for the treatment policy after an abdominal or vaginal hysterectomy to reduce the complication rate and improve the general well being of our patients. | The purpose of this study is to evaluate the short and long term complications after an abdominal or vaginal hysterectomy and to detect the prevalence of occult/subclinical haematomas and vaginal cuff abscesses and the postoperative course of these.~The investigators will also evaluate the physical and mental well being after a hysterectomy with a questionnaire and correlate these results with the occurrence of complications. |
The study is a randomized, double blind, placebo controlled trial. Subjects will be admitted to the General Clinical Research Center (GCRC) as outpatients to undergo their baseline pumping study. One lactation consultant will educate all subjects in the proper technique for pumping on the first day of the study and will evaluate their technique on day 5 and day 8 of the study. The lactation consultant will also instruct patients to record the volume of milk pumped and the time of each pumping episode. Subjects will be encouraged to have direct contact with their infants prior to pumping. All infant contact, infant latching onto the breast and mother's stress level will also be recorded throughout the study. Starting at 8 am on day 1, a hospital grade breast pump will be used to drain both breasts as confirmed by the absence of milk flow for 2 min during each episode of pumping and by palpation. Pumping will be performed in this manner every 3 hours around the clock. Subjects will be allowed a 5 hour window to sleep, however, as long as the total number of pumping episodes equals 8 in 24 hours.~During the first episode of pumping, a baseline prolactin level will be drawn immediately before the start of a pumping and repeated at 10 min intervals for 60 min, and then every 30 min for a total of 3 hours to document the peak prolactin level. An intravenous line will be placed to draw blood. Subsequently, subjects will be randomized to receive prolactin or placebo. On the morning of days 2, 5 and 8, blood will be collected for a prolactin level before medication injection. Subsequently, prolactin 60 mg/kg or placebo will be injected subcutaneously by the study nurse 3 hrs after the last pumping episode. On days 2 and 8, additional blood will be collected every 10 min for the first hour, every 30 min for hour 2 and 3, then at 4, 6 and 8 hours after injection to determine the peak prolactin level during a pumping session. Subjects will then drain both breasts as confirmed by the absence of milk flow for 2 min during each episode of pumping and by palpation and milk volume recorded. The subjects' vital signs will be monitored immediately before and every 15 minutes for 1 hr, every 30 min for hours 2 and 3, and then at 4, 6 and 8 hours after injection of prolactin/placebo. Temperature will be measured before the injection, every hour for hours 2 and 3, and then at 4, 6 and 8 hours after injection of placebo/prolactin. If there are no changes in vital signs, on days 5 and 8 vital signs will be monitored at baseline, only. Subjects will be taught to do SC injections on their own and will administer their second dose of SC r-hPRL or placebo 12 hours after the first dose. Subjects will continue every 12 hour SC r-hPRL or placebo administration for the next 7 days. Subjects will be asked to refrigerate all milk and bring it in to GCRC visits so that the volume that is recorded can be confirmed and for testing the milk composition and prolactin level before it is given to the infants. The final prolactin injection will be given on the evening of study day 8. All side effects in the mother and baby will be recorded daily throughout the study. Subjects will return for a final outpatient visit on day 16, to determine if any treatment effect persists. During this visit, milk will be pumped at baseline and volume recorded. In addition, blood will be drawn at 10 min intervals for 60 min, and then every 30 min for a total of 3 hours to document the peak prolactin level. Subjects will turn in their pumping diary the next day. | The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production). |
The efficacy of recombinant human prolactin (r-hPRL) for treatment of primary lactation insufficiency in women with prolactin deficiency, either congenital or acquired, will be examined. Subjects will participate in an open-label study of r-hPRL administration for prolactin deficiency. On study day 1, subjects will be seen between 8 and 10 am. A baseline prolactin level will be obtained. Subjects will subsequently be taught to use a breast pump by a designated lactation consultant and will pump for 10 minutes at each breast, simultaneously or sequentially. Any milk production will be recorded, along with milk volume throughout the study. Prolactin levels will be obtained every 10 minutes for 60 minutes after pumping begins, then every 30 minutes for a total of 3 hours. At 3 hours, r-hPRL 60 mg/kg will be administered SC. Blood will be drawn every 2 hours for 8 hours to obtain a peak prolactin level. Vital signs will be monitored every 15 minutes for the first hour, then every 2 hours for a total of 8 hours. Subjects will again pump both breasts 0, 3 and 6 hours after the r-hPRL injection, to maintain an every 3 hour schedule. Any milk production will be recorded. Subjects will administer their second dose of SC r-hPRL 12 hours after the first dose.~Subjects will continue every 12 hour SC r-hPRL administration for the next 28 days. They will also pump every 3 hours, with the exception of a 5 hour break for sleep at one time during the 24 hours, as long as the total number of pumping episodes equals 8. Subjects will record any milk production and will call as soon as any milk is expressed. When the first milk is produced, the infant will not be allowed to suckle at the breast until the milk is tested and readministered to the infant in a controlled setting to avoid any potential risks or r-hPRL exposure to the infant in the interim. After each pumping episode, if no milk is produced mothers will be encouraged to let their infants feed at the breast using a Lact-Aid device.~Subjects will be seen in the GCRC, weekly for 28 days. At each visit, subjects will have a breast exam for galactorrhea and a baseline prolactin level, then subjects will administer their own SC r-hPRL injection and pump at 0, 3 and 6 hours after r-hPRL administration, as described above. Any milk production will be recorded. In addition, at the end of week 1 and on the final day, r-hPRL will be administered, blood will be drawn every 2 hours for prolactin levels as on the first day of the injection, for a total of 8 hours, and subjects will pump and milk volume will be recorded at 0, 3 and 6 hours after r-hPRL administration.~When at least 0.25 cc of milk is produced by pumping, it will be sent for a prolactin level measurement to determine whether levels are elevated compared to levels in the control milk. If the prolactin level is not elevated, milk will be readministered to the infant. When breast milk is first given to the infants, they will be monitored in the GCRC under the supervision of a neonatologist, with vital signs, including temperature, measured every hour after feeding for 4 hours. The mother will also record stool and gastric output and any changes noted in the quality or quantity of output for the following 24 hours. If any significant and adverse changes in vital signs or gastric output are observed, any additional stored breast milk will be discarded and the study stopped. After the prolactin level in milk has been documented in the normal range and milk readministered to the infant under supervision in the GCRC, mothers will continue to pump immediately after the am r-hPRL dose, but at all other times will be encouraged to breastfeed.~When at least 1 cc of milk is available, milk composition will also be analyzed for fat, protein, glucose, lactose and IgA levels (see Procedure for Analyzing Collected Milk, above). Studies in mothers of premature infants will be performed before starting this protocol. If the level of any of these components is 50% below the lower limit of normal, breast milk will be supplemented with formula at a ratio determined by the neonatologist to ensure that all nutrients are received.~After completing 28 days of every 12 hour r-hPRL administration, breast milk production will continue to be monitored for a 14 day control period. Subjects will be seen at 7 and 14 days after their final prolactin injection. After a baseline prolactin level is drawn, milk will be pumped until the breasts are emptied. Blood will be drawn at baseline and then every 10 minutes for 60 minutes, then every 30 minutes for a total of 3 hours to obtain a prolactin peak. | The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production). |
Subjects will participate in a randomized, double-blind, placebo-controlled, crossover trial comparing breast pumping, alone, to breast pumping and r-hPRL. Subjects will have one week of instruction with the breast pump alone. Subsequently, subjects will receive 2 weeks of r-hPRL or placebo followed by 2 weeks of the alternate treatment.~Week 1: Study day 1, a baseline prolactin level will be obtained and subjects will be taught to use an electrical, hospital grade breast pump by a designated lactation consultant. Subjects will pump for 10 minutes at each breast. The total volume of milk will be recorded in a diary throughout the study. Prolactin levels will be obtained every 10 minutes for 60 minutes after pumping begins, then every 30 minutes for a total of 3 hours. Subjects will pump 3 times per day increasing to 8 times per day by the end of the first week and will continue this regimen throughout the study.~Week 2: One week after the initial visit, subjects will return to the GCRC for re-evaluation of the pumping technique and the first dose of medication. Subjects will pump for 10 minutes at each breast as on day 1 and prolactin levels will be obtained every 10 minutes for 60 minutes, then every 30 minutes for a total of 3 hours. At 3 hours, r-hPRL 60 mg/kg or placebo will be administered SC. Blood will be drawn every 10 minutes for 60 minutes, every 30 minutes for 2 hours, then at 4, 6 and 8 hours to obtain a peak prolactin level. Vital signs will be monitored every 15 minutes for the first hour, then every 2 hours for a total of 8 hours. Subjects will pump both breasts every 3 hours, starting after the r-hPRL or placebo injection. Subjects will be taught to give themselves SC injections and will administer their second dose of SC r-hPRL or placebo 12 hours after the first dose. Subjects will continue SC r-hPRL or placebo administration every 12 hours for the next 14 days. They will continue to pump daily, approximately every 3 hours, with a 5 hour break in the night to sleep. Subjects will be asked to refrigerate all milk and bring it in to GCRC visits for prolactin levels.~Subjects will return weekly for 4 additional visits (weeks 3, 4, 5, 6). At the weekly visits, blood will be drawn at baseline for a prolactin level and r-hPRL or placebo will be administered. Blood will then be drawn every 10 minutes for 60 minutes, then every 30 minutes for 2 hours, then every 2 hours for a total of 8 hours after the injection. Vital signs will be monitored as described above. At the week 4 visit, subjects will be switched to the alternate treatment for weeks 4 and 5. Subjects will be seen 14 days after their final injection. A baseline prolactin level will be drawn, then milk will be pumped, as previously. Blood will be drawn every 10 minutes for 60 minutes, then every 30 minutes for a total of 3 hours. A 1 cc sample of the milk will also be obtained 14 days after the final injection for analysis of composition. All side effects of r-hPRL will be recorded throughout the study. All milk obtained during the study will be stored and the milk composition will be determined before it is used. Infants receiving milk produced during the study will initially be monitored in the GCRC under the supervision of a neonatologist. | The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production). |
Healthy volunteers are seen on three separate visits and receive 4 gm of curcumin as a single oral dose either alone or with piperine or with silybin. Serial timed blood draws then are collected for pharmacokinetic analysis. | This study looks to describe the pharmacokinetics of curcumin delivered as a single oral dose in healthy female volunteers. The impact of piperine and silybin on the pharmacokinetics of curcumin is also studied. |
Concerta is a stimulant medication approved for the treatment of ADHD in children. We propose to study the safety and efficacy of Concerta therapy in adults with ADHD NOS. Adult ADHD NOS is operationalized by either~An adult satisfying current diagnostic criteria for ADHD but with insufficient number of childhood symptoms to fulfill the required diagnostic threshold for this disorder set forth in DSM-IV~An adult who has five current symptoms of inattention and/or five current symptoms of impulsivity/hyperactivity, but does not meet the full diagnosis criteria of six current symptoms within one of these categories.~Our hypotheses will be examined in two phases of an open label, pilot study. Phase I of the study consists of a six-week acute effectiveness trial. Phase II consists of continuation for responders in which subjects who respond in Phase I will be re-assessed every four weeks for six months. Effectiveness will be measured by improvements in clinician-rated scales, including: ADHD Symptom Checklist, Clinical Global Impression: ADHD, and Global Assessment of Functioning. | This will be an open label pilot study of Concerta in the treatment of adults with the diagnosis of Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS). We hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive to Concerta treatment in the short term and Concerta-associated response of ADHD symptomatology in adults with ADHD NOS will be sustained over the medium term. |
A randomized controlled trial compared the efficacy of a proactive pregnancy-tailored telephone-delivered smoking cessation counseling program with a best practice brief counseling control condition among pregnant women referred by prenatal care providers and a managed care plan in Massachusetts. Intervention group patients received up to 105 min of cognitive-behavioral counseling delivered in a motivational interviewing style by trained counselors throughout pregnancy and for 2 months postpartum. Control group patients received 5 minutes of brief counseling at 1 telephone call. All participants were mailed written self-help smoking cessation material tailored to pregnancy. The primary outcome measure was cotinine-validated tobacco abstinence at the end of pregnancy. Secondary outcomes were cotinine-validated abstinence at 3 months postpartum and self-reported significant (>50%) reduction in daily cigarette use. | The principal objective is to test whether offering pregnant smokers a proactive telephone counseling program throughout pregnancy and for 2 months postpartum increases the rate of smoking cessation at end of pregnancy and 3 months postpartum, compared to a best practice control condition. |
Strattera (atomoxetine) is a non-stimulant presynaptic norepinephrine reuptake inhibitor recently approved by the Food and Drug Administration for use in child, adolescent and adult patients with ADHD. Atomoxetine is a potent inhibitor of the presynaptic norepinephrine transporter with minimal affinity for other noradrenergic receptors or for other neurotransmitter transporters or receptors. Thus, Strattera could be a viable alternative treatment for ADHD individuals who do not respond to stimulants.~The purpose of this study is to assess the effectiveness, safety and tolerability of Strattera in youth, ages 6-17 years with ADHD who failed to respond to an adequate trial of stimulant treatment. If this initial study shows proof of the concept, we will follow-up the study with a randomized clinical trial. | This will be a 6-week, unblinded study using the medication Strattera for children and adolescents with attention deficit hyperactivity disorder (ADHD) who failed to respond to an adequate trial of stimulant treatment. Specific hypotheses are as follows:~Hypothesis 1: ADHD symptomatology in youth with ADHD will be responsive to Strattera treatment in the short term.~Hypothesis 2: Strattera treatment (in doses of up to 120 mg/day or 1.2 mg/kg/day) in children and adolescents with ADHD will be safe and well tolerated. |
