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Cardiovascular complications and chronic rejection are chief causes of transplant loss[1,2]. After renal transplantation patients are still characterized by their pre-existing arteriosclerotic changes [3]. Endothelial dysfunction and disturbed distensibility of great arteries are independent predictors of cardiovascular morbidity [4,5]. Additionally the activation of sympathetic nervous system leads to dysfunction of vessel wall[6,7]. There are important therapeutic options in improvement of endothelial function [8].~In addition monocytes of the recipient will contribute to vessel wall changes. [9-11]. Aim of therapy - especially of immunosuppressive therapy- have to prevent these fatal vessel wall changes.~Therefore in this study the following topics will be addressed.~1. Discontinuing of calcineurininhibitors will lead to improvement of vessel wall function 2. Sirolimus and Mycophenolat Mofetil affect vessel wall properties in a different way.~3. There are risk factors, e.g. activity of sympathetic nervous system, which may determine the efficacy of discontinuing the calcineurininhibitor concerning the vessel wall function.~4. Calcineurininhibitorfree immunosuppression reduces the activity of endothelial cells.~5. Survival of monocytes and release of procoagulatory activity will be changed by the immunosuppressive regimen.~Rostand SG, Brunzell JD, Cannon RO, Victor RG. Cardiovascular complications in renal failure. J Am Soc Nephrol. 1991; 2: 1053-1062~London GM, Druecke TB. Atherosclerosis and arteriosclerosis in chronic renal failure. Kidney Int 1997; 51(6):1678-1695.~Hausberg, M., K. Kisters, M. Kosch, K. H. Rahn, and M. Barenbrock. Flow-mediated vasodilation and distensibility of the brachial artery in renal allograft recipients. Kidney Int. 55: 1104-1110, 1999.~Barenbrock M, Kosch M, Jöster E, Kisters K, Rahn KH, Hausberg M: Reduced arterial distensibility is a predictor of cardiovascular disease in patients after renal transplantation. Journal of Hypertension 2002, 20:79-84.~London GM, Pannier B, Agharazii M, Guerin AP, Verbeke FHM, Marchais SY. Forearm reactive hyperemia and mortality in end-stage-disease. Kidney Int 2004, 65:700-704.~Converse RL, Jacobsen TN, Toto RD, Jost CMT, Cosentino F, Fouad-Tarazi F, Victor RG. Sympathetic overactivity in patients with chronic renal failure. N Engl J Med 1992; 327:1912-1918.~Hausberg M, Kosch M, Harmelink P, Barenbrock M, Hohage H, Kisters K, Dietl KH, Rahn KH. Sympathetic nerve activity in end-stage renal disease. Circulation. 2002, 106:1974-9.~Kosch M, Barenbrock M, Kisters K, Rahn KH, Hausberg M. Relationship between muscle sympathetic nerve activity and large artery mechanical vessel wall properties in renal transplant patients. J Hypertens. 2002, 20:501-8.~Österud, A., Björklid E. Role of monocytes in atherogenesis. Physiological reviews, 2003, 83: 1069-1112.~Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26.~Lessner SM, Prado HL, Waller EK, Galis ZS. Atherosclerotic lesions grow through recruitment and proliferation of circulating monocytes in a murine model. Am J Pathol. 2002 Jun;160(6):2145-55. | Chronic transplant nephropathy and cardiovascular death are the main reasons for loss of transplanted organs after kidney transplantation.~Vascular changes, induced by hypertension and/or immunological processes, determine long time transplant survival.~It will be tested whether the withdrawal of calcineurininhibitors will improve the vessel wall function in renal transplant patients. It is supposed that this immunosuppressive regimen reduces the activation of endothelial cells with important impact on arteriosclerosis and therefore on patient and transplant survival. |
Although physicians typically counsel for other risk factors of CVD, they are less likely to counsel for increasing levels of physical activity. This is surprising for two reasons: First, physical activity has been identified as an independent modifiable risk factor for CVD. Second, there is a high prevalence of physical inactivity among Canadians. The purpose of the current study is to examine interventions that are designed to promote adoption and maintenance of physical activity through physician recommendations and counseling. The primary outcome measures include possible differences in levels of self-reported physical activity. In addition, several behavioral predictors typically associated with physical activity will be assessed (e.g., self-efficacy, social support, anticipated benefits & enjoyment, and barriers). There are several unique aspects to this research including: 1) the fact that it compares two types of delivery systems 2) the examination of physical activity patterns over an extended period of time has not been done previously with this type of intervention, and as such, also forms another unique feature of this proposal 3) physician intervention for physical activity has not been done in Canada previously. If the intervention is found effective, the program will add significant value to health services in Saskatchewan and Canada. For instance, the program will enhance the role of physicians in promoting physical activity without increasing the cost of health-care delivery, and with a minimal investment of time required by the physician and his/her staff.~Comparison: To assess the efficacy of the interventions, a quasi experimental design will compare an intervention with a standard control condition. All physicians will be trained to use a standardized protocol to deliver PACE exercise counseling to sedentary patients during one office visit. In the intervention condition, patients will be randomly assigned to receive reminder calls from a research assistant who will provide suggestions as to possible physical activity resources in the community that could be used. | The purpose of this study is to systematically test the efficacy of two physician-based interventions in changing physical activity patterns of adults over a 20-month period. |
This study is a single-centre, randomized, open-label, double-controlled protocol to study the patterns of ovarian follicular growth and regression in women administered 0.15mg desogestrel /0.03mg ethinyl estradiol at different stages of the follicular phase of the menstrual cycle.~We tracked the growth and regression of dominant follicles after administration of OC by means of highly sophisticated transvaginal ultrasonography and computerized image analysis techniques. The extremely high resolution ultrasonography of the ovarian follicles and the computer-assisted image analysis are unique to the Women's Health Imaging Research Laboratory (WHIRL) at the University of Saskatchewan. The synergyne (© R.A. Pierson) image analysis program was developed in the WHIRL and has the ability to allow assessment of the physiologic status of follicles as small as 6 to 10 mm. This unique protocol will allow us to characterize patterns of follicular growth and atresia under the suppressive effects of oral contraception, as well as the assessment of anovulatory follicles which may develop when OCs are administered at advanced stages of follicular development.~The working hypothesis is that the administration of monophasic OCs prior to and during the time of physiologic selection of the dominant follicle will prevent the development of an ovulatory follicle (selection occurs when the dominant follicle reaches 10mm [Baerwald & Pierson, unpublished data]). In addition, we hypothesize that administration of OCs after selection of the dominant follicle, at more advanced stages of follicular development will result in 1 of 4 scenarios: 1.) Ovulation of the dominant follicle, 2.) Regression of the dominant follicle, 3). Formation of a Hemorrhagic Anovulatory follicle (HAF) or Luteinized Unruptured Follicle (LUF), or 4.) Formation of a follicular cyst. We hypothesize that atresia of dominant follicles and formation of anovulatory follicular structures will be associated with limited endometrial development. In testing these hypotheses, we will determine if OCs can safely and effectively be administered at any time during the follicular phase of the menstrual cycle.~This study will evaluate the ovarian and uterine responses to administration of a combined dose of 0.15mg desogestrel /0.03mg ethinyl estradiol at 1 of 3 different stages of the follicular phase of the menstrual cycle. The objectives of the trial are to:~Develop new and more user-friendly administration schemes for OC use;~Use the administration of OCs at different stages of follicular development in women as a model for studying follicular atresia;~Assess the differences in kinetics, physiologic status (state of viability or atresia), and ultrasonographic image attributes of follicles which grow, regress, ovulate, or form anovulatory follicular structures after the administration of exogenous steroid hormones;~Assess endometrial response to ovarian suppression by ultrasonographic evaluation of endometrial thickness and endometrial pattern.~After screening measurements confirm subject eligibility, subjects will be randomized to initiate OC therapy at one of three different times of the menstrual cycle:~Experimental Group #1: receives OCs when the dominant follicle reaches 10mm Experimental Group #2: receives OCs when the dominant follicle reaches 14mm Experimental Group #3: receives OCs when the dominant follicle reaches 18mm~Fifteen women will be randomized to each of the 3 experimental groups in a stratified design scheme. Data collected from an ongoing OC trial (BMC# 2000-169) will serve as OC control data (n=15). Data collected from a previous study (BMC# 1988-80) will serve as natural cycle control data (n=60). | We hypothesize that administration of OCs at varying follicular diameters will provide an appropriate model for the study of follicular atresia in women. Clinically, we hypothesize that the administration on OCs at different stages of the follicular phase will result in markedly different patterns of follicular development and/or atresia. |
Recombinant human deoxyribonuclease I (rhDNase, dornase alpha), administered by inhalation, is currently used as a mucolytic agent in the treatment of cystic fibrosis. This prospective, randomized, placebo-controlled, double-blind clinical study should carry out whether the therapeutic use of rhDNase can be extended to adults who are undergoing long term ventilation at the intensive care. It is hypothesized that mechanically ventilated patients show elevated concentrations of DNA in airway secretions, and that these pathological DNA levels are reduced by rhDNase. The primary clinical goal of the study is to establish wether ventilation times are shortend under inhalation of rhDNAse during the ventilation time. hDNase (verum) is compared with equal amounts of 0.9% saline solution (placebo). | The purpose of this study is to determine whether Inhalation of Recombinant Human Deoxyribonuclease Shortens Ventilation Time in Mechanically Ventilated Adults |
This is a Phase I, single center, open-label study of the dietary supplement calcium formate in normal, healthy female subjects. The purpose of the study is to determine whether daily use of calcium formate is safe and whether it accumulates in the eye. | This is a Phase I, single center, open-label study of the dietary supplement calcium formate in normal, healthy female subjects. The purpose of the study is to determine whether daily use of calcium formate is safe and whether it accumulates in the eye. |
We hypothesized that ingesting calcium tablets prior to a spine bone density scan will not affect the bone mineral density as measured by DXA. To test this, 36 subjects ingested various calcium supplements after a spine DXA scan and were then scanned again 15, 30 and 45 minutes after ingestion. Subsequently a subset of 15 subjects had three spine scans performed for instrument precision and subsequently ingested a calcium tablet with scans 15 and 30 minute intervals after ingestion. | We, the investigators at the University of Wisconsin, hypothesized that ingesting calcium tablets prior to a spine bone density scan will not affect the bone mineral density as measured by dual energy x-ray absorptiometry (DXA). |
At the University Hospital Vrije Universiteit the PET ligand PK11195 labeled with carbon-11, (R)-[11C]PK11195, will be used to study microglia activation in-vivo in patients with traumatic brain damage, Alzheimer disease, multiple sclerosis and neuritis optica, disorders with unknown pathophysiology and treatment difficulties.~PK11195 (1-(2-chlorophenyl)-N-methyl-N-1(1-methylpropyl)-3 isoquinolinecarboxamide) is a highly specific ligand for the peripheral benzodiazepine-binding site, which is particularly abundant on cells of the mononuclear macrophage line (Myers et al., 1991). In normal human brain, the peripheral-type benzodiazepine receptor ligand PK11195 exhibits low to minimal binding primarily associated with the choroid plexus, ependymal linings and glial cells. However, following neuronal damage, the cells involved in the ensuing gliosis, microglia, show a marked increase in expression of these sites (Stephenson et al., 1995;Conway et al., 1998).~PK11195 labeled with carbon-11 is a PET ligand to peripheral type benzodiazepine receptors which has already been used in patients with stroke (Ramsay et al., 1992), Rasmussen's encephalitis (Banati et al., 1999), multiple sclerosis (Banati et al., 1997) and facial nerve lesions (Myers et al., 1999). However, no tracer kinetic model for quantification has been fully validated for(R)-[11C]PK11195. In order to use (R)-[11C]PK11195 for PET-imaging of microglia activation and to use it in the longitudinal monitoring of disease progression, baseline levels of ligand uptake in a healthy control population are required. This study aims to measure (R)-[11C]PK11195 uptake in normal brain in different age groups and to develop methods for quantification of specific binding of (R)-[11C]PK11195. Because (R)-[11C]PK11195 uptake depends on regional bloodflow, each (R)-[11C]PK11195 scan will be preceded by a cerebral bloodflow scan with H215O.~OBJECTIVES~Determine the distribution of (R)-[11C]PK11195 in normal brain~Develop methods for quantification of specific binding of (R)-[11C]PK11195~Determine the metabolic profile of (R)-[11C]PK11195 in healthy volunteers~DESIGN OF THE STUDY Forty healthy subjects will be recruited, 20 males and 20 females. This is an open study. The study consists of one PET scan, which will be performed at the Department of Nuclear Medicine & PET research of the VU University Medical Centre. | This is a study using Positron Emission Tomography (PET) to study the normal distribution of the PET ligand (R)-[11C]PK11195. This ligand will be used to study inflammation in the brain in several brain disorders like Alzheimer's disease and traumatic brain injury. |
The healing effect should be demonstrated by using MRI pictures during the entire FU's in order to demonstrate the differences if COLLOSS E is applied or not. | The aim of this RCT is to show, that in a patient group receiving COLLOSS E combined with TomoFix for medical open wedge high tibial osteotomy, the onset of bone healing is earlier in time, compared to patients receiving TomoFix without COLLOSS E. |
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals Inc.. Bayer HealthCare Pharmaceuticals Inc. is the sponsor of the trial. | The purpose of this study is to determine whether the study drug is safe and effective in the prevention of pregnancies in a large group of volunteers. |
A lot of osseous substitution products were already used to fill osseous defects in order to prevent losses of osseous that are envisaged and so prejudicial.~Synthetic calcium phosphate ceramics (particularly granulated forms) already has shown their osteoconduction potential in human at different sites. But it is difficult to put these granules in very little place.~The injectable form of calcium phosphate granules ready to use is easier to be used and allow a diminution of the risk of infection during surgery, and permit homogeneity of the biomaterial.~Injectable form of calcium phosphate granules did already has shown his biocompatibility and biofunctionality in animals.~The purpose of this study is to study the biocompatibility and biofunctionality of this biomaterial in his injectable form in fillings of little losses of osseous substance from various origins were no charge will act to the biomaterial. | The purpose of this non-comparative study is to test, for the first time, the bioactivity of a new ready to use calcium phosphate biomaterial in fillings of little losses of osseous substance from various origins, such as traumatic and benign tumoral causes. |
