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Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore,ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure.~ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.	Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore, ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure.~ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.
Subjects will participate in a two-period, single-sequence study to assess the effects of administration of a nasal corticosteroid, Nasonex (mometasone furoate), on the pharmacokinetics, safety and tolerability of PMI-150 (intranasal ketamine HCl) in healthy adult volunteers.	To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal absorption of PMI-150 (intranasal ketamine HCl)
Forehead lift method of fixation is variable and lots of different methods have been described with different rates of success.~The comparison of to different techniques in a RCT has not been reported before.~The objective is to compare periosteum versus bone fixation in forehead lift, in a randomized, blinded, controlled, split-face trial.	To compare periosteum versus bone fixation in forehead lift.
The primary aim of this project is to study more closely the role played by post-release aftercare in the outcomes of criminal offenders who received in-prison substance abuse treatment. Prison-based therapeutic communities (TC) (Pelissier et al., 2001; Wexler, 1995) have demonstrated efficacy, especially when combined with post-release TC aftercare (Melnick et al., 2001). For example, Inciardi et al. (2003) showed that TC aftercare substantially reduced criminal behavior and significantly decreased illicit drug use when compared to outcomes for inmates who dropped out of prison TC care or graduated prison TC, but who did not enter or remain long in TC aftercare. Moreover, some released TC participants may prefer and feel that they are ready for a less-structured environment than TC aftercare.~Several important questions relevant to public health issues remain unclear in the scientific literature regarding prison TC aftercare. The answers might help establish more enlightened post-release aftercare policy affecting prison inmates. For example, it is unclear whether the main therapeutic effect of TC aftercare is TC substance abuse treatment or the supportive residential setting. Typically, TC aftercare outcomes for prison TC graduates are compared to aftercare-as-usual, which can range across a wide variety of interventions. Few if any comparison groups have included a residential setting that emphasizes socialization and abstinence from drugs and alcohol - a hallmark of TC aftercare settings. This study proposes to compare the relative effectiveness of TC aftercare to an aftercare alternative that provides a supportive living environment without the professional treatment of TC aftercare. Oxford Houses (OH) provide, like TCs, a residential post-release setting that emphasizes socialization and abstinence from drugs and alcohol, but they do not include the formal therapeutic change interventions common to TCs, nor do they include any on-site access to drug abuse or health care professionals. Such a comparison will possibly clarify the value added of TC aftercare intervention processes not present in OHs.~The aims of this project are important from a public health perspective as there may be treatment matching, case management, and financing factors that could be manipulated to enhance the cost-effectiveness of community-based substance abuse treatment for offenders leaving prison. It is possible that both TC and OH aftercare modalities increase abstinence social support, self-efficacy, and employment, which mediate reductions in drug use, reincarceration, and health problems, but overall benefits are likely to be greater for TCs because they employ professional services and empirically based behavioral strategies. However, OHs might have advantages compared to more traditional post-incarceration modalities (e.g., low costs). Bringing scientific methods to the examination of TCs and the OH community-based recovery models for addiction might help to identify the active ingredients of these recovery settings. The proposed study will utilize ex-offenders randomly assigned to either TCs, OHs, or usual care post-release settings, and examine program effects (i.e., substance use, criminal and health outcomes), and economic factors associated with these models. A research finding from a study that contrasts these different approaches has the potential to influence practice and inform policy.~Several theoretically based hypotheses include:~TCs and OHs in comparison to usual aftercare will have less substance use, less criminal recidivism, and better health outcomes. TCs are expected to have better outcomes than OHs on these measures, due to the professionally structured and inpatient nature of TC.~Factors related to the programs (i.e., abstinence social support, self-efficacy, employment) will mediate the differential outcomes. For example, due to the inpatient nature of TCs and the requirement for employment to remain in OH, OH residents are expected to have more employment and earnings during the first year. However, these differences are expected to converge at 18 and 24 months. Usual aftercare should reflect the lowest employment and earning relative to TC and OH for all time periods.~The long term post release outcomes will be moderated by gender, ethnicity, substance abuse (i.e., severity and typology), and in-prison treatment (i.e., in prison TC fidelity, days in prison TC).~Although outcomes overall are expected to be best for TC, followed by OH and usual aftercare, we expect the cost-benefit ratios to be most favorable for OH, followed by TC, with the lowest cost benefit ratio for usual aftercare.	The primary aim of this project is to study more closely the role played by post-release aftercare in the outcomes of criminal offenders who received in-prison substance abuse treatment. Prison-based therapeutic communities (TC) (Pelissier et al., 2001; Wexler, 1995) have demonstrated efficacy, especially when combined with post-release TC aftercare (Melnick et al., 2001). The aims of this project are important from a public health perspective as there may be treatment matching, case management, and financing factors that could be manipulated to enhance the cost-effectiveness of community-based substance abuse treatment for offenders leaving prison. It is possible that both TC and Oxford House(OH) aftercare modalities increase abstinence social support, self-efficacy, and employment, which mediate reductions in drug use, reincarceration, and health problems, but overall benefits are likely to be greater for TCs because they employ professional services and empirically based behavioral strategies. However, OHs might have advantages compared to more traditional post-incarceration modalities (e.g., low costs). Bringing scientific methods to the examination of TCs and the OH community-based recovery models for addiction might help to identify the active ingredients of these recovery settings.
The study design is a single arm treatment (all patients assigned to receive etravirine), open label (patients will know the identity of the treatments they are receiving) safety and antiviral activity of Etravirine (TMC125) in treatment-experienced, HIV infected children and adolescents 6 to 17 years of age. Etravirine is a new drug belonging to the NNRTI (a non-nucleoside reverse transcriptase inhibitor) drug class that slows down the growth of the human immunodeficiency virus (HIV). This drug has been tested for safety and effectiveness in adults, however, there is no data on the drug's long-term safety and antiviral activity in children and adolescents. This study will last for a maximum of 48 weeks. A total of 100 ptients will receive etravirine tablets based on body weight and an investigator selected optimized background regimen (OBR) of at least 2 antiretrovirals (ARVs), consisting of a boosted protease inhibitor (PI) and nucleoside reverse transcriptase inhibitor(s) (NRTI[s]). Use of enfuvirtide is optional. Safety will be monitored throughout the study.	The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.