Main Research Question: Does community-based specialist oncology nursing case management improve continuity of cancer care and lead to fewer unmet cancer patient needs?~Why this research is important: This research proposal addresses the issue of gaps in continuity of supportive care for cancer patients during the early phases of the disease trajectory that result in unmet needs and unnecessary morbidity, prior to entry into a formalized cancer care system (e.g., a regional cancer centre or hospital with a cancer treatment program). This initial diagnostic period of cancer is associated with significant stress, anxiety and uncertainty that can impact upon overall quality of life for all types of cancer. These problems are further exacerbated by waiting times of up to 16 weeks between diagnosis and attendance in a formalized cancer treatment system. During this time patients will face a fragmented supportive care service system resulting in a substantial number of patients reporting unmet needs and distress. These care gaps have significant implications considering that 38% of women and 41% of men will develop cancer during their lifetime and that cancer incidence continues to rise with an estimated 139,000 new cases in Canada (over 54,000 of these in Ontario) in 2003. There has been growing interest in nursing models to address these gaps in supportive cancer care but at this time there is not sufficient high quality evidence upon which to base policy decisions to support the widespread introduction of this type of model. The results of this study will be very important for policy development for community cancer care in Ontario and in other provinces in Canada.~What is being studied: We will study the impact of a specialized nursing intervention (Interlink) on patient outcomes early in the disease trajectory. Impact will be assessed directly using validated measures in a randomized controlled trial design. These measures will include: continuity of care, unmet needs, psychological distress, uncertainty in illness, and quality of life. | This research project will address the issue of gaps in continuity of supportive care for cancer patients during the early phases of the disease trajectory that result in unmet needs and unnecessary morbidity. The investigators intend to study the impact of a specialized cancer-nursing program, Interlink Community Cancer Nurses (Interlink) on patient outcomes. Impact will be assessed directly using a validated measure of continuity of care from the patients' perspective and validated measures of key supportive care patient outcomes including unmet needs, distress, uncertainty in illness, and quality of life, in a randomized trial. |
Continuity of care is a concept that has been garnering increased attention in the last few years. There have been multiple methods proposed by researchers for measuring continuity of care, most of which are based on proportions or ratios of visits to the same health care provider or centre. While a consistent method for measuring continuity of care is lacking, increased continuity of care using various definitions and measurement tools has been related to better well being, lower health care costs, better glucose control, and higher satisfaction but has also not been found to improve health outcomes in other scenarios. Whether a patient is better served by high sequential access to one provider or any provider within the same system or management team is controversial. Finally, patients' perceptions of continuity of care have not been generally evaluated or correlated with current measurement methods. This project was conducted with patients at the Group Health Centre in Sault Ste Marie, Ontario, a multi-disciplinary, multi-specialty health services organization serving 44,000 rostered patients | This project was conducted with patients at a multi-disciplinary, multi-specialty health services organization serving 44,000 rostered patients in Northern Ontario. It investigated continuity of care for patients with diabetes in the areas of barriers and potential solutions to, and correlates of continuity; and variability in costs associated with continuity of care and patient outcomes. |
Adolescents and young adults who use drugs are at high risk for infection with HIV, STDs and other diseases with similar transmission dynamics. Although several age-appropriate and effective HIV, STD and disease prevention efforts have been identified for young substance abusers, most interventions have been narrow in focus and are generally not structured to readily address changing patterns of drug use among adolescents that place them at risk for infection with these diseases. In this study, we are developing and evaluating an interactive, computer-assisted HIV, STD and disease prevention program for young substance abusers that incorporates effective components of both prevention science and educational technologies. We plan to develop this program with the input from the target population of adolescents and young adults. We also plan to conduct a randomized, controlled trial to evaluate the benefit of including this program in HIV and disease prevention efforts with youth in substance abuse treatment. In so doing, we will evaluate the ability of the program to promote accurate knowledge about HIV and other diseases, promote self-efficacy to reduce risk behavior and change actual rates of risk behavior among young substance abusers. This computer-based program will be designed to promote the increased adoption of effective HIV and disease prevention science for this population. New information about changing patterns of drug use and HIV risk behaviors can be readily incorporated into the program as it becomes available. The program can be easily exported and able to be applied with fidelity. Importantly, the program will be structured such that a therapist or educator may customize the program content for use by various sub-populations of substance-abusing adolescents and young adults. Thus, the program will be able to address risk factors specific to each young drug user. This program may address many of the challenges associated with the current delivery of evidence-based HIV prevention programs to this population. | In this study, the investigators are developing and evaluating an interactive, computer-assisted HIV, STD and disease prevention program for young substance abusers that incorporates effective components of both prevention science and educational technologies. |
Differences in at least 4 genes are believed to have an important effect on responses to hormones and drugs. For this study, healthy volunteers of normal body weight will be screened to find xxx individuals with the genes of interest. Very small doses of hormones and drugs will be given so that changes in forearm blood flow can be measured, while not causing effects throughout the body. A brachial artery line and venous line will be placed in the study arm so that blood samples may be withdrawn to compare amounts given into the artery and coming out of the vein after circulating through the arm. Forearm blood flow is determined by the rate of swelling of the arm after a blood pressure cuff is inflated (above venous and below arterial blood pressure). The hormones and drugs being studied include angiotensin I, angiotensin II, acetylcholine, sodium nitroprusside, enalaprilat, L-arginine, phenylephrine, endothelin-1, verapamil, and isoproterenol. This procedure will last 4-6 hours. The process will be repeated with the same participant over 2 weeks later. | The purpose of this study is to learn the effect of inherited differences on forearm blood flow responses to hormones and drugs |
This collaborative model of care, Geriatric Resources for Assessment and Care of Elders (GRACE), involves a geriatric nurse practitioner and a geriatric social worker caring for the vulnerable older adult in collaboration with the patient's primary care physician to improve coordination and quality of care. The specific components of GRACE mirror those recommended in recent reviews: a) specific targeting of elders at risk; b) availability of collaborative expertise in geriatrics; c) integration of the program into primary care; d) coordination of care across all sites of care; e) integration of data systems that support physician's practice and facilitate monitoring of pertinent clinical parameters; and f) institutionally endorsed clinical practice guidelines. To our knowledge, there are no prior studies investigating the effectiveness of such a comprehensive approach among vulnerable older adults.~We are hypothesizing that, compared to usual care, patients enrolled in the intervention will have:~greater independence in activities of daily living over 2 years of follow-up;~better health status scores as assessed by the HEDIS® 2000 Health Outcomes Survey~fewer nursing home days over 2 years of follow-up; and~fewer hospitalizations over the 2 years of follow-up. | The purpose of this study is to test the effectiveness of a collaborative model of team care as compared to usual care in improving functional outcomes among community-dwelling low-income older adults. |
DHEA and DHEA sulfate (DHEAS) plasma concentrations peak at about 20 years of age and decline rapidly and markedly after age 25 yr. DHEA is a PPAR-alpha activator. PPAR-alpha plays major roles in regulating lipid metabolism and controlling inflammation. DHEA also appears to have anabolic effects on muscle and bone. The study is designed to determine the effects of 12 months of DHEA replacement in 65-75 year old women and men on (a) truncal and visceral fat, (b) insulin resistance and serum triglycerides, (c) muscle mass and strength, (d) bone mineral density, (e) chronic inflammation, (f) arterial-endothelium-dependent vasodilation, and (g) sense of well being.~The specific aims of this study are to test the hypotheses that 12 months of DHEA replacement will (a) Result in significant decreases in truncal and visceral fat by shifting metabolism to fat oxidation and increasing energy wastage; (b) Decrease insulin resistance and decrease serum triglycerides; (c) Increase muscle mass and strength, by decreasing catabolic stimuli and increasing anabolic stimuli; (d) Increase bone mineral density by increasing anabolic stimuli and decreasing catabolic stimuli; (e) Reduce chronic inflammation and decrease pro-inflammatory cytokine production by peripheral blood mononuclear cells; (f) Improve arterial endothelium dependent vasodilation; and (g) Improve general sense of well being. | The purpose of this study is to determine whether bringing back the DHEA levels of older persons to the young range produces beneficial effects. |
Regular physical activity contributes to the health and quality of life of older adults, but unfortunately only 20% of men and 25% of women aged 65 years and greater meet the minimal national guidelines for physical activity. Older Latinos have higher rates of diseases that are most likely to benefit from physical activity, but have disproportionately high rates of sedentary lifestyle. To address this major public health problem, this study will implement and evaluate a multifaceted intervention to raise and sustain walking levels among older Latinos.~A total of 600 sedentary older Latinos will be recruited from community-based senior centers in the greater Los Angeles region. The specific aims of the study are to test the effect of the intervention on:~the change in steps per week measured by digital pedometer from baseline to 1, 12, and 24-month follow-up;~self-reported physical activity level and intervening constructs (including expectations regarding aging and self-efficacy expectations for physical activity);~psychosocial health constructs, physical performance measures, and clinical health outcomes.~The core of the intervention consists of a series of 4 weekly 1-hour group discussion sessions that utilize attribution retraining techniques from the field of motivational psychology in combination with behavioral strategies based in social cognitive theory. Discussion sessions will be conducted at senior centers and led by a bilingual health educator; each session will be followed by a 1-hour exercise class aimed at increasing strength, flexibility and endurance. During the discussion sessions, the health educator will administer a structured culturally-tailored curriculum in which participants are taught to raise their expectations for physical activity with aging and not to attribute being sedentary to old age. The 4 weekly sessions will be followed by monthly sessions for 11 months, and sessions every 2 months for the following 12 months (total intervention duration = 24 months). Participants will be randomized to 1 of 2 arms:~intervention arm: receiving the discussion session and the exercise class;~control arm: receiving just the exercise class with the same frequency and duration as the intervention group. | The purpose of this study is to examine the efficacy of a multifaceted behavioral intervention aimed at raising walking levels among sedentary older Latinos. |
This study is a 3-phase investigation designed to test two caloric restriction (CR) regimens for participant compliance and variability in metabolic and physiologic effects. Initially, and through phase 1 (1 week pre-phase, and 6 weeks phase 1), participants will maintain normal habits at home.~Then for phase 2 (24 weeks), the 44 participants will be randomized to one of two diets (Diet HG or Diet LG), which they will consume at either 70% or 90% of baseline energy intake. The participants randomized to 90% CR (both diets) will form the control group. All food will be provided during this phase, and participants will be required to attend weekly group or individual meetings with the behavioral counselor and dietitian, and perform regular self-monitoring.~During phase 3 (24 weeks), participants will prepare their own food at home according to their CR regimen and will eat to maintain the CR specified for phase 2. They will continue to attend the weekly meetings and to perform self-monitoring.~Diet HG: a diet based on the USDA Food Guide Pyramid, but with additional emphasis on adequate fiber and low energy density foods, including use of whole grains rather than refined carbohydrates, limited liquid calories, high variety of low energy items such as fruits and vegetables and low variety of high-energy discretionary foods.~Diet LG: a modification of the HG diet in which low energy density is maintained even though the percent of energy from fat and protein is increased (by increased use of high-protein foods and foods with high water content) and use of different carbohydrate sources and physically intact food items (whole grains, raw fruits and vegetables) to further lower glycemic load through reducing the glycemic index (GI). High fiber intakes, low energy density, limited use of liquid calories, high variety of low energy items such as fruits and vegetables and low variety of high-energy discretionary foods will be the same as for the HG diet. | The purpose of this study is to develop an effective calorie restricted diet. |