Numerous studies point to an increased serotoninergic activity in schizophrenia. Additionally, patients with schizophrenia often show reduced filtering of sensory information, which is reflected in reduced P50 suppression and reduced prepulse inhibition of the startle refex (PPI). Currently, the reports in literature on the effects of serotonergic agonists on sensory gating in humans are inconclusive. In an initial study performed in our laboratory, however, we found reduced P50 suppression following administration of imipramine (a combined serotonin- and noradrenalin reuptake inhibitor) to healthy volunteers. This result provides evidence for the involvement of either serotonergic, noradrenergic, or a combination of both pathways in sensory gating. In numerous animal studies however, sensory gating is reduced by agonists of 5-HT, which suggests a serotonergic, rather than a noradrenergic, involvement in sensory gating. Therefore, in a follow-up study, the effects of a selective serotonin reuptake inhibitor (escitalopram) will be investigated on sensory gating parameters of healthy volunteers. To further extend the data of our initial study, the subjects will additionally be tested for two more psychophysiological parameters of attention that are usually found to be disturbed in patients with schizophrenia, i.e. mismatch negativity and selective attention. The design will be a double blind, placebo controlled experiment, in which a single dose of escitalopram or placebo will be given to healthy, non-smoking male volunteers on two occasions, separated by at least a week, after which the subjects will be tested in the psychophysiological test battery. | It is of great clinical relevance to know if selective serotonin re-uptake inhibitors affect information processing. Our hypothesis was that aspects of information processing would be disturbed whereas others would improve. |
Schizophrenic patients exhibit impairments in filtering of sensory information, as can be assessed by use of prepulse inhibition (PPI) of the acoustic startle response and P50 suppression paradigms. In the treatment of negative symptoms or depressive syndromes during the course of schizophrenia antidepressants are often combined with antipsychotic medication. However, antidepressants increase monoaminergic activity, of which in turn it has been suggested to decrease sensory gating, although these presumptions are mostly based on results from animal studies. Currently, little is known about monoaminergic modulation of sensory filtering in humans, and the few reports that can be found in literature show discrepancies with animal studies. The current study was designed to study the effects of increased monoaminergic activity on sensory filtering and habituation of healthy volunteers. In a double-blind, placebo controlled cross-over design, twenty healthy male volunteers will receive either placebo or a dose of 50 mg of imipramine (a dual acting antidepressant), after which they will be tested in a P50 suppression-, a PPI-, and a habituation of the startle reflex paradigm. | We wanted to compare the relation of two different psychophysiological paradigms (PrePulse Inhibition of the startle response = PPI and P50 suppression) to each other. Additionally, we wanted to test the effect of the combined serotonin- and noradrenaline re-uptake inhibitor, imipramine, on these measures. The primary hypothesis was that PPI and P50 gating would not correlate with each other at baseline. The secondary hypothesis was that increased noradrenergic and serotonergic activity would disrupt PPI as well as P50 gating. |
Engaging in regular physical activity that requires a moderate to vigorous effort is related to good health and a reduced risk of a multitude of diseases. Currently physical activity and health promotion research is limited by self- report data that is confounded by participants' ability to accurately remember and record their physical activity. A potentially new method of accurately assessing moderate-intensity physical activity is called context sensitive- ecological momentary assessment (CS-EMA). Mobile computing devices (personal computing devices, PDAs) that automatically identify when a specific type of physical activity (e.g., moderate-intensity physical activity) is being performed has the potential to provide valuable objective data for naturalistic, experimental, and clinical intervention research purposes, and has the potential for educational, recreational, and clinical applications. The goal of this exploratory study is to assess the accuracy of two methods of collecting data on moderate-intensity physical activity. The study will compare the use of a paper diary to collect self-reported data on moderate-intensity physical activities performed throughout the day to self-reported data collected using ecological momentary assessment methods which are facilitated by a PDA that cues the participant to record when specific intensity levels of physical activity are achieved. This study will also develop algorithms that will automatically identify specific types of physical activities being performed. The data collected from the heart rate monitor, motion sensor, and information requested directly from the participant via the PDA interface will be used to train pattern recognition systems to classify the intensity and type of physical activity being performed by the participant. This study will contribute to research on context- awareness and human activity recognition. | The purpose of this study is to develop a tool that can more accurately assess the intensity and kind of physical activity that a person performs. The experimental tool, which will use a mobile computing device as a way of automatically identifying when a certain activity is being performed and at what intensity, will be tested against a self reported paper diary of activities performed on a day to day basis. It is hoped that this study will increase understanding of the health benefits of certain types of physical activity performed in the home. |
Patients undergo an initial screening visit. Inclusion criteria include adults 18 -70 years of age with type II diabetes currently using insulin and recording SMBG measurements. Exclusion criteria include history of severe hypoglycemic episodes, current use of ASBG measurements, serious co-morbid illness or pregnancy. For eligible subjects baseline data including HbA1C is obtained. The goal for enrollment is 176 subjects. Subjects are randomized into either a fingertip or an arm-testing group within strata of baseline HbA1C. Each subject who does not already have one receives a One Touch Ultra® SMBG device. All subjects receive training in the use of this device, but for those in the arm-testing group this includes training on obtaining samples from the forearm. Arm- testing subjects are encouraged to use arm testing as much as possible but to use finger testing if they are not able to obtain a sample from the arm. All subjects are asked to perform SMBG testing before breakfast, before dinner and 2 hours after dinner and to complete diaries of all SMBG readings. At 1, 3 and 5 months after the training visit subjects see a diabetes provider who makes adjustments in the therapeutic regimen based on the SMBG measurements, as they would during routine diabetes management. Diary sheets are then collected and the data they contain is entered into a database. At months 2, 4 and 7 subjects present for a visit to drop off their diary sheets. At months 4 and 7 they have blood drawn for HbA1C measurement. The principal outcome variable is level of diabetic control as measured by 7-month HbA1c. The means for each group will be compared, and we will test the hypothesis that glycemic control as represented by 7-month HbA1C is not worse for the ASBG group than the FTBG group. Secondary outcome variables are compliance with testing and number of hypoglycemic episodes. | The objective is to assess the effect of using ASBG (alternate site blood glucose) versus FTBG (finger tip blood glucose) testing on long-term glycemic control in diabetics. Since ASBG measurements appear to lag behind FSBG measurements at times of changing glucose concentration, it is possible that ASBG measurements will yield lower postprandial readings than FTBG, potentially causing a negative impact on long-term control. It is also possible that since ASBG is reportedly more comfortable than FTBG testing, it's use might improve adherence to testing and improve long term control. |
The primary goal of this project is to develop and evaluate an intervention that will increase the number of people who, having been exposed to a sexual partner with chlamydia, gonorrhea or syphilis, (a) are notified and (b) receive evaluation and treatment. The intervention program will be presented entirely by an automated multimedia computer system with touch screen interface. The intervention will be tailored to user, based on demographic and recent sexual history factors. The intervention is designed to (a) motivate and prompt STD clinic clients to recall and identify sexual partners, (b) teach clinic clients a set of social skills for minimizing negative reactions while informing partners that they may be infected with an STD; (c) increase client's self-efficacy relative to disclosing partners names and informing them of their STD exposure, and (d) provide clients with tools for motivating their partners to seek treatment. | To help public health professionals (DIS) in interviews of patients infected with STD for the names of their sex partners, this project used a computer-based partner elicitation program before the actual DIS interview. The main outcome was the mean number of partners named by those who had the intervention versus those those who did not. |
Patinets will be observed for 2 six hour periods. Patients will be videotaped; every 10 minutes: EMG reading will be obtained; hourly - vital signs, pain score and saliva cortisol from spit will be obtained. | The purpose of the pilot study is to validate an assesment tool to be used in the assessment of pain in the verbal, congitively intact patient. The ultimate goal is to be able to validate this tool in the non-verbal/cognitively impaired patient. |
This is a body composition analysis study of people self-identifying Maori and non-Maori participants from both Dunedin and Invercargill. The study consists of a clinical visit for anthropometry and oral glucose tolerance test (OGTT), followed by a single Dexa Scan visit. Participants meeting all the inclusion criteria were invited to participate in the study.~Outcome will be determined by examining Dexa Scan data and surrogate clinical endpoints. The clinical endpoints include: anthropometric measurements, Dexa analysis, bioelectric impedance, and BP measurements, and the biochemical measures of: lipid profile, fasting insulin and glucose, liver functions and uric acid levels. | It has been proposed that a higher cut off for BMI (body mass index) is to be used in Maori to define overweight and obesity. However, no one has assessed the prevalence of co-morbid conditions associated with BMI. It is well known that Maori are at greater risk of diabetes and cardiovascular disease compared to non-Maori and a delay in the identification of those who are overweight and obese may be detrimental for Maori. We will assess BMI, other measures of adiposity and prevalence of co-morbid conditions with a comparison with a similar matched non-Maori population. |
We were unable to configure the software to get started on this study. | The purpose of this study is to determine if a simple 'pick-list' menu applied to a handheld computer's time-motion program can be used to record reliably what a hospital-based doctor does while working a shift in the hospital. In this study reliability will be measured by comparing the data collected by at least two different observers recording data from the same hospitalist during the same period of time. |
This is a randomized, open-label study designed to assess the safety and efficacy of AQUAVAN® Injection versus midazolam HCl following pretreatment with an analgesic, fentanyl citrate injection, in producing sedation in patients undergoing a flexible bronchoscopy procedure. Randomization will be stratified by site. Following completion of pre-procedure sedation assessments, patients will be randomly assigned to 1 of the 2 i.v. treatment groups at a 3:1 (AQUAVAN® Injection: midazolam HCl) allocation ratio.~All study patients, irrespective of treatment group assignment, will receive fentanyl citrate injection as an analgesic pretreatment. Supplemental doses of fentanyl citrate injection may be administered if the patient reports pain or if inadequate analgesia is present as demonstrated by increased heart rate and/or blood pressure in the presence of adequate sedation. At no time should fentanyl citrate injection be administered to increase sedation levels. AQUAVAN® Injection and midazolam HCl will be administered to induce a state of adequate sedation, defined as a Modified Observer's Assessment of Alertness / Sedation (OAA/S) score of 4 or less. Supplemental doses will be administered to increase depth or duration of sedation. Supplemental doses will not be administered if the Modified OAA/S score is 2 or less or if there is no purposeful response to stimulation. The depth of sedation will be measured by the Modified OAA/S scale, a validated measure. Patient and Investigator assessments will be used to confirm that the depth of sedation provided met the goals of sedation, reduction of anxiety and reduced awareness. | This study was designed to demonstrate that AQUAVAN® is effective in providing adequate sedation in patients undergoing flexible bronchoscopy as well as to assess the safety profile of AQUAVAN versus that of midazolam. Prior to the procedure, patients receive fentanyl citrate for pain management followed five minutes later by either AQUAVAN® Injection or midazolam HCl for sedation. During the procedure, study personnel assess the patient's vital signs and depth of sedation. After the procedure, the patient, physician, and an evaluator are asked to complete satisfaction surveys. |
Aim of the study: to compare postoperative complaints (PONV, pain, etc) and PACU discharge time between two groups, for patients admitted for planned abdominal hysterectomy with or without BSO:~A: standard of care (SOC) receiving paracetamol, celecoxib, epidural analgesia, dexamethasone, ondansetron and droperidol, and general anaesthesia with propofol, remifentanil and cisatracurium~B: SOC with sham epidural analgesia, preoperative gabapentin, intraoperative lidocaine, s-ketamine and sufentanil | The purpose of this study is to test the current standard of care (SOC) treatment for abdominal hysterectomy with a group receiving SOC minus epidural analgesia plus additional perioperative analgesics in terms of postoperative abilities, postoperative nausea and vomiting (PONV), pain and discharge time from the PACU (post-anaesthesia care unit). |
This is a randomized, open-label, multi-center study to compare end of study hemoglobin level between Epoetin alfa (PROCRIT) at 40,000 units administered subcutaneously once every week (qw) and at 80,000 units subcutaneously every two weeks (q2w) in approximately 280 anemic patients with cancer receiving chemotherapy. The study hypothesis is that a dosing regimen of PROCRIT 80,000 Units q2w subcutaneously (sc) is non-inferior to a dosing regimen of PROCRIT 40,000 Units qw sc with respect to the change in hemoglobin (Hb) from baseline to Study Week 13 for patients with chemotherapy associated anemia and this respective dosing regimen is generally well-tolerated. The patients will receive subcutaneous (under the skin) injections of Epoetin alfa (PROCRIT) at one of the following dosing regimens: 1- Starting dose of 40,000 units sc qw (once every week) OR 2- Starting dose of 80,000 units sc q2w (every two weeks) | The primary objective of this study is to compare end of study hemoglobin levels between Epoetin alfa at 40,000 units administered subcutaneously once every week and at 80,000 units subcutaneously every two weeks in anemic patients with cancer receiving chemotherapy. The secondary objectives of the study are to assess the Hb response, time to Hb response, transfusion requirements, and safety. |
Cartilage restoration, in general, is a relatively new option for the treatment of articular cartilage lesions primarily of the knee. In the initial autologous cultured chondrocyte transplantation (ACT or, by others implantation, thus ACI) reported by Peterson et. al., the results of femoral lesions were favorable, while 5 of 7 patellofemoral treatments were poor. In the United States, the expedited FDA approval based on these results excluded the patella. As a result, in the United States, it has been difficult to further evaluate use of ACI at the patellofemoral joint in light of the exclusion of off label uses by many governmental and private insurance programs. Nevertheless, a growing body of knowledge is accumulating outside the United States that the use of ACI at the patella is a viable option and soon similar findings will be published in the US by Minas et. al. (accepted for publication) | The purpose of this study is to measure the outcomes of patients who have articular cartilage lesions in the patellofemoral joint and are treated with the Autologous Chondrocyte Implantation. |
The purpose of this 3-month (cycle) study was to evaluate the effects of hormonal contraceptives containing a progestin and an estrogen on liver proteins and coagulation factors that are sensitive to estrogen. In this study, a contraceptive vaginal ring containing Nestorone® (a progestin with no androgenic properties) and ethinyl estradiol was compared to an oral contraceptive containing levonorgestrel (an androgenic progestin) and ethinyl estradiol. | The purpose of this 3-month (cycle) study was to evaluate the effects of hormonal contraceptives containing a progestin and an estrogen on liver proteins and coagulation factors that are sensitive to estrogen. In this study, a contraceptive vaginal ring containing Nestorone® (a progestin with no androgenic properties) and ethinyl estradiol was compared to an oral contraceptive containing levonorgestrel (an androgenic progestin) and ethinyl estradiol. |