This study will compare compare the effectiveness of four creams (urea 40% cream, fluocinonide 0.05% cream, tazarotene 0.1% cream, and Udderly smooth® Udder Cream) in treating hand-foot skin reaction (HFSR), a rash caused by sorafenib.	The purpose of this study is to evaluate treatments for a rash caused by sorafenib.
Tetracaine gel 4% is a topical anaesthetic gel commonly used in the UK that contains 40 mg of tetracaine base per gram. Adequate anaesthesia can usually be achieved following a 30 minute application time for venopuncture and a 45 minute application time for venous cannulation. The hypothesis is that Rapydan medicated plaster is more effective than tetracaine gel in preventing venous cannulation related pain when applied for the recommended treatment durations of 30 minutes and 45 minutes respectively. This study has been withdrawn and no additional data is available.	Tetracaine gel 4% is a topical anaesthetic gel commonly used in the UK that contains 40 mg of tetracaine base per gram. Adequate anaesthesia can usually be achieved following a 30 minute application time for venopuncture and a 45 minute application time for venous cannulation. The hypothesis is that Rapydan medicated plaster is more effective than tetracaine gel in preventing venous cannulation related pain when applied for the recommended treatment durations of 30 minutes and 45 minutes respectively.
OBJECTIVES:~Primary~To compare pain rating in cancer patients undergoing bone marrow aspiration and biopsy (BMAB) treated with magnetic acupressure at bilateral large intestine 4 (LI 4) points vs sham acupressure at bilateral proximal fourth interosseus space of the hand.~Secondary~To compare the duration of BMAB, patient's rating of the procedure, and patient's willingness to receive acupressure during subsequent BMABs.~OUTLINE: Patients are stratified according to the number of prior bone marrow aspirations and biopsies (BMAB) (0-1 vs ≥ 2) and type of procedure (bone marrow aspiration alone vs BMAB). Patients are randomized to one of two treatment arms.~Arm I (acupressure): Patients receive acupressure at bilateral large intestine 4 (LI 4) points using Haci Magnetic Acupressure Suction Cups (MASC) during BMAB.~Arm II (sham acupressure): Patients receive acupressure at bilateral proximal fourth interosseus space of the hand using the same size MASC as in arm I during BMAB.~Patients in both arms also receive analgesic and anxiolytic medications as determined by the acupressure operator and physician.~Patients complete a questionnaire before and after BMAB to assess pain experienced before and during BMAB and their attitude towards the procedure.	RATIONALE: Acupressure may help relieve pain in cancer patients undergoing bone marrow aspiration and biopsy. It is not yet known whether magnetic acupressure is more effective than sham acupressure in reducing pain in cancer patients undergoing bone marrow aspiration and biopsy.~PURPOSE: This randomized clinical trial is studying magnetic acupressure to see how well it works compared with sham acupressure in reducing pain in cancer patients undergoing bone marrow aspiration and biopsy.
The present work had as purpose to analyze estomy-individuals according to the feelings of their current situation. It is about a descriptive research of qualitative approach that took place in September, 2006. The population under study was composed by five estomy patients participants in a Grupo de Atenção dos Estomizados, which has multi-disciplinary character, at the Universidade da Região da Campanha (URCAMP) in the city of Bagé in South Brazil. The collection of data was given through not structuralized interviews and with the estomy-individuals, after the same ones read and signed the term of informed free ssent. The data form analyzed through the method of analysis of categories. Each one received a denomination with capital letters from the alphabet (A, B, D, and E) for their identification. The most significant categories in the answers from the ones being tested were manifestations and feelings of daptation, resignation and affective bond.The manifestation of anger and suffering shown by subjects D and E were only mentioned in this study, not being considered categories. The feeling shown by subjects A, B and C show an acceptance of their reality as rehabilitated from a surgical procedure, in the attempt of decreasing the psycho suffering caused by the mutilation and adaptation to the new status quo, fact which was observed for not appearing in the answers feeling such as revolt and guilty, which are mentioned in the review of literature as characteristics of subjects who suffered a surgical intervention. It is noticed that family support is a determinant fact to accept the new reality. The study contributed to know the subjectivity of the estomated, opening possibilities to improve the attention to health by the multi-professional staff.~Descriptors: Perception; emotions; Adaptation; estomia	The present work had as purpose to analyze estomy-individuals according to the feelings of their current situation.
Preterm birth occurs in 25% of women with insulin requiring diabetes in pregnancy. The administration of corticosteroid therapy to accelerate fetal lung maturation is indicated in women at risk for preterm birth. Although corticosteroid therapy significantly decreases the risk for respiratory distress syndrome in the newborn, such therapy can lead to transient elevations in maternal glucose levels, potentially resulting in life-threatening maternal metabolic abnormalities, low oxygen levels in the fetus, and in extreme cases, stillbirth. Because the elevations in glucose levels may drastically increase over a short period of time, intense monitoring of maternal glucose levels to achieve strict glycemic control and treatment is preferred with the use of insulin. The purpose of this study is to compare the timing, duration and severity of maternal hyperglycemia after corticosteroid administration in women with insulin-requiring diabetes compared to those without diabetes in pregnancy.~This is a prospective, observational study. Hourly glucose levels will be obtained for a total of 7 days after corticosteroid administration using the Dexcom Seven continuous glucose monitoring system. In addition, hemoglobin A1C will be obtained to assess the overall level of glycemic control of the participant prior to the corticosteroid therapy.~The study group will include pregnant women > 18 years of age with insulin-requiring diabetes who will receive corticosteroid therapy to accelerate fetal lung maturation between 24 and 34 weeks of pregnancy. Only those women not in active labor and with singleton gestations will be included. A control group will be comprised of pregnant women with singleton gestations without insulin-requiring diabetes who will receive corticosteroid therapy also to accelerate fetal lung maturation.~Women will be excluded if they have diet controlled diabetes, twins or higher gestation, are in active labor and anticipate imminent delivery, were previously on any form of steroid therapy, or who have or will be receiving beta-adrenergic medications.	Preterm birth occurs in 25% of women with insulin requiring diabetes in pregnancy. The administration of corticosteroid therapy to accelerate fetal lung maturation is indicated in women at risk for preterm birth. The purpose of this study is to compare the timing, duration and severity of maternal hyperglycemia after corticosteroid administration in women with insulin-requiring diabetes compared to those without diabetes in pregnancy.~This is a prospective, observational study. Hourly glucose levels will be obtained for a total of 7 days after corticosteroid administration using the Dexcom Seven continuous glucose monitoring system. In addition, hemoglobin A1C will be obtained to assess the overall level of glycemic control of the participant prior to the corticosteroid therapy.