Proximity alarm systems are promoted as an approach to reduce falls and decrease use of physical restraints in hospitals, but they have not been tested rigorously. This study will implement proximity alarms at Methodist-University Hospital (M-UH), a 652-bed urban community hospital in Memphis, Tennessee. The hospital provides primary to tertiary care to a diverse adult patient population. The group randomized trial will be conducted on 16 25-bed general medical-surgical nursing units at M-UH. Nursing units will be randomized within blocks of 2 based on rates of falls that occur during an initial 3-month observation period. Over a 15-month intervention, 8 nursing units will be randomized to receive the alarm-based intervention, and 8 will utilize existing nursing care methods to minimize falls. Intervention units will receive an adequate supply of proximity alarm monitoring systems to apply to all patients considered by nursing staff to be at high risk for falls. An implementation team, consisting of a nurse-champion, geriatrician and biomedical instrumentation specialist, will train and conduct regular follow-up on intervention units to address technical issues related to use of the alarms. The primary outcome measure, patient falls, will be ascertained prospectively by a nurse-manager using a method developed to collect patient (e.g., orientation and postural blood pressure) and environmental data collected in a standardized manner. The primary aim of the study is to determine whether proximity alarm monitoring reduces falls. The study has been designed to test the hypothesis that patient falls will be 25% lower on intervention units compared to control units. The secondary aims are to determine whether proximity alarm monitoring reduces the use of physical restraints, or decreases patient care costs. This will be the first methodologically sound study to evaluate this promising approach to reducing falls in hospitals. Whether or not alarms successfully reduce falls, findings from this study have the potential to widely impact purchasing decisions and clinical practice related to fall prevention in acute-care settings. | The purpose of this study is to test an intervention to introduce and implement proximity alarms on the risk of falls in hospitalized patients. |
This study is designed to provide bone marrow cells for other research studies. The research is being done because there are ongoing experiments in a number of National Institute on Aging (NIA) laboratories that require access to normal human bone marrow aspirate for their studies of the immune system. These studies are done to understand how blood cells are formed and how they function. Samples will be used to study problems such as the immune system in bone marrow failure and related conditions. Cells will be used in laboratory research and may be banked for future laboratory studies | The purpose of this study is to collect bone marrow cells for research purposes. |
This study is based on the clinical observation that patients who are not well controlled on morphine or oxycodone may benefit from switching to another opioid, in this case methadone. Although the mechanism for such switch is not completely understood, evidence indicates that opioids with different chemical structures have different characteristics, not least in relation to new knowledge about genetic variation in opioid receptors. Another challenge is that there is much uncertainty regarding equianalgesic dose ratios for morphine and methadone. It seems that the higher the morphine doses, the relatively lower methadone doses are needed to substitute morphine. Furthermore, there is uncertainty to which switching procedures one should use, the most common ones are stop and go and a three days switch. Finally, it is reported that methadone may increase the QT interval of the ECG, and thus increase the risk for the ventricular arrhythmia Torsade de pointe. The aim of this randomized, open label, multicenter study is primarily to compare the switching procedures, but it will also provide more knowledge about equianalgesic dose ratios, the effect of methadone on the QT interval, genetical factors that may characterize patients needing opioid switch as well as their response to it, and finally if pharmacokinetic factors plays a role. | Cancer patients on morphine for chronic pain, with side effects or unsatisfactory pain relief, will be rotated to Methadone. We will try to find out what is the best methode to rotate, and the equivalent dosage. |
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.~Bayer Schering Pharma AG, Germany is the sponsor of the trial. | The purpose of this study is to investigate the effect of a testosterone replacement therapy called Testogel in men with PADAM. The effects on body composition (lean, fat and bone) and other symptoms of PADAM and safety will be studied. |
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial. | The purpose of this study is to confirm the safety of SH T00658ID with regard to plasma lipids, hemostatic variables, and carbohydrate metabolism. In addition, the pharmacokinetic parameter following the long term administration of SH T00658ID will be assessed. |
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial. | The purpose of this study is to evaluate the safety and effectiveness of a new 4-phasic preparation in the prevention of pregnancies in a large group of volunteers. |
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.~Bayer Schering Pharma AG, Germany is the sponsor of the trial. | To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms. |
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial. | The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH P00331F to a marketed comparator. |
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial. | The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new four-phasic oral contraceptive in comparison to a reference OC. |
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.~Bayer Schering Pharma AG, Germany is the sponsor of the trial.~Although the title of the study describes open, it was in fact single-blinded.~Issues on side effects are addressed in the Adverse Event section. | The purpose of this study is to investigate if drug doses lower than the one released from Mirena® would be as effective for contraception as Mirena®. Subjects participating in the study will be randomly assigned to be inserted with any of the three different intrauterine systems (IUSs). The IUSs are nearly alike except that the amount of hormone released from them is different. |
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.~Bayer Schering Pharma AG, Germany is the sponsor of the trial. | The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive Yasmin and Marvelon on cycle control in healthy Chinese women |
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial. | The study has been designed to look at the transfer from using LNG IUS for contraception only, in reproductive age to using it for endometrial protection in menopausal age. The main area of interest in the study is the pattern of any vaginal bleeding that occurs. |
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial. | The purpose of this study is to determine whether the study drug is effective in prevention of pregnancy in healthy women in reproductive age |
Increasing children's physical activity has become an important public health concern. Active transportation (walking and bicycling) is one aspect of children's physical activity that has received little attention but may provide a means of increasing children's activity levels. Traveling to school is a common activity for most children in the United States. Due to this regularity, active transportation to school provides a possible way to incorporate an increase in children's moderate-to-vigorous physical activity into a routine activity.~Several walk to school programs have been implemented but it is not known if the physical activity levels of children walking to school are greater than those that get chauffeured or bused. Theoretically, moderate intensity activity should be greater in the walkers compared to others. This difference should be in proportion to the duration of the walk to and from school; determined by how far the child lives from the school. However, more activity in the morning may have an impact on activity levels later in the day. Therefore, differences in daily activity patterns in addition to total activity need to be considered.~Comparison(s): Following a baseline week, the physical activity of students randomized to a Walk to School group will be compared to those randomized to a Control group, who will continue to be driven to school. | The purpose of the proposed study is to determine the effect of walking to school for one week on total physical activity and patterns of physical activity in third, fourth and fifth grade students. |
Physical activity and exercise have been shown to prevent falling in older adults, although the exact mechanisms by which exercise prevents falls is unclear. Compensatory stepping and grasping reactions are frequently used to prevent a fall to the ground following a loss of balance. Age-related impairment in these reactions may be related to an increased risk of falling. Therefore, the purpose of this study is to investigate means for reversing age-related impairment in compensatory stepping and grasping reactions. A training program involving perturbation-evoked reactions will be evaluated.~Comparison(s): Balance recovery ability before and after a 6-week training program will be assessed. Performance of the training group will be compared to a control group not receiving stepping and grasping training. | This study aims to investigate the potential to train compensatory stepping and grasping reactions for the prevention of falls. |
For twin pregnancies of 32-38 weeks gestation, where twin A is presenting cephalic, does a policy of planned CS decrease the likelihood of perinatal or neonatal mortality or serious neonatal morbidity, during the first 28 days after birth, compared to a policy of planned VB? | For twin pregnancies at 32-38 weeks gestation, where twin A is head down, does a policy of planned caesarean section (CS) lower the likelihood of death or serious illness, during the first 28 days after birth, compared to a plan for vaginal birth (VB)? |
One year retrospective look at outcome measures followed by a one year trial of a phone call after each ER visit in half of the group. Outcomes measured are cost, ER visits, hospitalizations, death, length of stay. Adults only, English or Spanish, questionnaire on depression, appointments, drug use with referral to case management services, drug rehab services, or followup appointments. Time for intervention is recorded to estimate cost. | Case management has become an integral part of HIV care. There is little science however demonstrating its effectiveness. This is a randomized, controlled trial of a phone call intervention after an ER visit to see if this can reduce further ER visits, hospitalizations, deaths, and cost. |
Traditionally, clinical pharmacogenetic studies have begun with identifying a known phenotype (e.g., an aberrant response to a drug) followed by isolating the variant protein and gene responsible for that phenotype. With the sequence of most human genes known, it is possible to carry out pharmacogenetic studies in the reverse manner (i.e., genotype to phenotype). Patients with a known variant of a gene can be studied for their response to certain drugs, which can help elucidate the importance of that gene in drug response. In the proposed study, we plan to use a genotype to phenotype strategy to study the role of OAT3 and related variants in drug response.~Renal elimination of anionic drugs occurs by filtration and active secretion. For secretion, the drug is transported from the blood into the renal tubular cell through the basolateral membrane. This transport occurs against both a concentration and electrochemical gradient, and must therefore be mediated by organic anion transporters (OATs). To date, six human OATs have been identified, OAT 1-5, and OAT7. OAT1 and OAT3 are the dominant OATs found on the basolateral aspect of the renal proximal tubular cells and are hence suspected of playing a significant role in renal anionic drug elimination [3, 4].~Active renal tubular secretion of most beta-lactam antibiotics, including cephalosporins, has long been recognized, with OATs likely playing a major role, though the relative role of each is unclear [5]. In vivo studies have demonstrated that the cephalosporin cefotaxime has a ten-fold higher affinity for OAT3 than OAT1 [6]. Thus, patients with OAT3 variants would be expected to exhibit altered renal secretion of cefotaxime.~Cefotaxime is a common cephalosporin used in the treatment of bacterial infections. Dosed up to 1-2 mg every 6-8 hours, it has been shown to be safe in patients with normal renal function. Cefotaxime is given intravenously, and is metabolized to desacetyl cefotaxime (DACM) which retains antibacterial activity. DACM is further metabolized to two inactive metabolites, M2 and M3; all four forms of cefotaxime are renally eliminated, with active secretion representing a significant percentage of total clearance (44% for cefotaxime, 64% for DACM) [7]. The half-life of cefotaxime and DACM are 1 and 1.5 hours, respectively. Patients with poorly functional OAT3 and related variants might be expected to exhibit reduced tubular secretion of both cefotaxime and its metabolites, and result in higher or prolonged blood levels. Because such variants may reduce the amount of cefotaxime that enters the tubular cells, they may also be associated with a reduced incidence of cephalosporin-induced nephrotoxicity.~The PMT group has a collection of 500 DNA samples from young, healthy adults from four major ethnic groups (125 each from Caucasians, African-Americans, Mexicans, and Chinese). This collection (The Pharmacogenetics of Membrane Transporters), is referred to as SOPHIE (Study of Pharmacogenetics in Ethnically-diverse Populations), and includes only volunteers who have consented to be called back for consideration of enrollment in future studies.~In recent studies, we identified nine non-synonymous OAT3 variants among subjects participating in the SOPHIE study. We cloned and introduced each variant into a heterologous expression system and tested the encoded transporters for their ability to transport estrone sulfate (a documented substrate for OAT3). Four variants were identified that resulted in a complete loss of function: F129L (in one Hispanic subject), R149S (in an Caucasian and an African American subject), Q239stop (in the same African American subject), and R277W (in an Asian subject). In the subject with two non-functional variants, it is unknown whether the variants occur on the same chromosome, or if the variants are on different chromosomes. The latter would potentially make the subject completely OAT3 deficient. An additional variant (I305F) which showed reduced transport ability for some, but not all, OAT3 substrates was identified in three Asian and one Hispanic subject. One variant (A310V) which showed increased transport of estrone sulfate compared to the common allele was identified in a single Caucasian subject.~This study will address the following question: Do individuals who carry altered-function in OAT3 and related variants exhibit differences in the pharmacokinetics of cefotaxime in comparison to individuals who carry the common allele? | In the proposed study, we plan to use a genotype to phenotype strategy to study the role of the organic anion transporter, OAT3, in drug response. More specifically we will examine the contribution of OAT3 to the renal clearance of anionic drugs such as cefotaxime by studying individuals with a non-functional (or poorly-functional) variant of OAT3. |
DNA and plasma will be used to identify and determine allele frequencies of genetic variants in membrane transporters and other genes relevant to human disease or drug response, including drug metabolizing enzymes, collagen, race/ethnicity, neurovascular disease, asthma/allergy/lung disease, and cardiovascular disease. This phase of the study will serve as the hypothesis-generating phase for future studies by identifying genetic variants and determining allele frequencies among an ethnically diverse cohort of healthy volunteers. Future investigations (separate IRB applications) will attempt to correlate genotypes to phenotypes among this cohort of volunteers. The allele identification and frequency data from this group of healthy volunteers will also be used to design association studies in relevant disease populations.~Determine if identified sequence variants are associated with gain or loss of in vitro biologic function using lymphocytes obtained from patients. | Collect DNA from well-characterized healthy volunteers. |