Solid organ transplantation (SOT) has emerged as a lifesaving therapy for many patients with end organ failure. SOT recipients have a lifelong increased risk for infections as a result of immunosuppression, including those caused by pneumococci. The increased susceptibility to pneumococcal infections is multi-factorial and is related to underlying immunosuppression as well as varying degrees of splenic dysfunction as a result of underlying pretransplantation diseases, among other factors.~The types and severity of invasive pneumococcal disease vary among each transplant population. However, comparative data are lacking. Lung transplant recipients have the highest incidence of bacterial pneumonia among solid organ transplant recipients. Pneumonia secondary to Streptococcus pneumoniae occurs in heart transplant patients at a rate 10 times that found in the general population. It is suggested that besides the intensity of immunosuppression, ongoing immunosuppression is important as a risk factor for invasive pneumococcal disease in transplant recipients.~Despite the fact that 23-valent polysaccharide pneumococcal vaccine is one of the vaccines that receives priority among organ transplant recipients, at the Hospital for Sick Children, several cases of pneumococcal disease have been seen. The advent of the 7-valent conjugate vaccine affords the opportunity to possibly reduce the burden of pneumococcal disease in the patient population by virtue that it may be more immunogenic in transplant patients~This study will examine the antibody titres achieved among transplant recipients who are immunized with Prevnar™, as well as evaluate the safety and tolerability or Prevnar™ administered as a three-dose regimen to children and adolescents following organ transplantation. | We plan to study whether the 7-valent pneumococcal conjugate vaccine (Prevnar™) is safe and effective in protecting children who have had a solid organ transplantation and healthy children from pneumococcal infections.~We expect that two or more doses of Prevnar™ will result in similar antibody responses among transplant recipients compared with healthy control subjects, and that children who have undergone solid organ transplant will have a similar number of serious vaccine-related adverse events within 7 days after Prevnar™ as the healthy patients. |
An antigen challenge is when a participant inhales either cat, ragweed, or dust dander in increasing concentrations until their lung function drops 15 or 20 percent. | This study is designed to test the hypothesis that salmeterol use, and not fluticasone use or the combination treatment with fluticasone and salmeterol, is associated with a greater number of sputum eosinophils following antigen challenge and, under these circumstances, the migrating peripheral blood eosinophils are less adherent. |
Guidelines recommend physical training in the treatment of patients with CHF. Several studies have demonstrated that even short-term training programmes can increase maximal oxygen intake, improve muscular strength, reduce neurohumoral activity and result in other effects, which are of potential benefit. Following 2-3 months training at 70 - 80% of maximal capacity, improved exercise capacity and oxygen uptake due to increased cardiac output and also better oxygen uptake in the peripheral muscles have been demonstrated. Moreover, studies have indicated an improvement of the quality of life (QOL). However, the effects of exercise training are rapidly lost without maintenance. Thus the crucial question is to identify a method to sustain the physical activity outside an expensive, enthusiastic and highly motivating protocol.~The aim of the study is to determine whether a low-cost home-based training programme can maintain the achieved effect of physical training on exercise capacity and QOL in patients with Chronic Heart Failure.~Comparison:~Patients fulfilling specified criteria for Chronic Heart Failure are randomised to either eight weeks with supervised group-based training (1.5 hrs.) twice a week followed by home-based training according to a specified protocol with supervised group-based training every 2 weeks (1,5 hrs), or to eight weeks with supervised training followed by usual care. During the whole period patients in both groups can contact the Heart Failure Clinic when needed. | The aim of the study is to determine whether a low-cost home-based training programme can maintain the achieved effect of physical training on exercise capacity and QOL in patients with Chronic Heart Failure. |
The safety of a novel drug product containing a new chemical entity should be assessed in an extensive post marketing safety surveillance program. It is also prudent to assess both, the safety outcomes that relate specifically to the targeted population, as well as those that could potentially be related to the special pharmacological characteristics of the novel drug product. Differentiating between the inherent background population risk and a potential incremental risk due to treatment is often challenging. Active safety surveillance using valid epidemiological study designs has been proven to be a pertinent and reliable method to approach this endeavour.~The primary objective of the study, the European Active Surveillance Study of Women taking HRT (EURAS-HRT), is to compare incidence rates of serious adverse events in users of all types of newly prescribed oral continuous combined HRT products. This active surveillance study will assess pertinent cardiovascular outcomes in new HRT users over a study period of up to 8.5 years. Also, all other serious adverse events will be reported.~The new drug product under surveillance in the EURAS - HRT study contains the novel synthetic progestagen drospirenone (DRSP) combined with estradiol.~As estrogen/progestagen combinations increase the risk for thromboembolism, all new drug products that contain a novel estrogen or progestagen should be investigated for their influence on venous and arterial thromboembolic events rates. A large, prospective, controlled cohort study of OC users (EURAS OC study), which compared DRSP-containing OC users with other OC users, demonstrated that DRSP is not associated with an increased incidence for any of the above-mentioned adverse events in OC users. However, because OC users are two to three decades younger than the typical HRT user the results of the OC study can only partially be extrapolated to older age groups.~The participating women will complete a baseline survey using a self-administered questionnaire to describe the baseline risk. After 6 months, 12 months, and then on an annual basis, they will fill out a questionnaire in which they record complaints and events during the use of the prescribed HRTs. All adverse outcomes (including cancer) occurring during the observational period will be evaluated additionally. Reported serious adverse events will be validated and analyzed. As study participants may switch from oral continuous combined products to other oral or non-oral HRT products the outcomes for these preparation are recorded too. However, these results represent not the scientific focus of the study.~Based on experience obtained in previous HRT studies, complex sources of bias and confounding are expected. Multivariate methods will therefore be used to adjust for confounding. | The objective of the active surveillance study is to compare incidence rates of serious adverse events in users of all types of newly prescribed oral continuous combined HRT products. The primary focus is the assessment of pertinent cardiovascular outcomes (such as venous and arterial thromboembolism) in new HRT users for up to 8.5 years. |
Dose-limiting edema and effusions associated with cumulative docetaxel administraton have necessitated the recommendation that all patients should be premedicated with oral corticosteroids such as dexamethasone prior to docetaxel administration. Dexamethasone pre-medication may also decrease the incidence and severity of acute hypersensitivity reactions associated with docetaxel administration. However, administration of weekly dexamethasone can cause additional untoward side effects, especially in the older population. If the data from this phase II study is encouraging, a study to evaluate an even lower dose of dexamethasone can be conducted. | This study is to explore the feasibility of an alternative dose of dexamethasone pre-medication in older breast and lung cancer patients who are receiving weekly docetaxel chemotherapy. |
Traditional agents such benzodiazepines and propofol have long been used to sedate critically ill patients. Unfortunately, these agents have serious disadvantages that may have a negative impact on patient outcomes. These disadvantages include respiratory depression, prolonged mechanical ventilation, paradoxical agitation, myocardial depression, hypotension, tachyphylaxis, physical dependence, and an unpredictable duration of action following long term infusions. Additionally, concomitant use of an opioid or other analgesic is often required for ICU patients to achieve adequate levels of pain relief, which may also prolong awakening and possibly increase respiratory depression.~Dexmedetomidine may offer a new treatment option that remedies many of the deficiencies of traditional sedatives. This agent would provide for accurate, titratable sedation and analgesia without the concurrent respiratory depression and accumulation common to other agents. It may permit greater patient interaction due to reduced impairment of cognition and may reduce risks associated with opioids due to its analgesia sparing property. Although such a drug may have important benefits for ICU patients requiring sedation for greater than 24 hours, dexmedetomidine is not currently approved for such long-term usage. | The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine in ICU subjects who are initially intubated, mechanically ventilated and require sedation for beyond 24 hours. |
Stroke is the third leading cause of death in the United States and other developed countries and a major source of disability, often leading to hospitalization. Prognosis for regaining the ability to walk is good, with 64% of those initially dependent in walking regaining independence by three months. However, many gait abnormalities persist.~Reduced hip, knee and ankle excursions during swing are among the persistent gait abnormalities contributing to poor or inefficient limb clearance. This is generally referred to as foot drop, since the foot drops or drags along the ground during the swing phase. Swing phase abnormalities can result in decreased velocity, limited endurance and an increased risk for falls. These factors can limit mobility and independence in the community. Therefore, intervention is warranted.~The conventional approach to address the poor swing limb function, specifically, insufficient ankle dorsiflexion, is the prescription of an ankle-foot orthosis (AFO). An AFO commonly limits ankle plantarflexion to enhance limb clearance during swing. An alternative approach is to stimulate the ankle dorsiflexors electrically during swing phase to reproduce motion, which can no longer be performed volitionally.~The WalkAide is a new foot drop stimulator. This small, self-contained device attaches to the leg below the knee. The WalkAide contains a number of patented features, including a tilt sensor that measures the orientation of the leg with respect to the vertical. When the leg is tilted back at the end of stance, stimulation of the common peroneal nerve is initiated. This produces flexion of the ankle and other joints (if a flexion reflex is elicited) so that the leg can clear the ground during swing. When the leg is tilted forward at the end of swing phase, the stimulus is terminated. The electrodes attach to the inside of a cuff that is molded to the leg for reproducible positioning from day to day. The device is also designed so that all operations can be done with a single hand, since hemiparesis may prevent the subject from using the other hand. Because of its enhanced features, the WalkAide is anticipated to increase walking speed and improve the quality of life. | To assess the effectiveness of a new stimulator (WalkAide) for the treatment of foot drop. The comparison will involve physical measurements (e.g. walking speed, physiological cost index, Modified Rivermead Mobility Index, etc.) and questionnaires on the quality of life and acceptance of the technology by stroke survivors. |
Healthy Families Alaska (HFAK) is a well-established child abuse prevention program targeted to at-risk families. HFAK is based on the Healthy Families America initiative promoted by Prevent Child Abuse America. The State Department of Health and Social Services (DHSS) administers the HFAK program.~In 1998, the Alaska State Legislature requested a controlled study of HFAK to determine its effectiveness in preventing child maltreatment, promoting healthy family functioning, and promoting child health and development. DHSS awarded the Johns Hopkins University School of Medicine a contract to conduct the study from July 1999 through June 2004.~The study is a randomized trial of six HFAK sites throughout Alaska. It aims to compare services actually provided to HFAK standards, assess program success in achieving intended outcomes, and relate program impact to service delivery.~Families are enrolled over 21 months beginning in January 2000. Families are randomized to either the HFAk group or the control group. Baseline data on family attributes are collected from HFAK files and maternal interviews. HFAK service data are collected from the program's management information system, record reviews, surveys of staff, and staff focus groups. Outcome data are collected when the children were two years old through maternal interview, home-based observations, child developmental testing, review of medical records, and review of OCS child welfare records. | This study will assess the effectiveness of early home visitation by a professional in preventing child maltreatment, promoting healthy family functioning, and promoting child health and development.~The investigators will test the following hypotheses regarding the effectiveness of early paraprofessional home visiting for at-risk families~Actual home visiting services adhere to HFAK standards.~HFAK promotes healthy family functioning, promotes child health and development, and prevents child abuse and neglect.~Adherence to HFAK process standards is positively associated with achievement of outcomes. |
The principle sources of plasma free arginine are (i) diet, (ii) release from protein breakdown and (iii) de novo synthesis directly from citrulline and the recycling of orthinine via the urea cycle. The major pathway of arginine disposal is i)oxidation via orthinine glutamate and subsequently the Tricarboxylic Acid (TCA) cycle and ii)via formation of nitric oxide. The latter pathway plays an important regulatory role in the body's response to stress and is significantly increased after burn injury.~Previous studies with burn patients show i)an increased rate of total arginine flux, ii)a limited rate of arginine de novo synthesis, and iii) an apparent increase in the rate of arginine catabolism as measured indirectly by increased orinthine oxidation. These changes render arginine a conditionally essential amino acid for burn patients. Studies have shown that feeding glutamine to healthy adults significantly alters the blood concentrations of urea cycle intermediates arginine, citrulline and orthinine. Therefore, we hypothesize that the availability of arginine can be improved in the burn patient by supplementing total parenteral nutrition (TPN) support with glutamine.~Using stable isotope tracer studies our specific aims are:~To explore the dynamic aspects of arginine and citrulline metabolism. There will be an emphasis on arginine disposal via oxidation and urea nitrogen formation via nitric oxide production.~To explore the effect of a) depleting arginine and its immediate precursors proline and glutamine, and b)glutamine supplementation on the metabolic pathways of burn patients.~To estimate the rate of nitric oxide (NO) formation in burn patients using arginine and citrulline tracers | The purpose of the study is to understand the way the body uses amino acids and proteins in burned patient during the time they cannot eat normally. This study aims to understand the metabolism of the amino acid arginine in the body after burn injury. The results of this study will help determine the best composition of food needed during an acute burn injury so that body can more efficiently use the supplied nutrient for optimal burn wound healing and early recovery. |
This is a multicenter, randomized, double-blind controlled clinical trial. The trial has been designed to determine whether total homocysteine lowering treatment with a standard multivitamin augmented by a multivitamin containing no folic acid B12, and vitamin B6, versus treatment with an identical multivitamin containing no folic acid, will reduce the pooled rate of recurrent or new cardiovascular disease outcomes or events. Participants will have a brief visit, at which the participant will have physical measurements, blood pressure and history taken. Urine and blood tests will be performed to determine the levels of homocysteine, vitamins and creatinine. Qualifying participants will be randomly assigned to receive multivitamins containing a high dose of folic acid, vitamin B6, and vitamin B12, or an identical multivitamin containing no folic acid, and estimated average requirement amounts of vitamin B6 and vitamin B12. The participant will be required to return annually throughout the next five years for physical exams, blood and urine tests. | This study is being done to compare arteriosclerotic cardiovascular disease in kidney transplant recipient taking a standard multivitamin versus those taking a multivitamin augmented by a high dose combination of folic acid, vitamin B12, and vitamin B6. |