In this study, we investigated the effect of glutamine, an amino acid, on glycemia and on GLP-1 and insulin in participants with type 2 diabetes. Preliminary data published by our group suggests that glutamine is a strong determinant of GLP-1 secretion in vitro. We tested the hypothesis that glutamine lowers postprandial blood glucose and investigated whether the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin modifies this effect.	This study investigated the effect of glutamine, an amino acid, glycemia, glucagon-like peptide-1 (GLP-1) and insulin in participants with type 2 diabetes.
Context: Patients' recruitment is difficult in clinical trials. Financial incentives are frequently proposed to clinicians in private funded trials. However, the effect of these financial incentives has never been evaluated.~Objective: to evaluate the effect of financial incentive on the rate of recruitment of patients in a cohort study.~Design: randomized controlled trial Setting: primary care Participants: physicians (GP and cardiologists) participating in the recruitment of patients in a cohort study (the COFRASA study). The COFRASA cohort study is including aortic stenosis aging patient.~Intervention:75 euros for each patient included Main outcome: percentage of physician including at least one patient at 3 months Secondary outcome: mean number of patients included at 6 months. Sample size 270 physicians	Patients' recruitment is difficult in clinical trial. Financial incentives are frequently proposed to clinicians in private funded trials. However, the effect of these financial incentives has never been evaluated.~The purpose of this study is to evaluate the effect of financial incentive on the rate of recruitment of patients in a cohort study.
This is a two week (two days baseline and two weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® and GW-2000-02 in subjects with cancer-related pain. Subjects are screened to determine eligibility and completed a two-day baseline period. Subjects then return to the centre for assessment, randomisation and dose introduction. All subjects are allowed to continue using all their current medications, provided that the dose remains stable throughout the study period. Their progress is reviewed after seven to 10 days and at the end of the study (day 14 to 20), or upon withdrawal. Subjects in this study are given the opportunity to be enrolled in an open label extension study (GWEXT0101).	The purpose of this study is to determine whether Sativex® and GW-2000-02 are effective in the management of subjects with intractable cancer-related pain.
The purpose of this protocol is to provide ongoing data collection and review of long-term outcome and late effects in a large cohort of St. Jude Children's Research Hospital autologous and allogeneic hematopoietic stem cell recipients. Central coordination of clinical and psychosocial late effects monitoring and reporting can facilitate timely communication about life-threatening or unanticipated clinical outcomes as well as significant psychological, social and behavioral sequelae effects on the recipient and their family members. The resultant data may enable researchers in their development of current clinical and psychosocial studies, as well as monitoring predisposed survivors who may benefit from preventive or corrective interventions. Physicians and researchers may be able to learn how to identify these problems earlier, to take better care of these problems, or to implement preventive measures for future transplant recipients	This protocol allows for ongoing data collection to assess the long-term clinical and psychosocial outcomes of pediatric patients who have received a hematopoietic stem cell transplant at St. Jude Children's Research Hospital.
The drug substance to be studied is a powder produced from shiitake mushroom, containing beta-glucans. The purpose of this study is to evaluate the safety of increasing doses of MM-10-001 and to determine the dose of MM-10-001 that enhances the immune system in normal healthy subjects.	The purpose of this study is to evaluate the safety of increasing doses of MM-10-001 and to determine the dose of MM-10-001 that enhances the immune system in normal healthy subjects.
The primary purpose of this study is to evaluate the patient education efficacy of the pharmacists in National Taiwan University Hospital. We designed twelve questions about reconstitution, storage, and administration of oral antibiotic suspension from powder dosage form in a questionnaire. We will recruit pediatric patients who are prescribed one of the two oral antibiotics powder for suspension, Augmentin and Zithromax. We will randomize the family of these patients into one of the following three groups:~To read the package insert of the drug~To read the education information provided by Pharmacy of NTUH~Oral education provided by the pharmacist~Then we will ask them the twelve questions in the questionnaire and record their answer. Eventually, we will be able to compare the number of the correct answer, and to evaluate the difference on patient knowledge of reconstitution, storage, and administration of oral antibiotic suspension from powder dosage form between these three groups.	The primary purpose of this study is to evaluate the patient education efficacy of the pharmacists in National Taiwan University Hospital. We randomize patient family into one of the following three groups:~To read the package insert of the drug~To read the education information provided by Pharmacy of NTUH~Oral education provided by the pharmacist~Then we will evaluate the difference on patient knowledge of reconstitution, storage, and administration of oral antibiotic suspension from powder dosage form between these three groups.