In the proposed studies, we will address two questions:~•Do individuals who carry one of OCT1 variants with reduced or no function exhibit differences in the pharmacokinetics of metformin in comparison to individuals who carry the common allele?~Compared to wild type mice, Oct1-/- mice have reduced metformin distribution to the liver and intestine. We expect a similar pattern between persons who carry the variant OCT1 allele and those who carry the common allele. This effect might be reflected by a difference of Tmax or Cmax after oral administration of metformin. Other differences in metformin pharmacokinetic properties such as volume of distribution, half life and clearance may also be evident.~•Do individuals who carry the decreased or non-functional variants exhibit differences in the response to metformin in comparison to individuals who carry the common allele? Specially, we will test the hypothesis that the OCT1-expressing tissues are target organs for metformin, and that individuals with the variant transporters may have reduced metformin uptake into these sites (is this the correct meaning?) and therefore a reduced drug response to metformin.~In this study, we will evaluate metformin pharmacokinetics and glucose metabolic effects in healthy subjects rather than in patients with type 2 diabetes. Our rationale is as follows. The hepatic glucose production in diabetic patients is abnormally increased. Metformin decreases fasting blood glucose concentration by reducing hepatic glucose production and improving glucose utilization. However, the fasting blood glucose concentration is not decreased by metformin in non-diabetics who have a normal hepatic glucose production. It was suggested that the glucose-lowering effect of metformin was difficult to demonstrate in non-diabetics unless glucose concentrations were artificially raised. Although there are studies showing that metformin improves the glucose tolerance both in non-diabetics and diabetics, the results for non-diabetics have been inconsistent, depending on the variable experimental condition. Variation in OCT1 expression and activity may be one of those variables, and the time points for blood sampling after drug and glucose (meal) intakes may also be important to observe the glucose-lowering effect [16]. In this study, we employ a similar study design as that reported [16] to observe the glucose-lowering effect by metformin in healthy subjects. Before and after metformin administration, oral glucose tolerance test (OGTT) will be conducted. We expect a difference of glucose tolerance between different OCT1 genotypes, under the hypothesis that individuals with different OCT1 genotypes have different metformin concentrations in the target tissues, and hence have different glucose uptakes into (and so utilization in) the target tissues (primary muscle and liver).~In non-diabetic healthy subjects, metformin significantly attenuated the rise in immediate postprandial insulin levels. In this study, we will also determine insulin levels after glucose administration. With metformin treatment, we expect to observe significant difference in post-glucose-administration insulin levels between individuals with different OCT1 genotypes.~When mice were given metformin, the blood lactate concentration significantly increased in the wild-type mice, whereas only a slight increase was observed in Oct1-/- mice. This is consistent with our hypothesis that OCT1 is a determinant of metformin effect on glucose utilization. It will be interesting to compare plasma lactate concentrations after metformin treatment between individuals with different OCT1 genotypes.~Metformin can improve lipid metabolism in obese and diabetics patients, which is reflected by the reduced plasma levels of free fatty acid, cholesterol, and triglycerides. However, in this study with a single dose of metformin, it may not be possible to observe those effects in healthy subjects, although the corresponding concentrations will be measured. | Specific Objectives:~To determine if individuals who carry a decreased or non-functional variant of OCT1 exhibit differences in the pharmacokinetics of metformin in comparison to individuals who carry the common allele.~To determine if individuals who carry the decreased or non-functional variants exhibit differences in the response to metformin in comparison to individuals who carry the common allele. |
The drug, which is used in the treatment of Type II diabetes, has a narrow therapeutic range. Its net renal clearance by secretion (i.e., renal clearance minus filtration clearance) ranges from approximately 100 ml/min to 800ml/min in normal, healthy subjects. Although many factors may contribute to inter-individual variation in renal secretory clearance, initial estimates of heritability (greater than 0.6) suggest that genetic factors play an important role in the renal secretion of metformin. Available evidence supports the idea that hOCT2 is the primary transporter involved in the first-step of renal secretion of metformin, i.e., uptake from the blood to the tubule cell across the basolateral membrane. In particular, (a) hOCT2 is the primary organic cation transporter on the basolateral membrane of the human kidney; and (b) metformin interacts with and is translocated by hOCT2 in heterologous expression systems.~In recent studies, we identified four variants (M165I, A270S, R400C, and K432Q) with ethnic-specific allele frequencies ≥1% [6] that have altered function in studies in heterologous expression systems. In addition, we identified a common haplotype of hOCT2 and one haplotype that contain the non-synonymous cSNP, A270S. We will determine whether variability in the renal secretory clearance of the model organic cation, metformin, in healthy individuals is associated with genetic variation in hOCT2. In particular, we will determine whether the renal clearance of metformin differs in individuals who are homozygous for the common haplotype of OCT2 (OCT2*1) and those who are heterozygous for the less common haplotype OCT2*3D, which we have identified in a comprehensive screen of ethnically identified DNA samples. We will also determine whether individuals who are heterozygous for the less common OCT2 variants, M165I, R400C and K432Q, have reduced renal clearances of metformin. | The current study is part of a large multi-investigator grant to look at the pharmacogenetics of a number of membrane transporters. We will study individuals with particular genotypes of the human organic cation transporter, (hOCT2), to test the hypothesis that genetic variation in hOCT2 is associated with variation in the renal clearance of the antidiabetic agent, metformin. |
There are two major routes of elimination for drugs - hepatic metabolism and renal elimination. For small, hydrophilic molecules, the renal route predominates. The renal function of patients taking these medications therefore determines the pharmacokinetics of (and by extension the clinical response to) these medications. One of the most common causes of reduced renal function is a decline with age.~Renal drug elimination is comprised of passive drug filtration, active secretion, and reabsorption (which can occur by both active and passive processes). The filtration function of the kidney, approximated by the glomerular filtration rate (GFR) falls by 25-50% between the ages of 20 and 90 [Turnheim 2003]. The decline in renal function with age has been identified as a major cause of adverse drug reactions in the elderly population [Lindeman 1995; Mühlberg 1999]. To avoid overdosing and exaggerated responses from these medications, algorithms have been established for dosing in patients with reduced renal function due to changes in glomerular filtration.~However, in a previous study looking at the pharmacokinetics of a drug cleared only by the renal route, we made an observation that appeared to contradict the renal clearance declines with age dogma. In this study, Effect of Genetic Variation in the Renal Transporter, OAT1, on the Renal Secretion of Adefovir), we identified individuals with genetic variants in OAT1, a transporter that was believed to be involved in the active secretion of Adefovir. All OAT1 non-synonymous genetic variants we identified were in the African American population. We administered 10mg Adefovir dipivoxil to 10 African American subjects between the ages of 19 and 49 (4 who had a genetic variant in OAT1, and six without one). These subjects were identified from a parent study, called SOPHIE (NCT00187668). SOPHIE (Studies Of Pharmacogenetics In Ethnically Diverse Individuals) is a study where DNA was collected from Bay Area adults (18-40 years of age) for the testing of drug response genes. In addition to DNA donation, subjects consent to be contacted for future studies.~We collected blood and urine over 24 hours to calculate the total renal clearance and net secretory clearance of adefovir. Although we saw no difference in the renal elimination of adefovir in the subjects attributable to OAT1 variants, we found a correlation between the age and renal clearance. Filtration (calculated from the measured creatinine clearance) remained constant in this population (112 ml/min + 18 (SD)), and the clearance of Adefovir increased with age. Both the total renal clearance and net secretory clearance increased with age (p=0.017 and p=0.010, respectively).~This incidental finding is interesting, as it may indicate an age-dependence of active drug elimination mechanisms. However, the sample size in this previous study is small, and the observation may not be accurate. We therefore have planned this confirmatory study, to expand the study population. As the initial finding was made in African American subjects, we plan to enroll an additional 16 African American subjects (8 each from the following age groups: 18-25 and 48-55). We will also genotype these individuals for variants in transporters and other proteins that may play a role in adefovir renal elimination. If the unexpected finding of an age-related increase of adefovir renal clearance is observed in this study, additional follow-up studies will be planned to examine whether the same holds true for other ethnic groups. | Healthy African American subjects with normal hepatic and renal function will be administered 10mg adefovir dipivoxil in a fasting state. Subjects will have blood and urine collections over the following 24 hours for the measurement of adefovir renal clearance. To investigate the role of age in renal adefovir elimination, 8 subjects will be enrolled from each of the following age groups: 18-25 years and 48-55 years. |
This study examines the efficacy of Child-Parent Psychotherapy (CPP) for the treatment of preschoolers exposed to marital violence. Multi-ethnic preschool-mother dyads from diverse socioeconomic backgrounds were randomly assigned to CPP or to a case management plus community referral for individual treatment comparison group. It was hypothesized the children who received CPP treatment would show significantly greater improvement in general symptomatology and in traumatic stress symptoms than those in the comparison group.~There is growing recognition that, contrary to the long-standing assumption that young children are impervious to environmental stresses, preschoolers exposed to violence show increased rates of disturbances in self-regulation and in emotional, social and cognitive functioning (Osofsky, 2004; Pynoos et al., 1999; van der Kolk, 2003). The present study examines the efficacy of a relationship-based treatment approach involving the child and the mother. Dyads were randomly assigned to either the Child-Parent Psychotherapy (CPP) treatment group or to a comparison group that consisted of monthly case management by an experienced Ph.D.-level clinician plus referrals for individual treatment in the community for mothers and child. We hypothesized that Child-Parent Psychotherapy would be more effective in alleviating children's traumatic stress symptoms and behavior problems because it focuses on improving the quality of the child-mother relationship and engages the mother as the child's ally in coping with the trauma. Treatment was offered for 50 weeks. | This study will examine the efficacy of Child-Parent Psychotherapy (CPP) for the treatment of preschoolers exposed to marital violence. |
Twin studies have long been a valuable tool for examining the relative role of environment and heredity in health issues such as disease and drug response. For example, twin studies in the 1960's and 1970's showed for the first time that variability in the elimination of many drugs was largely influenced by heredity. Monozygotic twin pairs showed little variability in the elimination of various drugs while dizygotic twin pairs, sharing only about one half of their genes, showed much greater variability. It is now known that the some of the variability in drug elimination observed in dizygotic twins was due to genetic differences in drug metabolizing enzymes, such as the cytochrome P450's. However, genetic variation in other genes, such as membrane transporters may also contribute to variability in drug response.~Membrane transporters play multiple roles in the body; they help to maintain cellular homeostasis through import and export mechanisms and also play an important role in drug response, affecting both the pharmacokinetics and pharmacodynamics of drugs. Animal studies using mice genetically deficient in drug transporters and reports of drug interaction studies involving transporter substrates have provided convincing evidence that the level of function of several important drug transporters is an important determinant of drug response.~The current study will examine differences in the renal clearance of metformin in monozygotic and dizygotic twin pairs. Metformin is an antidiabetic drug that has no significant hepatic metabolism and is actively secreted by the kidneys. Studies in our lab have shown that metformin is a substrate of the human organic cation transporter, hOCT2, which appears to be a major transporter involved in the renal secretion of cationic drugs. Data in the literature indicate that there is substantial variation in the net secretory clearance of metformin in normal, healthy volunteers. In five healthy volunteers, the ratio of renal clearance to creatinine clearance ranged from 1.5 to 4.2, nearly a 3-fold variation. We hypothesize that genetic variation in secretory transporters in the kidney, like hOCT2, may be responsible for the inter-individual differences in the secretory clearance of metformin and other drugs. Studies examining renal clearance of metformin in monozygotic and dizygotic twins will allow us to better understand the influence of heredity on variation in renal elimination. Furthermore, genotyping monozygotic and dizygotic twin pairs with significant differences in renal clearance of metformin may give us insight into the genes responsible for this variability. | Specific Aims: To compare metformin pharmacokinetics in monozygotic and dizygotic twin pairs. Comparing renal clearance of metformin in monozygotic and dizygotic twins will allow us to better understand the influence of heredity on variation in renal elimination. Furthermore, genotyping renal transporter genes in monozygotic and dizygotic twin pairs with significant differences in renal clearance of metformin may give us insight into the genes responsible for this variability. |
Mycophenolate mofetil or MMF (CellCept® by Roche) is the mofetil ester of mycophenolic acid (MPA), the active immunosuppressant.~MMF significantly decreases the episodes of acute rejection in kidney transplant patients; but as with any medication without adequate pharmacokinetic drug monitoring, the issue of under or over immunosuppression arises. For this reason, the biggest challenge lies with establishing a feasible mean of MPA pharmacokinetic monitoring. Thus far no study has shown that measuring MPA trough levels alone correlates with rejection, unlike MPA Area Under the concentration time Curve (AUC), due to the large incidence of inter- and intra-patient variability.~This is the first prospective blinded trial set up to analyze the correlation between individualized MPA AUC and trough levels of kidney transplant patients in hopes of establishing a more efficacious way of monitoring MPA. MPA target trough levels that correspond to AUC greater than 30 mg x h/L could then be utilized as maintenance measurements. | This study is a prospective interventional trial of de novo renal transplant recipients, aiming to validate a strategy which combines the use of early post transplant MPA AUC sampling, and subsequent MPA trough level monitoring to implement MPA PK monitoring in a clinically applicable fashion. |
Patients post Lung Biopsy have a chest X-ray (CXR) and a MnDCT post lung biopsy. Both studies are compared for the detection of a pneumothorax | The aim is to evaluate whether Minimum Dose CT (MnDCT) is useful in the management of patients post Lung Biopsy |