Data will be collected from the participant's medical records, local health care providers and participant's to clarify or add any information. Participants will have samples of blood, and urine obtained during their routine visits, that will be saved for testing in this study. In addition, participant's receiving a kidney biopsy performed as a part of their clinical care, will have a piece of the biopsy used for the study. This study will be followed for five years. | This study is being done to create a kidney transplant database with information from many transplant centers for the purpose of studying ways to help improve transplant outcomes and the care of transplant recipients. This is also being done to learn why kidney transplant recipients have worsening of their kidney function, and whether there are specific findings that could result in future treatments. |
OBJECTIVES:~Primary~Determine the maximum tolerated dose (MTD) of paricalcitol when given with gemcitabine in patients with advanced malignancy.~Secondary~Determine safety and toxicity of this regimen in these patients.~Determine the pharmacokinetics of these regimens in these patients.~Determine the clinical outcome (overall survival and best overall response) of patients treated with this regimen.~OUTLINE: This is a dose-escalation, open-label study.~Patients receive gemcitabine IV over 80 minutes on days 1, 8, and 15 and paricalcitol IV over 15 minutes on days 7 and 14 in course 1. Beginning in course 2, patients receive paricalcitol IV over 15 minutes on days 1, 8, and 15 and gemcitabine IV over 80 minutes on days 2, 9, and 16. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of paricalcitol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A minimum of 6 patients are treated at the MTD.~After completion of study treatment, patients are followed for survival.~PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study. | RATIONALE: Paricalcitol may cause cancer cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving paricalcitol together with gemcitabine may be an effective treatment for cancer.~PURPOSE: This phase I trial is studying the side effects and best dose of paricalcitol when given together with gemcitabine in treating patients with advanced cancer. |
OBJECTIVES:~Compare 3-, 12-, and 18-month changes in self-reported daily servings of fruits and vegetables and percent of energy from fat in healthy women undergoing dietary modification intervention comprising in-person individualized counseling vs automated computer-based counseling vs both dietary modification interventions vs automated computer-based physical activity counseling (control).~Compare the efficacy and long-term effects of these interventions in these participants.~Compare participant acceptance of these interventions, in terms of the proportion and characteristics (e.g., age and race) of participants who accept the intervention and participate in intervention activities.~Compare initial dietary change, in terms of dietary habits, socio-demographics, and self-efficacy, in participants undergoing these interventions.~Compare the maintenance of dietary change, in terms of demographics, self efficacy, and perceived community environmental support, in participants undergoing these interventions.~Compare the cost of delivering these interventions to these participants.~Compare the cost of these interventions when used in routine practice.~OUTLINE: This is a randomized study. Participants are randomized to 1 of 4 arms.~Arm I (in-person individualized dietary modification counseling): Participants undergo in-person individualized counseling in weeks 0 and 3 and receive a phone call by a counselor in weeks 1, 6, and 9 about increasing daily fruit and vegetable intake to 5-9 servings and reducing fat intake to no more than 25% of energy.~Arm II (automated computer-based dietary modification counseling): Participants undergo automated computer-based counseling in weeks 0 and 3 and receive an automated phone call in weeks 1, 6, and 9 about increasing daily fruit and vegetable intake to 5-9 servings and reducing fat intake to no more than 25% of energy.~Arm III (in-person individualized and automated computer-based dietary modification counseling): Participants undergo in-person individualized counseling and automated computer-based counseling in weeks 0 and 3 and receive a phone call by a counselor in week 6 and an automated phone call in weeks 1 and 9 about increasing daily fruit and vegetable intake to 5-9 servings and reduce fat intake to no more than 25% of energy.~Arm IV (automated computer-based physical activity counseling [control]): Participants undergo automated computer-based counseling in weeks 0 and 3 and receive an automated phone call in weeks 1, 6, and 9 about increasing daily physical activity to a moderate amount (20-30 minutes per day).~After study completion, patients are followed at 3, 12, and 18 months.~PROJECTED ACCRUAL: A total of 600 participants (150 per arm) will be accrued for this study within 2 years. | RATIONALE: Eating a diet high in fruits and vegetables and low in fat may lower the risk of some types of cancer. Dietary counseling may be effective in helping women change to a healthy diet.~PURPOSE: This randomized clinical trial is studying how well individual counseling and/or computer-based counseling work in helping healthy women adopt a cancer prevention diet. |
Tobacco use is the single leading preventable cause of death in the United States. Nicotine is an alkaloid that is derived from the tobacco plant responsible for the psychoactive and addictive effects of smoking. Immunotherapy may be useful in preventing and treating nicotine dependent individuals. NicVAX is a nicotine vaccine, a type of immunotherapy that may be effective in smoking cessation and preventing relapse to nicotine. The purpose of this study is to evaluate the safety and efficacy of various dosing levels and dosing frequencies of NicVAX in treating nicotine dependent individuals. | Nicotine is highly addictive and many individuals are unable to quit smoking even with treatment. The purpose of this study is to determine the effectiveness of various doses of NicVAX in treating nicotine dependent individuals. |
Hawaii's Healthy Start Program (HSP) is a well-respected home visiting program for families at risk for abuse of their newborn children. The program incorporates early identification of at-risk families. Each family then begins receiving long-term home visitations. The home visiting component aims to promote child health and development and to prevent child abuse by improving family functioning and parenting. Home visitors are trained paraprofessionals working under professional supervision. The program includes both direct services and referrals to community resources. Direct services include providing emotional support to parents, encouraging them to seek needed professional help, teaching parents about child development, and role-modeling parenting skills and problem-solving techniques. In a previous study, at-risk families were randomly assigned to either HSP or no intervention. Evaluations were conducted at the time of the child's birth and at ages 1, 2, and 3 in order to assess the home environment and the development and well-being of the child. This study is a continuation study. Participants will include the original families from the previous study, as well as a new group of families who are not at risk for child abuse. By interviewing and observing these two groups of families, this study will evaluate the effectiveness of HSP in promoting children's mental health, cognitive and social-emotional development, and academic achievement in the first years of school.~All families will be evaluated on a yearly basis when the child is in 1st, 2nd, and 3rd grade. Interviews will be conducted with the parents, children, and teachers. Parent interviews will focus on family functioning, including mental health of the parents, parenting attitudes and behaviors, quality of the home environment, and any domestic violence or substance abuse that occurred. In addition, the child's health and development, as well as use of any community resources will be assessed. Interviews with the children and teachers will focus on assessing the child's behavior and emotional well-being. The family's home environment, the interaction between the parents and children, and the children's classroom behavior will be observed. Each child will also undergo developmental testing. All measurements will be collected at each yearly visit. | This study will evaluate the effectiveness of Hawaii's Healthy Start Program (HSP), a home visitation program for families at risk for child abuse, in promoting the health and development of children. |
This is a three-group randomized placebo-controlled double blind trial to assess which postoperative analgesia is best after total hip replacement. The conventional analgesia includes both intrathecal morphine at surgery and Patient Controlled Analgesia (PCA) with morphine in the first 48 hours after surgery. This will be compared with two experimental groups which will receive either intrathecal morphine and PCA with placebo or intrathecal placebo and PCA with morphine. Escape medication with intramuscular morphine is available in all groups. A total of 120 patients will be randomized.~VAS- score at rest and with movement will be recorded every three hours for the first 48 hours after surgery, as well as PCA-bolussum and Morphine IM. | There are several treatments for postoperative pain after Hip Replacement Surgery. However, some require an intravenous line which may interfere with rehabilitation after surgery. This study aims to evaluate which method of pain treatment is best after Hip Replacement Surgery. Patients will either receive pain treatment at surgery, continuous intravenous pain treatment, or both. In the first two days after surgery, patients will frequently be asked to rate their pain, and use of other pain medication will be monitored. |
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 contraceptive efficacy, bleeding pattern, and safety of SH D00342A. Subjects participating in the study will be treated with an oral contraceptive pill containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel. |
Thirty (30) eligible normal subjects will be randomized to one of two study groups: rabeprazole 20 mg OD (n=15) or placebo OD (n=15). Both rabeprazole and identically appearing placebo will be given to Temple from Janssen Pharmaceuticals. The randomization schedule will be prepared by John Gaughan, PhD of Temple University School of Medicine Department of Biostatistics using a random number generator. The coded medications will be dispensed by Temple's Department of Pharmacy. Study subjects and the investigators will be blinded as to the subject receiving either placebo or rabeprazole. The sealed code will not be broken until after the data analysis.~Study subjects will be admitted to the Temple Clinical Research Center for the duration of the study. Appendix I has the study time line. Study subjects will arrive at the CRC at 6:00 A.M. on study day 1. Female subjects will have a urine pregnancy test performed. Blood tests will be obtained for salicylate and alcohol levels. Each study subject will receive a single dose of study drug (rabeprazole or placebo) at 7:00 A.M. on study days 1, 2 and 3-one hour before breakfast on days 1 and 3 and 90 minutes before breakfast on study day 2. All research subjects will receive aspirin (ASA), 325 mg tablets as 2 tablets with 8 oz. water every 4 hours at 8:30 A.M., 12:30 P.M., 4:30 P.M., 8:30 P.M., 12:30 A.M. and 4:30 A.M. daily for study days 1, 2 and 3 (a total of 3900 mg aspirin per day). Esophagogastroduodenoscopy will be performed at 8:00 A.M. on the mornings of days 2 and 4; that is, 24 hours and 72 hours after initiation of aspirin and test drug. During each endoscopy, the maximum number of submucosal hemorrhages and erosions in an endoscopic field from the anterior and posterior walls of the antrum will be counted. In addition, a Lanza score will be assigned for each endoscopic examination (Appendix II). Endoscopic photographs will be obtained for each endoscopic examination. A blood sample will be obtained at 7:00 A.M. on study days 2, 3 and 4 for measurement of hemoglobin and serum salicylate. Meals will be standardized as follows for each day of the study:~Breakfast: 8:00 A.M. (study days 1 and 3); 8:30 A.M. (study day 2) 2 eggs, 2 slices of soft white bread, 4 oz unsweetened orange juice Lunch: 1:00 P.M. (study days 1, 2 and 3) Turkey sandwich, 2 slices of wheat bread, lettuce, tomato, 1 orange, 8 oz apple juice Dinner: 6:00 P.M. (study days 1, 2 and 3) Two plain hamburgers, ketchup, mustard, lettuce and tomato; tossed green salad with thousand island dressing, 1 cup of French fries, 8 oz whole milk Snack: 10:00 P.M. (study days 1, 2 and 3) 4 graham crackers, 4 oz orange juice~If the Lanza score reaches 4 for any subject indicating widespread involvement of the stomach with submucosal hemorrhages, erosions, or ulcerations, that subject will not receive any more aspirin, but continue with study drug of placebo or rabeprazole. If this was detected on day 2 of the study, the subject will continue to receive the study drug with the repeat study endoscopy on day 4. If the Lanza score day 4 (the end of the study) is 4, the subject will be treated with rabeprazole 20 mg po qd for one month. If there was an ulcer, a repeat upper endoscopy will then be performed at 4 weeks to ensure healing. | To determine the effectiveness of rabeprazole in preventing or decreasing acute gastroduodenal injury caused by therapeutic doses of aspirin in a placebo-controlled, randomized, double-blind parallel group study. |
The overall aim of the proposed project is to increase receipt of a broad array of childhood preventive health services in a population of disadvantaged inner city children. Specific hypotheses concerning risk factors for infant under-immunization and lack of receipt of well child care will be tested. This study will first examine these risk factors in a defined population of inner city children, using a historical cohort. Finally, through the use of a randomized controlled trial in a prospective birth cohort, it will test an intervention, based partly on the evidence gathered from the initial study phases, to increase immunization rates and well child care delivery in those children most at risk for falling through the cracks. These studies will be conducted in the Denver Health community health network, the largest integrated community health care system in the United States.~Information gathered via rigorous exploration of risk factors for inadequate preventive service receipt in inner city children is especially important at present, because despite rising immunization rates around the country, it is clear that pockets of need remain in many urban locations. Children in these pockets of need, in addition to being under-immunized, also are at higher risk for lack of other preventive services, and suffer from higher rates of iron deficiency anemia and lead poisoning. The knowledge gained from both the descriptive and interventional parts of the study will provide crucial information for physicians who care for these children, health care systems that serve them, and policy makers responsible for promoting effective tools and funding their implementation. The information gained herein will also provide important methodological insight for generalists who wish to conduct interventional studies in large urban populations, by further refining existing methods used in design and implementation of large cohort studies in disadvantaged children.~Although this project will be conducted among a population of disadvantaged inner city children, many of the findings from these studies will likely be applicable in health care systems that serve other socioeconomic groups. All primary care physicians who care for children face the challenge of trying to boost childhood immunization rates over 90%, and to increase the delivery of a full spectrum of preventive health services to children. The investigators hope that the evidence from this project will inform and shape both the clinical practice of individual health care providers and health care systems charged with providing preventive health care to children in a wide variety of settings. | The study hypothesis is that case management using patient navigators (promatoras in the Latino community) will increase infant immunization rates and use of well child care in an inner city population of low socioeconomic status. |