Objective:~The purpose of this study is to compare the LMA StoneBreakerTM to the current standard of pneumatic lithotripsy, the Swiss LithoClastR, during percutaneous nephrolithotripsy (PNL).~Rationale:~Percutaneous nephrolithotripsy (PNL) is the preferred treatment modality for renal stones greater than 2cm in diameter.~The pneumatic lithotriptor functions as a pneumatic jackhammer, providing either a single pulse or a train of pulses at 2Hz as determined by the operator. Its chief advantage is its ability to fragment even the hardest calculi. The pneumatic lithotriptor, while extremely effective, does not utilize thermal energy and therefore has no risk of thermal damage to the surrounding tissue. The pneumatic lithotriptor currently in use, the Swiss LithoClast is powered by compressed medical air. The primary disadvantage of this device is that the residual calculi must be individually removed with forceps following fragmentation.~The StoneBreaker, manufactured by the Laryngeal Mask Airway Company, is a novel hand-held pneumatic lithotriptor. This device is powered by a compressed carbon dioxide cartridge.~Hypothesis:~The LMA StoneBreaker, provides more efficient lithotripsy of renal calculi treated by PNL over the existing pneumatic intracorporeal lithotriptor the Swiss LithoClast.~Methods:~Patients would be recruited to the study from the clinical population who present for stone management at VGH. None of the physicians involved has a financial interest in either of the devices being evaluated. The purpose is to compare the pneumatic lithotripsy devices and is not an evaluation of PNL, a procedure whose safety and efficacy is well established.~Patients who consented to PNL for management of their renal stone would be approached about entry into the study by either of the primary surgeons, the research coordinator, or the research fellows. Patients would understand that PNL is not an experimental procedure and that the research project specifically is comparing the two lithotripsy devices with similar mechanism of action and safety profile. The goal in all cases would be to render the patient stone free. The patients care would not deviate from our standard PNL care protocol, summarized below, with the exception of the use of a different lithoclast.~Pre-operatively, the patients are assessed in the Preanaesthetic clinic as necessary. Blood tests including CBC and differential, blood type and antibody screen, creatinine and electrolytes are routinely obtained. Urine samples will be sent preoperatively for culture and sensitivity. If the urine culture is positive, organism specific antibiotics will be prescribed prior to treatment. If the urine culture is negative, prophylactic antibiotics will be ordered and administered, prior to the induction of anaesthesia, by the treating surgeon.~Our standard operative protocol for PNL as described next will be followed for all cases. After receiving a general anaesthetic, cystoscopy and placement of a ureteral catheter on the affected side may be performed. The will be used to perform retrograde pyelography in order to determine the optimal access site to the kidney. A Foley catheter will be placed to drain the bladder throughout the procedure. Next, under fluoroscopic guidance, access to the affected renal collecting system will be obtained with a needle down which a guide wire is passed by the interventional radiology department or the operating surgeon.~The tract will be dilated to accommodate the 30F working sheath. The stone will then be visualized and fragmented with either of the two devices, determined by randomization. Remaining fragments will be removed using grasping forceps and an ultrasound suction device until the patient is rendered stone free. A final visual inspection of the collecting system will ensure the patient is stone free. The choice of renal drainage method after the procedure will be left to the discretion of the treating surgeon.~Statistical Analysis: Student's t-test and ANOVA will be used to determine statistical significance. P-values < 0.05 will be considered significant.	The purpose of this study is to compare the LMA StoneBreakerTM to the current standard of pneumatic lithotripsy, the Swiss LithoClastR, during percutaneous nephrolithotripsy (PNL).
The objectives of this study are:~Evaluate the role of sciatic nerve block in total knee replacement. There is conflicting data as to whether sciatic nerve block would provide significant analgesic benefit in addition to femoral nerve block and the usual multimodal and preemptive analgesic regimen for TKA.~Investigate the efficacy of single-shot sciatic nerve block on early rehabilitation, functional recovery and patient satisfaction.~Evaluate the previously described technique of local anesthetic infiltration into the posterior capsule/fat pad of the knee as an alternative technique to sciatic nerve block in providing analgesia to the posterior aspect of the knee in this select group of patients.~Investigate the efficacy of local anesthetic infiltration into the posterior capsule/fat pad of the knee on early rehabilitation, functional recovery and patient satisfaction.~Study Design:~All patients will have a femoral nerve block (FNB) and spinal anesthesia.~Patients will be randomized into one of the 3 possible groups:~Group 1: Femoral nerve block + Sciatic nerve block + Spinal anesthesia + Infiltration of normal saline at the end of surgery~Group 2: Femoral nerve block + Sham Sciatic nerve block + Spinal anesthesia + Infiltration of local anesthetic at the end of surgery.~Group 3: Femoral nerve block + Sham Sciatic nerve block + Spinal anesthesia. + Infiltration of normal saline at the end of surgery.~In summary, this study will help further define the role of sciatic nerve block as well as the alternative technique of local anesthetic infiltration in the perioperative analgesic regimen of total knee arthroplasty surgery, in an effort to develop a standardized perioperative protocol for this patient population. The advent of this protocol should allow reduced risk, improved analgesia, and potentially earlier discharged from hospital with better function.	Many methods of pain relief have been implemented in an attempt to provide safe and effective analgesia for patients following total knee arthroplasty. Numerous studies have demonstrated that nerve blocks can provide superior pain control and reduce side effects. There are two major nerves that provide sensation to the knee: the femoral nerve provides sensation to the front of the knee and sciatic nerve provides sensation to the back of the knee. Putting local anesthetic close to these nerves provides superior pain control. The literature has supported the use of femoral nerve block for analgesia as well as improved functional outcome after total knee arthroplasty. The purpose of this study is to see if the same is true for sciatic nerve block for the back of the knee. We also would like to study an alternative approach to make the back of the knee pain free. This involves injecting local anesthetic directly into this area at the end of your surgery.Patients will be randomized into 3 groups: sciatic block, posterior infiltration of local anesthetic and placebo.This study will help further define the role of sciatic nerve block as well as the alternative technique of local anesthetic infiltration in the perioperative analgesic regimen of total knee arthroplasty surgery, in an effort to develop a standardized perioperative protocol for this patient population. The advent of this protocol should allow reduced risk, improved analgesia, and potentially earlier discharged from hospital with better function.