Patients with Lymphoma are recruited and have a follow up CT performed at 50% of the standard exposure parameters. The studies are compared for image quality with a recent (<3 months) thoracic CT performed at standard exposure parameters. | Hypothesis: Does a 50% reduction in radiation in dose significantly affect the diagnostic quality of chest CT |
To prospectively determine the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch.~Hypothesis: By withdrawing ARV drug pressure, resistant HIV virus will revert to wild-type. In treatment-experienced HIV patients who experience virologic failure, a STI prior to starting a salvage regimen will result in an improved virologic response and more prolonged vral suppression compared to immediate switching to a new regime.~Interventions:~Immediate Switch to Salvage Therapy: Patients randomized to the control arm will be switched immediately to a salvage regimen using the information from the treatment history and genotype results.~Structured Treatment Interruption: Patients randomized to the STI arm will have their present regimen stopped for 12 weeks and will have a genotype repeated in the 12th week. A salvage regimen will be started at week 12 using the information from the treatment history and baseline genotype results. | The purpose of this study is to assess the virologic impact of switching treatment-experienced HIV-infected patients with virologic failure to a salvage regimen with or without a 12 week STI prior to the switch.~Hypothesis: A STI prior to starting a salvage regimen will result in an improved virologic response. |
A multicentre, 1:1 randomised, double blind, double dummy, two arm parallel group phase III study comparing a dual modified release FK506E (MR4) / steroid regimen with a standard tacrolimus FK506 / steroid regimen. | To evaluate and to compare efficacy and safety of a dual regimen with oral modified release tacrolimus FK506E (MR4) / steroids versus a dual regimen with oral tacrolimus FK506 / steroids in patients undergoing primary liver transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint. |
A multicentre, 1:1 randomised, double blind, double dummy, two arm parallel group phase III study comparing a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen. | The purpose of this study is to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint. |
Pharmacokinetic/Pharmacodynamic Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora Bacterial resistance to antibiotics has been a growing therapeutic problem since the late 1980s. Resistant strains of pathogenic bacteria can arise through initial selection of resistant strains in the commensal flora. The emergence of fluoroquinolone resistance in the commensal flora will be assessed in 48 healthy volunteers receiving variable doses of ciprofloxacin during 14 days. Emergence of resistance will be correlated to pharmacokinetic characteristics of ciprofloxacin. | Bacterial resistance to antibiotics has been a growing therapeutic problem since the late 1980s. Resistant strains of pathogenic bacteria can arise through initial selection of resistant strains in the commensal flora. The emergence of fluoroquinolone resistance in the commensal flora will be assessed in 48 healthy volunteers receiving variable doses of ciprofloxacin during 14 days. Emergence of resistance will be correlated to pharmacokinetic characteristics of ciprofloxacin. |
The purpose of this study is to evaluate the viral shedding, immunogenicity and safety of FluMist when administered to healthy individuals between 5-49 years of age. | To describe the proportion of individuals 5-49 years of age who shed vaccine strain viruses.~To describe the duration of shedding of vaccine viruses in individuals 5-49 years of age.~To describe the genotypic and phenotypic stability of shed vaccine viruses.~To describe the immune responses of FluMist in individuals 5-49 years of age.~To describe the safety of FluMist in individuals 5-49 years of age in relation to shedding and the immune response |
This was a phase II, prospective, open-label, multicenter, outpatient study designed to evaluate the safety, tolerability, and immunogenicity of one or two doses of CAIV-T in children and adolescents between 6 and 17 years of age. Subjects were allocated to one of three study groups according to age at the time of enrollment: study group one consisted of subjects between 6 and 9 years of age, group two of subjects 10 to 12 years of age, and group three of subjects 13 to 17 years of age.~Approximately 450 subjects (ie, 150 subjects per age group) participated in the study and were scheduled to receive two intranasal doses of CAIV-T separated by 35 ± 7 days in an open-label manner. | The study was designed to determine the number of doses of CAIV-T required to effectively immunize children and adolescents in the 6 to 17 year age group. |
The primary objective of this Phase I study is to evaluate the safety and tolerability of escalating single IV doses of MEDI-528 administered to healthy adult volunteers. | Phase I study to evaluate the safety and tolerability of escalating single IV doses of MEDI-528. |
The objective of this study was to compare the safety and tolerability of one and two doses of influenza virus vaccine, trivalent, types A and B, live cold-adapted liquid (CAIV-T) with placebo when administered intranasally to healthy infants aged 6 < 24 weeks. | Trial to compare the safety and tolerability of one and two doses of influenza virus vaccine. |
- A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase III, Multicenter Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) in Healthy Children | - Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of(CAIV-T) in Healthy Children. |
The incidence of hypotension during onset of spinal anesthesia in elderly patients varies from 27% to 80% depending on which definition being used. Studies of cardiac output (CO) has shown that it is maintained or only slightly decreased .~Unfortunately, the time-resolution in these studies is often several minutes, and the description of changes is consequently often a start-to-end relation rather than a description of the dynamic changes during onset of spinal anesthesia.~A recent advance in measuring CO is the LiDCOTMplus hemodynamic monitor, which has proved reliable compared to pulmonary artery catheters in various intensive care settings. This monitor allows for beat-to-beat measuring during various procedures and thus early warning of hemodynamic events.~Another method with potential for early warning of decreased perfusion is near-infrared spectroscopy (NIRS). NIRS is used for continuous and non-invasive monitoring of cerebral oxygen saturation (ScO2) and even a small reduction has recently shown to predict maternal hypotension during caesarian section.~The aim of our study was to describe the changes in CO during onset of spinal anesthesia in elderly patients using a method with high time-resolution. We also attempted to evaluate NIRS as predictor of hemodynamic events. | The purpose of this study was to evaluate the changes in heart function during onset of spinal anesthesia using a new and less invasive method, the LidcoTMplus. |
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:~For ever 2 patients treated, 1 will receive treatment A (Paclitaxel + Carboplatin + Gemcitabine) and 1 will receive treatment B (Gemcitabine + Vinorelbine). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.~Upon determination of eligibility, patients will be receive:~Docetaxel + Topotecan~In order to determine the most appropriate dosing regimen to progress into future phase II trials, two different dosing schedules of Topotecan and docetaxel will be utilized. | This phase I study will characterize the safety, tolerability, and maximum tolerated dose and dose-limiting toxicity of weekly bolus Topotecan when administered in combination with to different dosing regimens of docetaxel. We will also evaluate any anti-tumor activity of the combination regimen. |
Upon determination of eligibility, patients will be receive:~Topotecan + Carboplatin~In order to determine the most appropriate dosing regimen to progress into future phase II trials, two different dosing schedules of topotecan and carboplatin will be utilized (ARM I and ARM II). Patients will be accrued to both treatment arms simultaneously. | In this phase I study we will characterize the safety, tolerability, maximum tolerated dose and dose-limiting toxicity of weekly bolus topotecan when administered in combination with two different dosing schedules of carboplatin. We will also evaluate any antitumor activity of these combination regimens. |
Skin reactions are a common and undesirable result of radiation treatment. Preventative measures are often used although there are few controlled trials. Commonly employed agents for established reactions have included sorbolene (10% Glycerine), silver sulphadiazine, hydrocolloid dressings, topical steroids, salt water or bicarbonate of soda water solution bathing and hydrogen peroxide. One trial found that Cavilon No-Sting Barrier film reduced Grade 3 skin reaction compared to sorbolene, although this film did not contain any moisturising agents.~General Hypothesis: That in a paired double blind randomised study peak and overall skin reactions experienced by post mastectomy breast cancer patients receiving radiotherapy may be reduced by Cavilon Durable Barrier Cream (CDBC) compared to Sorbolene.~Alternative Hypothesis of primary outcome: the frequency of grade 3 or more skin reaction will be reduced from 35% to 25% for skin care using sorbolene or CDBC respectively.~Alternative Hypothesis of secondary outcome: the mean area under the curve (AUC) of total skin reaction will be reduced from 9 to 8 for skin care using sorbolene or CDBC respectively. | This study has patients using two different moisturising creams during radiation therapy after mastectomy. These are Cavilon and sorbolene. It is hypothesised that skin reactions may be reduced by the Cavilon cream compared to sorbolene. |
Patients who come to the Hospital of the University of Pennsylvania, Presbyterian Medical Center or American Access in Northeast Philadelphia with a dialysis catheter that's not functioning well, will be screened for this study.~If the patient qualifies and consents to participate, an envelope will be opened that tells us to exchange the catheter for a new one OR infuse TPA (clot-dissolving drug) into the 2 ports for two and a half hours. Some dialysis patients have had a TPA dwell at the dialysis clinic to help increase blood flow during dialysis. The motion of the infusion of TPA is expected to be more effective than a dwell that sits still. Also, there is more TPA used during infusion than during the dwell.~Once the catheter is functioning, the patient goes home as usual and follow-up is done by phone after the next dialysis session, at 30 days and at 60 days. Follow-up is done to check for flow rates during dialysis and to check for any problems related to the catheter treatment. Participation is complete after the 60-day follow-up phone call. | Treating central venous dialysis catheter malfunction due to fibrin sheath formation with rt-PA(TPA)infusion will give equal patency rates in a more cost effective manner when compared to catheter exchange.~Subjects are randomized to TPA infusion or catheter exchange and then followed for catheter function at the post treatment dialysis session, 30-day dialysis session and 60-day dialysis session. Costs and treatment results will be compared. |
Participants will be recruited from the parent study The Safety and Efficacy of Low and High Carbohydrate Diets. Participants will attend one 30-minute training session to learn the computer tasks and rate food desirability. Participants will rate their desire to eat 24 foods on a 9-point Likert scale (e.g., 1 = do not desire at all; 5 = neutral, neither desire nor not desire; 9 = desire extremely). These ratings will be used to establish emotionally salient and neutral cues for the computerized tests (i.e., Cue Reactivity and Stroop test) used during the study.~Each individual will participate on separate occasions in one 45-60 minute testing session before onset of treatment (week 0), and four 45-60 minute testing sessions that coincide with treatment assessments in the approved study (weeks 12, 26, 54). Testing will be conducted one and a half hours following consumption of a standard snack to ensure that all participants are in the same metabolic state. Participants will complete three consecutive computerized tests in the following order: 1) Continual Performance Test (CPT), 2) Stroop test, 3) Cue Reactivity Test. Based on a previous study showing impairments in cognitive function one week after initiation of a low carbohydrate diet, participants will also complete a 5-minute cognitive task (e.g., Continual Performance Task) one and four weeks after modifications in eating have begun. On these weeks, participants will be given a small snack prior to the group meeting. Testing will occur at the conclusion of weekly group meetings, ensuring that participants have abstained from food for approximately one and half hours.~The 15 minute cue reactivity test consists of three cue trials that vary only in terms of the cue presented (one neutral non-food cue, one neutral food cue, and one emotionally salient food cue). The order of these trials will be presented in a counter-balanced order.Participants will complete a VAS questionnaire, rating their feelings of hunger, craving, and anxiety. Participants will insert dental rolls prior to each of three, five-minute cue-presentation trials. While participants insert the dental rolls, the experimenter will place the relevant cue on a platter. This platter will have a divider/ barrier attached to it that obstructs the cue from the participant's view while the experimenter is in the room. After the rolls are inserted and the cue is placed on the platter, the experimenter will leave the room, and rotate the platter via remote control until the cue is in clear view of the participant.5-minute psychophysiologic data (i.e., heart rate, skin conductance) acquisition will begin as the platter is being rotated. Participants will be instructed via audiotape to focus their attention on the cue, imagine picking it up, smelling it, and tasting it, etc. At the end of this 5-minute interval, blood pressure measures will be taken.Participants will remove the dental rolls and place them in a plastic zip-lock bag.The experimenter will return to the room and ask the participant to complete the post-trial VAS questionnaire, rating their feelings of hunger, craving, and anxiety. Then participants will be provided with one ounce of water. | We are interested in testing differences in cognitive function and food reactivity at various time points in individuals following low and high carbohydrate diets. We wish to achieve an understanding of these time-specific differences using repeated measures analysis of variance (ANOVA), with diet condition (low vs. high carbohydrate) as a between subject factor and time as a within-subject factor. |
The purpose of the study is to use valganciclovir to define the role of antiviral therapy in suppression of HHV-8 shedding in HHV-8 seropositive men. Our hypothesis is that valganciclovir will substantially reduce the frequency of detection and amount of HHV-8 in the mouth. Such reduction will serve to confirm that the mouth is the site of active HHV-8 replication. If valganciclovir is found to be effective, the findings from this proposal would serve as the basis for a clinical trial with valganciclovir for prevention of Kaposi's Sarcoma (KS) in high-risk HHV-8 seropositive persons.~After informed consent, all subjects will undergo medical history, physical examination and screening laboratory examination. Eligible patients will return to clinic for randomization to receiver either valganciclovir 900 mg qd or placebo. Participants will receive a diary for noting adverse events and concurrent medications. The clinician will instruct the participants on collection of mouth swabs and provide Dacron swabs, vials with PCR media and pre-printed labels. Subjects will be asked to obtain a swab of oral mucosa every morning. Clinic visits every other week will serve to review interim medical history and diaries for adverse events, collect PCR swabs, dispense additional medication and draw safety labs. The study uses a double-blind, randomized placebo design. Therefore, participants will not know whether they will be taking a placebo or active medication at any time during the study. Due to the crossover study design, however, all participants will receive the same amount of placebo and study drug over the duration. | The purpose of the study is to use valganciclovir to define the role of antiviral therapy in suppression of HHV-8 shedding in HHV-8 seropositive men. Our hypothesis is that valganciclovir will substantially reduce the frequency of detection and amount of HHV-8 in the mouth. |