This study is a randomised controlled trial. Its objective is to compare results and complications between two techniques of nerve localisation for nerve blocks of the lower limb. We have developed a real-time, image guided approach to nerve blocks of the lower extremities in three locations: the femoral nerve in the groin and the sciatic nerve in the buttock and/or popliteal fossa. We have used ultrasound imaging to locate and asess the nerves of the lower extremities and to use it as a real-time guidance for performance of lower extremity blocks in patients undergoing orthopaedic procedures. The results of our previous study will be presented as a case series reporting anatomical appearance of the nerves studied, time for block performance and success rates. In this study we aim to compare these parambeters between standard and ultrasound techniques of lower extremity block, to show any advantage. | Nerve freezing injections of the leg are very useful in providing anesthesia and pain relief for knee and ankle surgery. However, current nerve freezing techniques are blind. As a result, they are not always successful and may cause complications, albeit infrequent.~The objective of the current study is to determine any advantage in performing these freezing injections under direct ultrasound guidance, to visualize the nerves. We feel that by developing this technique, it will allow us to perform these procedures with greater success and fewer complications. |
Randomized clinical trial to test the effects of a comprehensive prenatal, in-hospital, and postpartum education and support intervention on breastfeeding initiation and duration among teenage mothers. Experimental, attention control, and usual care groups are used to test the hypotheses. Drawing on the Theory of Planned Behavior and begun during the second trimester of pregnancy, the experimental condition uses a lactation consultant-peer counselor team to influence pregnant adolescents' beliefs and intentions about breastfeeding their newborns. The attention control (placebo) condition mimics the experimental condition, using an advanced practice nurse and peer counselor intervention team, and focuses on healthy pregnancy behaviors and labor/birth preparation. Teens in the two intervention groups attend two prenatal classes specific to their focus between the fourth and ninth month of pregnancy and receive telephone calls from a peer counselor. Teens in a usual care group receive no interventions beyond their standard prenatal care and education. After giving birth and still in the hospital, teens in the intervention groups receive a peer counselor phone call and visit. Breastfeeding teens in the experimental group also receive a breastfeeding counselor visit. After hospital discharge, breastfeeding teens from both intervention groups continue to receive peer counselor telephone support and, in the experimental condition, breastfeeding counselor phone calls for four weeks. Breastfeeding teens from all three groups complete short telephone interviews until six months after birth or until they stop breastfeeding. | Breastfeeding initiation and duration in adolescent mothers. |
The Feldenkrais Method is an educational process which involves exploration of novel movement sequences that lead to expansion of the movement repertoire. This Method has been used with the aim of improving balance and mobility in several studies, and has been compared to the benefits of Tai Chi for improving balance in older adults. The current study investigates the effects of a 10 week series of Feldenkrais movement classes on gait parameters as measured on an instrumented gait mat, a balance test of stepping and turning (the Four Square Step Test) and a questionnaire about balance confidence (the Activites Specific Balance Confidence scale. | The purpose of this study is to investigate the effects of a series of Feldenkrais movement lessons on mobility and balance, particularly for older adults. The investigators hypothesise that mobility and balance will improve following the classes. |
We test the effectiveness of an homeopathic drug versus placebo and a temporal control group (patient with no add-on treatment) following orthopedic knee surgery.~All patients have a PCA of morphine for 24 hours after surgery. After this period they can take an oral tablet of morphine on request.~Group A: Patients with study treatment (homeopathy) allocation. Double blind group with 70 patients~Group B: Patients with placebo allocation. Double blind group with 70 patients~Group C: Temporal control group with patients who take only the morphine. Open group with 25 patients~The total power: 70 +70 + 25 = 165 patients~Main Objective:~To assess the effect of homeopathy in terms of morphine consumption delivered by PCA (patient control analgesia) for 24 hours after a knee ligamentoplasty.~Secondary Objectives:~To assess the effect of homeopathy in terms of total morphine consumption between H24 and H72 after a knee ligamentoplasty.~To assess the effect of homeopathy on the pain perception using a analogical visual scale for 72 hours.~To asses the placebo effect of the homeopathic treatment.~Main Assessment Criterion:~Morphine consumption delivered by PCA between 0 and 24 hours after knee ligamentoplasty~Secondary Assessment Criteria:~Morphine consumption between 0 and 72 hours after ligamentoplasty~Pain assessment at H0, H4, H24 and H72 using 10 cm Analogical Visual Scale~Inclusion Criteria:~age ranging from 18 to 60.~patients candidates for a ligamentoplasty of the anterior cruciate ligament.~Exclusion Criteria:~patient with corticoid and immunodepressor treatment | This is an add-on, double blind, and randomised clinical trial with three groups: a homeopathic group, a placebo group, and a temporal control group.~The aim of this trial is to assess the effect of homeopathy on the consumption of morphine delivered by PCA (patient control analgesia) for 24 hours after a knee ligamentoplasty. |
Design: A prospective, randomized, controlled clinical trial to study the effectiveness of applying fluoroscopy guided femoral artery access in the cardiac catheterization lab and its effect on the usage of FDA approved femoral artery closure devices. This trial will randomize patients between fluoroscopy guided femoral artery access or femoral artery access using the usual anatomic landmarks and will then study the difference in the ability to use closure devices on the access site.~Purpose: To establish the safety and efficacy of using fluoroscopic assistance to allow access of the common femoral artery rather than its branches and thus increase the ability to use closure devices.~Enrollment: An approximate enrollment of up to 1000 patients (all patients randomized) who will be undergoing cardiac catheterization and who meet all the eligibility criteria at OUMC and VAMC in Oklahoma City.~Duration: The study will be conducted over approximately one year.~Primary Endpoint: Prediction of ability to use femoral artery closure device based on angiographic data of the femoral artery from fluoroscopy arm versus traditional technique arm.~Secondary Endpoints:~Compare the incidence of known major side effects of femoral artery puncture between the two methods of access~Compare the time and number of attempts needed to obtain arterial access between the two groups of patients.~Compare the ability to puncture the common femoral artery using fluoroscopy vs. anatomical landmarks among different levels of trainees (cardiology fellows) and attending cardiologists.~Assess whether fluoroscopic guidance is a superior method to obtain access and thus should be used as a training technique for cardiology fellows.~Analytical Subset: Intention-to-treat sample | The purpose of this study is to compare the use of fluoroscopic guidance, (a commonly used X-ray technique), with the traditional approach, (where the doctors feel for the strongest pulse), to obtain access to the blood vessel in the groin. These two methods are being compared to assess which is faster, safer and more often allows your physician to use an arterial closure device, a small suture or plug applied at the end of the angiogram where the needle enters your blood vessel if he/she chooses. |
Postpartum perineal pain is common after vaginal delivery. Naproxen suppositories have been shown to be effective at reducing postpartum perineal pain. To date, no studies have investigated the efficacy of oral naproxen for perineal pain control. Currently, rectal naproxen is used postpartum because of an assumption that there is a local effect compared to oral administration. However, this effect has never been documented in the literature.~Principles of pharmacology dictate that the least invasive route of drug administration should be used when two or more routes are equally effective. If oral and rectal naproxen are equally efficacious at controlling post-vaginal delivery perineal pain, then current practice would be challenged.~The primary objective of this study is to determine whether the route of administration of naproxen influences post-vaginal delivery perineal pain control. Pain scores will be measured using a visual analog scale. The secondary outcome measures are three-fold: patient preference of route of administration, medication adverse effects, and additional requests for analgesia. The working hypothesis is that there is no difference in pain control between oral and rectal administration and that patients will prefer the oral route. | The primary objective of this study is to determine whether the route of administration of naproxen (either by mouth or rectally) influences post-vaginal delivery perineal pain control. |
The use of chlorhexidine for skin asepsis for the placement of intravascular catheters is known to decrease the incidence of central line colonization and blood stream infection when compared to the use of povidone-iodine. While the development of an infectious complication following spinal or epidural analgesia, such as epidural abscess or meningitis, is fortunately rare, when it does happen, there can be devastating consequences for the affected individual. The low frequency of infection makes a trial with an endpoint of clinical infection not feasible, however a reduction in skin and needle contamination following attempts at asepsis should reduce the risk of infectious complication. Ongoing work by the authors is examining the skin culture rates following randomized standardized skin disinfection. The purpose of this randomized trial is to compare needle culture rates to further assess effectiveness of skin disinfection following a standardized skin preparation with either povidone-iodine or chlorhexidine in pregnant women requesting lumbar epidural pain relief in labour. | Infection after epidural catheter placement is fortunately rare. When it does happen, the affected person can become seriously ill.~This study examines which skin disinfectant, chlorhexidine or povidone-iodine, decreases the number of bacteria that can be grown from the skin washed with each disinfectant prior to placing an epidural catheter for pain control in labour. |
Cardiovascular disease after renal transplantation is an important problem. Patients after renal transplantation with low LDL-Levels (<130mg/dl) receive Fluvastatin 80mg/day (or no medication, to look for the cardiovascular outcome with and without statins. | Cardiovascular disease after renal transplantation is an important problem. Patients after renal transplantation with low LDL-Levels (<130mg/dl) receive Fluvastatin 80mg/day (or no medication, to look for the cardiovascular outcome with and without statins. |
Primary endpoint is the~serum creatinine in patients with and without polymorphysms~rate of rejections in patients with and without polymorphysms | In this study the researchers want to investigate genetic polymorphisms of cytochrome 450 enzymes and the multiple drug resistance (MDR) gene in renal transplant patients to look for differences in dosing of immunosuppressive drugs (tacrolimus, sirolimus, everolimus, cyclosporine A).~All patients who receive one of these drugs can be included and drug blood trough levels, dosing and genetics are compared. |
Purpose/Objectives~a. Specific Aims Specific Aim 1: Characterize in humans the effects of inflammation and neuronal degeneration on peripheral levels of NPY, and related Y receptors (Y1, Y2, Y5) in periradicular tissue.~Specific Aim 2: Determine whether NPY inhibits neurosecretion from peripheral terminals of capsaicin-sensitive neurons innervating normal versus inflamed tissue.~Specific Aim 3: Determine whether peripheral administration of NPY is analgesic and/or anti-allodynic in patients experiencing spontaneous pain and mechanical allodynia in a clinical model of inflammation with associated neuronal degeneration.~Specific Aim 4: Evaluate whether population characteristics are associated with altered pain reports. First, we will determine whether patients with the C1128 single nucleotide polymorphism (SNP) of the PreProNPY gene, whose phenotype confers substantially augmented peripheral NPY neurosecretion, report less pain compared with patients without this genetic polymorphism. Second, we will determine whether ethnic/cultural factors associated with an underserved minority population (Hispanics in the San Antonio area) are associated with altered pain reports. | This protocol is for a number of in vitro studies using human surgical biopsies and evaluating the pharmacology and genetics of human nociceptors (pain detecting) neurons |
Randomized clinical trials and naturalistic studies show that among patients meeting criteria for chronic mental illness, those participating in vocational rehabilitation (VR) have significantly reduced days of inpatient hospitalization. Unfortunately, the majority of eligible adults fail to enter VR and almost half of those who do, drop out or are involuntarily discharged. The reasons for nonparticipation and drop out and their impact on rehabilitation outcomes are poorly understood.~The study will provide needed naturalistic data documenting:~the way in which barriers function to reduce entry to services and contribute to the high rate of dropout,~the outcomes associated with different patterns of participation, and~relative rates of entry and retention in a non-VHA VR exemplar of the Intensive Placement and Support (IPS) model at the Manchester Mental Health Center in Manchester, New Hampshire.~While we need to know more about these barriers in order to develop the range of appropriate interventions, the enhancement of client motivation for work and rehabilitation is likely to have a positive impact both on entry and sustained compliance. We are proposing a random assignment single blind trial of a brief Motivational Interviewing (MI) intervention designed to address the low entry and retention rates of veterans with Serious Mental Illness (SMI) in Veterans Health Administration's (VHA) VR services. | This study will examine the barriers and supports for entering and receiving work-related services for veterans with a serious mental illness. It will also determine the effectiveness of a brief motivational interviewing intervention designed to help veterans receive these services. |
A Multi-Center, Open-Label, Parallel Group Study of the efficacy and safety of Ferrlecit in the Maintenance of Iron Stores and Serum Hemoglobin Concentration in Hemodialysis Patients Receiving Erythropoietin. Patients with normal iron indices receive one of two doses of Ferrlecit administered weekly throughout the treatment period. Efficacy was assesses at designated timepoints throughout the study and after the last Ferrlecit dose. | This is a phase 4 clinical investigation of the efficacy and safety of Ferrlecit in the maintenance of iron stores and serum hemoglobin concentration in hemodialysis patients receiving Erythropoietin. |
This study explores the impact of initiating statin therapy on subsequent dietary as well as other lifestyle beliefs, attitudes and behaviors.~Specific aims:~To test whether the initiation of statin therapy increases dietary saturated fat intake among statin naive patients.~To determine what role attitudes, beliefs, expectations, motivation, intention and self-efficacy regarding drug or diet therapy may play in observed changes in dietary behavior after starting statin therapy. | The purpose of this research is to improve our understanding of the effects that taking cholesterol reducing pills have on dietary behavior as well as other health related behaviors |
This model will identify potentially modifiable variables in the post-hospitalization clinic setting that result in increased rates of hospital readmission and mortality. Specifically, it is hypothesized that longer time to first outpatient visit after hospitalization, multiple providers, poor follow-up with scheduled appointment and discrepancies between discharge and outpatient medication lists will be predictors of adverse outcomes. Utilizing statistical modeling methods, it will be possible to recognize at risk patients, to identify modifiable risk factors and outpatient care characteristics, and in the future, to direct patient specific interventions to improve outcomes. | The aim of this study is to construct a prognostic model to identify risks of poor outcomes at one year following hospital discharge of patients treated in an ambulatory cate setting. The study will incorporate pre-hospitalization characteristics, hospitalization events, comorbidity burden, psychosocial measures and post-hospitalization care characteristics to predict re-hospitalization and mortality at one year. |
We are recruiting women who are presenting for their first (primary) cesarean delivery. They will be randomized to one- or two-layer myometrial closure at the time of their cesarean delivery. Ultrasound will be used to serially assess the myometrial thickness and myometrial remodeling process. | Our hypothesis is that there is no difference in the healing process in those women who have a one- or two-layer uterine closure at the time of cesarean delivery. |