There are numerous studies that report on the quality of life in solid organ transplant recipients. However, very few studies target quality of life parameters for these children and their families across all solid organ transplantation. Furthermore, no literature directly addresses a comparison of perceptions and wellness, impact on family, and vulnerability in a comparative format by these distinct, but definitely related populations.~The goal of this study is to compare parent and child perceptions of wellness and vulnerability in children who have undergone solid organ transplant. It is hypothesized that there will be significant differences between parent and child perceptions. Outcomes will be measured by using five different instruments:~Pediatric Quality of Life Inventory (PedsQL)~PedsQL Family Impact Module~PedsQL Family Information Form~Functional Status II-R~Child Vulnerability Scale (CVS)~Patients will be enrolled at the time of transplant listing, or after transplant. Patients and families will complete the survey once every 6 months while the patient is active on the respective transplant waiting list. After transplant, the patients and families will be asked to complete the survey once every 6 months for the first two years and annually thereafter.~This study may provide us with an improved understanding of parent and child perceptions in wellness, impact on family, and vulnerability within each transplant group. The results may also indicate trend differences between these three populations. These differences may help to provide insight into family perspectives allowing for greater anticipatory guidance and targeted interventions.	The goal of this study is to compare parent and child perceptions of wellness and vulnerability in children who have undergone solid organ transplant. It is hypothesized that there will be significant differences between parent and child perceptions.
We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium handling, renal hemodynamics, tubular function and vasoactive hormones in healthy humans during normal and high sodium intake.~We wanted to analyze if changes in renal hemodynamics, tubular function, hormones, blood pressure and HR under acute treatment with atorvastatin depends on sodium intake.	We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium handling, renal hemodynamics, tubular function and vasoactive hormones in healthy humans during normal and high sodium intake.
Trial design~Phase II, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the clinical efficacy and safety of alfuzosin (10mg, qd) from baseline to 8 weeks of treatment in female patients with non-neurogenic voiding dysfunction.~Efficacy Assessment~Primary efficacy endpoint~Actual change in the score of IPSS from baseline to 8 weeks of treatment.~Secondary efficacy endpoint~IPSS parameters~Percent change in the score of IPSS from baseline to 4 and 8 weeks of treatment.~Actual and percent changes in the sub-scale of IPSS from baseline to 4 and 8 weeks of treatment~Storage score: sum of questions 2, 4 and 7~Voiding score: sum of questions 1, 3, 5 and 6~Scored form of the Bristol Female Lower Urinary Tract Symptoms (BFLUTS-SF)parameters~Actual and Percent change in BFLUTS-SF from baseline to 4 and 8 weeks of treatment.~Actual and percent changes in the sub-scale of BFLUTS-SF from baseline to 4 and 8 weeks of treatment~BFLUTS-FS: sum scores F1-F4~BFLUTS-VS: sum scores V1-V3~BFLUTS-IS: sum scores I1-I5~BFLUTS-sex: sum scores S1 & S2~Uroflowmetry & PVR parameters~Numeric and percent changes from baseline to 4 and 8 weeks of treatment.~Maximum flow rate (mL/s)~Average flow rate (mL/s)~Post-void residual urine (mL)~Micturition diary parameters~Change in mean number of micturitions per 24 hours at weeks 4 and 8 relative to baseline~Percent change of micturitions per 24 hours at weeks 4 and 8 relative to baseline~Change in mean number of nighttime micturitions per 24 hours at weeks 4 and 8 relative to baseline~Percent change of nighttime micturitions per 24 hours at weeks 4 and 8 relative to baseline~Change in mean number of urgency episodes per 24 hours at weeks 4 and 8 relative to baseline (Urgency episodes are defined as those with Bladder Sensation Scale rating of ≥ 3 in the diary).~Percent change of urgency episodes per 24 hours at weeks 4 and 8 relative to baseline~Change in the mean and sum rating on the Bladder Sensation Scale at weeks 4 and 8 relative to baseline~Quality of life (QoL) parameters~Change in Bother score of IPSS from baseline to 4 and 8 weeks of treatment.~Change in QOL subscale scores of BFLUTS SF from baseline to 4 and 8 weeks of treatment~BFLUTS-QoL: Sum scores QoL1-QoL5~Patient Perception of Bladder Condition (PPBC)~Change from baseline in PPBC after 8 weeks of double-blind treatment~Benefit, Satisfaction, and Willingness to Continue (BSW) Questions~Patient Perception of Treatment Benefit at week 8~Patient Perception of Treatment Satisfaction at week 8~Willingness to continue with treatment at week 8	The purpose of this study is to explore the efficacy of Alfuzosin (10 mg, qd) in reducing the score of International Prostate Symptom Score (IPSS) from baseline to 8 weeks of treatment in female patients with voiding dysfunction.
This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the clinical safety and effectiveness (healing rates) of the OP Device to that of traditional bone autografts to repair nonunions.	This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the healing rates of the OP Device to that of autograft.
Treatment of chronic pain typically relies on the effectiveness of opioid analgesics, however, side effects and the potential for users to develop tolerance and addiction may make physicians hesitant to prescribe them. The development of opioid analgesics with fewer side effects and decreased potential tolerance and addiction would increase the ability to safely and effectively treat pain. This study will determine whether the addition of an ultra-low dose of naloxone, an opioid antagonist, to buprenorphine, an opioid analgesic pain medication, increases the analgesic potency and reduces side effects compared to buprenorphine alone. Low doses of naloxone added to buprenorphine have been shown to increase the potency and reduce the side effects of buprenorphine in animal studies and in a human study with healthy volunteers. The current study aims to extend these findings by assessing the analgesic potency and side effects of a 15:1 ratio of buprenorphine to naloxone in a sample of 12 outpatient participants with moderate pain (4 or greater pain intensity) who are experienced with opioid analgesics. Participants will be randomly assigned to begin blinded treatment starting with one of two medication regimens: IV buprenorphine + ultra-low-dose naloxone or IV buprenorphine alone. Participants receive 5 daily doses of medication (no more than 2 days between each dose) followed by crossover to the opposite treatment condition for 5 additional daily doses. Each study day, participants will provide a daily pain assessment, receive administration of study medication, and will then be monitored and assessed for pain and side effects over the next six hours. Outcomes for the study include: (1) pain intensity as measured using the Brief Pain Inventory, pain intensity numerical rating scale, and the Beck Depression Inventory, and (2) self-reported side effects/adverse events. After completion of study participation, participants will resume pre-study pain treatments with their own physician.	This study compares two medications for analgesic potency and side effects in a sample of individuals with moderate pain. After screening, eligible participants will be randomly assigned to begin blinded treatment with one of two medications. Participants receive 5 daily doses of medication (no more than 2 days between each dose) followed by crossover to the opposite treatment condition for 5 additional daily doses. Each study day, participants will provide a daily pain assessment, receive administration of study medication, and will then be monitored and assessed for pain and side effects over 6 hours.