Glycosphingolipids (GSL) are a main constituent of the sperm cell membrane in mammals. Male mice deficient in enzymes involved in GSL synthesis have severely impaired fertility and knockout mice are infertile. Recently, it was demonstrated that administration to mice of an inhibitor of ceramide-specific glycosyltransferase, the first step in the biosynthetic pathway of GSL formation, resulted in reversible infertility without discernable adverse side effects. This inhibitor was Miglustat, which is an alkylated imino sugar. The impact of Miglustat therapy on human spermatogenesis is unknown. If the effects on sperm morphology and motility are similar to those observed in mice, Miglustat or other GSL inhibitors might have potential utility as non-hormonal male contraceptives. | The purpose of this research study is to help in the development of safe, effective and reversible male contraception. We are examining the impact of the drug Miglustat on sperm production in normal men.~We want to see if Miglustat will inhibit sperm production in men and act as a reversible male contraceptive, as a study in mice administered Miglustat showed a reversible inhibition of sperm production. We believe Miglustat may have some potential as a safe, reversible male contraceptive. |
Specifically, from a random sample of 2000 patients taken from a cohort of established patients followed for at least three years in a general medicine practice, the objectives are:~to identify the demographic, clinical, and functional status variable that predict the risk of death, morbid events (e.g., the development of new complications or deterioration of existing conditions), or the deterioration in functional status using a half of the cohort chosen at random;~to combine these findings into a prognostic scale that can be employed in routine clinical practice; and~to validate the performance of this scale in the second half of the cohort.~There are no interventions in this study. Patients already under medical care by Cornell physicians will be enrolled. The only requirements for patients are to complete the questionnaires on an annual basis. | The primary objective of this prospective study is to develop a new method of classifying the prognosis of ambulatory patients according to their risk of long term mortality, institutionalization, morbidity (including the deterioration of pre-existing conditions or development of new problems) and functional deterioration. |
Background: Obesity and inactivity independently increase risks of chronic disease in adolescence and all-cause mortality in adulthood. In clinical trials, changes in exercise and diet can reduce adiposity and risk of diabetes and other chronic diseases in obese adults and youth. In many school systems, physical education is mandatory in elementary school but not high school, and physical activity often declines during adolescence. Because physical activity habits track from adolescence to adulthood, adolescence may represent a critical period for establishing a physically active lifestyle to prevent diseases associated with inactivity in adulthood. Obesity can make adherence to aerobic activity challenging, but would present less of an obstacle to resistance training. Resistance exercise has shown favorable effects on lean body mass, metabolic rate, insulin resistance, and quality of life in adults, but almost no research has examined effects of resistance training in obese adolescents. Our own survey in a sample of obese, primarily sedentary youth found greater overall interest in resistance exercise than aerobic exercise.~Objectives: The primary objective of this study is to evaluate the effects of resistance training, aerobic training, and combined aerobic and resistance training on percent body fat measured using Magnetic Resonance Imaging (MRI) in sedentary post-pubertal overweight or obese youth aged 14-18 years.~Study Design: Randomized controlled trial conducted at a single site. After a 4-week supervised low-intensity exercise run-in period to test compliance, 292 adolescents with BMI ≥ 85th percentile for age and gender will be randomized in equal numbers to one of 4 arms: Diet + aerobic exercise, diet + resistance exercise, diet + combined aerobic and resistance exercise, or diet-only control. The intervention will last 22 weeks, with a follow-up assessment at 6-months post-treatment (11-months post-randomization).~Hypotheses: Reduction in percent body fat will be larger in diet + aerobic exercise and diet + resistance exercise than diet-only controls at post-treatment, and the combined aerobic and resistance training will be superior to either aerobic or resistance training alone in reducing percent body fat at post-treatment. The combined resistance and aerobic group will show greater improvements in percent body fat, body composition, and physiological and psychosocial function at post-treatment and 12-months follow-up. Groups that include resistance training will produce greater psychosocial changes and better adherence than aerobic training alone at post-treatment and follow-up.~Significance: The global burden of obesity in youth is increasing, and more effective intervention is needed. This study may identify that resistance training is an important component in the treatment of overweight adolescents. As such, findings may influence clinical decision making in the management of juvenile obesity, as well as inform public health exercise guidelines and school-based physical education curricula in attempt to reduce the economic, medical, and psychosocial burden of obesity in youth. | The purpose of this study is to evaluate the effects of resistance training, aerobic training, and combined aerobic and resistance training on percent body fat, measured using Magnetic Resonance Imaging (MRI), in sedentary post-pubertal overweight or obese youth aged 14-18 years. |
There is widespread agreement that pain is under-treated in the Emergency Department (ED). The current recommended treatment of acute pain in the ED setting is administration of an initial bolus of morphine followed by titration until adequate analgesia is achieved. Several studies have shown that even 0.1 mg/kg IV morphine (7-10 mg administered to the average 70-100 kg patient) inadequately treats many patients' acute pain. In spite of this, it has been observed that many emergency physicians and nurses are hesitant to give 7-10 mg of morphine as an initial IV dose. In contrast, it has been observed that these same healthcare providers were not similarly reluctant to administer a roughly equianalgesic dose of hydromorphone (1-1.5 mg), perhaps because the more potent hydromorphone is given in much smaller milligram quantities than morphine, thus providing the illusion of substantially less opioid administered to the patient. Having repeatedly observed this phenomenon, it is reasonable that if a smaller milligram dose of hydromorphone were shown to provide an efficacy, safety, and side-effect profile comparable or superior to a larger milligram dose of morphine, it would provide evidence supporting use of hydromorphone as an alternative first line opioid in the treatment of acute pain presenting to the ED. As a practical corollary to this, it is reasoned further that the increased willingness of healthcare providers to use hydromorphone might contribute to reducing one component of the multifaceted problem of oligoanalgesia in the ED. | To compare a standard weight-based dose of intravenous (IV) hydromorphone (Dilaudid) to a standard weight-based dose of IV morphine in adults presenting to the Emergency Department (ED) with acute severe pain. |
The goal of this study is to identify infants who are at risk for developing problems related to being breast-fed. A previous study identified items that place an infant at a high risk for developing complications related to being breast-fed. The present study will use the same survey and collect data from more participants. These additional participants are necessary to provide statistical analysis for the survey. The survey being developed will assist health care professionals to identify those infants at risk for developing health problems related to being breast-fed and provide care that will minimize the chances of developing complications. | The goal of this study is to identify infants who are at risk for developing problems related to being breast-fed. |
The purpose of this study is to validate the psychometrics of the Individual Workload Perception Scale (IWPS) designed to measure the perception of individual workloads of inpatient registered nurses. | The purpose of this study is to validate the psychometrics of the Individual Workload Perception Scale (IWPS). |
This study is being conducted to evaluate the safety of an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years. This is an extension of the Seasonique Phase 3 clinical trial to evaluate long-term safety. Only patients enrolled in the earlier trial are eligible for participation. | This study is being conducted to evaluate the safety of ethinyl an extended-regimen oral contraceptive, with ethinyl estradiol supplementation during the usual hormone-free week, for up to an additional three consecutive years. |
Glaucomatous neuropathy is a condition that worsens with time causing atrophy of the optic nerve and narrowing of the visual field which may culminate in blindness. The treatment tested in the trial employs certain food additives intended to reverse this pathology. | The purpose of this study is to determine if certain food additives are effective in the treatment of glaucoma, improving and reversing the progress of the disease. |
The purpose of this study is to analyze stored samples and data collected during the conduct of the study A Trial of Vitamins in HIV Progression and Transmission (HD32257). The aims are to examine the effect of vitamin supplementation on HIV infected women during pregnancy | The purpose of this study is to analyze stored samples and data collected during the conduct of the study A Trial of Vitamins in HIV Progression and Transmission (HD32257). The aims are to examine the effect of vitamin supplementation on HIV infected women during pregnancy on a number of parameters in breastmilk. |
Electroporation therapy (EPT) is a tumor-specific ablative treatment modality with the potential to manage local tumors without the potentially undesirable side effects of systemic chemotherapy agents or radiotherapy. Surgical resection of cutaneous lesions may lead to significant organ dysfunction and/or permanent disfigurement requiring reconstructive surgery (i.e. nose, eye area, ears, medial canthus, nasolabial fold, lip, scalp, etc.). In contrast, electroporation therapy may offer equivalent disease control to conventional surgery with a lessened need for reconstructive surgery.~The ability to ablate local cutaneous lesions with the MedPulser® System when used in conjunction with intralesional Bleomycin is an important new treatment for the local management of recurrent Basal Cell Carcinoma (BCC), recurrent Squamous Cell Carcinoma (SCC), Melanoma, Adenocarcinoma (i.e. local recurrence of breast cancer), Merkel Cell Carcinoma and Cutaneous Lymphoma and other solid tumors with symptomatic subcutaneous recurrences and provides an alternative treatment option to subjects who:~have failed standard treatments; or who~are unwilling or unsuitable to undergo conventional surgical excision or radiation.~EPT with Bleomycin spares normal tissue and its use in local disease management may preserve organ function and/or appearance relative to surgery. | The purpose of the study is to study the safety and efficacy of MedPulser Electroporation with bleomycin treatment of cutaneous and subcutaneous foci of cancer. |
This study aims to verify dosages of gentamicin for use in Uniject, chosen based on a consideration of gentamicin pharmacokinetics, safety, efficacy, target population body weight, cost, feasibility and acceptability. | The purpose of this study is to determine what dosage of gentamicin for use in one-time administration device (Uniject) is appropriate. |
Maternal mortality is a substantial burden in developing countries. The World Health Organization (WHO) estimates that between 500,000 to 600,000 women die from complications related to pregnancy and childbirth each year, with 99% of these deaths occurring in developing countries (WHO/UNICEF/UNFPA, 2000). It is estimated that pregnancy-related causes result in about one-quarter to one-third of the deaths of women in their reproductive years (Koblinsky, 1995). Improving maternal mortality has received recognition at the global level as evidenced by the inclusion of reducing maternal mortality in the Millennium Development Goals (United Nations, 2004).~Among problems experienced by women related to child-bearing, maternal mortality is the tip of the iceberg. Consideration of the morbidity associated with pregnancy, delivery and the postpartum period is essential in understanding the burden of diseases due to maternal causes. The WHO estimates that up to 300 million women suffer from short- or long-term illnesses related to pregnancy and childbirth (WHO, 1998). In addition, the WHO estimates that in developing countries, death and disability related to maternal morbidity account for 18.5% of the burden of disease among women of reproductive age (WHO, 1998).~In Bangladesh, recent studies have suggested that a large proportion of women giving birth in rural areas experience pregnancy- and delivery- related complications (NIPORT et al, 2001), and more than 80% of the women suffer from a serious postpartum illness (Goodburn et al, 1994; BIRPERHT, 1994). In the baseline survey for the project Community-Based Interventions to Reduce Neonatal Mortality in Bangladesh in Sylhet, a total of 75% of women reported at least one maternal complication during pregnancy, delivery and the postpartum.~There is little evidence as to the effect of maternal care interventions on maternal morbidity. Several studies have evaluated the impact of traditional birth attendant (TBA) training on morbidity and referral rates. In a review of 15 studies on the effects of TBA training programs, Ray and Salihu found an improvement in maternal morbidities in two of the three studies reviewed, and an impact on referral rates in six of the seven studies reviewed (Ray & Salihu, 2004). In a meta-analysis conducted by Sibley et al, there was no effect detected between TBA training and recognition of maternal complications, referral for complications or on maternal compliance with referral (Sibley, Sipe, & Koblinsky, 2004).~Maternal morbidity is a substantial burden on the health of women in Bangladesh and throughout developing countries. Further research is needed to more carefully document the community-based incidence of maternal morbidity and to evaluate program impact on maternal morbidity.~The objectives of this study are to provide data on descriptive information on self-reported maternal morbidities for future planning, and to measure the effect of a package of maternal care interventions by comparing differences in care seeking for perceived complications and the unmet obstetric need (based on major obstetric interventions (MOI) for facility-validated absolute maternal indications (AMI) ) among the three arms, and by comparing anemia rates among the three arms. | Maternal death is a substantial burden in developing countries. In Bangladesh, recent studies have suggested that a large proportion of women giving birth in rural areas experience pregnancy and delivery related complications. This study, which is set in context where home-birth is the norm, provides the opportunity to provide descriptive information on the self-reported prevalence of maternal behaviors and morbidities during pregnancy, delivery and postpartum periods and to quantify the effects of provision of maternal care interventions through trained community health workers on a few selected maternal behaviors and morbidities. |