The primary objective of the study was to investigate the safety and tolerability of CAIV-T liquid formulation in healthy Japanese male adults by evaluating the incidence of influenza-like symptoms, and the type, incidence, and severity of adverse events. | The primary objective of the study was to investigate the safety and tolerability of CAIV-T liquid formulation in healthy Japanese male adults. |
Evaluation of the dipping status of blood pressure (wether blood pressure decreases at night) and renal functional reserve and wether non-dippers (those whose blood pressure does not decrease at night) can be modulated to dippers with potassium treatment. | Evaluation of the dipping status of blood pressure (wether blood pressure decreases at night) and renal functional reserve and wether non-dippers (those whose blood pressure does not decrease at night) can be modulated to dippers with potassium treatment. |
To compare male and female smokers, with and without current depressive symptoms, in a prospective study of the intensity, content & duration of nicotine abstinence effects during an eight-day abstinence period, and responses to cue exposure (invivo cigarette cues, alcohol and negative affect-inducing imagery cues) during acute vs. prolonged abstinence and,~To compare male and female smokers, who are either heavy alcohol drinkers or light alcohol drinkers, in a prospective study of the intensity, content & duration of nicotine abstinence effects during an eight-day abstinence period, and responses to cue exposure (invivo cigarette cues, alcohol and negative affect-inducing imagery cues) during acute vs. prolonged abstinence. | This proposal will conduct a prospective examination of the clinical course (intensity, content and duration) of tobacco (nicotine) abstinence effects in male and female smokers who are either heavy/light alcohol drinkers with/without depressive symptoms. |
To determine the outcome and side effects following thoracoscopic sympathectomy in patients treated for disabling isolated facial blushing. In addition, following randomization investigate if there are any significant differences between two different routine procedures: T2 or T2-T3 sympathectomy. Includes QoL before and 12 months after surgery | To determine outcome and side effects following thoracoscopic sympathectomy in patients treated for disabling isolated facial blushing and investigate if there are any significant differences between two different routine procedures: T2 or T2-T3 sympathectomy. |
Chondrogen is a preparation of adult mesenchymal stem cells (MSCs) in a solution containing hyaluronic acid. Preclinical studies have shown that injection of Chondrogen aids in the repair of meniscal tissue following meniscectomy. In Chondrogen treated subjects, surgically removed meniscal tissue was regenerated, cartilage surface was protected, and joint damage was decreased in comparison to control subjects. These benefits persisted at least one year.~Three groups of recent meniscectomy patients will be followed in this study, including patients that will receive placebo and patients that will be treated with one of two possible doses of Chondrogen. | The purpose of this study is to determine whether Chondrogen is a safe and effective post-operative treatment of the knee following menisectomy (the surgical removal of all or part of a torn meniscus). |
For the past 10 years, the use of computer-assisted surgery has expanded and is now widely spread in the orthopaedic domain, but not in maxillary-facial surgery. The main disadvantages of this technique are the necessity to fix a mark on the eyebrow with two transcutaneous pins, which is a long and invasive act, and to connect the infrared transmitter which is in contact with the patient with the computer in a limited surgery area. In this study, we want to show that the new repositioning optic systems are performing similarly to the actual validated one, that they permit to suppress the transcutaneous pins and the computer connection, and that it reduces the financial cost of this surgery. Neither the surgery technique, nor the pre-operative check-up will be modified in the study. The two repositioning systems will be used simultaneously during the mandibular osteotomy. | The main objective of this study is to validate a simplified platform of a repositioning system in orthognathic surgery (a third generation optic repositioning system called MicronTracker) compared with the actual clinically validated one (Orthopilot system). |
We propose to measure differences in patient safety and quality measures among three groups: the control group consisting of physicians with paper-based office practices, a group of physicians using the clinical messaging system and electronic prescribing, and a group of physicians using the EMR and electronic prescribing.~We plan to introduce a vendor based electronic prescribing system by July 2005. This system will be offered to all physicians using clinical messaging and will be integrated with the EMR system. The system will have clinical decision support, such as checks for drug-drug interactions.~Our evaluation will measure differences in rates of medication errors and quality measures amongst these three groups. We will use a study design of a pre-post evaluation with a comparison control group. We will detect medical errors by prescription and chart review. We will determine compliance with quality measures through a combination of electronic data and chart review. | The Taconic IPA, a 2,500 physician independent practice association (IPA) located in Fishkill, New York (NY), is involved in an information technology project to improve the quality, safety and efficiency of healthcare in the region. Over the past three years, the organization has worked with area hospitals and laboratories to create a community wide electronic data exchange. Currently, the Taconic IPA is in the midst of implementing a full electronic health record in some practices and e-prescribing in other practices. The purpose is to study the impact of an electronic health record on safety and quality measures. |
From the practices committed to implementing EHR in early 2005, we randomly selected 15 adult community-based primary care physicians. We selected 15 similar physicians in practices that were not planning to adopt in that time period.~At each of these physicians' practices we documented rates of medication errors for one week prior to the implementation of an EHR using duplicate prescription pads. Two months after the implementation in the adopting group, allowing some time for familiarization with the tool, we collected two weeks of data using computer-based information (in the adopting arm) and duplicate prescriptions (in the non-adopting arm). | To determine the effects of Electronic Health Record use on medication error rates in primary care office practices.~Hypothesis: Adoption of Electronic Health Records through this program will reduce medication errors |
This study is a 10-week double-blinded treatment study of perimenopausal and postmenopausal women who present with menopause-related symptoms after discontinuing Hormone Therapy(HT), with or without concomitant symptoms of depression and anxiety.~The menopausal transition is a period of heightened vulnerability to mood and anxiety disturbances. It is also a period when women may experience significant vasomotor symptoms (i.e. hot flushes and night sweats). More recently, the occurrence of vasomotor symptoms has been associated with increased risk for depression in menopausal women.~The efficacy of estrogens for the treatment of vasomotor symptoms is well established. In addition, the literature support a modulatory effect exerted by estrogen on various neurotransmitter systems that regulate mood and anxiety.~Despite the efficacy of hormone therapy (HT) for the treatment of menopause-related symptoms, a significant number of women discontinue its use during the first year of treatment. Moreover, recent findings from the Women's Health Initiative Study (WHI) have challenged the safety and the benefits that were initially thought to be associated with long-term use of HT. As a result, many women who have been taking HT decided to discontinue the use of HT, which may result in significant changes in their physical well being, quality of life and, possibly, their mental health status. Therefore, the efficacy and tolerability of other interventions such as antidepressants for these sub-populations warrant further investigation.~Treatment with Paroxetine has shown to be efficacious for menopause-related vasomotor symptoms. To date, no studies have examined the extent to which SSRIs may improve physical and psychological symptoms in women who discontinued HT. | To evaluate the efficacy, safety, and tolerability of Paroxetine treatment in perimenopausal and postmenopausal women who present with menopause-related symptoms after discontinuing hormone therapy (HT), in the presence or absence of concomitant symptoms of depression or anxiety. |
Fase 1: 600 patients waiting for or already having received total hip-/knee-replacement participated in a questionnaire study using SF- 36. The aim was to document self-rated health among this population.~Fase 2: Results from the cross section study form the base for the RCT, where 160 patients over 65 years undergoing THR, 80 patients are in an intervention group and 80 patients in a control group. A nurse intervention program is tested, and results from the study will form the base for a structured rehabilitation program. | Patients over 65 years do not have a self care ability the surgery benefits them.~The aim of this study is development of a rehabilitation program based on patients' self-rated health.~A cross section study including 600 patients~RCT including 160 patients |
The SF prototype is an ultrasound (US) display device under development at our institution that replaces the traditional US monitor by using a half -silvered mirror to reflect real-time US images into the body. When the operator looks through the half -silvered mirror, the US image appears to float beneath the surface of the skin, exactly where it is being scanned. The SF merges the US image, probe, needle, operator's hands, and patient into the same field of view, making procedures more intuitive to the novice user, in contrast to conventional US (CUS) guided procedures, where hand-eye coordination is displaced, forcing the operator to look away from the field to see the US screen. We have previously shown that VA in phantoms is easier to use, faster to use, and faster to learn than CUS in novice and experienced US users. The current SF prototype uses a 10MHz US system (Terason, Burlington, MA) modified by attaching a small flat-panel display (AM550L OLED, Kodak, Rochester, NY) and a 20x50x1mm half -silvered mirror to the probe. A standard, clear, sterile polyethylene US probe cover was placed over the entire SF to sterilize the device. 15 subjects needing PICC lines were enrolled in this study. Scanning the upper arm of each patient with the SF, the basilic vein, brachial vein, and brachial artery were identified on the in situ US image. A 21ga needle was guided into the basilic or brachial vein. The number of attempts, or sticks, per PICC line placement, specific vein accessed, and reason for a failed attempt were recorded.~The vasculature was clearly visualized in situ using the SF. The needle was aimed and easily inserted into the basilic or brachial vein, and the needle tip visualized at its expected location. Successful vascular access was obtained with all 15 subjects, 13 of 15 on the first attempt, and 2 of 15 on the second attempt. 3 of the 15 lines encountered mild blurriness looking through the SF due to inconsistent optical properties of the probe cover.~This study shows that venous access can be obtained using the SF. Once the optical problems with the probe covers are addressed, the SF will be ready for a larger clinical trial. | The purpose of the study is to perform the first clinical trial on human subjects using the Sonic Flashlight (SF) to guide placement of Peripherally Inserted Central Catheters (PICCs). |
We have developed a new device for guiding invasive procedures with ultrasound (US), which we call the Sonic Flashlight (SF). We attach a half-silvered mirror and a small flat-panel monitor directly to an ultrasound transducer to project a virtual image of the US scan into its actual location within the patient. This permits the operator to guide a needle through the skin by aiming directly at the image, using natural hand-eye coordination rather than looking away from the patient at a conventional display. We believe the SF will increase accuracy, safety, and speed for a wide variety of invasive procedures and yield a faster learning of these procedures than conventional US displays.~The research proposed here would bring the application of guided needle insertion to its clinical implementation, specifically addressing the placement of the Peripherally Inserted Central Catheter (PICC) line. The PICC line is increasingly viewed as a safe alternative to direct central line placement in the jugular, subclavian, and femoral veins, while being easier to maintain than a peripheral intravenous line. This study will test the hypothesis that PICC lines can be placed by experienced intravenous (IV) team nurses using the SF for real-time US guidance.~Thirty nurse participants (ages 18-65) will be recruited from the IV team at UPMC Presbyterian Hospital to participate in the study. 200 patient subjects will be recruited from the adult (18 years and older) population of patients already scheduled to receive the PICC placement procedure; patients will have the lines placed by experienced IV team nurses using ultrasound guidance with either the SF or conventional ultrasound (CUS). Investigators will observe each procedure, using audio and video recording, ultrasound image data, and other characteristics of the procedure to monitor the success of each procedure. A set of feasibility trials will be conducted in the interventional radiology (IR) suite to assess the level of training the nurses have received prior to the start of the comparison trial. | The purpose of this study is to test whether peripherally inserted central catheters can be safely placed on patients by intravenous team nurses at the bedside. |
The purpose of this research is to create a manual wheelchair propulsion-training program (MWPTP) that emphasizes propulsion techniques that improve the manual wheelchair users stroke pattern and efficiency. It is our hope that the design of a manual wheelchair-training program can help to minimize the upper extremity pain and injury often associated with manual wheelchair propulsion.~The MWPTP will exist in three forms, and will be given to three randomly assigned groups of subjects. An instruction only group (IO) will receive general instructions on how to best propel their wheelchair. A feedback group (FB) will receive additional instruction in wheelchair propulsion using a monitor displaying a random combination and amount of biomechanical feedback variables, such as cadence and proportion of time spent in propulsion. Subjects will be coached to develop an appropriate propulsion style that minimizes all of the predetermined feedback measures, which indicate poor technique and maximize all of the graphical measures indicating good propulsion technique. A control group (CG) will receive only testing which will be identical to the testing procedures followed by the IO and FB groups.~Participation in this study will consist of four visits to the Human Engineering Research Lab (HERL) for the FB, IO and CG. Visits 1-4 will be the same, except visit 4 will not include training for any of the groups. All subjects will use their own wheelchair and cushion; however researchers will attach SMART Wheels TM to the subjects' wheelchair in place of their current wheels. The SMART Wheels TM are used to record the forces and moments that occur during propulsion and will not alter the dimensions or feel of the subjects current wheelchair. During each visit, all subjects will be asked to push over a real life course that includes various grades and surfaces. Then they will be asked to push on a wheelchair dynamometer at 1 meter/sec for one minute, 2 meter/sec for one minute, and a self selected speed for one minute. During this time, data will may also be collected with use of an Optotrak kinematic measurement system that incorporates a camera 3D-motion analysis system. | The purpose of this research study is to investigate a manual wheelchair training program to improve the way manual wheelchair users push their wheelchairs. |