The HPV vaccine offers hope that the incidence of cervical cancer can be greatly reduced in the U.S. and globally. However, because the vaccine is recommended for children and early adolescents, vaccine awareness and acceptance among parents is critical to insuring vaccine uptake and public health benefit. Although culturally specific concerns may reduce HPV vaccination among African-American youth, research has not addressed this possibility. Accordingly, the proposed study will enroll 300 mothers in a study to identify barriers to HPV vaccination among low-income, African-American teens. Surveys assessing culturally-specific barriers to HPV vaccination acceptance will be administered to both parents and their vaccine-eligible children. Upon completion of the survey, parents with vaccine-eligible daughters will be invited to receive a free HPV vaccination for their child through a local, teen-friendly health clinic. Outcome analyses will focus on identification of predictors of completed vaccinations among girls and barriers to vaccine acceptance among mothers of teenage sons. Our study will provide critically important behavioral outcome data linking barriers to vaccination to subsequent vaccination decisions in a real-world, health care setting.	This will enroll 300 mothers of teenage girls and boys to identify barriers to HPV vaccination among low-income, African-American teens.
OBJECTIVES: To develop, assess feasibility, and test the validity of the Resident Supervision Index (RSI), a survey tool for medical residents designed to measure quantitatively the level of supervision the resident received while caring for an outpatient during a patient care encounter.~RESEARCH DESIGN: This is a prospective trial assessing the Residency Supervision Index (Index) applied to outpatient care encounters for test-retest reliability and construct validity.~METHODOLOGY: Trained interviewers administered the Index during face-to-face and in-clinic interviews with 60 consenting resident physicians and their 37 consenting attending physicians to descsribe the care they provided to 143 patients at the outpatient clinics involving 148 clinical encounters at the Loma Linda VA Medical Center.~For each encounter, data comes from administering the Resident Supervision Index to the resident and attending. Baseline data describing each subject (attending physicians and resident physicians) came from face-to-face interviews.~Test-retest reliability is assessed by re-administering the Index to residents for within 24 hours of the encounter. Concurrent validity is assessed by re-administering the Index to the attending physician responsible for the patient's care.~CLINICAL RELATIONSHIPS: The study will help our understanding of how residents at VA medical centers receive training and are supervised for the purpose of both education and patient outcomes.~IMPACT/SIGNIFICANCE: The instrument is planned for future studies to assess the association between resident supervision and training outcomes, clinical workload, patient outcomes, quality of care, and care costs.	OBJECTIVES: To develop, assess feasibility, and test the validity of the Resident Supervision Index (RSI), a survey tool for medical residents designed to measure quantitatively the level of supervision the resident received while caring for an outpatient during a patient care encounter.~RESEARCH DESIGN: This is a prospective trial assessing the Residency Supervision Index (Index) applied to outpatient care encounters for content validity, test-retest reliability, and construct validity.
The purpose of this study is to evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing primary unilateral total knee arthroplasty	Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing total knee replacement
The WHO estimates that half the children in the world are exposed to secondhand smoke. Despite recent smoke free legislation across the country, an estimated 22 percent of children are still exposed in their home environments. These children have increased rates of lower respiratory illnesses, middle ear effusion, asthma, reduced lung function and SIDS. This study aims to evaluate the effectiveness of using a structured tobacco cessation education program, CEASE (Clinical Effort against Secondhand Smoke Exposure), delivered by pediatric residents in the outpatient continuity clinic of a pediatric residency program in reducing the exposure of infants to secondhand smoke. It will also evaluate the efficacy of using a secondhand smoke biomarker, urine cotinine level measurement and feedback as an adjunct to counseling.~Residents(and faculty) whose continuity clinic will be doing the intervention will be receiving tailored training on CEASE NY. The control continuity residents and faculty will receive no additional training. Pre and Post test questionnaires will be administered to all residents of both continuity clinics to test effectiveness of the teaching intervention and use of cotinine level on knowledge and practice. Consecutive newborns with a history of smoking in their home will be recruited into the study ( 22 in each group) when they first establish care ( between days 3 and 15), using a screening question on the nurses portion of the well child form. The study coordinator will obtain consent for participation from those screening positive for smoking in the home. Once consent is obtained the newborns will be randomly assigned to either intervention or control group by the study coordinator. The intervention group will be assigned to a CEASE trained resident for follow-up continuity care. The controls will be assigned to a non- CEASE trained resident for follow-up care. The study coordinator will log the date, agreement/non-agreement to participate, and who the caregiver is (parent vs. other) and to what group they have been assigned, giving them a unique study number. To account for the possibility of dropout, we will recruit 22 infants into each group. Baseline urine samples will be obtained for both groups. The intervention group will receive specific CEASE materials (see attached) and counseling at 2, 4, 6, month well child visits and urine for cotinine will be obtained at 4 and 9 months. Intervention parents will be given feedback on the urine cotinine levels at the next well child visit. The control group will receive no intervention at 2, 4, 6 months. A urine cotinine level will be obtained and a follow-up questionnaire will be given at the 9 month visit to both group parents evaluating their readiness to quit/cut down smoking and their subjective perception of the efficacy of resident counseling.~Baseline urine samples will be obtained for both groups. The intervention group will receive specific CEASE materials (see attached) and counseling at 2, 4, 6, month well child visits and urine for cotinine will be obtained at 4 and 9 months. Intervention parents will be given feedback on the urine cotinine levels at the next well child visit. Control Group will receive no intervention at 2, 4, 6 months. A urine cotinine level will be obtained and a follow-up questionnaire will be given at the 9 month visit to both group parents evaluating their readiness to quit/cut down smoking and their subjective perception of the efficacy of resident counseling. All children will receive a small age-appropriate toy at the 12 month well child check as a thank you for participating in the study	This is a pilot study that aims to~Evaluate the effectiveness of using a structured tobacco cessation education program, CEASE (Clinical effort against second hand smoke exposure), NY, delivered by pediatric residents in the outpatient continuity clinic of the pediatric residency program in reducing the exposure of infants to second hand smoke.~Evaluate the efficacy of using a second hand smoke exposure biomarker, Urine cotinine level measurement and feedback as an adjunct to counseling.