The aromatase inhibitors are drugs already approved for the treatment of breast cancer in the adjuvant and metastatic setting, and have demonstrated a superiority when compared to other hormone therapy agents as tamoxifen. FRAGRANCE is a trial of neoadjuvant hormone therapy activated in September 2004 at the Jules Bordet Institute. The main objective of this study is to find a genetic signature of de novo resistance to letrozole The standard dose of letrozol, 2,5 mg/day, is given orally during 4 months previous to the definitive breast surgery. The advantages of the neoadjuvant setting are a) the possibility to directly evaluate the response to therapy, which is of great value to decide adjuvant treatment; b) the increase chance of performing breast conserving surgery; c) and, because a tumor sample is obtained before and after treatment, the identification of predictive markers of response or resistance to treatment, including a genetic signature, obtained using the microarray technology. Eligible patients are women with early hormonal receptor positive breast cancer, with any contra-indication or refusal to the administration of chemotherapy The side effects of letrozole are already well known, and include more commonly hot flashes, nausea and vomiting, headache, arthralgia/myalgia, fatigue, and oedema. After surgery, adjuvant treatment will be done according to the standard practice of the Institute, considering the possibility of continuing letrozole for a total of at least 5 years, if a satisfactory response is achieved The first part of this trial will include 49 patients.~This trial will soon become a multicenter, multinational trial of 160 patients. | Find a genetic signature of de novo resistance to letrozole in adjuvant breast cancer; |
One hundred patients were randomized to two groups. Group DEX was given 30 mg tablets of oral dextromethorphan with their pre-medication and three more times in the first 24 hours after surgery. Group P received the placebo following the same schedule. Post-operative analgesic requirements were assessed using a patient-controlled analgesia system.~Pain was assessed at rest using a visual analog scale in the post anesthetic care unit(PACU), 6 and 24 hours after surgery. | We studied the effect of dextromethorphan (DEX), an N-methyl-d-aspartate antagonist, on analgesic consumption and pain scoring after abdominal hysterectomy. Our aim was to compare the analgesic effectiveness and incidence of adverse side effects of oral DEX with placebo (P) |
Hypotension during cesarean section with spinal anesthesia is common. We compare low dose versus standard dose spinal anesthesia with and without intravenous phenylephrine-infusion. | The purpose of this study is to determine the effect of low dose versus standard dose spinal anesthesia with and without intravenous phenylephrine-infusion on blood pressure, cardiac output and systemic vascular resistance. |
This is a pilot study of patients of HLA-A2 phenotype whose tumor expresses the NY-ESO-1 or LAGE-1 antigen. Patients will receive NY-ESO-1b peptide mixed with 0.5 milliliter (mL) of Montanide® ISA-51 and 1 mg of CpG 7909 given every three weeks for four doses by subcutaneous injection. There will be a three-week follow-up period after the fourth injection making the cycle 13 weeks long. In the absence of toxicity and progressive disease, a second cycle will be offered to patients who have received four vaccinations.~The primary objective is to evaluate the immune response (antibodies, CD8+ T-cells, and DTH) and safety to vaccination with NY-ESO-1b peptide mixed with CpG 7909 and Montanide® in patients with cancer expressing NY-ESO-1 or LAGE-1. The secondary objective is to document tumor responses in patients with evaluable or measurable disease. | This cancer vaccine research study involves the injection of the NY-ESO-1b peptide along with 2 other agents to help stimulate the immune system. Peptides are small fragments of protein. NY- ESO-1 peptides are normally found in the testis and the placenta. They have also been found on various types of cancer cells. The purpose is to stimulate the immune system to react against the peptides that are found on cancer cells. |
NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine was administered by particle-mediated epidermal delivery (PMED) at a pressure of 500 psi using the XR-1 Powderject® delivery device. The 4 microgram dosage of NY-ESO-1 was administered as 4 X 1 microgram PMEDs in close proximity. Similarly, the 8 microgram dosage was administered as 8 X 1 microgram PMEDs. The third cohort of patients received the 8 microgram dosage as a cluster dosage of 4 doses (day 1, 3, 5, 8) as 2 X 1 microgram PMEDs per day.~Blood samples were to be obtained at baseline, 2 weeks after each vaccination, prior to the second and third vaccination, and 4 weeks after the third vaccination for the assessment of clinical hematology, biochemistry measurements and immunology responses. Patients were to be evaluated for toxicity throughout the study.~Delayed-type hypersensitivity (DTH) testing was to be performed at baseline and at the 2-week visit following the first and third vaccinations.~NY-ESO-1 and/or LAGE-1 specific antibodies were to be assessed in all patients by an enzyme-linked immunosorbent assay (ELISA). NY-ESO-1 specific CD4+ and CD8+ T-cells were to be assessed in all patients by tetramer and/or ELISPOT assays.~Disease status was to be assessed at baseline and 4 weeks after the third vaccination in patients with measurable disease. | To evaluate the safety of NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine given by particle-mediated epidermal delivery (PMED) in patients with tumor types known to express NY-ESO-1 or LAGE-1. |
Gastroesophageal reflux disease(GERD) is a common disorder of the esophagus, affecting 7-10% of the U.S. population. Characteristic symptoms include heartburn, chest pain, and indigestion. EER denotes gastroesophageal refluxate that reaches structures above the upper esophageal sphincter. EER has been implicated in the pathogenesis of several otolaryngologic disorders such as chronic posterior laryngitis, laryngeal contact ulcer or granuloma, paroxysmal laryngospasm, vocal cord nodules, Reinke's edema, subglottic or laryngotracheal stenosis, globus pharyngeus,and laryngeal and hypopharyngeal carcinoma. In addition, EER has been associated with disorders of both the lower and upper respiratory tract and with chronic sinonasal inflammation.~Patients with EER rarely complain of the common symptoms of GERD, such as heartburn. Often they present with symptoms involving the larynx and pharynx, including throat-clearing, globus pharyngeus, and postnasal drainage. These symptoms may be present due to direct irritation of the nasal epithelium by gastric refluxate and/or a neurogenic inflammatory process mediated by the autonomic nervous system.~Specific Aims:~Specific Aim 1: To establish the relation ship between EER and PND in patients without sinonasal inflammatory disease.~Hypothesis 1: In patients without radiographic or endoscopic evidence of sinonasal inflammatory disease, PND is a symptom of EER.~Method 1: We will test this hypothesis utilizing a 2-site 24-hour pH probe test in a symptomatic patient group and compare then to a previously tested age and sex-matched control group.~Specific Aim 2: To establish the efficacy of PPI in the management of PND.~Hypothesis 2: Patients with a chief complaint of PND and no sinonasal inflammatory disease will improve with 3-month PPI treatment with Rabeprazole 20 mg twice a day.~Method 2: A group of patients with a chief complaint of postnasal drainage, without radiographic or endoscopic evidence of sinonasal inflammatory disease will be entered into a prospective placebo-controlled trial utilizing BID PPIs over a 3-month period. the primary outcome measures will be: 1) Visual analog Scales, assessing the severity and frequency of PND at days 0 and 90 of treatment and 2)A quantitative color analysis of laryngeal erythema, utilizing videolaryngoscopy at days 0 and 90 of treatment. | Objectives of this study are:~To quantitatively evaluate the relationship between extraesophageal manifestations of gastroesophageal reflux (EER) and postnasal drainage(PND)in a group of patients without radiographic or endoscopic evidence of sinonasal inflammatory disease.~To assess the efficacy of BID proton pump inhibitors (PPI) in the management of patients with symptomatic postnasal drainage. |
The use of cranberry (CB) juice and powders, both alone and in combination with conventional medicine, has become more common for the treatment of urinary tract infections (UTIs) and and other acute or chronic conditions. Cytochromes P450 enzymes are a group of proteins involved in metabolism of certain substances. A group of cytochrome P-450 (CYP) enzymes are extensively involved in drug metabolism. The pharmacokinetics of many drugs often vary considerably among individuals, largely because of variations in the expression of different cytochrome P-450 (CYP) enzymes in the liver and other tissues. Flavonoids are antioxidants that may have health benefits. The flavonoids may also be responsible for cranberry's effects on urinary tract infections.~To evaluate the drug interaction potential of cranberry, single doses of the three safe probe drugs alprazolam, dextromethorphan, and caffeine will be administered before and after a 14-day treatment period with cranberry powder. Changes in the pharmacokinetics of these probe drugs will indicate the degree of enzyme inhibition or induction. The key pharmacokinetic parameters for four major CB flavonoids will be estimated by following the plasma concentration versus time course of absorbed flavonoids and their excretion in urine. The area under the plasma concentration versus time curve (AUC), oral clearance (Clo), terminal elimination half-life (T1/2) and renal clearance (Clren) will be determined for: epicatechin, quercetin (total glycosides), procyanidin A2, and cyanidin-3-galactoside. | The purpose of this study is to evaluate the potential of cranberry juice to interact with conventional drugs. This study will also determine the the amount of cranberry flavonoids that appear in the blood and in the urine. |
Light has long been proposed to have a stimulatory effect on a range of biological functions in humans including increased feelings of activation, such as improved alertness or ability to perform. The mechanisms underlying how light stimulates these neurobiological systems remain to be elucidated. We propose to investigate the effects of different colors of light on human physiology, and in particular, test the claims that specific colors of light preferentially stimulate neurobiological, physiological and hormonal systems. Using classical photobiological techniques, we will construct action spectra for the effects of different colors of light on a range of non-image forming responses in humans.~We will test the hypotheses that: 1) light-induced activation of the neurobiological sleep-wake regulatory system, as indicated by increased alertness, faster reaction time, suppression of EEG alpha activity, microsleeps and slow rolling eye movements, and suppression of pineal melatonin, is most sensitive to retinal exposure to short wavelength blue light (460 nm) compared to equal photons of other colors of visible light; 2) light-induced activation of autonomic and hypothalamic-pituitary-adrenal axis measures of arousal, as indicated by increased heart rate variability, core body temperature, blood pressure, respiration rate, plasma cortisol levels and urinary catecholamines, is most sensitive to exposure to short wavelength blue light (460 nm) compared to equal photons of other colors; 3) phase shifts of the human circadian pacemaker, as assessed by changes in temperature, melatonin and cortisol rhythms, are most sensitive to exposure to short wavelength blue light (460 nm) compared to equal photons of other colors. The resultant action spectra will help to identify the photoreceptor mechanism(s) by which light activates arousal and circadian resetting, these non-image-forming physiological responses and enable us to distinguish between major candidate photoreceptive mechanisms, including potential novel photoreceptor systems, that might mediate such responses. | This study will determine which color of light is most effective in stimulating a range of biological functions in humans including activation of sleep-wake regulatory system (alertness, performance, microsleeps, brain activity), activation of the nervous system (heart rate, temperature, blood pressure, breathing rate), and shifting the timing of the internal 24-hour (circadian) pacemaker. |
Evidence suggests that the expectation of pain relief, even if a person receives only a placebo, can provide actual therapeutic benefits. The µ-opioid receptor system, located in the brain, is activated during anticipation of pain relief; this activation suppresses stress and pain responses. This study will use brain imaging technology to examine the effects of a placebo intervention on µ-opioid neurotransmitters. Examination of the factors that regulate these placebo-activated neurotransmitter responses will clarify the overall neurobiology underlying variations in the responses to placebos, as well as pain and other stressful conditions, ultimately leading to the optimization of medical and psychological interventions.~This study will last several hours during one study visit. Participants will receive both a painful and a painless injection while undergoing positron emission tomography (PET) brain imaging. The painful injection will consist of small amounts of hypertoninc saline (concentrated saline that causes cell shrinkage) in the jaw muscle over a 20-minute period. Several minutes after participants receive hypertonic saline, they will receive an injection with isotonic saline not associated with pain in the opposite jaw muscle. After participants receive the injections, they will either be told or not be told about a pain relief intervention. PET imaging will continue as participants either anticipate or do not anticipate pain relief. Participants will be asked about their pain levels repeatedly throughout the study; their responses will be entered into a computer-controlled system which will modulate rates of saline infusion. | This study will use brain imaging technology to examine chemical systems in the brain that suppress pain and stress when an individual has an expectation of pain relief. |
Scientific research into the basic mechanisms underlying neuromodulation is relatively recent and incomplete. The purpose of the proposed study is to determine how a form of neuromodulation, transcutaneous vagus nerve stimulation, which is non-invasive and non-painful, affects human brain and autonomic activity. We will accomplish this by integrating whole brain functional MRI (fMRI) methodologies with gastric MRI and physiological monitoring.~This study will comprise 2 functional magnetic resonance imaging (fMRI) brain-gut scans and 2 behavioral visits consisting of a nutrient drink test, all while receiving the neuromodulation with varying parameters. Participants will also have their heart rate, breathing, and gastric activity monitored during all visits. | This study will determine how vagus nerve stimulation affects human brain, stomach, and autonomic activity. |
In this interventional study we want to evaluate the effect of Variable ventilation (1) in patients with ARDS. Patients will be mechanically ventilated with Variable Ventilation (3 step with increased level of variability) and traditional CMV, for a total of 4 step. Each step lasts in 60 minutes. During this period we will record the gas exchange parameters and the mechanics of the respiratory system.~1. Arold S, Mora R, Lutchen K, et al. Variable ventilation improves lung mechanics and gas exchange in a rodent model of acute lung injury. Am J Resp Crit Care Med 2000; 165: 366-71. | The purpose of this study is to determine the effects of variable ventilation on respiratory system of patients affected by acute respiratory distress syndrome. |