The exercise part of cardiac rehabilitation today is often composed of low to moderate intensity training. Several studies have found interval training with high intensity to be more effective in improving physical capacity in healthy subjects and also in different patient populations. We therefore wish to compare high intensity interval training with moderate intensity training in patients operated with coronary bypass surgery. Maximal oxygen consumption is shown to be the best indicator of how many years you life, both in healthy persons and in cardiac patients.~The subjects in this study is attending a four week rehabilitation program at an residential institution in Norway. They are randomised to do either a moderate or a high intensity aerobic training session each day.~The hypothesis in advance, was that high intensity interval training lead to a greater improvement in maximal oxygen consumption than training with moderate intensity. We also hypothesised that there would be no difference between the two groups after 6 months, since then the patients had to administer their own exercise training. | The purpose of this study is to investigate the effect of high and moderate intensity exercise training after coronary bypass surgery. The subjects are randomised to training at either 60-70% or 85-95% of their maximal capacity daily for four weeks. Primary outcome measure is change in maximal aerobic capacity, measured as change in maximal oxygen consumption, after the training period. Secondary outcome measures are change in quality of life, heart rate variability, ultrasound measures of the heart and blood variables, including endothelian markers. |
We randomised patients to 0% 33% or 66% nitrous oxide during sevoflurane induction and measured anesthetic endpoints. | Our hypothesis is that a new method of depth of anaesthesia monitoring, using theoretically based time series modelling will result in improved ability to determine nitrous oxide anaesthetic effect |
In this study, we will record the depth of anaesthesia during surgery with the BIS monitor and then interview patients immediately upon emergence to determine whether they recall dreaming or not. The depth of anaesthesia of dreamers and non-dreamers will be assessed. | Patients commonly report that they have been dreaming when they awaken from general anaesthesia. Our hypothesis is that patients who report dreaming are less deeply anaesthetised during anaesthesia than patients who do not report dreaming. Depth of anaesthesia will be determined using a processed electroencephalographic monitor (called the BIS monitor). |
Once intervention class or staff contact is removed, obese adults participating in behavioral weight-loss programs often give up healthy eating habits and regain weight. We examined whether taste-based goal setting, which minimizes perceived deprivation by promoting taste and moderation, would sustain long-term reductions in saturated fat and body mass index (BMI). Participants were randomized to Taste-Based Choices (taste-based goal setting + a standard 6-month behavioral weight-loss intervention), Smart Consumers (a standard 6-month intervention alone) or Community Access (access to commercial/community-based behavioral weight-loss programs) and followed over 18 months. To test our hypotheses, we examined a set of orthogonal contrasts (TBC and SC vs. CA; TBC vs. SC) on reductions in saturated fat (Block FFQ) and clinic-measured BMI. | Once intervention class or staff contact is removed, obese adults participating in behavioral weight-loss programs often give up healthy eating habits and regain weight. We examined whether taste-based goal setting, which minimizes perceived deprivation by promoting taste and moderation, would sustain long-term reductions in saturated fat and body mass index (BMI). |
During the operation,before the first incision a randomization envelope is opened. Always starts on the same side, with or without Arista according to the envelope. After surgery, vacuum drains are placed and the amount of drained material and hgb content is measured 24 hours later by nursing staff blinded to what side had Arista.Patients scores postoperative pain with VAS score bilaterally.~Three months postoperatively the patients are checked by a physician blinded for what side had Arista | To evaluate whether Arista AH which contains microporous polysaccharides used as a powder applied to the wound area during mammary surgery reduces the amount of bleeding and the duration of surgery. Both mammae are operated on in the same procedure, and one side without Arista serves as control side |
Standard strategies for the implementation of recommendations are exclusively focused on practitioners. But often they do not appear to be effective (insufficient time accorded per patient, lack of training…).~However some qualitative surveys have shown the benefit of a greater role on the part patient in the process of transmitting recommendations through the practitioner.~In this study, patient education is begun by the angiologist or a pharmacy student under the responsibility of the hospital investigator. Follow-up is realized by the patient's general practitioner.~More patient involvement in the realization of the recommendations could increase the proportion of practitioners who follow the recommendations and decrease the iatrogenicity of antivitamin K (AVK). | The objective of the project Educ'Avk, is to document the efficacy of a strategy combining a specific follow up-notebook and education of attending patient with a pedagogic support, comparatively to an usual education on the impact of clinical events at three months (minor or major hemorrhagic events + recurrence of thrombi-embolic's disease). |
PRIMARY OBJECTIVES:~I. Determine the maximum tolerated dose of vorinostat (SAHA) and bortezomib in patients with metastatic or unresectable solid tumors.~SECONDARY OBJECTIVES:~I. Determine the pharmacokinetics and antitumor activity of this regimen in these patients.~II. Determine the toxic effects of this regimen in these patients.~OUTLINE: This is a dose-escalation study.~Patients receive oral vorinostat (SAHA) twice daily on days 1-14 in step A. Patients receive oral vorinostat (SAHA) twice daily on days 1-4 and 8-11 in Step B and bortezomib IV over 3-5 seconds on days 2, 5, 9, and 12 during the first course and on days 1, 4, 8, and 11 during subsequent courses in both steps A and B. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 1-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 6 additional patients receive bortezomib at the MTD. Subsequent cohorts of 3-6 patients receive escalating doses of SAHA until the MTD of that drug is determined. | This phase I trial is studying the side effects and best dose of vorinostat and bortezomib in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with bortezomib may kill more tumor cells. |
OBJECTIVES:~Primary~Determine the response rate in patients with platinum-sensitive or -resistant relapsed or refractory ovarian epithelial or peritoneal cavity cancer treated with gemcitabine and docetaxel.~Secondary~Determine the toxicity of this regimen in these patients.~Determine the overall survival of patients treated with this regimen.~Determine the time to treatment failure and progression-free survival of patients treated with this regimen.~OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment with a platinum-containing regimen (platinum-resistant disease vs platinum-sensitive disease).~Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 3 additional courses beyond CR (≥ 6 total courses of treatment).~PROJECTED ACCRUAL: Approximately 36-62 patients (19-29 for stratum I [platinum-resistant disease] and 17-33 for stratum II [platinum-sensitive disease]) will be accrued for this study. | RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.~PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with relapsed or refractory ovarian epithelial or peritoneal cancer. |
Nasal lavage is a relatively simple way to measure the degree of upper airway inflammation. It is useful in research because it is noninvasive, relatively discomfort-free, and simple to perform. Yet there is no standardized method for collecting upper airway cells. The definition of nasal lavage can differ widely between research groups. The method, and its pooled modification, chosen for this trial are based on the commonly used Naclerio technique.~Upper airway inflammation is linked to a broad spectrum of disease: nasal polyposis, seasonal and perennial allergic rhinitis, vasomotor or non-allergic rhinitis, and sinusitis. Assessing the degree of upper airway inflammation through objective measures has obvious clinical and research benefits. For example, nasal polyps contain a large number of activated eosinophils - about 20% of the constituents of nasal polyp tissue. Allergic rhinitis is also associated with elevated inflammatory cell counts - eosinophils, basophils, mast cells, lymphocytes and their mediators. The impact of treatment on nasal inflammation is a key factor in the evaluation of new nasal polyp or allergic rhinitis therapies. Therefore it is imperative that nasal inflammation measurements be evaluated for reliability.~As nasal inflammation is present in a variety of diseases, a cross section of subjects will be enrolled in this trial. Nasal lavages will be performed on nasal polyp subjects, perennial allergic rhinitis subjects, and normal subjects. This project will assess the repeatability of a single sample lavage in comparison to the repeatability of a modified version, i.e. a lavage sample conducted three times, 15 minutes apart, and then pooled, or combined. We expect to find the highest eosinophil counts in patients with nasal polyposis, intermediate levels in patients with perennial allergic rhinitis and low levels in normal subjects, based on previous work.~This project will be a single-centre, randomized trial involving three sets of seven subjects - polyp subjects, perennial allergic rhinitis subjects, and normals. All subjects will be blinded to the assessment of outcome measurements.~The study will be comprised of four clinic appointments. Appointments will be scheduled seven to 10 days apart. All subjects will be randomly assigned their lavage sampling group at their baseline visit. Group one will consist of a single sample lavage at visit one, a multiple sample lavage at visit two, a single sample lavage at visit three, and a multiple sample lavage a visit four. Group two will be the reverse order. | Nasal lavage could be an integral component of assessing airway inflammation. Research into the reproducibility of cell counts is key to understanding the value of lavage results.~The objective of this study is to evaluate and compare the reproducibility of a common nasal lavage technique and its variation in a sample of subjects with nasal symptoms (e.g. runny nose, congestion, sneezing, post nasal drip), and in individuals without nasal symptoms. |
Patient safety and the prevention of medical error are primary goals of healthcare organizations. One of the means of reducing such errors is teamwork improvement. Simulation training, using advanced patient simulators, has been shown to improve diagnostic, resuscitation and technical skills amongst physicians and nurses. We intend to compare simulation training of a mixed team of physicians and nurses, using specifically designed scenarios based on real life experience, to frontal teaching sessions designed to enhance teamwork, by assessing teamwork, using accepted behavioral scales, during routine work, before and after both interventions. | The purpose of the study is to check whether training mixed teams of physicians and nurses from intensive care units on patient simulators improves teamwork within the teams. |
The success of hormonal male contraception depends on the near complete suppression of spermatogenesis without producing any untoward effects on libido or other androgen-dependent functions or any other adverse events. The treatment with androgen alone has geen shown to be highly effective in Asian men but less effective in non-Asian men in clinical trials. To increase the efficacy of androgen alone treatment on spermatogenesis, combined regimens of a progestin and an androgen have shown promising results. The steady-state delivery of a progestin and an androgen by transdermal gel application would be a user-friendly delivery method as compared to injectable or implant approaches. Nestorone (NES) is a synthetic progestin that does not have any androgenic and estrogenic activity and is not expected to have some of the undesirable side effects of other drugs.~We propose to evaluate whether NES gel alone or in combination with T gel applied transdermally will result in more effective suppression of gonadotropins than NES or T gel applied alone in healthy men. Fifty healthy male subjects, age 18-50 will be enrolled at each center (2 sites). | The purpose of this study is to determine the usefulness of two transdermal gels to be used in the future development for a male contraceptive. |
Objective 1: For children who develop graft failure following cardiac transplantation, retransplantation is often considered. While some centers have reported equivalent results for retransplantation as compared to primary transplantation, this strategy remains controversial. We seek to examine outcomes following re-transplantation in children and identify risk factors for mortality.~Objective 2: Adult African-Americans have been reported to have lower survival following heart and other solid-organ transplantation. The relationship of recipient race to survival following pediatric heart transplantation has not previously been reported.~Methods: We would like to review the United Network for Organ Sharing database. We plan on reviewing database records of heart transplantation subjects <18 years of age from 1987 to 2004. Indications for retransplantation and patient race characteristics will be collected and evaluated. Analysis will be performed using proportional hazards regression controlling for other potential risk factors. The contribution economic disparity, insurance status and HLA mismatching to disparities in outcome will also be explored. | For children who develop graft failure following cardiac transplantation, retransplantation is often considered. While some centers have reported equivalent results for retransplantation as compared to primary transplantation, this strategy remains controversial. We seek to examine outcomes following re-transplantation in children and identify risk factors for mortality. In addition, adult African-Americans have been reported to have lower survival following heart and other solid-organ transplantation. The relationship of recipient race to survival following pediatric heart transplantation has not previously been reported. |
The purpose is to determine what factors, if any, lead to delayed feeding, discharge with a NG tube, G-tube placement or Nissen fundoplication. Will review the newborn database (Lumedx as most interested in those children who have never been fed prior to their cardiac surgery. The medical charts will be reviewed at Children's Healthcare of Atlanta at Egleston Hospital. Approximately 90 charts will be reviewed for newborns undergoing surgery in the 2003 calendar year.~The factors that will be reviewed are pre-op feeding regimen, diagnosis, single vs two ventricle, open vs closed heart procedure, length of bypass, level of hypothermia, circulatory arrest, presence of TEE probe and post-op ventilation. | The purpose is to determine what factors, if any, lead to delayed feeding, discharge with a NG tube, G-tube placement or Nissen fundoplication. |
Dr. Kogon would like to do a case-report and review of the literature regarding children with the diagnosis of anomalous drainage of the inferior vena cava to the left atrium. At Children's Healthcare of Atlanta, we have seen a single patient with this diagnosis in 2004 and Dr. Kogon would like to discuss this patient in combination with the others already in the literature to see if any conclusions can be drawn about this uncommon heart defect. Currently there are about 20 cases reported in the literature and Dr. Kogon will be reporting on this one case seen in 2004.~The case report of our patient will utilize his medical chart. We hope to provide a brief summary of his clinical presentation, his radiographic evaluation, his operative findings, and his outcome. The only PHI that will be collected will be dates (i.e. date of birth, dates of procedures). | The purpose is to see if any conclusions can be drawn about the uncommon heart defect: anomalous drainage of the inferior vena cava to the left atrium. |
The MOM Program is a 3 year randomized controlled trial of mothers and newborns. At enrollment subjects are given a questionnaire to assess self efficacy and a non-verbal test of intelligence. Program personnel are blind to the results of this testing. Test results will be used in data analysis at the end of the study to compare outcomes of the intervention and control groups and to assess how mothers with impaired cognitive ability have benefited from participation in the study.The Intervention consists of frequent phone calls and home visits to encourage mothers to have their babies immunized on schedule and to participate in needed developmental and educational services. At 33 months of age all children receive a developmental assessment. | The purpose of the MOM Program is to promote child development by helping families become more competent in accessing and using available resources. The program focuses are childhood immunizations, Early Intervention services, lead screening, Early Head Start and Head Start enrollment. The hypothsis is that children receiving the intervention will participate in more of the public services and primary healthcare activities which have been shown to be effective in improving their development. |
Comparison of the uremic toxin removal by haemodialysis either with a low flux or a new high flux cellulose triacetate membrane | Comparison of the uremic toxin removal by haemodialysis either with a low flux or a new high flux cellulose triacetate membrane |