The purpose of this study is to evaluate the efficacy, safety, and tolerability of a single intraoperative dose of 4975 in patients undergoing primary unilateral total hip arthroplasty	Evaluate the efficacy, safety and tolerability of a single intraoperative dose of 4975 in patients undergoing total hip replacement
Induction of labor in term pregnancy may be challenging, especially in patients with unfavorable cervical conditions. Numerous trails have presented evidence of the efficacy of the trans cervical Foley catheter for pre-induction cervical ripening.The purpose of the present study is to evaluate the possible benefit of concurrent IV Oxytocin infusion with trans cervical Foley catheter for pre-induction cervical ripening.	The purpose of the present study is to evaluate the possible benefit of concurrent IV Oxytocin infusion with trans cervical Foley catheter for pre-induction cervical ripening.
The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of Lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose administered under fed conditions.~Fifty-four healthy, light/non/or ex-smoking, non-obese, male volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two Lovastatin dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive a standardized high-fat, high-calorie meal 30 minutes before drug administration. Thirty minutes after the start of the breakfast, a single oral dose of either the test formulation, Lovastatin (1 x 40 mg tablet), or a single oral dose of the reference formulation, Mevacor® (1 x 40 mg tablet) will be administered. After a 7 day washout period, on the morning of Day 8, following an overnight fast of at least 10 hours and 30 minutes after the start of a standardized high-fat, high-calorie meal, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of Lovastatin. Blood sampling will then continue on a non-confined basis at 36 and 48 hours post-dose. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Vital signs will be monitored if judged necessary by the physician in charge. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.	The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of Lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose administered under fed conditions.
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under fasting conditions. Thirty-two non-smoking, non-obese, healthy male and female volunteers between the ages of 18 and 55 will be randomly assigned in a crossover fashion to receive each of two cilostazol dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of the test formulation, cilostazol (1 x 100 mg tablet), or a single oral dose of the reference formulation, Pletal® (1 x 100 mg tablet). After a 7 day washout period on the morning of Day 8, following an overnight fast of at least 10 hours, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of cilostazol. Blood sampling will then continue on a non-confined basis at 36 and 48 hours post-dose. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and pulse will be measured before dosing and at 3 and 24 hours post-dose. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.	The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under fasting conditions.
The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available reference drug product Ambien® (zolpidem tartrate tablets) in adult subjects under fasted conditions.~Thirty-eight healthy, non-smoking, non-obese male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two zolpidem tartrate dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of the test formulation, zolpidem tartrate (1 x 10 mg tablet) or a single oral dose of the reference formulation, Ambien® (1 x 10 mg tablet). After a 7 day washout period, on the morning of Day 8 after an overnight fast, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 12 hours post dose at times sufficient to adequately define the pharmacokinetics of zolpidem tartrate. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drugs and/or procedures. Blood pressure and pulse rate will be obtained prior to dosing and at 0.5, 1, 2, 4 and 12 hours post-dose. All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.	The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available reference drug product Ambien® (zolpidem tartrate tablets) in adult subjects under fasted conditions.
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of zonisamide capsules to an equivalent dose of a reference formulation, Zonegran® (zonisamide) capsules, after a single oral dose administered under fasting conditions.~Thirty-four healthy, non-smoking, non-obese male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two zonisamide dosing regimens in sequence with a 28 day washout period between dosing periods. On the morning of Day 1, after an overnight fast, subjects will receive either a single oral dose of the test formulation, zonisamide (1 x 100 mg capsule) or a single oral dose of the reference formulation, Zonegran® (1 x 100 mg capsule). After a 28 day washout period, on the morning of Day 29 after an overnight fast, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 72 hours post dose at times sufficient to adequately define the pharmacokinetics of zonisamide. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and heart rate will be obtained prior to dosing and as scheduled following dose administration. All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.	The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of zonisamide capsules to an equivalent dose of a reference formulation, Zonegran® (zonisamide) capsules, after a single oral dose administered under fasting conditions.
The purpose of this study is to compare the bioequivalence of a test formulation of primidone tablets to an equivalent oral dose of the commercially available Mysoline® (primidone tablets) in adult subjects under fasting conditions.~Twenty-two healthy, non-smoking, non-obese male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two primidone dosing regimens in sequence with a 14 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of the test formulation, primidone (1 x 50 mg tablet) or a single oral dose of the reference formulation, Mysoline® (1 x 50 mg tablet). After a 14 day washout period, on the morning of Day 15 after an overnight fast, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 72 hours post dose at times sufficient to adequately define the pharmacokinetics of primidone. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drugs and/or procedures. Blood pressure and heart rate will be obtained prior to dosing and at 3, 4, 6, 24 and 72 hours post-dose. All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.	The purpose of this study is to compare the bioequivalence of a test formulation of primidone tablets to an equivalent oral dose of the commercially available Mysoline®(primidone tablets) in adult subjects under fasting conditions.
The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose administered under fasting conditions.~Fifty-four healthy, light/non/or ex-smoking, non-obese, male volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two lovastatin dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of the test formulation, lovastatin (1 x 40 mg tablet), or a single oral dose of the reference formulation, Mevacor® (1 x 40 mg tablet). After a 7 day washout period on the morning of Day 8, following an overnight fast of at least 10 hours, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of lovastatin. Blood sampling will then continue on a non-confined basis at 36 and 48 hours post-dose. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Vital signs will be monitored if judged necessary by the physician in charge. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.	The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose administered under fasting conditions.