The project will determine the advantages of double erythrocytapheresis in the collection of preoperative autologous erythrocytes as compared to the standard collections of whole blood. The study will assess the total reduction in the number of procedures required to obtain the preoperative units ordered by the surgeon. Also, successfulness of erythrocytaphereses versus classical whole blood collection for these patients will be compared. | The project will determine the advantages of double erythrocytapheresis in the collection of preoperative autologous erythrocytes as compared to the standard collections of whole blood. The study will assess the total reduction in the number of procedures required to obtain the preoperative units ordered by the surgeon. Also, successfulness of erythrocytaphereses versus classical whole blood collection for these patients will be compared. |
Single centered, randomized, placebo-controlled,double-blind, outpatient pilot study to evaluate the efficacy, safety and tolerability of 2 doses of nalmefene on smoking cessation. | To determine if nalmefene is safe and effective in smoking cessation. |
Although Rf group was less effective, they felt less discomfort. | We hypothesis that radiofrequency will cause less post-operative discomfort when compared with laser assited uvulopharyngoplasty. 40 patients with primary snore will be enrolled into this study. After overnight sleep test confimred that no obstructive sleep apnea existed, cases were informed consented. Then they were randomized into two groups. Post-operative pain, duration of analgesics were recorded. |
Kidney transplantation has emerged as a desired treatment of choice for patients with end stage renal disease. Although transplantation has become increasingly successful, there continues to be risks associated with it. Prior to performing a kidney transplant patients are cross-matched (a test to determine whether or not they have preformed antibodies to the donor). Preformed antibodies result from a previous pregnancy, blood or platelet transfusion or prior transplant. Performing a transplant in patients who have preformed antibodies against the donor generally results in hyperacute rejection (when the immune system attacks the new kidney). This hyperacute rejection usually results in kidney loss in a very high percentage of patients. Due to these consequences, pre-transplant cross-matching has emerged as a standard of care. Although hyperacute kidney loss has now been avoided, a large population of highly sensitized patients that has little hope of receiving a transplant has been identified.~A number of groups have studied methods to lower specific antibody levels in a variety of clinical settings. The two primary methods used today in transplantation are plasmapheresis (the separation of plasma from cells, and the removal of solutes, immune globulins, and medications) and administration of immune globulin therapy. Employing either of these techniques individually or jointly has substantially reduced acute rejection and improved kidney survival in these highly sensitized patients. The immune globulin treatments that have been studied have included large variations in dosage as well as differences in immune globulin products. The results from these small studies have not identified one therapy, product or dosage that could be considered standard of care.~The kidney transplant work-up also consists of matching ABO blood group between donor and recipient. Transplantation against the recipient blood group has resulted in very poor outcomes due to antibody mediated rejection (when the immune system attacks the kidney). However, due to the shortage of organs available for transplantation, the increasing number of patients awaiting a transplant and the favorable outcomes with live donor transplant, some transplant programs have developed protocols for transplanting against the recipient ABO blood group. These protocols are centered around plasmapheresis and treatment with immune globulin. As with the positive cross-match patients stated earlier, the standard of care has yet to be identified.~Dr. Lloyd Ratner, currently at Columbia University and former Chief of Transplant at Thomas Jefferson University Hospital and his former colleagues at Johns Hopkins University have studied the use of plasmapheresis in combination with Cytomegalovirus Immune Globulin Intravenous (CytoGam) to reverse a positive cross match and to transplant organs against ABO incompatible blood groups. This has enabled over 20 kidney transplants to be performed with patient and graft survival at one year being very similar to our traditional cross match negative and ABO compatible patients. These results are generally considered outstanding given the fact that antibody mediated rejection historically had a 75 to 100% incidence of graft loss.~The treatment protocol that is used consists of plasmapheresis treatments alternating with CytoGam infusions every other day for 3 to 9 treatments prior to transplantation and another 1-5 treatments after transplant. Plasmapheresis is increasingly performed to treat various infectious, immunological, metabolic and inherited diseases. In this procedure, plasma and cellular components of blood are separated and solutes in plasma, including drugs may be removed. Generally, a volume of 1 to 1.5 times the plasma volume is removed and replaced with an equivalent volume of crystalloid or colloid. The procedure removes solutes or drugs from the blood compartment and the tissue stores remain unaffected except for re-equilibration with decreasing plasma concentrations. After each plasmapheresis treatment patients receive an infusion of CytoGam which is used to inactivate the remaining antibody. However, it is not known to what extent subsequent treatments of plasmapheresis remove CytoGam that patients received only hours or days prior.~During the treatment phase with plasmapheresis patients also receive a number of other medications such as immunosuppressants for the prevention and treatment of graft rejection, antibiotics for prevention and treatment of infection and various other medications for related illnesses. The effects that plasmapheresis may have on removal of these medications is not known for many of these agents. This information would be helpful for the potential need to re-dose or give supplemental doses of medications. This is extremely important for the immunosuppressant medications since under-dosing of these agents may result in serious negative outcomes. Due to these many unknown aspects it would be useful to know the extent of drug removal during plasmapheresis treatments. This would enable more precise dosing and ultimately better patient care. | Based on the limited amount of experience with plasmapheresis and CytoGam concomitant use, the researchers seek to evaluate the pharmacokinetics (drug absorption, distribution, and elimination) of this therapy. The researchers are also interested in evaluating the pharmacokinetics of the various immunosuppressant medications that patients will receive such as tacrolimus, mycophenolate mofetil and daclizumab. |
Without adequate debridement, chronically infected wounds persist and form a nidus for the acquisition of antimicrobial-resistant microorganisms. Multiple studies state that patients with chronic wounds were colonized with one or more resistant bacteria, and that the presence of a chronic wound or decubitus ulcer was associated with a statistically increased likelihood of colonization with methicillin-resistant Staphylococcus aureus (MRSA), ciprofloxacin-resistant gram-negative bacilli (GNB),colonization and infection with ceftazidime-resistant Escherichia coli and Klebsiella pneumoniae.~Recently, a newly formulated gauze dressing impregnated with an antiseptic agent has become available. This product offers the promise of a combined benefit of wet-to-dry mechanical debridement, while providing high local concentrations of a potent antiseptic to prevent colonization and infection of the wound by resistant microorganisms, potentially enhancing wound healing.~This study proposes to determine if use of the antimicrobial gauze in routine wound care results in a lower rate of chronic wound colonization with resistant microorganisms and prevalent microorganisms as compared to standard wound care (with non-antimicrobial gauze). | The purpose of this study is to determine if a new antimicrobial gauze dressing is better than the current method of dressing open wounds with plain sterile gauze. It is hoped that the antimicrobial gauze will reduce the number of germs in the open wound and even improve the rate of healing. |
During the last decade, international adoptions have doubled in the United States. Because many of these infants and children have experienced institutionalization and poor caretaking before their adoption, international adoptees have special medical and emotional needs that must be met by both their parents and pediatricians. Currently, most clinical information about these children has focused on their physical health status so that protocols for evaluation and treatment can be established. Some systematic research has also focused on their overall developmental status including both cognitive and motor capabilities. These studies show that most of the children are developmentally delayed upon arrival to the U.S. Furthermore, follow-up studies have found international adoptees to score (on the average) significantly lower in cognitive functioning than their nonadopted peers even after spending substantial time in their adopting homes and falling mostly within the normal range. Not surprisingly, children's level of functioning at older ages is related to the length of time spent in institutional care.~These findings are consistent with an emerging literature on the lingering effects of early adversity on children's development. Potent adverse circumstances may include the unbuffered effects of poverty, experience in an institutional setting, physical or sexual abuse, and parental negligence Regardless of the source, children who are not protected from these disadvantageous situations demonstrate changes in their behavior as well as their biophysiological regulation. | This study aims to provide information about the emotional and physiological responses of post-institutionalized children in both a stressful situation (immunization) and a play situation. |
In 2001, a study titled, A Multi-Center Trial of Academic Hospitalists began at the University of Chicago Hospital along with five additional academic institutions. The study is currently and successfully collecting data solely at the University of Chicago Medical Center.~The comprehensive aim of this proposed research is to measure and analyze the effects of hospitalists on patient outcomes, costs, and medical education on the general medicine services at the University of Chicago Medical Center (UC). The comprehensive aim of this research will be pursued through five specific aims:~Specific Aim #1- To assess whether hospitalists affect the cost and quality of inpatient care. This will be accomplished by analyzing the outcomes of 50,000 patients assigned to hospitalists or non-hospitalists using a quasi-randomized design based on day of the week of admission. Outcomes will include in-hospital and post-discharge mortality, readmission, emergency room use, and patient satisfaction.~Specific Aim #2- To assess the mechanisms by which hospitalists may effect the cost and quality of care. Understanding these mechanisms is essential if hospitalist programs are to be designed in ways that permit them to achieve their desired benefits. We will develop measures to assess the whether these possible mechanisms by which hospitalists may have their effects are related to costs and outcomes.~Specific Aim #3- To assess the effects of hospitalists on housestaff and student education and satisfaction. This will be accomplished by surveys administered to medical students and housestaff.~Specific Aim #4 - To attempt to quantify primary care providers' (PCP's) satisfaction with the frequency, promptness, manner, and content of communication with the in-hospital healthcare team, and to assess differences in PCP satisfaction with teams led by hospitalist and non-hospitalist attending physicians. We hypothesize that deficiencies in such communication may impair continuity of care with outpatient physicians during hospitalization and at the time of discharge, and may be improved when the attending physician is a hospitalist.~Specific Aim #5- To assess the quality of care for vulnerable elders for specific geriatric syndromes and diseases by modifying our current surveys and chart abstraction tools in our project with questions aimed to address these issues. | Care of hospitalized patients by hospitalists -- often defined as physicians who dedicate at least 25% of their practice to inpatient care -- is a recent, growing, and controversial trend in health care delivery in the United States. But despite the growth of interest in hospitalists, there have been few scientific evaluations of the concept. The comprehensive aim of this research study is to measure and analyze the effects of hospitalists on patient outcomes, costs and medical education on the general medical services of a group of academic centers. |
Despite several multicenter studies, there is no hard evidence on the superiority of a cyclosporine or tacrolimus based immunosuppressive regimen following kidney transplantation, in a single-center setting. Existing studies concentrated on benefits in safety and efficacy, but seldomly evaluated the cost-effectiveness of one treatment.~The study has been designed in a fashion as close to the daily clinical practice as possible. Patients are randomized in pairs, receiving kidneys from the same donor, thus avoiding donor-related bias. Those having specific indications or contraindications for one of the study medications were not entered into the study. All other study-related decisions are made only on a clinical basis and according to the standard practice of the center. Patients are followed on the intention-to-treat rule. Cost-effectiveness will be calculated on 12-month treatment for each patient entered into the study. | The purpose of this study is to evaluate and compare, in the single center setting, the safety, efficacy and cost-effectiveness of the two standard immunosuppressive regimens based on tacrolimus and cyclosporine. |
Single-dose intrapartum and neonatal nevirapine (NVP), either alone or in combination with short course zidovudine (ZDV) is in widespread use to prevent mother-to-child HIV transmission throughout the developing world. Though the public health benefits cannot be overstated, widespread use of NVP in this fashion may come at a cost. Non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance mutations are induced in at least 20% and probably a larger proportion of women exposed to NVP in this fashion. Addition of short-course ZDV does not appear to mitigate this effect substantially. The full implications of these NVP resistance mutations are yet unknown, though there is concern that they may result in reduced efficacy of the NVP or other NNRTIs in long-term, therapeutic regimens.~We are conducting a clinical trial of tenofovir (TDF) and emtricitabine (FTC), marketed as a fixed dose combination, Truvada ™, to reduce NNRTI-resistance post-delivery in the setting of NVP with or without ZDV for PMTCT. TDF and FTC are both Category B drugs and are approved for use in pregnancy. They have several characteristics that make them ideal candidate drugs for use in conjunction with NVP, including long intracellular half-lives and established safety profile among adults for HIV treatment.~Women will be enrolled between 28 and 38 weeks of gestation. As part of normal PMTCT services, they may choose NVP-boosted ZDV or single dose NVP for PMTCT; We anticipate that most (~80%) will choose the former. At arrival for delivery, they will be randomized to receive either the two study drugs (intervention) or no drug (control). A total of 400 women will be randomized, and followed, along with their infants, for 6 months. | The purpose of this study is to determine whether the addition of tenofovir (TDF) and emtricitabine (FTC)to a standard PMTCT regimen containing single-dose nevirapine (NVP) can reduce the development of post-ingestion HIV resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs). |
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