The MOM Program Continuation builds on the work of The MOM Program, a 3 year randomized intervention. The premise of the MOM Program was that professional support through home visits and frequent phone contacts would improve children's cognitive and behavioral development, ultimately improving their early educational success. The children were enrolled in the MOM Program at birth. The MOM Program Continuation provides continued intervention for the children and mothers of the original cohort to assure that the children are prepared for kindergarten entry at 5 years of age and to evaluate the children's cognitive and behavioral outcomes at age 5 years. The program will also create a longitudinal database to study the linkages between maternal cognitive ability and child cognitive, educational, and behavioral outcomes through entry into school. | The purpose of the MOM Program Continuation is to promote child development by helping families become more competent in accessing and using available health, developmental and educational resources. The program focuses are childhood immunizations, Early Intervention services, lead screening, Early Head Start and Head Start enrollment. The Intervention consists of frequent phone calls and home visits to encourage mothers to have their babies immunized on schedule and to participate in needed developmental and educational services. The program seeks to fill the gap between children's need for services and mothers' ability to assure their children's participation in those services. |
The present study will compare the prevalence of FSH receptor polymorphisms P1 and P2 in women having reduced follicle count (1 to 9 antral follicles) or normal follicle count (13 to 20 antral follicles) determined by ultrasound scans. | The deficit in the total number of antral follicles is associated with a reduction of the ovarian fertility potential in young women.~The principal objective of this study is to evaluate the relationship between FSH receptor polymorphism and antral follicle count.~The investigators have designed a study of FSH receptor polymorphisms P1 and P2 as an association with a low antral follicle count in the ovary. |
The purpose of the SYMPHONY study is to compare four different immunosuppressive regimens. They are each given for one year. The following four combinations are tested in four groups of patients:~Group A: Cyclosporine in a normal dosage, mycophenolate mofetil (MMF) and corticosteroids~Group B: Daclizumab in the first two months after transplantation, cyclosporine in a lower dosage compared to group A, mycophenolate mofetil (MMF) and corticosteroids~Group C: Daclizumab in the first two months after transplantation, tacrolimus in low dosage, mycophenolate mofetil (MMF) and corticosteroids~Group D: Daclizumab in the first two months after transplantation, sirolimus in a low dosage, mycophenolate mofetil (MMF) and corticosteroids.~All drugs of the four immunosuppressive regimes are approved by the Health Authorities in the participating country for use in kidney transplantation. The regimen administered to the patients in Group A represents a standard treatment, currently given with success to many transplant patients in a number of countries in the world. The treatments in Groups B, C and D are experimental in the sense that either the doses administered are lower than the ones used before and/or the combination of drugs is experimental. Nevertheless, there are results of scientific studies indicating that they are all effective alternatives and that they might have advantages compared to the standard immunosuppressive regimen, in particular as far as their safety (side effects, long-term toxicity) is concerned. However, from the previous clinical experience, it is not yet clear which regimen offers the most advantages for the patients. To find this out, in SYMPHONY the four regimens are administered to the four groups of patients (A-D) and the results in the different groups will be compared. | To determine the renal function, as expressed by the glomerular filtration rate at 12 months, in renal transplant recipients receiving mycophenolate mofetil, daclizumab, and corticosteroids as mainstay immunosuppression in combination with low-dose cyclosporine, tacrolimus, or sirolimus, and compare it to that of renal transplant recipients receiving standard immunosuppression with mycophenolate mofetil, normal dose cyclosporine and corticosteroids. |
Patient safety and the prevention of medical error are primary goals of healthcare organizations. Stress reduction may reduce or ameliorate such errors. Simulation training, using advanced patient simulators, has been shown to improve diagnostic, resuscitation and technical skills amongst physicians and nurses.We intend to check wether stress during ICU shifts may be reduced by using specifically designed scenarios based on real life experience,in integrative multidisciplinary ICU teams. | The purpose of the study is to check wether training mixed teams of physicians and nurses from intensive care units on patient simulators reduces stress in team members. |
In a multicenter, randomized, nonblinded clinical study, 4,089 non-insulin dependent diabetic patients were screened for glutamic acid decarboxylase autoantibodies (GADAb). Sixty GADAb-positive non-insulin requiring diabetic patients with duration of diabetes =/<5 years were assigned to either the SU group (n = 30) or the Insulin group (n = 30). Serum C-peptide response to annual oral glucose tolerance tests were followed for 57 mean months. The primary endpoint was insulin-dependency (IDDM: integrated C-peptide values [sigma C-peptide] <4 ng/ml). | We tested the hypothesis that insulin therapy rather than sulfonylurea (SU) treatment has a preferable outcome to reverse or preserve beta cell function in the patients with diabetes that is called slowly progressive insulin-dependent (type 1) diabetes (SPIDDM) or latent autoimmune diabetes in adult (LADA). |
The purpose of this study is to describe the 24-hour urine output including the urinary excretion of hormones, electrolytes and other osmotically active substances in healthy children age 0 to 3 years old. | The purpose of this study is to describe the 24-hour urine output including the urinary excretion of hormones, electrolytes and other osmotically active substances in healthy children age 0 to 3 years old. |
The purpose of this research project is to further develop and test the effectiveness of a novel exercise system for wheelchair users, the GAMECycle. People in wheelchairs who have a desire to exercise are faced with barriers with respect to access to exercise equipment and to availability of exercise equipment that is specifically suitable for use with a wheelchair. The GAMECycle exercise system removes these barriers and offers the wheelchair user an entertaining, motivational environment in which to exercise. The long-term goal is to improve the overall activity level of individuals who use wheelchairs as their primary means of mobility and increase their general well being.~The GAMECycle Exercise System is a modified arm-ergometer that sits on a turnstile to allow steering in much the same way as an arm-cycle. More specifically, it is a crank and pedal set that is turned using the arms, similar to a bicycle that is turned with the feet. When using the system, subjects will be seated in their own wheelchair in front of the system comfortably positioned to be able to grasp the handles and use the arm crank. The GAMECycle is designed to provide upper body aerobic exercise in an environment (computer game play) that will help to make exercise more enjoyable by, among other things, distracting people from some of the less pleasant aspects of exercising. Although upper-body exercise systems for wheelchair users do exist, the GAMECycle is unique in its ability to combine arm-ergometry with playing computer videogames. And, in contrast to wheelchair roller systems, the arm-ergometry provided by the GAMECycle affords the user an exercise option that uses a motion that differs significantly from the motion of wheelchair propulsion.~This research consists of two phases: a Training Phase and an In Home Trial Phase. The training phase will last a maximum of two hours and the In Home Phase will last 4 months. Subjects who complete the Training Phase will be asked to participate in the In Home Trial.~Training Phase The purpose of the training sessions are to determine the users ability to reach and maintain target aerobic training zones during 15 minute exercise trials, teach new users how to use the GAMECycle Exercise System, and to obtain feedback from new users regarding perceived comfort, fit, and ease of use.~A GAMECycle exercise system will be set up in participating local rehab and research facilities. A clinician will ensure that the GAMECycle is adjusted to fit each user. The amount of resistance from the arm-ergometer will be adjusted to a level that feels comfortable during exercise. Heart rate and breathing rate will be monitored during a 15-minute exercise session. Subjects will rate their level of exertion every 2 minutes during the 15-minute exercise phase and will be asked to complete a questionnaire about their opinion of the GAMECycle System.~In Home Phase This phase involves a 4-month trial period divided into 2 two-month sessions. For two months, subjects will be asked to use the GAMECycle and for the other two months, subjects will be asked to use an arm-ergometer. It will randomly be determined whether the GAMECycle or the arm-ergometer is used first. Subjects will be required to record their exercise sessions and will be followed by a member of the research team by telephone. In addition, once a month for four months, a member of our research staff will visit each participant with a portable metabolic cart and heart rate monitor in order to collect heart rate date, metabolic date (VO2, VCO2), and ratings of perceived exertion using the Borg scale. This data will be collected during exercise with or without game play, depending on the condition of that session. | The purpose of this research project is to further develop and test the effectiveness of a novel exercise system for wheelchair users, the Game Cycle. |
Specific Aims and Research Questions Aim 1: To compare adolescents' levels of reporting of their own reproductive health knowledge, attitudes and behaviors using three survey methodologies: (1) Face-to-face interview (2) Audio-CASI (Computer Assisted Self Interview) and (3) a culturally appropriate interactive methodology.~The following hypothesis will be tested:~• Overall, adolescents will be more likely to divulge their own reproductive knowledge, attitudes and behaviors with Audio-CASI and the interactive method as compared to face-to-face interviews. Levels of knowledge, attitudes and behaviors will vary by education, age and gender.~Aim 2: To compare respondents' levels of comfort, accuracy and honesty with the survey methodologies (i.e. face to face, audio-CASI and interactive methodology) to their reporting of knowledge, attitudes and behaviors related to sexual and reproductive health. | The goal of this study is to use three different survey methodologies to evaluate whether adolescents report on their knowledge, attitudes and behaviors on sexual and reproductive health issues differently based on the manner in which questions are asked. |
Genetic variability of various components of the coagulation system has been reported. Data on racial and gender differences in platelet aggregation are lacking.~We hypothesize that there are significant racial and gender differences on aggregatory response of platelets to commonly used agonists to evaluate platelet function such as adenosine diphosphate (ADP), epinephrine, collagen and arachidonic acid. | The purpose of this study is to see if there is a racial and/or gender difference in platelet aggregation. |
Clinical trial with direct individual profit. Study phase 2. Study center: University Hospital Grenoble Principal investigator: Pr. Serge HALIMI Sponsor: University Hospital Grenoble~The principal objective is to assess and analyze the effects of a six month programme in Adapted Physical Activity (APA) on physical activity, compliance, and insulin resistance among type 2 diabetics.~Secondary objectives are to assess and analyze the effects of a six month programme in APA of:~arterial tension~weight, body composition and abdominal perimeter~quality of life~treatment dosage~number of hospitalisation thick a diabetes complication acute for one year and for each patient Compare two exercise's intensity: first lactate threshold (SL1) and crossover (PCGL).~Inclusion criteria:~type 2 diabetics~age > 40 years~first education in Education Diabetics Department of University Hospital Grenoble~sedentary patients~HbA1c > 7%-~BMI > 25~to be affiliate disease assurance~to give consent written and inform~Judgment criteria for physical activity compliance:~leisure time physical activity: Modifiable Activity Questionnaire~training note-book~Judgment criteria for resistance insulin:~Crossover (PCGL)~HOMA and FIRI index~HbA1c~Programme test: Rehabilitation programme in Adapted Physical Activity (APA)~Programme test period: 6 months~Study total period: 28 months~Study period for each patient: 18 months~Safety criteria: clinical compendium undesirable events | The principal objective is to assess and analyze the effects of a six month programme in Adapted Physical Activity (APA) on physical activity, compliance, and insulin resistance among type 2 diabetics. |
We use CT as tools to reconstruct 3D images of portal vein and hepatic artery before and one month after operation. The images are transferred to CAD and computer simulation is performed. | This 1-year project is intended to study the hemodynamic changes of poratal and hepatic artery during living related liver transplantation. We hypothesize that after right hepatectomy for living related liver transplatation, portal vein overflow will change the remnant liver contour and result in liver hyperplasia. |
A randomized trial compared health care systems with and without IHHC. Eligible children presented to the Emergency Department of our medical center, had common acute problems, and were considered for hospital admission.~Physicians decided disposition from the emergency department. Note that subjects were not randomized directly to IHHC but to a system of care that either included IHHC or did not. To allow best use of scarce home nursing resources, we used a disproportionate selection favoring the system with IHHC.~Quality measures included adverse events, parent anxiety and satisfaction with care, family disruption, and perceived child health. | To assess the hypothesis that In Home Hospital Care (IHHC) is as safe and effective, less burdensome to families, and less expensive for care of common acute pediatric problems now managed with hospitalization. |
The purpose of this study is:~to develop a time-and-attention control condition to better assess the direct and mediational effect of PSST independent of social support (placebo);~to develop a personal digital assistant hand-held supplement to standard PSST to provide real-time training, reinforcement, and on-the-spot documentation of PSST usage;~to develop independent measures of the application of problem-solving strategies in everyday life; and~to measure utilization of and satisfaction with other resources accessed by mothers as independent indicators of the usefulness and cost-effectiveness of PSST. | The purpose of this study is to help mothers of children with cancer to cope more effectively by increasing their problem-solving skills. |
This involves estimating the impact of reduced absence due to illness on parents and their employers and estimating the value of a telehealth visit to these stakeholders. An interview instrument was developed to administer before experience with telehealth and again after a family has had experience with the program. In addition program attendance (childcare or school) records will be collected to document changes in absenteeism pre and post telehealth service implementation.~This study involves a before and after research design including both historical and concurrent controls comparing a detailed utilization of health services including telehealth visits, emergency department services and illness related office visits. Analyses will include center-level analyses of service utilization on a weekly basis pre and post as well as a child-level analyses including utilization before enrollment in a participating childcare center or school through program participation and, eventually, telehealth participation.~This is a descriptive observational study of the feasibility and acceptability of integrating telehealth service into 10 primary care pediatric practices. This study will document the integration process by maintaining a log of key communications relating to decision making (meeting minutes, memos, written agreements, protocols) and by interviewing key staff such as residents, nurse practitioners, attending physicians, staff nurses, and administrative leaders following the study period. | This study aims to take the existing model from the pilot of Telemedicine in Daycare and expand it to other suburban childcare centers and both urban and suburban elementary schools.~An assessment of the value of telehealth in the child programs will then be initiated to detail the impact of utilization and costs.~An assessment of the value of integrating telehealth into primary care practice will also be evaluated. The impact of continuity of care, well child visit rates, and immunization status will be among the various measures used in this evaluation. |