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under fasting conditions. Thirty-two non-smoking, non-obese, healthy male and female volunteers between the ages of 18 and 55 will be randomly assigned in a crossover fashion to receive each of two cilostazol dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of the test formulation, cilostazol (2 x 50 mg tablets), or a single oral dose of the reference formulation, Pletal® (2 x 50 mg tablets). After a 7 day washout period on the morning of Day 8, following an overnight fast of at least 10 hours, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of cilostazol. Blood sampling will then continue on a non-confined basis at 36 and 48 hours post-dose. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and pulse will be measured before dosing and at 3 and 24 hours post-dose. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.	The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under fasting conditions.
Recent reports indicate that hormone therapy (HT) may have a protective effect on the aging brain. Although previous studies have examined the effects of HT on age-related cognitive changes, there is little information on the effect of a new class of estrogenic agents, selective estrogen receptor modulators (SERMs), on cognitive aging. The two most commonly prescribed SERMs are tamoxifen, for treatment and prevention of breast cancer, and raloxifene, for maintaining bone density. In the face of potential widespread use of SERMs in healthy women, information on the effects of these agents on memory and other cognitive functions is essential.~The principal goals of Co-STAR are to compare the effects of tamoxifen and raloxifene~on age-associated declines in measures of verbal and nonverbal memory in women over age 65~other cognitive abilities and mood~with those resulting from more common forms of HT, specifically ET (conjugated equine estrogen) and ET plus progesterone~Co-STAR results will be compared to results from the Women's Health Initiative Study of Cognitive Aging (WHISCA), a study involving 6-year longitudinal assessment of cognitive outcomes in 2969 women randomly assigned to receive active treatment (Premarin or Premarin plus medroxyprogesterone acetate) or placebo. A comparison of the Co-STAR treatment groups with the group of WHISCA participants receiving placebo will provide insights into the effects of SERMs relative to no treatment. A comparison of the Co-STAR treatment groups with WHISCA treatment groups receiving ET or ET plus progesterone will provide insights into the effects of SERMs relative to common HT treatments.~Co-STAR participants will be recruited from The National Cancer Institute's (NCI) Study of Tamoxifen and Raloxifene (STAR) NCT00003906, a multi-center, 5-year, randomized clinical trial among 22,000 women at increased risk for breast cancer, to compare the effects of tamoxifen and raloxifene on risk for breast cancer.	The purpose of this study is to assess the effects of tamoxifen and raloxifene on cognitive aging in selected cognitively-healthy women.
The purpose of this study is to evaluate the relative bioavailability (rate and extent of absorption) of a test formulation of zonisamide capsules compared to the reference formulation, Zonegran® (zonisamide)capsules, after a single oral dose administered under non-fasting conditions.~Thirty-four healthy, non-smoking, non-obese male and female volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two zonisamide dosing regimens in sequence with a 28 day washout period between dosing periods. On the morning of Day 1, 30 minutes after initiation of a standardized, high-fat breakfast, subjects will receive either a single oral dose of the test formulation, zonisamide (1 x 100 mg capsule) or a single oral dose of the reference formulation, Zonegran® (1 x 100 mg capsule). After a 28 day washout period, on the morning of Day 29, 30 minutes after initiation of a standardized, high-fat breakfast, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 72 hours post dose at times sufficient to adequately define the pharmacokinetics of zonisamide. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Blood pressure and heart rate will be obtained prior to dosing and as scheduled following dose administration. All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.	The purpose of this study is to evaluate the relative bioavailability (rate and extent of absorption) of a test formulation of zonisamide capsules compared to the reference formulation, Zonegran® (zonisamide)capsules, after a single oral dose administered under non-fasting conditions.
An endotracheal tube, which is used to secure the airway and allow ventilation of the lungs during general anesthesia, is inserted into the trachea either through the nose or mouth. In children, different formulae exist to determine the approximate size of the tube according to age, and how far it should be advanced into the airway. Once a tracheal tube is inserted, its position is routinely checked to make sure both lungs are ventilated. To prevent displacement, the tube is taped to the lip, chin or at the nose. However, head movement could cause alteration of the tube position, and risk selective endobronchial intubation or inadvertent extubation. Knowledge of how the different tracheal tubes move with head position can help determine the best tube selection to reduce the risk of accidental tube advancement or removal, in cases where certain head positions are required for surgical access.~The aim of this study is to assess the accuracy of the formulae commonly used in our institution for depth of breathing tube placement, and to measure the degree of tube displacement on head movement with different types of tube. Testing the formulae will enable us to be more aware of how frequently inaccurate tube placement may occur. Knowledge of how the different breathing tubes move with head position can help determine the best tube selection to reduce the risk of the tube going in too far or coming out accidentally, for cases were certain head positions are required for surgery.	A breathing tube, which is used to secure the airway and allow ventilation of the lungs during general anaesthesia, is inserted into the windpipe either through the nose or mouth. In children, different formulas exist to determine the appropriate size of the tube according to age, and how far it should be advanced into the airway. Head movement can alter the position of the breathing tube, making it go in or come out too far. Different types of breathing tubes may also differ in their change of position with head movement. The aim of this study is to assess the accuracy of the formulae commonly used in our institution for depth of breathing tube placement, and to measure the degree of tube displacement on head movement with different types of tubes.
The primary objective of this study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to signing consent. Secondary objectives included but were not limited to: assessing the success or failure to achieve abstinence (confirmed by at least two methamphetaminenegative urines and no methamphetamine-positive urines) each week during the last two weeks (Weeks 11 and 12) for subjects using methamphetamine 18 or less days during the 30 days prior to signing consent, assessing the safety of bupropion in this study population, assessing other measures of efficacy of bupropion in reducing methamphetamine use or craving, and other psychological assessments of methamphetamine dependence.~It is hypothesized that bupropion, compared to placebo, would be associated with an increase in the proportion of subjects who achieved abstinence (confirmed by at least two methamphetamine-negative urines and no methamphetaminepositive urines) each week during the last two weeks (Weeks 11 and 12) for non-daily users.	This study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to the start of signing consent.